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

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"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.

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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.

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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.

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"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.

On March 4, 2020 Evogene Ltd. (NASDAQ: EVGN, TASE: EVGN.TA), a leading company in leveraging computational biology to design novel products for life-science-based industries, reported its financial results for the fourth quarter and full year, ending December 31, 2019 (Press release, Evogene, MAR 4, 2020, View Source [SID1234555163]).

Ofer Haviv, Evogene’s President and CEO, stated, "2019 has been a turning point year in the life of the company, with the completion of the organizational plan introduced at the beginning of 2018.

"The rationale behind this change was to capture the value of our diverse capabilities in computational biology. To this end, we established dedicated subsidiaries in specific markets, while at the heart of all activities is Evogene’s unique technology, the CPB (Computational Predictive Biology) platform serving as the subsidiaries’ core technological advantage.

"The transition to this structure was completed in 2019 with the establishment of Lavie Bio (ag-biologicals) and Canonic (medical cannabis), joining the companies Biomica (human microbiome based therapeutics) and AgPlenus (ag-chemicals), which were established in the last two years, and joining the more long-standing, Casterra (ag-solutions for castor oil production).

"Evogene will continue to focus on maintaining the technological edge of the CPB platform leveraging the revolutions in Big Data and Artificial Intelligence while incorporating a deep understanding of biology, and the subsidiaries will continue to utilize this platform to support their product development pipeline.

"The initial achievements reached by our subsidiaries during 2019, presented below, are confirmation that the undertaking of this strategic and organizational change was warranted and we look forward to the fruit of this new strategy in the coming years, as demonstrated by the following targeted milestones for 2020."

2019 Highlights

Lavie Bio

Investment in Lavie Bio by Corteva Agriscience, a major US agricultural chemical and seed company –

Lavie Bio secured an external strategic equity investment from Corteva, which included $10 million dollars in cash and the transfer of Corteva’s holdings in its subsidiary, Taxon Biosciences, in exchange for approximately 28% of Lavie Bio’s shares.

Advancement of Lavie Bio’s bio-stimulants for wheat program in line with plans –

Lavie Bio advanced its leading product candidate LAV211 to ‘development stage 2’, while continuing the development of additional product candidates. LAV211 has shown consistent positive results in multiple trials, demonstrating up to 25% yield improvement in target locations.

Advancements in bio-fungicide and bio-insecticide product programs including the successful completion with positive results of vineyard trials in Europe in its bio fungicide program for fruit and vegetables.

Biomica

Advancement of Biomica’s immuno-oncology program with completion of a first pre-clinical study with positive results.

Initiation of pre-clinical trials in Biomica’s GI related disorders program.

Collaboration between Biomica and Weizmann Institute of Science to develop a selective treatment against antibiotic resistant bacteria – in-licensing IP and knowhow generated by Prof. Ada E. Yonath, Nobel Prize laureate.

Canonic

Initiation of the development of Canonic’s cannabis varieties for medical cannabis products –

received regulatory approvals for its activities,

established dedicated facilities for cannabis breeding,

successfully imported a diverse genetic collection for its product development program, and

completed two cannabis growth cycles.

AgPlenus

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Progress achieved in AgPlenus’ herbicide pipeline with ‘Hit-to-Lead’ optimization efforts, including promising greenhouse results of compounds confirming a new mode of action. New mode-of-action herbicides are expected to provide a solution to the problem of growing weed resistance to existing commercial solutions.

Casterra

Advancement of Casterra’s semi-commercial trials, which led to the decision to focus company efforts on the Brazilian market.

Targeted 2020 Milestones

Looking forward to 2020, the Company’s subsidiaries target to reach the following described milestones.

Lavie Bio

File for regulatory approval for a wheat bio stimulant product and to advance to the pre-commercialization phase in preparation for its targeted 2022 commercialization.

Initiation of additional trials in its bio fungicide program for fruit and vegetables in preparation for phase advancement.

Biomica

Extend pre-clinical studies in its immuno-oncology program.

Initiate the scale-up process and first GMP production of drug candidates towards ‘first in man’ proof-of-concept clinical trials in 2021.

