On August 9, 2016 Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, reported financial results for the second quarter ended June 30, 2016 (Press release, Puma Biotechnology, AUG 9, 2016, View Source [SID:1234514457]).

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Unless otherwise stated, all comparisons are for the second quarter and six months ended June 30, 2016, compared to the second quarter and six months ended June 30, 2015.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss applicable to common stock of $66.6 million, or $2.05 per share, for the second quarter of 2016, compared to a net loss applicable to common stock of $64.7 million, or $2.01 per share, for the second quarter of 2015. Net loss applicable to common stock for the first half of 2016 was $137.6 million, or $4.23 per share, compared to $117.1 million, or $3.68 per share, for the first half of 2015.

Non-GAAP adjusted net loss was $37.9 million, or $1.17 per share, for the second quarter of 2016, compared to non-GAAP adjusted net loss of $36.5 million, or $1.13 per share, for the second quarter of 2015. Non-GAAP adjusted net loss for the first half of 2016 was $79.3 million, or $2.44 per share, compared to $68.8 million, or $2.16 per share, for the first half of 2015. Non-GAAP adjusted net loss excludes stock-based compensation expense, which represents a significant portion of overall expense and has no impact on the cash position of the Company. 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. The Company anticipates that non-GAAP net loss will continue to decrease in subsequent quarters due to a continued reduction in clinical trial expenses and due to a reduction in expenses associated with the completion of the regulatory filings for neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer in Europe and the United States, which were submitted in June and July, respectively.

Net cash used in operating activities for the second quarter of 2016 was $30.8 million. Net cash used in operating activities for the first half of 2016 was $65.8 million. At June 30, 2016, Puma had cash and cash equivalents of $57.8 million and marketable securities of $85.9 million, compared to cash and cash equivalents of $31.6 million and marketable securities of $184.3 million at December 31, 2015. The Company anticipates that net cash used in operating activities will continue to decrease in subsequent quarters due to a reduction in the expenses described above.

"We are very pleased with the accomplishments of the Company," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "These milestones include the submission of the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in June and the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in July for neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer based on the positive ExteNET Phase III trial. We also reported positive Phase II data from an investigator sponsored trial of neratinib in patients with HER2 mutated, non-amplified breast cancer in June. In addition, our Phase II trial of neratinib in the front-line treatment of HER2-positive metastatic breast cancer (NEfERT-T trial) was published in JAMA Oncology in April, and positive results from the I-SPY 2 Phase II clinical trial of neratinib for the neoadjuvant treatment of breast cancer was published in the July 7 issue of The New England Journal of Medicine.

"In the second half of 2016, we look forward to several regulatory and clinical milestones with neratinib. From the regulatory perspective, we look forward to working with the EMA and FDA as they review our MAA and NDA submission, respectively. We also look forward to continuing our development of neratinib in the second half of 2016 and beyond. We anticipate (i) reporting additional data from the Phase II trial of neratinib as an extended adjuvant treatment in HER2-positive early stage breast cancer using loperamide prophylaxis in the fourth quarter of 2016; (ii) reporting additional Phase II data from the FB-7 neoadjuvant HER2-positive breast cancer trial in the subgroup of patients who are MammaPrint High in the fourth quarter of 2016; (iii) reporting data from the Phase II trial of neratinib plus fulvestrant in patients with HER2 non-amplified breast cancer that has a HER2 mutation during the fourth quarter of 2016; (iv) reporting data from the Phase III trial of neratinib in third-line HER2-positive metastatic breast cancer patients in either the fourth quarter of 2016 or the first quarter of 2017; and (v) reporting data from the Phase II trial of neratinib in metastatic breast cancer patients with brain metastases during the fourth quarter of 2016."

Operating Expenses

Operating expenses were $66.5 million for the second quarter of 2016, compared to $64.9 million for the second quarter of 2015. Operating expenses for the first half of 2016 were $137.7 million compared to $117.5 million for the first half of 2015.

