On March 4, 2021 Foresee Pharmaceuticals (6576.TWO) ("Foresee") announced today that it has entered into an exclusive license agreement with Intas Pharmaceuticals ("Intas") for the US commercialization of Foresee’s novel FP-001 program, Leuprolide Mesylate Injectable Suspension (LMIS) ready-to-use subcutaneous 6-month and 3-month depot formulations ("Camcevi") (Press release, Foresee Pharmaceuticals, MAR 4, 2021, View Source [SID1234576128]). The application for the 3-month indication of Camcevi has not yet been filed with the US Food and Drug Administration (FDA) and is under development by Intas and Foresee, the Section 505(b)(2) New Drug Application for the 6-month Camcevi indication, is currently under review by the FDA.

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Under the terms of this partnership, Foresee, a Taiwan and US-based biopharmaceutical company, will receive 10 million US Dollars upfront, along with certain regulatory milestones and sales milestones payments having a combined value totaling up to 207 million US dollars, plus a share of the product revenue in the territory. Intas’ US affiliate, Accord BioPharma, Inc. will be commercializing the Camcevi products in the US market. Intas, a global biopharmaceutical company, will cover all costs of commercialization in the territory.

Dr. Ben Chien, Founder and Executive Chairman of Foresee commented: "We are very pleased to have entered into this license agreement with Intas for commercialization of Camcevi in the US; it allows us to build on our existing partnership with Intas, where they have demonstrated strong commitment to the success of this complex and promising product. We look forward to successfully leveraging Intas’ US commercial platform together."

Chrys Kokino, President US Specialty at Accord Healthcare Inc., said "Intas and its US specialty arm, Accord BioPharma, Inc., is very committed to bringing complex and accessible, added value medicines to the US market, improving the standard of care and ultimately the lives of patients and the public health in general. This agreement will contribute another key therapy to our fast-growing US business. We look forward to continuing our successful collaboration with Foresee."

On March 4, 2021 ESSA Pharma Inc. ("ESSA", or the "Company") (Nasdaq: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported that the underwriters have exercised their option (the "Option") to purchase an additional 724,637 common shares in the capital of the Company (the "Common Shares"), in connection with the Company’s recently completed underwritten public offering of 4,830,918 Common Shares, which closed on February 22, 2021 (the "Offering") (Press release, ESSA, MAR 4, 2021, View Source [SID1234576127]). On closing of the Option, the Company will have issued 5,555,555 Common Shares pursuant to the Offering for gross proceeds of approximately $150 million.

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Jefferies and Piper Sandler acted as joint book-running managers for the Offering, Oppenheimer & Co. acted as lead manager and Bloom Burton Securities Inc. acted as co-manager.

As previously announced, ESSA intends to use the net proceeds from the Offering to fund clinical activities, chemistry, manufacturing and controls, and research and development, as well as working capital and general corporate purposes. Clinical activities include supporting multiple combination studies with EPI-7386 and anti-androgens, a Phase 2 clinical study, and preparatory work on a Phase 3 confirmatory study.

The securities described above were offered by ESSA in the United States pursuant to a shelf registration statement on Form S-3 (File No. 333-250971) that was previously filed by ESSA with the Securities and Exchange Commission (the "SEC") and became effective on December 29, 2020 and in Canada pursuant to ESSA’s Canadian short form base shelf prospectus (the "Canadian Base Shelf Prospectus") dated August 24, 2020 that was previously filed with the securities regulatory authorities in each of the provinces of British Columbia, Alberta and Ontario.

A preliminary prospectus supplement related to the Offering was filed with the SEC on February 16, 2021, and a final prospectus supplement related to the Offering was filed with the SEC on February 18, 2021, and each are available on the SEC’s website at View Source A preliminary prospectus supplement to ESSA’s Canadian Base Shelf Prospectus was also filed with the securities regulatory authorities in each of the provinces of British Columbia, Alberta and Ontario on February 16, 2021 and is available at View Source and a final prospectus related to the Offering was filed with the securities regulatory authorities in each of the provinces of British Columbia, Alberta and Ontario on February 18, 2021 and is available at View Source.

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

On March 4, 2021 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported the closing of its previously announced underwritten public offering of 4,375,000 American Depositary Shares (ADSs) of the Company, at a price to the public of $8.00 per ADS. Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company (Press release, RedHill Biopharma, MAR 4, 2021, View Source [SID1234576126]).

