On May 6, 2020 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, reported a corporate and financial update for the first quarter ended March 31, 2020 (Press release, G1 Therapeutics, MAY 6, 2020, View Source [SID1234557133]).

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"We have activated business continuity plans in response to the COVID-19 pandemic to ensure we can advance therapies that patients with cancer, their families, and healthcare providers are counting on to improve outcomes, and also taken actions to safeguard the well-being of our employees," said Mark Velleca, M.D., Ph.D., Chief Executive Officer. "We are on track to complete a New Drug Application filing for trilaciclib for patients with small cell lung cancer this quarter, and have initiated virtual medical education programs as we prepare for commercial launch in the U.S. We remain committed to evaluating the benefits of trilaciclib in other indications and expect to initiate the I SPY-2 breast cancer trial this quarter and a pivotal trial in colorectal cancer in the fourth quarter of 2020. Cancer patients experiencing chemotherapy-induced myelosuppression are an especially vulnerable population, and trilaciclib has the potential to be the first proactively administered myelopreservation therapy for these patients."

First Quarter Regulatory, Clinical and Corporate Highlights

NDA submission for trilaciclib in small cell lung cancer (SCLC) expected in 2Q20. A rolling NDA submission to the U.S. Food and Drug Administration (FDA) began in the fourth quarter of 2019 and is expected to be completed this quarter.

Pivotal trial of trilaciclib in colorectal cancer expected to begin in 4Q20. In 2Q20, the company discussed the design of a registrational clinical trial of trilaciclib in colorectal cancer with the FDA at a pre-Phase 3 meeting. The trial is on track to begin in the fourth quarter of 2020.

I-SPY 2 neoadjuvant breast cancer trial including trilaciclib on track for 2Q20 initiation. Trilaciclib was selected for inclusion in the ongoing Phase 2 I-SPY 2 TRIAL based on compelling overall survival (OS) findings in a Phase 2 triple-negative breast cancer (TNBC) trial (press release here). The I-SPY trial will generate data across a range of breast cancer subtypes that will allow the company to evaluate trilaciclib in combination with several broadly-used chemotherapy classes and an anti-PD-1 immunotherapy.

Initiation of rintodestrant and Ibrance combination trial on track for 2Q20. The company previously announced preliminary safety, tolerability and efficacy data on rintodestrant, its oral selective estrogen receptor degrader (SERD) (press release here) as monotherapy treatment for ER+, HER2- breast cancer. Based on these findings, G1 plans to initiate an additional arm of its ongoing Phase 1/2a trial in the second quarter of 2020 to explore the combination regimen of rintodestrant and the CDK4/6 inhibitor Ibrance (palbociclib). Palbociclib will be provided by Pfizer Inc. under a non-exclusive clinical supply agreement.

Soma Gupta named as Chief Commercial Officer. In March, the company appointed Soma Gupta as its Chief Commercial Officer (CCO) with responsibility for leading commercial preparations for the launch of trilaciclib in the U.S. Ms. Gupta and her team are focused on developing a patient access strategy that illustrates the value that trilaciclib can provide to patients and the healthcare system. Prior to joining G1, Ms. Gupta led the global commercial launch of Vyndaqel (tafamidis meglumine) while serving as Vice President, Global Marketing for Amyloidosis and Cardiac Rare Disease at Pfizer Inc. Previously, she led the global commercial team responsible for Pfizer’s oncology portfolio, including Ibrance (palbociclib).

Changes to the Board of Directors. In March, the company named Jack Bailey to its board of directors. Mr. Bailey most recently served as President – U.S. at GlaxoSmithKline (GSK) and is a past member of the board of directors of Pharmaceutical Research and Manufacturers of America (PhRMA). Sir Andrew Witty, who joined the G1 board in July 2017, has retired from this position. Sir Andrew recently took a leave of absence from his current role as president, UnitedHealth Group and CEO of Optum to co-lead the World Health Organization (WHO) COVID-19 vaccine program.

