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Deciphera Pharmaceuticals, Inc. Announces Fourth Quarter and Full Year 2019 Financial Results

On March 9, 2020 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported financial results for the fourth quarter and year ended December 31, 2019 and provided an update on clinical and corporate developments (Press release, Deciphera Pharmaceuticals, MAR 9, 2020, View Source [SID1234555314]).

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"2019 was a year of outstanding execution for Deciphera," said Steve Hoerter, President and Chief Executive Officer. "In 2020, our top priority is preparing for the potential approval and launch of ripretinib now that the NDA has been accepted by the FDA for Priority Review. Patients with GIST are in need of a new treatment option, and we believe ripretinib has the potential to transform the treatment of this disease."

Mr. Hoerter continued, "Our broad development program for ripretinib is on track, and we look forward to the completion of enrollment in INTRIGUE, our pivotal Phase 3 study of ripretinib in second-line GIST, in the second half of this year. Beyond ripretinib, we remain focused on the balance of our wholly-owned, clinical-stage pipeline, with updated clinical data for both DCC-3014 and rebastinib, as well as an IND submission for DCC-3116, expected later this year."

Recent Program Highlights

Ripretinib
Announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) seeking approval for ripretinib for the treatment of patients with advanced gastrointestinal stromal tumors (GIST) who have received prior treatment with imatinib, sunitinib, and regorafenib, and assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 13, 2020.

The NDA is being reviewed by the FDA under the Oncology Center of Excellence Real-Time Oncology Review (RTOR) pilot program. This pilot program aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible, while maintaining and improving review quality. Additional information about RTOR can be found at: View Source

Received Priority Review, under the Project Orbis initiative, for the marketing authorization applications in Canada and Australia. Project Orbis, an initiative of the FDA Oncology Center of Excellence, is designed to provide a framework for concurrent submission and review of oncology products among international partners. Additional information about the Project Orbis initiative can be found at: View Source
DCC-3014
Presented preliminary data from the ongoing Phase 1 study of DCC-3014, including anti-tumor activity in three initial patients with diffuse-type tenosynovial giant cell tumor (TGCT). These data, which provide clinical proof-of-concept for DCC-3014’s potential in diffuse-type TGCT, were presented at the Connective Tissue Oncology Society (CTOS) 2019 Annual Meeting. DCC-3014 was also shown to be generally well tolerated with no reported grade 3 or higher treatment-emergent adverse events in initial diffuse-type TGCT patients.
Rebastinib
Announced the selection of the Phase 2 dose for rebastinib in the Phase 1b/2 study in combination with carboplatin and activation of Part 2 of the study in patients with breast cancer, ovarian cancer, and mesothelioma.
Recent Corporate Updates

Announced the closing of an underwritten public offering of 3,659,090 shares of common stock at a public offering price of $55.00 per share in February 2020. Total net proceeds to Deciphera were approximately $188.4 million, after deducting underwriting discounts and commissions and other offering expenses.
Announced the appointment of Ron Squarer to its Board of Directors. Mr. Squarer served as Chief Executive Officer and a member of the Board of Directors of Array BioPharma, Inc. from 2012 until its acquisition by Pfizer Inc. in August 2019 following the successful commercial launches of both Braftovi and Mektovi and brings over two decades of experience in the biopharmaceutical industry.
Announced the appointment of Frank S. Friedman to its Board of Directors. Mr. Friedman recently served as the global Chief Operating Officer of Deloitte Touche Tohmatsu Limited, culminating a 40-year career at the organization.
Fourth Quarter 2019 Financial Results

