On November 9, 2016 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq:EGRX) reported its financial results for the three- and nine-months ended September 30, 2016 (Press release, Eagle Pharmaceuticals, NOV 9, 2016, View Source [SID1234516517]). Highlights of and subsequent to the third quarter of 2016 include:

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Business Highlights:

Bendeka total market share rose to 88%, as of November 6, 2016;
The Centers for Medicare & Medicaid Services (CMS) established a unique J-Code (J9034) for Bendeka effective January 1, 2017;
Positive initial results of animal study exploring use of Ryanodex in MDMA (Ecstasy) induced hyperthermia conducted at the National Institutes of Health (NIH);
Extended our licensing agreement with Teva Pharmaceutical Industries Ltd. (Teva) to include certain territories outside the US and Canada; and
Repurchased $18.0 million of Eagle common stock during the third quarter for a total of $32.0 million since commencing the Share Repurchase Program on August 9, 2016.
Financial Highlights:

Total revenue was $37.8 million during the third quarter of 2016 compared to $5.7 million for the three months ended September 30, 2015;
Product sales increased to $7.8 million during the third quarter of 2016 compared to $3.3 million for the prior year period;
Royalty income increased to $26.2 million during the third quarter of 2016 compared to $2.4 million for the prior year period;
License and other income was $3.8 million during the third quarter of 2016;
Sales of Ryanodex grew 92% to $2.5 million during the third quarter of 2016 compared to $1.3 million for the prior year period;
Net income was $12.0 million, or $0.77 per basic and $0.73 per diluted share, compared to a net loss of $10.2 million, or $(0.65) per basic and diluted share, for the three months ended September 30, 2016 and 2015, respectively; and,
Cash and cash equivalents were $59.3 million and accounts receivable were $47.1 million as of September 30, 2016.
"We had another strong quarter delivering results for our shareholders, reflecting our ability to execute Eagle’s strategy to develop and commercialize improved formulations that enhance patients’ lives. Bendeka market share continues to ramp up and is approaching our joint goal with Teva of 90%. We believe the CMS final ruling to establish a unique J-Code for Bendeka will not only aid further adoption, but also provide greater access for patients and facilitate reimbursement. We remain confident in our ability to drive continued growth in our bendamustine franchise well beyond 2019," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

"We are also particularly excited about the multiple opportunities within our pipeline to drive substantial value beyond 2020. We are very encouraged by early results of clinical testing to explore the potential of Ryanodex for the treatment of both exertional heat stroke and MDMA (Ecstasy) induced hyperthermia. If approved, both indications would address the needs of very significant new patient populations for whom no pharmaceutical treatment options are currently available. Our development work on additional product candidates continues, providing us with a robust pipeline from which to create long term value," added Tarriff.

"We remain focused on optimizing the deployment of our capital on behalf of shareholders and continue to evaluate opportunities to do so. As part of that effort, since August 9, we purchased a total of $32 million through our stock buyback program and are pleased with our solid financial position," concluded Tarriff.

Third Quarter 2016 Financial Results

Total revenue for the three months ended September 30, 2016 was $37.8 million, as compared to $5.7 million for the three months ended September 30, 2015. A summary of total revenue is outlined below:

Three Months Ended
September 30,

Increase
2016 2015
(in thousands)
Product sales $ 7,837 $ 3,314 $ 4,523
Royalty income 26,246 2,422 23,824
License and other income 3,750 3,750
Total revenue $ 37,833 $ 5,736 $ 32,097

Product sales increased $4.5 million to $7.8 million driven by due to increases in Bendeka, Non-Alcohol Docetaxel Injection, Argatroban, and Ryanodex net product sales of Ryanodex, offset by a decrease in net product sales of diclofenac-misoprostol. Royalty income increased $23.8 million to $26.2 million, as a result of the launch of Bendeka in January 2016.

Cost of revenue increased by $6.7 million to $10.4 million in the three months ended September 30, 2016 from $3.8 million in the three months ended September 30, 2015. This $6.7 million net increase resulted from $0.8 million in cost of revenue for Non-Alcohol Docetaxel Injection, an increase of $0.8 million in the cost of Argatroban, and an increase of $5.3 million related to the cost of Bendeka product sales: $2.4 million of product sales, $2.4 million of royalties and $0.5 million of other expense, and a decrease of $0.2 million in cost of revenue for Ryanodex.

