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Dynavax Announces Fourth Quarter and Full Year 2019 Financial Results

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.

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]).

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."