On August 5, 2020 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported it has entered into an exclusive worldwide license agreement with Mirati Therapeutics, Inc. (Nasdaq: MRTX), a leading targeted oncology company dedicated to advancing novel therapeutics (Press release, ORIC Pharmaceuticals, AUG 5, 2020, View Source [SID1234562914]). ORIC will have exclusive worldwide rights for the development activities and commercialization of a small molecule allosteric inhibitor program directed towards the polycomb repressive complex 2 (PRC2), a validated oncogenic target across several cancers with promising therapeutic potential in prostate cancer, among other indications.

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"We are excited to add another program to our pipeline that is well aligned with our mission of overcoming cancer resistance and our expertise in hormone-dependent cancers, key tumor dependencies and precision oncology," said Jacob Chacko, M.D., president and chief executive officer of ORIC. "Our lead program, ORIC-101, and the rest of our innovative, wholly-owned pipeline of precision medicines have thus far been internally generated by our fully integrated drug discovery and development team. This PRC2 inhibitor is the first externally sourced program we’ve added to our pipeline and, based on work conducted at ORIC, we believe Mirati’s novel approach in targeting PRC2 may address an area of significant unmet medical need in treatment-resistant prostate cancer."

"We are pleased to enter into this agreement with ORIC, which enables the continued advancement of Mirati’s PRC2 inhibitors" said James G. Christensen, Ph.D., executive vice president and chief scientific officer of Mirati. "With ORIC’s focus on novel treatments for prostate cancer, ORIC is an ideal partner to further the research and development of this program."

Mirati has developed highly selective allosteric inhibitors of PRC2, including a lead candidate now designated as ORIC-944, that target its regulatory embryonic ectoderm development (EED) subunit and may represent a best-in-class approach for the treatment of advanced prostate cancer. Prior to entering into the license agreement with Mirati, ORIC generated compelling in vivo efficacy data in enzalutamide-resistant prostate cancer models with ORIC-944. ORIC expects to file an IND for ORIC-944 in the second half of 2021.

Under the terms of the agreement, in exchange for an exclusive worldwide license to develop and commercialize Mirati’s PRC2 inhibitor program, ORIC paid to Mirati a one-time non-cash payment of $20 million in shares of ORIC common stock. The number of shares issued to Mirati was based on a price of $34.00 per share, representing a premium of 10% to the 60-day trailing volume-weighted average trading price of ORIC’s common stock. ORIC is not subject to any future milestone or royalty payment obligations to Mirati.

Webcast and Conference Call

ORIC will host a webcast and conference call today, August 5th, at 4:30 p.m. ET. To participate in the conference call, please dial (866) 393-4306 (domestic) or (734) 385-2616 (international) and refer to conference ID: 5167646. Please join the conference call at least 15 minutes early to register. A live webcast will be available in the Investors section of the company’s website at www.oricpharma.com. The webcast will be archived for 60 days following the presentation.

About PRC2

The polycomb repressive complex 2 (PRC2) has methyltransferase activity required for long term epigenetic silencing of chromatin and plays a critical role in cancer. PRC2 core subunits EED, EZH2, and SUZ12 function as part of a complex to selectively repress gene expression by regulating the transfer of methyl groups to a distinct lysine residue on histone proteins associated with DNA. Overexpression and/or mutations in PRC2 can result in aberrant methylation activity, leading to tumorigenesis in multiple solid tumors and hematological malignancies. In particular, PRC2 dysfunction can lead to decreased expression of tumor suppressor genes and other target genes that have been associated with poor prognosis in patients with metastatic prostate cancer.

First-generation PRC2 inhibitors, which target the catalytic EZH2 subunit, have demonstrated clinical activity in several cancers, and one has been approved by the FDA for the treatment of epithelioid sarcoma and follicular lymphoma. More recent scientific advances have focused on developing allosteric inhibitors of PRC2, which may help to address several limitations of first-generation PRC2 inhibitors. Research conducted at ORIC demonstrated that allosteric inhibitors of PRC2 are more efficacious in treatment-resistant prostate cancer models than has been reported by traditional non-allosteric PRC2 inhibitors.