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H.C. Wainwright & Co. acted as the sole book-running manager for the offering.

In addition, the Company has granted to the underwriter a 30-day option to purchase up to additional 656,250 ADSs at the public offering price, less underwriting discounts and commissions.

The gross proceeds to RedHill, before deducting underwriting discounts and commissions and offering expenses are $35 million. The Company intends to use the net proceeds from this offering to fund its clinical development programs, commercialization activities and for acquisitions and general corporate purposes.

The securities described above were offered by RedHill pursuant to a "shelf" registration statement on Form F-3 (File No. 333-232777) previously filed with the Securities and Exchange Commission (the "SEC") on July 24, 2019 and declared effective by the SEC on August 8, 2019. The offering of the securities was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities offered have been filed with the SEC and are available on the SEC’s website at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction.

On March 4, 2021 ViewRay, Inc. (Nasdaq: VRAY) (the "Company") reported financial results for the fourth quarter and year ended December 31, 2020 (Press release, ViewRay, MAR 4, 2021, View Source [SID1234576125]).

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Full Year 2020 Highlights

Total revenue of $57.0 million primarily from nine revenue units, including two system upgrades, compared to 2019 revenue of approximately $87.8 million, primarily from 15 revenue units, including two system upgrades.
Received 17 new orders for MRIdian systems, including two upgrades, totaling $94.6 million, compared to 22 new orders, including three upgrades, totaling $118.5 million in 2019.
Total backlog increased to $241.3 million as of December 31, 2020, compared to $227.3 million as of December 31, 2019.
Cash and cash equivalents were $156.7 million as of December 31, 2020. Cash burn in the fourth quarter of 2020 was approximately $7.2 million.
Fourth Quarter 2020 Highlights

Total revenue of approximately $18.5 million in the fourth quarter of 2020, primarily from three revenue units including one system upgrade, compared to total revenue of approximately $16.5 million, primarily from three revenue units including one system upgrade, in the fourth quarter of 2019.
Received five new orders for MRIdian systems totaling $24.0 million in the fourth quarter of 2020, compared to four new orders totaling $21.2 million in the fourth quarter of 2019.
2021 Public Offering of Common Stock

In January 2021, the Company raised aggregate net proceeds of approximately $53.5 million after deducting the underwriting discounts, commissions, and estimated offering expenses via a public offering in which 11,856,500 shares of our common stock were issued and sold, including the full exercise of the underwriters’ option to purchase additional shares, at a price to the public of $4.85 per share.
"We are pleased with our solid fourth quarter and full year 2020 results despite the ongoing impact of the COVID-19 pandemic. Our recently bolstered balance sheet, coupled with our clinical, strategic, and economic value propositions, have positioned us well for 2021 and beyond," said Scott Drake, President and CEO. "Innovation is the hallmark of ViewRay, and our pipeline is focused on sub-20 minute treatment times, improved workflow and efficiency, and cost reduction. By protecting and extending our innovation lead, we are improving the lives of cancer patients worldwide."

Financial Results

Total revenue for the three months ended December 31, 2020 was $18.5 million compared to $16.5 million for the same period last year. Total revenue for the full year 2020 was $57.0 million compared to $87.8 million for the full year 2019.

Total cost of revenue for the three months ended December 31, 2020 was $18.3 million compared to $20.4 million for the same period last year. Total cost of revenue was $61.1 million for the full year 2020 compared to $93.3 million for the full year 2019.

Total gross margin for the three months ended December 31, 2020 was $0.2 million, compared to a gross margin of $(3.9) million for the same period last year. Total gross margin for the full year 2020 was $(4.1) million compared to $(5.5) million for the full year 2019.

Total operating expenses for the three months ended December 31, 2020 were $25.5 million, compared to $28.5 million for the same period last year. Total operating expenses for the full year 2020 were $101.9 million compared to $115.3 million for the full year 2019.

Net loss for the three months ended December 31, 2020 was $26.1 million, or $0.18 per share, compared to $35.2 million, or $0.31 per share, for the same period last year. Net loss for the full year 2020 was $107.9 million, or $0.73 per share, compared to $120.2 million, or $1.18 per share, for the full year 2019.

