On January 9, 2020 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported the agreement by several accredited investors to exercise certain warrants to purchase up to an aggregate of 22,278,540 ordinary shares represented by 742,618 American Depositary Shares (ADSs) having exercise prices ranging from $12.90 to $78.75 per ADS issued by Can-Fite in September 2015, October 2015, March 2018, January 2019 and April 2019, at a reduced exercise price of $3.25 per ADSs (Press release, Can-Fite BioPharma, JAN 9, 2020, View Source [SID1234552919]).

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The ADSs and the ordinary shares issuable upon exercise of the warrants issued in March 2018, January 2019 and April 2019 are registered pursuant to a registration statement on Form F-1 (File No. 333-231209) which became effective by the Securities and Exchange Commission (SEC) on October 18, 2019 and the ADSs and the ordinary shares issuable upon exercise of the warrants issued in September 2015 and October 2015 are registered pursuant to a registration statement on Form F-3 (File No. 333-209037) which became effective on January 29, 2016. The gross proceeds to Can-Fite from the exercise of the warrants are expected to be approximately $2.4 million, prior to deducting placement agent fees and estimated offering expenses.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

In consideration for the immediate exercise of the warrants for cash, the exercising holders will receive new unregistered warrants to purchase ordinary shares represented by ADS in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act"). The warrants will be exercisable into an aggregate of up to 22,278,540 ordinary shares represented by 742,618 ADS, at an exercise price of $3.45 per ADS and have a term of exercise equal to five and one-half years.

Can-Fite intends to use the net proceeds from the offering for working capital including for the progression of its Phase III psoriasis and the rheumatoid arthritis studies and the preparatory work for the Phase III liver cancer study as well as other general corporate purposes.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the 1933 Act and, along with the ADSs or the ordinary shares issuable upon their exercise, have not been registered under the 1933 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. The securities were offered only to accredited investors. The Company has agreed to file a registration statement with the SEC covering the resale of the ADSs and ordinary shares of issuable upon exercise of the new warrants.

This press release shall not constitute an offer to sell or a 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 January 9, 2020 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported preliminary unaudited Andexxa global net revenues for the fourth quarter and full year 2019 (Press release, Portola Pharmaceuticals, JAN 9, 2020, View Source [SID1234552930]). For the fourth quarter, the Company expects Andexxa global net revenues to be approximately $28 million. For the full year 2019, the Company expects Andexxa global net revenues to be approximately $111 million.

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In the U.S., net revenues of Andexxa in the fourth quarter 2019 were approximately $24 million, which compares to net revenues of $14.0 million in the same period a year ago and $33.0 million in third quarter 2019.

In Europe, net revenues of Ondexxya were approximately $4 million, which compares to net revenues of $2.7 million in the third quarter of 2019. Fourth quarter 2019 was Ondexxya’s first full quarter of sales following its launch in July 2019 in Europe, where it is now marketed in Germany, Austria, the U.K., the Netherlands, Sweden, Denmark and Finland.

During the fourth quarter, approximately 90 new accounts, and over 425 new accounts in 2019, ordered Andexxa in the U.S. This brings the total number of accounts now ordering Andexxa to approximately 640 at the end of 2019. There continues to be a significant hospital penetration opportunity within the Company’s 2,100 target accounts in 2020 and beyond. Also in the fourth quarter, re-ordering accounts contributed 80% of U.S. revenues, compared to 76% of revenues in the third quarter.

Fourth quarter Andexxa net sales in the U.S. were impacted primarily by two factors:

A $5 million gross to net adjustment due to a return reserve for short-dated product. The Company expects this to be mitigated going forward by its current longer-dated, 36-month product, which began shipping in November 2019.

Flat quarter over quarter demand due to a decrease in utilization, primarily in tier 1 accounts. While physician demand remains strong, the Company believes that in certain of these accounts, hospital pharmacies curtailed use of Andexxa following drug utilization reviews in an effort to manage pharmacy budgets. Following this reduction, re-ordering patterns are stabilizing in many of these accounts.

