On August 9, 2018 Protalix BioTherapeutics, Inc. (NYSE American:PLX, TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, reported its financial results for the six-month period ended June 30, 2018 and provided a corporate update (Press release, Protalix, AUG 9, 2018, View Source;p=RssLanding&cat=news&id=2363036 [SID1234528668]).

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"This has been a fantastic quarter for the company highlighted by the expansion of our partnership with Chiesi that resulted from the strong relationship developed over the past months," commented Moshe Manor, Protalix’s President and Chief Executive Officer. "Additionally, we believe that the recent draft guidelines from the U.S. Food and Drug Administration, or the FDA, released in July regarding enzyme replacement therapies could significantly benefit the regulatory path forward for PRX-102."

2018 Second Quarter and Recent Clinical Highlights

Expanded partnership with Chiesi Farmaceutici S.p.A., or Chiesi, to include exclusive U.S. rights for the development and commercialization of PRX-102. Terms of the agreement include an up-front payment of $25 million, up to $20 million in development costs, up to $760 million, in the aggregate, in regulatory and commercial milestone payments and tiered royalties ranging from 15 to 40%.
In July, the FDA issued a draft guideline "Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies". The draft guideline recognizes the challenges in achieving clinical evidence in rare, slow progressing diseases and provides additional preclinical and clinical results that may be acceptable to the FDA in its consideration for accelerated approval. The Company is reviewing the draft guidelines to determine how they might apply to the Company’s Fabry clinical development program.
With the additional cash from Chiesi, the Company is funded through read-outs of all clinical trials of PRX-102.
Presented data at the Digestive Disease Week (DDW) 2018 Annual Meeting on OPRX-106, which showed mucosal improvement in 61% of patients, mucosal healing in 33% of patients and clinical responses in 67% of patients.
Exchanged 4.50% convertible notes for a combination of shares and cash, and effectively discharged the remainder of the 4.50% notes.
Financial Results for the Six Months ended June 30, 2018

The Company reported a net loss of $20.7 million, or $0.14 per share, basic and diluted for the six-month period ended June 30, 2018 compared to a net loss of $20.6 million, or $0.16 per share, basic and diluted, excluding a one-time, non-cash net charge of $38.1 million in connection with the remeasurement of a derivative, for the same period of 2017.
The Company recorded total revenues of $6.6 million for the six-month period ended June 30, 2018, compared to $9.2 million for the same period of 2017. The decrease is attributed mainly to lower sales of drug substance to Pfizer Inc. and of alfataliglicerase in Brazil.
Research and development expenses were $14.8 million for the six-month period ended June 30, 2018, compared to $15.3 million for the same period of 2017. Chiesi’s participation in the clinical trials of PRX-102 for the treatment of Fabry disease in the amount of $5.0 million was recorded as deferred revenues and not as a deduction from the research and development expenses.
Selling, general and administrative expenses were $4.7 million for the six-month period ended June 30, 2018 compared to $5.4 million for the same period of 2017.
As of June 30, 2018, the Company had $28.3 million of cash and cash equivalents.
Pro forma cash balance for June 30, 2018 to include the upfront from the exclusive license signed with Chiesi for the rights to PRX-102 in the United States is $53.3 million.
Conference Call and Webcast Information

The Company will host a conference call on Thursday, August 9, 2018, at 8:30 am ET 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: United States: +1-844-358-6760; International: +1-478-219-0004. Conference ID number 9488046.

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 August 9, 2018 AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, reported financial results for the second quarter ended June 30, 2018 (Press release, AmpliPhi Biosciences, AUG 9, 2018, View Source [SID1234528749]). AmpliPhi Biosciences will not be conducting a conference call in conjunction with this financial release.

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"I’m delighted to report that we have made substantial progress with our expanded access program for AB-SA01 and AB-PA01," said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. "As of today, we have treated a total of nineteen patients at seven different hospitals and we are encouraged by the results. We are analyzing the data and plan to share a more detailed update in the near future. We look forward to our two meetings with the FDA over the next two months, the goal of which is to obtain important clinical development feedback for Phase 2 and potentially pivotal trials in one or more indications."

