On November 7, 2019 VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet need, reported financial results for its fiscal year 2020 second quarter ended September 30, 2019 (Press release, VistaGen Therapeutics, NOV 7, 2019, View Source [SID1234550704]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"During the quarter, we achieved several important milestones intended to advance development of each of our three differentiated CNS drug candidates," stated Shawn Singh, Chief Executive Officer of VistaGen. "We recently achieved target enrollment and completed patient dosing in our randomized, double-blind, placebo-controlled Phase 2 ELEVATE study of AV-101, our novel oral NMDA receptor antagonist, in major depressive disorder. In addition, for development of AV-101 in suicidal ideation, with emphasis on U.S. Military Veterans, our collaborators at Baylor University recently completed dosing in their Phase 1b target engagement study in healthy volunteer Veterans, a study funded by the U.S. Department of Veteran’s Affairs. We are also encouraged by post-Phase 2 feedback from the FDA earlier this year regarding our Phase 3 development plan for PH94B, our first-in-class, rapid-acting neuroactive nasal spray, in social anxiety disorder. We expect the coming months to be equally active and potentially transformative, as we look forward to topline readouts from two studies involving AV-101 before the end of 2019, and potential regulatory milestones involving PH94B before the end of fiscal 2020."

Financial Results for the Fiscal Quarter Ended September 30, 2019:

Net loss attributable to common stockholders for the fiscal quarter ended September 30, 2019 decreased to approximately $5.7 million compared to $7.7 million for the fiscal quarter ended September 30, 2018, primarily attributable to research and development activities relating to the Company’s CNS drug development programs.

Research and development expense decreased to $4.2 million for the fiscal quarter ended September 30, 2019, compared with $5.3 million for the fiscal quarter ended September 30, 2018. Expense for the quarter ended September 30, 2018 included $2.25 million noncash expense associated with the Company’s acquisition of its exclusive worldwide license to develop and commercialize PH94B and an option to acquire an exclusive worldwide license to develop and commercialize PH10, the Company’s first-in-class, rapid-onset neuroactive nasal spray in Phase 2 development for major depressive disorder, which option was subsequently exercised. Offsetting this noncash expense in the quarter ended September 30, 2019 are increased expenses for the ELEVATE study and various nonclinical activities across the Company’s CNS pipeline.

General and administrative expense decreased to approximately $1.1 million in the fiscal quarter ended September 30, 2019, compared to approximately $2.2 million in the fiscal quarter ended September 30, 2018. Noncash expense of $272,000 in the quarter ended September 30, 2019, decreased from $792,000 in the quarter ended September 30, 2018, primarily due to decreases in stock-based compensation and other expenses.

At September 30, 2019, VistaGen had cash and cash equivalents of $4.1 million, compared to $13.1 million at March 31, 2019.

As of November 6, 2019, there were 43,222,965 shares of common stock outstanding.

VistaGen’s CNS Pipeline

VistaGen is developing three new generation clinical-stage CNS drug candidates, AV-101, PH10 and PH94B, each with a differentiated mechanism of action, an exceptional safety profile in all clinical studies to date, and therapeutic potential in multiple CNS markets where current treatments are inadequate to meet high unmet patient needs.

AV-101 belongs to a new generation of investigational medicines in neuropsychiatry and neurology known as NMDA (N-methyl-D-aspartate) receptor modulators. The NMDA receptor is a pivotal receptor in the brain and abnormal NMDA function is associated with numerous CNS diseases and disorders. AV-101 is an oral prodrug of 7-Cl-KYNA, a potent and selective full antagonist of the glycine co-agonist site of the NMDA receptor. Based on several positive preclinical studies and its exceptional safety profile in all preclinical and clinical studies to date, AV-101 has potential to be a new at-home, non-sedating treatment for multiple large market CNS indications, including major depressive disorder, neuropathic pain, suicidal ideation, epilepsy and dyskinesia associated with levodopa therapy for Parkinson’s disease. The FDA has granted Fast Track designation for development of AV-101 as both a novel potential adjunctive treatment for MDD and a non-opioid treatment for neuropathic pain.

PH10 is a first-in-class, odorless, rapid-onset CNS neuroactive nasal spray in development for treatment of major depressive disorder. Administered in microgram doses, PH10 activates nasal chemosensory receptors that, in turn, engage neural circuits that lead to rapid antidepressant effects without psychological side effects, systemic exposure or safety concerns often associated with current oral antidepressants and ketamine-based therapies (intravenous ketamine or esketamine nasal spray). In an exploratory (n=30) randomized, double-blind, placebo-controlled Phase 2a clinical study in major depressive disorder, at microgram doses, rapid-onset antidepressant effects were observed and sustained for 8 weeks, without psychological side effects or systemic exposure. VistaGen is preparing for planned Phase 2b clinical development of PH10 for major depressive disorder.

