On February 7, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported financial results for the fourth quarter and year ended December 31, 2018 (Press release, Seattle Genetics, FEB 7, 2019, View Source [SID1234533134]).

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The company also highlighted ADCETRIS (brentuximab vedotin) commercialization and clinical development accomplishments and progress with its late-stage clinical programs for cancer.

"During 2018, we received FDA approval for two ADCETRIS frontline indications, a major accomplishment that significantly expands the number of patients eligible to benefit from treatment. These approvals for frontline advanced Hodgkin lymphoma and CD30-expressing peripheral T-cell lymphoma (PTCL) were based on phase 3 data showing superior efficacy of the ADCETRIS-containing regimens compared to combination chemotherapy agents that have been used for decades," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "Additionally, we made progress in 2018 with our late-stage clinical programs, leading to important anticipated milestones this year. Notably, we expect to report top-line data in the first quarter of 2019 from the pivotal trial of enfortumab vedotin in metastatic urothelial cancer and to report top-line data later in the year from the pivotal trial of tucatinib in HER2-positive metastatic breast cancer. Taken together, we are positioned to establish ADCETRIS as the standard of care in the frontline setting in both advanced Hodgkin lymphoma and CD30-expressing PTCL, and realize our vision of becoming a company with multiple oncology products addressing unmet medical needs."

ADCETRIS Program Highlights

New Indication for CD30-Expressing Frontline PTCL: In November 2018, the U.S. Food and Drug Administration (FDA) approved ADCETRIS in combination with chemotherapy for adults with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified. The approval is based on the successful outcome of the ECHELON-2 phase 3 clinical trial. The FDA granted Breakthrough Therapy Designation in this setting and reviewed the application under the Real-Time Oncology Review Pilot Program leading to approval less than two weeks after submission of the supplemental Biologics License Application (BLA).
New Indication in Canada: Health Canada approved ADCETRIS for the treatment of adult patients with primary cutaneous ALCL or CD30-expressing mycosis fungoides who have had prior systemic therapy.
Multiple Abstracts at ASH (Free ASH Whitepaper): In addition to the presentation of ECHELON-2 data, which were also simultaneously published in The Lancet, ADCETRIS was featured in more than 30 data presentations at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting from both corporate and investigator-led clinical trials. The trials highlighted the potential application of ADCETRIS as monotherapy and as part of combination regimens in a range of CD30-expressing lymphomas.
Enfortumab Vedotin (EV) Program Highlights

EV-201 Pivotal Trial Data in First Quarter 2019: Seattle Genetics and Astellas expect to report top-line data in the first quarter of 2019 from the ongoing EV-201 pivotal trial evaluating EV in patients with locally advanced or metastatic urothelial cancer who previously received both platinum chemotherapy and a checkpoint inhibitor (PD-1 or PD-L1). Data from this trial could serve as the basis for a BLA submission under the FDA’s accelerated approval pathway.
Multiple Trials Enrolling: Seattle Genetics and Astellas continue enrollment in the global randomized phase 3 clinical trial called EV-301 for patients with locally advanced or metastatic urothelial cancer who were previously treated with a PD-1 or PD-L1 inhibitor and a platinum-containing regimen. EV-301 is intended to support global regulatory submissions for approval and serve as a confirmatory trial in the United States. Additionally, enrollment is ongoing in the phase 1 trial called EV-103 in earlier lines of locally advanced or metastatic urothelial cancer, including first-line, evaluating EV in combination with pembrolizumab and/or platinum agents.
Tucatinib Program Highlights

HER2CLIMB Pivotal Trial Data in 2019: Seattle Genetics achieved enrollment of 480 patients in the HER2CLIMB pivotal trial to enable analysis of the primary endpoint of PFS, with top-line data expected to be reported in 2019. In addition, HER2CLIMB enrollment is continuing up to 600 patients, to support the analyses of key secondary endpoints, including overall survival as well as progression-free survival in patients with brain metastases. The company anticipates completing enrollment of the additional patients in mid-2019.
Tisotumab Vedotin (TV) Program Highlights

innovaTV 204 Pivotal Trial Enrollment: Seattle Genetics and Genmab expect to complete enrollment by mid-2019 in the pivotal innovaTV 204 trial evaluating TV in patients with recurrent and/or metastatic cervical cancer who have relapsed or progressed after standard of care treatment.
Broad Development Program: Seattle Genetics and Genmab are evaluating TV in multiple ongoing or planned clinical trials, including trials in earlier-stage cervical cancer and in multiple types of other solid tumors.
Other Recent Activities