ViewRay had total cash and cash equivalents of $156.7 million at December 31, 2020.

Financial Guidance

Due to the ongoing impact and uncertainty of the COVID-19 pandemic globally, the company will not be providing financial guidance at this time.

Conference Call and Webcast

ViewRay will hold a conference call to discuss results on Thursday, March 4, 2021 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (844) 277-1426 for domestic callers and (336) 525-7129 for international callers. The conference ID number is 5976583. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at View Source

After the live webcast, a replay will remain available online on the investor relations page of ViewRay’s website, under "Financial Events and Webinars", for 14 days following the call. In addition, a telephonic replay of the call will be available until March 11, 2021. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 5976583.

On March 4, 2021 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need, reported financial results for the year ended December 31, 2020 (Press release, Synthetic Biologics, MAR 4, 2021, View Source [SID1234576124]).

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Recent developments:

Received Institutional Review Board ("IRB") approval from Washington University School of Medicine in St. Louis for the SYN-004 (ribaxamase) Phase 1b/2a clinical trial protocol in allogeneic hematopoietic cell transplant ("HCT") recipients
Commenced screening of patients for enrollment of the first of three sequential antibiotic cohorts in the SYN-004 Phase 1b/2a clinical trial in allogeneic HCT recipients
Current cash position of approximately $72.6 million
Received $8.0 million from the exercise of warrants
Current cash runway provides funding into 2023 and ability to fully fund Phase 1b/2a clinical trial of SYN-004 and Phase 1 safety studies of SYN-020 intestinal alkaline phosphatase ("IAP") program
Upcoming milestones:

Expect to begin dosing patients in the first antibiotic cohort of the SYN-004 Phase 1b/2a clinical trial during Q1 2021; A topline data readout of the first antibiotic cohort is expected during Q4 2021
Expect to commence first Phase 1 single-ascending-dose study ("SAD") of SYN-020 during Q2 2021; Topline data anticipated during Q3 2021
Expect to commence second Phase 1 multiple-ascending-dose ("MAD") study of SYN-020 during Q3 2021; Topline data anticipated during Q2 2022
"We are more encouraged than ever by the outlook for the business as we have made important progress during the fourth quarter advancing and demonstrating the significant value of our clinical development programs. With a number of upcoming catalysts later this year, we believe there is potential to continue to deliver significant value for our shareholders," stated Steven A. Shallcross, Chief Executive and Financial Officer. "IRB approval by Washington University of the SYN-004 Phase 1b/2a clinical program protocol marks a major milestone for the Company. Looking ahead, we believe SYN-004 has the potential to address an important and underserved patient population, and may significantly improve outcomes for allogeneic HCT recipients by preventing downstream complications often associated with disruption of the gut microbiome by intravenous ("IV") beta-lactam antibiotics. We are pleased to announce that Washington University has begun screening patients for enrollment of the first of three sequential antibiotic cohorts and look forward to reporting topline data for this group towards the end of this year, pandemic conditions permitting."

Mr. Shallcross continued, "During the fourth quarter of 2020, we also made significant progress and gained additional clarity on potential clinical development pathways for our SYN-020 IAP program. Looking ahead, we intend to commence safety studies starting with a planned Phase 1 single-ascending-dose study in healthy volunteers during the second quarter of 2021; a topline data readout is expected during the third quarter of 2021. A second Phase 1 multiple-ascending-dose study is also expected to begin enrollment during the third quarter of 2021. Both studies are designed to support the advancement of SYN-020 in multiple potential therapeutic indications, including celiac disease, nonalcoholic fatty liver disease ("NAFLD") and age-related metabolic and inflammatory diseases. We are very excited about the potential for this program to be a long-term value driver for our Company and look forward to sharing important updates and progress as we continue to advance it towards clinical trials."

Mr. Shallcross concluded, "While remaining keenly focused on the execution of our clinical development activities, we also significantly strengthened our balance sheet and raised net proceeds of approximately $63.8 million, in addition to $8.0 million in proceeds from the cash exercise of warrants, which has helped to streamline our capital structure. As a result of these activities, our current cash position is approximately $72.6 million. Our fortified financial footing will now allow the Company to continue its operations into 2023 as well as fully fund the Phase 1b/2a clinical trial of SYN-004 and our planned Phase 1 safety studies of SYN-020 IAP."

