On November 16, 2022 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported results for the third quarter and the first nine months of 2022 (Press release, MorphoSys, NOV 16, 2022, View Source [SID1234624173]).

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"As we approach the end of this year, I am proud of what we have achieved so far. I want to highlight the progress we have made with the patient enrollment of our pivotal studies for pelabresib and tafasitamab as well as the preliminary phase 1/2 results we released for tulmimetostat suggesting anti-tumor activity across multiple tumors", said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "We are highly engaged to ensure increasing awareness and use of Monjuvi for appropriate patients with relapsed or refractory diffuse large B-cell lymphoma. Looking ahead we are focused on continued execution and delivering on the pelabresib pivotal study timeline."

Monjuvi/Minjuvi Highlights:

Monjuvi (tafasitamab-cxix) U.S. net product sales of US$ 22.2 million (€ 21.9 million) for the third quarter 2022 (Q3 2021: US$ 22.0 million (€ 18.6 million)) and US$ 64.1 million (€ 60.2 million) for first nine months 2022 (9M 2021: US$ 55.5 million (€ 46.4 million)).

Minjuvi royalty revenue of € 0.9 million for sales outside of the U.S. in the third quarter 2022 and € 2.3 million for the first nine months of 2022.

Conference Data Highlights:

New data presented at SOHO conference in September 2022

Data from the ongoing L-MIND study presented at the Society of Hematologic Oncology (SOHO) conference suggests that tafasitamab plus lenalidomide followed by tafasitamab monotherapy provided durable response in patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) treated for at least two years, including six patients on treatment for 5 years or more.

Preliminary results of tulmimetostat (CPI-0209) study presented in October 2022

Preliminary results from the ongoing phase 1/2 study of the investigational EZH2 inhibitor tulmimetostat were presented at the ENA Symposium on Molecular Targets and Cancer. Tulmimetostat monotherapy in heavily pretreated patients with advanced cancers showed responses or disease stabilization in five cohorts with evaluable patients.

Pelabresib and tafasitamab presentations and posters at ASH (Free ASH Whitepaper) in December 2022

MorphoSys will contribute 14 presentations – including four oral presentations – on the investigational BET inhibitor pelabresib and on tafasitamab to the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH) (Free ASH Whitepaper) from December 10-13, 2022 in New Orleans, Louisiana, USA.

Corporate Developments:

On August 31, 2022, MorphoSys announced Tim Demuth, M.D., Ph.D. as new Chief Research and Development Officer, following the retirement of Malte Peters, M.D. Tim Demuth started his new role on October 1, 2022.

Significant Events After the End of the Third Quarter of 2022:

On October 27, 2022, MorphoSys’ license partner GSK provided an update on the ContRAst phase III program for otilimab in moderate to severe rheumatoid arthritis.

On November 14, 2022, MorphoSys’ license partner Roche disclosed that the GRADUATE studies with gantenerumab in early Alzheimer’s disease did not meet the primary endpoint of slowing clinical decline.

Financial Results for the Third Quarter of 2022 (IFRS):

Total revenues for the third quarter 2022 were € 95.8 million compared to € 41.2 million for the same period in 2021. This increase resulted mainly from higher revenues from licenses due to the out-licensing agreements with HI-Bio.

Cost of Sales: In the third quarter of 2022, cost of sales was € 8.1 million compared to € 7.5 million for the comparable period in 2021.

Research and Development (R&D) Expenses: In the third quarter 2022, R&D expenses were € 77.8 million (Q3 2021: € 64.4 million). The increase in R&D expenses is primarily due to higher investments to support the advancement of clinical programs.

Selling, General and Administrative (SG&A) Expenses: Selling expenses in the third quarter 2022 were € 23.5 million (Q3 2021: € 32.4 million). The decrease was driven by higher investments in 2021 made into the commercial organization, the first full year after the Monjuvi launch. General and administrative (G&A) expenses amounted to € 15.6 million (Q3 2021: € 19.4 million). The decrease was driven by the transaction costs for the Constellation acquisition which was completed in the third quarter of 2021.

Operating Loss: Operating loss amounted to € 29.3 million in the third quarter 2022 (Q3 2021: operating loss of € 82.4 million).

Consolidated Net Loss: For the third quarter 2022, consolidated net loss was € 122.9 million (Q3 2021: consolidated net loss of € 112.8 million).

