On August 8, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the second quarter ended June 30, 2019 (Press release, Puma Biotechnology, AUG 8, 2019, View Source [SID1234538440]). Unless otherwise stated, all comparisons are for the second quarter 2019 compared to the second quarter of 2018.

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Product revenue, net consists entirely of sales revenue from NERLYNX, Puma’s first commercial product. Net NERLYNX revenue in the second quarter of 2019 was $53.8 million, compared to net NERLYNX revenue of $50.8 million in the second quarter of 2018. Net NERLYNX revenue in the first six months of 2019 was $99.4 million, compared to net NERLYNX revenue of $86.8 million in the first six months of 2018.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss of $37.4 million, or $0.97 per share, for the second quarter of 2019, compared to a net loss of $44.3 million, or $1.17 per share, for the second quarter of 2018. Net loss for the first six months of 2019 was $47.5 million, or $1.23 per share, compared to a net loss of $68.7 million, or $1.82 per share, for the first six months of 2018.

Non-GAAP adjusted net loss was $22.0 million, or $0.57 per share for the second quarter of 2019, compared to non-GAAP adjusted net loss of $22.2 million, or $0.59 per share for the second quarter of 2018. Non-GAAP adjusted net loss for the first six months of 2019 was $13.9 million, or $0.36 per share, compared to non-GAAP adjusted net loss of $21.2 million, or $0.56 per share, for the first six months of 2018. Non-GAAP adjusted net loss excludes stock-based compensation expense. For a reconciliation of GAAP net loss to non-GAAP adjusted net loss and GAAP net loss per share to non-GAAP adjusted net loss per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the second quarter of 2019 was $44.2 million, compared to net cash used in operating activities of $17.6 million in the second quarter of 2018. Net cash provided by operating activities for the first six months of 2019 was $28.1 million, compared to net cash used in operating activities of $23.9 million in the first six months of 2018. At June 30, 2019, Puma had cash, cash equivalents, and marketable securities of $117.7 million, compared to cash, cash equivalents and marketable securities of $165.4 million at December 31, 2018. The reduction in cash, cash equivalents and marketable securities in the second quarter was the result of the previously disclosed repayment of the $155 million outstanding loan using cash on hand and $100 million in new borrowings from an amended and restated loan agreement in June 2019.

"The second quarter of 2019 included the achievement of several key milestones for Puma," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "This included sequential NERLYNX sales growth and the expansion of our global presence with NERLYNX with our European licensing agreement with Pierre Fabre. We saw the achievement of additional key milestones in July with the filing of the new drug application for neratinib in the metastatic breast cancer indication and obtaining approval for NERLYNX in the extended adjuvant indication from Health Canada."

Mr. Auerbach added, "We anticipate the following key milestones during the remainder of 2019: (i) meeting with the FDA to discuss the clinical development and regulatory strategy for the SUMMIT trial in the third quarter of 2019; (ii) reporting additional data from the Phase II CONTROL trial in the fourth quarter of 2019; and (iii) receiving regulatory decisions for the extended adjuvant HER2-positive early stage breast cancer indication in additional countries."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, license revenue and royalty revenue. For the second quarter ended June 30, 2019, total revenue was $53.9 million, of which $53.8 million was net NERLYNX revenue and $0.1 million was royalty revenue received from Puma’s sub-licensees. This compares to total revenue of $50.8 million in the second quarter of 2018, all of which was net product revenue. For the first six months of 2019, total revenue was $153.0 million, of which $99.4 million was net product revenue, $53.5 million was license revenue received from Puma’s sub-licensees, and $0.1 million was royalty revenue. This compares to total revenue for the first six months of 2018 of $117.3 million, of which $86.8 million was net product revenue and $30.5 million was license revenue.

Operating Costs and Expenses

Total operating costs and expenses were $79.7 million in the second quarter of 2019, compared to $92.2 million in the second quarter of 2018. Operating costs and expenses in the first six months of 2019 were $168.9 million, compared to $182.1 million in the first six months of 2018.

Cost of Sales:

Cost of sales was $9.3 million for the second quarter of 2019 and $17.3 million for the first six months of 2019, compared to $8.8 million for the second quarter of 2018 and $15.2 for the first six months of 2018.

