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.

On March 11, 2020 Ipsen Biopharmaceuticals, an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY) reported the presentation of the PRESTO study by ENETS, and its simultaneous publication in the peer-reviewed journal, Advances in Therapy (Press release, Ipsen, MAR 11, 2020, View Source [SID1234555430]).1

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PRESTO was a multi-national, multi-center, prospective, non-interventional, simulated-use study that enrolled 90 nurses with ≥ 2 years’ experience injecting with the lanreotide (Somatuline Depot) syringe and/or the syringe for long-acting release octreotide. The primary objective of the PRESTO study was to assess nurse preference between the redesigned Somatuline Depot syringe and the syringe for long-acting release octreotide after performing injections into injection pads.

The PRESTO study incorporated an anonymous, web-based questionnaire, where nurses reported their overall preference. Virtually all participants (97.8%) expressed a preference (85.6% "strong", 12.2% "slight") for the redesigned Somatuline Depot syringe versus the octreotide syringe. Comparative safety and efficacy between Somatuline Depot and octreotide were not evaluated in this study.

"The experiences, attitudes and knowledge of both patients and healthcare practitioners, including nurses, was essential in the redesign of the syringe," said Daphne T. Adelman, Clinical Nurse Specialist from Northwestern University in Chicago, and a lead author on the PRESTO study. "In the absence of head-to-head trials, these data give healthcare professionals important insights. The ENETS poster presentation and the Advances in Therapy publication of the PRESTO study provide further details on the benefits of the redesigned syringe."

Indications for Somatuline Depot include the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival; treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy; and the long-term treatment of patients with acromegaly who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. Please see Important Safety Information below and accompanying full Prescribing Information.

"The redesigned Somatuline Depot syringe was developed based on feedback from physicians, nurses and patients;2 and the PRESTO study, for the first time, demonstrates the nurses’ preference for it versus the octreotide syringe," said Tamer Garawin, M.D., Vice President, Medical Affairs Oncology at Ipsen Biopharmaceuticals. "PRESTO is an example of how Ipsen continues our commitment to partnering with patients and healthcare providers, especially nurses, who play a key role in the management of GEP-NETs and acromegaly."

In addition to the PRESTO study, Ipsen had a record 12 abstracts accepted by ENETS.

*ABOUT PRESTO

PRESTO was a randomized, multinational, multicenter, noninterventional, simulated-use study involving nurses (n=90) with experience injecting with the Somatuline Depot syringe and/or the syringe for long-acting release octreotide. The primary objective of this study was to assess preferences of nurses between injecting with the Somatuline Depot syringe and the syringe for long-acting release octreotide. Nurses attended a single testing session, during which they injected injection pads with each type of syringe twice before reporting their preferences. Data were collected using an anonymous, self-administered, web-based questionnaire. Limitations of this study included the need for a change in injection pad after 10 injection sessions due to clogging issues which resulted in two separate cohorts, and that the injections performed were simulated. There were imbalances noted in sociodemographics and clinical setting of nurses which potentially introduces biased reporting of preferences. Another limitation was that some nurses were recruited from the CRO (Contract Research Organization) network organizing the study. This study was not designed to evaluate the efficacy or safety of Somatuline Depot or long-acting release octreotide and no assessment of efficacy or safety should be interpreted based on this study.

ABOUT NETs

A neuroendocrine tumor (NET) begins in the hormone-producing cells of the body’s neuroendocrine system, which is made of cells that are a combination of hormone-producing endocrine cells and nerve cells.3 NETs are a group of uncommon tumors occurring in both men and women aged 50 to 60 years old although they can affect anyone of any age.3

The three main areas where NETs are found in the body are the gastrointestinal tract, the pancreas and the lungs.3

Gastrointestinal NETs (GEP-NETs) are found in the gastrointestinal tract or digestive system and are the most common type of NETs.3
Pancreatic NETs (pNETs) are formed in the islet cells of the pancreas and include several uncommon types of NETs.3
Lung NETs are less common than other types, accounting for about one quarter of NETs.3
The symptoms of NETs are often not distinct and difficult to identify, and average time from initial onset of symptoms to proper diagnosis can take more than 5 years.4 Although NETs affect only a small percentage of the general population at any one time, the number of people being newly diagnosed with NETs overall is believed to be rising.3 This is mainly due to increased awareness of the condition and diagnostic testing.3 NETs are now the fastest growing class of cancers worldwide, accounting for around 2% of all cancers at any time.3

ABOUT ACROMEGALY

Acromegaly is an uncommon hormonal or endocrine disorder with slowly developing, but eventually distinct clinical symptoms.5 In the U.S., approximately 3,500 new cases of acromegaly are diagnosed each year.6

It is usually caused by having too much growth hormone in the body which, over time, results in some characteristic symptoms and signs, such as heavy or prominent facial features with a prominent jaw line and enlarged hands and feet.5

What is SOMATULINE DEPOT (lanreotide) Injection?