Research and development expenses decreased by $3.7 million to $3.2 million in the three months ended September 30, 2016, compared to $6.9 million in the prior year quarter. The decrease resulted from certain cost reimbursements from one of our suppliers, non-recurrence of project spending for Ryanodex (dantrolene sodium) for exertional heatstroke related to the completion of the clinical treatment portion of the safety and efficacy study, and lower project spending for pemetrexed, offset by the increase in project spending for bivalirudin, and other projects, and higher salary and other personnel-related expenses due to increased headcount.

SG&A expenses increased $6.4 million to $11.9 million in the third quarter of 2016 compared to $5.5 million in the three months ended September 30, 2015. Personnel-related expenses accounted for the bulk of the $6.4 million increase and were due to overall expansion of the business.

Net income for the third quarter was $12.0 million, or $0.77 per basic share and $0.73 per diluted share, compared to a net loss of $10.2 million, or ($0.65) per basic and diluted share in the three months ended September 30, 2015, as a result of the factors discussed above.

Liquidity

As of September 30, 2016, the Company had $59.3 million in cash and cash equivalents; $47.1 million in receivables, with approximately $30.9 million due from Teva; and no debt.

Events Subsequent to the End of the Third Quarter

The Centers for Medicare & Medicaid Services (CMS) established a unique, product-specific billing code, or J-code (J9034), for Bendeka (bendamustine hydrochloride) Injection. The J-code will become effective on January 1, 2017.

The new J-code provides reimbursement coding clarity to outpatient facilities and physicians that administer Bendeka, facilitating access for patients and Medicare, Medicaid and commercial insurance reimbursement.

The J-Code decision triggered a $40 million milestone payment from Teva and an increase in Eagle’s royalty from 20% to 25% of net sales of Bendeka.

On November 9, 2016 SciClone Pharmaceuticals, reported financial results for the quarter ended September 30, 2016 (Filing, 8-K, SciClone Pharmaceuticals, NOV 9, 2016, View Source [SID1234516725]).

·
Revenues: In the third quarter of 2016, SciClone reported revenues of $40.5 million, compared to $42.9 million for the same period in 2015.
·
GAAP Diluted EPS: In the third quarter of 2016, SciClone reported GAAP diluted net income per share of $0.19, compared to GAAP diluted net income per share of $0.23 for the same period in 2015.
·
Non-GAAP Diluted EPS: In the third quarter of 2016, SciClone reported non-GAAP diluted net income per share of $0.24, compared to $0.26 for the same period in 2015.

Revenues in the third quarter of 2016 were $40.5 million, a $2.4 million or 6% decrease, compared to $42.9 million for the same period in 2015. The decrease in revenue in the third quarter 2016 compared to the same period last year included $1.0 million in revenue related to initial sales of DC Bead recorded in the third quarter of 2015. ZADAXIN revenues were $37.8 million in the third quarter of 2016, a $1.4 million or 3% decrease, compared to $39.2 million for the same period in 2015. The 3% decrease in ZADAXIN revenues for the third quarter of 2016 compared to the same period last year includes a 15% revenue decrease (9% of which was due to a price decrease for ZADAXIN and 6% of which was due to the effects of foreign exchange), partially offset by a 12% increase in ZADAXIN volume sales compared to the same period last year. An agreement with the Company’s exclusive China importer and tier 1 distributer implemented on January 1, 2016, affects a portion of the price decrease which impacts the timing of when SciClone recognizes revenue from sales, but this does not materially impact the total amount of revenue recognized on an annual basis. In the third quarter 2016, ZADAXIN volume sales increased by 12% compared to the same period last year. Promotion services revenues were $1.1 million for the third quarter of 2016, a $0.2 million or 22% increase, compared to $0.9 million in the same period in 2015, reflecting continued strong growth in the Company’s oncology portfolio. For the nine months ended September 30, 2016, revenues were $116.0 million, compared to $114.4 million for the same period last year.

On a GAAP basis, SciClone reported net income in the third quarter of 2016 of $10.1 million, or $0.20 and $0.19 per share on a basic and diluted basis, respectively, compared to net income of $12.0

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million, or $0.24 and $0.23 per share on a basic and diluted basis, respectively, for the same period in 2015. SciClone’s net income for the nine months ended September 30, 2016 was $24.3 million, compared with net income of $16.9 million for the same period in the prior year, or $0.49 and $0.46 per share on a basic and diluted basis, respectively, for the nine months ended September 30, 2016, compared with $0.34 and $0.32 per share on a basic and diluted basis, respectively, for the same period in 2015.

