On March 16, 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that the U.S. Food and Drug Administration (FDA) has scheduled the pre-approval inspection at the ROLONTIS (eflapegrastim) manufacturing site in May 2021 (Press release, Spectrum Pharmaceuticals, MAR 16, 2021, View Source [SID1234576739]). In October 2020, the company received notification from the agency that it would defer its decision on the BLA because an inspection of the Hanmi Bioplant in South Korea could not be conducted during the review cycle due to restrictions on travel related to the COVID-19 pandemic.

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"I am thrilled that the FDA informed us that they will be conducting a pre-approval inspection of the ROLONTIS manufacturing facility in May," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "We believe the pre-approval inspection marks the final step in the ROLONTIS review process."

About ROLONTIS

ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) seeking an indication for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs. The BLA for ROLONTIS is supported by data from two identically designed Phase 3 clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of ROLONTIS in 643 early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive chemotherapy. In both studies, ROLONTIS demonstrated the pre-specified hypothesis of non-inferiority (NI) in duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. ROLONTIS also demonstrated non-inferiority to pegfilgrastim in the DSN across all 4 cycles (all NI p<0.0001) in both trials.

On March 11, 2021 Prelude Therapeutics Inc. ("Prelude", "the Company", "we", "our") (Nasdaq: PRLD), a clinical-stage precision oncology company, reported its financial results for the fourth quarter and full year ended December 31, 2020 and provided an update on recent developments (Press release, Prelude Therapeutics, MAR 16, 2021, View Source [SID1234576737]).

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"2020 marked a highly transformational year for Prelude with the successful completion of an initial public offering and progress across our three clinical-stage programs," said Kris Vaddi, PhD, Chief Executive Officer of Prelude Therapeutics. "We are firmly committed to bringing novel therapies to patients in areas of high unmet need, and we have entered 2021 with both the momentum and resources that we believe will carry us through several key milestones. Notably, we are pleased to announce the completion of dose escalation activities in our ongoing Phase 1 trial of PRT543, our lead PRMT5 inhibitor, in patients with advanced solid tumors and hematologic malignancies, and that we will soon begin initiating additional expansion cohorts. We look forward to sharing clinical data for this program, as well as for our second PRMT5 inhibitor, PRT811, in the second half of this year."

Dr. Vaddi added, "The ongoing Phase 1 trial of our third clinical candidate, PRT1419, an MCL1 inhibitor, also continues to progress, with the addition of dose expansion cohorts expected in the second half of the year. Finally, the continued advancement of our preclinical programs remains a high priority for us in 2021, with the anticipated submission of an IND application for PRT2527, our CDK9 inhibitor, in the second half of this year."

Recent Highlights and Upcoming Milestones

PRT543

Phase 1 Dose Escalation Complete; Additional Expansion Cohorts to Open in the Second Quarter. The Company reported that the dose escalation portion of the Phase 1 trial of its lead product candidate, PRT543, is now complete, and that a recommended expansion dose with adequate safety, pharmacokinetics, and target engagement profile has been established. PRT543 is designed to be a potent, selective, and oral inhibitor of PRMT5. The dose expansion portion of the Phase 1 trial is currently open for the patient cohort with adenoid cystic carcinoma, and will be open for additional patient cohorts with solid tumor and hematologic malignancies early in the second quarter. As previously announced, preliminary data from the dose escalation portion of the trial demonstrated early signs of clinical activity and tolerability. The Company anticipates presenting initial clinical data from the Phase 1 trial at medical meetings in the second half of 2021.

Preclinical Data to be Featured at the 2021 AACR (Free AACR Whitepaper) Annual Meeting. Three preclinical presentations on PRT543 will be featured at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held April 10-15, 2021 in a virtual setting. A copy of the posters, titled "PRMT5 inhibition downregulates MYB and NOTCH1 signaling, key molecular drivers of adenoid cystic carcinoma" (abstract 1138), "PRMT5 inhibition epigenetically regulates DNA damage response pathways in cancer cells and sensitizes to chemotherapy and PARP inhibition" (abstract 1185), and "PRMT5 inhibition regulates alternative splicing and DNA damage repair pathways in SF3B1 R625C expressing uveal melanoma cells" (abstract 1137), will be available in the Publications section of the Prelude Therapeutics website following the conclusion of the meeting.
PRT811