Selling, General and Administrative Expenses:

Selling, general and administrative expenses (SG&A) were $33.5 million for the second quarter of 2019, compared to $40.1 million for the second quarter of 2018. SG&A expenses for the first six months of 2019 were $79.0 million, compared to $76.7 million for the first six months of 2018. The approximately $2.3 million year-to-date increase resulted primarily from increases of approximately $2.9 million for professional fees, such as legal fees and marketing and commercial support, $0.6 million in office and banking expenses, and $0.4 million in payroll and payroll-related expenses. These were partially offset by decreases of approximately $1.4 million in travel and meeting-related expenses and $0.2 million related to stock-based compensation expense.

Research and Development Expenses:

Research and development (R&D) expenses were $36.9 million for the second quarter of 2019, compared to $43.3 million for the second quarter of 2018. R&D expenses for the first six months of 2019 were $72.6 million, compared to $90.2 million for the first six months of 2018. The $17.6 million year-to-date decrease resulted primarily from decreases of approximately $13.8 million for stock-based compensation, $3.5 million for internal R&D primarily related to payroll and payroll-related expenses, and $0.5 million in consulting fees related to clinical trials.

Total Other Income (Expenses)

Total other expenses were $11.6 million for the second quarter and $31.6 million for the first six months of 2019, compared to total other expenses of $2.9 million for the second quarter and $3.9 million for the first six months of 2018. The increase in other expenses recorded in the first six months of 2019 primarily included $16.4 million related to a March 2019 jury verdict against Puma and $8.1 million related to the debt refinancing.

Conference Call

Puma Biotechnology will host a conference call to report its second quarter 2019 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, August 8, 2019. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international) at least 10 minutes prior to the start of the call and referencing the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on the company’s website for 90 days.

On August 8, 2019 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company"), a novel bioelectric medicine company bringing to market its proprietary CellFX System, reported recent corporate developments and financial results for the three- and six-month periods ended June 30, 2019 (Press release, Pulse Biosciences, AUG 8, 2019, View Source [SID1234538439]).

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Recent Corporate Developments

The Company is working with the FDA on its 510(k) submission for the CellFX System, continues to believe the 510(k) path is the appropriate path, and is looking forward to finalizing and submitting all responses to FDA during Q3 2019 for a potential clearance in Q4 2019.

The Company commenced enrollment and treated the first patient in its CellFX Warts Pivotal Study. The CellFX Warts Pivotal Study is a prospective, non-randomized, multicenter study evaluating the safety and effectiveness of the CellFX System in up to 60 patients with non-genital warts. The Company expects to complete enrollment by the end of 2019.

Nano-Pulse Stimulation (NPS) technology peer reviewed manuscripts featured by leading dermatology publications:

"A Dose Response Study of a Novel Method of Selective Tissue Modification of Cellular Structures in the Skin with Nanosecond Pulsed Electric Fields" with lead author David Kaufman, MD, FACS, published in the August 2019 edition of the journal of the American Society for Laser Medicine and Surgery and highlights the Company’s initial histologic skin studies that demonstrated the safety and unique mechanism of NPS to impact cellular structures while sparing surrounding non-cellular structures.

"Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Sebaceous Gland Hyperplasia" with lead author Girish Munavalli, MD, MHS, FACMS, has been accepted for publication in an upcoming edition of the journal of Dermatologic Surgery and outlines the results, findings and observations from the Company’s clinical study evaluating the safety and efficacy of NPS for the treatment of Sebaceous Hyperplasia.

The Company’s Nano-Pulse Stimulation Technology is scheduled to be prominently featured during the "Hot Topics" session of the prestigious Controversies and Conversations in Lasers & Cosmetic Surgery symposium in San Francisco, CA on Friday August 9, 2019. Investigators Drs. Thomas Rohrer, Girish Munavalli, and Brian Zelickson will be presenting from the podium clinical study data and their experiences with NPS in Pulse Biosciences’ ongoing programs in Sebaceous Hyperplasia, Seborrheic Keratosis, Warts, BCC and tattoo removal.

Financial Highlights

Cash, cash equivalents, and investments totaled $42.6 million at June 30, 2019, compared to $59.6 million at December 31, 2018. Cash use totaled $10.2 million for the second quarter of 2019 compared to cash use of $6.8 million for the first quarter of 2019 and $6.4 million for the fourth quarter of 2018.

