On March 5, 2020 Caladrius Biosciences, Inc. (Nasdaq: CLBS) ("Caladrius" or the "Company"), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse, not manage, cardiovascular disease, reported financial results for the three and twelve months ended December 31, 2019 (Press release, Caladrius Biosciences, MAR 5, 2020, View Source [SID1234555221]).

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"I am pleased with the Company’s many achievements throughout 2019 as we made significant progress advancing our CD34+ technology-based clinical programs while maintaining strict financial controls," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. "Notably, in November at the American Heart Association Scientific Sessions 2019, we reported the data for those patients (17 of 20) who, at that time, had completed their six-month follow-up visit in our ESCaPE-CMD study of CLBS16. The results showed highly statistically significant improvement in coronary flow reserve ("CFR") correlating with angina symptom relief for patients with coronary microvascular dysfunction ("CMD") after a single administration of CLBS16. To our knowledge, this is the first therapy to show the ability to durably increase CFR and potentially reverse CMD after a single administration. We look forward to reporting the full study data in the first half of 2020 in an appropriate forum. In Japan, enrollment continues to progress for the study of CLBS12 in critical limb ischemia ("CLI"), and we anticipate completing enrollment in the first half of 2020. Current data in both the no-option CLI and Buerger’s Disease cohorts of that study (the latter cohort has been fully enrolled and data are available in our corporate presentation) remain corroborative of previously published results, which we believe are an indication of a high probability of clinical success of the trial. We continue to anticipate top line data for the full study in early 2021 leading to an earliest possible approval in Japan in late 2021 or early 2022. Finally, we have completed all preparatory measures for the initiation of the single confirmatory phase 3 study agreed with U.S. Food and Drug Administration (the "FDA") to conclude development of CLBS14 in no-option refractory disabling angina (NORDA) and are awaiting finalization of a funding plan before commencing the trial.

"We are excited about what lies ahead in 2020 and expect to build on this momentum as we continue to advance our clinical development pipeline and strive to achieve a number of important development milestones throughout the balance of the year," concluded Dr. Mazzo.

Fourth Quarter and Full Year 2019 Financial Highlights

Research and development expenses for the fourth quarter of 2019 were $2.8 million, an 84% increase compared with $1.5 million for the fourth quarter of 2018, and $10.8 million for 2019, a 42% increase compared with $7.6 million for 2018. Research and development in both the current year and prior year periods focused on the advancement of our ischemic repair platform and related to:

ongoing registration-eligible study expenses for CLBS12 in critical limb ischemia in Japan, whereby we continue to focus spending on our patient enrollment;

ongoing Phase 2 proof-of-concept study expenses for CLBS16 in coronary microvascular dysfunction, for which study enrollment was completed in the second quarter of 2019; and

expenses associated with preparation of our confirmatory Phase 3 study of CLBS14 in NORDA. In late 2019, we projected that the Phase 3 study would cost approximately $70 million in external expenses over the next several years to complete, and as a result, we elected to postpone the initiation of the study until we have confidence that we can access sufficient capital to allow us to complete the study uninterrupted

General and administrative expenses, which focus on general corporate related activities, were approximately $2.3 million for both the fourth quarters of 2019 and 2018, and $9.3 million for 2019, a slight decline compared to $9.4 million in 2018.

The net loss for the fourth quarter of 2019 was $5.0 million, or $0.47 per share, compared with $3.6 million, or $0.36 per share, for the fourth quarter of 2018. The net loss for 2019 was $19.4 million, or $1.88 per share, compared with $16.2 million, or $1.67 per share, for 2018.

Balance Sheet Highlights

As of December 31, 2019, Caladrius had cash, cash equivalents and marketable securities of $25.2 million. Based on existing programs and projections, the Company remains confident that its cash balances will fund its operations through at least the second quarter of 2021.

Conference Call

Caladrius’ management will host a conference call for the investment community later today, March 5, 2020, at 4:30 p.m. (ET) to discuss the financial results, provide a company update and answer questions.