Phase 1 Dose Expansion Cohorts Expected to Commence in Mid-2021. The dose escalation portion of the Company’s Phase 1 trial of its second clinical product candidate, PRT811, which is designed to be a potent, selective, and brain penetrant PRMT5 inhibitor, in patients with advanced solid tumors, including glioblastoma multiforme (GBM), remains ongoing. As previously reported, the trial has demonstrated early signs of clinical activity and tolerability. Prelude remains on track to establish the recommended expansion dose and commence the dose expansion portion of the trial in mid-2021 in patients with central nervous system cancers including GBM, with initial clinical data expected by the end of 2021.
PRT1419

Oral Formulation: Dose Expansion and Combination Cohorts Expected to be Added to Ongoing Phase 1 Trial in the Second Half of 2021. The dose escalation portion of the Company’s first-in-human Phase 1 open-label, multicenter, dose-escalation study of oral PRT1419 in patients with relapsed/refractory hematologic malignancies, including acute myeloid leukemia and high-risk myelodysplastic syndromes, remains ongoing. PRT1419, which is the Company’s third clinical candidate, is designed to be an orally available, potent, and selective MCL1 inhibitor. The Company expects to add dose expansion and combination cohorts to the Phase 1 clinical trial in the second half of 2021.

IV Formulation: IND Application Cleared. Prelude reported the recent U.S. Food and Drug Administration (FDA) clearance of the Company’s Investigational New Drug (IND) application for an intravenous (IV) formulation of PRT1419. A Phase 1 trial of the IV formulation, which leverages the optimized physicochemical properties of PRT1419, is expected to commence in the first half of 2021 in patients with solid tumors.

Data on Preclinical Characterization to be Featured at the 2021 AACR (Free AACR Whitepaper) Annual Meeting. Data on the preclinical characterization of PRT1419 will be featured during a poster session at the 2021 AACR (Free AACR Whitepaper) Annual Meeting. A copy of the poster, titled "Preclinical characterization of PRT1419, a potent, selective and orally available inhibitor of MCL1" (abstract 983), will be available in the Publication section of the Prelude Therapeutics website following the conclusion of the meeting.
Discovery Programs

Advancement of Earlier-Stage Candidates Expected in 2021. Prelude remains on track to submit an IND application for PRT2527, which is designed to be a potent and selective CDK9 inhibitor, in 2021. The Company also continues to expect to initiate IND-enabling studies for PRT-SCA2, which is designed to be a SMARCA2 protein degrader, in 2021.

Preclinical Data on SMARCA2 Protein Degradation to be Featured at the 2021 AACR (Free AACR Whitepaper) Annual Meeting. A poster presentation on Prelude’s SMARCA2 protein degradation program, titled "Potent SMARCA2 targeted degraders induce genetic synthetic lethality in SMARCA4 deleted cancer" (abstract 1139), will be presented at the 2021 AACR (Free AACR Whitepaper) Annual Meeting. A copy of the poster will be available in the Publications section of the Prelude Therapeutics website following the conclusion of the meeting.
Corporate

Completed Successful Upsized Public Offering of $172.5 Million. In January 2021, the Company announced the closing of its upsized public offering of 2,583,334 shares of its voting common stock and 291,666 shares of its non-voting common stock, each at a public offering price of $60.00 per share, which includes the exercise in full of the underwriters’ option to purchase an additional 375,000 shares of its voting common stock. The aggregate gross proceeds from this offering were $172.5 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Prelude.
Fourth Quarter and Full Year 2020 Financial Results

Cash and Cash Equivalents: Cash and cash equivalents as of December 31, 2020 were $218.3 million.

Research and Development (R&D) Expenses: For the fourth quarter of 2020, R&D expense increased to $14.6 million from $8.8 million for the prior year period, and for the full year increased to $48.2 million compared to $24.3 million for 2019. The fourth quarter and full year increases were primarily due to increased clinical research costs for the PRT543 and PRT811 clinical trials and increased costs associated with the initiation of the clinical trial for PRT1419, which began in the third quarter of 2020. The Company also incurred an increase in chemistry, manufacturing, and other costs for those trials.

