1stOncology™: Cancer Intelligence Service – Page 10020 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Veracyte Announces Closing of Public Offering of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On February 9, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported the closing of its public offering of 8,547,297 shares of common stock, including 1,114,864 shares sold upon full exercise of the underwriters’ option to purchase additional shares, at a price to the public of $74.00 per share (Press release, Veracyte, FEB 9, 2021, View Source [SID1234574792]). The net proceeds to Veracyte from the offering were approximately $593.8 million, after deducting underwriting discounts and commissions and estimated offering expenses.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

Schedule Your 30 min Free Demo!

Goldman Sachs & Co., LLC and SVB Leerink LLC acted as joint lead book-running managers for the offering. William Blair & Company, L.L.C. acted as a book-running manager and BTIG, LLC, Needham & Company, LLC, and Lake Street Capital Markets, LLC acted as co-managers.

The public offering was made pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission on February 3, 2021. This offering was made solely by means of a prospectus supplement and accompanying prospectus relating to and describing the terms of the offering, copies of which may be obtained by contacting Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by email at [email protected], or by telephone at (866) 471-2526; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 01220, by email at [email protected], or by telephone at (800) 808-7525, ext. 6105.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

Veracyte, Afirma, Percepta, Envisia, Prosigna, "Know by Design" and the Veracyte, Afirma, Percepta, Envisia and Prosigna logos are Veracyte’s registered trademarks in the U.S. and selected countries.

Exelixis to Host Investor Briefing to Discuss Data Presented at the American Society of Clinical Oncology’s 2021 Genitourinary Cancers Symposium

On February 9, 2021 Exelixis, Inc. (Nasdaq: EXEL) reported that it will host an investor briefing to discuss data presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s 2021 Genitourinary Cancers Symposium (ASCO GU 2021) (Press release, Exelixis, FEB 9, 2021, View Source [SID1234574791]). The online-only event will be held on Saturday, February 13, 2021, beginning at 5:30 p.m. EST / 2:30 p.m. PST.

During the briefing, Exelixis management and invited guests from the clinical community will discuss and provide context for cabozantinib clinical data presented at ASCO (Free ASCO Whitepaper) GU 2021, including updated results with extended follow-up data from CheckMate -9ER, the phase 3 pivotal trial evaluating CABOMETYX (cabozantinib) in combination with OPDIVO (nivolumab) compared with sunitinib as first-line treatment in patients with advanced or metastatic renal cell carcinoma (RCC). The investor briefing is also expected to include discussion of other ASCO (Free ASCO Whitepaper) GU 2021 data sets evaluating the use of cabozantinib in treatment settings for RCC and other genitourinary cancers.

To access the investor briefing, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the event to ensure adequate time for any software download that may be required to view the webcast. After the event concludes, a replay will be available at that same location for a minimum of one year.

Deciphera Pharmaceuticals, Inc. Announces Fourth Quarter and Full Year 2020 Financial Results

On February 9, 2021 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported financial results for the fourth quarter and year ended December 31, 2020, and provided a business update (Press release, Deciphera Pharmaceuticals, FEB 9, 2021, View Source [SID1234574790]).

"We made significant progress in 2020 with the successful launch of QINLOCK, completing enrollment in the Phase 3 INTRIGUE study in second-line GIST patients, and generating promising new data for both vimseltinib and rebastinib," said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. "We’re incredibly excited by the opportunities ahead for the Company in 2021. Specifically, we look forward to top-line results from the INTRIGUE study and are actively preparing for a potential EMA approval for QINLOCK in fourth-line GIST in the second half of this year."

Mr. Hoerter continued, "In addition, we remain very excited by the prospects of our maturing pipeline. We are on track to report additional data from and finalize pivotal development plans for both vimseltinib and rebastinib in the second half of this year, and also plan to initiate the Phase 1 study of DCC-3116, our ULK kinase inhibitor for the potential treatment of patients with cancers driven by mutations in RAS or RAF genes, in the second quarter of 2021."