"On behalf of our shareholders and associates, I want to thank Sir Andrew for his many contributions to G1. He has provided valuable insights and counsel, particularly related to patient access and the global reimbursement landscape," said Dr. Velleca. "We commend him for applying his considerable talents and experience to the WHO COVID-19 vaccine initiative."

COVID-19 impact on operations. The company has implemented business continuity plans to address the COVID-19 pandemic and minimize disruptions on ongoing operations. The timeline for filing the trilaciclib NDA has not been impacted by COVID-19, and the company expects to complete the NDA submission in the second quarter of 2020. Initiation of two clinical trials, the rintodestrant/palbociclib combination trial and the I-SPY 2 trial, is on track to begin in 2Q20. Initial enrollment of these trials is likely to be impacted by COVID-19. The company does not anticipate significant supply chain delays or shortages as a result of the COVID-19 pandemic.

First Quarter 2020 Financial Highlights and 2020 Guidance

Cash Position: Cash and cash equivalents totaled $242.4 million as of March 31, 2020, compared to $269.2 million as of December 31, 2019.

Operating Expenses: Operating expenses were $31.8 million for the first quarter of 2020, compared to $25.9 million for the first quarter of 2019. GAAP operating expenses include stock-based compensation expense of $4.7 million for the first quarter of 2020, compared to $3.8 million for the first quarter of 2019.

Research and Development Expenses: Research and development (R&D) expenses for the first quarter of 2020 were $20.4 million, compared to $18.1 million for the first quarter of 2019. The increase in R&D expenses was primarily due to an increase in clinical program costs, costs for manufacturing pharmaceutical active ingredients, and personnel costs due to additional headcount.

General and Administrative Expenses: General and administrative (G&A) expenses for the first quarter of 2020 were $11.4 million, compared to $7.8 million for the first quarter of 2019. The increase in G&A expenses was largely due to an increase in compensation due to additional headcount, increase in pre-commercialization activities, increase in medical affairs costs, and an increase in professional fees and other administrative costs necessary to support our operations.

Net Loss: G1 reported a net loss of $31.0 million for the first quarter of 2020, compared to $24.0 million for the first quarter of 2019.

2020 Guidance: The company is reiterating its previous financial guidance and expects to end 2020 with $110-$130 million in cash and cash equivalents, prior to the consideration of potential proceeds from partnerships, collaboration activities, and/or other sources of capital. The company expects current cash and cash equivalents to be sufficient to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2021.

Key Anticipated 2020 Milestones

Complete NDA submission for trilaciclib in SCLC in 2Q20.

Initiate I-SPY 2 clinical trial of trilaciclib in neoadjuvant breast cancer in 2Q20.

Initiate additional arm of rintodestrant Phase 1/2a trial to evaluate combination with Ibrance (palbociclib) in 2Q20; additional Phase 1/2a monotherapy data expected in 4Q20.

Initiate Phase 3 clinical trial of trilaciclib in colorectal cancer in 4Q20.

Webcast and Conference Call

The management team will host a webcast and conference call at 4:30 p.m. ET today to provide a corporate and financial update for the first quarter 2020 ended March 31, 2020. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 5669692. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

On May 6, 2020 Veracyte, Inc. (Nasdaq: VCYT) reported financial results for the first quarter ended March 31, 2020 and provided an update on recent business progress (Press release, Veracyte, MAY 6, 2020, View Source [SID1234557132]).

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"Despite late-quarter challenges from the COVID-19 pandemic, we delivered solid results for the first quarter of 2020, with strong revenue and volume growth across our genomic testing business. We continued to strengthen our position for long-term success by advancing our pipeline and solidifying our infrastructure for global expansion. We also established a new biopharmaceutical partnership in lymphoma, our newest clinical indication, and made strong progress with all of our biopharmaceutical collaborations," said Bonnie Anderson, chairman and chief executive officer of Veracyte.