Recent Business Highlights

Two meetings are scheduled with the FDA for August and September to discuss Phase 2 trial plans and the path forward to regulatory approval for investigational drug candidates AB-SA01, targeting Staphylococcus aureus (S. aureus), and AB-PA01, targeting Pseudomonas aeruginosa (P. aeruginosa).
North America’s first Center for Innovative Phage Applications and Therapeutics (IPATH) was launched by UC San Diego (UCSD) in June 2018 with AmpliPhi as an industry partner. As part of the IPATH launch, UCSD announced the successful case of a patient treated with AmpliPhi’s AB-SA01. Prior to phage therapy, the patient had a persistent S. aureus ventricular assist device infection that was not eradicated for three years despite antibiotic treatment.
Presented four case studies of critically ill patients suffering from severe S. aureus bloodstream infections, who received treatment with AB-SA01, at the American Society for Microbiology (ASM) Microbe 2018 annual meeting in Atlanta in June 2018. In all cases, standard medical and surgical therapy was considered inadequate before starting bacteriophage therapy. AB-SA01 was well-tolerated and bacterial elimination was demonstrated in three out of four patients.
Presented a successful case study of a patient with cystic fibrosis (CF), suffering from recurrent multi-drug resistant (MDR) P. aeruginosa pneumonia and multiple CF exacerbations, who received treatment with AB-PA01, at the 41st European Cystic Fibrosis Conference in Belgrade, Serbia, in June 2018. Prior to treatment with AB-PA01, the patient received multiple courses of antibiotics, including colistin, but due to renal failure, colistin administration was discontinued. Treatment with AB-PA01 was well tolerated and the patient’s infection resolved. No recurrence of pneumonia or CF exacerbation was reported during the two-month follow-up period after the completion of treatment with AB-PA01. The patient’s renal failure resolved.
Presented a successful case study of a lung transplant recipient suffering from recurrent episodes of MDR P. aeruginosa pneumonia who received treatment with bacteriophage therapeutics, including AB-PA01, at the International Society of Heart and Lung Transplant Annual Meeting in Nice, France, in April 2018. The patient clinically responded to bacteriophage and antibiotic therapy with resolution of pneumonia and improved respiratory status.
Utilized the Therapeutic Development Services funded by the National Institute of Allergy and Infectious Disease (NIAID), part of the National Institutes of Health (NIH), to conduct further preclinical studies of AB-SA01. The Therapeutic Development Services program funds the provision of preclinical services for selected companies and researchers in order to advance development of promising interventional agents.
Second Quarter and Six Months Ended June 30, 2018 Financial Results

Research and development (R&D) expenses for the second quarter of 2018 were $1.7 million compared to $1.1 million for the second quarter of 2017, primarily attributable to a $0.2 million increase in professional and consulting fees and a $0.2 million increase in clinical costs.
R&D expenses for the six months ended June 30, 2018 increased by $0.6 million to $3.2 million from $2.6 million for the six months ended June 30, 2017, primarily due to an increase in clinical costs.
General and administrative (G&A) expenses were $1.4 million for the second quarter of 2018 compared to $2.8 million for the second quarter of 2017. The decrease was primarily due to lower payroll-related costs, lower legal and professional fees, as well as a $0.6 million decrease in non-cash stock-based compensation and other non-cash charges.
G&A expenses for the first six months of 2018 decreased by $1.7 million to $3.0 million from $4.7 million for the first six months of 2017. The decrease was primarily attributable to a decrease in the items described above for the second quarter comparison.
Net cash used in operating activities for the six months ended June 30, 2018 was $5.7 million compared to $6.2 million for the six months ended June 30, 2017.
Cash and cash equivalents as of June 30, 2018 totaled $5.8 million.
In July 2018, the Company received $1.2 million of tax rebate incentive payments in cash from the Australian tax authority. The incentive payments are based on R&D activities in Australia in 2017.
As of August 6, 2018, there were 16.5 million shares of common stock outstanding.

On August 9, 2018 BioCardia, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, reported financial results and business highlights for the second quarter 2018 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2018 with the Securities and Exchange Commission (Press release, Biocardia, AUG 9, 2018, View Source [SID1234528586]).

