On November 7, 2019 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, is reported it has been accepted for a poster presentation at the 61st Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting, which takes place from 7-10 December 2019 in Orlando, Florida (Press release, BerGenBio, NOV 7, 2019, View Source [SID1234550702]).

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The poster will provide an update on its phase II study of bemcentinib (BGB324) in combination with Low-dose Cytarabine in elderly AML patients.

Abstract titles have been announced online. Details of the presentation are below.

Title: Durable responses observed in elderly AML patients unfit for intensive chemotherapy with first-in class selective AXL inhibitor bemcentinib (BGB324) in combination with LDAC: Phase II open-label study

Date: Monday 9th December 2019

Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III

Time, Location: 6:00 PM – 8:00 PM, Orange County Convention Center, Hall B

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body’s immune response to tumours and drives cancer treatment failure across many indications. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases.

About bemcentinib

Bemcentinib (formerly known as BGB324), is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme. Ongoing clinical trials are investigating bemcentinib in multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity. Increase in AXL function has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers.

On November 7, 2019 Cardinal Health (NYSE: CAH) reported first quarter fiscal year 2020 revenue of $37.3 billion, an increase of 6 percent from the first quarter last year (Press release, Cardinal Health, NOV 7, 2019, View Source [SID1234550701]).

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First quarter GAAP operating loss was $5.3 billion and included a $5.6 billion accrual related to opioid litigation. Non-GAAP operating earnings increased 6 percent to $577 million. GAAP diluted loss per share was $16.65, while non-GAAP diluted earnings per share (EPS) decreased 2 percent to $1.27.

"We are off to a solid start to fiscal year 2020, giving us confidence in our operating rigor and path forward," said Mike Kaufmann, CEO of Cardinal Health. "Our disciplined cost management is enabling strategic investment across the enterprise. We recognize that as our industry and the healthcare sector continue to evolve, there is more work to be done. Our core capabilities, deep industry knowledge and scale position us to adapt and deliver long-term shareholder value."

Q1 FY20 summary

Q1 FY20

Q1 FY19

Y/Y

Revenue

$37.3 billion

$35.2 billion

6%

Operating earnings/(loss)

$(5.3) billion

$816 million

N.M.

Non-GAAP operating earnings

$577 million

$542 million

6%

Net earnings/(loss) attributable
to Cardinal Health, Inc.

$(4.9) billion

$593 million

N.M.

Non-GAAP net earnings attributable
to Cardinal Health, Inc.

$378 million

$396 million

(4)%

Diluted EPS/(loss per share)
attributable to Cardinal Health, Inc.2

$(16.65)

$1.94

N.M.

Non-GAAP diluted EPS attributable
to Cardinal Health, Inc.

$1.27

$1.29

(2)%

Segment results

Pharmaceutical segment

Q1 FY20

Q1 FY19

Y/Y

Revenue

$33.4 billion

$31.4 billion

6%

Segment profit

$398 million

$409 million

(3)%

First quarter revenue for the Pharmaceutical segment increased 6 percent to $33.4 billion due to sales growth from Pharmaceutical Distribution and Specialty Solutions customers.

Pharmaceutical segment profit decreased 3 percent to $398 million in the first quarter, which reflects the adverse impact of Pharmaceutical Distribution customer contract renewals, partially offset by benefits from cost savings initiatives and the performance of Specialty Solutions.

Medical segment

Q1 FY20

Q1 FY19

Y/Y

Revenue

$3.9 billion

$3.8 billion

3%

Segment profit

$170 million

$135 million

26%

First quarter revenue for the Medical segment increased 3 percent to $3.9 billion due to organic growth across the segment, led by products and distribution, and Cardinal Health at Home. This was partially offset by the divestiture of the naviHealth business.

Medical segment profit increased 26 percent to $170 million in the first quarter, which reflects the benefits from cost savings initiatives, as well as growth in products and distribution, services, and Cardinal Health at Home. This was partially offset by the divestiture of the naviHealth business.