SciClone’s non-GAAP net income in the third quarter of 2016 was $12.7 million, or $0.25 and $0.24 per share on a basic and diluted basis, respectively, compared with non-GAAP net income of $13.4 million, or $0.27 and $0.26 per share on a basic and diluted basis, respectively, for the same period last year. SciClone’s non-GAAP net income for the nine months ended September 30, 2016 was $33.1 million, compared with non-GAAP net income of $36.7 million for the same period in the prior year, or $0.66 and $0.63 per share on a basic and diluted basis, respectively, for the nine months ended September 30, 2016, compared with non-GAAP net income of $0.73 and $0.70 per share on a basic and diluted basis, respectively, for the same period in 2015.

Friedhelm Blobel, PhD, SciClone’s Chief Executive Officer, commented: "We are pleased with our performance in the third quarter and year to date, which is in line with our expectations and reflects the value and continued growth potential of our core business, led by ZADAXIN. ZADAXIN continues to significantly out-perform the growth rate of the China pharmaceuticals market, with double-digit volume growth. The decrease in revenue was in line with our expectations, and predominantly reflects a stabilizing overall growth rate of China’s pharmaceuticals market, in the range of 6%-9%, and pricing pressure at the provincial level. We continue to expect that pricing pressures on revenue in 2016 will be offset, at least in significant part, through sharing of the burden with our China distributor and through our strategies to increase volume. Moreover, we are pleased with the continuing strong cash generation of our business.

"ZADAXIN continues to have significant growth potential as a differentiated, high quality, Western-manufactured brand, and the thymalfasin marketplace demand remains strong. We achieved a major milestone with the initiation and dosing of the first patient in our investigator-initiated clinical trial in sepsis, a major unmet medical need and growth opportunity for ZADAXIN.

"We made considerable progress in advancing our development portfolio. During the third quarter, we announced a regional licensing agreement with Soligenix, Inc, for SGX942, a novel first-in-class therapy being developed for oral mucositis. We also announced that the first patient had been dosed in the Phase 1 proof-of-concept trial of PT-112 in Taiwan, a novel anticancer agent in-licensed from Phosplatin Therapeutics. SGX942 and PT-112 are valuable additions to our development portfolio, offering opportunities to participate in the Chinese Class 1 regulatory pathway including local manufacturing, and with the potential to meaningfully expand our oncology business in China and adjacent markets for the future.

"The healthcare reform movement in China continues to offer opportunities for SciClone to grow our marketed product portfolio and to advance our development pipeline of high quality, differentiated medicines. We remain confident about our prospects for near-term growth and maximizing long-term value creation."

For the third quarter of 2016, sales and marketing (S&M) expenses were $13.3 million, compared with $15.1 million for the same period in 2015. The decrease in S&M for the third quarter of 2016,

2

compared to the same period in 2015, is primarily related to decreases in sales and marketing events and lower DC Bead-related launch costs. For the nine months ended September 30, 2016, S&M expenses were $40.1 million, compared with $39.7 million, for the same period last year.

For the third quarter of 2016, research and development (R&D) expenses were $3.3 million, compared with $1.0 million of R&D expenses for the same period of 2015. For the third quarter of 2016 and 2015, we recorded $0.3 million and zero, respectively, related to in-license arrangements with certain licensees and $2.8 million and $1.0 million, respectively, related to R&D expenses for clinical and preclinical R&D activities with certain licensees. For the nine months ended September 30, 2016, R&D expenses were $9.5 million, compared with $8.7 million, for the same period last year.

For the third quarter of 2016, general and administrative (G&A) expenses were $7.9 million, compared with $7.3 million for the same period in 2015. For the nine months ended September 30, 2016, G&A expenses were $23.5 million, compared with $20.8 million for the same period last year. G&A was higher for both the third quarter and nine-month periods of 2016, compared to the same periods of 2015, related to legal costs in connection with the Company’s ongoing strategic review and stock-based compensation expenses.

For the third quarter of 2016, SciClone’s income tax expense was $1.1 million, compared with $0.6 million for the same period in 2015. Income tax expense was lower in the third quarter of 2015 related to the restructuring of the Company’s China business. For the nine months ended September 30, 2016, income tax expense was $2.6 million, compared with $0.6 million, for the same period last year, and included a $1.3 million uncertain tax provision for our China operations from 2013 to 2015.