On August 5, 2020 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported the company will present at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Wednesday, August 12, 2020, at 1:45 p.m. ET/10:45 a.m. PT (Press release, Alpine Immune Sciences, AUG 5, 2020, View Source [SID1234562913]).

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A live webcast of the presentation will be available online in the investor relations section of the company’s website at View Source A replay of the presentation will be available on the company website for 90 days following the webcast.

On August 5, 2020 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best–in-class treatments to address some of the most important unmet patient needs, reported financial results for the three and six months ended June 30, 2020 and highlighted recent corporate updates (Press release, Heron Therapeutics, AUG 5, 2020, View Source [SID1234562912]).

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Recent Corporate Updates

Pain Management Franchise

Positive CHMP Opinion Received for ZYNRELEF for the Management of Postoperative Pain: In July 2020, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for ZYNRELEF (formerly known as HTX-011), intended for the treatment of postoperative pain. The CHMP’s positive opinion will now be reviewed by the European Commission (EC), with a final decision on the Marketing Authorisation Application expected in the coming months. An EC marketing authorisation through the centralized procedure is valid in all 27 European Union (EU) member countries as well as the European Economic Area countries. The CHMP recommended that ZYNRELEF be indicated for treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults.

Complete Response Letter Received from the FDA Regarding the NDA for HTX-011 for the Management of Postoperative Pain: In June 2020, Heron received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for HTX-011. The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional non-clinical information. Based on the complete review of the NDA, the FDA did not identify any clinical safety or efficacy issues or chemistry, manufacturing and controls (CMC) issues. There are four non-clinical issues in the CRL, none of which relate to any observed toxicity. Three relate to confirming exposure of excipients in preclinical reproductive toxicology studies, and the fourth relates to changing the manufacturing release specification of the allowable level of an impurity based on animal toxicology coverage. We do not believe that any of the issues are significant barriers to ultimate approval, as all of the excipients have extensive histories of use in pharmaceuticals and the specification can be revised.

Initiation of Phase 1b/2 Clinical Study of HTX-034 for the Treatment of Postoperative Pain: In May 2020, Heron initiated a Phase 1b/2 clinical study in patients undergoing bunionectomy of HTX-034, Heron’s next-generation product for the treatment of postoperative pain. The study initiation followed clearance from the FDA of Heron’s Investigational New Drug (IND) application for HTX-034 for the treatment of postoperative pain.
CINV Franchise

Initiation of Phase 2 Clinical Study of CINVANTI for the Treatment of COVID-19: In July 2020, Heron initiated the GUARDS-1 Study, a Phase 2 clinical study evaluating CINVANTI (aprepitant) injectable emulsion in early hospitalized patients with Coronavirus Disease 2019 (COVID-19). The study initiation followed clearance from the FDA of Heron’s IND application for CINVANTI for the treatment of COVID-19.

CINV Net Product Sales: For the three and six months ended June 30, 2020, chemotherapy–induced nausea and vomiting (CINV) franchise net product sales were $22.7 million and $48.1 million, respectively, compared to $36.7 million and $68.3 million, respectively, for the same periods in 2019.

CINVANTI Net Product Sales: Net product sales of CINVANTI for the three and six months ended June 30, 2020 were $22.6 million and $47.8 million, respectively, compared to $33.2 million and $61.2 million, respectively, for the same periods in 2019. Heron expects the impact of the generic arbitrage to be resolved in 2020, with a return to growth in 2021 and beyond.

SUSTOL Net Product Sales: Net product sales of SUSTOL (granisetron) extended–release injection for the three and six months ended June 30, 2020 were $0.1 million and $0.3 million, respectively, compared to $3.5 million and $7.1 million, respectively, for the same periods in 2019. On October 1, 2019, the Company discontinued all discounting of SUSTOL, which resulted in significantly lower SUSTOL net product sales. Heron expects SUSTOL to return to growth in 2021 and beyond.