Cash Position: As of December 31, 2019, cash, cash equivalents, and marketable securities were $579.6 million, compared to cash and cash equivalents of $293.8 million as of December 31, 2018. The increase was primarily due to the follow-on public offering in the third quarter of 2019 and did not include the proceeds from the Company’s follow-on public offering completed in February 2020. We expect our current cash, cash equivalents, and marketable securities, together with the proceeds from our recent follow-on public offering in February 2020, will enable us to fund our operating and capital expenditures into the second half of 2022.
R&D Expenses: Research and development expenses for the fourth quarter of 2019 were $46.6 million, compared to $27.4 million for the same period in 2018. The increase was primarily due to personnel costs as well as clinical trial costs related to ripretinib, DCC-3014, and rebastinib. Non-cash stock-based compensation was $2.5 million and $1.0 million for the fourth quarters of 2019 and 2018, respectively.
SG&A Expenses: Selling, general, and administrative expenses for the fourth quarter of 2019 were $23.7 million, compared to $6.5 million for the same period in 2018. The increase was primarily due to personnel costs as well as external spend associated with commercial readiness and moving to our new headquarters. Non-cash stock-based compensation was $2.9 million and $1.8 million for the fourth quarters of 2019 and 2018, respectively.
Net Loss: For the fourth quarter of 2019, Deciphera reported a net loss of $67.2 million, or $1.31 per share, compared with a net loss of $32.3 million, or $0.86 per share, for the same period in 2018. The increase in the net loss is primarily due to the increase in R&D expenses and G&A expenses discussed above.
Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, March 9, 2020 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 1669368. 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.

Numab Therapeutics Closes Series B Financing at CHF 22M to Advance Portfolio of Novel Multi-specific Antibodies in Immuno-Oncology

On March 9, 2020 Numab Therapeutics reported the closing of its Series B financing round at a total volume of CHF 22M (approximately USD 22.6M) (Press release, Numab, MAR 9, 2020, View Source [SID1234555313]). New investors in this round included 3SBio/Sunshine Guojian, Mitsubishi UFJ Capital Co., Ltd. and Eisai Co., Ltd. as well as Numab’s board member Dr. Daniel Vasella . Existing shareholders that participated in Numab’s Series A round also contributed to today’s financing. With the financing secured, Numab plans to further broaden its proprietary pipeline and accelerate the development for a number of programs towards the clinic. The company also plans to initiate a clinical trial for its lead oncology program ND021 during the course of 2020.

Mitsubishi UFJ Capital is one of Asia’s leading venture capital firm focusing on life science, information and communications technology and high technology investments. Numab and Eisai entered into a global research and option agreement to discover and develop a portfolio of multi-specific antibody immunotherapies for cancer in October 2019. In December 2019, Numab added a regional alliance with 3SBio’s subsidiary Sunshine Guojian Pharmaceutical Co., Ltd. to its growing roster of pharmaceutical partnerships.

"We are very pleased to have attracted a renowned institutional investor in Mitsubishi UFJ Capital to the Numab story and likewise appreciate the additional display of confidence in our platform and pipeline strategy by our partners as well as existing Series A investors and our board member Daniel Vasella," commented Dr. David Urech, Chief Executive Officer of Numab Therapeutics.

Multi-specific antibodies have the potential to unlock entirely novel modes-of-action aiming at superior benefit-to-risk profiles relative to conventional cancer immune therapies. Numab’s proprietary MATCH technology platform represents one of the most versatile and flexible sources for multi-specific antibodies. MATCH molecules can incorporate up to six binding specificities in true plug-and-play fashion. The individual antibody Fv building blocks are designed for maximum stability and developability

Zentalis Leads a Trio of Biotechs Charting a Course for Wall Street

On March 9, 2020 Zentalis Pharmaceuticals reported set a preliminary $100 million target for its IPO, according to documents filed with the Securities and Exchange Commission (Press release, Zentalis Pharmaceuticals, MAR 9, 2020, View Source [SID1234555312]). The New York-based company has applied for a Nasdaq listing under the stock symbol "ZNTL." That company is joined by Ayala Pharmaceuticals and Lyra Therapeutics, both of which also filed IPO paperwork last Friday.