Initiated Phase 1 Trial of SEA-BCMA: Seattle Genetics announced the dosing of the first patient in a phase 1 trial evaluating the safety and tolerability of SEA-BCMA in relapsed or refractory multiple myeloma. SEA-BCMA is an empowered antibody using the company’s proprietary Sugar Engineered Antibody (SEA) technology designed to enhance antibody dependent cellular cytotoxicity.
ADC Collaborator Regulatory Submission: In December 2018, Roche submitted regulatory applications in the U.S. and the European Union for approval of polatuzumab vedotin to treat patients with relapsed or refractory diffuse large B-cell lymphoma. Polatuzumab vedotin utilizes Seattle Genetics’ proprietary antibody-drug conjugate (ADC) technology.
FOURTH QUARTER AND FULL YEAR 2018 FINANCIAL RESULTS

Revenues: Total revenues in the fourth quarter and year ended December 31, 2018 increased to $174.5 million and $654.7 million, respectively, compared to $129.6 million and $482.3 million for the same periods in 2017. Revenues are comprised of the following three components:

Product Revenues: ADCETRIS net sales in the U.S. and Canada for the fourth quarter were $132.1 million, a 58 percent increase over net sales of $83.7 million in the fourth quarter of 2017. ADCETRIS net sales in the U.S. and Canada were $476.9 million for the full year in 2018, a 55 percent increase over net sales of $307.6 million for the same period in 2017. Growth over 2017 reflects ADCETRIS label expansions in 2018, most notably in frontline Stage III and IV Hodgkin lymphoma in March 2018 and to a lesser degree in frontline CD30-expressing PTCL in November 2018.
Royalty Revenues: Royalty revenues in the fourth quarter were $24.6 million, compared to $20.0 million in the fourth quarter of 2017. Royalty revenues were $83.4 million for the full year in 2018, compared to $66.1 million for the same period in 2017. Royalty revenues are primarily driven by sales of ADCETRIS outside the U.S. and Canada by Takeda.
Collaboration and License Agreement Revenues: Amounts earned under the company’s ADCETRIS and ADC collaborations were $17.8 million in the fourth quarter and $94.4 million for the full year in 2018, compared to $25.9 million and $108.6 million, respectively, for the same periods in 2017.
Research and Development (R&D) Expenses: R&D expenses in the fourth quarter were $149.8 million, compared to $110.5 million in the fourth quarter of 2017. R&D expenses were $565.3 million for the full year in 2018, compared to $456.7 million for the same period in 2017. The increase in 2018 reflects increased investment in the company’s late-stage pipeline and technology acquisition costs in the first quarter of 2018.

Selling, general and administrative (SG&A) Expenses: SG&A expenses in the fourth quarter were $79.5 million, compared to $48.5 million in the fourth quarter of 2017. The increase in SG&A expenses for the fourth quarter of 2018 was primarily driven by the rapid approval and launch of ADCETRIS for frontline CD30-expressing PTCL. SG&A expenses were $261.1 million for the full year in 2018, compared to $167.2 million for the same period in 2017. The increase for the full year in 2018 was primarily related to costs to support the launch of ADCETRIS in the frontline indications as well as transaction costs associated with the acquisition of Cascadian Therapeutics.

Cost of Sales: Cost of sales in the fourth quarter were $30.2 million, compared to $10.2 million in the fourth quarter of 2017. Cost of sales were $66.1 million for the year in 2018, compared to $34.8 million for the same period in 2017. The increases in 2018 reflect an inventory write-off of $18.1 million recorded in the fourth quarter of 2018 related to in-process production that did not meet manufacturing specifications and did not impact availability of product supply required to meet demand for ADCETRIS.

Non-cash, share-based compensation cost for the full year in 2018 was $78.9 million, compared to $63.8 million for the same period in 2017.

