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Mallinckrodt to Present at Piper Jaffray Annual Healthcare Conference

On November 19, 2019 Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, will present on Tuesday, Dec. 3, 2019, at the Piper Jaffray Annual Healthcare Conference at the Lotte New York Palace, 455 Madison Ave, New York (Press release, , NOV 19, 2019, View Source [SID1234551504]).

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Mark Trudeau, President and Chief Executive Officer, and Steven Romano, M.D., Executive Vice President and Chief Scientific Officer, will represent the company in a fireside chat at 8:30 a.m. Eastern.

Individuals who cannot attend the meeting in person can find webcast information at: http://www.mallinckrodt.com/investors. A replay will also be available following the meeting.

Cellect Biotechnology Reports Third Quarter 2019 Financial and Operating Results

On November 19, 2019 Cellect Biotechnology Ltd. (NASDAQ: APOP), a developer of innovative technology which enables the functional selection of stem cells, reported financial and operating results for the third quarter ended September 30, 2019 and provided a corporate update (Press release, Cellect Biotechnology, NOV 19, 2019, View Source [SID1234551503]).

Recent Highlights

Received an Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for the commencement of a clinical trial to determine the safety and tolerability of the ApoGraft technology for haploidentical bone marrow transplantations. This development represents the Company’s first-ever clinical trial approval in the U.S. using its ApoGraft stem cell selection technology, which is designed to significantly reduce acute graft-versus-host disease (aGVHD) following bone marrow transplantation.
Successfully validated the Company’s technology in collaboration with a regenerative medicine company. The study, when combined with others and internal findings increase the body of evidence supporting the Company’s technology and add further proof to support Cellect ASCs derived stem cells program. Biocompatibility with certain collagen-based matrixes successfully demonstrated that cells grown utilizing the Company’s protocol can be incorporated into matrixes for expansion, transplantation and tissue regeneration.
"Our clinical and regulatory teams remained focused during the third quarter and the more recent positive developments position us to achieve our goals, both in the U.S. and Israel," commented Dr. Shai Yarkoni, Chief Executive Officer. "In the U.S., the IND approval is a significant achievement and represents our first-ever FDA IND in the U.S., with Washington University School of Medicine. In Israel, our Phase 1/2 clinical study of ApoGraft is progressing slowly and we expect to complete the recruitment around the end of the year."

"With our prudent use of cash during the third quarter and the anticipated cash usage needs over the coming quarters, we continue to believe we have the resources to execute our clinical and regulatory plans for the foreseeable future," said Eyal Leibovitz, Chief Financial Officer.

Third Quarter 2019 Financial Results:

Research and development (R&D) expenses for the third quarter of 2019 were $0.71 million compared to $1.18 million in the third quarter of 2018. The Company remains committed to the ongoing clinical trials in Israel as well as pursuing the regulatory approval from the FDA to commence its US-based trial.

General and administrative (G&A) expenses for the third quarter of 2019 were $0.80 million compared to $1.13 million in the third quarter of 2018. The decrease reflects the cost cutting initiatives implemented by the Company during the third quarter of 2019.

Finance income for the third quarter of 2019 were $0.12 million compared to finance income of $0.36 million in the third quarter of 2018. The decrease was primarily due to changes related to fair value of the tradable and non-tradable warrants issued in prior fundraising.

Net loss for the third quarter of 2019 was $1.4 million, or $0.01 per share and $0.12 per ADS, compared to $1.9 million, or $0.014 per share and $0.29 per ADS, in the third quarter of 2018.

Cash and cash equivalents, $6.27 million as of September 30, 2019.
*For the convenience of the reader, the amounts above have been translated from NIS into U.S. dollars, at the representative rate of exchange on September 30, 2019 (U.S. $1 = NIS 3.482).

Strategic Review Progress Update

On May 16, 2019, the Company disclosed that it commenced plans to explore strategic alternatives to maximize shareholder value. Potential strategic alternatives that may be evaluated include, but are not limited to, an acquisition, merger, business combination, including in other business fields than the Company’s in-licensing, or other strategic transaction involving the Company or its assets. The Company continues to evaluate business development opportunities and will keep investors informed as they mature or warrant investor disclosure.

PTC Therapeutics to Present at the Evercore ISI 2nd Annual HealthCONx Conference

On November 19, 2019 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that management will participate in a panel discussion titled, "Gene Therapy with Base Business – Extracting Value," at the 2nd Annual Evercore ISI HealthCONx Conference on Tuesday, December 3rd at 2:45 p.m. ET (Press release, PTC Therapeutics, NOV 19, 2019, https://www.prnewswire.com/news-releases/ptc-therapeutics-to-present-at-the-evercore-isi-2nd-annual-healthconx-conference-300960397.html [SID1234551502]).

The panel discussion will be webcast live on the Events and Presentations page under the investor relations section of PTC Therapeutics’ website at www.ptcbio.com and will be archived for 30 days following the presentation. It is recommended that users connect to PTC’s website several minutes prior to the start of the webcast to ensure a timely connection. PTC’s current Corporate Presentation is available at the same website location.

Biosight Announces Data to be Presented at ASH 2019 Annual Meeting

On November 19, 2019 Biosight Ltd., a pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, reported that results from an ongoing Phase 2b clinical trial of BST-236 (aspacytarabine) for treatment of acute myeloid leukemia (AML), will be presented during an oral session at the 61st Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Orlando, FL (Press release, BioSight, NOV 19, 2019, View Source [SID1234551501]).

The data, to be presented by Dr. Jessica K. Altman, Northwestern University, Chicago IL, will include integrated results from a Phase 1/2a study and an ongoing Phase 2b study, of BST-236 as a first-line single-agent treatment for AML patients who are unfit to receive standard intensive chemotherapy.