General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2020 increased to $4.9 million from $1.2 million for the prior year period, and for the full year increased to $10.6 million compared to $3.8 million for 2019. The fourth quarter and full year increases were primarily due to an increase in personnel related expense due to increased employee headcount and an increase in professional fees as the Company expanded its operations to support R&D efforts and incurred additional costs associated with operating as a public company.

Net Loss: For the fourth quarter of 2020, net loss was $19.3 million, or $0.45 per share, compared with a net loss of $10.0 million, or $5.56 per share, for the same period in 2019. Net loss for the year ended December 31, 2020 was $56.9 million, or $4.56 per share, compared with a net loss of $27.6 million, or $16.52 per share, for the year ended December 31, 2019.

Financial Guidance: The Company believes that its current cash and cash equivalents will be sufficient to fund operating expenses and capital expenditure requirements into 2023.

On March 16, 2021 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, reported financial results for the fourth quarter and full year ended December 31, 2020 and provided a corporate update (Press release, Vaccinex, MAR 16, 2021, View Source [SID1234576736]).

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"We had a productive fourth quarter, during which we presented topline data from our SIGNAL phase 2 study in Huntington’s disease which indicated that treatment with pepinemab has a potential cognitive benefit in patients with Huntington’s disease," stated Maurice Zauderer, Ph.D., president and chief executive officer. "Looking forward, during the second quarter of 2021 we anticipate initiating studies of pepinemab in head and neck cancer in combination with Merck’s KEYTRUDA as well as a new trial in Alzheimer’s disease, with financial assistance from the Alzheimer’s Association and the Alzheimer’s Drug Discovery Foundation. Importantly, having raised $32 million in the first quarter of 2021 through our open sale market agreement with Jefferies, we believe we are well positioned to fund these trials, which are anticipated for completion in H2 2022/Q1 2023. Based on existing clinical data, we are hopeful that the results will demonstrate the broad clinical potential of SEMA4D inhibition and support further development of pepinemab in these important indications."

"With regards to our Huntington’s disease program, after completing analysis of the full data set, we believe there is a promising path forward in mid-stage disease, and we are currently engaged in potential partnering discussions to fund and execute a rigorously designed Phase 3 study," Dr. Zauderer concluded.

Pepinemab Clinical Updates:

Alzheimer’s disease. Vaccinex previously announced that it had been awarded a $750,000 development grant from the Alzheimer’s Association under the 2020 Part the Cloud Program, as well as a $3 million award from the Alzheimer’s Drug Discovery Foundation. The awards were based in part on earlier findings that treatment with pepinemab prevented the characteristic loss of glucose transport in the brain during underlying Huntington’s disease progression as detected by conventional FDG-PET imaging. Uptake of glucose, the main source of energy in the brain, is also known to decline with underlying disease progression in Alzheimer’s disease. In particular, previous studies in AD have shown that decline in brain glucose transport correlates with cognitive decline and, more recently, that FDG-PET is a superior indicator of cognitive performance compared to Aβ amyloid-PET in AD.
Dr. Eric Siemers, MD, formerly senior medical director of the Alzheimer’s Disease Global Development Program at Eli Lilly and Company, will serve as Senior Medical Director of this randomized, placebo-controlled, multi-center clinical study which is expected to begin enrolling patients in 2Q 2021.

Head and Neck cancer. In September 2020, Vaccinex announced a clinical collaboration with Merck to evaluate pepinemab in combination with Merck’s anti-PD-1 cancer immunotherapy, KEYTRUDA (pembrolizumab), in a Phase 2 study for front-line treatment of advanced, recurrent or metastatic head and neck squamous cell carcinoma. Multiple prior studies suggest that inhibition of SEMA4D increases immune infiltration and alters the balance of cytotoxic and immunosuppressive cells in the tumor microenvironment. As SEMA4D is highly expressed in head and neck cancer, we believe there is strong rationale for development in this indication.
The Company expects to begin enrollment of up to 65 patients in the second quarter of 2021. The study is designed to assess whether combination therapy can significantly improve responses to KEYTRUDA in this population. Key endpoints of the study are expected to include objective response, progression free survival and overall survival.

