On August 9, 2016 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company developing topsalysin (PRX302) for the treatment of urological diseases, reported financial results for the three and six months ended June 30, 2016 (Press release, Sophiris Bio, AUG 9, 2016, View Source [SID:1234514574]).

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Business Highlights:

On June 9, 2016, the Company announced successful results from its completed Phase 2a study of topsalysin in localized prostate cancer.
On May 12, 2016, the Company announced the engagement Oppenheimer & Co. Inc. as its financial advisor to assist with the evaluation of various strategic options for advancing topsalysin development programs.
On May 11, 2016, the Company announced the closing of a registered offering in which the Company raised net proceeds of $4.6 million. During June and July, the Company received proceeds of $2.4 million from the exercise of warrants included in this transaction bringing the total proceeds from this offering to $7.0 million.
On May 7, 2016, the Company presented positive data from its successful Phase 3 clinical trial of topsalysin as a treatment for the symptoms of benign prostatic hyperplasia ("BPH") as a late breaking poster at the 111th American Urological Association Annual Meeting. A copy of the poster is available on the Company’s website at www.sophirisbio.com.
"2016 is proving to be a transformational year for Sophiris," stated Randall Woods, president and CEO of Sophiris Bio. "In the past quarter, we completed a Phase 2a proof of concept trial of topsalysin in localized prostate cancer in which topsalysin demonstrated the ability to ablate tumor cells in 50 percent of patients, including two men who experienced complete ablation of their targeted tumor with no evidence of any tumor remaining at 6 months post treatment. We also presented complete results from the Phase 3 BPH study in a late breaking presentation at the AUA 2016 Annual Meeting, demonstrating that topsalysin met the primary endpoint of a reduction in symptom score compared to the vehicle control arm. These two indications represent very large patient populations with very few adequate treatment options, and these clinical results are generating interest from investigators and the medical community. We are currently evaluating our options for moving these programs forward into additional clinical trials."

Financial Results:

At June 30, 2016, we had cash and cash equivalents of $8.3 million and net working capital of $5.7 million. We expect that our cash and cash equivalents will be sufficient to fund our operations for at least the next twelve months assuming that we do not initiate any new development activities for topsalysin. We do not plan to initiate any new clinical trials, including a second Phase 3 trial in BPH or a second Phase 2 trial in localized prostate cancer unless we obtain additional financing. We are actively evaluating strategic alternatives, including potential partnering arrangements, financings or a strategic transaction. As of June 30, 2016, the outstanding principal balance of our term loan was $4.3 million on which we make principal and interest payments monthly.

For the three months ended June 30, 2016

The Company reported a net loss of $4.1 million ($0.21 per share) for the three months ended June 30, 2016 compared to a net loss of $3.7 million ($0.22 per share) for the three months ended June 30, 2015.

Research and development expenses

Research and development expenses were $1.0 million for the three months, ended June 30, 2016, compared to $2.6 million for the three months ended June 30, 2015. The decrease in research and development costs are primarily attributable to a decrease in the costs associated with the Company’s Phase 3 PLUS-1 clinical trial and our Phase 2a proof of concept clinical trial for the low to intermediate risk prostate cancer. These decreases are partially offset by an increase in personnel related costs and a $0.1 million milestone payment payable as the result of the completion of Phase 1 clinical activities of topsalysin for the treatment of prostate cancer.

General and administrative expenses

General and administrative expenses were $1.4 million for the three months ended June 30, 2016 compared to $1.0 million for the three months ended June 30, 2015. The increase is primarily due to increases in personnel related costs, legal costs and closing costs which were allocated to the warrants issued in our financing completed in May 2016. These increases were partially offset by a decrease in non-cash stock-based compensation expense.

For the six months ended June 30, 2016

The Company reported a net loss of $6.3 million ($0.35 per share) for the six months ended June 30, 2016 compared to a net loss of $8.0 million ($0.48 per share) for the six months ended June 30, 2015.

Research and development expenses

Research and development expenses were $1.9 million for the six months ended June 30, 2016 compared to $5.6 million for the six months ended June 30, 2015. The decrease in research and development costs are primarily attributable to a decrease in the costs associated with the Company’s completed Phase 3 PLUS-1 clinical trial of topsalysin and costs associated with the manufacturing activities for topsalysin. These decreases are partially offset by increases in personnel related costs and a $0.1 million milestone payment payable as the result of the completion of Phase 1 clinical activities of topsalysin for the treatment of prostate cancer.