Net Loss: Net loss for the fourth quarter of 2018 was $119.8 million, or $0.75 per share, compared to a net loss of $59.2 million, or $0.41 per share, for the fourth quarter of 2017. Net loss in the fourth quarter of 2018 includes a net investment loss of $53.2 million primarily associated with Seattle Genetics’ common stock holdings in Immunomedics, which are marked-to-market. For the full year in 2018, net loss was $222.7 million, or $1.41 per share, compared to a net loss of $125.5 million, or $0.88 per share, for the year in 2017. Net loss for the full year in 2018 includes net investment income of $13.7 million primarily associated with Seattle Genetics’ common stock holdings in Immunomedics. Net loss for both the fourth quarter and the full year in 2018 included a non-cash income tax benefit of $23.7 million related to acquired intangible assets as part of the acquisition of Cascadian Therapeutics.

Cash and Investments: As of December 31, 2018, Seattle Genetics had $459.9 million in cash and investments. In addition, the company held stock investments, primarily in Immunomedics common stock, valued at $113.8 million.

2019 FINANCIAL OUTLOOK

Seattle Genetics anticipates 2019 total revenues to be in the range of $790 million to $840 million, driven by the following components:

ADCETRIS net product sales $610 million to $640 million
Collaboration and license agreement revenues $95 million to $110 million
Royalty revenues $85 million to $90 million

Operating expenses and other costs are expected to be within the following ranges for the year in 2019:

R&D expenses $600 million to $650 million
SG&A expenses $280 million to $310 million
Cost of sales 5 percent to 6 percent
Cost of royalty revenues
Low single digit percent on ex-US sales

Non-cash costs (primarily attributable to share based compensation) $135 million to $145 million

Conference Call Details

Seattle Genetics’ management will host a conference call and webcast with supporting slides to discuss its fourth quarter and full year 2018 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 on the Seattle Genetics website at www.seattlegenetics.com, under the Investors section. Investors may also participate in the conference call by calling 877-260-1479 (domestic) or 334-323-0522 (international). The conference ID is 1660553. A replay of the live event and supporting slides will be available starting on February 7, 2019 on the Seattle Genetics website at www.seattlegenetics.com, under the Investors section, for at least 30 days. A replay of the audio only will be available by calling 888-203-1112 (domestic) or 719-457-0820 (international), using conference ID 1660553. The telephone replay will be available until 5:00 p.m. PT on February 11, 2019.

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On February 7, 2019 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel medical therapy company bringing to market its proprietary CellFX System, reported recent corporate developments, and financial results for the quarter and year-ended December 31, 2018 (Press release, Pulse Biosciences, FEB 7, 2019, View Source [SID1234533132]).

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The Company also announced today treatment of the first of up to 20 patients in a clinical feasibility study to evaluate the CellFX System for acne on the back. This study leverages the unique mechanism of action of the CellFX System in order to target sebaceous glands deep in the dermis, as demonstrated in the previously announced clinical study evaluating NPS for the treatment of facial sebaceous hyperplasia (SH).

Recent Corporate Developments

Demonstrated efficacy of over 99.5% of Sebaceous Hyperplasia (SH) lesions treated with Nano-Pulse Stimulation (NPS) in a clinical feasibility study, the second successful study of a dermatologic application of the Company’s NPS technology platform.
99.5% of the treated lesions were assessed as clear or mostly clear by investigators at the 60-day post-treatment follow-up evaluation.
92% (n=203) of treated lesions were assessed as clear or mostly clear after a single NPS treatment.
Patients rated 78% of lesion outcomes as satisfied or mostly satisfied at study end.
The study data has been accepted for presentation at the upcoming American Academy of Dermatology Annual Meeting by Dr. Girish Munavalli, one of the study’s principal investigators.
Successfully completed a $45 million rights offering, an important financial milestone enabling Pulse Biosciences to accelerate its progress towards commercialization of the CellFX System.
Appointed key personnel focusing on CellFX commercialization:
Promotion of Edward Ebbers to Executive Vice President and General Manager, Dermatology. Mr. Ebbers brings over 35 years of leadership and management experience with major dermatology, pharmaceutical and medical device companies, including extensive experience introducing products with utilization-based revenue models in the private pay aesthetic dermatology market.
Addition of Robert Tyson as Vice President of Sales, North America. Mr. Tyson brings a proven track record as a sales leader with over 20 years of medical technology experience.
"We are pleased with our accomplishments over the past year in advancing our proprietary CellFX System and look forward to achieving key commercialization milestones in 2019," said Darrin Uecker, Pulse Biosciences’ President and Chief Executive Officer.