General and Administrative Expenses:

General and administrative expenses were $12.3 million for the second quarter of 2016, compared to $5.5 million for the second quarter of 2015. General and administrative expenses for the first half of 2016 were $23.3 million compared to $13.4 million for the first half of 2015. The increase of approximately $9.9 million resulted primarily from increases of approximately $4.6 million in stock-based compensation, $2.9 million in professional fees and expenses, $1.3 million in payroll and related costs, and $1.0 million in facility and equipment costs. These increases reflect higher legal and compliance expenses, as well as overall corporate growth.

Research and Development Expenses:

Research and development expenses were $54.2 million for the second quarter of 2016, compared to $59.4 million for the second quarter of 2015. Research and development expenses for the first half of 2016 were $114.4 million, compared to $104.1 million for the first half of 2015. The increase of approximately $10.3 million resulted primarily from increases of approximately $5.3 million in stock-based compensation and $4.3 million for internal clinical development, regulatory and quality assurance expenses. We expect research and development expenses to decrease in subsequent quarters as we complete clinical trials and as our regulatory filings for neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer have been submitted in the United States and European Union.

On August 9, 2016 BioTime, Inc. (NYSE MKT:BTX), a clinical-stage regenerative medicine company with a focus on pluripotent stem cell technology, reported financial results for the second quarter ended June 30, 2016 and provided a corporate update (Press release, BioTime, AUG 9, 2016, View Source;p=RssLanding&cat=news&id=2194367 [SID:1234514456]).

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"During the second quarter, we continued to sharpen our focus on clinical progress and simplifying our corporate structure," said Adi Mohanty, Co-Chief Executive Officer. "Our key therapeutic programs, Renevia in medical aesthetics and OpRegen in dry AMD, continue to advance in the clinic, and we expect additional meaningful milestones from these programs in the second half of 2016. Meanwhile, our public subsidiaries continue to demonstrate their ability to make solid clinical progress. We strengthened our balance sheet by completing a successful public equity offering with gross proceeds of approximately $20.1 million from new and existing investors. Additionally, as we previously announced in May, we have deconsolidated Asterias Biotherapeutics, Inc. from our financial statements as result of its recent financing. We continue to see Asterias playing an important role in furthering therapies based on pluripotent stem cell technology. Asterias will continue to file its own financial statements with the SEC, allowing our shareholders to continue to follow its financial progress."

Second Quarter and Recent Highlights

Clinical Progress

Renevia (adipose cells + cell delivery matrix)

The Renevia pivotal clinical trial for HIV-related facial lipoatrophy continues to enroll new patients and is on track to complete patient enrollment by the second half of 2016. The objective of the trial is to assess the efficacy of Renevia in restoring normal skin contours in patients whose subcutaneous fat has been lost due to antiviral drug treatment for HIV. The Company expects top-line efficacy data in the first half of 2017, and plans to submit an application for CE Mark approval in Europe in the first half of 2017 if the data are positive. Positive data from the pivotal trial could provide support for future studies of Renevia in certain broader applications of fat tissue deficits in various medical aesthetics applications, such as age-related and trauma-related facial fat loss.
OpRegen (retinal pigment epithelial cells)

In June, the Data Safety Monitoring Board (DSMB) for the OpRegen Phase I/IIa clinical trial for the treatment of the advanced form of dry age-related macular degeneration (AMD) completed its review of the initial safety data from the first cohort and recommended dose escalation to the second cohort. Enrollment has begun for the second patient cohort, which is receiving a higher, more clinically significant, dose of OpRegen cells. The Company expects completion of enrollment for the second cohort in 2016 and, if the data are positive, anticipates DSMB approval to proceed to the third cohort by the end of 2016. OpRegen has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of dry AMD, which occurs in approximately 90% of those afflicted with AMD.
AST-OPC1 (oligodendrocyte progenitor cells)