Operating expenses for the three-month period ended June 30, 2019 totaled $11.6 million, compared to $9.3 million for the three-month period ended June 30, 2018. Operating expenses for the three-month period ended June 30, 2019 included non-cash stock-based compensation of $2.7 million, compared to non-cash stock-based compensation of $3.2 million for the three-month period ended June 30, 2018.

Operating expenses for the six-month period ended June 30, 2019 totaled $22.1 million, compared to $18.0 million for the six-month period ended June 30, 2018. Operating expenses for the six-month period ended June 30, 2019 included non-cash stock-based compensation of $5.1 million, compared to non-cash stock-based compensation of $6.6 million for the six-month period ended June 30, 2018.

Net loss for the three-month period ended June 30, 2019 totaled $11.4 million compared to $9.2 million for the three-month period ended June 30, 2018. Net loss for the six-month period ended June 30, 2019 totaled $21.4 million compared to $17.8 million for the six-month period ended June 30, 2018.


Conference Call Details

Pulse Biosciences will host an investor call on August 8, 2019, at 1:30 p.m. PDT / 4:30 p.m. EDT. The telephone dial-in number for the call is (844) 494-0190 (U.S. toll-free) or (508) 637-5580 (international) using Conference ID 9229379. Listeners will also be able to access the call via webcast available on the Investors section of the Company’s website at www.PulseBiosciences.com.

On August 8, 2019 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, 2019 and provided a corporate update (Press release, Protalix, AUG 8, 2019, View Source;p=RssLanding&cat=news&id=2406197 [SID1234538438]).

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"We are very optimistic about our interactions with the U.S. Food and Drug Administration over the second quarter of 2019, which resulted in our decision to, together with our partner Chiesi Farmaceutici, begin preparing a biologics license application for pegunigalsidase alfa for the treatment of Fabry disease, which we expect to submit in the first quarter of 2020 through the FDA’s Accelerated Approval pathway," said Mr. Dror Bashan, Protalix’s President and Chief Executive Officer. "We are now focused on completing the anticipated filing."

Second Quarter 2019 and Recent Clinical and Corporate Highlights

The Company, together with its collaboration partner, Chiesi Farmaceutici S.p.A, or Chiesi, announced that, following a series of meetings and correspondence with the U.S. Food and Drug Administration (FDA), they plan to file a biologics license application (BLA) for pegunigalsidase alfa, or PRX-102, for the treatment of Fabry disease via the FDA’s Accelerated Approval pathway.

The Company and Chiesi have initiated preparations for the BLA submission based on data from the completed Phase I/II clinical trials of pegunigalsidase alfa and the ongoing Phase III BRIDGE clinical trial, and expect to hold a pre-BLA meeting with the FDA in the fourth quarter of 2019.

Enrollment completed in the Phase III BRIGHT clinical trial of pegunigalsidase alfa for the treatment of Fabry disease, via intravenous (IV) infusions of 2 mg/kg administered every 4 weeks.

To date, substantially all patients enrolled in the BRIGHT clinical trial remain on the 4‑week dosing regimen, and all of the patients that completed the study opted, with the advice of the treating physician, to continue treatment under the 4‑week dosing regimen in a long-term extension study.

The Company’s Phase III BALANCE clinical trial of pegunigalsidase alfa for the treatment of Fabry disease is currently 95% enrolled.

To date, more than 55 patients are being treated in the Company’s various extension studies after opting to continue treatment with pegunigalsidase alfa after completion of an initial study.

Results from the Company’s Phase I/II clinical trial of pegunigalsidase alfa were published in an article in the May 2019 edition of the Journal of Inherited Metabolic Disease.

Financial Results for the Six Months Ended June 30, 2019

The Company recorded total revenues of $22.7 million for the six-month period ended June 30, 2019, compared to $11.6 million for the same period of 2018. The increase is primary attributable to the recognition of $15.7 million of license revenues for the six-month period ended June 30, 2019 compared to the recognition of $5.0 million in the same period of 2018.

Research and development expenses, net were $25.0 million for the six months ended June 30, 2019, compared to $13.7 million for the same period in 2018. The increase is mainly due to advancement of the Phase III studies in PRX-102.

