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Ignyta Announces Second Quarter 2016 Company Highlights and Financial Results

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.

Aeglea BioTherapeutics Announces Second Quarter 2016 Financial Results

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]).

"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.

Provectus Biopharmaceuticals, Inc. Reports Second Quarter 2016 Financial Results

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]).

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.

NantHealth Reports Strong 2016 Second-Quarter Revenues and Continued Progress on GPS Cancer and NantOS Platform

On August 9, 2016 NantHealth, Inc. (NASDAQ-GS: NH), a next-generation, evidence-based, personalized healthcare company, reported financial results for its 2016 second quarter ended June 30, 2016 (Press release, NantHealth, AUG 9, 2016, View Source;p=IROL-news&nyo=0 [SID:1234514450]). The company completed its initial public offering (IPO) in early June 2016, raising net proceeds of approximately $83.2 million.

For the 2016 second quarter, total net revenues increased 167% to $31.5 million from $11.8 million in last year’s second quarter. Gross profit grew 69% to $9.3 million, from $5.5 million, for the 2015 second quarter. Selling, general and administrative (SG&A) expenses were $47.2 million, including stock compensation expense related to the company’s IPO, compared with $17.8 million for the prior year second quarter. Research and development (R&D) expenses, including stock compensation expense related to the company’s IPO, increased to $24.3 million from $5.0 million in the comparable quarter of last year.

With the inclusion of stock based compensation expense related to the IPO, equal to $0.42 per share, net loss was $54.1 million, or $0.52 per share, compared with $17.2 million, or $0.21 per share, for the 2015 second quarter. Financial results for the 2016 second quarter included approximately $43.7 million in stock based compensation, equal to $0.42 per share, related to the vesting of equity tied to the company’s Initial public offering. On a non-GAAP basis, for the 2016 second quarter, adjusted net loss was $16.5 million, or $0.15 per share, compared with adjusted net loss of $14.3 million, or $0.15 per share, in the prior year second quarter.

"We achieved stellar topline results across all of our revenue lines, reflecting how strongly customers have responded to NantHealth’s innovative offerings," said Patrick Soon-Shiong, M.D., chief executive officer and chairman of NantHealth. "Our strong second-quarter financial performance included revenues recognized from several large implementations and service contracts for our technology offerings, which were completed and delivered earlier than anticipated. As a result, we recognized certain revenues in our second quarter that we previously projected to be recorded in the second half of 2016.

"Looking ahead, we are focused on adding customers and executing on our opportunities across the spectrum of our offerings. In addition, the acquisitions we completed in the last year are paying dividends and our GPS Cancer product continues to gain traction and acceptance among insurers. Combined, these efforts and initiatives will drive our growth in the near term and beyond."

GPS Cancer – Highlights
Number of covered cancer lives: at June 30, the number of patients with cancer covered by a payer for GPS testing was approximately 180,000. Subsequent to the quarter through August 9, the company added approximately 20,000 covered cancer lives, bringing the total number of cancer patients covered by GPS Cancer to approximately 200,000.
Number of GPS Cancer payers: at June 30, the number of payers covering GPS Cancer was three. Subsequent to the end of the quarter through August 9, the company added three new payers, bringing the total number of payers covering GPS Cancer to six, resulting in 200,000 covered cancer lives.
Number of international GPS Cancer payers: During the second quarter, the company added an international reseller.
NantOS – Highlights
During the second quarter:
The company executed five-year contractual arrangements with two significant, large healthcare system clients.
More than 25 current clients renewed or expanded their contractual commitments.
Eight clients achieved go-live status.
Other Corporate Highlights
In July, announced a partnership with the University of Utah to analyze the entire genomic profiles of at least 1,000 individuals who have a history of rare and life-threatening diseases and conditions in their respective families. The landmark project will focus on researching the genetic causes of 25 conditions, including, breast, colon, ovarian, and prostate cancers, amyotrophic lateral sclerosis (ALS), chronic lymphocytic leukemia, autism, preterm birth, epilepsy, and other hereditary conditions. Genomic sequencing will be conducted with unique, comprehensive molecular tests offered by NantHealth, which will enable the development of a rare disease and inherited genomic risk product, GPS Heritage.
In June, jointly announced with Cancer MoonShot 2020, the nation’s most comprehensive cancer collaborative initiative, the formation of the Melanoma and Sarcoma Working Group to accelerate molecular-informed immunotherapy trials. The team consists of physicians, researchers and oncology professors who have come together to focus their collective wisdom and expertise on identifying and developing the most effective, cancer-directed immunotherapy treatments for patients with melanoma and sarcoma, utilizing GPS Cancer to guide therapy.
In June, announced the commercial availability of Genomic Proteomic Spectrometry Cancer, or GPS CancerTM, a unique, comprehensive molecular test and decision support solution that measures the proteins present in the patient’s tumor tissue, combined with whole genomic and transcriptomic sequencing of tumor and normal samples.
In June, raised net proceeds of approximately $83.2 million from its IPO of 6,900,000 shares of its common stock, which includes the exercise of 400,000 shares of the underwriters’ overallotment option. On June 2, 2016, NantHealth’s shares began trading on the NASDAQ Global Select Market under the symbol "NH."
In May, launched NaviNet Open Claims Management, a powerful new suite of payer-sponsored claims applications available to providers through the NaviNet Open multi-payer provider portal.
In May, expanded adoption of its GPS Cancer product, by partnering with major self-insurers that have agreed to cover the costs for their employees requiring this test.