In July, enrollment and dosing of the first efficacy cohort was completed in the AST-OPC1 SCiSTAR Phase 1/2a clinical trial in complete cervical spinal cord injury. This is the second of three cohorts in the study and it represents the first cohort in which patients have been administered a dose high enough to fall within the potentially efficacious range predicted by preclinical studies conducted by Asterias. Top-line six-month efficacy and safety results from this patient cohort are expected in January 2017. As of May 13, 2016, BioTime owned approximately 49% of the common shares outstanding of Asterias Biotherapeutics (NYSE MKT:AST).
Cancer Diagnostics

OncoCyte Corporation (NYSE MKT:OCX), the cancer diagnostics subsidiary of BioTime and developer of novel, non-invasive blood and urine based tests for the early detection of cancer, presented positive data from a clinical study for the non-invasive detection of bladder cancer at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Interim data from the clinical study, which was first reported at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2015 Annual Meeting, demonstrated a high level of sensitivity and specificity in the detection of urothelial carcinoma, the most common type of bladder cancer.
Corporate Developments

In June, BioTime closed a public offering of shares of its common stock. In July, the underwriters exercised in full their over-allotment option. Gross proceeds of the offering and full exercise of the over-allotment option totaled approximately $20.1 million, before deducting underwriting discounts and commissions and other offering expenses payable by BioTime.
On May 13, 2016, BioTime deconsolidated its former majority-owned subsidiary, Asterias Biotherapeutics, Inc. As result, Asterias’ financial statements for periods after May 12, 2016 are no longer included in BioTime’s consolidated financial statements, and BioTime is now accounting for its investment in Asterias at fair value based on the closing stock price of Asterias common stock on the NYSE MKT and the number of shares held by BioTime. Changes in the fair value of Asterias common stock are reflected as unrealized gains or losses in BioTime’s consolidated statements of operations, as a non-operating item. See Second Quarter Financial results below.
Second Quarter Financial Results

Note on deconsolidation of Asterias and comparability of results:

BioTime’s consolidated balance sheet at December 31, 2015, as reported, included Asterias’ assets and liabilities. However, Asterias’ assets and liabilities are not included in BioTime’s consolidated balance sheet at June 30, 2016 due to the deconsolidation of Asterias on May 13, 2016. Furthermore, BioTime’s consolidated statements of operations for the three and six months ended June 30, 2016 include Asterias’ results for the period through May 12, 2016, the day immediately preceding the deconsolidation. For the three and six months ended June 30, 2015, BioTime’s consolidated results include Asterias’ results for the full periods presented.

All discussions about the results of operations, or balance sheet amounts that follow, as appropriate and indicated, include both the actual results and amounts pertaining to Asterias.

Cash Position and investments: Cash and cash equivalents totaled $27.7 million as of June 30, 2016, compared to $42.2 million as of December 31, 2015, which included Asterias’ cash and cash equivalents of $11.2 million. The cash on hand as of June 30, 2016 includes $7.0 million held by subsidiaries and excludes Asterias due to the deconsolidation. As of June 30, 2016, BioTime owned 21.7 million shares of Asterias common stock and 14.7 million shares of OncoCyte common stock, which represented an aggregate market value of approximately $104 million as of that date. On June 21, 2016, BioTime closed a $17.5 million public offering of shares of its common stock. On July 5, 2016, BioTime announced the exercise in full of the underwriters’ over-allotment option to purchase an additional 1,098,326 shares of BioTime common stock. The gross proceeds of the offering, including the over-allotment option were approximately $20.1 million before deducting underwriting discounts and commissions and other offering expenses payable by BioTime.

Revenues: BioTime’s operating revenues are currently primarily generated from research grants, licensing fees and advertising from the marketing of online database products. Total consolidated revenues were $1.3 million for the second quarter, compared to $2.0 million in the second quarter of 2015. Asterias’ total revenues included in the second quarter of 2016 and 2015 were $0.8 million in each respective period as shown in the table below (in thousands).