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Second Quarter 2018 Financial Results:

Revenues increased to $239,000 for the second quarter of 2018 compared to $112,000 for the second quarter of 2017.
Net loss was $3.2 million for the second quarter of 2018, compared to $2.9 million for the second quarter of 2017.
Research and development expenses increased to $2.0 million in the second quarter of 2018, compared to $1.3 million in the second quarter of 2017, primarily due to expenses associated with the pivotal CardiAMP Heart Failure Trial and development of the Company’s second cell therapy candidate, the CardiALLO Cell Therapy System.
Selling, general and administrative expenses decreased to $1.3 million in the second quarter of 2018, compared to $1.6 million in the second quarter of 2017, primarily due to lower stock compensation expense.
Net cash used in operations in the second quarter of 2018 was $2.8 million, as compared to $2.1 million in the second quarter of 2017.
2018 Corporate Highlights:

Enrollment in the pivotal CardiAMP Heart Failure Trial has expanded to 17 world class centers in the United States as detailed on ClinicalTrials.Gov.
Two abstracts have been accepted for presentation at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Diego, one of the world’s largest and most important educational meeting specializing in interventional cardiovascular medicine. Both presentations are scheduled for September 24, 2018:
"The CardiAMP Heart Failure Study: First Results from Unblinded Roll-In Phase", to be presented at 9:06 am PDT.
"Performance of Helix Transendocardial Biotherapeutic Delivery System after 300 Cases", to be presented at 9:18 am PDT.
The U.S. Food and Drug Administration approved a second pivotal Investigational Device Exemption trial for the CardiAMP Cell Therapy System for the treatment of chronic myocardial ischemia with refractory angina, the "CardiAMP Chronic Myocardial Ischemia Trial". The Centers for Medicare and Medicaid Services (CMS) has approved this trial for national reimbursement coverage.
The Company received a new US patent related to its CardiAMP cell potency assay, providing further protection to its autologous cell therapy programs in both heart failure and chronic myocardial ischemia indications.
Anticipated Upcoming Milestones:

12-month data from the CardiAMP Heart Failure Trial 10-patient roll-in cohort in the fourth quarter 2018.
Filing of the Investigational New Drug (IND) for the CardiALLO Cell Therapy System, an investigational allogenic culture expanded "off the shelf" mesenchymal cell therapy for the treatment of ischemic heart failure, in the fourth quarter 2018.
Filing for FDA approval of an advanced bidirectional steerable guide system in the fourth quarter 2018.
Dosing of the first patient in the pivotal CardiAMP Chronic Myocardial Ischemia Trial in the first quarter 2019.
Completion of enrollment in the pivotal CardiAMP Heart Failure Trial in the third quarter 2019.

On August 9, 2018 argenx (Euronext & Nasdaq: ARGX) a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported that the Company will present on Tuesday, August 14th at 1:20 p.m. ET at the 2018 Wedbush PacGrow Healthcare Conference in New York (Press release, argenx, AUG 9, 2018, View Source;p=RssLanding&cat=news&id=2363190 [SID1234528607]).

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A live webcast of the presentation will be available on the Company’s website at www.argenx.com. A replay of the webcast will be available for 90 days following the presentation.

On August 6, 2018, PRA Health Sciences, Inc. (the "Company") entered into an Underwriting Agreement (the "Underwriting Agreement") by and among the Company, the selling stockholder named therein (the "Selling Stockholder"), and Morgan Stanley & Co. LLC and Goldman Sachs & Co. LLC (the "Underwriters"), relating to an underwritten offering (the "Offering") of 6,500,000 shares (the "Shares") of the Company’s common stock, par value $0.01 per share, pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-209883), filed on March 2, 2016, as supplemented by the prospectus supplement dated August 6, 2018 (Filing, 8-K, PRA Health Sciences, AUG 9, 2018, View Source [SID1234528791]). All of the Shares are being sold by the Selling Stockholder. Pursuant to the Underwriting Agreement, the Underwriters purchased the Shares at a price of $101.01 per share in a transaction that was completed on August 9, 2018.

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