General and administrative expenses

General and administrative expenses were $2.5 million for the six months ended June 30, 2016 compared to $2.0 million for the six months ended June 30, 2015. The increase is primarily due to an increase in legal, accounting, professional services, personnel related costs and closing costs which were allocated to the warrants issued in our financing completed in May 2016. These increases were partially offset by a decrease in non-cash stock-based compensation expense.

On August9, 2016 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq:EGRX) reported its financial results for the three- and six-months ended June 30, 2016 (Press release, Eagle Pharmaceuticals, AUG 9, 2016, View Source [SID:1234514398]). Highlights of and subsequent to the second quarter of 2016 include:

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Business Highlights:

Bendeka total market share rose to 80%, as of Aug 5, 2016;
US Food and Drug Administration ("FDA") determined that no additional human safety and efficacy data is required for the submission of Eagle’s New Drug Application ("NDA") for Ryanodex for the treatment of exertional heat stroke ("EHS"), further confirming that a hybrid development program comprised of clinical data from EHS patients and positive preclinical data from animal studies constitutes an adequate regulatory pathway for the NDA submission;
Eagle reduced royalty payments owed for Ryanodex from 15% to 3% for a purchase price of $15 million in cash;
Discussions with the FDA regarding the design of a human study for RTU bivalirudin are underway;
Michael Graves appointed Chairman of the Board of Directors, Douglas Braunstein and Robert Glenning joined the board; and,
Eagle’s Board of Directors authorized a share repurchase program of up to $75 million in Eagle stock.
Financial Highlights:

Total revenue was $40.9 million during the second quarter of 2016 compared to $6.0 million for the three months ended June 30, 2015;
Product sales increased to $9.6 million during the second quarter of 2016 compared to $3.7 million for the three months ended June 30, 2015;
Sales of Ryanodex grew 81% quarter over quarter to $3.4 million during the second quarter of 2016;
Net income was $13.1 million, or $0.84 per basic and $0.80 per diluted share, compared to a net loss of $8.2 million, or $(0.53) per basic and diluted share, for the three months ended June 30, 2016 and 2015, respectively; and,
Cash and cash equivalents were $75.6 million and accounts receivable were $52.0 million as of June 30, 2016.
"During the quarter, we gained clarity on Bendeka and its associated cash flows through 2019. And, we are confident in our ability to continue to drive growth beyond 2019. Our meeting with the FDA provides us with an agreement for Ryanodex expansion. And, our Company’s cash position allows us to optimize the deployment of capital for our shareholders, a process we have already begun. With our new board in place, we are well positioned to take full advantage of the opportunities before us," said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

"Bendeka now commands 80% of a branded market and will be an important earnings driver through at least 2019. With Eagle’s right to launch our bendamustine 500mL formulation at any time and the right, under certain circumstances, to take back Bendeka in 2019, we believe our bendamustine franchise will be a solid contributor to Eagle’s growth for many years to come," added Tarriff.

"Likewise, we are excited about the potential of our pipeline to drive value beyond 2020. We expect the Ryanodex portfolio to be a key contributor to our growth. The FDA’s determination that the pivotal study we conducted on EHS patients combined with the clinical animal studies we are working on now will be sufficient to complete our NDA submission means that, if approved, Ryanodex for EHS could be on the market as early as next year, assuming the animal studies are successful. In parallel, we continue to explore additional indications for Ryanodex in the treatment of Ecstasy and methamphetamine intoxication, and are advancing multiple other product candidates through the development process, each of which could open up significant new markets for us," added Tarriff.

"As Eagle transitioned to a fully commercial company, we were able to grow our cash position significantly without incurring any debt. We are committed to deploying our excess capital prudently. As such, we signed an agreement that reduces our royalty obligations for Ryanodex. Eagle’s board has also approved the purchase of up to $75 million in Eagle’s stock. We will continue to evaluate opportunistic ways to invest our capital, reflecting our commitment to maximizing the value of our formulations and ensuring the long term earnings potential of the business," concluded Tarriff.

Second Quarter 2016 Financial Results

Total revenue for the three months ended June 30, 2016 was $40.9 million, as compared to $6.0 million for the three months ended June 30, 2015. A summary of total revenue is outlined below:

Three Months Ended
June 30, Increase
2016 2015
(in thousands)
Product sales $ 9,607 $ 3,730 $ 5,877
Royalty income 31,311 2,272 29,039
Total revenue $ 40,918 $ 6,002 $ 34,916

Product sales increased $5.9 million to $9.6 million driven by increases in Bendeka, Non-Alcohol Docetaxel Injection, Argatroban, and Ryanodex net product sales, offset by a decrease in net product sales of diclofenac-misoprostol. Royalty income increased $29.0 million to $31.3 million, as a result of the launch of Bendeka in January 2016.

