On March 11, 2020 LifeArc has reported that leading UK venture capital firm UK Innovation & Science Seed Fund (UKI2S) in investing into GyreOx Therapeutics (GyreOx) (Press release, LifeArc, MAR 11, 2020, View Source [SID1234555418]). The funding will support a two-year programme to develop and automate GyreOx’s proprietary drug discovery platform, MACRO.

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The MACRO platform generates a range of highly modified macrocyclic peptide molecules, known as gyrocycles, which can penetrate cells and be targeted to tackle the protein-protein interactions (PPI) within. These intracellular processes are potentially implicated in many health conditions including cancer, inflammation and autoimmune diseases and are difficult to reach with currently available medicine classes. Automation of the MACRO platform will enhance the generation process further to allow a greater number of novel macrocycles to be generated more quickly and more cheaply.

Dr Bill Primrose, Founder and CEO of GyreOx said: "It’s a strong endorsement of our technology that we have been able to attract support from such quality investors. We have an ambitious plan to develop the platform and to deploy it on a number of internal programmes, including one targeting an epigenetic cancer target. It is our ambition to make GyreOx into a clinical stage company with a strong drug pipeline and a number of discovery alliances with major players in the pharmaceutical industry."

Common medicines classes include small molecules and biologics. While small molecules can enter cells to modulate intracellular process, they have difficulty in addressing complex targets, including PPIs. Biologics, such as humanised antibodies, are unable to enter the cell and are therefore only suitable for addressing drug targets on the cell surface. GyreOx’s Gyrocycle highly modified macrocyclic peptides combine the targeting ability of biologics with the cell-entry ability of small molecules; these molecules present an attractive, novel therapeutic modality as they can also be engineered to further improve their pharmacokinetic profile and ability to penetrate cells to reach previously "undruggable" targets.

Dr David Holbrook, Head of Seed Fund, LifeArc said: "The LifeArc Seed Fund is delighted to be supporting GyreOx on its work on the macrocycles platform and helping translate the science on the next step towards the patient. GyreOx is a great example of the type of company we are trying to support—great science, great scientists, strong start up management all addressing a significant unmet health need."

GyreOx Ltd. was founded in May 2019 as a result of the ground-breaking science carried out by Professor James Naismith (University of Oxford, previously at the University of St Andrews) and Professor Marcel Jaspars (University of Aberdeen). This seed investment has been led by UKI2S with LifeArc as the major investor and a contribution from Oxford University’s University Challenge Seed Fund. Part of the investment will also provide match funding for an Innovate UK grant to GyreOx.

Oliver Sexton, Investment Director UKI2S said: "GyreOx can design truly novel compounds with the ability to target intracellularly. This opens up a whole new drug space. UKI2S is excited to back such groundbreaking and medically important research."

On March 11, 2020 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, reported an expanded research collaboration with Cancer Research UK and the University of Manchester, UK, to develop small molecule inhibitors of Poly(ADP-ribose) glycohydrolase (PARG) (Press release, Ideaya Biosciences, MAR 11, 2020, View Source [SID1234555417]). PARG is a cellular enzyme that hydrolyzes Poly (ADP-ribose) polymerase (PARP), a protein function required for DNA repair.

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Since initiating the Cancer Research UK partnership in 2017, IDEAYA has developed a selective and cell potent PARG small molecule series, that demonstrates robust on-target in vivo pharmacodynamic modulation. In 2019, Dr. Stephen Taylor and Pilay et. al., published a paper in Cancer Cell, entitled "DNA Replication Vulnerabilities Render Ovarian Cancer Cells Sensitive to Poly(ADP-Ribose) Glycohydrolase Inhibitors", which provides a potentially differentiated and complementary treatment approach to PARP inhibitors.

The expanded research collaboration will evaluate IDEAYA’s PARG inhibitors in vitro in multiple ovarian cancer cell lines and in vivo in ovarian cancer xenograft models. Dr. Stephen Taylor, B.Sc., Ph.D., Leech Professor of Pharmacology, University of Manchester, the principal investigator at University of Manchester, will lead the in vitro investigations. Dr. Caroline Springer, Ph.D., Director, Drug Discovery Unit, Cancer Research UK Manchester Institute, the principal investigator at the Cancer Research UK Manchester Institute, will lead the in vivo studies.

"We are excited to expand our partnership with IDEAYA to evaluate key biological hypotheses based on DNA replication vulnerabilities to predict sensitivity of PARG inhibitors in ovarian cancer. A large percentage of ovarian cancer patients still do not respond to PARP inhibitors, and there is an important need to advance other synthetic lethality DDR-based targets," said Dr. Stephen Taylor, B.Sc., Ph.D. "This collaborative research builds on our existing relationship with IDEAYA, and could potentially inform effective patient selection strategies of PARG inhibitors," added Dr. Caroline Springer, Ph.D.

"Cancer Research UK has made important research contributions to the DNA Damage Repair and PARP-BRCA synthetic lethality field, and we are delighted to expand our partnership with this leading cancer research institute to advance our potential first-in-class PARG inhibitor program," said Yujiro S. Hata, Chief Executive Officer and President, IDEAYA Biosciences.

On March 11, 2020 Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, reported financial results for the fourth quarter and full year 2019 (Press release, Dynavax Technologies, MAR 11, 2020, View Source [SID1234555416]).