Shareholders and other interested parties may participate on the conference call by dialing (866) 595-8403 (U.S.) or (706) 758-9979 (International), using the conference ID code: 4155934. The live webcast will be accessible via the Events page listed under the Investor section of the Company’s website at www.caladrius.com/investors/news-events/events.

For those unable to participate on the live conference call, an audio replay will be available approximately two hours after the conclusion of the call until 11:59 p.m. ET on March 12, 2020. To access the replay, please dial (855) 859-2056 (U.S.) or (404) 537-3406 (International) and provide the conference ID code: 4155934.

A webcast replay of the conference call will remain available on the Company’s website for 90 days.

On March 5, 2020 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, reported that it will report its fourth quarter and full year 2019 financial and operating results on Thursday, March 12, 2020, following the close of the U.S. financial markets (Press release, Lineage Cell Therapeutics, MAR 5, 2020, View Source [SID1234555237]). Lineage management will also host a conference call and webcast on Thursday, March 12, 2020, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its fourth quarter and full year 2019 financial and operating results and to provide a business update.

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Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through March 20, 2020, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 3827019.

On March 4, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the Elecsys GALAD score (Press release, Hoffmann-La Roche, MAR 4, 2020, View Source [SID1234555161]).* This algorithmic score combines gender and age with the biomarker results of the Elecsys AFP, AFP-L3 and PIVKA-II and is intended to aid diagnosis of early stage hepatocellular carcinoma (HCC).

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Dr. Amit Singal, Medical Director of the Liver Tumor Program and Clinical Chief of Pathology at UT Southwestern Medical Center in Dallas, USA, stated, "HCC is the fourth leading cause of cancer-related death worldwide, with the highest burden of disease in East Asia and Africa. This high mortality is largely driven by most patients being detected at a late stage, when curative therapies are no longer possible. Therefore, improving early HCC detection is a critical area of need."

The Elecsys GALAD score will be the first GALAD score, with regulatory approval, for use in In Vitro Diagnostics and is an integral part of the Roche Diagnostics Liver Indication Program, which aims to improve diagnostic workflows throughout chronic liver disease management. Combined with ultrasound, the Elecsys GALAD score has the potential to support clinicians by giving them more accurate information at an earlier stage, thus improving patient outcomes while being minimally invasive for people and potentially also more affordable to healthcare systems.

Liver cancer is one of the few cancers that are on the rise.2 While recent developments in screening and new treatments are making advances in the prevention, diagnosis and treatment of HCC, clinicians still face challenges in diagnosing the disease early enough. Only 44% of liver cancer patients are diagnosed at an early stage.3 Of HCC patients, which are diagnosed with late-stage disease, less than 16% survive a period of 5 years. Of the patients diagnosed at an early stage, 70% percent are still alive after five years1. Therefore, diagnosing HCC, as early as possible, is essential to improving patient outcomes.

"We are excited about FDA’s recognition of the potential clinical benefit the Elecsys GALAD score could bring in diagnosing hepatocellular cancer at an early stage," said Thomas Schinecker, CEO of Roche Diagnostics. "The combination of blood-based biomarkers with clinical algorithms has the potential to significantly reduce mortality of HCC patients as they can receive a more timely diagnosis and treatment."

About GALAD Score
Pioneered by Professor Philip Johnson, Deputy Director of NWCR Centre and Professor in Translational Oncology at the University of Liverpool, and colleagues from the UK, the GALAD score is a serum biomarker-based model that predicts the probability of having hepatocellular carcinoma in patients with chronic liver disease. This combines gender and age with the results from assays AFP, AFP-L3 and PIVKA-II to give the clinician a clearer picture of HCC risk.

In chronic liver diseases, such as hepatitis and cirrhosis, Alpha1-fetoprotein (AFP) may be chronically elevated. Very high concentrations of AFP may be produced by certain tumors. This characteristic makes the AFP test useful as a tumor marker. AFP-L3 is a subtype of AFP and can be used to differentiate an increase in AFP due to HCC, or benign liver disease. PIVKA-II is a precursor and abnormal form of prothrombin that is found in patients with HCC. This can be used to differentiate HCC from non-HCC hepatic diseases.PIVKA-II is an alternate name for des-gamma-carboxy prothrombin (DCP).