"While we anticipate impact to our business from the pandemic through 2020, we believe we are well-positioned to emerge strong over the long term due to the fundamental strength and diversification of our business, as well as our strong cash position. Moreover, we believe our focus on improving diagnosis and treatment decisions for patients with cancer and lung disease, while reducing unnecessary procedures, aligns with the needs of our healthcare system."

First Quarter 2020 Financial Results

For the first quarter of 2020, as compared with the first quarter of 2019:

Total Testing and Product Revenue was $30.4 million, an increase of 20%; including biopharmaceutical revenue, total revenue was $31.1 million, an increase of 5%;
Gross Margin was 61%, which included a $1.1 million write-down of supplies;
Operating Expenses, Excluding Cost of Revenue, were $31.1 million, an increase of 35%;
Net Loss and Comprehensive Loss was $(11.7) million, versus $(1.9) million;
Basic and Diluted Net Loss Per Common Share was $(0.24), versus $(0.05);
Net Cash Used in Operating Activities was $5.3 million, versus $1.0 million; and
Cash and Cash Equivalents were $153.1 million at March 31, 2020.
COVID-19 Impact and Recent Events

As previously announced, Veracyte’s business was impacted by the COVID-19 pandemic and the company observed genomic testing volume decline in the second half of March and through April, where it experienced an over-50 percent volume decline during the month compared to prior year. In response to this unprecedented challenge, the company took the following steps to reduce costs:

Veracyte’s chairman and chief executive officer reduced her base pay and target bonus by 25% until the company resumes normal operations.
Veracyte’s board of directors, executive leaders and certain other employees took a reduction in pay until the company resumes normal operations.
Approximately 60 employees were put on a temporary furlough with a goal of bringing them back from furlough once the company’s business rebounds. Veracyte will continue at this time to provide furloughed employees certain benefits including covering employee healthcare contributions during the furlough. In addition, Veracyte terminated a small number of employees.
Instituted a temporary hiring freeze.
Secured vendor discounts and halted all nonessential outside spending.
First Quarter 2020 and Recent Business Highlights

Core Diagnostics Business:

Grew total genomic test volume (Afirma, Percepta and Envisia) by 15% to 10,559 tests.
Launched "More About You," a national campaign to help patients navigate the work-up of thyroid nodules and ask for Afirma testing by name.
Announced that data accepted for oral presentation at the ENDO 2020 conference identified novel or rare gene fusions that are included in the newly expanded Afirma Xpression Atlas and may potentially be targeted with drugs that are approved or under development.
Reported new data published in npj Breast Cancer, which suggest potential growth opportunities for the Prosignatest in global markets where the test reports intrinsic breast cancer subtypes. Additionally, data published in Clinical Breast Cancer suggest the Prosigna test’s ability to provide significant prognostic information beyond clinicopathologic factors in patients with invasive lobular breast cancer, a major breast cancer histopathologic subtype.
Strategic Collaborations and Pipeline Advancement:

Secured an exclusive licensing and research agreement with Yale University to advance the first genomic monitoring test for idiopathic pulmonary fibrosis prognosis, complementing our Envisia classifier for improved early diagnosis of the disease. The non-invasive, blood-based test was developed for use on our nCounter diagnostic platform.
Signed an exclusive licensing agreement with Boston University for technology that will help advance development of the first-ever, non-invasive nasal swab test for lung cancer early detection.
Announced a multi-year collaboration with Acerta Pharma, the hematology research and development arm of AstraZeneca plc, to provide genomic information that will support the biopharmaceutical company’s development of oncology therapeutics in lymphoma.
Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 5:00 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

On May 6, 2020 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company generated revenue of $347.8 million for the first quarter ended Mar. 31, 2020, compared to $162.0 million for the same period of 2019 (Press release, Exact Sciences, MAY 6, 2020, View Source [SID1234557131]).