Three months ended June 30, 2016

Three months ended June 30, 2015
Consolidated
Results of
Operations

Less: Asterias
(42 days)

Consolidated
Results less
Asterias

Consolidated
Results of
Operations

Less: Asterias
(3 months)

Consolidated
Results less
Asterias

Total revenues $ 1,266 $ 760 $ 506 $ 2,009 $ 772 $ 1,237

The decrease in BioTime’s total revenues was mainly due to less grant revenue recorded in 2016 due to expiration of a National Institutes of Health (NIH) grant in August 2015.

Operating Expenses (in thousands)

Three months ended June 30, 2016

Three months ended June 30, 2015
Consolidated
Results of
Operations

Less: Asterias
(42 days)

Consolidated
Results less
Asterias

Consolidated
Results of
Operations

Less: Asterias
(3 months)

Consolidated
Results less
Asterias

Research and development $ 8,938 $ 2,343 $ 6,595 $ 9,059 $ 3,696 $ 5,363
General and administrative 6,636 1,357 5,279 6,186 1,845 4,341

R&D Expenses: Research and development expenses were $8.9 million for the second quarter, compared to $9.1 million for the comparable period in 2015, including $2.3 million and $3.7 million attributable to Asterias’ research and development for the respective periods.

The increase in R&D of approximately $1.2 million is in part a result of increased expenses primarily related to regulatory and clinical trials of BioTime’s Renevia program and OncoCyte’s cancer diagnostics, offset by a decrease of approximately $1.3 million principally due to the deconsolidation of Asterias.

G&A Expenses: General and administrative expenses were $6.6 million for the second quarter, compared to $6.2 million for the second quarter of 2015, including $1.4 million and $1.8 million attributable to Asterias for the same periods, respectively. The $0.9 million increase is in part a result of increased staffing needed to advance programs under development at BioTime, including non-cash stock-based compensation from BioTime and OncoCyte, offset by a $0.5 million decrease due to the deconsolidation of Asterias.

Net Income attributable to BioTime: Net income attributable to BioTime was $24.5 million for the three months ended June 30, 2016, or $0.26 per share primarily due to the $49.0 million noncash gain on deconsolidation of Asterias, offset by unrealized losses of $13.5 million from the decline in the fair value of the Asterias shares owned by BioTime that occurred during the period May 13 through June 30, 2016. There was no deferred income tax provision or benefit recorded in the three months ended June 30, 2016. For the second quarter of 2015, net loss attributable to BioTime was $9.7 million, or ($0.12) per share. Net income (loss) attributable to BioTime includes losses from BioTime’s majority owned and consolidated subsidiaries based upon BioTime’s percentage ownership of those subsidiaries.

On August 9, 2016 Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, reported company highlights and financial results for the second quarter ended June 30, 2016 (Press release, Ignyta, AUG 9, 2016, View Source [SID:1234514455]). Ignyta will not be conducting a conference call in conjunction with this release.

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"During the second quarter, we continued to make significant advancements toward our objective of becoming a leading precision medicine oncology company and offering cancer patients potentially life-saving, precisely targeted therapeutics (Rx) guided by companion diagnostic (Dx) tests," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "For our lead program, entrectinib – our potent, CNS-active, Trk, ROS1 and ALK inhibitor – we continued to successfully execute our potentially registration-enabling Phase 2 clinical trial, STARTRK-2; announced at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting compelling results from our two Phase 1 clinical trials; and participated in a meeting of the Pediatric Oncology Subcommittee of the FDA’s Oncologic Drugs Advisory Committee. For RXDX-105 – an oral, multikinase inhibitor with potent activity against such targets as RET and BRAF – we announced interim data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from our Phase 1 clinical trial, highlighting its emerging safety and efficacy profile. Finally, we strengthened our balance sheet via an equity offering and term loan refinancing, providing us with the resources to continue moving rapidly to develop meaningful new therapies for the benefit of cancer patients, and we augmented our management team."