Outlook

The company does not provide a GAAP EPS outlook because it is unable to reliably forecast most of the items that are excluded from GAAP EPS to calculate non-GAAP EPS. These items could cause EPS to differ materially from non-GAAP EPS. See "Use of Non-GAAP Measures" following the attached schedules for additional explanation.

The company reaffirms its fiscal year 2020 guidance range for non-GAAP diluted earnings per share attributable to Cardinal Health, Inc. of $4.85 to $5.10.

Opioid lawsuits developments

In October 2019, the company agreed in principle to a global settlement framework with a leadership group of four state attorneys general that is designed to resolve all pending and potential opioid lawsuits by states and political subdivisions. The global settlement framework includes, among other significant components, an agreement in principle by the company to pay up to $5.56 billion over 18 years. There is no assurance that a definitive settlement agreement will be finalized by the necessary parties or that the contingencies to any agreement will be satisfied. The company also agreed to a $66 million settlement with two Ohio counties. In connection with these matters, the company accrued $5.63 billion ($5.14 billion after tax) which is excluded from its non-GAAP earnings.

Quarterly dividend

Cardinal Health board of directors approved a quarterly dividend of $0.4811 per share. The dividend will be payable on January 15, 2020 to shareholders of record at the close of business on January 2, 2020.

Tax rate

During the first quarters of fiscal 2020 and 2019, GAAP effective tax rates were 7.9 percent and 19.4 percent, respectively. Non-GAAP effective tax rates were 23.7 percent and 14.0 percent, respectively.

The GAAP effective tax rate for the first quarter of fiscal 2020 was impacted by the assessment of the future deductibility of the $5.6 billion opioid litigation accrual.

The effective tax rates in the first quarter of fiscal 2019 were affected by an approximately $0.18 per share positive impact of discrete tax benefits primarily related to international legal entity changes.

Webcast

Cardinal Health will host a webcast today at 8 a.m. Eastern to discuss first quarter results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required.

Presentation slides and a webcast replay will be available until November 6, 2020.

Upcoming webcasted investor events

Credit Suisse 28th Annual Healthcare Conference on November 12 at 2:25 p.m. Mountain in Scottsdale, Ariz.
38th Annual J.P. Morgan Healthcare Conference on January 13-16, 2020 in San Francisco, Calif.

On November 7, 2019 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported its third quarter 2019 financial results and provided a corporate update (Press release, Protalix, NOV 7, 2019, View Source [SID1234550700]).

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"This has been a consequential quarter for Protalix during which we continued to make solid progress on our goals to move our Fabry program toward commercialization and to pursue strategic partnerships and alliances, and we commenced efforts to improve our capital structure," said Dror Bashan, Protalix’s President and Chief Executive Officer. "During the third quarter, we completed enrollment in our pivotal, head-to-head BALANCE study evaluating PRX‑102 compared to Fabrazyme. We also recently reported positive 12-month interim data from our switch-over Phase III BRIDGE study comparing PRX‑102 to another standard-of-care treatment, Replagal."

"With three, now fully enrolled Phase III clinical trials of PRX‑102, we have a robust and thorough clinical program for the treatment of Fabry disease," concluded Mr. Bashan. "Our management, scientific and clinical teams are all fully committed to bringing this important treatment to the Fabry patient community."