"Even in unprecedented times, cancer doesn’t stop. The coronavirus pandemic highlights and increases the need for novel ways to screen for cancer, detect it early, and guide treatment. Our Cologuard, Oncotype DX, and Paradigm tests meet that need," said Kevin Conroy, chairman and CEO. "In a world that is trying to avoid unnecessary physician office visits, invasive procedures, and treatments, our tests and deep pipeline are more valuable now than ever. We plan to play an even greater role in cancer screening and guiding therapy decisions after the coronavirus pandemic abates."

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First Quarter 2020 Financial Results

For the three-month period ended March 31, 2020, as compared to the same period of 2019 (where applicable):

Total revenue was $347.8 million, compared to $162.0 million

Screening revenue was $219.5 million, an increase of 35 percent

Precision Oncology revenue was $128.4 million

Gross margin including amortization of acquired intangible assets was 71 percent, and non-GAAP gross margin excluding amortization of acquired intangible assets was 77 percent

Net loss was $105.7 million, or $0.71 per share, compared to a net loss of $82.9 million, or $0.66 per share

EBITDA was $(51.0) million and adjusted EBITDA was $(8.2) million

Non-cash interest expense related to convertible debt was $22.5 million, which included a non-cash loss on extinguishment of debt of $8.0 million, compared to $19.6 million, which included a non-cash loss on extinguishment of debt of $10.6 million

Cash, cash equivalents, and marketable securities were $1.2 billion at the end of the quarter, including $975.5 million, net, raised in relation to the issuance of new convertible notes and the repayment of a portion of previously issued convertible notes

Screening includes laboratory service revenue from Cologuard and revenue from Biomatrica products. Precision Oncology includes laboratory service revenue from global Oncotype DX products and the recent Paradigm acquisition.

Non-GAAP Disclosure
In addition to the company’s financial results determined in accordance with U.S. GAAP, the company provides non-GAAP measures that it determines to be useful in evaluating its operating performance. The company presents EBITDA, adjusted EBITDA, as well as non-GAAP gross margin and non-GAAP gross profit. EBITDA and adjusted EBITDA consist of net loss after adjustment for those items shown in the table below. The company defines non-GAAP gross profit and non-GAAP gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of acquisition-related intangible assets used in the calculation of non-GAAP gross profit and non-GAAP gross margin pertain only to the amortization associated with developed technology acquired and recorded through purchase accounting transactions. The amortization of these intangible assets will recur in future periods until such intangible assets have

been fully amortized. The company believes that these non-GAAP measures are useful in evaluating the company’s operating performance. The company uses this non-GAAP financial information to evaluate ongoing operations and for internal planning and forecasting purposes. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For example, non-GAAP gross margin and non-GAAP gross profit exclude the amortization of acquired intangible assets although such measures include the revenue associated with the acquisitions. For a reconciliation of these non-GAAP measures to GAAP, see below "EBITDA and Adjusted EBITDA Reconciliations."

First Quarter Conference Call & Webcast
Company management will host a conference call and webcast on Wednesday, May 6, 2020, at 5 p.m. ET to discuss first quarter 2020 results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 833-235-7650 and international callers should dial +1-647-689-4171.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 7874149. The webcast, conference call and replay are open to all interested parties.

About Cologuard
Cologuard was approved by the FDA in August 2014, and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use Cologuard if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. Cologuard is not a replacement for colonoscopy in high risk patients. Cologuard performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. Cologuard performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again.

Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx only.

About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention, and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Exact Sciences. With more than 1 million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.

On May 6, 2020 MorphoSys (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported the results for the first quarter of 2020 (Press release, MorphoSys, MAY 6, 2020, View Source [SID1234557130]).

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Financial Highlights

Group revenue in the first quarter of 2020 increased to €251.2 million (Q1 2019: €13.5 million), mainly driven by the upfront payment from the Incyte collaboration.
EBIT increased to €213.6 million (Q1 2019: €-23.6 million).
At the end of the first quarter of 2020, MorphoSys has a liquidity position of €1.1 billion (December 31, 2019: €357.4 million).
Financial guidance for 2020 re-affirmed (Group revenues €280 to €290 million, R&D expenses €130 to €140 million, EBIT €-15 to €5 million).

