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]).

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"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.

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]).

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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.

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]).

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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).

On February 9, 2021 China Oncology Focus Limited (COF), an affiliate of Lee’s Pharmaceutical Holdings Limited (Lee’s Pharma, HKEX: 950), and Sorrento Therapeutics, Inc. (Sorrento, Nasdaq: SRNE), reported that its anti-PD-L1 antibody, socazolimab, licensed from Sorrento to COF for the greater China territory, has been granted breakthrough therapy designation (BTD) by the China National Medical Products Administration (NMPA) to treat recurrent or metastatic cervical cancer (Press release, Sorrento Therapeutics, FEB 9, 2021, View Source [SID1234574787]).

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The NMPA established its BTD program in July 2020 to facilitate the research and development of innovative drugs that treat severe life-threatening or quality-of-life impairing diseases with no existing therapy or with proven evidence to demonstrate clear clinical benefits as compared to existing therapies. Products with BTD from the NMPA may be considered for conditional approval and priority review when submitting a New Drug Application (NDA).

"China NMPA granted socazolimab breakthrough therapy designation in recognition of both significant unmet medical need and positive and promising clinical results of socazolimab treatment for patients with recurrent or metastatic cervical cancer," said Dr. Benjamin Li Xiaoyi, Chief Executive Officer of Lee’s Pharma. "Cervical cancer is the fourth most lethal cancer in women worldwide and the third cause of cancer-related death in developing countries. There is currently no recommended standard of care treatment for this disease in China. Socazolimab has the potential to be the leading anti-PD-L1 antibody in the treatment of this indication. Socazolimab has demonstrated outstanding efficacy and safety profile in the clinical trials so far in treating cervical cancer patients."

Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics, stated, "We at Sorrento are happy with the collaboration with our colleagues at Lee’s Pharma and are satisfied with the clinical advance of our first therapeutic antibody partnership in socazolimab. We currently plan to expand our partnership with Lee’s Pharma and are in discussions regarding the co-development of additional therapeutic antibodies from Sorrento to treat hematologic and solid tumors."

Lee’s Pharma plans to file a new drug application to China NMPA and request a fast-track conditional approval of socazolimab for the treatment of cervical cancer in Q2 2021.

About Socazolimab

Socazolimab is a fully human anti-PD-L1 monoclonal antibody identified by Sorrento using its proprietary G-MAB library platform. COF received exclusive rights to develop and commercialize the antibody for Greater China, which includes Mainland China, Hong Kong, Macau, and Taiwan. Socazolimab has the following potential advantages over its competitors:

Fully human antibody potentially allows it to have minimal immunogenicity; demonstrated by its negative antigen-derived antibody (ADA) generation in humans in studies to date.
Potentially lower dose required to achieve efficacy compared to other anti-PD-L1 antibodies.
Dual mechanism of action observed with both immune-checkpoint inhibition and antibody-dependent cellular cytotoxicity (ADCC) effect.
The antibody has been tested or is being tested in various cancer indications including recurrent or metastatic cervical cancer, maintenance therapy for high-grade osteosarcoma after adjuvant chemotherapy, locally advanced and metastatic urothelial carcinoma, extensive small cell lung cancer in combination with carboplatin and etoposide, advanced urothelial carcinoma in combination with albumin-bound paclitaxel and esophageal carcinoma.

On February 9, 2021 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported it has entered into securities purchase agreements with two healthcare-dedicated institutional investors for the purchase and sale of 4,000,000 shares of its common stock at a purchase price of $6.25 per share in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Genprex, FEB 9, 2021, View Source [SID1234574786]). No warrants will be issued in connection with the transaction. The closing of the offering is expected to occur on or about February 11, 2021, subject to the satisfaction of customary closing conditions.

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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

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A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-239134) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or 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 jurisdiction.