PH94B is a first-in-class, odorless, rapid-onset (approximately 10 to 15 minutes) CNS neuroactive nasal spray with the potential to be the first FDA-approved, as-needed, on-demand treatment for millions of Americans who suffer from social anxiety disorder, with additional potential in peripartum anxiety, pre/postoperative anxiety, post-traumatic stress disorder, panic disorder and generalized anxiety disorder. Administered at microgram doses, PH94B activates nasal chemosensory receptors that trigger neural circuits in the brain that suppress fear and anxiety associated with everyday social and work or performance situations. Following successful Phase 2 development, VistaGen is preparing for Phase 3 clinical development of PH94B for social anxiety disorder.

On November 7, 2019 Selvita (WSE: SLV) – one of the largest preclinical contract research organizations in Europe – reported third quarter 2019 financial results and provided a corporate update following a recent corporate split of the oncology therapeutics (Ryvu Therapeutics) and contract research (CRO) business units (Selvita) (Press release, Selvita, NOV 7, 2019, View Source [SID1234550703]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The services segment of the Company has recorded USD 5.59 million of commercial revenue in Q3 2019, which marks a 45% increase compared to Q3 2018.

In the first three quarters of 2019, Selvita Group recorded USD 18.8 million of revenues, 32% increase comparing to the corresponding period in 2018. Operating profits, (EBITDA excluding IFRS16 impact) result amounted to USD 3.5 million, an increase of 21% compared to Q3 2018, and the backlog **for 2019 currently amounts to USD 25.1 million and is 38% higher than at corresponding time in 2018.

– Our financial results up to date represent more than we wished for. The increase in the commercial revenues was significantly higher than the declared 30%, as it amounted to 36% in the period from January to September, and 45% in Q3 2019 alone. Operating margin for Q1-Q3 2019 amounted to 11.4% – says Boguslaw Sieczkowski, co-founder, significant shareholder and Chief Executive Officer at Selvita.

Revenues of the services segment in the first three quarters amounted to USD 15.1 million, up by 36% comparing to Q1-Q3 2018, and operating profit to USD 2.0 million (11% more y/y). In the third quarter alone, these dynamics reached 45 and 13%, respectively.

– The last quarters of this year were a period of a dynamic development for Selvita. Not only we have increased employment, but also made significant investments in the equipment. This has allowed us to build a solid base for another organic leap of business scale. The first results of our work were already visible in Q3 2019 – says Boguslaw Sieczkowski.

The service segment is comprised of two departments: chemistry and biology. In 2019, the dynamics of the biology department have stood out in particular – its backlog currently amounts to USD 9.9 million and is 75% higher than for a corresponding point of time in 2018.

The total commercial backlog of the service segment currently sums up to USD 20.9 million, a 40% increase compared to 2018.

Revenues of the bioinformatics segment (Ardigen, in which Selvita S.A. holds 52 percent of shares), amounted to USD 2.5 million and were 32% higher than in Q3 2018. Operating profit amounted to USD 0.2 million, compared to USD 0.3 million in the same period last year.

– At the moment, Ardigen’s primary goal is dynamic development of its own technology platforms, as well as marketing and sales activities. This drives the increase in costs, but in the long run it will lead to a significant growth in the scale of business, resulting in the increase in the value of the company – explains Bogusław Sieczkowski.

The backlog of the bioinformatics segment amounts to USD 2.6 million, which is 27% higher than a year ago.

Selvita after the split

At the beginning of October, the National Court Register of Poland ("KRS") has recognized the corporate split of the Selvita parent company into two distinct organizations. The recognition by the court follows the Sept. 19, 2019, shareholder resolution to separate oncology therapeutics and contract research (CRO) business units.

Selvita provides comprehensive research and development services, mainly to clients in the pharmaceutical and biotechnology industries. The company’s medium-term goal is to enter the top ten largest preclinical CROs in the world.

Selvita’s Services Segment has been growing in the last years at a rate of 30-40% per year and has been permanently profitable. The company assumes maintaining this level of growth dynamics. At the same time, the company plans to grow through acquisitions, expecting the first transaction in 2020. Selvita is interested both in domestic and foreign companies which will allow it to achieve its business goals: increasing the scale of operations and expanding the portfolio of services offered. As a leading company on the market, Selvita will be in an excellent position to build lasting value, thanks to selective and systematic takeover strategies, which will be made possible through e.g. debt financing, which was difficult to access before the corporate split.

Boguslaw Sieczkowski, serves currently as the Chief Executive Officer at Selvita. He is also one of the co-founders of the company, and former Executive Vice President and Chief Operating Officer. In addition, the Management Board is comprised of three members from the company’s current top management: dr Milosz Gruca, Director of the Biology Department and Executive Vice President, dr Miroslawa Zydron, Director of the Chemistry Department and Edyta Jaworska responsible for the development of integrated drug discovery projects. New appointments to the Management Board have also been made, which include Dawid Radziszewski, General Counsel and Head of Corporate Development who will be directly responsible for the acquisitions and integration of companies within the Group, and Dariusz Kurdas, who assumed the position of Chief Financial Officer.

**Backlog for 2019 as on 28/10/2019, backlog for 2018 as on 9/11/2018. Backlog defined as the value of the portfolio of contracts signed as of the report publication date, incl. commercial contracts and grant agreements.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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.