As of September 30, 2016, cash and cash equivalents totaled $130.1 million, compared to $101.4 million as of December 31, 2015, excluding the $12.8 million of restricted cash held in escrow as of December 31, 2015 for the SEC settlement which was released and paid in February 2016.

SciClone has presented non-GAAP information above as the Company believes this non-GAAP information is useful for investors, taken in conjunction with SciClone’s GAAP financial statements, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of SciClone’s operating results as reported under GAAP. The non-GAAP calculations and reconciliation are provided in the accompanying table titled "Reconciliation of GAAP to Non-GAAP Net Income" except that for the non-GAAP EPS referenced in "2016 Non-GAAP Earnings Guidance Revised Upward" below, the Company is unable to provide a quantitative reconciliation of its forward-looking estimate of non-GAAP EPS to a forward-looking estimate of GAAP EPS because certain information needed to make a reasonable forward-looking estimate of GAAP EPS for the full fiscal year 2016 is difficult to predict and estimate and is often dependent on future events which may be uncertain or outside of the Company’s control, for example, milestone payments.

2016 Non-GAAP Earnings Guidance Revised Upward

Based on the continued volume growth of ZADAXIN and implementation of effective operating cost controls, SciClone is revising upwards its projected non-GAAP earnings per share on a fully diluted basis to be in the range of $0.78 to $0.82, up from the previously expected range of $0.70 to $0.74 for

3

the year. The Company continues to project its 2016 revenue to be in the range of $158 million to $163 million.

The Company’s outlook for 2016 continues to be influenced by several factors, including the overall growth rate of the China pharmaceuticals market, anticipated pricing pressure at the provincial level and higher R&D expenses as it continues to advance its pipeline products toward commercialization. The Company further expects that pricing pressures on revenue in 2016 will be offset, at least in significant part, through sharing of the burden with its China distributors and potentially through volume increases.


On November 9, 2016 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported financial results and a corporate update for the third quarter ended September 30, 2016 (Press release, Immune Design, NOV 9, 2016, View Source [SID1234516561]).

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"During the third quarter, we continued enrollment of our clinical programs, recruited senior leadership with late-stage oncology development expertise, and advanced the range of future potential products from our differentiated ZVex platform," said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer of Immune Design. "Backed by both new and existing investors who participated in our recent financing, we are focused on delivering meaningful results in both of our approaches in 2017."

Recent Highlights

Product Development: Continued progress on all programs from ZVex and GLAASTM platforms

Antigen Specific: CMB305 Program

CMB305, the novel prime-boost NY-ESO-1 cancer vaccine using the ZVex platform, is being evaluated in soft tissue sarcoma (STS) patients both as a potential monotherapy and in combination with an anti-PD-L1 antibody.
CMB305 monotherapy:
Follow-up continues on the two fully enrolled monotherapy Phase 1 trials (CMB305; n=24 patients, and its vector-only component, LV305; n=23 patients). As reported by investigators, at the end of the third quarter:
The safety profile remains favorable, with a consistent rate of NY-ESO-1-triggered T cell responses that appear stronger with CMB305.
The median overall survival (OS) has still not been reached in either study, with CMB305 and LV305 having a median follow-up of approximately 221 days and 640 days, respectively. Chemotherapeutic agents approved to treat metastatic STS have shown a median OS of 12.4-13.5 months.
CMB305 in combination with TECENTRIQ (atezolizumab): Enrollment continues in this randomized 80 patient, Phase 2 study comparing CMB305 plus atezolizumab vs. atezolizumab alone, pursuant to a collaboration with Genentech.
Immune Design intends to submit data for presentation from the CMB305 studies beginning at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in 2017 (ASCO 2017).
Antigen Agnostic: G100 Program

G100, the formulated TLR4 synthetic agonist from the GLAAS platform, GLA-SE, injected intratumorally, is being evaluated in an ongoing randomized Phase 2 trial in patients with follicular non-Hodgkin lymphoma (fNHL). Patients receive either G100 and low-dose radiation (RadRx) or G100 and low-dose RadRx with the systemic administration of the anti-PD-1 antibody, Keytruda (pembrolizumab), pursuant to a collaboration with Merck. In contrast with CMB305’s focus on OS, the initial endpoint focus for this study is on response rates in both treated and distal, non-treated lesions.
Immune Design intends to submit data from this Phase 2 study for presentation beginning at ASCO (Free ASCO Whitepaper) 2017.
Expansion of the versatility of the ZVex platform and further support for ongoing product development: upcoming presentations at SITC (Free SITC Whitepaper) and ASH (Free ASH Whitepaper)