Clinical Development and Operational Update

Announced approval by the IRB at Washington University of the SYN-004 Phase 1b/2a clinical program protocol in allogeneic HCT recipients, allowing the clinical trial to commence as planned;
Announced Washington University has begun screening patients for enrollment of the first antibiotic cohort for the Company’s Phase 1b/2a clinical trial of SYN-004 in allogeneic HCT recipients for the prevention of acute graft-versus-host-disease (aGVHD)
The Phase 1b/2a clinical trial comprises a single center, randomized, double-blind, placebo-controlled clinical trial of oral SYN-004 in up to 36 evaluable adult allogeneic HCT recipients,
The goal of this clinical trial is to evaluate the safety, tolerability and potential absorption into the systemic circulation (if any) of oral SYN-004 administered to allogeneic HCT recipients who receive an IV beta-lactam antibiotic to treat fever,
Study participants will be enrolled into three sequential cohorts and administered a different study-assigned IV beta-lactam antibiotic. Eight participants in each cohort will receive SYN-004 and four will receive placebo,
Safety and pharmacokinetic data for each cohort will be reviewed by an independent Data and Safety Monitoring Committee ("DSMC"), which will make a recommendation on whether to proceed to the next IV beta-lactam antibiotic,
A topline data readout for the first antibiotic cohort is anticipated during the fourth quarter of 2021, pandemic conditions permitting;
A Phase 1 SAD clinical trial in healthy volunteers of the Company’s SYN-020 IAP is anticipated to commence during the second quarter of 2021
A topline data readout is anticipated during the third quarter of 2021, pandemic conditions permitting,
A second Phase 1 clinical trial evaluating multiple-ascending doses of SYN-020 in healthy volunteers is expected to commence during the third quarter of 2021; topline data is anticipated during the second quarter of 2022, pandemic conditions permitting,
Both studies are intended to support the development of SYN-020 in multiple potential clinical indications;
Strengthened balance sheet by raising net proceeds of $63.8 million from the sale of the common stock via the Company’s At-The-Market ("ATM") facility, and $8.0 million resulting from the cash exercise of a portion of Company’s 2018 warrants
As a result of these activities, the Company has extended its cash runway into 2023 and has the ability to fully fund its Phase 1b/2a clinical trial of SYN-004 and planned Phase 1 SAD and MAD clinical trials of SYN-020;
Announced the appointment of senior biotech executive John Monahan, PhD, to the Company’s Board of Directors
Dr. Monahan brings to the Company more than 45 years of executive leadership experience in the pharmaceutical and biotechnologies industries.
Year Ended December 31, 2020 Financial Results

General and administrative expenses increased to $5.0 million for the year ended December 31, 2020, from $4.6 million for the year ended December 31, 2019. This increase of 8.7% is due to increased legal costs related to business development, patent execution, employee contract matters, vacation expense, insurance costs and registration fees. The charge relating to stock-based compensation expense was $300,000 for the year ended December 31, 2020, compared to $300,000 for the year ended December 31, 2019.

Research and development expenses decreased to $5.1 million for the year ended December 31, 2020, from $11.1 million for the year ended December 31, 2019. This decrease of 54.1% is primarily due to a reduction in preclinical and manufacturing activity of SYN-020 IAP and the result of the response to the global COVID-19 pandemic by our clinical development partners which led to the postponement of the Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients and the SYN-010 clinical trial and to a lesser extent the discontinuation of the Phase 2b investigator sponsored clinical trial of SYN-010. Research and development expenses also include a charge relating to non-cash stock-based compensation expense of $66,000 for the year ended December 31, 2020, compared to $75,000 for the year ended December 31, 2019.

Total other income was $44,000 for the year ended December 31, 2020, compared to other income of $283,000 for the year ended December 31, 2019. Total other income for the year ended December 31, 2020 and 2019 is primarily comprised of interest income from investments.

Cash and cash equivalents on December 31, 2020 were $6.2 million, a decrease of $8.8 million from December 31, 2019.

Conference Call

Synthetic Biologics will hold a conference call today, Thursday, March 4, 2021, at 4:30 p.m. (EST). The dial-in information for the call is as follows, U.S. toll free: 1-888-347-5280 or International: +1 412-902-4280. Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source An archive of the call will be available for replay at the same URL, View Source, for 90 days after the call.