Financial Results for the first nine months (IFRS):

Revenues for the first nine months of 2022 were € 196.7 million (9M 2021: € 126.7 million). The increase resulted mainly from higher revenues from licenses due to the out-licensing agreements with HI-Bio. Revenues include € 60.2 million from the recognition of Monjuvi product sales in the U.S. Royalties in the first nine months included € 2.3 million from the sale of Minjuvi outside of the U.S. by our partner Incyte and € 68.5 million from Tremfya sales which is fully passed on to Royalty Pharma.

Cost of Sales: For the first nine months of 2022, cost of sales were € 33.2 million compared to € 22.7 million in 2021. The increase was primarily driven by higher sales of Monjuvi in the U.S. and Minjuvi outside of the U.S.

R&D Expenses: In the first nine months of 2022, R&D expenses were € 203.8 million compared to € 138.2 million in 2021. The R&D expenses increased primarily due to higher development activity and the inclusion of expenses from the Constellation acquisition since Q3 2021.

SG&A Expenses: Selling expenses decreased in the first nine months of 2022 to € 69.4 million compared to € 89.0 million in 2021. The decrease was primarily driven by higher investments made into the commercial organization in 2021, the first full year after the Monjuvi launch. G&A expenses amounted to € 42.6 million compared to € 60.1 million in the first nine months of 2021. The decrease was driven primarily by the transaction costs related to the Constellation and Royalty Pharma agreements in 2021.

Operating Loss: Operating loss amounted to € 152.3 million in the first nine months of 2022 compared to an operating loss of € 183.3 million in 2021.

Consolidated Net Loss: For the first nine months of 2022, consolidated net loss was € 480.5 million compared to a net loss of € 133.5 million in 2021.

Cash and Other Financial Assets: As of September 30, 2022, the Company had cash and other financial assets of € 1,038.1 million compared to € 976.9 million on December 31, 2021.

Number of shares: The number of shares issued totaled 34,231,943 on September 30, 2022, no change compared to December 31, 2021.

53% to 58% of mid-point of SG&A expenses represent Monjuvi U.S. selling costs of which 100% are recorded in MorphoSys’ income statement. Incyte reimburses MorphoSys for half of these selling expenses.

Additional information related to 2022 Financial Guidance:

Tremfya royalties will continue to be recorded as revenue without any cost of sales in MorphoSys’ income statement. These royalties, however, will not contribute any cash to MorphoSys as 100% of the royalties will be passed on to Royalty Pharma.
MorphoSys anticipates receiving royalties for Minjuvi sales outside of the U.S.
MorphoSys does not anticipate any significant cash-accretive revenues from the achievement of milestones in 2022.
MorphoSys anticipates sales of commercial and clinical supply of tafasitamab outside of the U.S. to its partner Incyte. Revenue from this supply is recorded in the "Licenses, milestones and other" category in MorphoSys’ income statement. These sales result in a zero gross profit/margin. As such, MorphoSys does not provide guidance for these sales.
While R&D expense is anticipated to grow year-over-year due to investments in three pivotal studies, the growth is partially being offset by the consolidation of research/discovery activities.
SG&A expense guidance range reflects savings from synergies following the acquisition of Constellation and streamlined commercialization efforts.
MorphoSys Group Key Figures (IFRS, end of the third quarter: September 30, 2022)

*Value as of December 31, 2021

MorphoSys will hold its conference call and webcast tomorrow, November 17, 2022, at 2:00pm CET (1:00pm GMT/8:00am EST) to present the results for the third quarter and the first nine months 2022.

Participants for the conference call and webcast may pre-register and will receive dedicated dial-in details to easily and quickly access the call:

View Source;linkSecurityString=5f6d0a600

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

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

The statement for the third quarter and the first nine months 2022 (IFRS) are available for download at:

View Source/en/investors/financial-information

On November 16, 2022 Parthenon Therapeutics, a precision oncology company inventing a novel class of anti-cancer therapies that reprogram the tumor microenvironment (TME), reported its precision medicine approach to address cancers with hight unmet need, at the Stifel Healthcare Conference (Press release, Parthenon Therapeutics, NOV 16, 2022, View Source [SID1234624172]).

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"We are delighted to showcase our pipeline and technology to the scientific community and anticipate that we will pioneer a new approach to treating patients with immune-excluded tumors. Specifically, immune exclusivity describes a distinct category of TME where a patient’s T-cells are unable to attack a tumor due to the formation of a barrier around the tumor cells. Our data have shown over 50% of solid tumors are immune-excluded, indicating a significant unmet need for these patients," said Laurent Audoly, co-founder and Chief Executive Officer of Parthenon Therapeutics. "We also presented our lead asset, PRTH-101, which targets DDR1 (Discoidin Domain Receptor 1) to open up the mechanical barrier that characterizes immune-excluded tumors, and thus make the tumors vulnerable to treatment. We are excited to be developing one of the first therapeutics and patient selection strategy to address this class of tumors, and we anticipate providing more details in the upcoming months. Notably, the second half of 2023 will be a catalyst as we will initiate our first-in-human clinical study in a well-defined patient population."

