On November 5, 2020 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that its board of directors declared a quarterly cash dividend of $0.22 per share (Press release, Thermo Fisher Scientific, NOV 5, 2020, View Source [SID1234570208]). The dividend will be paid on January 15, 2021, to shareholders of record as of December 15, 2020.

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The board also authorized the repurchase of $2.5 billion of shares of its common stock in the open market or in negotiated transactions. The authorization has no expiration date. This replaces the company’s existing repurchase authorization, of which $1 billion was remaining.

On November 5, 2020 Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, reported its financial results for the third quarter ended September 30, 2020 (Press release, Nevro, NOV 5, 2020, View Source [SID1234570225]).

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Third Quarter 2020 Financial Overview
Worldwide revenue for the third quarter of 2020 was $108.5 million, an increase of 8% compared to $100.2 million in the prior year period. On a sequential basis, third quarter worldwide revenue increased 92% compared to the second quarter of 2020. U.S. revenue in the third quarter of 2020 was $90.9 million, an increase of 8% compared to $84.2 million in the prior year period. On a sequential basis, third quarter U.S. revenue increased 78% compared to the second quarter of 2020. In the third quarter of 2020, total U.S. permanent implants increased 9%, while trials were down 5% compared to the prior year period. U.S. revenue growth in the third quarter of 2020 was driven by an increase in patient and customer activity compared to the severely COVID-impacted second quarter of 2020. Daily patient trial activity increased 50% over the second quarter of 2020 and improved sequentially every month from July to October. The Company estimates a majority of the canceled permanent implant cases from the second quarter of 2020 were completed by the end of the third quarter of 2020. International revenue was $17.5 million, an increase of 10% on an as reported basis (5% on a constant currency basis), compared to $15.9 million in the prior year period. On a sequential basis, third quarter International revenue increased 226% compared to the second quarter of 2020 International revenue in the third quarter of 2020 was primarily driven by a successful Omnia launch, an increase in patient and customer activity, and a rebound in customer inventory levels compared to the second quarter of 2020.

"We are pleased by the rebound in sales after a difficult second quarter and continue to be encouraged by the month-over-month improvement in trial procedures," said D. Keith Grossman, Chairman, CEO and President of Nevro. "With trials recovering, we believe our earlier expectations for roughly flat revenues compared to the prior year is still reasonable. However, increases in COVID activity around the world and any further pressure on facility capacity and patient willingness to seek care could provide some downward pressure to that view."

Gross profit for the third quarter of 2020 was $76.1 million, an increase of 9% compared to $69.9 million in the prior year period. Gross margin was 70.1% in the third quarter compared to 69.8% in the prior year period. Compared to the prior year period, the increase in gross margin in the third quarter of 2020 was primarily attributable to product mix.

Operating expenses for the third quarter of 2020 were $79.6 million, a 7% decrease compared to $85.9 million in the prior year period. The year-over-year decrease in operating expenses was primarily related to reduced travel and training-related expenses, decreases in discretionary expenses during the COVID-19 pandemic, as well as continued management focus on driving leverage throughout the business which had begun well before COVID. This was partially offset by a one-time charge of $2.5 million in the quarter related to the Company’s CFO transition. Legal expenses associated with patent litigation were $2.3 million for the third quarter of 2020, compared to $1.9 million in the prior year period.

Net loss from operations for the third quarter of 2020 was $3.5 million, a 78% improvement compared to a loss of $16.0 million in the prior year period. Adjusted EBITDA for the third quarter of 2020 was $13.6 million, compared to a loss of $2.0 million in the prior year period. Adjusted EBITDA excludes certain litigation expenses, interest, taxes and non-cash items such as stock-based compensation and depreciation and amortization. Please see the financial table below for GAAP to Non-GAAP reconciliations.

Cash, cash equivalents and short-term investments totaled $572.9 million as of September 30, 2020, an increase of $10.5 million in the third quarter of 2020.

PDN and NSRBP Clinical Update
Nevro’s Painful Diabetic Neuropathy (PDN) study continues to move forward and remains on track to present the next round of complete six-month data, along with a preview of 12-month responder rate data, at NANS in January of 2021. The Company has been in early discussions with the FDA regarding the submission strategy and is now planning to submit its PMA Supplement to the FDA in the fourth quarter of 2020. The Company remains on track for a second half 2021 commercial launch.