Fourth Quarter 2020 Highlights and Upcoming Milestones

QINLOCK (ripretinib)
Recorded $19.5 million in QINLOCK net product revenue in the fourth quarter of 2020, including $18.5 million in U.S. net product revenue.
Completed enrollment in the INTRIGUE Phase 3 clinical study evaluating the efficacy and safety of QINLOCK compared to sunitinib in patients with second-line GIST. Top-line results for this study are expected in the second half of 2021.
Received validation from the European Medicines Agency (EMA) for the Marketing Authorisation Application for QINLOCK in fourth-line GIST. Potential EMA approval is expected in the second half of 2021.
Presented new data at the Connective Tissue Oncology Society (CTOS) 2020 Virtual Annual Meeting with results from an exploratory analysis from the Phase 3 INVICTUS study that highlighted the broad spectrum of mutations that drive GIST and clinical data demonstrating QINLOCK’s clinically meaningful activity in patients with a broad spectrum of KIT and PDGFRA mutations.
Expects potential approval from the China National Medical Products Administration (NMPA) in the first half of 2021.
Vimseltinib (DCC-3014)
Presented preliminary results from the ongoing Phase 1/2 study of vimseltinib, a CSF1R inhibitor, in patients with tenosynovial giant cell tumor (TGCT) at the CTOS 2020 Virtual Annual Meeting. The results showed a 41% objective response rate, confirmed and unconfirmed, including one confirmed complete response, and treatment was generally well-tolerated with treatment-emergent adverse events mostly grade 1 or 2. Based on these preliminary results, the expansion cohorts for vimseltinib in TGCT patients opened at the recommended Phase 2 dose of 30 mg twice weekly.
Expects to present updated data from the ongoing Phase 1/2 study in patients with TGCT in the second half of 2021.
Plans to finalize the pivotal development plan for vimseltinib in TGCT in the second half of 2021.
Rebastinib
Completed enrollment in the endometrial cancer cohort and the platinum-resistant ovarian cancer cohort of the ongoing Phase 1b/2 study of rebastinib, an inhibitor of TIE2, in combination with paclitaxel.
Expects to present updated data from the ongoing Phase 1b/2 study of rebastinib in combination with paclitaxel in the endometrial cancer cohort in the second quarter of 2021, and the platinum-resistant ovarian cancer cohort in the second half of 2021.
Plans to finalize the pivotal development plan for rebastinib in combination with paclitaxel in the second half of 2021.
DCC-3116
Submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA).
Plans to initiate the Phase 1, multicenter, open-label, first-in-human study of DCC-3116 as a single agent and then in combination with trametinib in patients with advanced or metastatic tumors with a mutant RAS or RAF gene in the second quarter of 2021.
Corporate Update
Today announced the appointment of Margarida Duarte as Senior Vice President, Head of International. Ms. Duarte was most recently Vice President, Head of Commercial for Canada, Europe, Middle East and Africa at Alnylam Pharmaceuticals, where she was instrumental in the launch of multiple new products. She brings to Deciphera over 15 years of experience in the global pharmaceutical industry and previous leadership roles in commercial, marketing, and strategy, along with experience leading cross functional teams in medical, regulatory, supply chain, and global product development.
Fourth Quarter and Full Year 2020 Financial Results

Revenue: Total net revenue for fourth quarter was $19.5 million, which includes U.S. sales of QINLOCK of $18.5 million and ex-U.S. sales of QINLOCK of $1.0 million. In the fourth quarter of 2019, the Company did not generate revenue. Total revenue for the year ended December 31, 2020 was $42.1 million, which includes $39.5 million in sales of QINLOCK and $2.6 million in collaboration revenue. Net product revenues for the year ended December 31, 2020 includes U.S. sales of QINLOCK of $38.0 million and ex-U.S. sales of QINLOCK of $1.5 million. This compares to total revenue of $25.0 million for the year ended December 31, 2019, which was related to the Company’s exclusive license agreement with Zai Lab to advance the development and commercialization of ripretinib in Greater China.
Cost of Sales: Cost of sales were $0.1 million in the fourth quarter of 2020 and $0.2 million for the year ended December 31, 2020. There were no cost of sales in 2019 as no product sales were generated during that period. Cost of sales will not be significant until the initial pre-launch inventory is depleted, and additional inventory is manufactured and sold.
R&D Expenses: Research and development expenses for the fourth quarter of 2020 were $52.3 million, compared to $46.6 million for the same period in 2019, and $199.0 million for the year ended December 31, 2020, compared to $157.6 million for the same period in 2019. The increase was primarily due to personnel costs, preclinical costs, and clinical trial costs related to vimseltinib, rebastinib, DCC-3116, and the Phase 3 INTRIGUE study in second-line GIST. The increase was partially offset by a decrease in clinical trial expenses related to the Phase 3 INVICTUS study in fourth-line and fourth-line plus GIST. Non-cash, stock-based compensation was $17.4 million and $7.9 million for the year ended December 31, 2020 and 2019, respectively.
SG&A Expenses: Selling, general and administrative expenses for the fourth quarter of 2020 were $30.1 million, compared to $23.7 million for the same period in 2019 and $114.1 million for the year ended December 31, 2020, compared to $68.1 million for the same period in 2019. The increase was primarily due to personnel costs as well as external spend associated with commercial preparedness and launch of QINLOCK, increased expenses incurred in connection with Deciphera’s new headquarters that commenced in October 2019, and technology-related costs to support the growth of the business. Non-cash, stock-based compensation was $19.7 million and $12.5 million for the year ended December 31, 2020 and 2019, respectively.
Net Loss: For the fourth quarter of 2020, Deciphera reported a net loss of $62.7 million, or $1.10 per share, compared with a net loss of $67.2 million, or $1.31 per share, for the same period in 2019. Net loss for the year ended December 31, 2020 was $266.5 million, or $4.78 per share, compared with a net loss of $192.3 million, or $4.48 per share, for the year ended December 31, 2019.
Cash Position: As of December 31, 2020, cash, cash equivalents and marketable securities were $561.3 million, compared to $579.6 million as of December 31, 2019. Based on its current operating plans, Deciphera expects its current cash, cash equivalents, and marketable securities together with anticipated product revenues, but excluding any potential future milestone payments or other payments under its collaboration or license agreements, will enable the Company to fund its operating and capital expenditures into the second half of 2022.
Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, February 9, 2021 at 4:30 PM ET. To access the live call by phone please dial (866) 930-5479 (domestic) or (409) 216-0603 (international); the conference ID is 5826559. A live audio webcast of the event may also be accessed through the "Investors" section of Deciphera’s website at www.deciphera.com. A replay of the webcast will be available for 30 days following the event.

