On February 11, 2021 Seagen Inc. (Nasdaq:SGEN) reported financial results for the fourth quarter and year ended December 31, 2020 (Press release, Seagen, FEB 11, 2021, View Source [SID1234574919]). The Company also highlighted ADCETRIS (brentuximab vedotin), PADCEV (enfortumab vedotin-ejfv) and TUKYSA (tucatinib) commercial and development accomplishments, as well as progress with its lead pipeline programs to treat cancer.

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"In 2020, we generated record product revenues of more than $1 billion driven by successful launches of PADCEV and TUKYSA, as well as continued growth of ADCETRIS," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seagen. "These strong results are in addition to several significant business, regulatory and development accomplishments during the year. Looking ahead, we are focused on maximizing the global potential of our approved medicines, advancing our late-stage programs towards securing approvals of new products, and expanding our innovative early-stage pipeline. In collaboration with our partner Genmab we submitted a BLA for tisotumab vedotin to the FDA, positioning it to be our fourth commercial product. We are on track for several other milestones across our pipeline over the course of 2021, and are in a strong financial position to continue executing against our goals."

COMMERCIAL PRODUCT HIGHLIGHTS

ADCETRIS

Presented 5-year Follow-up Results for ECHELON-1 and ECHELON-2 Trials at the ASH (Free ASH Whitepaper) Annual Meeting: Key long-term updates for two phase 3 ADCETRIS trials were presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting. Notably, the five-year update of the phase 3 ECHELON-1 clinical trial showed treatment with ADCETRIS in combination with AVD (Adriamycin [doxorubicin], vinblastine and dacarbazine) resulted in superior long-term outcomes when compared to ABVD, which includes bleomycin, in frontline advanced Hodgkin lymphoma.
PADCEV

Reporting Phase 3 EV-301 and EV-201 Cohort 2 Data in Oral Presentations at ASCO (Free ASCO Whitepaper) GU; Regulatory Submissions Planned: Full results from the phase 3 EV-301 trial and the second cohort of the pivotal phase 2 EV-201 trial will be presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Genitourinary Cancers Symposium (ASCO-GU) being held February 11-13. Both trials were conducted in patients with previously treated locally advanced or metastatic urothelial cancer. The EV-301 data are intended to support global registration submissions planned for the first quarter of 2021. The results from the second cohort of EV-201 will support a supplemental Biologics License Application (BLA) submission with the U.S. Food and Drug Administration (FDA) planned for the first quarter of 2021.
Initiated Second Phase 3 Trial in Muscle Invasive Bladder Cancer (MIBC): In collaboration with Astellas and Merck, the randomized phase 3 EV-304/KEYNOTE-B15 trial was initiated to evaluate PADCEV in combination with KEYTRUDA (pembrolizumab) in cisplatin-eligible MIBC. This is in addition to the ongoing randomized phase 3 study, EV-303/KEYNOTE-905, in cisplatin-ineligible MIBC patients.
TUKYSA

Received Positive CHMP Opinion for TUKYSA: In December 2020, the European Medicines Agency adopted a positive opinion recommending the approval of TUKYSA in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least 2 prior anti-HER2 treatment regimens. The CHMP positive opinion is now being considered by the European Commission, which has the authority to approve medicines in the European Union.
Presented Multiple TUKYSA Abstracts at SABCS: In December 2020, eight abstracts highlighted Seagen’s commitment to addressing unmet needs in breast cancer at the San Antonio Breast Cancer Symposium (SABCS). One presentation provided new exploratory analyses from the pivotal HER2CLIMB trial in metastatic HER2-positive breast cancer that demonstrated progression-free survival, overall survival and objective response rate improvements with TUKYSA were observed consistently across hormone receptor status subgroups, including in patients with brain metastases.
PIPELINE HIGHLIGHTS

Submitted Tisotumab Vedotin BLA to FDA: In February 2021, Seagen and Genmab submitted a BLA to the FDA seeking accelerated approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Results from the innovaTV 204 trial formed the basis of the submission.
Initiated Phase 3 Trial of Tisotumab Vedotin: A phase 3 trial, called innovaTV 301, was initiated to evaluate tisotumab vedotin compared to chemotherapy in patients with recurrent or metastatic cervical cancer who have received one or two prior lines of therapy. innovaTV 301 is intended to support global regulatory applications and potentially serve as a confirmatory trial in the U.S.
Treated First Patient in Phase 1 Trial of SGN-STNV: In January 2021, the first patient was dosed in a phase 1 trial of SGN-STNV, a novel antibody-drug conjugate (ADC) targeting Sialyl Thomsen-nouveau (STN). STN is highly expressed across multiple solid tumors.
For additional information on Seagen’s pipeline, visit www.seagen.com/science/pipeline.