The Company also expects to present its Non-Surgical Refractory Back Pain (NSRBP) study with three-month data at NANS 2021 in January, with journal publications thereafter. In total, Nevro is expected to have a very large presence with several data presentations at the conference, including PDN and NSRBP.

Webcast and Conference Call Information
Management will host a conference call today at 1:30 pm PT/ 4:30 pm ET. Investors interested in listening to the call may do so by dialing (866) 324-3683 in the U.S. or +1 (509) 844-0959 internationally, using Conference ID: 6693376. In addition, a live webcast, as well as an archived recording, will be available on the "Investors" section of the Company’s website at: www.nevro.com.

On November 5, 2020 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported its financial results for the quarter ended September 30, 2020 and its recent business highlights and developments (Press release, Sutro Biopharma, NOV 5, 2020, View Source [SID1234570243]).

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"The third quarter of 2020 has been an exciting period for Sutro as we are progressing well on the clinical development of our proprietary antibody-drug conjugate (ADC) candidates. In September at the International Gynecologic Cancer Society Annual Meeting (IGCS), we provided interim data from our STRO-002 dose-escalation Phase 1 trial in ovarian patients with improved efficacy outcomes as our data mature with longer follow-up," said Bill Newell, Chief Executive Officer of Sutro Biopharma. "We look forward to providing a further update in December and also to initiate the dose-expansion portion of the trial in a population who are less heavily pretreated. In addition, we will be sharing our updated interim findings from the non-Hodgkin’s lymphoma (NHL) cohort of the STRO-001 dose-escalation Phase 1, which has been accepted at the 62nd Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper). Finally, the Sutro team has been diligently working to advance cancer therapeutics and we were honored to receive The World ADC Best New Drug Developer Award for our work in developing clinical programs including STRO-001, STRO-002, and, in partnership with Bristol Meyers Squibb (BMS), CC-99712."

Recent Business Highlights and Developments

STRO-002: Continued progress on our program in STRO-002, folate receptor-alpha (FolRα) targeting ADC for development in ovarian cancer

The dose-escalation portion of the STRO-002 Phase 1 clinical trial completed enrollment as of August 31, 2020. Interim data on dose-escalation trial in patients with recurrent platinum resistant or refractory ovarian cancer was presented at the IGCS in September.
Additional Phase 1 data will be presented by key opinion leader (KOL) and management at the KOL Discussion of STRO-002 Data Event on December 3, 2020.
The dose-expansion portion of the Phase 1 trial is expected to enroll patients in the fourth quarter of 2020.
STRO-001: Dose escalation continues in STRO-001, a CD74 targeting ADC for development in B-cell malignancies

STRO-001 is currently in Phase 1 dose-escalation trial enrolling patients with lymphoma and multiple myeloma. Dose-escalation in the Phase 1 trial is ongoing and the maximum tolerated dose has not yet been reached.
Based on the reported data to date in heavily pre-treated patients, STRO-001 has been generally well-tolerated with no ocular toxicity signals observed.
A dose-expansion portion of the Phase 1 is expected to begin enrolling patients in first half of 2021.
ASH Annual Meeting: Additional Phase 1 dose-escalation data for STRO-001 will be presented at ASH (Free ASH Whitepaper) by Nirav N. Shah, M.D., Assistant Professor of Medicine at the Medical College of Wisconsin. Presentation will include results from patients with advanced, relapsed/refractory NHL and details are as follows:

Title: Preliminary Results of an Ongoing Phase 1 Dose Escalation Study of the Novel Anti-CD74 Antibody Drug Conjugate (ADC), STRO-001, in Patients with B-cell Non-Hodgkin Lymphoma
Session Name: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas) – Results from Prospective Clinical Trials: Poster III
Session Date: Monday, December 7, 2020
Session Time: 7:00am-3:30pm PT / 10:00am-6:30pm ET
Abstract: The abstract can be found in the ASH (Free ASH Whitepaper) meeting program under #3030
Merck collaboration: Cytokine derivative programs are advancing in research development for cancer and autoimmune diseases

Sutro is working with Merck on two research programs to discover new therapeutics for cancer and autoimmune diseases and Merck retains the right to nominate a third program.
The collaboration is advancing two cytokine-derivative programs through lead optimization and in March 2020, Merck extended by one year the research term of the collaboration’s first program, which included a $5.0 million payment to Sutro.
BMS collaboration: Phase 1 trial for CC-99712, an ADC targeting BCMA, is continuing to enroll with 3.0 mg/kg in the last reported dose level