Quest Diagnostics to Host Virtual Investor Day On March 11, 2021

On February 9, 2021 Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will host a virtual Investor Day for institutional investors and financial analysts on Thursday, March 11, 2021 at 9:00 a.m. ET.
During the event, Steve Rusckowski, Chairman, CEO and President, Mark Guinan, Executive Vice President & Chief Financial Officer, and other senior executives will provide updated views of the U.S. laboratory market and the company’s growth and capital deployment strategies (Press release, Quest Diagnostics, FEB 9, 2021, View Source [SID1234574789]).

To access the live webcast, including audio, video and presentation slides, register here. Securities analysts and institutional investors are advised to register in advance.

Investors and analysts will have an opportunity to ask questions in live Q&A sessions with speakers. Participants who would like to ask a question can dial 888-455-0391 within the U.S. and Canada, or (773) 756-0467 internationally, using the passcode "7895081."

Interested parties unable to watch the live webcast will be able to view and listen to an archived copy of the webcast, which will be available on the Quest Diagnostics Investor Relations website following the conclusion of the event.

Arch Oncology to Collaborate with Merck on Phase 1/2 Clinical Trial of Anti-CD47 Antibody AO-176 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Select Solid Tumors

On February 9, 2021 Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of anti-CD47 antibody therapies, reported that it has entered into a clinical trial collaboration and supply agreement with Merck, known as MSD outside of the United States and Canada (Press release, Arch Oncology, FEB 9, 2021, View Source;utm_medium=rss&utm_campaign=arch-oncology-to-collaborate-with-merck-on-phase-1-2-clinical-trial-of-anti-cd47-antibody-ao-176-in-combination-with-keytruda-pembrolizumab-in-patients-with-select-solid-tumors [SID1234574788]).

Under this collaboration, Arch Oncology is expanding its ongoing Phase 1/2 clinical trial to evaluate AO-176, the Company’s novel anti-CD47 antibody, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of patients with select solid tumors. This part of the study will include patients with relapsed, platinum-resistant ovarian cancer, endometrial cancer, and gastroesophageal cancer. The open-label, multi-center, dose-escalation study is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics, and preliminary efficacy of AO-176, first as a monotherapy, then in combination with chemotherapy (paclitaxel), and now in combination with KEYTRUDA (pembrolizumab). As a monotherapy, AO-176 demonstrated encouraging safety and evidence of anti-tumor activity in patients with select solid tumors.

"This collaboration with Merck is part of our commitment to conducting a broad clinical development program to evaluate AO-176’s potential for patients," said Jackie Walling, MBChB, Ph.D., Chief Medical Officer of Arch Oncology. "In our Phase 1 trial, we saw encouraging anti-tumor activity for AO-176 as a single agent. These results led us to expand our clinical development program to explore different combination therapy approaches. Combining either PD-1 or PD-L1 checkpoint inhibition with a CD47 blockade has strong scientific rationale and in our preclinical studies resulted in enhanced anti-tumor activity over monotherapy alone. We are excited to advance AO-176 as we aim to deliver new cancer treatments to broader groups of patients."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About AO-176

AO-176 is a humanized anti-CD47 IgG2 antibody with a potential best-in-class profile. AO-176 is highly differentiated, with the potential to improve upon the safety and efficacy profile relative to other agents in this class of innate checkpoint inhibitors. AO-176 works by blocking the "don’t eat me" signal, the standard mechanism of anti-CD47 antibodies. Beyond blocking this signal, AO-176 has additional mechanisms, including directly killing tumor cells and inducing DAMPs (Damage Associated Molecular Patterns), resulting in Immunogenic Cell Death. Importantly, AO-176 binds preferentially to tumor cells, instead of to normal cells, and binds even more potently to tumors in their acidic microenvironment (low pH). Publications and presentations on AO-176 can be found at View Source

AO-176 is being evaluated in Phase 1/2 clinical trials for the treatment of patients with select solid tumors and multiple myeloma, both as monotherapy and in combination with standard therapies. In a Phase 1 trial in solid tumors, AO-176 demonstrated encouraging safety and evidence of anti-tumor activity when administered as a single agent. Additional information about these trials may be found at www.clinicaltrials.gov using the trial identification number NCT03834948 (solid tumors) or NCT04445701 (multiple myeloma).