FOURTH QUARTER AND FULL YEAR 2020 FINANCIAL RESULTS

Revenues: Total revenues in the fourth quarter and year ended December 31, 2020 increased to $601.3 million and $2.2 billion, respectively, compared to $289.8 million and $916.7 million for the same periods in 2019. Revenues were comprised of the following three components:

Note: Sum of product sales may not equal total net product sales due to rounding.

Royalty Revenues: Royalty revenues in the fourth quarter were $39.2 million, compared to $72.3 million in the fourth quarter of 2019. The fourth quarter of 2019 included a $40 million milestone from Takeda triggered by annual net sales exceeding $400 million in Takeda’s territory during 2019. Royalty revenues were $126.8 million for the full year in 2020, compared to $138.5 million in 2019. Royalty revenues are primarily driven by sales of ADCETRIS outside the U.S. and Canada by Takeda and, to a lesser extent, also include royalties from sales of POLIVY (polatuzumab vedotin) by Roche and BLENREP (belantamab mafodotin) by GlaxoSmithKline, which are ADCs that use Seagen technology.
Collaboration and License Agreement Revenues: Amounts earned under the Company’s collaboration and license agreements were $267.9 million in the fourth quarter and $1.0 billion for the full year in 2020, compared to $51.1 million and $150.2 million, respectively, for the same periods in 2019. The fourth quarter of 2020 included $250.1 million in revenue related to the premium over market price paid by Merck under a $1 billion stock purchase that closed in October 2020 as part of the ladiratuzumab vedotin collaboration agreement. The full year in 2020 included $975.1 million in license revenue related to the Merck collaborations for ladiratuzumab vedotin and TUKYSA that were entered into in September 2020.
Cost of Sales: Cost of sales in the fourth quarter were $61.8 million, compared to $11.9 million in the fourth quarter of 2019. Cost of sales were $217.7 million for the full year in 2020, compared to $44.0 million for the same period in 2019. The increases in 2020 were primarily due to the gross profit share payment to Astellas based on PADCEV sales, which were $32.1 million and $104.6 million in the fourth quarter and full year, respectively. Cost of sales for the periods in 2020 also reflect amortization of acquired in-process technology costs that began with the approval of TUKYSA in April 2020, and third-party royalties owed for ADCETRIS, PADCEV and TUKYSA net product sales. Cost of sales for the year in 2020 included a payment owed to a third-party technology licensor related to the TUKYSA license agreement with Merck reflected in the third quarter of the year.

Research and Development (R&D) Expenses: R&D expenses in the fourth quarter were $216.2 million, compared to $201.1 million in the fourth quarter of 2019. R&D expenses were $827.1 million for the full year in 2020, compared to $719.4 million in 2019. The increase in 2020 primarily reflected continued investment in the Company’s pipeline.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses in the fourth quarter were $158.4 million, compared to $115.2 million in the fourth quarter of 2019. SG&A expenses were $533.8 million for the full year in 2020, compared to $373.9 million for the same period in 2019. The increases were primarily attributed to increased field sales personnel in the U.S. for Seagen’s recently commercialized products, PADCEV and TUKYSA, as well as higher infrastructure costs to support the Company’s continued growth and international expansion.

Non-cash share-based compensation cost for the full year in 2020 was $147.2 million, compared to $127.3 million for the same period in 2019.

Net Income / Loss: Net income for the fourth quarter of 2020 was $167.1 million, or $0.90 per diluted share, compared to net income of $25.8 million, or $0.14 per diluted share, for the fourth quarter of 2019. For the full year in 2020, net income was $613.7 million, or $3.37 per diluted share, compared to a net loss of $158.7 million, or $0.96 per diluted share, for the year in 2019. Net income for 2020 was driven by the revenue recognized in the third and fourth quarters under the Merck collaborations. Seagen utilized federal net operating loss carryforwards as allowed, however the Company incurred income taxes in certain states which resulted in an income tax provision of $2.0 million for the year in 2020.