"While we are disappointed in the fourth quarter net revenues for Andexxa in the U.S., 2019 was a year of significant growth. We exceeded $100 million in revenues, including encouraging contributions from our global launch of Ondexxya, and Andexxa remains on track as one of the top five hospital drug launches in the U.S. in the last 30 years," said Scott Garland, Portola’s president and chief executive officer. "Our belief in the long-term potential of Andexxa remains

strong, and we maintain our projection that this highly innovative, orphan drug has an over $2 billion opportunity in the rapidly growing FXa-inhibitor market in the U.S. and Europe. We look forward to continuing to build long-term revenue growth and value for our shareholders as we establish Andexxa as the standard for care for doctors addressing the urgent needs of patients facing serious, life-threatening bleeds."

"Physician support for Andexxa and Ondexxya in the U.S. and Europe has been tremendous, and we continue to receive outstanding feedback from members of the medical community who have seen first-hand the benefits of Andexxa in treating DOAC-related bleeds," said Sheldon Koenig, Portola’s chief commercial officer. "The drug has excellent efficacy, works fast and is the only FDA-approved agent available. In 2020, we are moving aggressively to execute on our launch strategy and build greater awareness of the life-saving benefits of Andexxa by further educating hospitals on its value."

2020 Growth Drivers

The Company expects continued strong demand of Andexxa, driven by the growth of the Factor Xa inhibitor market in the U.S. and Europe. In 2019, the Factor Xa inhibitor market volume grew by 27% globally to reach $24 billion. In addition, growth in new hospital customers and deeper hospital utilization of Andexxa is expected in 2020 driven by:

Presentation and publication of newly generated health economics and outcomes research data at multiple medical meetings starting with three abstracts at the American College of Cardiology’s Annual Scientific Session together with the World Congress of Cardiology, showing the impact of Andexxa on inpatient mortality, burden of illness, budget impact model and cost effective analysis

Presentation and publication of data demonstrating 4-factor PCC’s, which are only approved to reverse warfarin, are not effective for reversing Factor Xa related bleeds

The launch of key educational initiatives to raise awareness of best practices for the various access and reimbursement pathways available, including: The New Technology Add-on Payment (NTAP) for Medicare beneficiaries in the inpatient setting; a pass through C-code for Medicare and commercial patients in the outpatient setting; participation in both Medicaid and the 340B drug pricing program; and consignment opportunities

Initiation of a single arm study in patients taking Factor Xa inhibitors that require urgent surgery, providing experience to inform the design of a randomized clinical trial

Conclusion of reimbursement discussions in European Wave 1 countries

Expansion of European launch into Wave 2 countries

The Company has a strong cash position to continue to invest in the launch of Andexxa and Ondexxya. As of December 31, 2019, the Company’s cash position totaled $464 million, compared with $317 million as of December 31, 2018.

These preliminary results are based on management’s initial analysis of operations for the quarter ended December 31, 2019. The Company expects to issue full financial results for the fourth quarter and fiscal year 2019 in late February.

Conference Call Details

The Company will host a live conference call on Thursday, January 9, 2020, at 5:00 p.m. ET, which can be accessed by phone by calling (844) 452-6828 from the United States and Canada or 1 (765) 507-2588 internationally and using the passcode 3995797. The webcast can also be accessed live on the Investor Relations section of the Company’s website at View Source

Corporate Update on January 14, 2020

As previously announced, Portola will provide a corporate update on Tuesday, January 14, at 7:00 a.m. PT (10:00 a.m. ET). The live webcast will be available on the Company’s website at View Source A replay of that presentation will remain available on the website after the live webcast.

On January 9, 2020 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported preliminary unaudited Andexxa global net revenues for the fourth quarter and full year 2019 (Press release, Portola Pharmaceuticals, JAN 9, 2020, View Source [SID1234552946]). For the fourth quarter, the Company expects Andexxa global net revenues to be approximately $28 million. For the full year 2019, the Company expects Andexxa global net revenues to be approximately $111 million.