About Hepatocellular Carcinoma
The American Association for the Study of Liver Diseases (AASLD) guidelines recommend surveillance of high risk populations for HCC, every 6 months using ultrasound, either with or without a blood test to check protein levels (AFP).4 Ultrasound examinations can be sensitive enough to detect small masses on the liver. While easily done in a doctor’s office, ultrasound examinations are less conclusive with inexperienced technicians and in patients with obesity and fatty liver disease. A recent meta-analysis suggested that ultrasound may miss more than half of early stage HCCs.5 Therefore, other methods of diagnosis, such as abdominal CT scan, abdominal MRI scan or liver biopsy are often needed.4 These are more accurate than ultrasound, though are more invasive and uncomfortable for patients, as well as being costly to the healthcare system.

Liver cancer is one of the few cancers that are on the rise, and hepatocellular carcinoma (HCC), the primary type of liver cancer, accounts for 90% of these cases.6 Worldwide, the most common risk factor for HCC is viral hepatitis – known to cause inflammation of the liver.6,7 Chronic hepatitis B accounts for approximately 50% of all cases of HCC, and the majority of cases of childhood HCC.8 Other risk factors include aflatoxin – a carcinogenic mould found in contaminated foods, especially rice, in hot and humid climates.6

Viral hepatitis B has a particularly high prevalence in most countries in Asia, and this prevalence directly contributes to higher incidences of HCC in the region.7,9 An increasingly important risk factor for the development of HCC is non-alcoholic fatty liver disease (NAFLD), linked with fatty foods and obesity.10 This is the fastest-growing rate of any cancer and is thought to be driven in part by this risk factor, along with increased alcohol use.11

On March 4, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported that its Management Board, with the approval of the Supervisory Board, has resolved to increase the share capital of MorphoSys AG by issuing 907,441 new ordinary shares from the authorized capital 2017-I, excluding pre-emptive rights of existing shareholders, to implement the purchase of 3,629,764 American Depositary Shares (ADSs) by Incyte Corporation (Press release, MorphoSys, MAR 4, 2020, View Source [SID1234555179]). Each ADS will represent 1/4 of a MorphoSys ordinary share. The new ordinary shares underlying the ADSs represent 2.84% of the registered share capital of MorphoSys prior to the consummation of the capital increase.

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"We are pleased to announce resolving the capital increase, which marks the final step in formalizing our partnership with Incyte," said Jens Holstein, Chief Financial Officer of MorphoSys. "We are grateful for our partner’s long-term commitment and are excited to kick off and operationalize our collaboration at full speed over the coming weeks and months."

Incyte’s purchase of ADSs in the aggregate amount of $150 million is part of the consideration due under its collaboration and licensing agreement with MorphoSys for the further development and commercialization of MorphoSys’ investigational compound tafasitamab; the agreement has become effective upon receiving antitrust clearance. Incyte will purchase the 3,629,764 new ADSs at a price of $41.32 per ADS, including a premium of 20 percent on the volume-weighted average price of ADSs thirty days prior to execution of the collaboration and licensing agreement. Incyte has agreed, subject to limited exceptions, not to sell or otherwise transfer any of the new ADSs, which will represent 2.76% of the registered share capital of MorphoSys following the capital increase, for an 18-month period.

About Tafasitamab
Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing. In January 2020, MorphoSys and Incyte Corporation entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. In the U.S., MorphoSys and Incyte will co-commercialize tafasitamab, outside the U.S., Incyte will have exclusive commercialization rights.
MorphoSys is clinically investigating tafasitamab as a therapeutic option in B cell malignancies in a number of ongoing combination trials. An open-label phase 2 combination trial (L-MIND study) is investigating the safety and efficacy of tafasitamab in combination with lenalidomide in patients with relapsed/refractory DLBCL who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). The ongoing phase 3 study B-MIND assesses the combination of tafasitamab and bendamustine versus rituximab and bendamustine in r/r DLBCL. In addition, tafasitamab is currently being investigated in patients with relapsed/refractory CLL/SLL after discontinuation of a prior Bruton tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib) in combination with idelalisib or venetoclax.

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.