Corporate and Program Updates

Tafasitamab (MOR208);
Collaboration and licensing agreement with Incyte to further develop and commercialize tafasitamab globally
Priority Review for BLA submission granted by U.S. FDA for tafasitamab in combination with lenalidomide for relapsed/refractory diffuse large B cell lymphoma (r/r DLBCL)
Expanded Access Program (EAP) for tafasitamab in the U.S. initiated
MOR202: First phase 3 patient in mainland China treated in multiple myeloma
Roland Wandeler, Ph.D., appointed Chief Commercial Officer and member of the MorphoSys AG Management Board to lead global commercial operations and oversee the Company’s U.S. operations with its planned launch of tafasitamab
In April 2020, MorphoSys decided not to exercise its exclusive option granted under the agreement with Vivoryon Therapeutics, signed in July 2019, to license Vivoryon’s small molecule QPCTL inhibitors in the field of oncology. This decision was based on the thorough analysis of data from preclinical validation studies. MorphoSys owns a minority stake in Vivoryon Therapeutics that is based on an equity investment in 2019

Update on Impact of the Global COVID-19 Pandemic:

MorphoSys acknowledges the impact of the global COVID-19 pandemic on health systems and broader society worldwide and the resulting potential impact on preclinical and clinical programs and in particular on clinical trials. Beyond the previously communicated measures to mitigate the impact of the pandemic on MorphoSys’ employees, patients and the broader community, additional measures may need to be implemented in the future, including potential adjustments to clinical trials due to factors including restrictions of visits to healthcare facilities, increased demands on the health services and changes to trial staff availability. Consequently, MorphoSys is continuously monitoring the situation and deciding how to proceed in its clinical trials on a "trial-by-trial" and "country-by-country" basis to ensure patient and site personnel safety and data integrity
Despite the uncertainty caused by the COVID-19 pandemic in the US, launch preparations continue including through digital channels to ensure launch readiness of MorphoSys and Incyte should tafasitamab be approved on or before its PDUFA date of August 30, 2020
Enrollment of patients in all tafasitamab related clinical trials is currently expected to continue as planned, but the above-mentioned restrictions might lead to future delays in timelines
Enrollment/screening of patients in the M-PLACE study for MOR202 has been temporarily paused
"Despite the ongoing global COVID-19 pandemic, we have made significant progress during the first quarter of 2020. MorphoSys had another strong quarter of execution across the entire organization. We completed hiring and onboarding of our sales force, switched to virtual interactions with the medical community to overcome travel restrictions and have been able to further raise the awareness of our company," commented Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "With our partnership with Incyte and having been granted Priority Review by the FDA, we are continuously working towards bringing our lead product candidate tafasitamab to patients needing new therapeutic options. We are excited that Dr. Roland Wandeler has joined our leadership team as Chief Commercial Officer with a strong track record of growing businesses internationally. During these challenging times, the safety and well-being of our employees and patients continue to be our top priority and we remain committed to taking every necessary precaution to help reduce the spread of the virus and to break the cycle of infection."

"The Company is continuously gearing up for the upcoming launch of tafasitamab, if approved by the FDA. With a strong financial position and together with our partner Incyte, we are well positioned for the next chapter of the Company’s development," added Jens Holstein, Chief Financial Officer of MorphoSys. "The first quarter was positively impacted by the upfront payment from our partnership with Incyte, which was cleared by the antitrust authorities. In addition, as part of the collaboration agreement, Incyte also purchased ~2.8% of MorphoSys registered share capital in American Depositary Shares (ADSs) at a price of $41.32 per ADS."

Financial Review for Q1 2020 (IFRS)

In Q1 2020, MorphoSys continued to focus on applying its proprietary technology and expertise to the research and development of innovative drug candidates, both for partners and for its own account. Group revenues for the first quarter of 2020 rose to €251.2 million (2019: €13.5 million). The increase was primarily driven by the collaboration and licensing agreement with Incyte to further develop and commercialize tafasitamab globally. Revenues for the first quarter of 2020 include success-based payments of €10.3 million, primarily from Janssen (Q1 2019 success-based payments: €11.0 million).