Since initiation in the second half of 2019, BMS has been enrolling patients in a Phase 1 dose escalation/expansion trial to assess treatment of relapsed and refractory multiple myeloma. The last reported dose level was 3.0 mg/kg with dose escalation expected to continue.
BMS is responsible for the worldwide clinical development and commercialization of CC-99712. Sutro is entitled to development and regulatory milestone payments and tiered royalties on sales ranging from mid to high single digit percentages.
EMD Serono collaboration: IND for M1231, MUC1-EGFR bispecific ADC, is on track in 2021 for the treatment of solid tumors

EMD Serono is projected to commence first-in-human studies of M1231 in non-small cell lung cancer (NSCLC) and esophageal squamous cell carcinoma in the first quarter of 2021.
Sutro earned a milestone payment during the third quarter of 2020 for the successful delivery of GMP clinical supply for Phase 1 clinical trial testing of M1231, a bispecific ADC manufactured using XpressCF+ technology.
Sutro is responsible for manufacturing early clinical supply of the bispecific ADC and is eligible for development and regulatory milestones and royalties.
Vaxcyte relationship: Demonstrates the power of Sutro’s cell-free technology

Under a license from Sutro, Vaxcyte has the right to use the XpressCF and XpressCF+ platforms to discover and develop vaccine candidates for the treatment or prophylaxis of infectious diseases.
Vaxcyte is progressing their broader spectrum pneumococcal conjugate vaccine (VAX-24) through the late stages of preclinical development and is targeting an IND filing and clinical study initiation during the second half of 2021.
Sutro is eligible to receive four percent (4%) royalties on worldwide net sales of any licensed vaccine candidates for human health use. Sutro retains the right to discover and develop vaccines for treatment or prophylaxis of any disease not caused by an infectious pathogen, including cancer.
In June 2020, Vaxcyte closed its initial public offering of its common stock. Sutro owns approximately 1.6 million shares of Vaxcyte common stock as of September 30, 2020.
Industry Recognition: Recipient of Best New Drug Developer Award at the 7th Annual World ADC Awards

The award recognizes the work on STRO-001 and STRO-002, both currently in Phase 1 studies, and CC-99712, which is under investigation in a Phase 1 trial by collaboration partner BMS.
Sutro’s proprietary rapid and precise protein engineering platform allows for the design and manufacturing of homogeneous molecules, yielding potentially best-in-class ADCs and other therapeutics. Two additional candidates from this platform are projected to enter the clinic in 2021.
Third Quarter 2020 Financial Highlights

Cash, Cash Equivalents and Marketable Securities

As of September 30, 2020, Sutro had cash, cash equivalents and marketable securities of $202.4 million, as compared to $133.5 million as of December 31, 2019, which represents a net cash increase of $68.9 million during the 2020 nine-month period. The cash, cash equivalents and marketable securities balance noted above does not include the value associated with Sutro’s holdings of approximately 1.6 million shares of Vaxcyte common stock, which are subject to a lock-up agreement that expires in December 2020. As of September 30, 2020, the fair value of the Vaxcyte common stock held by Sutro was $78.8 million.

Net Income due to Unrealized Gain on Vaxcyte Common Stock

Sutro recorded net income of $17.1 million and $27.4 million for the three and nine months ended September 30, 2020, respectively, due primarily to an unrealized gain related to its Vaxcyte common stock of $78.6 million during 2020. The unrealized gain consisted of $78.8 million from the change in estimated fair value of Vaxcyte common stock, partially offset by approximately $0.2 million in adjustments related to revaluations of certain Vaxcyte equity items. Vaxcyte common stock held by Sutro will be measured at fair value based on the closing price of Vaxcyte’s common stock on the last trading day of each reporting period, with any unrealized gains and losses recorded in Sutro’s statements of operations.

Revenue

Revenue was $17.8 million and $34.4 million for the three and nine months ended September 30, 2020, respectively, compared to $12.3 million and $31.4 million for the same periods in 2019, related principally to the Merck, BMS, and EMD Serono collaborations. Future collaboration revenue from Merck, BMS, and EMD Serono, and from any future collaboration partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones and other collaboration agreement payments.