Huntington’s disease. In September 2020, Vaccinex reported topline data from its Phase 2, double-blind, placebo-controlled SIGNAL trial of pepinemab in patients with early manifest and prodromal Huntington’s disease (HD). The study had two co-primary endpoints, a family of two cognitive assessments from the Huntington’s Disease Cognitive Assessment Battery and Clinical Global Impression of Change (CGIC).
Although the study did not meet the above pre-specified co-primary endpoints, we believe the results of each of the two cognitive assessments in patients with early manifest disease demonstrated a strong trend for beneficial change (OTS, p=0.028 and PTAP, p=0.06, 1-sided). Given the favorable trend of results, an exploratory endpoint, the HD-CAB composite score encompassing the full set of 6 different cognitive assessments was also evaluated and is believed to indicate highly significant treatment-related benefit (p=0.007). Similarly, the treating physicians’ evaluation of CGIC in these patients did not show a statistically significant difference between the placebo and pepinemab-treated groups. However, given the difficulty of detecting changes in CGIC at the top of the functional capacity scale (TFC 12-13), a subpopulation analysis of patients who were somewhat more advanced in disease progression at baseline (TFC 11) indicated an improved outcome (p=0.04, 1-sided), albeit in a smaller population that was not powered for statistical significance. Beneficial effects of pepinemab treatment were supported by imaging analysis. Exploratory volumetric MRI analysis of brain in patients with early manifest disease demonstrated statistically significant treatment-related reduction in atrophy of the brain caudate, a key brain region in early HD progression. In addition, FDG-PET analysis of metabolic activity indicated that treatment resulted in a statistically significant increase in glucose transport in the majority of brain regions examined.

Overall, we believe that the results of the SIGNAL trial suggest that pepinemab may help protect against cognitive decline during HD progression. Vaccinex is actively exploring partnering pepinemab for a large pivotal Phase 3 HD trial in collaboration with a biopharmaceutical partner.

Other Trials. Pepinemab is also being evaluated in multiple investigator-sponsored trials (ISTs) being conducted by the Winship Cancer Institute of Emory University to evaluate pepinemab in combination with checkpoint inhibitors in "Window of Opportunity" studies in colorectal, pancreatic, head and neck cancer and melanoma.
Other Recent Accomplishments:

Entered into multi-project deals with two leading pharmaceutical companies focused on leveraging Vaccinex’s ActivMAb antibody discovery and novel viral display platform to discover drugs against complex membrane receptors such as GPCRs and ion channels.
Announced that Surface Oncology will be exercising its option to license the anti-CCR8 antibody discovered via Vaccinex’s ActivMAb platform. The terms of agreement with Surface Oncology provided that Surface Oncology pay technology access and licensing fees in addition to research funding, and that Vaccinex will qualify for development milestone payments and royalties on commercial sales.
Subsequent to the end of the fourth quarter, the Company raised $32 million in net proceeds through its existing open sale market agreement, or ATM.
Upcoming Anticipated Milestones:

Q2 2021 – Planned initiation of a Phase 1b/2 clinical trial of pepinemab in combination with KEYTRUDA for the treatment of patients with HNSCC
Q2 2021 – Expected initiation of Alzheimer’s disease Phase 1/2 trial
H2 2022 – Data anticipated from open head and neck cancer trial of combination immunotherapy with KEYTRUDA
Late 2022/Q1 2023 – Data anticipated from randomized Alzheimer’s trial
Financial Results for the Three and Twelve Months Ended December 31, 2020:

Revenue. Revenue for the year ended December 31, 2020 was $625,000 as compared to $523,000 for the year ended December 31, 2019. The Company’s revenues were generated primarily from a grant awarded under the Part the Cloud Program from the Alzheimer’s Association.

Research and Development Expenses. Research and development expenses for the three months ended December 31, 2020 were $4.2 million as compared to $4.4 million for the comparable period in 2019. For the full year 2020, research and development expenses were $21.5 million as compared to $25.7 million for the full year 2019. Research and development expense decreased compared to the prior year periods primarily as a result of decreased spend associated with the Huntington Disease trial.