On November 16, 2022 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported a collaboration agreement to participate in an investigator-initiated, non-therapeutic pilot study to evaluate the cerebrospinal fluid tumor and immune cell microenvironment in patients with metastatic breast cancer and brain metastases and/or leptomeningeal disease (Press release, Biocept, NOV 16, 2022, View Source [SID1234624171]). The study is designed to identify biomarkers associated with central nervous system (CNS) metastasis, enabling a better understanding of treatment response, prognosis, and treatment resistance that may improve the management of CNS disease in patients with metastatic breast cancer.

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The study is being conducted by breast oncologists Michelle E. Melisko, M.D. and Laura A. Huppert, M.D. at the University of California, San Francisco (UCSF) under a grant from the California Breast Cancer Research Program and the UCSF Brain Spore. Results from cerebrospinal fluid using Biocept’s CNSide assay and matched patient blood samples will be analyzed and compared to detect and characterize cancer in the cerebrospinal fluid with the goal of identifying new targets and to guide therapeutic decisions. In addition, Drs. Huppert and Melisko will work with Dr. Chris Im in the laboratory of Dr. Max Krummel at UCSF to examine the immune-cell microenvironment in a companion study, and the results will be analyzed together.

"We hypothesize that patients with metastatic breast cancer and brain metastases and/or leptomeningeal disease will have tumor cells and cell-free tumor DNA (ctDNA) that can be detected in cerebrospinal fluid, and that higher concentrations of cerebrospinal fluid tumor cells and ctDNA will correlate with progression of brain metastases and/or development of leptomeningeal disease," said Dr. Melisko. "The ability to identify cancer biomarkers that predict an elevated risk of CNS disease progression will have prognostic and therapeutic implications in treating these patients."

"This collaborative study is designed to provide important information derived from cerebrospinal fluid samples that will better inform physicians treating patients with metastatic breast cancer involving the CNS, in particular those with leptomeningeal disease, who have a very poor prognosis if untreated," said Michael Dugan, M.D., Biocept’s Chief Medical Officer and Medical Director. "CNSide will help these physicians determine the extent of involvement, potential targets for treatment and help them evaluate the response to treatment."

"This study will also evaluate and compare the information derived from cerebrospinal fluid versus that of matched blood samples, where—based on our early experience—we believe cerebrospinal fluid could be more informative of intracranial response to treatment than related blood-based tests or radiologic changes routinely assessed by MRI," he added.

The pilot study will collect cerebrospinal fluid and blood samples from 20 patients with metastatic breast cancer and brain metastases and/or leptomeningeal disease. The samples will be analyzed for the presence, quantity and mutational profile of cerebrospinal fluid ctDNA and cerebrospinal fluid tumor cells, which will be paired with results from peripheral blood mononuclear cell samples. Exploratory analysis of changes in cerebrospinal fluid ctDNA, tumor cell, and immune cell characteristics will be performed over time in a limited number of serial samples. The cerebrospinal fluid findings will then be correlated with clinical outcomes, including CNS disease progression and survival.

The Rationale for the Study

One of the most devastating complications of metastatic breast cancer is the development of CNS disease, including brain metastases and/or leptomeningeal disease. Among patients with metastatic breast cancer, approximately 15-45% develop brain metastases and approximately 5-10% develop leptomeningeal disease during the course of their disease, resulting in significant morbidity and mortality. As patient outcomes improve with better systemic treatment options, control of CNS disease has become increasingly important to reduce morbidity and prolong survival.

Patients with leptomeningeal disease are often excluded from clinical trials and there are few effective treatments. In order to develop better tools for the diagnosis and treatment of metastatic breast cancer with CNS disease, it is critical to better understand the biology of this condition. Specifically, the profiling of the cerebrospinal fluid tumor and immune microenvironment in patients with brain metastases and/or leptomeningeal disease will enable a better understanding of the characteristics that may contribute to the development and progression of CNS disease.

About the California Breast Cancer Research Program

The mission of the California Breast Cancer Research Program (CBCRP) is to prevent and eliminate breast cancer by leading innovation in research, communication, and collaboration in the California scientific and lay communities. CBCRP is the largest state-funded breast cancer research effort in the nation and is administered by the Research Grants Program Office within the University of California Office of the President. The CBCRP funds California investigators to solve questions in basic breast cancer biology, causes and prevention of breast cancer, innovative treatments and ways to live well following a breast cancer diagnosis, and involves advocates and scientists in every aspect of CBCRP decision-making, including program planning and grant application review. Since 1994 the CBCRP has awarded more than $280 million in research funds to institutions across California, with 95% of its revenue going directly to funding research and education efforts.