Company Highlights

Participated in FDA’s Pediatric Oncologic Drugs Advisory Committee (pedsODAC)

In June 2016, Ignyta was invited by the FDA to participate in a meeting of its pedsODAC. The meeting was intended to improve and encourage the development of oncology and hematology drugs for pediatric use. Ignyta prepared a briefing package for the meeting and the meeting’s proceeding are available in an archived webcast.

Announced Updated Entrectinib Phase 1 Data at AACR (Free AACR Whitepaper) Annual Meeting

In April 2016, updated results of the two Phase 1 clinical trials of entrectinib, the company’s proprietary oral tyrosine kinase inhibitor targeting solid tumors harboring activating alterations to NTRK1, NTRK2, NTRK3, ROS1 or ALK, were presented in an oral plenary session at the AACR (Free AACR Whitepaper) 2016 Annual Meeting in New Orleans, Louisiana.

The data cut-off for the AACR (Free AACR Whitepaper) presentation was March 7, 2016. A total of 119 patients with a range of solid tumors had been dosed across both clinical trials, with 45 patients treated at the RP2D of 600 mg, taken orally once per day (QD). Entrectinib was well tolerated across both studies and there was no evidence of cumulative toxicity, hepatic or renal toxicity, or QTc prolongation.

Among the 25 patients treated who met the company’s Phase 2 clinical trial eligibility criteria, significant tumor regression was seen in 80% (20 out of 25 treated patients).

Twenty-four patients had tumors that were evaluable by RECIST criteria. The overall confirmed response rate was 79% (19 responses, including 2 complete responses, out of 24 treated patients).
For a patient with astrocytoma, the clinical site performed three-dimensional volumetric analysis, which demonstrated an estimated 45% decrease in tumor size from baseline.
Many of these responses occurred rapidly, within the first four weeks of entrectinib treatment. Of note, durable CNS tumor regression was seen, both in patients with primary brain tumors and with metastatic disease, including one complete response.

Announced Interim Data from Phase 1 Clinical Trial of RXDX-105 at ASCO (Free ASCO Whitepaper)

In June 2016, interim data from the Phase 1 clinical trials of RXDX-105, the company’s orally available, small molecule multikinase inhibitor with potent activity against such targets as RET and BRAF, were presented at the 2016 ASCO (Free ASCO Whitepaper) Meeting in Chicago.

The Phase 1 dose escalation portion of the clinical trial was designed to determine the MTD and/or recommended RP2D, as well as preliminary anti-cancer activity, of single agent RXDX-105 in patients with advanced or metastatic solid tumors.

The data cut-off for the ASCO (Free ASCO Whitepaper) presentation was May 3, 2016. A total of 55 patients with a range of solid tumors were dosed with RXDX-105 in the clinical trial.

RXDX-105 was well tolerated. Based upon overall safety and exposure during Phase 1, the provisional RP2D was determined to be 350 mg, once daily in the fed state, and is being further evaluated in the Phase 1b portion of the study.

There were 20 patients dosed at or above the clinically relevant dose of 275 mg in the fed state, 11 of whom had an actionable RET or BRAF alteration. Tumor regression of greater than 20% was observed in four of the 20 patients, including:

an unconfirmed partial response (38% reduction) in a patient with medullary thyroid cancer with a RET M918T mutation;
a 28% reduction in target lesions in a patient with non-small cell lung cancer (NSCLC) with a BRAF D594G mutation;
a 26% reduction in target lesions in a patient with ovarian cancer with a BRAF V600E mutation; and
a confirmed partial response (40% reduction) in a patient with NSCLC with a KRAS G12C mutation, who continues on treatment after 10 cycles.
Bolstered the Balance Sheet

In May 2016, the company issued an aggregate of 9.2 million shares of its common stock in an underwritten public offering at a purchase price of $6.25 per share, which resulted in aggregate gross proceeds of $57.5 million.