Cash and Investments: As of December 31, 2020, Seagen had $2.7 billion in cash and investments. This includes proceeds from a $1.0 billion equity investment by Merck, which closed in October 2020.

2021 FINANCIAL OUTLOOK

Seagen anticipates 2021 revenues, operating expenses and other costs to be in the ranges shown in the table below.

Revenues

1. Non-cash costs include share-based compensation, depreciation and amortization of intangible assets.

Conference Call Details

Seagen management will host a conference call and webcast with supporting slides to discuss its fourth quarter and full year 2020 financial results and provide an update on business activities. The event will be held today at 1:30 p.m. Pacific Time (PT); 4:30 p.m. Eastern Time (ET). The live event and supporting slides will be simultaneously webcast and available for replay from the Seagen website at www.seagen.com, under the Investors section. Investors may also participate in the conference call by calling 844-763-8274 (U.S.) or 412-717-9224 (international). The conference ID is 10150708. A webcast replay will be archived on the Company’s website www.seagen.com, under the Investors section.

On February 11, 2021 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation therapies targeting the tumor microenvironment, reported that Robert Ross, M.D., who has served as chief medical officer at Surface Oncology since 2016, will become the company’s president and chief executive officer and will also be appointed to the board of directors (Press release, Surface Oncology, FEB 11, 2021, View Source [SID1234574935]). Rob will succeed current CEO Jeff Goater, who will assume the role of chairman of the Surface Oncology board of directors.

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"Surface has evolved significantly over the past year into a development stage company with multiple promising immuno-oncology programs in clinical development," Rob said. "Together with our outstanding leadership team and all of Surface’s dedicated employees, I look forward to building on that success and leading the company at this important transition point as we continue to advance and expand our pipeline of novel therapies for patients with cancer."

In addition to the CEO transition, Daniel Lynch, who currently serves as the chairman of the board of directors, will transition to a senior advisory role with the company. Geoffrey McDonough, M.D., who currently serves as a director, will be appointed to the new role of lead independent director of the board. These transitions will also become effective on April 1, 2021.

"We are delighted that Rob will be the next CEO of Surface Oncology," Jeff said. "Rob has been a key contributor to Surface’s overall success. His leadership within the organization stretches well beyond clinical development, and his breadth of expertise will be a key driver of our success going forward. With four Surface programs expected to be in clinical development by the end of 2021, including our two wholly owned programs SRF617 and SRF388, Rob is the ideal person to lead the company through its next phase of growth. I also want to thank Dan for his support and guidance over the years. His contributions to Surface’s success have been significant."

Prior to joining Surface, Rob served as head of oncology at bluebird bio, building a multifaceted oncology program. Before bluebird bio, he worked at Genentech and Infinity Pharmaceuticals on both small molecule and antibody programs from Phase 1 through pivotal trials. Rob was a faculty member at the Dana Farber Cancer Institute as a genitourinary oncologist. He earned his bachelor’s degree from Stanford University, his master’s degree from Harvard Medical School and his medical degree from Columbia University Vagelos College of Physicians and Surgeons. Rob was a resident in internal medicine at the University of California, San Francisco and an oncology fellow in the Dana Farber/Massachusetts General Brigham program.

On February 11, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer,reported it will release its fourth quarter 2020 financial results after the market closes on Thursday, February 25, 2021 (Press release, Personalis, FEB 11, 2021, View Source [SID1234574954]). In conjunction with the release, the Company will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.