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In the U.S., net revenues of Andexxa in the fourth quarter 2019 were approximately $24 million, which compares to net revenues of $14.0 million in the same period a year ago and $33.0 million in third quarter 2019.

In Europe, net revenues of Ondexxya were approximately $4 million, which compares to net revenues of $2.7 million in the third quarter of 2019. Fourth quarter 2019 was Ondexxya’s first full quarter of sales following its launch in July 2019 in Europe, where it is now marketed in Germany, Austria, the U.K., the Netherlands, Sweden, Denmark and Finland.

During the fourth quarter, approximately 90 new accounts, and over 425 new accounts in 2019, ordered Andexxa in the U.S. This brings the total number of accounts now ordering Andexxa to approximately 640 at the end of 2019. There continues to be a significant hospital penetration opportunity within the Company’s 2,100 target accounts in 2020 and beyond. Also in the fourth quarter, re-ordering accounts contributed 80% of U.S. revenues, compared to 76% of revenues in the third quarter.

Fourth quarter Andexxa net sales in the U.S. were impacted primarily by two factors:

A $5 million gross to net adjustment due to a return reserve for short-dated product. The Company expects this to be mitigated going forward by its current longer-dated, 36-month product, which began shipping in November 2019.
Flat quarter over quarter demand due to a decrease in utilization, primarily in tier 1 accounts. While physician demand remains strong, the Company believes that in certain of these accounts, hospital pharmacies curtailed use of Andexxa following drug utilization reviews in an effort to manage pharmacy budgets. Following this reduction, re-ordering patterns are stabilizing in many of these accounts.
"While we are disappointed in the fourth quarter net revenues for Andexxa in the U.S., 2019 was a year of significant growth. We exceeded $100 million in revenues, including encouraging contributions from our global launch of Ondexxya, and Andexxa remains on track as one of the top five hospital drug launches in the U.S. in the last 30 years," said Scott Garland, Portola’s president and chief executive officer. "Our belief in the long-term potential of Andexxa remains strong, and we maintain our projection that this highly innovative, orphan drug has an over $2 billion opportunity in the rapidly growing FXa-inhibitor market in the U.S. and Europe. We look forward to continuing to build long-term revenue growth and value for our shareholders as we establish Andexxa as the standard for care for doctors addressing the urgent needs of patients facing serious, life-threatening bleeds."

"Physician support for Andexxa and Ondexxya in the U.S. and Europe has been tremendous, and we continue to receive outstanding feedback from members of the medical community who have seen first-hand the benefits of Andexxa in treating DOAC-related bleeds," said Sheldon Koenig, Portola’s chief commercial officer. "The drug has excellent efficacy, works fast and is the only FDA-approved agent available. In 2020, we are moving aggressively to execute on our launch strategy and build greater awareness of the life-saving benefits of Andexxa by further educating hospitals on its value."

2020 Growth Drivers

The Company expects continued strong demand of Andexxa, driven by the growth of the Factor Xa inhibitor market in the U.S. and Europe. In 2019, the Factor Xa inhibitor market volume grew by 27% globally to reach $24 billion. In addition, growth in new hospital customers and deeper hospital utilization of Andexxa is expected in 2020 driven by:

Presentation and publication of newly generated health economics and outcomes research data at multiple medical meetings starting with three abstracts at the American College of Cardiology’s Annual Scientific Session together with the World Congress of Cardiology, showing the impact of Andexxa on inpatient mortality, burden of illness, budget impact model and cost effective analysis
Presentation and publication of data demonstrating 4-factor PCCs, which are only approved to reverse warfarin, are not effective for reversing Factor Xa related bleeds
The launch of key educational initiatives to raise awareness of best practices for the various access and reimbursement pathways available, including: The New Technology Add-on Payment (NTAP) for Medicare beneficiaries in the inpatient setting; a pass through C-code for Medicare and commercial patients in the outpatient setting; participation in both Medicaid and the 340B drug pricing program; and consignment opportunities
Initiation of a single arm study in patients taking Factor Xa inhibitors that require urgent surgery, providing experience to inform the design of a randomized clinical trial
Conclusion of reimbursement discussions in European Wave 1 countries
Expansion of European launch into Wave 2 countries
The Company has a strong cash position to continue to invest in the launch of Andexxa and Ondexxya. As of December 31, 2019, the Company’s cash position totaled $464 million, compared with $317 million as of December 31, 2018.