Operating Expenses

Total operating expenses for the three and nine months ended September 30, 2020, were $28.4 million and $80.7 million, respectively, compared to $25.0 million and $72.1 million for the same periods in 2019, including non-cash stock-based compensation of $8.8 million and $7.6 million, and depreciation and amortization expense of $3.1 million and $3.6 million, in the nine months ended September 30, 2020 and 2019, respectively. Total operating expenses for the third quarter of 2020 were comprised of research and development expenses of $19.4 million and general and administrative expenses of $9.1 million, which are expected to increase in future periods as Sutro’s internal product candidates advance in clinical development and additional general and administrative expenses are incurred as a public company.

On November 5, 2020 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported that the Company will present at the Wolfe Virtual Healthcare Conference on Thursday, November 19 at 11:25 a.m. ET (Press release, PerkinElmer, NOV 5, 2020, View Source [SID1234570417]).

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Prahlad Singh, president and chief executive officer of PerkinElmer, will provide an update of the Company and its strategic priorities.

A live audio webcast of the presentation will be available on the Investors section of the Company’s website at www.perkinelmer.com. A replay of the presentation will be posted on the PerkinElmer website after the event and available for 90 days following.

On November 5, 2020 Seagen Inc. (Nasdaq:SGEN) reported multiple ADCETRIS (brentuximab vedotin) data presentations at the upcoming 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place virtually December 5-8, 2020 (Press release, Seagen, NOV 5, 2020, View Source [SID1234570001]). Data presentations will include five-year updates from the phase 3 ECHELON-1 and ECHELON-2 clinical trials evaluating ADCETRIS plus a chemotherapy combination regimen in frontline advanced stage Hodgkin lymphoma (HL) or frontline peripheral T-cell lymphoma (PTCL). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL and expressed on the surface of several types of PTCL. ADCETRIS is being evaluated globally in more than 70 corporate- and investigator-sponsored clinical trials across multiple settings in lymphoma and other indications.

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"At this year’s ASH (Free ASH Whitepaper) meeting, ADCETRIS will be featured in 18 data presentations, including five-year analyses from the ECHELON-1 and ECHELON-2 phase 3 frontline trials," said Roger Dansey, M.D., Chief Medical Officer at Seagen. "Reaching five-years without disease recurrence represents a significant clinical milestone for patients, as they may be considered disease-free at this time point. The five-year data presentations from our phase 3 ECHELON-1 and ECHELON-2 trials demonstrate ADCETRIS plus chemotherapy resulted in superior clinical activity and durable benefit when compared to outcomes with a standard chemotherapy regimen. We will also present additional analyses from trials evaluating ADCETRIS in combination with other therapies, with the goal of identifying potential new treatment strategies that improve outcomes for patients."

Details of Seagen Presentations at ASH (Free ASH Whitepaper):

Abstract Title

Abstract #

Presentation

Type / Date

Presenter

Company-Sponsored Trials

Frontline Brentuximab Vedotin as Monotherapy or in Combination for Older Hodgkin Lymphoma Patients

#471

Oral presentation / Sunday, Dec. 6 at 2:15 p.m. PT

C. Yasenchak

Brentuximab Vedotin with Chemotherapy for Patients with Previously Untreated, Stage III/IV Classical Hodgkin lymphoma: 5-year Update of the ECHELON-1 Study

#2973

Poster presentation / Monday, Dec. 7, 7:00 a.m. – 3:30 p.m. PT

D. Straus

The ECHELON-2 Trial: 5-Year Results of a Randomized, Double-Blind, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in Frontline Treatment of Patients with CD30-positive Peripheral T-cell Lymphoma

#1150

Poster presentation / Saturday, Dec. 5, 7:00 a.m. – 3:30 p.m. PT

S. Horwitz

Economic Assessment of Diagnostic Revision in Peripheral T-cell Lymphoma

#1606

Poster presentation / Saturday, Dec. 5, 7:00 a.m. – 3:30 p.m. PT

N. Liu

Nivolumab Combined with Brentuximab Vedotin for Relapsed/Refractory Mediastinal Gray Zone Lymphoma: Primary Efficacy and Safety Analysis of the Phase 2 CheckMate 436 Study

#2045

Poster presentation / Sunday, Dec. 6, 7:00 a.m. – 3:30 p.m. PT

A. Santoro

Real-World Characteristics of Patients with Classical Hodgkin Lymphoma Receiving Frontline Brentuximab Vedotin with Chemotherapy: A Retrospective Analysis with Propensity Score Matching