General and Administrative Expenses. General and administrative expenses for the three months ended December 31, 2020 were $1.8 million as compared to $1.9 million for the comparable period in 2019. For the full year 2020, general and administrative expenses were $7.4 million as compared to $6.7 million for the full year 2019. The increased expense versus the prior year was primarily driven by increased D&O insurance premiums.

Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on December 31, 2020 were $10.6 million, as compared to $2.8 million as of December 31, 2019. Subsequent to the end of the fourth quarter 2020, the Company raised $32 million in net proceeds through its pre-existing ATM.

On March 16, 2021 Oncocyte Corporation (Nasdaq: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, reported financial results for the fourth quarter and full year 2020 ended December 31, 2020, along with a corporate update (Press release, Oncocyte, MAR 16, 2021, View Source [SID1234576734]).

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"In a short time, we have transformed Oncocyte from a single-product, development stage company into a commercial stage oncology diagnostics company with a broadening product portfolio and multiple engines of revenue growth," said Ron Andrews, President and Chief Executive Officer of Oncocyte. "We began to build momentum in the commercialization of our expanding product portfolio targeting a multi-billion-dollar global market opportunity for diagnostic tests to help physicians make critical treatment decisions across the cancer care continuum. We launched DetermaRx, which in Q4 generated strong unit growth and even faster revenue growth. We completed clinical studies of DetermaIO, our flagship proprietary product for immune therapy selection, laying the groundwork to launch that product in the second half of 2021. We also are preparing for the commercial launch of a complementary targeted therapy panel later this year as well as the launch of DetermaCNI for research and pharma clinical trial use, also in the second half of this year. Our recent equity offering strengthened our balance sheet in preparation for our broadening commercialization efforts, including our planned expansion in medical education programs and sales coverage. We are now focused on executing several anticipated product launches throughout 2021 to ensure that we create maximum value from our product portfolio for patients and shareholders."

Commenting on the fourth quarter, Padma Sundar, Chief Commercial Officer stated, "We continue to be encouraged with the commercial success of DetermaRx in its first year. Despite the headwind of the surge in COVID-19 cases in the fourth quarter, we generated 36% sequential growth in DetermaRx orders and 58% sequential revenue growth. In its first year as a commercial product, DetermaRx received high value Medicare coverage, including adoption into the standard of care menu for multiple hospital systems and large oncology groups. We also struck several domestic and global collaboration and distribution agreements. For example, our agreement with Burning Rock Biotech may provide access to the DetermaRx test to the estimated 250,000 patients in China who receive surgical resections for non-small cell lung cancer each year."

Mr Andrews concluded, "In Q4, we were offered the opportunity to make additional investments in new studies that allowed us to expand our indications for DetermaIO as well as expand our sales and medical education teams which increased our expense burden for the quarter. With the lineup of publications, papers and abstracts now scheduled for release over the coming months, like the AACR (Free AACR Whitepaper) abstract released yesterday, we feel the ROI on the additional expenses will be significant and thus, we anticipate a rapid cadence of important data releases and new product launches in 2021. We are on track to launch DetermaIO for immunotherapy response prediction and DetermaTx for targeted therapy selection, both planned in the fourth quarter. These two expected product launches will expand the focus of Oncocyte’s commercialized product portfolio to an estimated combined addressable market opportunity of over $5 billion."

"Our broadening product portfolio will also position Oncocyte as a one-stop oncology lab capable of rapidly and efficiently providing comprehensive testing across treatment decisions, not just for lung cancer but also potentially as a pan cancer test for the majority of solid tumors. With our strengthened balance sheet, we plan to continue driving rapid unit and revenue growth across our expanded product portfolio. We also plan to hire additional high-performing sales and market access staff, and to onboard additional leading cancer centers, in part with the advice and guidance of our new Medical Advisory Board. We look forward to continuing to penetrate the multi-billion-dollar market opportunity anticipated for our tests and building Oncocyte’s brand as a leading partner to physicians, patients and payers in making cost effective, critical treatment decisions across the cancer care continuum."