Selling, general and administrative expenses for the six months ended June 30, 2019 were $4.3 million, compared to $4.7 million for the same period in 2018.

Net loss for the six months ended June 30, 2019 was $15.0 million, or $0.10 per share, basic and diluted, compared to a net loss of $15.7 million, or $0.11 per share, basic and diluted, for the six months ended June 30, 2018.

On June 30, 2019, the Company had $25.1 million of cash and cash equivalents.

If the BLA submitted for pegunigalsidase alfa is approved by the FDA, the Company will be entitled to a milestone payment, which is currently expected to be payable around the fourth quarter of 2020 or first quarter of 2021.

Based on the Company’s current cash resources and commitments, the Company believes it may not be able to maintain its current planned development activities and the corresponding level of expenditures for at least 12 months from the date of approval of the financial statements as of June 30, 2019 in the absence of a refinancing or restructuring of its existing obligations. These factors raise substantial doubt as to the Company’s ability to continue as a going concern. Additional information will be included in Note 1(a) and other parts of the Company’s Quarterly Report on Form 10-Q which will be filed the day of the earnings call. The Company is evaluating various financing alternatives and related transactions.

The Company’s management is in the process of evaluating refinancing and restructuring alternatives, including a restructuring of its outstanding convertible notes, and related transactions. However, there is no certainty about the Company’s ability to obtain such funding.
Conference Call and Webcast Information

The Company will host a conference call on Thursday, August 8, 2019, 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 1497319.

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 8, 2019 Propanc Biopharma, Inc. (OTC: PPCB) ("Propanc"), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, reported it has developed a method to quantify the active ingredients of Propanc’s lead product candidate, PRP, in preparation for the company’s First-In-Human ("FIH") study, planned for early 2020 (Press release, Propanc, AUG 8, 2019, View Source [SID1234538437]). The work was conducted by Propanc’s research partner based in Berlin, Germany, who has extensive experience in the development of functional assays for unique bio-therapeutics. This bioanalytical method development and validation plays a significant role in evaluation and interpretation of the systemic absorption of PRP in clinical studies including its distribution, and clinical effects throughout the body.

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PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen, administered by intravenous injection. The naturally derived proenzymes are very large and complex protein structures that can be broken down into different fragments that can be difficult to separate and analyze from human serum. The remarkable achievement to identify and develop a suitable method to measure four key analytes from PRP, the two proenzymes, trypsinogen and chymotrypsinogen, as well as the activated enzymes, trypsin and chymotrypsin, is particularly significant due to the close structural similarity of each protein structure. By using a highly sensitive detection system like Liquid Chromatography/Mass Spectrometry, a suitable method was developed that could separate, identify and quantify all four analytes. Moreover, a strong correlation between the concentration and signal intensity was established with a R2 = 0.9996, where 1.0000 represents a linear, straight line, indicating a direct correlation between the two variables measured. This is especially important when measuring the concentration of the analytes within a certain range over time, providing valuable information regarding dosing and the clinical effects of a drug, like PRP, when administered to patients. Lower limits of quantification and detection were also established.

"This is an important step for the advancement of PRP towards commencing our First-In-Human study. Understanding clinical effects and their relationship to the concentration of the drug over time is especially important so that we can optimize dosing of PRP when administered to patients," said Dr. Julian Kenyon, Propanc’s Chief Scientific Officer. "We think measuring all four analytes, the two proenzymes and their activated enzymes is critical, because it is the activated enzymes which exert their effects on cancerous cells, so this will provide an important link to the action of PRP and its clinical effects."

The development of the bioanalytical assay is also an important step for the clinical development of PRP, as Propanc evaluates sites to conduct the FIH study in advanced cancer patients, such as the Peter Mac Center, Australia’s largest cancer hospital, which has significant experience in early stage clinical development. Propanc is evaluating Australia as a potential destination where it may commence the Phase Ib clinical trial because of its research and development tax incentives, as well as a simplified regulatory environment. As part of such incentives, eligible companies conducting clinical trials in Australia may receive up to 43.5% "cash-back" benefit in the form of a refund of their qualified research and development costs and expenses.