2020 Net Product Sales Guidance: Although Heron anticipates a decrease in new diagnoses and chemotherapy patient starts because of the onging COVID-19 pandemic, the Company is maintaining its 2020 guidance for net product sales for the CINV franchise of $70 million to $80 million.
"We are pleased with the CHMP’s recent positive opinion for ZYNRELEF in the EU, and we remain committed to bringing this important non-opioid analgesic to patients in the U.S. as soon as possible. We have submitted a request for a Type A meeting with the FDA and look forward to working with the FDA to achieve this goal," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron. "In our CINV franchise, we are encouraged by the continued performance of CINVANTI during both a generic arbitrage period and the COVID-19 pandemic and are maintaining our 2020 net product sales guidance of $70 million to $80 million."

Financial Results

Net product sales for the three and six months ended June 30, 2020 were $22.7 million and $48.1 million, respectively, compared to $36.7 million and $68.3 million, respectively, for the same periods in 2019.

Heron’s net loss for the three and six months ended June 30, 2020 was $55.2 million and $106.8 million, or $0.61 per share and $1.18 per share, respectively, compared to $50.2 million and $113.2 million, or $0.63 per share and $1.43 per share, respectively, for the same periods in 2019. Net loss for the three and six months ended June 30, 2020 included non-cash, stock-based compensation expense of $11.1 million and $23.1 million, respectively, compared to $12.7 million and $30.6 million, respectively, for the same periods in 2019.

As of June 30, 2020, Heron had cash, cash equivalents and short-term investments of $300.8 million, compared to $391.0 million as of December 31, 2019. Net cash used for operating activities for the six months ended June 30, 2020 was $90.2 million, compared to $72.1 million for the same period in 2019. Heron expects that its current cash, cash equivalents and short-term investments will be sufficient to fund its operations into 2022.

About HTX-011 (ZYNRELEF in the European Union) for Postoperative Pain

HTX-011 (ZYNRELEF in the European Union), an investigational non-opioid analgesic, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. HTX-011 was granted Fast Track designation from the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. Heron submitted a new drug application (NDA) to the FDA for HTX-011 in October 2018 and received Priority Review designation in December 2018. A complete response letter (CRL) was received from the FDA regarding the NDA for HTX-011 on June 26, 2020 relating to non–clinical information. No clinical safety or efficacy issues and no chemistry, manufacturing and controls (CMC) issues were identified. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for ZYNRELEF in July 2020. Heron’s New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was granted Priority Review status by Health Canada in October 2019 and accepted by Health Canada in November 2019. Heron is working to respond to a list of questions received from Health Canada in July 2020.

About CINVANTI (Aprepitant) Injectable Emulsion

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist (RA). CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the United States prescribing information for CINVANTI is a 30-minute IV infusion or a 2-minute IV injection.

CINVANTI is under investigation for the treatment of COVID-19 as a daily 2-minute IV injection when added to the current standard of care.

Please see full prescribing information at www.CINVANTI.com.

About SUSTOL (Granisetron) Extended-Release Injection

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy).

Please see full prescribing information at www.SUSTOL.com.

About HTX-034 for Postoperative Pain

HTX-034, an investigational non-opioid, is a fixed-dose combination, extended–release solution of the local anesthetic bupivacaine, the nonsteroidal anti-inflammatory drug meloxicam and an additional agent that further potentiates the activity of bupivacaine. HTX-034 is formulated in the same proprietary polymer as HTX-011. By combining two different mechanisms that each enhance the activity of the local anesthetic bupivacaine, HTX-034 is designed to provide superior and prolonged analgesia. Local administration of HTX-034 in a validated preclinical postoperative pain model resulted in sustained analgesia for 7 days.

On August 5, 2020 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that management will participate in a fireside chat at the Canaccord Genuity 40th Annual Growth Conference on Wednesday, August 12, 2020 at 8:00 a.m. ET (Press release, Bicycle Therapeutics, AUG 5, 2020, View Source [SID1234562911]). The conference will be held in a virtual meeting format.