In June 2016, the company secured a $42 million term loan facility from Silicon Valley Bank and Oxford Finance. Under the loan facility, the company received initial funding of $32 million, substantially all of which was used to repay the company’s prior loan with Silicon Valley Bank, and has a conditional option to receive an additional $10 million.

Enhanced Leadership Capacity

In July 2016, the company announced that Dr. Christian V. Kuhlen had been appointed to serve as its General Counsel and Secretary. Prior to joining the company, Dr. Kuhlen served as General Counsel, Vice President and Secretary of Genoptix, Inc., where he led its legal and corporate governance functions as well as its internal public policy function.

Second Quarter 2016 Financial Results

For the second quarter of 2016, net loss was $26.7 million, or $0.70 per share, compared with $13.1 million, or $0.51 per share, for the second quarter of 2015.

Ignyta did not record any revenue for the three months ended June 30, 2016 or for the three months ended June 30, 2015.

Research and development expenses for the second quarter of 2016 were $20.0 million, compared with $8.8 million for the second quarter of 2015. This increase was primarily due to the $7.7 million increase in the external development costs associated with entrectinib, taladegib and other product candidates. The remaining increase in costs between periods was due to personnel expenses related to hiring and engaging additional employees and consultants to help advance the company’s product candidates.

General and administrative expenses were $5.5 million for second quarter of 2016, compared with $3.9 million for second quarter of 2015. This increase was driven by higher personnel and share-based compensation costs, higher facilities related expenses resulting from the expansion of our leased facilities space, and increases in consulting fees and depreciation expense.

At June 30, 2016, the company had cash, cash equivalents and available-for-sale securities totaling $174.6 million and current and long-term debt of $32.0 million. At December 31, 2015, the company had cash, cash equivalents and available-for-sale securities totaling $172.1 million and current and long-term debt of $31.0 million.

On August 9, 2016 Aeglea BioTherapeutics, Inc., (NASDAQ:AGLE), a biotechnology company committed to developing enzyme-based therapeutics in the field of amino acid metabolism to treat rare diseases and cancer, reported financial results for the quarter ended June 30, 2016 (Press release, Aeglea BioTherapeutics, AUG 9, 2016, View Source;p=irol-newsArticle&ID=2194025 [SID:1234514453]).

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"We have made significant progress in advancing our AEB1102 clinical program with the initiation of two Phase 1 clinical trials in Arginase I deficiency and hematological malignancies. At the same time, we’ve been working closely with regulatory agencies and are pleased with the momentum we have generated for the AEB1102 program, receiving both Orphan Drug Designation from the European Commission and Fast Track designation from the FDA," said David G. Lowe, Ph.D., co-founder, president and chief executive officer of Aeglea. "Additionally, we are continuing to make progress in the enrollment of our Phase 1 trial of AEB1102 in patients with advanced solid tumors."

Recent Highlights

Received Orphan Drug Designation for AEB1102 for the treatment of hyperargininemia from the European Commission.

Received Fast Track designation for AEB1102 for the treatment of hyperargininemia secondary to Arginase I deficiency from the U.S. Food & Drug Administration (FDA).

Initiated a Phase 1 clinical trial for the treatment of patients with Arginase I deficiency. Enrollment is anticipated to be completed in 2016 with topline data expected in the first half of 2017.

Initiated a Phase 1 trial of AEB1102 in patients with the hematological malignancies acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Enrollment is expected to be completed in 2017.
Second Quarter 2016 Financial Results

At June 30, 2016, Aeglea had available cash, cash equivalents and marketable securities of $73.6 million. Management believes that Aeglea has sufficient capital resources to fund anticipated operations through the first quarter of 2018.

Aeglea recognized grant revenue of $1.4 million in the second quarter of 2016 compared with $3.4 million in the second quarter of 2015. This grant revenue is the result of a $19.8 million research grant received from the Cancer Prevention and Research Institute of Texas (CPRIT). The decrease was due to grant revenue recognized in connection with the execution of the CPRIT grant agreement in June 2015. Upon execution of the agreement, all accumulated qualified expenditures paid and incurred during the period from June 1, 2014 through June 30, 2015 were recognized as grant revenue in the three months ended June 30, 2015.