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 Q1 2020, this segment recorded revenues of €240.4 million (Q1 2019: €5.8 million), with the increase primarily driven by the collaboration and licensing agreement with Incyte.

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 €7.8 million in Q1 2019 to €10.8 million in Q1 2020.

Total operating expenses in Q1 2020 increased to €-47.7 million from €-37.3 million in Q1 2019, based on the ramp-up of preparations for a potential tafasitamab U.S. commercialization as well as the build-up of MorphoSys US Inc. In the first quarter of 2020, cost of sales amounted to €3.3 million (Q1 2019: €5.0 million). In Q1 2020, research and development expenses amounted to €21.5 million, as compared to €24.7 million in Q1 2019. Selling expenses increased to €12.8 million (Q1 2019: €1.7 million), and general and administrative expenses increased from €5.9 million in Q1 2019 to €10.1 million in the first quarter of 2020, both primarily as a result of higher personnel expenses and expenses for external services.

Earnings before interest and taxes (EBIT) amounted to €213.6 million in Q1 2020 (Q1 2019: €-23.6 million), with the increase primarily driven by the collaboration and licensing agreement with Incyte. The Proprietary Development segment reported an EBIT of €210.8 million (Q1 2019: €-25.0 million). EBIT in the Partnered Discovery segment was €8.5 million (Q1 2019: €5.5 million). In 2020, the consolidated net profit amounted to €195.5 million (consolidated net loss Q1 2019: €-22.7 million). Basic earnings per share for 2020 was €6.12 (loss per share Q1 2019: €-0.72).

On March 31, 2020, the Group’s liquidity position amounted to €1,132.1 million, reported on the balance sheet under the line 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 Q1 2020 (year-end 2019: 31,957,958).

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 are anticipated in a corridor of €130 to €140 million. The Company expects earnings before interest and taxes (EBIT) of €-15 to €5 million. This guidance is based on constant currency exchange rates and does not include any contributions from tafasitamab 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.

In its Proprietary Development segment, MorphoSys expects the following events and activities in 2020:

Tafasitamab (MOR208)

MorphoSys and Incyte continue launch preparations including through digital channels to ensure launch readiness should tafasitamab be approved on or before its PDUFA date of August 30, 2020; Despite the uncertainty caused by the COVID-19 pandemic in the U.S., to date there has not been a change of the PDUFA date of August 30, 2020 for tafasitamab
Support of Incyte for the submission of a marketing authorization application for tafasitamab in combination with lenalidomide for r/r DLBCL to the European Medicines Agency (EMA) by mid-2020; Incyte has exclusive commercialization rights outside of the U.S.; MorphoSys is not currently aware of the COVID-19 pandemic negatively impacting the expected achievement of a regulatory filing for tafasitamab with the EMA
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
Continue expansion of the commercial infrastructure and strategic presence in the U.S. to ensure tafasitamab launch readiness, matched by the resources provided by Incyte

MOR202

I-Mab: Continue pivotal development program with MOR202 in multiple myeloma in the Chinese region
MorphoSys: Continue clinical development of MOR202 in membranous nephropathy as well as other autoimmune indications; enrollment/screening of patients in the M-PLACE study temporarily paused due to COVID-19. This could lead to delays in previously communicated timelines
Otilimab (MOR103/GSK3196165): GSK to continue clinical phase 3 development program with otilimab in rheumatoid arthritis (recruitment currently proactively paused by GSK due to COVID-19).

MOR107: Continue preclinical investigation of MOR107 with a focus on oncology indications.

In its Partnered Discovery segment, MorphoSys expects the following events in 2020:

Tremfya(R) (guselkumab):

Janssen is currently conducting a series of clinical studies with Tremfya(R) (guselkumab) in various indications that 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. Decisions on these applications could potentially 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, and/or 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.