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A live webcast of the fireside chat will be accessible in the Investors & Media section of Bicycle’s website at www.bicycletherapeutics.com. An archived replay of the webcast will be available for 90 days following the fireside chat date.

On August 5, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported results for the second quarter and first half of 2020 (Press release, MorphoSys, AUG 5, 2020, View Source [SID1234562910]).

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Financial Results for the First Half of 2020

Group revenue increased to €269.7 million (H1 2019: €48.2 million), mainly driven by the upfront payment from the Incyte collaboration in Q1 2020
EBIT thus reached €163.5 million (H1 2019: €-29.3 million)
Liquidity position of €1.06 billion at end of Q2 2020 (December 31, 2019: €357.4 million)
Financial guidance for 2020 (excluding Monjuvi(R) contribution) confirmed: Group revenues of €280 to €290 million, R&D expenses of €130 to €140 million, EBIT of €-15 to €5 million

Highlights Second Quarter 2020 and beyond

Proprietary Development
– Monjuvi(R) (Tafasitamab-cxix)

FDA approves Monjuvi(R) (tafasitamab-cxix) 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
Validation of 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
Long-term follow-up results from ongoing L-MIND study in r/r DLBCL confirm previously reported results
First-MIND study in newly diagnosed DLBCL patients is on track, as are plans to start a pivotal study in this patient population in early 2021
Presentation of tafasitamab data at virtual annual meetings of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper)
– Felzartamab (MOR202)

I-Mab: First phase 3 patient in mainland China treated in relapsed or refractory multiple myeloma
MorphoSys: Recruitment of patients for the M-PLACE study with felzartamab in membranous nephropathy, which has been temporarily paused due to the COVID-19 pandemic, has been resumed. The first patient was dosed on July 27, 2020
– Otilimab (MOR103/GSK3196165)

GSK started a clinical trial (OSCAR) to evaluate the efficacy and safety of otilimab in patients with severe pulmonary COVID-19-associated disease

Partnered Discovery
– Janssen: FDA approval of Tremfya(R) (guselkumab) as a treatment for adult patients living with active psoriatic arthritis (PsA)

– 15th antibody from Novartis collaboration entered clinical development

Roland Wandeler, Ph.D., appointed to MorphoSys’ Management Board, effective May 5, 2020, in his function as today’s Chief Operating Officer leading global commercial operations and overseeing the Company’s U.S. operations

Re-election of Wendy Johnson, Dr. George Golumbeski and Michael Brosnan to MorphoSys’ Supervisory Board by the Company’s Annual General Meeting on May 27, 2020

Update on the Impact of the Global COVID-19 Pandemic:

MorphoSys recognizes the impact of the global COVID-19 pandemic on healthcare systems and society worldwide, as well as the resulting potential impact on preclinical and clinical programs, especially clinical trials. In addition to the steps already communicated to mitigate the impact of the pandemic on MorphoSys’ employees, patients and the broader community, further measures may need to be implemented in the future. MorphoSys will take various factors into consideration, including potential adaptation of clinical trials due to restrictions on visits to healthcare facilities, increased demands on healthcare services and changes in the availability of study personnel. MorphoSys continuously monitors the situation and takes appropriate decisions on a case-by-case basis to ensure the safety of patients, study personnel and other stakeholders as well as to safeguard data integrity.
MorphoSys and Incyte are prepared for the successful commercial launch of Monjuvi(R) (tafasitamab-cxix), following its FDA approval on July 31, 2020. Despite the uncertainty caused by the COVID-19 pandemic in the United States, the commercial and medical teams of both companies are well-prepared for the launch of Monjuvi(R), using a combination of virtual engagement tools.
Patient enrollment for all ongoing tafasitamab studies continues as planned. However, a delay cannot be excluded due to the factors mentioned above.
Recruitment of patients for the M-PLACE study with felzartamab, which had been temporarily paused due to the COVID-19 pandemic, has been resumed.
"We are all very proud that Monjuvi(R) received FDA approval as a combination therapy with lenalidomide," commented Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "This accelerated approval is an important milestone, not only for MorphoSys, but also for patients battling relapsed or refractory diffuse large B-cell lymphoma, as Monjuvi(R) is the first FDA-approved second-line therapy for adult patients with DLBCL. The approval not only marks an important transformational step for MorphoSys into an integrated biopharmaceutical company but also provides a significant value creation opportunity for all our stakeholders."