Third Quarter 2019 and Recent Clinical and Corporate Highlights

The Company, together with its development and collaboration partner, Chiesi Farmaceutici S.p.A, or Chiesi, announced the completion of enrollment in the Phase III BALANCE clinical trial of PRX‑102 for the treatment of Fabry disease. The head-to-head Phase III BALANCE clinical study is designed to evaluate the safety and efficacy of PRX‑102 compared to agalsidase beta (Fabrazyme) on renal function in Fabry patients with progressing kidney disease previously treated with agalsidase beta. To date, more than 66 patients are being treated in the Company’s various extension studies after opting to continue treatment with PRX‑102 after completion of an original study.
The Company announced positive 12-month interim on-treatment data from the first 16 out of the 22 adult patients (9 males and 7 females) enrolled in the BRIDGE Phase III open label switch-over study of PRX‑102 for the treatment of Fabry disease. The interim data demonstrate a mean improvement in kidney function, in both male and female patients, when switched from agalsidase alfa (Replagal) to PRX‑102, and will help to support the expected U.S. Food and Drug Administration ("FDA") BLA filing under Accelerated Approval.
The Company and Chiesi plan the submission of a BLA for PRX‑102 via the FDA’s Accelerated Approval pathway based on data from the completed Phase I/II clinical trials of PRX‑102 and the ongoing Phase III BRIDGE clinical trial by April 2020.
Financial Results for the Nine Months Ended September 30, 2019

The Company recorded revenues from selling goods of $12.1 million during the nine-month period ended September 30, 2019, an increase of $4.9 million, or 67%, compared to revenues of $7.2 million for the same period of 2018. The increase is primarily due to higher sales of Elelyso in Brazil.
Research and development expenses, net, were $35.0 million for the nine months ended September 30, 2019, an increase of $11.3 million, or 47%, compared to $23.8 million for the same period of 2018. The increase resulted primarily from an increase of $8.5 million in clinical trial related costs as well as a decrease of $1.8 million in grants received from the Israeli Innovation Authority.
Selling, general and administrative expenses for the nine months ended September 30, 2019 were $6.9 million, a decrease of $1.9 million, or 21%, compared to $8.7 million for the same period in 2018. The decrease is primarily due to costs related to the Chiesi US Agreement we entered into in the third quarter of 2018, which were not incurred in the third quarter of 2019.
Net loss for the nine months ended September 30, 2019 was $18.6 million, or $0.13 per share, basic and diluted, compared to a net loss of $21.0 million, or $0.14 per share, basic and diluted, for the nine months ended September 30, 2018.
At September 30, 2019, the Company had $21.4 million in cash and cash equivalents.
The Company received a communication from NYSE American LLC stating that the Company is not in compliance with the continued listing standards as set forth in the NYSE American Company Guide as it has reported a stockholders’ equity deficiency as of June 30, 2019 and net losses in its five most recent fiscal years ended December 31, 2018. Subsequently, in accordance with the NYSE American Company Guide, the Company submitted to the NYSE American a plan to regain compliance with the continued listing standards.
The Company has engaged a first-tier financial advisory firm to assist in evaluating and pursuing strategic alternatives to maximize stakeholder value and address the foregoing.
As part of the Company’s efforts to advance its clinical development program and to realize future benefits of commercial success, the Company’s Board of Directors, along with the management team, has determined that it is in the Company’s best interest to seek to address to its capital structure.
Accordingly, the Company convened a Special Meeting of Stockholders to seek approval for the following:
– A reverse stock split at a ratio of not less than 1-for-10 and not greater than 1-for-20, with the exact ratio to be set within that range at the discretion of the Board of Directors before the day prior to the Special Meeting of Stockholders without further approval or authorization of the stockholders; and to reduce the total number of shares of the Company’s common stock that the Company is authorized to issue from 350 million to 120 million shares.
The Special Meeting of Stockholders of Protalix BioTherapeutics, Inc. to vote on the proposal will be held at 1:00 p.m., Israel time, on December 9, 2019 at the offices of the Company’s Israeli counsel, Horn & Co., Law Offices, Amot Investments Tower, 2 Weizmann Street, 24th Floor, Tel Aviv 6423902, Israel.
Conference Call and Webcast Information

The Company will host a conference call on Thursday, November 7, 2019, at 8:30 am, Eastern Standard Time, to review the clinical, corporate and financial highlights. To participate in the conference call, please dial the following numbers prior to the start of the call:

Domestic (USA): 888-224-1005
International: 323-994-2093
Conference ID: 1931108
Webcast: http://bit.ly/2BSCaiY

The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

On November 7, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system in the fight against cancer, reported that data from its ongoing studies utilizing Cchek, its artificial intelligence (AI) driven early cancer detection technology will be displayed in a poster presentation at the Cell Symposia: Hallmarks of Cancer (Press release, Anixa Biosciences, NOV 7, 2019, View Source;hallmarks-of-cancer-300953509.html [SID1234550699]).