Oral presentation details:

Title: Aspacytarabine (BST-236) Is Safe and Efficacious As a Single-Agent, First-Line Therapy for Patients with Acute Myeloid Leukemia Unfit for Standard Chemotherapy. Integrated Results from a Phase 1/2a and an Ongoing Phase 2b
Presenter: Jessica K. Altman MD
Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: New Treatment Strategies
Session Date: Saturday, December 7, 2019
Session Time: 12:00 PM – 1:30 PM
Presentation Time: 1:00 PM
Room: Orange County Convention Center, Chapin Theater (W320)

About BST-236 (Aspacytarabine)

BST-236 (aspacytarabine) is a novel proprietary anti-metabolite. It is composed of cytarabine covalently bound to asparagine, acting as a pro-drug of cytarabine. Cytarabine serves as the backbone of AML therapy for over 40 years due to its superior efficacy, however, it is associated with severe bone marrow, gastrointestinal, and neurological toxicities, which significantly limit its use, especially in older and medically unfit patients. BST-236 is designed to enable high-dose therapy with lower systemic exposure to free cytarabine and relative sparing of normal tissues. As such, BST-236 may serve as a superior core therapy for AML and other hematological malignancies and disorders, including for older adults who are unfit for intensive therapy.

BST-236 was granted Orphan Drug Designation from the FDA, which entitles Biosight to seven years of market exclusivity upon BST-236 marketing approval for the treatment of AML.

A Phase 2b study is ongoing to confirm the promising results obtained in a Phase 1/2a study of BST-236 as a single-agent first-line AML therapy. For more information regarding the Phase 2b clinical study of BST-236, please visit www.clinicaltrials.gov.

Agendia to Present New Data at SABCS 2019 Demonstrating How Comprehensive Genomic Profiling Benefits Early-Stage Breast Cancer Patients

On November 19, 2019 Agendia, Inc., a world leader in precision oncology for breast cancer, reported that five abstracts featuring data and updates from its ongoing clinical research evaluating the MammaPrint and BluePrint genomic tests have been accepted for presentation at the 2019 San Antonio Breast Cancer Symposium (SABCS) taking place December 10-14, 2019, in San Antonio, Texas (Press release, Agendia, NOV 19, 2019, View Source [SID1234551500]).

Data selected for presentation offer new insights into the unique clinical characteristics, tumor biology, risk of recurrence risk and treatment responses among specific populations of women with early-stage breast cancer. These include data from a study evaluating the clinical risk of recurrence among premenopausal women ≤50 years of age with breast cancer.

Two additional presentations will feature the first datasets from Agendia’s ongoing multicenter, prospective, observational trial for patients with Stage I, II, and III breast cancer (FLEX). Researchers will share data from FLEX analyses evaluating the predisposing clinical and molecular features associated with breast cancer tumor biology in African American women, and an initial clinical review of the molecular profiles and clinical-pathological features of early-stage breast cancer in Chinese patients.

"These data offer important insights into unique patient characteristics and associated clinical risk that will better equip clinicians to provide personalized treatment plans for their patients with breast cancer," says William Audeh, MD, MS, chief medical officer at Agendia. "Agendia remains committed to advancing the scientific and medical community’s understanding of the biologic drivers of breast cancer among specific populations of women, especially those who have historically been under represented in clinical studies, and we are excited to share new data that may benefit these patients and their health care professionals. Given the comprehensive gene set interrogated by MammaPrint + BluePrint, we are uniquely positioned to deliver valuable clinical insights that may improve patient outcomes."

Following are details of the five Agendia abstracts that have been accepted for poster presentations at 2019 SABCS:

Title: Racial disparities in breast cancer: Identifying predisposing clinical and molecular features associated with African American patients (Presentation P2-10-08)
Authors: Nunes R., et al.
Session: Epidemiology, Risk, and Prevention: Ethnic/Racial Aspects
Date/Time: Thursday, December 12 at 7:00 – 9:00 am
Location: Poster Session 2, Hall 1

Title: Different MammaPrint and BluePrint molecular profiles and clinical-pathological features of early stage breast cancer in Chinese patients in the United States and Hong Kong (Presentation P2-10-15)
Authors: Kwong A., et al.
Session: Epidemiology, Risk, and Prevention: Ethnic/Racial Aspects
Date/Time: Thursday, December 12 at 7:00 – 9:00 am
Location: Poster Session 2, Hall 1

Title: Treatment recommendations in ER+ patients ≤ 50 years: Comparison of the 21-gene assay and 70-gene signature in the PROMIS study (Presentation P2-14-11)
Authors: Tsai M., et al.
Session: Treatment: Adjuvant Therapy – Adjuvant Chemotherapy
Date/Time: Thursday, December 12 at 7:00 – 9:00 am
Location: Poster Session 2, Hall 1

Title: Cyclin E overexpression is associated with high risk 70 gene signature, and may indicate intrinsic resistance to CDK4/6 inhibitors (Presentation P4-10-24)
Authors: Mittempergher L., et al
Session: Prognostic and Predictive Factors: Biomarkers Predicting Treatment Sensitivity and Resistance
Date/Time: Friday, December 13 at 7:00 – 9:00 a.m.
Location: Poster Session 4, Hall 1

Title: The FLEX real world data platform explores new gene expression profiles and investigator-initiated protocols in early stage breast cancer (Presentation OT3-17-02)
Presenter: Crozier, J., et al.
Session: On-going Trial Response Predictions
Date/Time: Friday, December 13 at 5:00 – 7:00 p.m.
Location: Poster Session OT3, Hall 1

The full SABCS 2019 abstract book can be found at View Source Visit www.agendia.com for additional information about Agendia.