* Percentage point

** Including MOR107, which concluded a phase 1 study in 2017 and is currently in preclinical investigation with a focus on oncology indications. 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, May 7, 2020, to present the first quarter 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: 14809293#

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 View Source

The interim statement for the first quarter of 2020 (IFRS) is available online:
View Source

About tafasitamab
Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing. In January 2020, MorphoSys and Incyte Corporation entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. In the U.S., MorphoSys and Incyte will co-commercialize tafasitamab, outside the U.S., Incyte will have exclusive commercialization rights. Tafasitamab is being clinically investigated as a therapeutic option in B cell malignancies in a number of ongoing combination trials. An open-label phase 2 combination trial (L-MIND study) is investigating the safety and efficacy of tafasitamab in combination with lenalidomide in patients with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL) who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). The ongoing phase 3 study B-MIND assesses the combination of tafasitamab and bendamustine versus rituximab and bendamustine in r/r DLBCL. In addition, tafasitamab is currently being investigated in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after discontinuation of a prior Bruton tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib) in combination with idelalisib or venetoclax.

On May 6, 2020 Immunomedics, Inc., (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported financial results for the first quarter of 2020 (Press release, Immunomedics, MAY 6, 2020, View Source [SID1234557129]). Please refer to the Company’s Quarterly Report on Form 10-Q for more details on the Company’s financial results.

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As the world responds to the outbreak of COVID-19, the thoughts of the Immunomedics team are with those affected, the staff who are providing essential services and healthcare workers fighting at the front lines of this pandemic. We also thank our colleagues, who are working tirelessly under the constraints of the current environment, to support the Company’s mission of delivering breakthrough treatments to those in need.

"We entered 2020 with strong momentum across our operations," stated Dr. Behzad Aghazadeh, Executive Chairman of Immunomedics. "Following a successful biologics license application resubmission in late 2019, we were pleased to receive accelerated approval for Trodelvy in late April and accomplished our goal of bringing this therapy to patients with metastatic triple-negative breast cancer (mTNBC). Trodelvy was launched within days of receiving FDA approval and transformed Immunomedics into a fully-integrated biopharmaceutical company in the process. We also announced the early stoppage of our confirmatory Phase 3 ASCENT study due to compelling evidence of efficacy and look forward to reporting topline study results in mid-2020. These data are expected to establish Trodelvy as a new standard of care in mTNBC and help improve the lives of people with hard-to-treat cancers worldwide. Finally, we significantly strengthened our balance sheet with an over-subscribed follow-on offering that will allow us to build on our momentum during the growth period ahead."

Recent Highlights and New Developments

The Phase 3 confirmatory ASCENT study of Trodelvy in third-line mTNBC was halted early due to compelling evidence of efficacy across multiple endpoints, based on the unanimous recommendation by the independent Data Safety Monitoring Committee during its recent routine review of the study. Topline readout is expected around mid-2020.
Trodelvy received accelerated approval from the FDA for the treatment of adult patients with mTNBC who have received at least two prior therapies for metastatic disease. Trodelvy is the first ADC approved by the FDA specifically for previously-treated mTNBC and is also the first FDA-approved anti-Trop-2 ADC.

Commercial launch of Trodelvy is underway, with the first patient treated within days of FDA approval and a National Drug Rebate Agreement with The Centers for Medicare & Medicaid Services fully executed.

The Company entered into a clinical collaboration with Dana-Farber Cancer Institute to conduct two Phase 2 studies to evaluate the safety and efficacy of combining Trodelvy with pembrolizumab (Keytruda), Merck’s anti-programmed cell death protein 1 (PD-1) antibody, in patients with (i) mTNBC and (ii) hormone receptor positive (HR+)/human epidermal growth factor receptor 2-negative (HER2–) metastatic breast cancer (mBC). In the mTNBC study, approximately 110 newly-diagnosed patients, who are programmed cell death ligand 1 (PD-L1)-negative, will be randomized to receive the combination of Trodelvy and pembrolizumab or Trodelvy alone. The same combination of Trodelvy and pembrolizumab will be used in the second randomized study in approximately 110 hormonal treatment- and chemotherapy-refractory patients with PD-L1-positive, HR+/HER2– mBC. Primary endpoint for both studies is progression-free survival. Other clinical outcome measures, including overall survival, objective response rate by RECIST 1.1, duration of response, and clinical benefit rate, will be used as secondary endpoints.

