1stOncology™: Cancer Intelligence Service – Page 13132 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Conatus Pharmaceuticals Reports 2019 Financial Results and Strategic Process Update

On March 11, 2020 Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) reported financial results for the fourth quarter and full year ended December 31, 2019, and provided an update on its strategic process (Press release, Conatus Pharmaceuticals, MAR 11, 2020, View Source [SID1234555415]).

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!

Recent Developments
In January 2020, Conatus announced that it had entered into a definitive agreement with Histogen Inc., a privately-held regenerative medicine company focused on developing patented, innovative technologies that replace and regenerate tissues in the body for aesthetic and therapeutic markets, pursuant to which Histogen will merge with a wholly-owned subsidiary of Conatus in an all-stock transaction. The combined company will operate under the name Histogen Inc., is expected to trade on the Nasdaq Capital Market under the ticker symbol HSTO and will focus on advancement of its regenerative tissue technology for dermatological and orthopedic indications.

The merger agreement has been unanimously approved by the board of directors of each company, who have also recommended to their respective company’s stockholders that they approve the merger agreement, the merger and, with respect to Conatus’s stockholders, a reverse stock split. The transaction is expected to close by the end of the second quarter of 2020, subject to approvals by the stockholders of Histogen and Conatus, a reverse stock split being implemented by Conatus, the continued listing of the combined company on Nasdaq and other customary closing conditions. As a result, based on the exchange ratio set forth in the merger agreement, current Conatus stockholders will collectively own approximately 26%, and Histogen stockholders will collectively own approximately 74%, of the combined company on a fully-diluted basis, after taking into account Histogen’s and Conatus’ outstanding options and warrants at the time of closing, irrespective of the exercise prices of such options and warrants, with such ratio subject to adjustment based on each company’s net cash balance at closing and changes in capitalization prior to the closing of the merger.

Financial Results
The net loss for the fourth quarter of 2019 was $2.7 million compared with $3.9 million for the fourth quarter of 2018. The net loss for the full year 2019 was $11.4 million compared with $18.0 million for the full year 2018.

Total revenues were $0.5 million for the fourth quarter of 2019 compared with $7.4 million for the fourth quarter of 2018, and $21.7 million for the full year 2019 compared with $33.6 million for the full year 2018. Total revenues consisted of collaboration revenues related to the Novartis agreement. The decreases in revenues for both periods were primarily due to lower emricasan-related research and development expenses resulting in corresponding lower revenues related to the Novartis agreement.

Research and development expenses were $0.8 million for the fourth quarter of 2019 compared with $8.9 million for the fourth quarter of 2018. Research and development expenses were $23.5 million for the full year 2019 compared with $41.4 million for the full year 2018. The decreases in both periods were primarily due to lower costs related to the ENCORE clinical trials as well as lower costs related to new product candidate development.

General and administrative expenses were $2.5 million for both the fourth quarter of 2019 and 2018. General and administrative expenses were $10.2 million for the full year 2019 compared with $10.5 million for the full year 2018. The decreases in both periods were primarily due to lower personnel costs in 2019 compared to the corresponding periods in 2018.

Cash, cash equivalents and marketable securities were $20.7 million at December 31, 2019, compared with $40.7 million at December 31, 2018.

Atreca Reports Fourth Quarter and Full Year 2019 Financial Results

On March 11, 2020 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, reported financial results for the fourth quarter and full year ended December 31, 2019 and provided an overview of recent developments (Press release, Atreca, MAR 11, 2020, View Source [SID1234555412]).

"2019 was a successful year for Atreca as we evolved into a public, clinical-stage company, positioning us for future growth," said John Orwin, Chief Executive Officer. "We recently dosed the first patient in our Phase 1b dose-escalation clinical trial evaluating ATRC-101 in multiple solid tumor types following clearance of our first IND by the FDA in November. Additionally, our new strategic collaboration with Merck to identify novel antibody targets in oncology underscores the potential of our differentiated approach to drug discovery and could help accelerate efforts to expand our clinical pipeline. We look forward to further progress in 2020."

