On January 11, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported 2021 financial guidance and commented on its outlook for the year (Press release, Halozyme, JAN 11, 2021, View Source [SID1234573793]).

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"2020 was a year of tremendous accomplishment at Halozyme highlighted by our successful transition to revenue growth and profitability, 2 U.S. FDA approvals and 2 European Commission approvals for ENHANZE partner products, and successful completion of $150 million in share repurchases in 2020," said Dr. Helen Torley, president and chief executive officer. "We are delighted with the strong first six months post launch market adoption of DARZALEX FASPRO in the US, which drove a return to royalty revenue growth in 2020. In 2021 we expect continued strong revenue and earnings growth driven by continued uptake of subcutaneous DARZALEX in US and international markets and by uptake of Roche’s Phesgo, which received approval from the European Commission in late December 2020. In addition, we expect to create catalysts for growth well into the future based on the advancement of multiple partners’ ENHANZE drug development programs."

Anticipated 2021 Key Events :

Strong subcutaneous DARZALEX (daratumumab) royalty revenue growth driven by continued US and international market uptake;
Potential Ministry of Health, Labour and Welfare approval in Japan for Janssen’s subcutaneous DARZALEX utilizing ENHANZE;
Potential U.S. FDA approval of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in light chain amyloidosis;
Strong Phesgo (pertuzumab, trastuzumab and hyaluronidase) royalty revenue growth driven by adoption in US and Europe;
Two new products entering Phase 3 development, resulting in a total of 4 products in Phase 3, including Roche’s TECENTRIQ (atezolizumab) and argenx’s efgartigimod;
Five new Phase 1 trial starts for ENHANZE partner programs resulting in a total of 13 Phase 1 studies completed or ongoing by end of 2021;
Continued commitment to capital return with up to $125 million in share repurchases anticipated in 2021 as part of the $550 million three-year share repurchase plan authorized by Halozyme’s board of directors in November 2019.
2021 Financial Guidance

For 2021, Halozyme expects revenues of $375 million to $395 million, representing growth of approximately 40% to 45% over 2020 expected revenue. This revenue guidance, per the Company’s standard practice, excludes any potential new ENHANZE deals. Notably, in comparison to 2020 expected results the Company expects a doubling in revenue from royalties, a significant increase in product sales related to API, and revenue under collaborative agreements in a similar range to the substantial milestones expected in 2020.

The Company further expects GAAP earnings per share of $1.40 to $1.55, representing growth of approximately 55% to 70% over 2020 expected EPS. Guidance includes the impact of an accounting change for convertible notes which eliminates non-cash interest expense.

Table 1. 2021 Financial Guidance

Guidance Range

Net Revenue

$375 million to $395 million

Earnings Per Share (GAAP)

$1.40 to $1.55

The Company plans to report fourth quarter and full year 2020 financial results on February 23, 2021.

On January 11, 2021 Clovis Oncology, Inc. (NASDAQ:CLVS) reported its preliminary, unaudited global product revenues for the fourth quarter and full year ended December 31, 2020 (Press release, Clovis Oncology, JAN 11, 2021, View Source [SID1234573792]). The financial information presented in this news release may be adjusted as a result of completion of customary quarterly review and audit procedures.

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Unaudited preliminary results include:

$43.0M – $43.5M in estimated Rubraca global product revenues for the fourth quarter of 2020 compared to $38.8M for Q3 2020 and $39.3M for Q4 2019;
U.S. product revenues of approximately $36.3M – $36.7M and E.U. of $6.5M – $6.8M
Highest quarterly global and E.U. product revenues to date
$164.2M -$164.7M in estimated Rubraca product revenues for FY 2020 compared to $143.0M for FY 2019
Approximately $240M in cash and cash equivalents at December 31, 2020 which is expected to fund the Company’s operating plan into early 2023 based on current revenue and expense forecasts
Clovis plans to discuss these results with investors this week at the 39th Annual J.P. Morgan Healthcare Conference which is being held virtually January 10-14, 2021.

"We are pleased with our strong finish to a challenging year, including achieving record quarterly and annual sales," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We believe we have set the stage for an important year in 2021, as we seek to continue to grow Rubraca sales and advance our pipeline, including plans to report top-line ATHENA monotherapy data in the second half of the year, initiate a clinical development program for FAP-2286 in the first half of the year, and show initial efficacy data for the LIO-1 lucitanib and Opdivo combination trial at a medical meeting this year."

Clovis Oncology to Present at 39th Annual J.P. Morgan Healthcare Conference on January 12
Clovis’ President and CEO, Patrick J. Mahaffy, will present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12 at 4:30 p.m. ET. A live webcast of the presentation/Q&A session can be accessed through the investor relations section of the Company’s website at clovisoncology.com. Approximately 24 hours following the live presentation, a replay of the webcast will be available on the Company’s website for 30 days.