Acne Clinical Feasibility Study

The objective of the acne clinical feasibility study announced today is to treat up to 20 patients between the ages of 18 and 80 to evaluate the reduction in number and severity of back acne eruptions post CellFX procedures through comparison of the treated to non-treated areas 90-days after the last procedure. Mark Nestor, MD, PhD, managing partner of Skin and Cancer Associates, and Brian Berman, MD, PhD, director of the Center for Clinical and Cosmetic Research in Miami and a past Vice President of the American Academy of Dermatology, are the principal investigators on the study.

"We are very excited to enroll our first back acne patient as chronic acne eruptions can be very difficult to control, and compliance with ongoing use of oral or topical therapies can be problematic," said clinical investigator Brian Berman, MD. "Through this rigorous study, we expect to achieve a meaningful reduction in the number and severity of acne lesions treated with the CellFX System."

Fourth Quarter and Full Year 2018 Financial Highlights

Cash, cash equivalents, and investments totaled $59.6 million at December 31, 2018, compared to $38.1 million at December 31, 2017. Cash use totaled $6.4 million for the fourth quarter of 2018 compared to cash use of $3.9 million for the fourth quarter of 2017. Cash use for 2018 totaled $23.5 million.

Operating expenses for the three-month period ended December 31, 2018 totaled $9.1 million, compared to $8.8 million for the three-month period ended December 31, 2017. Operating expenses for the three-month period ended December, 2018 included non-cash stock-based compensation of $2.4 million, compared to non-cash stock-based compensation of $4.5 million for the three-month period ended December 31, 2017.

Operating expenses for the fiscal year ended December 31, 2018 totaled $38.0 million, compared to $25.8 million for the fiscal year ended December 31, 2017. Operating expenses for the fiscal year ended December 31, 2018 included non-cash stock-based compensation of $12.3 million, compared to non-cash stock-based compensation of $10.9 million for the fiscal year ended December 31, 2017.

Conference Call Details

Pulse Biosciences will host an investor call on February 7, 2019, at 1:30 p.m. PDT / 4:30 p.m. EDT. The telephone dial-in number for the call is (844) 494-0190 (U.S. toll-free) or (508) 637-5580 (international) using Conference ID 5196202. Listeners will also be able to access the call via webcast available on the Investors section of the Company’s website at www.pulsebiosciences.com.

On February 7, 2019 Median Technologies (Paris:ALMDT), The Imaging Phenomics Company reported preliminary and unaudited financial results for the full year 2018, a year of successful transition that has led to the reconfiguration of the company into two separate business units, iCRO and iBiopsy, and to the realignment of its workforce and business activities with clarified strategic objectives (Press release, MEDIAN Technologies, FEB 7, 2019, View Source [SID1234533131]).

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During 2018, Median increased its focus on its iBiopsy platform, its next generation of medical imaging platform based on best-in-class technology, including image processing, cloud computing and artificial intelligence to improve targeting of current patient treatments, enhancing diagnostics and accelerating the development of next generation therapies. With the unprecedented growth in healthcare data, the iBiopsy platform’s imaging, analytical and machine learning functionalities will permit healthcare providers to derive insights from multi-omics data to reduce healthcare costs, develop personalized medicine, and manage patient care proactively. Median Technologies has grouped all of its science and development activities into its iBiopsy business unit. The iBiopsy business unit represented more than 40% of the company’s overall headcount as of December 31, 2018.

In 2018, the company’s revenues were generated by the iCRO business unit. Median decided to focus the majority of its iCRO activities on the high growth Chinese market and closed certain non-profitable activities. The restructuring of the iCRO business unit has allowed the company to dramatically reduce costs, improve margins and Median is targeting breakeven in 2019 for this part of the business. Even though 2018 company’s revenues were €6.3m, a decrease of 17.5% compared to 2017, the iCRO business is now not only stable but should see strong growth through conversion of it increased backlog and as part of this its focus on the Chinese market.

