Seattle Genetics to Host Conference Call and Webcast Discussion of Second Quarter 2020 Financial Results on July 30, 2020

On July 9, 2020 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that it will report its second quarter 2020 financial results on Thursday, July 30, 2020 after the close of financial markets (Press release, Seattle Genetics, JUL 9, 2020, View Source [SID1234561797]). Following the announcement, Company management will host a conference call and webcast discussion of the results and provide a general corporate update. Access to the event can be obtained as follows:

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Thursday, July 30, 2020
1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time

Telephone 866-248-8441 (domestic) or +1 720-452-9102 (international); conference ID 1128188
Webcast with slides available at www.seattlegenetics.com in the Investors section. A webcast replay will be archived on the Company’s website.

Arrowhead Pharmaceuticals to Webcast Fiscal 2020 Third Quarter Results

On July 9, 2020 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it will host a webcast and conference call on August 5, 2020, at 4:30 p.m. EDT to discuss its financial results for the fiscal third quarter ended June 30, 2020 (Press release, Arrowhead Pharmaceuticals, JUL 9, 2020, View Source [SID1234561796]).

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Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 6856804.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 6856804.

MacroGenics Announces Lancet Oncology Publication of Margetuximab Data in Gastric Cancer

On July 9, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that Lancet Oncology has published results from a Phase 2 study of margetuximab plus pembrolizumab as a chemotherapy-free regimen for patients with advanced HER2-positive gastroesophageal adenocarcinoma (GEA) who have previously been treated with chemotherapy and trastuzumab. Margetuximab is an investigational, Fc-engineered, monoclonal antibody targeting HER2. Pembrolizumab is an anti-PD-1 monoclonal antibody (Press release, MacroGenics, JUL 9, 2020, View Source [SID1234561792]).

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"Current standard of care treatment for patients with metastatic gastroesophageal adenocarcinoma is heavily dependent on the use of cytotoxic chemotherapy," said Stephen Eck, M.D., Ph.D., Senior Vice President, Clinical Development & Chief Medical Officer. "The published data suggest that a chemotherapy-free regimen combining the immune-enhancing properties of margetuximab with checkpoint blockade may improve upon clinical outcomes for certain first-line patients with metastatic HER2-positive gastroesophageal adenocarcinoma and provide a strong rationale for the ongoing Phase 2/3 MAHOGANY study."

The Phase 2 study enrolled patients with gastric cancer (GC) or gastroesophageal junction (GEJ) cancer whose tumors were IHC3-positive or IHC2-positive/FISH-positive at diagnosis. Enrollment was regardless of PD-L1 expression status, which was subsequently determined from available archived tumor tissue.

Tolerability of margetuximab and pembrolizumab was acceptable in patients treated in this study. Grade 3 or higher treatment-related adverse events (TRAEs) were reported in 20% of patients, with anemia (4%) and infusion-related reactions (3%) being the most common. No treatment-related deaths were reported.

Patients who had received margetuximab at the recommended Phase 2 dose of 15 mg/kg every three weeks were evaluable for response. In this overall population, the objective response rate (ORR) was 18% (17/92 patients), including complete responses (CR) and partial responses (PR). The disease control rate (DCR), which includes CR, PR, and stable disease (SD), was 53% (49/92 patients). Median progression-free survival (PFS) was 2.7 months (95% CI 1.6–4.3) and median overall survival (OS) was 12.5 months (95% CI 9.1–14.1).

Activity of margetuximab and anti-PD-1 in this study was more pronounced in key biomarker-positive subgroups. The most pronounced benefit was observed in patients whose tumors had high HER2 expression at diagnosis (HER2 IHC3-positive) and were PD-L1-positive. In this double-positive subgroup, the ORR was 44% (11/25 patients) and the DCR was 72% (18/25 patients). Median PFS was 4.8 months (95% CI 1.6–13.9) and median OS was 20.5 months (95% CI 8.1–NR).

Patients with initial HER2-positive GEA may lose HER2 expression after trastuzumab-based therapy. In this second-line study, HER2 amplification was not detectable in circulating tumor DNA (ctDNA) in 42% of patients who were tested, suggesting loss of HER2 following prior trastuzumab and before treatment with margetuximab and pembrolizumab. The presence of HER2 amplification in ctDNA was associated with better response rates in this study. HER2amp-positive/HER2 IHC3-positive/PD-L1-positive ORR was 60% (9/15 patients) and DCR was 80% (12/15 patients).

Consistent with prior studies of margetuximab in other tumor types, correlative analyses of samples from GEA patients treated in the study showed an increase in anti-HER2 specific T-cell immunity, suggesting the potential for engagement of both innate and adaptive immune responses.

These data in second-line patients who were refractory to trastuzumab provide the rationale for the ongoing Phase 2/3 MAHOGANY clinical trial of margetuximab in combination with checkpoint blockade, with or without chemotherapy, as a potential first-line treatment for patients with HER2-positive GC or GEJ cancer (NCT04082364). The data published in Lancet Oncology are reported as of July 10, 2019 and were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress in September 2019.

About Gastric and Gastroesophageal Junction Cancer

Cancer of the stomach (gastric cancer) or the gastroesophageal junction (where the esophagus joins the stomach) is collectively known as gastroesophageal adenocarcinoma. According to the American Cancer Society, approximately 27,600 new cases of gastric cancer will be diagnosed in the U.S in 2020 and more than 11,000 people will die from the disease. Both GC and GEJ cancer are often diagnosed at an advanced stage and therefore have very poor prognosis, with a 5-year survival of 5-20%. Chemotherapy is the standard of care for first-line therapy and may be combined with trastuzumab for the approximately 20% of patients whose tumors are HER2-positive.