An abstract containing early results from cohort 2 of TROPHY U-01 study of Trodelvy in metastatic urothelial cancer patients who are platinum-ineligible and progressed after prior checkpoint inhibitor therapy has been accepted for poster presentation at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) virtual meeting. Topline data from the full first cohort of 100 patients with prior platinum-based and PD-1 or PD-L1 inhibitor therapies are expected to be available in the second half of 2020.

Additionally, an abstract from a Phase 1/2 study of Trodelvy in patients with previously-treated metastatic endometrial cancer has also been accepted for poster presentation at the 2020 ASCO (Free ASCO Whitepaper) virtual meeting.

In adhering to federal and local guidelines on COVID-19, in March 2020 the Company proactively suspended activation of new study sites and slowed the enrollment of new patients for certain clinical studies. The Company continues to work closely with investigators and the FDA to ensure the safety of patients considering the health risks posed by the pandemic, while preserving the integrity of the studies.

Enrollment into the Phase 3 TROPiCS-02 study of Trodelvy in HR+/HER2– mBC is expected to resume in late May 2020 at select sites that have been carefully vetted for their ability to ensure normal clinical trial operations and patient safety.

The Company’s leadership team has been strengthened by the appointments of Harout Semerjian as President and Chief Executive Officer, and Dr. Loretta M. Itri as Chief Medical Officer. Dr. Behzad Aghazadeh remains as Executive Chairman while Scott Canute has resumed his role as a member of the Board of Directors.

John Stubenrauch has been appointed Senior Vice President, Global Head of Manufacturing. Mr. Stubenrauch has decades of experience in global commercial manufacturing across organizations, including AstraZeneca and Merck. Dr. Morris Rosenberg, who helped support the manufacturing operations leading up to Trodelvy’s commercial launch, will be stepping down from the management team, effective May 15, 2020, to pursue the next chapter in his career.

The Company raised approximately $464.6 million in net proceeds through a public offering of common stock.
Financial Results for the First Quarter of 2020

Total costs and expenses were $82.0 million for the three months ended March 31, 2020, compared to $79.6 million for the comparable quarter ended March 31, 2019. The increase was primarily due to a $4.3 million increase in research and development expenses and a $0.2 million increase in sales and marketing expenses, partially offset by a $2.1 million decrease in general and administrative expenses.

Interest expense was $13.5 million for the three months ended March 31, 2020, compared to $10.0 million for the comparable quarter March 31, 2019. The increase was due primarily to changes in the fair value of our debt balances as a result of the agreement with RPI Finance Trust.

Net loss attributable to stockholders was $93.0 million, or $0.44 per share, for the three months ended March 31, 2020, compared to $87.3 million, or $0.46 per share, for the comparable quarter ended March 31, 2019.

As of March 31, 2020, the Company had $540.6 million in cash, cash equivalents, and marketable securities. On May 1, 2020, the Company closed on its previously announced underwritten public offering of common stock with net proceeds of approximately $464.6 million. The Company believes its projected financial resources are adequate to support commercial launch of Trodelvy in the United States in mTNBC; continue to expand the clinical development programs for Trodelvy; invest in the broader clinical development of the ADC platform (including IMMU-130 and IMMU-140); continued scale up of manufacturing and manufacturing process improvements; and general working capital requirements.

Conference Call

The Company will host a conference call and live audio webcast today at 5:00 p.m. Eastern Time to discuss first quarter 2020 financial results and provide a corporate update. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 9146008. The conference call will be webcast via the Investors page on the Company’s website at View Source Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company’s website for approximately 30 days.