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Interested parties may access the live call via telephone by dialing (866) 990-1997 for domestic callers or (470) 495-9127 for international callers, using conference ID: 5065084. The live webinar of the call may be accessed by visiting the Events section of the company’s website at investors.personalis.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

On February 11, 2021 Cyteir Therapeutics, a leader in the discovery and development of next-generation synthetic lethal therapies for cancer, reported the close of an oversubscribed $80 million Series C financing (Press release, Cyteir Therapeutics, FEB 11, 2021, View Source [SID1234577663]). The company will use the new funds to advance its lead compound, the first-in-class inhibitor of RAD51-mediated DNA repair, CYT-0851, into phase 2 monotherapy trials in hematologic cancers and solid tumors, to initiate trials combining CYT-0851 with other cancer therapies, and to expand preclinical research to identify and advance additional novel cancer therapies.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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RA Capital Management led the round with Janus Henderson Investors, Acuta Capital Partners, Ally Bridge Group, Avidity Partners, Ample Plus Fund, and CaaS Capital Management, joined by existing investors Novo Holdings, Venrock, Lightstone Ventures, DROIA Ventures, Osage University Partners (OUP), and another undisclosed U.S.-based, healthcare-focused fund. Cyteir has now raised over $140 million in total to support its novel, synthetic lethal approach to cancer therapy.

"Our unique approach to inhibiting RAD51-mediated DNA repair allows us to potentially target hematologic cancers as well as solid tumors with reduced toxicity as compared to other DDR inhibitors," said Markus Renschler, M.D., Cyteir president and CEO. "This advantage and the speed at which we’ve advanced our lead program from discovery to the clinic has enabled us to secure interest and investment from multiple, high-tier healthcare investors. We’re grateful for their support, which will fund phase 2 studies of CYT-0851 monotherapy scheduled to begin later this year, as well as clinical studies beginning mid-year that will further explore its potential in combination with other cancer therapies."

CYT-0851 is an oral, once daily, first-in-class small-molecule inhibitor of RAD51-mediated DNA repair. Preclinical and early clinical findings support the broad potential for CYT-0851 to selectively target various cancers, including B-cell malignancies such as non-Hodgkin lymphoma, and solid tumors. The findings also suggest there is significant potential to combine CYT-0851 with other therapies that target or induce DNA damage, such as PARP inhibitors and chemotherapy. CYT-0851 is currently being evaluated in the dose-escalation portion of a Phase 1/2 monotherapy trial enrolling approximately 200 patients with solid tumors and hematologic malignancies at leading U.S. cancer centers. Cyteir expects to enter phase 2 later this year.

"We are intrigued by the potential of RAD-51 inhibition, particularly due to early findings suggesting it could be helpful in treating lymphomas and other hematologic malignancies," said Derek DiRocco, Ph.D., partner, RA Capital Management. "This promising mechanism, coupled with the demonstrated efficiency and expertise of Cyteir’s leadership team, inspired us to support the next stages of their exciting development program."

Cyteir is leveraging its expertise in DNA damage response (DDR) to create a pipeline of novel, first-in-class drugs that selectively target a key cancer vulnerability. Cancer cells are acutely reliant on DNA damage repair for their survival and growth; inhibiting key DNA-repair pathways causes them to become overwhelmed by their own damage and self-destruct, a validated scientific approach known as synthetic lethality. Cyteir is pursuing a novel application of synthetic lethality based on the discovery that many tumors rely on a specific DNA-repair pathway that is dependent on the protein RAD51 to repair breaks in DNA.

Beyond CYT-0851, Cyteir is actively identifying, prioritizing and evaluating DDR pathway targets based on their role in cancer and whether they have an identifiable patient population that could be predicted to benefit from targeted therapy. The company will use a portion of the Series C financing to initiate IND-enabling studies for CYT-1853, a second-generation RAD51 inhibitor. Cyteir also plans to initiate IND-enabling studies in 2023 for an undisclosed discovery compound targeted for the treatment of solid tumors.

Finally, Cyteir is developing a companion diagnostic assay to identify patients whose tumors overexpress certain cytidine deaminases, which may suggest that their cancer is more susceptible to CYT-0851. The company has received an investigational device exemption (IDE) from the U.S. Food and Drug Administration to begin evaluating this companion diagnostic in patients.

On February 11, 2021 Veracyte, Inc. (Nasdaq: VCYT), a global genomic diagnostics company, reported that Bonnie Anderson, chairman and chief executive officer, will participate in a fireside chat at the BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference on Thursday, February 18, at 1:30 p.m. Eastern Time (Press release, Veracyte, FEB 11, 2021, View Source [SID1234574920]).

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The link to the live audio webcast of the company’s presentation will be available by visiting Veracyte’s website at View Source A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.