Cost of revenue increased by $8.1 million to $11.5 million in the three months ended June 30, 2016 from $3.3 million in the three months ended June 30, 2015. This $8.1 million net increase resulted from $0.5 million in cost of revenue for Non-Alcohol Docetaxel Injection, an increase of $7.0 million related to the cost of Bendeka product sales, an increase of $0.5 million in cost of revenue for Ryanodex, and an increase of $0.1 million in cost of revenue for EP-1101.

Research and development expenses decreased by $2.2 million to $3.7 million in the three months ended June 30, 2016, compared to $5.9 million in the prior year quarter. The decrease is due to a decrease in spending on bivalirudin and cost reimbursement for Bendeka, offset by an increase in spending for the successful completion of the clinical treatment portion of the safety and efficacy study of Ryanodex for exertional heatstroke, an increase in project spending for pemetrexed, and investment in other pipeline projects.

SG&A expenses increased $6.9 million to $12.1 million in the second quarter of 2016 compared to $5.1 million in the three months ended June 30, 2015. Personnel-related expenses accounted for the bulk of the $7.0 million increase and were due to overall expansion of the business.

Net income for the second quarter was $13.1 million, or $0.84 per basic share and $0.80 per diluted share, compared to a net loss of $8.2 million, or $0.53 per basic and diluted share in the three months ended June 30, 2015, as a result of the factors discussed above.

Liquidity

As of June 30, 2016, the Company had $75.6 million in cash and cash equivalents; $52.0 million in receivables, with approximately $40 million due from Teva Pharmaceutical Industries Ltd. ("Teva"); $202.7 million in additional paid in capital; $107.8 million in stockholders’ equity; and no debt.

Events Subsequent to the End of the Second Quarter

Eagle purchased the majority of the royalty obligation on Ryanodex net sales, reducing its obligation from 15% to 3% in exchange for $15 million in cash.

Changes in the structure of Eagle’s shareholders’ stock holdings, which occurred in the second quarter of 2016 may trigger how Eagle utilizes accumulated Net Operating Losses ("NOL"). Eagle is evaluating whether or not these changes have, or soon will, trigger a technical change of control, as it is defined in Section 382 of the Internal Revenue Code. Upon a Section 382 change of control, the Company is required to amortize NOL utilization. How the Company utilizes accumulated NOL of approximately $99 million may be impacted by the outcome of this process. Eagle’s preliminary assessment is that the Company is close to a technical change of control. We estimate that should the Company be required to amortize NOL, there will be a cash impact of approximately $10 million incurred over the next few quarters.

On August 2, 2016, the Board of Directors has approved a share repurchase program, under which Eagle may repurchase up to $75 million of its outstanding common stock. The repurchase program has no time limit and may be suspended for periods or discontinued at any time. Repurchases under the program will be made from time to time on the open market at prevailing market prices or in privately negotiated transactions in compliance with Rule 10b-18 under the Securities Exchange Act of 1934, as amended, as determined by management and the Board of Directors in their discretion and subject to market conditions, applicable legal requirements, and other relevant factors.

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 AstraZeneca reported results from the Phase III SELECT-1 trial of the MEK 1/2 inhibitor, selumetinib, in combination with docetaxel chemotherapy as 2nd-line treatment in patients with KRAS mutation-positive (KRASm) locally-advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, AstraZeneca, AUG 9, 2016, View Source [SID:1234514372]).

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The results showed that the trial did not meet its primary endpoint of progression-free survival (PFS), and selumetinib did not have a significant effect on overall survival (OS). The adverse event profiles for selumetinib and docetaxel were consistent with those seen previously.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "A randomised Phase II trial showed promising activity of selumetinib in combination with docetaxel in patients with KRAS mutation-positive lung cancer. It is disappointing for patients that these results have not been confirmed in Phase III. We expect to present data at a forthcoming medical meeting. We remain committed to further developing treatments in the lung cancer setting, such as our immunotherapy combinations and targeted EGFR treatments."