#2499

Poster presentation / Sunday, Dec. 6, 7:00 a.m. – 3:30 p.m. PT

T. Phillips

Real-World Adherence to National Comprehensive Cancer Network (NCCN) Guidelines Regarding the Usage of PET/CT and Reported Deauville Scores in Advanced Stage Classical Hodgkin Lymphoma: A Community Oncology Practice Perspective

#2033

Poster presentation / Sunday, Dec. 6, 7:00 a.m. – 3:30 p.m. PT

C. Yasenchak

SGN-CD30C, an Investigational CD30-Directed Camptothecin Antibody-Drug Conjugate (ADC), Shows Strong Anti Tumor Activity and Superior Tolerability in Preclinical Studies

#2089

Poster presentation / Sunday, Dec. 6, 7:00 a.m. – 3:30 p.m. PT

M. Ryan

Real-World Characteristics of Patients with Peripheral T-Cell Lymphoma Receiving Frontline Brentuximab Vedotin with Chemotherapy: A Retrospective Analysis with Propensity Score Matching

#3418

Poster presentation / Monday, Dec. 7, 7:00 a.m. – 3:30 p.m. PT

J. Burke

Nodal Peripheral T-Cell Lymphoma with T Follicular-Helper Phenotype: A Different Entity? Results of the Spanish Retrospective Real-T Study

#2972

Poster presentation / Monday, Dec. 7, 7:00 a.m. – 3:30 p.m. PT

AM. Garcia-Sancho

Results from the International, Multi-Center, Retrospective B-Holistic Study: Describing Treatment Pathways and Outcomes for Classical Hodgkin Lymphoma

#2979

Poster presentation / Monday, Dec. 7, 7:00 a.m. – 3:30 p.m. PT

B. Ferhanoglu

Investigator-Sponsored Trials

Increased Tumor Specific Cytotoxic T Cell Responses and Reversion to a Favorable Cytokine Profile after Treatment in Patients with Newly Diagnosed High Risk Hodgkin Lymphoma Treated on Children’s Oncology Group Trial- AHOD1331

#595

Oral presentation / Monday, Dec. 7 at 9:15 a.m. PT

H. Dave

Addition of Brentuximab Vedotin to Gemcitabine in Relapsed or Refractory T-Cell Lymphoma: Results of a LYSA Multicenter, Phase II Study. "The TOTAL Trial"

#1161

Poster presentation / Saturday, Dec. 5, 7:00 a.m. – 3:30 p.m. PT

O. Tournilhac

A Pilot Study of Brentuximab Vedotin, Rituximab and Dose Attenuated CHP in Patients 75 Years and Older with Diffuse Large B-Cell Lymphoma

#2102

Poster presentation / Sunday, Dec. 6, 7:00 a.m. – 3:30 p.m. PT

P. Reagan

Dose-Dense Brentuximab Vedotin Plus Ifosfamide, Carboplatin, and Etoposide (ICE) Is Highly Active for Second Line Treatment in Relapsed/Refractory Classical Hodgkin Lymphoma: Final Results of a Phase I/II Study

#2964

Poster presentation / Monday, Dec. 7, 7:00 a.m. – 3:30 p.m. PT

R. Lynch

A Phase I Trial Assessing the Feasibility of Romidepsin Combined with Brentuximab Vedotin for Patients Requiring Systemic Therapy for Cutaneous T-Cell Lymphoma

#2970

Poster presentation / Monday, Dec. 7, 7:00 a.m. – 3:30 p.m. PT

S. Barta

Trials-in-Progress

Trial-in-Progress: Brentuximab Vedotin in Combination with Lenalidomide and Rituximab in Subjects with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

#2112

Poster presentation / Sunday, Dec. 6, 7:00 a.m. – 3:30 p.m. PT

N. Bartlett

A Phase 1 Study of Sea-CD70 in Myeloid Malignancies

#2874

Poster presentation / Monday, Dec. 7, 7:00 a.m. – 3:30 p.m. PT

A. Aribi

Trial-in-Progress: Frontline Brentuximab Vedotin and CHP (A+CHP) in Patients with Peripheral T-Cell Lymphoma with Less Than 10% CD30 Expression

#2976

Poster presentation / Monday, Dec. 7, 7:00 a.m. – 3:30 p.m. PT

D. Jagadeesh