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"Vaccines offer an unmatched value to the healthcare system and Dynavax continues to make tremendous progress on its transformation into a leading vaccine company. Our first product, HEPLISAV-B, provides adults higher and faster protection from hepatitis B in just two doses compared to previously available vaccines," commented Ryan Spencer, Chief Executive Officer of Dynavax. "We are excited by the response from our customers and our continued success in growing market share, which reinforces our belief that HEPLISAV-B has the potential to become the standard of care for adult hepatitis B vaccination in the U.S."

Mr. Spencer added, "Our focus in 2020 is driving annual revenue growth of HEPLISAV-B, generating data to support a unique dosing regimen for patients on hemodialysis, and supporting policy initiatives aimed at protecting more adults through adoption of a two-dose regimen, all of which position HEPLISAV-B for substantial long-term growth."

2019 Results and Recent Business Highlights

HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]

Full year 2019 net product revenue of $34.6 million compared to $6.8 million for 2018.
Market share in accounts targeted by the field sales team increased to 21% in the fourth quarter 2019 from 18% in the third quarter 2019.
The Company filed the cumulative analysis (comprising both required interim analyses) of its post-marketing study assessing the rates of occurrence of acute myocardial infarction in persons receiving HEPLISAV-B compared with Engerix-B with the U.S. Food and Drug Administration. The event rates were similar between the two treatment arms.
Announced partnership with Albertsons Companies’ 1,700 pharmacies nationwide, to provide HEPLISAV-B to people living with diabetes.
Corporate Updates

Established research collaboration with the University of Queensland and the Coalition for Epidemic Preparedness to develop a coronavirus (COVID-19) vaccine.
Appointed Ryan Spencer Chief Executive Officer and to the Board of Directors.
Appointed David Novack President and Chief Operating Officer.
2020 Milestones

HEPLISAV-B net product revenue expected to increase to $55-$62 million for the full year 2020
Release interim data from ongoing study of HEPLISAV-B in patients on hemodialysis in Q1 2020 and final immunogenicity data in the second half of 2020
Complete Phase 1-enabling animal studies and toxicology for improved pertussis vaccine with CpG 1018
Enter multiple strategic relationships focused on initial research in a variety of vaccine candidates to establish CpG 1018 as a leading adjuvant
Complete safety follow-up for HEPLISAV-B post-marketing studies in Q4 2020
Financial Results

Product Revenue, Net. HEPLISAV-B was launched in the first quarter of 2018. Net product revenue for the fourth quarter 2019 was $10.6 million, compared to $3.9 million for the fourth quarter 2018. Full year net product revenue for 2019 was $34.6 million compared to $6.8 million for the full year 2018. Product revenue from sales is recorded at the net sales price, which includes estimates of product returns, chargebacks, discounts and other fees.

Cost of Sales – Product. Cost of sales – product for the fourth quarter 2019 was $2.4 million, compared to $1.6 million for the fourth quarter 2018. Full year 2019 cost of sales – product was $10.2 million, compared to $10.9 million for the full year 2018.

R&D Expenses. Research and development (R&D) expenses for the fourth quarter of 2019 were $12.3 million, compared to $22.9 million for the fourth quarter of 2018. Full year 2019 R&D expenses were $62.3 million, compared to $75.0 million for the full year 2018. The decrease in R&D expenses is due to the winding down of oncology research and development activity resulting from the Company’s strategic organizational restructuring to focus on its vaccine business that was implemented in May 2019. R&D expenses in the fourth quarter of 2019 included approximately $3 million in external expenses related to oncology programs. These expenses are expected to continue to decrease over the next three quarters as activities are completed, with total additional external expenses over that period anticipated to be approximately $6 million.

SG&A Expenses. Selling, general and administrative (SG&A) expenses for the fourth quarter of 2019 were $20.3 million, compared to $16.4 million for the fourth quarter of 2018. Full year 2019 SG&A expenses were $75.0 million, compared to $64.8 million for the full year 2018. The increase for both the three and 12 months ended December 31, 2019 compared to 2018, was due primarily to increases in sales and marketing activities, payments for completion of certain milestones in the HEPLISAV-B post-marketing study and higher facility costs due to an increase in facility related overhead allocation to SG&A functions following the May restructuring and increased lease expense which is being recouped through a sublease to a third party and recorded as part of other income (expense).

Net Loss. Net loss allocable to common stockholders for the fourth quarter of 2019 was $36.8 million, or $0.44 per basic and diluted share, compared to a net loss of $40.0 million, or $0.64 per basic and diluted share, for the fourth quarter of 2018. Full year, net loss allocable to common stockholders, was $155.9 million, or $2.16 per basic and diluted share, compared to a net loss of $158.9 million, or $2.55 per basic and diluted share for the full year 2018.

Cash Position. Cash, cash equivalents and marketable securities totaled $151.1 million at December 31, 2019.

Conference Call and Webcast Information
Dynavax will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT. The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at www.dynavax.com. Alternatively, participants may dial 800-458-4121 (domestic) or 720-543-0206 (international) and refer to conference ID 1989638. A replay of the webcast will be available for 30 days following the live event.

About Hepatitis B
Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,I and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The U.S. Centers for Disease Control (CDC) recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.II Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician’s discretion.III Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.IV

About HEPLISAV-B
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

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]).

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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.

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]).

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"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.