As of December 31, 2018, the company’s order backlog was €23.7m, an increase of 10.8% compared to the backlog on June 30, 2018. During the second half of the year, Median signed up many of the leading Chinese pharmaceutical companies including major contracts for phase III clinical trials. The Chinese market is experiencing extremely strong growth given that Chinese pharmaceutical companies have been able to raise substantial amounts of funding for clinical trials through successful IPO’s. Median has benefited in China from the fact that there are no legacy or established relationships with local or International iCROs competing with the company; consequently, Median has experienced a strong market penetration by demonstrating a high quality of customer service. Median expects this growth to continue over the next few years and the company should gain further repeat business from existing customers. At the end of 2018, 39.2% of the order backlog was coming from Chinese business vs 5.4% in 2017. Over 75% of 2018 gross new business originated from China. Median’s strategic Chinese investor, Furui Medical Science Company, has been instrumental in supporting the growth in the Chinese market.

The company’s cash and cash equivalents were €12.7m as of December 31, 2018. The strategic restructuring into two business units and an increased focus on high growth and profitable markets has enabled the cash burn to decrease substantially during the second semester of 2018 with a cash burn of €5.8m versus €9.8m during the first semester of 2018. Excluding exceptional charges related to the company’s organizational changes, the cash burn would have decreased even more.

"In 2018 we have repositioned our iCRO business to allow Median to deliver on its promise of sustained profitable growth. We expect good growth in the years to come particularly in China and the rest of the Asia-Pacific region", said Fredrik Brag, CEO, Chairman and co-founder of Median Technologies. "Healthcare is being transformed by AI and cloud computing and as a technology company Median is very well positioned to profit from these disruptive changes in the delivery of healthcare through its groundbreaking iBiopsy imaging phenomics platform. In 2018 a new breed of data driven technology companies have emerged in the US and even though they are at an early stage of development, they have attracted large amounts of funding and generated significant market value based on the projected impact on drug development and patient treatment. We fully expect to leverage our unique technology in this rapidly emerging market and we look forward to a very exciting 2019".

The Company expects to announce full 2018 financial results on April 11, 2019, after market close.

The preliminary results set forth above are based on management’s initial review of the Company’s operations for the year ended December 31, 2018 and are subject to revision based upon the Company’s year-end closing procedures and upon the completion and external audit of the Company’s year-end financial statements. Actual results may differ materially from these preliminary results as a result of the completion of year-end closing procedures, final adjustments and other developments arising between now and the time that the Company’s financial results are finalized, and such changes could be material. In addition, these preliminary results are not a comprehensive statement of the Company’s financial results for the fourth quarter or full year ended December 31, 2018, should not be viewed as a substitute for full, audited financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the Company’s results for any future period.

On February 7, 2019 BioMotiv, a drug development accelerator associated with The Harrington Project for Discovery & Development, and researchers from Rutgers, The State University of New Jersey, reported the formation of a new biotech start-up, TamRx (Press release, BioMotiv, FEB 7, 2019, View Source [SID1234533130]). The new company will focus on the development of a novel family of small molecule inhibitors designed to block tumor growth and stimulate the immune system to fight various forms of cancer.

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"The potential held by this novel technology to both block tumor growth and elicit an anti-tumor immune response is very exciting," said Baiju R. Shah, CEO of BioMotiv. "We look forward to working with Drs. Birge, Welsh, and Peng as they advance their discoveries with the TamRx team."

The TamRx technology was developed by scientific founders Ray Birge of Rutgers New Jersey Medical School, William Welsh of Rutgers Robert Wood Johnson Medical School, Youyi Peng of Rutgers Cancer Institute of New Jersey, and other researchers. The technology blocks ligand (Gas6) binding, thereby inhibiting TAM (Tyro3, Axl, and Mertk)-mediated activation of cellular processes that may lead to aggressive growth and spread of tumors. In addition to blocking tumor growth and metastasis, the pan-TAM inhibitors work as anticancer agents to indirectly promote an anti-tumor immune response. The TamRx technology is expected to work in combination with immuno-oncology therapies—including checkpoint inhibitors—in a wide variety of cancers.

The TAM family of receptor tyrosine kinases are implicated in a wide spectrum of human cancers in which TAM over-expression is clinically-associated with both an aggressive tumor grade and poor survival outcomes. TamRx’s pipeline of small molecule inhibitors target the TAM-Gas6 interface. The TamRx inhibitors are advantageous due to their extracellular activity and ability to target all three receptors.

According to Drs. Birge, Welsh, and Peng, this new approach to fighting cancer and boosting the immune response shows promise to be a real game-changer in the oncology field. The Rutgers researchers are "excited to work with BioMotiv and the team at TamRx to advance this technology."