Recent Developments and Highlights

Following the clearance of an Investigational New Drug application (IND) by the U.S. Food and Drug Administration (FDA) in November 2019, Atreca commenced patient dosing in a Phase 1b first-in-human clinical trial evaluating ATRC-101 in patients with select solid tumor cancers.

In February 2020, Atreca announced a strategic research collaboration with Merck to identify the antigenic targets of select novel antibodies discovered by Atreca with potential utility in oncology. Under the terms of the agreement, Atreca retains exclusive ownership and rights to develop all Atreca antibodies included in the collaboration with Merck, while Merck will receive a right-of-first negotiation should Atreca seek to partner or out-license one or more of the antibodies.
Fourth Quarter and Full Year 2019 Financial Results

As of December 31, 2019, cash and cash equivalents and short-term investments totaled $183.4 million.

Research and development expenses for the year ended December 31, 2019 were $54.7 million, including non-cash share-based compensation expense of $3.0 million. Research and development expenses for the three months ended December 31, 2019 were $14.3 million, including non-cash share-based compensation expense of $886,000.

General and administrative expenses for the year ended December 31, 2019 were $17.8 million, including non-cash share-based compensation expense of $3.1 million. General and administrative expenses for the three months ended December 31, 2019 were $6.9 million, including non-cash share-based compensation expense of $1.2 million.

Atreca reported a net loss of $67.5 million, or basic and diluted net loss per share attributable to common stockholders of $4.26, for the year ended December 31, 2019. The Company reported a net loss of $20.1 million, or basic and diluted net loss per share attributable to common stockholders of $0.72, for the three months ended December 31, 2019.

Spectrum Pharmaceuticals to Present Data from Phase 2 Clinical Trial for Poziotinib at Upcoming Medical Conference

On March 11, 2020 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported the acceptance for presentation of its abstract of the results for Cohort 1 from its Phase 2 clinical trial, ZENITH20, evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations (Press release, Spectrum Pharmaceuticals, MAR 11, 2020, View Source [SID1234555406]). The abstract, titled "Oral poziotinib shows clinical activity and durable response in previously treated EGFR exon 20 NSCLC patients – a Phase 2 study," will be part of the Keynote Forum at the 11th Annual Congress on Pulmonary & Respiratory Medicine. The oral presentation will take place on March 18, 2020 from 9:30 to 10:15 a.m. CET in Amsterdam. The abstract can be found here: poziotinib abstract.

Conference Call and Webcast

Spectrum’s management will host a webcast and conference call at 8 a.m. ET / 5 a.m. PT on March 18, 2020 to review the data and program strategy. The live call may be accessed by dialing (877) 837-3910 for domestic callers and (973) 796-5077 for international callers and entering the conference ID#:2059147. A live webcast of the call will be available from the Investors and Media section of the company’s website at View Source and will be archived there shortly after the live event.

OncoSec Receives $850,000 from The Australian Research and Development (R&D) Tax Incentive Program for TAVO™ R&D Work in 2019

On March 11, 2020 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a company developing late-stage intratumoral cancer immunotherapies, reported that it has received a Research and Development (R&D) Tax Incentive cash rebate of $850,000 from the Australian Tax Office (Press release, OncoSec Medical, MAR 11, 2020, View Source [SID1234555405]).

The Australian government established this tax incentive program to stimulate local industry investment in R&D by offering businesses tax offsets for eligible R&D expenditures made in Australia. OncoSec previously established a subsidiary in Australia and is conducting a portion of both of its TAVO KEYNOTE clinical trials as well as other R&D activities in the region. This work enables OncoSec to qualify for the program and obtain reimbursement for certain expenditures.