MAST THERAPEUTICS REPORTS SECOND QUARTER 2016 FINANCIAL RESULTS

On August 9, 2016 Mast Therapeutics, Inc. (NYSE MKT: MSTX), a biopharmaceutical company developing novel, clinical-stage therapies for sickle cell disease and heart failure, reported financial results for the quarter ended June 30, 2016.
"We continued to advance our assets toward valuable inflection points during the second quarter. Announcing top-line data from the EPIC study continues to be our top priority. With 388 subjects randomized at study sites around the globe, EPIC was the largest placebo-controlled study in sickle cell disease ever concluded and we look forward to announcing results next month. To support our NDA for vepoloxamer, we also continue to enroll patients in EPIC-E, our repeat exposure study for EPIC patients, and in a clinical pharmacokinetics study of vepoloxamer in individuals with varying degrees of renal insufficiency," stated Brian M. Culley, Chief Executive Officer.

"In addition, clinical development of AIR001 in heart failure with preserved ejection fraction is progressing through multiple Phase 2 studies. In particular, we are pleased that the first patient was dosed in the 100-patient Phase 2 study being conducted by the Heart Failure Clinical Research Network," continued Mr. Culley.

Second Quarter 2016 Operating Results

The Company’s net loss for the second quarter of 2016 was $10.7 million, or $0.05 per share (basic and diluted), compared to a net loss of $10.2 million, or $0.06 per share (basic and diluted), for the same period in 2015.

Research and development (R&D) expenses for the second quarter of 2016 were $7.8 million, compared to $7.7 million for the same period in 2015. Increases of $0.5 million in external clinical study fees and expenses and $0.1 million in share-based compensation expense were offset by a $0.5 million decrease in external nonclinical study fees and expenses.

The increase in external clinical study fees and expenses was due primarily to increased costs related to the Company’s Phase 2 study of vepoloxamer in heart failure ($0.7 million) and the Phase 2 studies of AIR001 in HFpEF ($0.4 million), offset by decreases in costs for the EPIC study ($0.4 million) and the Phase 2 study of vepoloxamer in acute limb ischemia, which the Company began to wind-down in the third quarter of 2015 ($0.2 million). The decrease in external nonclinical study fees and expenses was due primarily to decreases in research-related manufacturing costs for vepoloxamer ($1.2 million) and nonclinical studies of vepoloxamer ($0.4 million), offset by increased costs related to preparing a new drug application for vepoloxamer ($0.9 million) and research-related manufacturing for AIR001 ($0.2 million).

Selling, general and administrative (SG&A) expenses were $2.4 million in each of the second quarter of 2016 and the second quarter of 2015.

Interest expense for the second quarter of 2016 was $512,000, $511,000 of which was related to the Company’s debt facility. There was interest expense of $1,000 for the second quarter of 2015.

Year-to-Date Financial Results

The Company’s net loss for the six months ended June 30, 2016 was $21.9 million, or $0.12 per share (basic and diluted), compared to a net loss of $19.8 million, or $0.12 per share (basic and diluted), for the same period in 2015.

R&D expenses for the six months ended June 30, 2016 were $15.6 million, an increase of $1.8 million, or 13%, compared to $13.8 million for the same period in 2015. The increase was due primarily to increases of $1.0 million in external clinical study fees and expenses, $0.4 million in external nonclinical study fees and expenses, $0.2 million in personnel expenses and $0.2 million in share-based compensation.

The $1.0 million increase in external clinical study fees and expenses was due primarily to increases in costs for our Phase 2 study of vepoloxamer in heart failure ($1.2 million) and the Phase 2 studies of AIR001 in HFpEF ($0.4 million), offset by a decrease in costs for the Phase 2 study of vepoloxamer in ALI ($0.5 million). The $0.4 million increase in external nonclinical study fees and expenses was due primarily to increases in costs related to preparing a new drug application for vepoloxamer ($1.4 million) and research-related manufacturing for AIR001 ($0.2 million), offset by decreases in research-related manufacturing costs for vepoloxamer ($0.8 million) and costs for nonclinical studies of vepoloxamer ($0.3 million).

SG&A expenses for the six months ended June 30, 2016 were $5.3 million, a decrease of $0.7 million, or 12%, compared to $6.0 million for the same period in 2015. SG&A expenses for the first six months of 2015 included $0.4 million of severance expenses and $0.3 million of share-based compensation resulting from the termination of employment of the Company’s former president and chief operating officer in February 2015 and the acceleration of stock option vesting pursuant to the terms of his option agreements.

Interest expense for the six months ended June 30, 2016 was $1,031,000, $1,029,000 of which was related to the Company’s debt facility. There was interest expense of $1,000 for the same period of 2015.