"We are very excited with the accelerated approval of Monjuvi(R) by the FDA," added Jens Holstein, Chief Financial Officer of MorphoSys. "MorphoSys is well prepared for its next step as an integrated biopharmaceutical company given our strong financial position. We, together with our partner Incyte, will drive forward the launch of Monjuvi(R) in the United States."

Financial Review for Q2 2020 (IFRS)

Group revenues for the second quarter of 2020 amounted to €18.4 million (Q2 2019: €34.7 million). The revenues include success-based payments of €12.8 million, primarily from Janssen (Q2 2019 success-based payments: €32.4 million, including a milestone payment from GSK of €22.0 million).

In the Proprietary Development segment, MorphoSys researches and develops its own drug candidates for cancer and inflammation. In Q2 2020, this segment recorded revenues of €5.0 million (Q2 2019: €25.9 million). The decline primarily reflects the €22.0 million milestone payment from GSK which was booked in the same time period of last year.

In the Partnered Discovery segment, MorphoSys applies its proprietary technology to discover new drug candidates for pharmaceutical companies and thus participates in its partners’ development advancements through research and development (R&D) funding, licensing fees, success-based milestone payments and royalties. Revenues in the Partnered Discovery segment climbed to €13.4 million in Q2 2020 from €8.7 million in Q2 2019.

Total operating expenses increased to €-66.8 million from €-40.3 million in the same time period last year, due to the expenditure in relation to the preparations for the anticipated Monjuvi(R) U.S. commercialization as well as the further expansion of MorphoSys US Inc. Cost of sales amounted to €+7.2 million versus €-4.9 million in the same quarter of 2019, while R&D expenses rose to €-30.9 million as compared to €-24.7 million in Q2 2019. Selling expenses in Q2 2020 increased to €-29.3 million (Q2 2019: €-3.2 million) and general and administrative expenses to €-13.8 million (Q2 2019: €-7.5 million). The increase of the two latter was primarily driven by higher personnel expenses and expenses for external services in association with the preparation for the Monjuvi(R) launch. Selling expenses also comprised expenses for services rendered by Incyte in connection with the joint US activities.

Earnings before interest and taxes (EBIT) for the Group amounted to €-50.1 million in Q2 2020 versus €-5.7 million in Q2 of the previous year. The Proprietary Development segment reported an EBIT of €-51.3 million (Q2 2019: €-7.0 million), while Partnered Discovery segment delivered an EBIT of €11.1 million (Q2 2019: €6.3 million). The consolidated net loss was €-53.1 million (Q2 2019: €-5.9 million). Basic earnings per share were €-1.62 compared to €-0.19 in Q2 2019.

On June 30, 2020, the Group’s liquidity position amounted to €1,061.8 million.This liquidity position is reported on the balance sheet under the items "cash and cash equivalents", "financial assets at fair value through profit or loss", and current and non-current "other financial assets at amortized cost".

The number of shares issued totaled 32,890,046 at the end of Q2 2020 (year-end 2019: 31,957,958).

Results for the First Half 2020 (IFRS)

During the first half of 2020, Group revenues soared to €269.7 million from €48.2 million in the first half of last year. The increase was primarily driven by the collaboration and licensing agreement with Incyte in the first quarter of this year to further develop and commercialize tafasitamab globally. Research and development expenses amounted to €-52.4 million versus €-49.3 million in the same time period last year. The EBIT rose to €163.5 million, compared to €-29.3 million in H1 2019.