About CNSide

CNSide is based on Biocept’s proprietary quantitative tumor cell capture and detection method, paired with assays to identify actionable molecular treatment targets. Given the genetic changes that can occur as metastatic cancer spreads to the central nervous system, the evaluation of cerebrospinal fluid with CNSide provides a unique opportunity to identify biomarkers such as HER2 and EGFR in patients with metastatic carcinoma or melanoma to help guide physicians in therapy selection. In addition, the quantitative tumor cell count assay can be used in a serial fashion to monitor the response to therapy more effectively than other current methods.

On November 16, 2022 Alexion, AstraZeneca Rare Disease, reported the completion of its acquisition of LogicBio Therapeutics, Inc. (NASDAQ: LOGC), a pioneering genomic medicine company (Press release, AstraZeneca, NOV 16, 2022, View Source [SID1234624170]).

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The acquisition creates an opportunity to accelerate Alexion’s growth in genomic medicines through unique technology, an experienced rare disease R&D team, and expertise in pre-clinical development. Frederic Chereau, CEO of LogicBio, will join Alexion as Senior Vice President, Strategy and Business Development.

Additional Transaction Details

The tender offer for all of the issued and outstanding shares of common stock of LogicBio expired as scheduled at one minute following 11:59 p.m., New York City time, on Tuesday, November 15, 2022. The minimum tender condition and all of the other conditions to the offer have been satisfied and on November 16, 2022, Alexion accepted for payment and will as promptly as practicable (but in any event within two business days) pay for all shares validly tendered and not validly withdrawn.

Following its acceptance of the tendered shares, on November 16, 2022, Alexion has completed its acquisition of all of LogicBio through the merger of a wholly owned subsidiary of Alexion with and into LogicBio, pursuant to Section 251(h) of the General Corporation Law of the State of Delaware, with LogicBio continuing as the surviving corporation and becoming a wholly owned subsidiary of Alexion.

In connection with the merger, all LogicBio shares of common stock not validly tendered in the tender offer have been converted into the right to receive $2.07 per share in cash, without interest thereon and net of any applicable withholding taxes, that would have been paid had such shares been validly tendered in the tender offer. In connection with the acquisition, LogicBio’s shares of common stock ceased trading on the NASDAQ Global Market. Alexion will retain LogicBio employees at their current location.

On November 16, 2022 Agendia, Inc., a commercial-stage company focused on assessing an individual tumor’s risk of metastasis and the molecular subtyping reasons for its growth, reported the first patient has enrolled in the LESS clinical trial, sponsored by Unicancer with the institutional support of Agendia (Press release, Agendia, NOV 16, 2022, View Source [SID1234624169]). In an effort to improve outcomes while preserving quality of life for early breast cancer patients, the study is designed to safely discontinue adjuvant endocrine therapy after two years for tumors with a MammaPrint Ultra Low result in post-menopausal women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer. The study aims to enroll 696 patients via 45 sites within the French breast cancer intergroup Unicancer (UCBG) by October 2024.

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"We are excited to identify early breast cancer tumors and further investigate the ability to reduce endocrine therapy duration, in an effort to minimize significant and varying side effects, while maintaining high survival rates," said Fabrice André, MD, PhD, Professor in the Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France and Co-coordinating Investigator of the study.

Elise Deluche, MD, Deputy Head of Department at Centre Hospitalier Universitaire de Limoges and Co-coordinating Investigator of the study, added, "Enabling personalized treatments to prevent over- and undertreatment in breast cancer care could give women freedom from intensive long-term treatment regimens that may not increase their chance of cure."

Previous studies have shown patients with HR+/HER2- breast cancer with a MammaPrint Ultra Low result can have an excellent prognosis at 20 years with reduced endocrine therapy.

"The LESS study is an important addition to Agendia leading the field in uncovering robust insights for patients and their providers to tailor treatments unique to every tumor," said William Audeh, MD, Chief Medical Officer at Agendia. "Through our partnership with Unicancer, we are expanding knowledge on the complexity of breast cancer and enabling further personalized treatments in cancer care."

Agendia’s singular focus on breast cancer facilitates continued investment in global research to unravel the intricacies of precision medicine and drive personalized treatment planning for women with breast cancer. This study reinforces Agendia’s commitment to practice changing research that will aid decision-making, aimed at improving outcomes.