On March 4, 2020 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality services to biotechnology and pharmaceutical companies, reported that its Board of Directors has declared a quarterly cash dividend payment on the Company’s 10.50% Series E Convertible Preferred Stock (the "Series E Preferred Stock") (Press release, Avid Bioservices, MAR 4, 2020, View Source [SID1234555170]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The quarterly dividend on the Series E Preferred Stock is payable on April 1, 2020 to holders of record at the close of business on March 16, 2020.

The quarterly dividend payment on the Series E Preferred Stock will be $0.65625 per share, which is equivalent to an annualized 10.50% per share, based on the $25.00 per share stated liquidation preference, accruing from January 1, 2020 through March 31, 2020. The Series E Preferred Stock is listed on the NASDAQ Capital Market and trades under the ticker symbol "CDMOP".

On March 4, 2020 AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) reported unaudited consolidated financial results for the fourth quarter and full year ended December 31, 2019 (Press release, AMAG Pharmaceuticals, MAR 4, 2020, View Source [SID1234555169]). Total revenues for the full year of 2019 totaled $327.8 million, including revenue of $167.9 million from Feraheme (ferumoxytol injection), revenue of $122.1 million from Makena (hydroxyprogesterone caproate injection), and revenue of $21.4 million from Intrarosa (prasterone). The company reported an operating loss of $445.5 million and an adjusted EBITDA loss of $65.0 million in 2019.1

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our financial results reported today reflect the successes and challenges of 2019. While we achieved record revenue for Feraheme and gained our third FDA approval in two years, we faced some challenges, namely the readout of the PROLONG study and the October Advisory Committee for Makena," said William Heiden, AMAG’s president and chief executive officer. "We acknowledged the Makena challenges in our recently-completed strategic review, resulting in our decision to divest Intrarosa and Vyleesi. We believe this decision will position the company well to focus on the continuing development of ciraparantag and AMAG-423, drive continued growth of Feraheme, and continue our work to retain patient access to Makena. Preparing for the future, the board of directors has initiated a search for my successor to lead the company on the next leg of the AMAG journey, serving shareholders and patients with unmet medical needs."

On March 4, 2020 Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement and/or leukotriene systems are implicated, reported it had closed its previously announced private placement, issuing an aggregate of 5,620,296 American Depositary Shares (the "ADSs") at $1.70 per ADS for aggregate gross proceeds of approximately $9.5 million to certain accredited and institutional investors, led by existing investors of the Company, including Dr. Ray Prudo, the Company’s Chairman (Press release, Akari Therapeutics, MAR 4, 2020, View Source [SID1234555168]). The offering initially closed on February 25, 2020 and a final closing was held on March 3, 2020. Additionally, for each ADS purchased, the investors received an unregistered warrant to purchase one-half of an ADS. The warrants are immediately exercisable and will expire five years from issuance at an exercise price of $2.20 per ADS.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Paulson Investment Company, LLC, acted as the exclusive placement agent in connection with this offering.

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

The ADS and warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs issuable upon exercise of the warrants, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

On March 4, 2020 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics, reported proof of concept data for a next generation dual conjugated combination immunostimulatory antibody drug conjugate (IADC) (Press release, Sutro Biopharma, MAR 4, 2020, View Source [SID1234555165]). This breakthrough concept of a tumor targeting monotherapy, which simultaneously attacks tumor cells while stimulating a patient’s own immune system, has the promise of generating long-term immunity.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The IADC was generated with Sutro’s proprietary and integrated cell-free protein synthesis platform XpressCF and site-specific conjugation platform XpressCF+. It enables precise tumor targeting with a combination of a novel toll-like receptor (TLR) agonist and a traditional antibody drug conjugate warhead.

"This is a next-generation approach that utilizes Sutro’s technology to take ADCs into the future, potentially enabling a sustained and adaptive anti-tumor immune response," said Sutro’s Chief Scientific Officer, Trevor Hallam, PhD. "Here we have showcased how a targeted cytotoxin can stimulate immunogenic cell death and provide a synergistic stimulation of immune system memory responses when paired together with TLR agonists. Generating adaptive and protective immunity from the patient’s own tumors in situ, especially in an off-the-shelf product, is a significant leap forward in targeted oncology therapeutics."

Dr. Hallam is a featured speaker at the 10th Annual World ADC London and delivering a plenary presentation titled "Targeted Immunostimulants; A Promising Approach to In Situ Immunisation." The slides will be accessible through the Clinical/Scientific Presentation and Publication Highlights page of the News section of the company’s website at www.sutrobio.com.

On March 4, 2020 NuCana plc (NASDAQ: NCNA) reported that the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion for orphan drug designation of Acelarin for the treatment of patients with biliary tract cancer (Press release, Nucana BioPharmaceuticals, MAR 4, 2020, View Source [SID1234555164]). Acelarin, in combination with cisplatin, is currently being evaluated in a global Phase III study (NuTide:121) for the first-line treatment of patients with biliary tract cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The receipt of a positive opinion for our orphan drug application in the European Union marks another important milestone in Acelarin’s development," said Hugh S. Griffith, NuCana’s Chief Executive Officer. "Acelarin in combination with cisplatin has achieved an approximate doubling in response rates when compared to the historical results achieved with the standard of care, gemcitabine plus cisplatin. NuTide:121 has the potential to establish Acelarin plus cisplatin as the first approved medicines for the treatment of patients with biliary tract cancer."

Orphan Drug Designation in the European Union (EU) is available to companies developing products for life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 people in the region. This designation creates regulatory and financial incentives for NuCana, including reduced fees from the EMA during the development phase and a 10-year market exclusivity period in the EU following marketing authorization.

NuCana previously received Orphan Drug Designation for Acelarin from the FDA’s Office of Orphan Products for the treatment of patients with biliary tract cancer.

About the NuTide:121 Study

NuTide:121 is a global, multi-center, randomized Phase III study that is enrolling up to 828 patients in approximately 120 sites across North America, Europe, Asia and Australia. Patients are being randomized 1:1 and treated with either a combination of Acelarin (725 mg/m2) plus cisplatin (25 mg/m2) or the current standard of care regimen, gemcitabine (1,000 mg/m2) plus cisplatin (25 mg/m2).

The primary objectives of NuTide:121 are Overall Survival (OS) and Objective Response Rate (ORR). Three interim analyses, including two designed to support accelerated approval, are planned as part of the Phase III study protocol, in addition to the final analysis. Based on discussions with the FDA and subject to any further regulatory guidance, the Company believes that a statistically significant improvement in ORR at either of the first two interim analyses, supported by positive trends in other endpoints, could potentially allow for an accelerated approval of a new drug application (NDA) for Acelarin. Accelerated approval requires a confirmatory clinical study to verify the drug’s clinical benefit. If accelerated approval were to occur, NuTide:121 would continue and the Company anticipates that data from subsequent analyses could provide the confirmatory data to support full (regular) approval.

More information about this study may be found here.

About Biliary Tract Cancer

Biliary tract cancer, including cholangiocarcinoma, gallbladder and ampullary carcinoma, is cancer originating in the bile duct, a vessel that transports bile from the liver to the gallbladder and small intestine. Approximately 178,000 new cases of biliary tract cancer are diagnosed each year worldwide, with more than 18,000 of those diagnoses in the United States. There are currently no agents approved for the treatment of biliary tract cancer; however, the worldwide standard of care in biliary tract cancer patients with locally advanced or metastatic disease is the combination of gemcitabine and cisplatin. Patients receiving this regimen have a median overall survival of 11.7 months.