SOMATULINE DEPOT is a prescription medicine used in adults for:

the long-term treatment of people with acromegaly when surgery or radiotherapy have not worked well enough or a patient is unable to have surgery or radiotherapy;
the treatment of a type of cancer known as neuroendocrine tumors, from the gastrointestinal tract or the pancreas (GEP-NETs) that has spread or cannot be removed by surgery; and
the treatment of carcinoid syndrome to reduce the need for the use of short-acting somatostatin medicine.
It is not known if SOMATULINE DEPOT is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not take SOMATULINE DEPOT if you are allergic to lanreotide.
SOMATULINE DEPOT may cause serious side effects, including:
Gallstones
Changes to your blood sugar (high or low blood sugar),
Slow heart rate,
High blood pressure, and
Changes in thyroid function in acromegaly patients.
Tell your healthcare provider (HCP) if you have any of the following symptoms:
Symptoms of gallstones may include sudden pain in your upper right stomach area (abdomen), sudden pain in your right shoulder or between your shoulder blades, yellowing of your skin and whites of your eyes, fever with chills, and nausea.
Symptoms of high blood sugar may include increased thirst, increased appetite, nausea, weakness or tiredness, urinating more than normal, and fruity smelling breath.
Symptoms of low blood sugar may include dizziness or lightheadedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, irritability or mood changes, and hunger.
Symptoms of slow heart rate may include dizziness or lightheadedness, fainting or near-fainting, chest pain, shortness of breath, confusion or memory problems, and weakness or extreme tiredness.
SOMATULINE DEPOT can cause the thyroid gland to not make enough thyroid hormone in people with acromegaly. Symptoms of low thyroid levels may include fatigue, weight gain, puffy face, being cold all the time, constipation, dry skin, thinning or dry hair, decreased sweating, and depression.
The most common side effects of SOMATULINE DEPOT in people with:
Acromegaly: diarrhea; stomach (abdominal) pain; nausea; and pain, itching, or a lump at the injection site
GEP-NETs: stomach area (abdominal) pain; muscle and joint aches; vomiting; headache; pain, itching or a lump at the injection site
Carcinoid syndrome: headache, dizziness, muscle spasm; side effects were generally similar to those commonly seen with GEP-NETs
SOMATULINE DEPOT may cause dizziness. If this happens, do not drive a car or operate machinery.
Tell your HCP right away if you have signs of an allergic reaction after receiving SOMATULINE DEPOT, including swelling of your face, lips or tongue; breathing problems; fainting, dizziness or feeling lightheaded (low blood pressure); itching; skin flushing or redness; rash; or hives.
Before taking SOMATULINE DEPOT, tell your HCP about all your medical conditions including if you: have diabetes; have gallbladder, heart, thyroid, kidney or liver problems; are pregnant or plan to become pregnant; or are breastfeeding or plan to breastfeed. It is not known if SOMATULINE DEPOT will harm your unborn baby or pass into breast milk. You should not breastfeed if you receive SOMATULINE DEPOT and for 6 months after your last dose. SOMATULINE DEPOT may affect your ability to become pregnant.
Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SOMATULINE DEPOT and other medicines may affect each other, causing side effects. SOMATULINE DEPOT may affect the way other medicines work, and other medicines may affect how SOMATULINE DEPOT works. Your dose of SOMATULINE DEPOT or your other medications may need to be changed. If you have diabetes, your HCP may change your dose of diabetes medication when you first start receiving SOMATULINE DEPOT or if your dose of SOMATULINE DEPOT is changed.
Especially tell your HCP if you take:
Insulin or other diabetes medicines,
A cyclosporine (Gengraf, Neoral, or Sandimmune), or
Medicines that lower your heart rate, such as beta blockers.
Know the medicines you take. Keep a list of them to show your HCP when you get a new medicine.

Tell your HCP if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of SOMATULINE DEPOT. For more information, ask your HCP.

To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 Pascal Biosciences Inc. (TSX.V:PAS) ("Pascal") reported that it has entered into a Term Sheet with SōRSE Technology ("SōRSE") to develop Pascal’s cannabinoid programs (Press release, Pascal Biosciences, MAR 11, 2020, View Source [SID1234555431]). Investing in and financially supporting Pascal Biosciences’ research marks the first step for SōRSE Technology moving into medical research applications. This partnership leverages SōRSE’s industry-leading formulation technology with Pascal’s cannabinoid programs for clinical trials, led by Patrick Gray and his team of world-class medical researchers.

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SōRSE Technology sells and licenses a proprietary water-soluble cannabinoid emulsion technology (patent-pending) that enables increased bioavailability, accurate dosing, and over 12 months shelf stability. SōRSE Technology is science and data-driven, with 53 employees, 30 of whom specialize in R&D and Quality Assurance. SōRSE currently has multiple partnerships which provide a profitable revenue stream.

SōRSE technology will enable other cannabinoid researchers to build a network of doctors and scientists that can lead the world in offering cannabinoid health solutions. Pascal is the first company to identify a mechanism for cannabinoids to directly benefit cancer immunotherapy and is also developing a cannabinoid-derived drug targeting glioblastoma.

Pascal Biosciences is actively evaluating cannabinoid application research studies for potential participation. As a reputable cannabinoid industry leader, SōRSE Technology will partake in Pascal approved studies for the advancement of the industry and pharmaceutical applications.

"The potential of Pascal’s cannabinoid programs for clinical applications in combination with SōRSE’s proprietary emulsification methods offers a promising path for future medical applications of cannabinoid products," said Dr. Patrick Gray, CEO of Pascal Biosciences. "This agreement comes on the heels of recent, successful collaborative efforts with SōRSE that allowed us to examine SōRSE formulations in several Pascal ongoing studies. The combination of SōRSE’s industry-leading technology with Pascal’s long-term biotech potential make this a meaningful transaction for our shareholders."

"At SōRSE, we’re driven by our mission to help people better their lives through superior cannabinoid ingredients and delivery methods," said SōRSE CEO Howard Lee. "We are excited to continue to support pharmaceutical studies of cannabinoids with the world-class researchers of Pascal 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.