Fourth Quarter and Full Year 2020 Financial Results Release Planned for February 23
The Company plans to report financial results for the fourth quarter and full year ended December 31, 2020 on Tuesday, February 23, 2021, before the open of the U.S. financial markets. Clovis’ senior management will host a conference call and live audio webcast at 8:30 a.m. ET to discuss the Company’s results in greater detail.

About Rubraca (rucaparib)
Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Additionally, Rubraca is approved in the U.S. for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The TRITON3 clinical trial is expected to serve as the confirmatory study for the Rubraca accelerated approval in mCRPC.

In Europe, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Rubraca is also approved in Europe for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

Rubraca is an unlicensed medical product outside of the U.S. and Europe.

About Lucitanib

Lucitanib is an investigational angiogenesis inhibitor, which inhibits vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs may reverse this immunosuppression and augment response to immunotherapy. Clovis holds global rights for lucitanib excluding China.

Lucitanib is an unlicensed medical product.

About FAP-2286

FAP-2286 is a preclinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two parts; a peptide that binds to FAP and a linker and site that can be used to attach radiation for imaging and therapeutic use. FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas.i Clovis holds U.S. and global rights for FAP-2286 excluding Europe, Russia, Turkey and Israel.

FAP-2286 is an unlicensed medical product.

On January 11, 2021 Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer immunotherapies to fight multiple cancer types, reported that Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer, will present a company overview on Thursday, January 14, 2021 at 5:20 p.m. ET during the 39th Annual J.P. Morgan Healthcare Conference (Press release, Gritstone Oncology, JAN 11, 2021, View Source [SID1234573791]).

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A live webcast will be available within the Investors & Media section of the Gritstone Oncology website at View Source An archived replay will be accessible for 30 days following the event.

On January 11, 2021 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported its key accomplishments in 2020 and updated its corporate priorities (Press release, Zymeworks, JAN 11, 2021, View Source [SID1234573790]).

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"2020 was a leap forward for our lead clinical program in terms of a potential first approval and future approvals," said Ali Tehrani, Ph.D., President and CEO at Zymeworks. "The launch of our first pivotal trial and achievement of Breakthrough Therapy designation for zanidatamab mark important milestones towards our accelerated commercialization strategy, and our new clinical partnerships further strengthen zanidatamab’s broad therapeutic profile. 2021 promises to be a data-rich year for both zanidatamab and ZW49 as we continue to demonstrate their potential to become foundational therapies in the treatment of HER2-expressing cancers."

2020 Achievements

Zanidatamab Enters Late-Stage Clinical Development with Accelerated Strategy

Zymeworks initiated a global pivotal trial (HERIZON-BTC-01) for zanidatamab monotherapy in patients with previously treated HER2 gene-amplified biliary tract cancer (BTC). This single arm trial is designed to support accelerated approval based on a primary endpoint of objective response rate and may enable submission of a Biologics License Application (BLA) as early as 2022.
Zanidatamab received additional drug review special designations in the U.S. and the European Union. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for BTC and the European Commission (EC) granted Orphan Drug designation for gastroesophageal adenocarcinoma (GEA), expediting potential commercialization. Previously the FDA granted two Fast Track designations to zanidatamab, in BTC and GEA, in addition to Orphan Drug designations for BTC, GEA, and ovarian cancer.
Zanidatamab Data and Partnerships Continue to Support Broad Therapeutic Potential

Gastric Cancer: Clinical data from patients with refractory GEA treated with zanidatamab monotherapy as well as zanidatamab in combination with chemotherapy were updated and support plans to launch a second pivotal trial as 1st line treatment for advanced HER2-positive GEA in mid-2021 with partner BeiGene. These data will be updated as part of an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, January 15, 2021.
Breast Cancer: Clinical collaborations were initiated to evaluate zanidatamab in combination with a CD47 blocker (ALX Oncology’s ALX148) in patients with advanced HER2‑expressing breast cancer and with a CDK4/6 inhibitor (Pfizer’s Ibrance) in patients with HER2‑positive, HR-positive breast cancer.
Endometrial Cancer: Zymeworks’ first investigator-led trial was initiated by Dr. Vicky Makker at Memorial Sloan Kettering Cancer Center. The Phase 2 trial will evaluate zanidatamab monotherapy in HER2-overexpressed advanced endometrial cancers and carcinosarcomas.
Clinical Advancement of HER2 Bispecific ADC, ZW49, for HER2 Expressing Cancers

ZW49 is being evaluated in a Phase 1 clinical trial as a treatment for patients with locally advanced or metastatic HER2-expressing cancers that have progressed following treatment with existing approved therapies, including HER2-targeted agents. Clinical studies continued in 2020 with dose escalation to determine the safety and efficacy profile of ZW49. Zymeworks will be providing a clinical progress update for ZW49 by webcast on Wednesday, January 27, 2021 at 4:30 pm ET.
Commercial, Clinical and Scientific Competencies Added to Leadership Team

Zymeworks welcomed key commercial, scientific and clinical development talent to the leadership team with the additions of Guowei Fang, Ph.D., as Senior Vice President, Research, James Priour as Senior Vice President, Commercial, Manny Duenas as Vice President, Global Value and Access, and Pamela Farmer, MD, as Vice President, Global Patient Safety.
Partnerships Advance: Milestone Payments Received and Deal Values Increase