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The symposium is being held in Seattle, WA, on November 17 – 19, 2019, and is designed to bridge multidisciplinary basic research, translational, and clinical perspectives to advance our understanding of key aspects of cancer biology. The program includes discussions on critical issues ranging from tumor cell plasticity, tumor microenvironment, to recent advances in immunotherapies, and personalized medicine.

Details for the poster presentation are as follows:

Title: Combining MDSC immunophenotyping with the HyperVOX computational technique: a usable input into pattern recognition neural networks for early detection of stage I/II breast cancer (BCa)

Authors: George A. Dominguez, Ph.D.; John Roop; Alex Polo; Anthony J. Campisi; Dmitry I. Gabrilovich, MD, Ph.D.; Amit Kumar, Ph.D.

Poster Number: P1.005

Location: Motif, Seattle; Emerald Ballroom

Date and Time: Monday, November 18, 2019 (12:00 PM – 2:00 PM PT)

To receive a copy of the presentation, please email your request to [email protected] starting November 19, 2019 and include your name, title, and contact information.

About Cchek
Cchek is an early cancer detection technology, which measures a patient’s immunological response to a malignancy by analyzing immune system cells in peripheral blood. The goal is to utilize the technology to determine a patient’s cancer status from a simple blood draw, eliminating the need for a biopsy, which can be an expensive, painful and invasive procedure. Further, conventional methods using current cancer screening tests often lack accuracy and reliability. Anixa’s orthogonal approach using flow cytometry coupled with artificial intelligence provides an alternative method with greater affordability, efficacy and efficiency. To date, Anixa has successfully used Cchek to detect the presence of 20 different cancers including lung, colon, breast and prostate. The robust cancer detection performance of Cchek makes it a platform from which multiple cancer diagnostic tests may be developed. The first such test, a prostate cancer confirmation test, is slated for commercial launch by the end of 2019.

On November 7, 2019 TransThera Biosciences Co. Ltd, reported that company received Orphan Drug Designation from US Food and Drug Administration (FDA) for TT-00420, a clinical stage investigational drug, for the treatment of cholangiocarcinoma (Press release, TransThera Biosciences, NOV 7, 2019, View Source [SID1234550698]).

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Dr. Frank Wu, Founder and CEO of TransThera, commented: "Cholangiocarcinoma lacks effective therapies and remains a huge unmet medical need around the world. TT-00420 has demonstrated great potential in multiple experiments. We believe that today’s orphan drug designation will help accelerate the development of this potential product in the clinical trials and bring meaningful benefit to cholangiocarcinoma patients. We are very excited about this news, which expands the horizon of our lead product in development. In addition to triple negative breast cancer, cholangiocarcinoma is identified by our scientists to be second indication for TT-00420."

TT-00420 is in global Phase I trial both in the US and China. Dose expansion Phase Ib/II trials in cholangiocarcinoma and triple negative breast cancer are planned to start in 2020.

About TT-00420

TT-00420 is a novel, small molecule, spectrum-selective multiple kinase inhibitor, developed by TransThera Biosciences. A global, phase I, first-in-human trial is currently ongoing to evaluate the safety and tolerability of TT-00420 in patients with advanced solid tumors. More information about this study can be found on ClinicalTrials.gov, using identifier NCT03654547.

About Cholangiocarcinoma

Cholangiocarcinoma is a rare cancer that forms in the bile ducts with poor prognosis. Common treatment options for cholangiocarcinoma include surgery and chemotherapy, but recurrence is common and disease-free survival time is low. Thus, clinical trials are necessary to develop and evaluate effective therapies for treatment of this disease.