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Cellectar Biosciences to Host a CLR 131 Clinical Data Call with Its Phase 2 Lead Investigator on February 19, 2020

On January 9, 2020 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that it will host a Clinical Data Call on Wednesday, February 19, 2020 at 10:30 am Eastern Time (Press release, Cellectar Biosciences, JAN 9, 2020, View Source [SID1234552921]).

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Members of Cellectar’s senior management team and Dr. Sikander Ailawadhi, M.D., the lead investigator for the company’s Phase 2 study, will provide additional clinical data, as well as an update and analysis of the CLR 131 Phase 1 and Phase 2 hematology focused trials. The team will also provide a summary of the data for patients with relapsed/refractory B-cell malignancies, including patients with multiple myeloma and select non-Hodgkins lymphoma. Additionally, the team will review the current treatment landscape and unmet medical need for treating patients with these cancers, and provide an overview of the market opportunity and its clinical development plan for CLR 131.

Sikander Ailawadhi, M.D., is an Associate Professor, Division of Hematology/Oncology at Mayo Clinic Florida and is the lead investigator for the company’s Phase 2 CLOVER-1 trial of CLR 131 in patients with relapsed/refractory B-cell hematologic cancers. Dr. Ailawadhi was awarded the 2013 NCI CCITLA as an Assistant Professor of Medicine at the Norris Cancer Center, University of Southern California (USC), Los Angeles CA. Subsequently, he joined the Division of Hematology and Oncology at Mayo Clinic in Florida as a Senior Associate Consultant in order to pursue his career goal of clinical, translational and outcomes-based research in B-cell malignancies, especially plasma cell disorders.

Dial-In & Webcast Information

Domestic: 877-705-6003

International: 201-493-6725

Conference ID: 13697717

Webcast: View Source

A replay of the call will be available on the Events section on the Investor Relations page of company’s website following the live event.

About the Phase 2 CLOVER-1 Trial

CLOVER-1 is a Phase 2 study of CLR 131 being conducted in approximately 10 leading cancer centers in the United States in patients with relapsed/refractory B-cell hematologic cancers. The hematologic cancers being studied in the trial include multiple myeloma (MM), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL).

The study will enroll up to 80 patients. Its primary endpoint is clinical benefit response (CBR), with additional endpoints of overall response rate (ORR), progression free survival (PFS), median overall survival (OS) and other markers of efficacy following a fractionated dose of 37.5mCi/m2 of CLR 131 administered in two 30-minute infusions of 18.75mCi/m2 of CLR 131 administered on day 1 and day 7 (± 1), with the option for a second dose cycle approximately 75-180 days later.

Cellectar was awarded approximately $2 million in non-dilutive grant funding from the National Cancer Institute to help fund the trial. More information about the trial, including eligibility requirements, can be found at www.clinicaltrials.gov, reference NCT02952508.

About the Phase 1 R/R MM Trial

The Phase 1 multicenter, open-label, dose-escalation study is designed to evaluate the safety and tolerability of CLR 131 administered as a 30-minute IV infusion, either as a single bolus dose or as two fractionated doses, in patients with relapsed/refractory multiple myeloma. All doses to date have been deemed safe and well tolerated by an independent Data Monitoring Committee (DMC). Based on the data and the recommendation of the DMC, the company is enrolling a Cohort 7 where patients will receive 40mCi/m2 fractionated dose of CLR 131.

About CLR 131

CLR 131 is a small-molecule, targeted Phospholipid Drug Conjugate (PDC) designed to deliver cytotoxic radiation directly to cancer cells, while limiting exposure to healthy cells. CLR 131 is the company’s lead product candidate and is currently being evaluated in a Phase 2 study in B-cell lymphomas, and two Phase 1 dose-escalating clinical studies, one in multiple myeloma and one in pediatric solid tumors and lymphoma. CLR 131 was granted Orphan Drug designation for the treatment of multiple myeloma by both the U.S. and the European Commission, and was granted U.S. Orphan Drug designation for the treatment of lymphoplasmacytic lymphoma and was granted U.S. Orphan Drug and Rare Pediatric Disease designations for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma.

Castle Biosciences Announces Preliminary Fourth Quarter and Full-Year 2019 Performance Results, Delivering 29% DecisionDx-Melanoma Test Report Volume Growth in 2019

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.

"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.

Can-Fite Announces Exercise of Warrants for Cash Proceeds of $2.4 Million

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]).

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.

Bio-Techne To Host Conference Call On February 4, 2020 To Announce Second Quarter 2020 Financial Results

On January 9, 2020 Bio-Techne Corporation (NASDAQ: TECH) reported that management will host a conference call on Tuesday, February 4, 2020, at 8:00 a.m. CST to review second quarter 2020 financial results (Press release, Bio-Techne, JAN 9, 2020, https://investors.bio-techne.com/news/detail/171/bio-techne-to-host-conference-call-on-february-4-2020-to-announce-second-quarter-2020-financial-results [SID1234552918]).

Access to the discussion may be obtained as follows:

Time:

8:00 a.m. CST

Date:

February 4, 2020

Dial-in:

1-800-289-0438 or 1-323-794-2423 (for international callers)

Conference ID:

2359733

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512-2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 2359733 or by going to:

View Source

The replay will be available from 11:00 a.m. CST on Tuesday, February 4, 2020 until 11:00 p.m. CST on Wednesday, March 4, 2020.

Ascendis Pharma A/S Announces Participation in 38th Annual J.P. Morgan Healthcare Conference

On January 9, 2020 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, reported that the company will participate in the upcoming 38th Annual J.P. Morgan Healthcare Conference (Press release, Ascendis Pharma, JAN 9, 2020, View Source [SID1234552917]). Company executives will provide a business overview and update on the company’s pipeline programs.

Details

Event 38th Annual J.P. Morgan Healthcare Conference
Location San Francisco
Date Monday, January 13, 2020
Time Presentation: 8:00 a.m. Pacific Time (PT)
Question & Answer Session: 8:30 a.m. PT
Live webcasts of both the presentation and Q&A session will be available in the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.