Our partnerships continued to advance in 2020 with Iconic/Exelixis achieving a milestone for ZymeLink together with new and expanded Azymetric and EFECT collaborations with Merck and BMS. Zymeworks has nine active collaborations that could result in up to US$8.6 billion in potential milestone payments in addition to royalties on potential product sales.
Balance Sheet Strengthened and Cash Runway Extended

In early 2020, Zymeworks completed an oversubscribed public financing raising US$320.8 million, extending its runway into 2022 and potentially beyond. The Company also received non-dilutive capital from several of its pharmaceutical partners.
Updated Corporate Priorities

Complete enrolment of zanidatamab pivotal trial in HER2+ biliary tract cancer
Launch pivotal trial in 1st line HER2+ GEA and present supporting Phase 2 clinical data
Present data to support zanidatamab breast cancer development strategy
Advance ZW49 into and complete cohort expansion
Present data from new therapeutic programs and technology platforms

On January 11, 2021 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, and Zai Lab (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, reported an expansion of their collaboration (Press release, Zai Laboratory, JAN 11, 2021, View Source [SID1234573787]).

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Under the terms of the new agreement, Zai Lab will obtain exclusive rights to develop and commercialize TPX-0022, Turning Point’s MET, SRC and CSF1R inhibitor, in Greater China, which includes mainland China, Hong Kong, Macau and Taiwan. Turning Point will receive a $25 million upfront payment, with up to approximately $336 million in potential development, regulatory and sales-based milestone payments. Turning Point will also be eligible to receive mid-teen- to low-twenty-percent royalties based on annual net sales of TPX-0022 in Greater China. In addition, Turning Point will have the right of first negotiation to develop and commercialize an oncology drug candidate discovered by Zai Lab.

This agreement builds on Zai Lab and Turning Point’s existing relationship under the exclusive licensing agreement announced by the companies in July 2020, under which Zai Lab gained the exclusive right to develop and commercialize Turning Point’s lead drug candidate, repotrectinib, in Greater China.

"The higher incidence of MET-driven cancers – particularly in gastric and lung cancer – in Asian countries led us to initiate the development of TPX-0022 in Greater China following our encouraging initial data from the Phase 1 SHIELD-1 study," said Athena Countouriotis, M.D., president and chief executive officer of Turning Point. "We have great confidence in Zai Lab as our partner to advance this important drug candidate in a key region of the world. Zai Lab also has a promising discovery pipeline and we are pleased to receive the right of first negotiation for a drug candidate from Zai’s discovery pipeline."

Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab, said, "Turning Point has assembled a formidable pipeline of next-generation oncology target therapies, and we are very pleased to broaden our global collaboration and strategic partnership. We believe TPX-0022 is a promising drug candidate that is also highly synergistic with our portfolio in gastric and lung cancer."

Jin Li, M.D., Professor, Chairman of Chinese Society of Clinical Oncology Foundation and Director of Department of Oncology, Tongji University Shanghai East Hospital said, "The initial safety and efficacy data for TPX-0022 are promising, and its novel mechanism to target MET, SRC and CSF1R encourages us to investigate its therapeutic potential further. We are particularly interested in the early but promising findings in patients with MET-driven gastric cancer and look forward to advancing the study of TPX-0022 in this area of high unmet need in China."

Initial data from the SHIELD-1 study reported in a late-breaker oral presentation at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) symposium highlighted preliminary clinical activity, including objective responses across multiple tumor types and a generally tolerable safety profile.

About TPX-0022

TPX-0022 is an orally bioavailable multi-targeted kinase inhibitor with a novel three-dimensional macrocyclic structure that inhibits the MET, CSF1R (colony stimulating factor 1 receptor) and SRC kinases. TPX-0022 has completed IND-enabling studies and cleared its IND. During the second half of 2019, Turning Point initiated the SHIELD-1 Phase 1 clinical trial of TPX-0022 for the treatment of advanced or metastatic solid tumors with abnormal MET/HGF or CSF1R/SCF1R signaling.

MET is a receptor tyrosine kinase that binds with high affinity to hepatocyte growth factor (HGF). MET alterations, including point mutations, amplifications, fusions, exon 14 skipping, and the generation of HGF-MET autocrine loops have been reported in many cancers. MET amplification has been detected in up to 20 percent of non-small cell lung cancer patients with EGFR mutations who acquired resistance to Iressa (gefitinib), Tarceva (erlotinib) or Tagrisso (osimertinib) treatment. SRC is a kinase involved in the MET signaling pathway. Inhibition of SRC has the potential to reduce or abolish the upregulation of HGF. Targeting CSF1R leads to the modulation of tumor-associated macrophages (TAMs), a type of immune cell that suppresses the T-cell mediated anti-tumor immune response, which is a promising therapeutic strategy for TPX-0022 as a single agent or in combination with standard of care chemotherapy and immunotherapy in various solid tumors.