Canonic

Demonstrate yield improvement in its unique cannabis lines, in preparation for commercialization of a first product in early 2022.

Conduct pre-clinical studies to support the development of Canonic’s medical cannabis products.

AgPlenus

Enter a later stage collaboration agreement based on its internal herbicide pipeline.

Reach the phase of a "lead" chemical (an important milestone towards commercialization).

Casterra

Initial commercial castor seed sales in Brazil.

"An on-going effort for the Company and its subsidiaries is to identify and evaluate alternatives to address their financial needs to support and accelerate their continuing development efforts. We aim to do so in a manner that will provide both the required resources to support and accelerate the subsidiaries’ activities; while at the same time maintaining shareholder value for Evogene shareholders, as demonstrated by the Corteva investment in Lavie Bio. " Mr. Haviv concluded

Consolidated financial results for the period ending December 31, 2019:

Cash position: As of December 31, 2019, Evogene had approximately $47 million in consolidated net cash, short-term bank deposits and marketable securities. The Company cash usage amounted to $17.6 million during the full year of 2019 and $5.2 million during the fourth quarter of 2019, in range with its cash usage estimate for 2019 of $16 to $18 million dollars.

$17.6 million of Evogene’s consolidated cash is appropriated to its subsidiary, Lavie Bio, including a $10 million investment received from Corteva during the third quarter of 2019.

For the full year of 2020, the Company estimates that its cash usage, excluding cash usage of Lavie Bio or payments from a significant collaboration, will be within the range of 14-16 million dollars. This cash use is mostly appropriated to Evogene’s subsidiaries, mainly Biomica, AgPlenus, Canonic and Evogene’s expenses as a public company such as D&O insurance and others.

Evogene does not have bank debt.

Revenues for the full year of 2019, were $0.8 million versus $1.8 million in 2018. Revenues for the fourth quarter of 2019, were $0.1 million versus $0.6 million in the same period the previous year. Revenues primarily consist of third-party research and development payments. These revenues represent R&D cost reimbursement and milestone payments under our various collaboration agreements. The majority of these agreements also provide for royalties or other forms of revenue sharing from successfully developed products.

Gross profit in 2019 was $419 thousand in comparison to $295 thousand in 2018. Gross profit for the fourth quarter of 2019 was $35 thousand in comparison to $8 thousand in the fourth quarter of 2018.

R&D expenses in 2019 were $15.8 million in comparison to $14.7 million in 2018. R&D expenses for the fourth quarter of 2019 were $5.2 million in comparison to $3.9 million in the fourth quarter of 2018. R&D expenses mostly represent product development activities of the Company and its subsidiaries, which include computational work, lab & greenhouse assays, field-trials and pre-clinical studies carried out by third parties.

The increase in R&D expenses during the quarter is attributed to payments made to third parties for (i) pre-clinical studies conducted for Biomica and (ii) field trials conducted in target locations for Lavie Bio, as well as (iii) the acquisition of a genomic-unique seed collection for Canonic.

Operating loss in 2019 was approximately $21 million in comparison to $20 million in 2018. Operating loss for the fourth quarter of 2019 was $6.9 million in comparison to $5.3 million in the fourth quarter of 2018.

Net financing income in 2019 was $2.1 million in comparison to net financing expense of $0.8 million in 2018. Net financing income for the fourth quarter of 2019 was $0.2 million in comparison to net financing expense of $0.6 million in the fourth quarter of 2018.

Loss for the full year of 2019 was approximately $19 million in comparison to a loss of approximately $21 million during 2018. Loss for the fourth quarter of 2019 was $6.7 million in comparison to a loss of $5.8 million during fourth quarter of 2018.

Conference Call & Webcast Details:

Date: March 4th, 2020

Time: 9:00am EST; 16:00 Israel time

Dial-in: 1-888-668-9141 toll free from the United States, or +972-3-918-0609 internationally

Webcast: Available at www.evogene.com.

Replay Information: A replay of the conference call will be available approximately three hours following the completion of the call.

To access the replay, please dial 1-888-326-9310 toll free from the United States, or +972-3-925-5904 internationally. The replay will be accessible through March 6, 2020, and an archive of the webcast will be available on the Company’s website.