These preliminary results are based on management’s initial analysis of operations for the quarter ended December 31, 2019. The Company expects to issue full financial results for the fourth quarter and fiscal year 2019 in late February.

Conference Call Details

The Company will host a live conference call on Thursday, January 9, 2020, at 5:00 p.m. ET, which can be accessed by phone by calling (844) 452-6828 from the United States and Canada or 1 (765) 507-2588 internationally and using the passcode 3995797. The webcast can also be accessed live on the Investor Relations section of the Company’s website at View Source

Corporate Update on January 14, 2020

As previously announced, Portola will provide a corporate update on Tuesday, January 14, at 7:00 a.m. PT (10:00 a.m. ET). The live webcast will be available on the Company’s website at View Source A replay of that presentation will remain available on the website after the live webcast.

On January 9, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, provides an update on its TACTI-002 and AIPAC studies for its lead product candidate, eftilagimod alpha ("efti" or "IMP321") (Press release, Immutep, JAN 9, 2020, View Source [SID1234552898]).

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TACTI-002 – Phase II study

The requisite number of predefined patient responses was observed in stage 1 of Part C. The decision by the DMC to recommend opening stage 2 recruitment follows its review of preliminary safety and efficacy data and is based on a predefined efficacy threshold.

This allows the Company to now proceed with the recruitment of an additional 19 patients, forming stage 2 of Part C of the study, having now also completed recruitment of the 18 HNSCC patients for stage 1. The staged approach to patient enrolment is based on the study’s Simon’s two-stage clinical trial design.

Stage 1 of Part A (first line Non-Small Cell Lung Cancer, NSCLC) was expanded in September 2019. Recruitment is ongoing for Part B (second line NSCLC) with 10 out of 23 patients now participating, and for stage 2 of Part A (first line NSCLC), where 4 out of 19 patients are now participating. The Company expects to report more mature data from TACTI-002 in Q1 CY20.

TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada).

Immutep CSO and CMO, Dr Frederic Triebel said: "The study is progressing well as the expansion of Part C to include 19 additional patients with second line HNSCC marks the second out of three parts of our TACTI-002 study to be expanded, having already observed the pre-determined number of partial responses in Parts A and C patients."

AIPAC – Phase IIb study in metastatic breast cancer

The Company continues to progress its AIPAC trial which evaluates efti in combination with chemotherapy in 227 metastatic breast cancer patients in a randomized, double blinded, placebo-controlled phase IIb clinical trial. The first progression-free survival read-out remains on track for Q1 CY20 and is expected to be reported in March 2020.

Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000

ABN: 90 009 237 889

About TACTI-002

TACTI-002 (Two ACTive Immunotherapies) is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of efti with MSD’s KEYTRUDA (or pembrolizumab, an anti-PD-1 therapy) in up to 109 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line. The trial is a Phase II, Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in up to 13 study centres across the U.S., Europe and Australia.

On January 9, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported certain unaudited preliminary performance results for the fourth quarter and full-year 2019 (Press release, Castle Biosciences, JAN 9, 2020, View Source [SID1234552920]). The Company will report its full financial results and other metrics during its fourth quarter and year-end 2019 conference call, which is expected to be held in March 2020. Additionally, the Company expects to provide certain preliminary guidance for 2020 when it reports its final results for the fourth quarter and year-end 2019.