Fourth Quarter and Recent Highlights Include:

DetermaIO

Over the course of 2020, the test was accepted for studies in several important trials, including the NeoTrip Trial for Neoadjuvant Triple Negative Breast cancer utility. Data from these studies will be presented at major medical meetings and via peer-reviewed publications throughout 2021
Published peer-reviewed study demonstrating that DetermaIO’s gene expression analysis of the complete tumor micro-environment followed by synthesis using a proprietary algorithm may be predictive of response across multiple solid tumors
Selection of abstract for mini-symposium presentation at AACR (Free AACR Whitepaper) 2021 demonstrating potential clinical utility of DetermaIO in a third cancer – bladder cancer, in addition to NSCLC and TNBC
Presented data at the Association for Molecular Pathology 2020 Conference, demonstrating that DetermaIO is reproducible at tissue inputs compatible with very small tissue samples, which is critical for driving broad test usage given the scarcity of tissue for competing molecular testing methods
Presented data at the ASCO (Free ASCO Whitepaper) 2020 conference and the IASLC North America 2020 which demonstrated DetermaIO outperformed PD-L1 testing in predicting response to immune-checkpoint inhibitors in triple negative breast cancer and non-small cell lung cancer
Established a Medical Advisory Board of world-renowned thought leaders in oncology to assist in accelerating our clinical development and publication efforts in immune-oncology and blood-based monitoring
DetermaRx

Test volumes continued to grow in Q4 2020 with 36% quarter over quarter increase in testing volume to 238 samples, 58% increase in DetermaRx revenues driven by initiation of Medicare payments starting in September 2020, and 22% increase in onboarded hospitals to 82 customers; maintained physician re-order rate of approximately 60%
Signed agreement with Multiplan networks, representing 60 million covered lives, to offer DetermaRx at a high-value reimbursement rate commensurate with Medicare
Signed exclusive agreement with Burning Rock Biotech in China to license DetermaRx in China, the world’s largest early stage lung cancer market, with an estimated 250,000 patient Total Addressable Market (TAM), reaching our goal of distribution to all major world markets within the first year of launch
Presented new data at the IASLC 2020 World Conference on Lung Cancer showing broad adoption and real-world clinical utility of its DetermaRx test for early-stage lung cancer
Closed second investment in Razor Genomics to complete acquisition of founding company behind DetermaRx
Pharma Services

Initiated clinical trial processing of proprietary, blood-based monitoring assay for targeted drug response for a top 20 Pharma company
Continued execution on FDA submission studies for a leading global diagnostic company
Executed on site certification for two new customers, a major global pharma and leading diagnostic company, which is expected to lead to new project revenues in 2021 and beyond
Finalizing Pharma service component of immune oncology testing for clinical trial for Fondazione Michelangelo, a leading non-profit Cancer research foundation
Fourth Quarter and Annual 2020 Financial Results

At December 31, 2020, Oncocyte had cash, cash equivalents and marketable securities of $7.8 million. In January and February 2021, Oncocyte raised an aggregate of $69 million in net proceeds from two public offerings and shares sold from its at-the-market (ATM) program. In February 2021, Oncocyte completed the acquisition of the remaining equity interests in Razor Genomics and paid the $10 million cash portion to the selling shareholders, so Oncocyte now owns all of the outstanding common stock of Razor and will consolidate Razor as of that date.

Oncocyte currently derives its revenues from the sale of its lung cancer test, DetermaRx, which was commercially launched in early 2020 and pharma services generated by its wholly owned subsidiary, Insight Genetics, which was acquired on January 31, 2020. Upon CMS and Noridian final pricing decision for the DetermaRx test, which became effective in September 2020, Oncocyte is able to recognize revenues for Medicare covered tests on an accrual basis, rather than on a cash basis, when the tests are performed.

Under U.S. accounting principles, for all payers other than Medicare, Oncocyte will be able to recognize revenues for DetermaRx on an accrual basis of accounting once it has contracts for reimbursement from third-party payers or a history of experience of cash collections for the tests performed, or both. Until that time, for all payers other than Medicare, Oncocyte expects to recognize revenue for DetermaRx tests performed on a cash basis. Accordingly, Oncocyte will incur and accrue cost of revenues and other operating expenses related to all DetermaRx tests ordered and processed, including its pharma services performed.

