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.

On March 11, 2020 AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company, reported that it will release fourth quarter and annual financial results before market open on Monday, March 16, 2020 (Press release, AcelRx Pharmaceuticals, MAR 11, 2020, View Source [SID1234555432]). AcelRx management will host a live webcast and conference call at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) on March 16, 2020 to discuss the financial results and provide an update on the company’s business.

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The webcast is accessible by visiting the Investors page of the company’s website at www.acelrx.com and clicking on the webcast link on the Investors home page. The webcast will be accompanied by a slide presentation. A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of the company’s website at www.acelrx.com.

Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers.

On March 11, 2020 Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, reported the pricing of an underwritten public offering of 7,500,000 shares of its common stock, at a price to the public of $0.60 per share (Press release, Apricus Biosciences, MAR 11, 2020, View Source [SID1234555499]). In addition, the Company granted the underwriters a 45-day option to purchase up to 1,125,000 additional shares of its common stock to cover over-allotments, if any. All of the shares of common stock in the offering are being sold by Seelos.

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Benchmark Company is acting as sole book-running manager for the offering.

Seelos anticipates the aggregate net proceeds from the offering will be approximately $3.9 million, after deducting the underwriting discounts and commissions and estimated offering expenses payable by Seelos, but excluding any exercise of the underwriters’ option to purchase additional shares of common stock. Seelos intends to use the net proceeds from the offering for general corporate purposes and to advance the development of its product candidates. This offering is expected to close on or about March 16, 2020, subject to the satisfaction of customary closing conditions.

The securities described above were offered by Seelos pursuant to a shelf registration statement on Form S-3 (File No. 333-221285) previously filed with the Securities and Exchange Commission (the "SEC") on November 2, 2017, amended on December 1, 2017 and declared effective by the SEC on December 7, 2017. The securities may be offered only by means of a prospectus. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the offering has been filed with the SEC. Electronic copies of the preliminary prospectus and, when available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained by visiting the SEC’s website at www.sec.gov or by contacting The Benchmark Company, LLC, Attn: Prospectus Department, 150 E. 58th Street, 17th floor, New York, NY 10155, by calling (212) 312-6700 or by e-mail at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On March 10, 2020 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported financial and operating results, including an update on its transformation program, for the year ended December 31, 2019 (Press release, Trillium Therapeutics, MAR 10, 2020, View Source [SID1234555348]).

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2019 Transformation Program

2019 was a critical year in Trillium’s evolution toward a more clinical development-focused CD47 immuno-oncology company. Key developments, as part of a wide-ranging transformation program, were:

Transitioned leadership to a new CEO, Jan Skvarka, who joined in September. Mr. Skvarka is an experienced healthcare executive, who was previously CEO of a PureTech Health portfolio company (Tal Medical), and leading Partner in the Healthcare practice at Bain & Company. He holds an MBA from Harvard Business School.
Established office in Cambridge, MA, which will allow the company to tap the local talent pool. The CEO office and clinical development are now based in Cambridge.
Restructured the company’s footprint by reducing staff by 40% to create a more efficient organization with stronger clinical development focus, as well as extend the cash runway.
Substantially revised the company strategy, namely:
Refocused on intravenous TTI-621 & TTI-622 programs and large hematologic malignancy indications, specifically acute myeloid lymphoma & myelodysplastic syndromes (AML/MDS), peripheral T-cell lymphoma (PTCL), diffuse large B-cell lymphoma (DLBCL) and multiple myeloma;
Deprioritized a lead intratumoral TTI-621 program with intended focus on early-stage cutaneous T-cell lymphoma (CTCL).
Zeroed in on execution of TTI-621 & TTI-622 dose escalation studies, which were declared mission critical path in the near term.
Subsequently, on January 7, 2020, the company announced a data update that confirmed TTI-621 monotherapy activity at initial low dose escalation levels (up to 0.5 mg/kg) across several hematologic malignancies. As such, TTI-621 is the only CD47 blocker that has shown meaningful single agent activity. Further dose optimization is in progress, and TTI-621 is now enrolling patients at a 1.4 mg/kg dose level, or 7 times the initially selected dose at which monotherapy activity was observed.

Following the (i) transformation program, (ii) changes in strategic direction, and (iii) encouraging data update, the company raised $117 million in January 2020, in a substantially oversubscribed public offering. Among key investors were experienced healthcare funds, such as Boxer Capital, Logos Capital, New Enterprise Associates, Venrock Healthcare Capital Partners and Vivo Capital. Paul Walker joined the Board of Directors, and Ali Behbahani became Board Observer; both are General Partners at NEA.

Cash Position and Guidance

As of February 28, the company had approximately $130 million in cash and cash equivalents.

Over the next three years (2020-22), the company plans to accomplish the following goals:

Complete TTI-621 and TTI-622 dose escalation studies, expected in 2020 (potentially in 2021, depending on the dose selected);
Conduct 3-4 new hematologic malignancy studies in AML/MDS, PTCL, DLBCL and/or multiple myeloma; and
Initiate and complete a solid tumor exploratory effort with TTI-621 in several key indications.
In 2020, the company will provide the following updates:

TTI-622 study update at the 2020 ASCO (Free ASCO Whitepaper) annual meeting;
TTI-621 study update mid-year and at the 2020 ASH (Free ASH Whitepaper) annual meeting;
TTI-621 and TTI-622 study updates once maximum tolerated doses or recommended phase 2 doses are identified.
Annual 2019 Financial Results:

As of December 31, 2019, Trillium had cash and cash equivalents and marketable securities, and working capital of $22.7 million and $9.8 million, respectively, compared to $33.4 million and $25.1 million, respectively at December 31, 2018. The decrease in cash and cash equivalents and marketable securities, and the decrease in working capital were due mainly to cash used in operations, partially offset by the cash received from the February 2019 public offering. The decrease in working capital was due mainly to cash used in operations and an increase to accounts payable and accrued liabilities due to timing of clinical trial related payments.

-2-

Net loss for the year ended December 31, 2019 of $41.6 million was higher than the loss of $32.9 million for the year ended December 31, 2018. The net loss was higher due mainly to a warrant liability revaluation loss of $5.7 million, the write down of Fluorinov intangible assets of $3.0 million, higher manufacturing costs, and a net foreign currency loss of $0.8 million in the current year compared to a net foreign currency gain of $2.7 million in the prior year. The higher loss was partially offset by lower clinical trial expenses.

In January 2020, the Company completed an underwritten public offering for gross proceeds of $117 million comprising 41,279,090 common shares and 1,250,000 Series II Non-Voting Convertible First Preferred Shares, each issued at $2.75 per share.