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"We are pleased with our solid execution in 2019, particularly the acceleration in DecisionDx-Melanoma volume seen since our first quarter 2019 commercial expansion," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We attribute this growth to a combination of ongoing evidence development, which included eight peer-reviewed publications, as well as the early 2019 commercial expansion. As a result of this growth, we executed a second commercial expansion on December 1, 2019. And as of December 31, 2019, we have more than doubled our commercial personnel compared to December 31, 2018. Evidence development continued in 2019, including prospective studies that further support the two intended uses of our DecisionDx-Melanoma test, which we believe contributed to the posting of a draft Medicare Local Coverage Determination (LCD) expansion, as well as the acceptance of our application for a Category I MAAA Current Procedural Terminology (CPT) code by the American Medical Association’s CPT Editorial Panel.

"We believe the substantial volume growth in our lead product, DecisionDx-Melanoma, is providing more patients diagnosed with early stage cutaneous melanoma the opportunity to have informed discussions with their doctors and potentially improve treatment decisions. Additionally, we remain on track for the commercial launch of our two additional skin cancer products – our DecisionDx-SCC gene expression profile (GEP) test for use in patients diagnosed with high risk cutaneous squamous cell carcinoma, and our skin cancer product for

use in patients with a suspicious pigmented lesion – in the second half of 2020. We believe these two late stage pipeline products will increase our estimated total addressable U.S. market by more than $1.4 billion, for an estimated total addressable U.S. market of $2.0 billion for current and pipeline products."

Fourth Quarter Ended December 31, 2019, Highlights

Delivered 4,480 DecisionDx-Melanoma test reports in the 2019 fourth quarter, compared to 3,270 reports during the fourth quarter of 2018, representing an increase of 37% compared to the same period in 2018.

Delivered 434 DecisionDx-UM test reports in the 2019 fourth quarter, compared to 385 reports during the fourth quarter of 2018, representing an increase of 13% compared to the same period in 2018.

Year- Ended December 31, 2019, Highlights

Delivered 15,529 DecisionDx-Melanoma test reports for the full year 2019, compared to 12,032 reports during the full year 2018, representing an increase of 29%.

In 2019, new ordering clinicians for DecisionDx-Melanoma increased 24% year-over-year. Additionally, total ordering clinicians in 2019 for DecisionDx-Melanoma increased 32% to 3,927, year-over-year.

Delivered 1,526 DecisionDx-UM test reports for the full year 2019, compared to 1,413 reports during the full year 2018, representing an increase of 8%. On a combined basis, overall reports increased by 27% for both DecisionDx-Melanoma and DecisionDx-UM for the full year 2019, compared to 2018.

Year-end 2019 cash and cash equivalents balance was approximately $99 million.

More than 1,000 squamous cell carcinoma patients from 56 U.S. centers enrolled in the DecisionDx-SCC clinical validation and performance studies as of December 31, 2019. The Company reported positive data from the clinical validation cohort study (n=321) in October 2019, and expects to report data from the performance cohort in 2020. Castle expects to launch its DecisionDx-SCC gene expression profile (GEP) test for use in patients diagnosed with high risk cutaneous squamous cell carcinoma in the second half of 2020.

More than 1,000 patients were also enrolled in the clinical development, validation and performance cohort studies for Castle’s GEP test for patients with a suspicious

pigmented lesion as of December 31, 2019. The Company expects to announce data from these studies and launch this GEP test in the second half of 2020.

Castle Biosciences has not completed the preparation of its financial statements for the fourth quarter or full -year 2019. The preliminary, unaudited performance results presented in this news release for the quarter and year-ended December 31, 2019, are based on management’s initial review of the information presented and are subject to adjustment based on the completion of the Company’s end-of-period reporting processes and related activities, including the audit of the Company’s financial statements, as such, any financial information contained herein may differ from the information reflected in our financial statements as of and for the year-ended December 31, 2019. Additional information and disclosures would be required for a more complete understanding of the Company’s financial position and results of operations as of and for the quarter and year-ended December 31, 2019. Accordingly, undue reliance should not be placed on this preliminary information.