About Margetuximab

Margetuximab is an Fc-engineered, monoclonal antibody that targets the HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors. Margetuximab was designed to provide HER2 blockade and has similar HER2 binding and antiproliferative effects as trastuzumab. In addition, margetuximab has been engineered using MacroGenics’ Fc Optimization technology to enhance the engagement of the immune system. A Biologics License Application (BLA) for margetuximab for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy is under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) goal date of December 18, 2020. A Phase 2/3 MAHOGANY clinical trial in of margetuximab in combination with checkpoint inhibition, with or without chemotherapy, as a potential first-line treatment for patients with HER2-positive GC or GEJ cancer (NCT04082364) is ongoing. Margetuximab has been granted an orphan drug designation by the FDA for the treatment of GC or GEJ cancer.

Integra LifeSciences Announces Preliminary Second Quarter Revenue Results; Will Host Second Quarter 2020 Financial Results Conference Call on August 10, 2020

On July 9, 2020 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported certain unaudited preliminary second quarter financial results (Press release, Integra LifeSciences, JUL 9, 2020, View Source [SID1234561791]). The company also announced that it will release full second quarter 2020 financial results on Monday, August 10, 2020 at 4:30pm ET.

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Preliminary Second Quarter Revenue Results

Second quarter 2020 reported revenue is expected to be in the range of $254 million to $256 million, representing a decline of approximately 34% on a reported basis and approximately 32% on an organic basis compared to 2019. Throughout the quarter, monthly sales performance improved sequentially due to the resumption of non-emergent surgical procedures and the easing of shelter-in-place restrictions. The Company’s average daily sales in the month of June were down approximately 15% when compared to the average daily sales rate for the full second quarter of 2019. The preliminary results set forth above are unaudited and remain subject to completion of the Company’s financial closing procedures.

The Company is encouraged by the improvement in monthly sales trends during the second quarter. However, given the continued uncertainty due to the ongoing impact of COVID-19, we currently are unable to determine the impact on revenue beyond the first half of 2020, and are continuing to monitor, assess and respond to the situation. The Company will provide an update on August 10, 2020, as part of our second quarter earnings call, along with a discussion of our full second quarter financial results.

Second Quarter 2020 Financial Results Conference Call

The Company will release full second quarter 2020 financial results on Monday, August 10 after the market closes. In conjunction with the earnings release, Integra’s management team will host a conference call at 4:30 p.m. ET.

The live call is accessible by dialing (800) 263-0877 and using the passcode 4133628. A simultaneous webcast of the call will be available via the Company’s website at www.integralife.com.

A webcast replay of the call can be accessed through the Investor Relations homepage of Integra’s website at www.integralife.com. A replay of the call will be available until August 15, 2020 by dialing (888) 203-1112 and using the passcode 4133628.

Vericel Announces Preliminary Second Quarter 2020 Financial Results and
Provides Business Updates

On July 9, 2020 Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, reported preliminary financial results for the quarter ended June 30, 2020, and provided business updates (Press release, Vericel, JUL 9, 2020, View Source [SID1234561790]).

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Preliminary Second Quarter Financial Results

·Preliminary total net product revenues for the second quarter are expected to be approximately $20 million, including approximately $15 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue and approximately $5 million of Epicel (cultured epidermal autografts) net revenue;
·Total net product revenues for the second quarter decreased approximately 23% compared to the second quarter of 2019, with MACI net revenue decreasing approximately 27% and Epicel net revenue decreasing approximately 8% compared to the second quarter of 2019;
·Total net product revenues, which declined approximately 78% in April and 32% in May compared to the same periods in 2019, increased approximately 30% in June compared to June 2019;
·Total net product revenues for the first half of 2020 decreased approximately 2% compared to the first half of 2019, with MACI net revenue decreasing approximately 5% and Epicel net revenue increasing approximately 7% compared to the first half of 2019; and
·As of June 30, 2020, the company had approximately $81 million in cash and investments and no debt.

Second Quarter Business Updates

·MACI implants, which declined approximately 84% in April and 37% in May compared to the same periods in 2019, increased approximately 21% in June compared June 2019;
·MACI biopsies declined approximately 79% in April and 22% in May compared to the same periods in 2019, and increased approximately 23% in June compared June 2019;

·Approximately 70% of scheduled MACI cases that were cancelled in the first half of 2020 due to the COVID-19 pandemic have been rescheduled, with over 50% of the cancelled cases completed by the end of the second quarter;
·Epicel graft volume, which declined 70% in April, increased approximately 20% in the May through June period compared to the same period in 2019; and
·Epicel biopsies increased by approximately 6% in the second quarter compared to the second quarter of 2019.

"We saw a very strong recovery for MACI during the second quarter as restrictions on elective surgeries were lifted across the country," said Nick Colangelo, President and CEO of Vericel. "While considerable uncertainties related to COVID-19 remain, absent a significant resurgence in restrictions related to COVID-19 we expect growth for MACI in the third quarter, albeit at a more moderate rate compared to pre-COVID-19 levels given the decline in MACI biopsies in April and May. We will continue to monitor the evolving landscape and we look forward to updating investors on our second quarter earnings call."

The company will host a webcast and conference call to discuss its second quarter 2020 financial results and business highlights on August 5, 2020 at 8:30am Eastern Time.