"We are always looking for ways to obtain non-dilutive sources of capital for OncoSec," said Daniel J. O’Connor, President and CEO of OncoSec Medical Incorporated. "In addition to leveraging the Australian R&D incentive through our Australian subsidiary, we also relocated our corporate headquarters to New Jersey from San Diego to capitalize on New Jersey’s tax incentive program for local businesses, which qualified OncoSec to receive approximately $875,000 for 2019 R&D work. Combined with the Australian payment, that’s over $1.7 million in non-dilutive capital for OncoSec for R&D work done in 2019. We will use this cash to fund our ongoing TAVO clinical development programs this year, including our pivotal KEYNOTE-695 study in checkpoint resistant metastatic melanoma. We will continue to participate in both the Australian and New Jersey R&D tax incentive programs, as well as pursue any and all opportunities that maximize value for OncoSec shareholders."

Silverback Therapeutics Raises $78.5 Million in Oversubscribed Series B Financing

On March 11, 2020 Silverback Therapeutics ("Silverback") ("the Company"), a private biopharmaceutical company pioneering a new class of immune-modulating ImmunoTAC drug conjugates targeting previously inaccessible disease pathways, reported the close of an oversubscribed $78.5 million Series B financing round (Press release, Silverback Therapeutics, MAR 11, 2020, View Source [SID1234555403]). U.S. Venture Partners ("USVP") led the round, with participation from new investors including Nextech Invest Ltd., Hunt Investment Group, Pontifax Venture Capital, Colt Ventures LP and NS Investment. Existing investors participating in the financing include OrbiMed Advisors LLC, Bristol-Meyers Squibb and Alexandria Venture Investments, LLC. Silverback will use the proceeds to support ongoing development of SBT6050, an anti-HER2 antibody conjugated to a potent TLR8 agonist for the treatment of HER2-expressing solid tumors, and to advance its pipeline of ImmunoTAC programs. The Company expects to file an Investigational New Drug Application ("IND") and initiate clinical investigation for SBT6050 this year.

"Our preclinical studies demonstrate that systemic delivery of our TLR8 agonist targeted to HER2-expressing tumors potently activates myeloid cells to kill cancer and reprograms the tumor microenvironment, resulting in durable, curative single-agent activity," said Peter Thompson, M.D., co-founder, Chairman, & CEO, Silverback Therapeutics. "We are pleased to attract a group of world-class investors who believe in our bold vision to develop potent immune-modulating agents that can be delivered systemically, but act locally at the site of disease. With these additional resources, we’re focused on advancing our lead program into the clinic this year and progressing our preclinical pipeline assets towards the clinic."

Along with the financing, Jonathan Root, M.D., general partner at USVP, and Thilo Schroeder, Ph.D., partner at Nextech Invest Ltd., have joined Silverback’s board of directors.

Dr. Root spent nine years in clinical practice before joining USVP in 1995 and becoming a general partner in 1997. Before USVP, he was on the faculty and clinical staff at The New York Hospital-Cornell Medical Center in New York City. Dr. Root is currently on the boards of several USVP portfolio companies and is also a former board member for the National Venture Capital Association. Dr. Root holds an A.B. in Economics from Dartmouth College, an M.D. from the University of Florida College of Medicine, and an M.B.A. from Columbia University.

Dr. Schroeder joined Nextech as a partner in 2012, helping grow and shape the organization as a leading oncology-focused venture firm. He began his biotech career at the pioneering cancer immunology company Micromet (acquired by Amgen) while studying at Ecole Supérieure de Biotechnologie de Strasbourg. Dr. Schroeder is currently on the boards of several private biotechnology companies. He obtained his Ph.D., focused on protein engineering in the development of Designed Ankyrin Repeat Proteins (DARPins), from the University of Zurich.

"The Silverback team is building a platform technology capable of unlocking potent immuno-modulatory pathways using an established antibody-guided approach for targeting disease sites," said Jonathan Root, M.D., general partner, USVP. "I look forward to supporting the company’s evolution as it moves these compelling therapies into the clinic, starting with SBT6050."