Research and development expenses totaled $4.4 million for the second quarter of 2016, compared with $2.7 million for the second quarter of 2015. The increase was primarily associated with the expanded nonclinical and clinical activity for Aeglea’s lead product candidate AEB1102, as Aeglea continued a Phase 1 trial in patients with advanced solid tumors, initiated a Phase 1 clinical trial for AEB1102 in patients with Arginase I deficiency, and prepared for the Phase 1 clinical trial in patients with hematological malignancies.

General and administrative expenses totaled $2.4 million for the second quarter of 2016, compared to $2.1 million in the second quarter of 2015. This increase was primarily due to additional employee compensation and insurance costs associated with being a public company.

Net loss totaled $5.4 million and $1.4 million for the second quarters 2016 and 2015, respectively.

About AEB1102

AEB1102 is a recombinant human arginase I enzyme designed to degrade the amino acid arginine. Aeglea is developing AEB1102 to treat two extremes of arginine metabolism, including arginine excess in patients with Arginase I deficiency, as well as some cancers which have been shown to have a metabolic dependency on arginine. In patients with Arginase I deficiency, AEB1102 is intended for use as Enzyme Replacement Therapy to restore the function of arginase I in patients and return elevated blood arginine levels to the normal physiological range. Aeglea is currently conducting a Phase 1 clinical trial in patients with advanced solid tumors to evaluate the safety and tolerability of AEB1102. Data from this trial demonstrated that AEB1102 has the ability to reduce blood arginine levels, providing initial human proof of mechanism.

About Arginase I deficiency

Hyperargininaemia, or excessively high levels of arginine, is the result of a hereditary deficiency of arginase I. Arginase I deficiency is a urea cycle disorder caused by a mutation in the arginase I gene that leads to the inability to degrade arginine, the last step of the urea cycle. AEB1102 is intended to replace the function of arginase I in patients by returning elevated blood arginine levels to the normal physiological range.

About Arginine Dependence in Cancer Cells

Dysregulation of amino acid metabolism has been shown to be a key event in tumor growth and development. Unlike healthy cells, these tumors cells have an abnormally high appetite for certain amino acids and are unable to create their own supply, making them vulnerable to starvation through depletion of that amino acid in the blood. AEB1102 is intended to address an unmet need for these tumor types by degrading arginine in the blood, reducing its level below the normal range to starve the tumor.

On August 10, 2016 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.provectusbio.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "The Company"), reported its financial results for the quarter ended June 30, 2016 (Press release, Provectus Pharmaceuticals, AUG 9, 2016, View Source [SID:1234514452]).

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Second Quarter Results and Balance Sheet Highlights

Our cash and cash equivalents were $4,891,313 at June 30, 2016, compared with $9,760,997 at March 31, 2016.

Shareholders’ equity at June 30, 2016 was $9,140,166. This compares to shareholders’ equity of $14,184,248 at March 31, 2016.

For additional information regarding Provectus’ results of operations and financial condition for the second quarter ended June 30, 2016, please see Provectus’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 9, 2016.

Management will host its 2016 second quarter business update conference call on Wednesday, August 10, 2016 at 4 pm Eastern Daylight Time. Management will provide a business update on PV-10 and PH-10 to the investment community and answer questions from investors.

Those who wish to participate in the conference call may telephone 877-407-4019 from the U.S. International callers may telephone 201-689-8337 approximately fifteen minutes before the call. A webcast will also be available at www.provectusbio.com.

A digital replay will be available by telephone approximately two hours after the completion of the call until November 30, 2016 and may be accessed by dialing 877-660-6853 from the U.S. or 201-612-7415 for international callers, and using the Conference ID # 13641484.