Zentalis is developing small molecules to address biological pathways of cancers. The company says in its prospectus its small molecules are different than currently marketed therapies, and that they also have the potential to address large populations of cancer patients.

The Zentalis pipeline consists of four compounds, three of which are in early-stage clinical testing. Lead drug candidate, ZN-c5, is designed to target estrogen receptors (ER), proteins to which the hormone estrogen binds. Tumors that are ER positive and human epidermal growth factor receptor (HER2) negative rely on these proteins for their growth and survival. Zentalis’s ZN-c5 is an oral drug that’s a selective estrogen receptor degrader (SERD). The compound is in Phase 1/2 testing.

The Zentalis drug is intended to challenge fulvestrant (Faslodex), an AstraZeneca (NYSE: AZN) SERD. In 2018, the last year prior to the launch of generic competition, fulvestrant accounted for more than $1 billion in revenue for AstraZeneca. This drug is administered via two 5 mL intramuscular injections given once a month. In addition to being painful, injections of the drug into the muscle restricts how much ER degradation can be achieved, limiting its efficacy, Zentalis says.

As a once-daily pill, Zentalis believes its drug would offer patients more convenience. The drug might also be more effective. According to early data from a Phase 1/2 study, the drug was rapidly absorbed and achieved high exposure levels in the body. The Zentalis drug was well tolerated by patients and no dose-limiting toxicities were reported. Additional preliminary data from the dose escalation portion of the study are expected in the second half of this year.

The Zentalis drug is also being tested in combination with palbociclib (Ibrance), a Pfizer (NYSE: PFE) cancer drug that is FDA approved as a treatment for HR positive, HER2 negative breast cancer. Under an agreement with Pfizer, the pharmaceutical giant is supplying its drug for the study at no cost to Zentalis, according to the filing. Zentalis is responsible for conducting the study and paying for it. The agreement does not give Pfizer the right to participate in future Zentalis clinical trials, and each company keeps rights to their respective drugs.

The Zentalis pipeline also includes ZN-c3 and ZN-e4, drugs in early-stage development for solid tumors and non-small cell lung cancer respectively. Preliminary data for those tests are expected in 2021. Another Zentalis compound, ZN-d5, is an experimental treatment for B-cell lymphoma. In the first half of this year, the company plans to seek FDA clearance to begin clinical testing of that drug. Zentalis says in the prospectus that it will use the IPO proceeds to continue development of its three clinical-stage compounds and to advance its B-cell lymphoma drug to human testing.

Since its 2014 founding, Zentalis has raised $162.1 million, according to the filing. The most recent financing was an $85 million Series C round that closed in December. As of the end of last year, the company had $67.2 million in cash. Its largest shareholders include Recurium Equity, Matrix Capital Management Master Fund, and Viking Global Investors. The percentage of Zentalis held by those shareholders is more than 5 percent, but the exact amount was not disclosed.

Lilly to Participate in Barclays Global Healthcare Conference

On March 9, 2020 Eli Lilly and Company (NYSE:LLY) reported that it will participate in the Barclays Global Healthcare Conference on Tuesday, March 10, 2020 (Press release, Eli Lilly, MAR 9, 2020, View Source [SID1234555311]. Ilya Yuffa, vice president, U.S. Diabetes, and Jeffrey Emmick, M.D., Ph.D., vice president, diabetes product development, will participate in a virtual fireside chat at 10:45 a.m., Eastern Time.

A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

ImmunoPrecise Announces Debt Settlement of Previously Issued Debentures

On March 9, 2020 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTC QB: IPATF) reported that it wishes to settle up to $796,875 of previously issued debentures including interest by issuing up to 1,328,125 Shares at a price of $0.60 per Share (the "Debt Settlement") (Press release, ImmunoPrecise Antibodies, MAR 9, 2020, View Source [SID1234555310]). The purpose of the Debt Settlement is to reduce the ongoing debt obligations of the debentures and is subject to the approval of the TSX Venture Exchange.