SELECT-1 is an international trial with 510 randomised patients in over 200 centres. Patients received either selumetinib (75mg, orally, twice daily) or placebo in combination with docetaxel (intravenously, 75mg/m2, on day one of every 21-day cycle).

Selumetinib is being explored as a treatment option in registration-enabling studies in patients with differentiated thyroid cancer where the treatment received Orphan Drug Designation, and patients with neurofibromatosis type 1, a genetic disorder that causes tumours to grow along nerve tissue.1

About KRASm non-small cell lung cancer
KRAS is one of the most common genetic mutations in NSCLC, and is found in 30% of patients.2 Adenocarcinomas make up the majority of cases with KRAS mutations, which are less common in squamous cell NSCLC.2,3

KRAS mutations are associated with activation of the RAS-ERK signalling pathway, which drives tumour growth.3

About selumetinib (AZD6244, ARRY-142886)
Selumetinib is an oral, potent and highly selective MEK 1/2 inhibitor. MEK 1/2 are critical components of the RAS-ERK pathway, activation of which is implicated in driving cancer growth and progression, including in patients with KRASm NSCLC.4,5

AstraZeneca acquired exclusive worldwide rights to selumetinib from Array BioPharma Inc. (NASDAQ: ARRY) in 2003.

In May 2016, selumetinib was granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC), and AstraZeneca is committed to exploring its full potential, including in Phase III trials in patients with DTC and in a US National Cancer Institute-sponsored Phase II registration trial in patients with paediatric neurofibromatosis type 1.

About SELECT-1
SELECT-1 (NCT01933932) is a Phase III, double-blind, randomised, placebo-controlled trial. It is designed to assess the efficacy and safety of selumetinib (75 mg twice daily, given orally on a continuous schedule) in combination with docetaxel (75 mg/m2 intravenously on day 1 of every 21-day cycle), compared with matched placebo in combination with docetaxel (same schedule) in 510 patients receiving 2nd-line treatment for KRASm locally advanced or metastatic NSCLC (stage IIIB-IV), confirmed by central testing of tumour tissue using the cobas KRAS Mutation Test (Roche Molecular Systems).3

The primary endpoint is PFS, and secondary endpoints include OS, objective response rate (ORR), duration of response (DoR), and safety and tolerability.3

On August 8, 2016 Varian Medical systems reported that The Cincinnati Children’s/UC Health Proton Therapy Center officially opened today equipped with the ProBeam System from Varian Medical Systems (NYSE: VAR). Housing two treatment rooms offering image-guided intensity-modulated proton therapy (IMPT), as well as one room dedicated to research, clinicians at the center are now working with patients and planning to begin treatments in September (Press release, Varian Medical Systems, AUG 8, 2016, View Source [SID:1234514360]). The center will also utilize the ARIA Oncology information system with Eclipse treatment planning, providing a fully integrated solution for adaptive proton therapy.

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With proton therapy, the risk of damage to healthy tissues and potential side effects are reduced because proton beams can be controlled so that they deposit their energy within the tumor site rather than passing all the way through the patient. The treatment is particularly suitable for pediatric cancer cases as well as for adults.

With the ProBeam system, Cincinnati Children’s/UC Health Proton Therapy Center is capable of delivering the most precise form of proton therapy using Varian’s pencil beam scanning technology. The system is designed to precisely deposit doses into tumors layer by layer using a pencil-point beam that scans back and forth across the target area.

Stated in a related release today from Cincinnati Children’s/UC Health Proton Therapy Center titled: Grand Opening of Cincinnati Children’s/UC Health Proton Therapy Center, one treatment room will be devoted to pediatric patients and the other to adult patients. The dedicated research room will focus on several different areas including: imaging, computer-targeting technologies and patient positioning.

"We are excited about our collaboration with Cincinnati Children’s and UC Health on the opening of this new proton center and bringing this advanced cancer fighting technology to the Cincinnati area," said Moataz Karmalawy, general manager of Varian’s Particle Therapy division. "This will be the 3rd center with Varian’s ProBeam System to commence clinical operation in North America. The opening of this center is another important step in the growing availability of ProBeam proton therapy around the world."

Additionally, Varian’s proton therapy technology is being used to treat patients at the Scripps Proton Therapy Center in San Diego, Maryland Proton Therapy Center in Baltimore, the Rinecker Proton Therapy Center in Munich, and at the Paul Scherrer Institute in Switzerland. Varian also has contracts for system installations at 12 other sites around the world.

For more information on Varian’s proton therapy solutions, visit View Source