Revenues for the three and twelve months ended December 31, 2020 were $0.5 million and $1.2 million respectively, generated from pharma services and DetermaRx tests completed that are covered by Medicare on an accrual basis since Oncocyte received a final pricing from CMS in September. DetermaRx revenues grew solidly in Q4 2020 versus Q3 2020, primarily due to revenue recognized for Medicare tests performed following the receipt of final CMS pricing decision in September 2020. The number of tests ordered increased significantly in the fourth quarter as compared to the third quarter of 2020 despite the COVID-19 resurgence. Pharma Services’ revenues in the fourth quarter of 2020 were lower sequentially when compared to the third quarter of 2020, due to delays in project completion as a part of the COVID surge which are being carried over and are expected to be completed in the first half of 2021. Prior to January 1, 2020, Oncocyte had no revenues and no cost of revenues.

Research and development expenses for fourth quarter of 2020 were $1.8 million as compared to $2.3 million for the same period in 2019, a decrease of $0.5 million, primarily due to reduced clinical trial expenses of DetermaDx. Research and development expenses for the year ended December 31, 2020, were $9.8 million as compared to $6.8 million for the same period in 2019, an increase of $3.0 million primarily attributable to increased investment in DetermaIO, personnel and related expenses.

General and administrative expenses for the fourth quarter of 2020 were $3.4 million, as compared to $4.2 million for the same period in 2019, a decrease of $0.8 million. General and administrative expenses for the year ended December 31, 2020 were $16.8 million, as compared to $13.3 million for the same period in 2019, an increase of $3.5 million, primarily attributable to personnel growth and related expenses.

Sales and marketing expenses for the three and twelve months ended December 31, 2020, were $1.9 million and $6.5 million, as compared to $1.0 million and $2.2 million for the same periods in 2019, respectively. The increases in the respective periods were primarily due to personnel and related expenses for ramp up in sales and marketing activities for the commercialization efforts of DetermaRx as well as market development investments in preparation for the launch of new products in 2021.

Operating losses, as reported, for the fourth quarter of 2020 were $6.3 million, a decrease of $1.2 million from $7.5 million as compared to the fourth quarter of 2019; and operating losses, on an adjusted basis, were $6.2 million, a decrease of $0.5 million from $6.7 million as compared to the fourth quarter of 2019. Operating losses, as reported, for the year ended December 31, 2020 were $29.7 million, an increase of $7.5 million from $22.2 million as compared to the same period in 2019; and operating losses, on an adjusted basis, were $26.5 million, an increase of $7.9 million from $18.6 million as compared to the same period in 2019.

Oncocyte has provided a reconciliation between GAAP and non-GAAP operating losses in the financial tables, included with this earnings release, which it believes is helpful in understanding its ongoing operations.

For the fourth quarter ended December 31, 2020, Oncocyte reported a net loss of $6.3 million, or ($0.09) per share, as compared to $8.0 million, or ($0.15) per share, for the fourth quarter ended December 31, 2019.

For the year ended December 31, 2020, Oncocyte reported a net loss of $29.9 million, or ($0.46) per share compared to $22.4 million, or ($0.44) per share for 2019.

Cash used in operations was approximately $6.2 million for the fourth quarter of 2020 and $26.0 million for the year ended December 31, 2020.

Conference Call Information

The Company will host a conference call today, March 16, at 4:30 pm EDT / 1:30 pm PDT to discuss the results along with recent corporate developments. The dial-in number in the U.S./Canada is 877-407-9716; for international participants, the number is 201-493-6779. For all callers, please refer to Conference ID 13717267. To access the live webcast, go to the investor relations section on the Company’s website, or by clicking here: View Source The webcast replay will be available on the Oncocyte website for 90 days following the completion of the call.

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

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Financial Highlights for Full Year 2020

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

Monjuvi (tafasitamab-cxix):

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

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

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

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

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

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

Financial Review for the Full Year 2020 (IFRS)

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

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

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

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

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

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

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

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

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

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

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

Financial Guidance and Operational Outlook for 2021

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

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

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

Tafasitamab

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

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

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

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

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

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

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

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

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

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

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

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

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