Financial Guidance and Operational Outlook for 2020

For the financial year 2020, MorphoSys confirmed its financial guidance. Management continues to expect Group revenues in the range of €280 to €290 million, R&D expenses of €130 to €140 million and EBIT of €-15 to €5 million. This guidance is based on constant currency exchange rates and does not include any contributions from Monjuvi(R) revenues and any effects from potential in-licensing or co-development deals for new development candidates. The operational and financial guidance might potentially be impacted by the ongoing global COVID-19 crisis on MorphoSys’ business operations including but not limited to the Company’s supply chain, clinical trial conduct, as well as timelines for regulatory and commercial execution. While MorphoSys is maintaining its previously communicated guidance on its clinical trials, these could potentially be affected in terms of patient enrollment and data collection timelines, among other factors.

Ongoing Trials and Other Highlights

Proprietary Development
– Monjuvi(R) (Tafasitamab-cxix)

Launch of Monjuvi(R) (tafasitamab-cxix) using a combination of virtual engagement tools to address customer needs and to grow connectivity with customers, following Monjuvi(R)’s FDA approval on July 31, 2020. Monjuvi(R)is expected to be available commercially shortly
Continue phase 1b study First-MIND in previously untreated DLBCL
Continue pivotal phase 3 trial evaluating tafasitamab plus bendamustine in r/r DLBCL in comparison to rituximab and bendamustine (B-MIND trial)
Continue phase 2 COSMOS trial of tafasitamab with idelalisib and venetoclax in CLL/SLL
Expansion of tafasitamab’s clinical development beyond DLBCL under the collaboration and licensing agreement with Incyte

– Felzartamab (MOR202)

I-Mab: Continue pivotal development program with felzartamab in multiple myeloma in the Chinese region
MorphoSys: Continue clinical development of felzartamab in membranous nephropathy; recruitment of patients in the M-PLACE study was resumed after having been temporarily paused due to COVID-19. The first patient was dosed on July 27, 2020
– Otilimab (MOR103/GSK3196165)

GSK to continue clinical phase 3 development program with otilimab in rheumatoid arthritis

Partnered Discovery
– Tremfya(R) (Guselkumab)

Janssen is currently conducting a series of clinical studies with Tremfya(R) (guselkumab) in various indications, some of which could generate data during 2020. In 2019, Janssen submitted marketing authorization applications to the U.S. FDA and EMA for Tremfya(R) for the treatment of psoriatic arthritis. On July 14, 2020, Janssen reported the approval of Tremfya(R) as a treatment for adult patients with active psoriatic arthritis by the U.S. FDA. A decision on the EMA application could potentially also be made in 2020.
– Other partnered programs

Publication of clinical data and achievement of regulatory milestones from other partnered programs may occur during 2020. Whether, when and to what extent news will be published following the primary completion of trials in the Partnered Discovery segment is at the full discretion of MorphoSys’ partners.
MorphoSys will continue to support its proprietary development activities by evaluating potential in-licensing, co-development, acquisition opportunities or the potential initiation of new proprietary development programs with the goal of maintaining and expanding the Company’s position in its current therapeutic and technological fields of activities.

MorphoSys continues its expansion of strategic presence of MorphoSys US Inc.

Percentage point

** Tremfya(R) is still considered as a clinical program due to ongoing studies in various indications.

*** Including otilimab (MOR103/GSK3196165), which is fully out-licensed to GSK.

MorphoSys will hold its conference call and webcast tomorrow, August 6, 2020, to present the second quarter and first half financial results 2020 and the further outlook for 2020.

Dial-in number for the analyst conference call (in English) at 2:00pm CEST; 1:00pm BST; 8:00am EDT:

Germany: +49 69 201 744 220
For UK residents: +44 203 009 2470
For US residents: +1 877 423 0830
(all numbers reachable from any geography)

Participant PIN: 43014391#

Please dial in 10 minutes before the beginning of the conference.

A live webcast and slides will be made available at www.morphosys.com.

Approximately two hours after the call, a slide-synchronized audio replay of the conference and a transcript of the prepared remarks will be available on www.morphosys.com.