"Since we have completed the development of bioanalytical assay and are commencing the pre-validation stage, we look forward to presenting the data package in the near future to the Director at the Peter Mac Center, Parkville Cancer Clinical Trials Unit, and his investigators, to discuss further details about the upcoming FIH study," said Professor Klaus Kutz, Propanc’s acting Chief Medical Officer.

On August 8, 2019 Principia Biopharma Inc. (Nasdaq: PRNB), a late-stage biopharmaceutical company dedicated to bringing transformative oral therapies to patients with significant unmet medical needs in immunology and oncology, reported financial results for the second quarter ended June 30, 2019 (Press release, Principia Biopharma, AUG 8, 2019, View Source [SID1234538436]).

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"During the second quarter we continued to execute on our clinical programs, including the global PEGASUS Phase 3 trial and a Phase 2 extension trial in patients with pemphigus, as well as our Phase 2 clinical trial in patients with immune thrombocytopenia," said Martin Babler, president and chief executive officer of Principia Biopharma. "For SAR442168, formerly known as PRN2246, we reached an important milestone with our partner Sanofi when the first patient was dosed in their Phase 2b dose-finding trial in patients with relapsing multiple sclerosis, triggering a $30 million payment."

2019 program highlights include:

PRN1008 for the treatment of pemphigus

Announced positive Phase 2 data during the late-breaking session at the annual meeting of the American Academy of Dermatology (AAD) in Washington, D.C.

Continued enrollment of patients in the global PEGASUS Phase 3 clinical trial

Completed enrollment of patients in the Believe-PV Phase 2 extension trial

Anticipating Phase 2 extension trial topline data by fourth quarter 2019

PRN1008 for the treatment of immune thrombocytopenia

Continued enrollment of patients in the global Phase 2 clinical trial

Anticipating Phase 2 trial topline data by fourth quarter 2019

SAR442168/PRN2246 for the treatment of multiple sclerosis

The first patient was dosed in Sanofi’s Phase 2b trial in patients with relapsing multiple sclerosis, which triggered a $30 million milestone payment

PRN1371 for the treatment of metastatic bladder cancer

Presented Phase 1 data at AACR (Free AACR Whitepaper) Bladder Cancer conference: Transforming the Field meeting in Denver, Colorado; PRN1371 was well tolerated in 36 patients in dose-escalation phase

Continued enrollment of patients in the dose expansion trial in metastatic urothelial carcinoma

General Corporate Highlights

Appointed two industry veterans, Shao Lee Lin, MD, Ph.D. and Patrick Machado, to our Board of Directors

Second Quarter 2019 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $178.5 million as of June 30, 2019, compared to $180.6 million as of December 31, 2018.

Revenues: Collaboration revenue was $30.0 million for the three months ended June 30, 2019, compared to $13.0 million for the same period in 2018. The $30.0 million revenue recognized for the three months ended June 30, 2019 was for the achievement of a milestone in our Sanofi collaboration. The $13.0 million revenue recognized for the same period in 2018 consists of a portion of upfront fees from our Sanofi and AbbVie collaborations, as well as a portion of a milestone we achieved in the three months ended June 30, 2018.

R&D Expenses: Total research and development expenses were $18.7 million for the three months ended June 30, 2019, including stock-based compensation expense of $1.8 million, compared to $8.9 million for the same period in 2018, including stock-based compensation expense of $0.2 million. The increase in total research and development expenses was mainly driven by an increase in personnel-related expenses as we build out our R&D team, and an increase in PRN1008 program costs, due to the initiation of a global Phase 3 trial in patients with pemphigus in November 2018 and certain manufacturing campaigns to supply drug products for our PRN1008 clinical trials.

G&A Expenses: General and administrative expenses were $5.2 million for the three months ended June 30, 2019, including stock-based compensation expense of $1.7 million, compared to $2.2 million for the same period in 2018, including stock-based compensation expense of $0.2 million. The increase in total general and administrative expenses was primarily driven by increased personnel-related expenses and headcount costs related to operating as a public company. The increased personnel-related expenses were attributable to increased stock-based compensation expenses due to a higher valuation of options granted in 2019.

Net Income (Loss): For the three months ended June 30, 2019, net income was $7.1 million compared to a net income of $1.8 million for the same period in 2018.