To avoid potential antigenic competition and to induce an immune response to multiple antigens that are co-delivered to dendritic cells, Immune Design has further developed the ZVex platform to enable the delivery of multiple RNA genes to dendritic cells to induce a simultaneous T cell response against each, separate antigen. The company intends to include this new feature in its planned next generation of product candidates, ZVex2.0, which will be designed to deliver both multiple conserved antigens and/or neo-antigens, in the latter case, distinct from ZVexNeo and the collaboration with Gritstone Oncology.
A preclinical prototype from this evolution of the ZVex platform will be presented at the upcoming SITC (Free SITC Whitepaper) annual meeting, as well as a presentation illustrating preclinical data from a new prime-boost option coupling a ZVex vector with an alternate boost modality. Also, at the ASH (Free ASH Whitepaper) 2016 annual meeting, Immune Design will present additional preclinical data describing the synergy of G100 with local radiation to eradicate lymphomas, further supporting its ongoing G100 Phase 2 study in fNHL.
Expansion of the Senior Leadership Team

Sergey Yurasov, M.D., Ph.D. Joins Executive Team: Addition of Late-Stage Oncology Development Expertise

Dr. Sergey Yurasov joined the Immune Design team as Senior Vice President of Clinical Development and Chief Medical Officer in October 2016. Dr. Yurasov brings more than 20 years’ experience in immunology and late-stage oncology drug development to the company.
Acquisition of Intellectual Property Rights and Settlement of Litigation and Patent Challenge

On October 21, 2016, Immune Design announced the acquisition of intellectual property rights from, and settlement of outstanding legal proceedings with, Theravectys SA (TVS). Immune Design obtained a license to certain present and future intellectual property of TVS related to the company’s ZVex platform, and resolved all outstanding proceedings in Delaware and Belgium and a patent opposition proceeding brought by TVS against one of the company’s patents related to ZVex. Please refer to Immune Design’s Current Report on Form 8-K filed on October 21, 2016 for a more complete description of the terms.
Completion of Follow-On Financing

In September 2016, Immune Design completed an underwritten follow-on public offering, which resulted in the sale of 5,226,369 shares of common stock, at a price of $6.25 per share. Net proceeds from the offering were $30.3 million after deducting underwriting discounts, commissions and estimated expenses. Both new and existing investors participated in the offering.
Financial Results

Third Quarter

Immune Design ended the third quarter of 2016 with $112.5 million in cash, cash equivalents and short-term investments, compared to $112.9 million as of December 31, 2015. Net cash used in operations for the nine months ended September 30, 2016 was $31.4 million and $10.9 million for the three months ended September 30, 2016.
Net loss and net loss per share for the third quarter of 2016 were $12.4 million and $0.60, respectively, compared to $7.4 million and $0.37, respectively, for the third quarter of 2015.
Revenue for the third quarter of 2016 was $8.2 million and was attributable primarily to $7.0 million in license revenue associated with Immune Design’s collaboration with Sanofi, $0.4 million in product sales to collaboration partner Sanofi, and $0.8 million in collaboration revenue associated with the Sanofi G103 (HSV2 therapeutic vaccine) collaboration. Revenue for the third quarter of 2015 was $4.7 million and was attributable primarily to $3.5 million in license revenue associated with Immune Design’s collaboration with Sanofi, $0.8 million in product sales to collaboration partners MedImmune and Sanofi, and $0.3 million in collaboration revenue associated with the Sanofi G103 (HSV2 therapeutic vaccine) collaboration.
Research and development expenses for the third quarter of 2016 were $11.2 million, compared to $8.3 million for the third quarter of 2015. The $2.9 million increase was primarily attributable to continuing advancement of Immune Design’s ongoing research and development programs, including ongoing Phase 1 and Phase 2 clinical trials.
General and administrative expenses for the third quarter of 2016 were $9.6 million, compared to $3.5 million for the third quarter of 2015. The $6.1 million increase was primarily attributable to the settlement and license agreements with TVS involving the acquisition of certain present and future intellectual property rights from TVS and resolving the litigation initiated by TVS in July 2014 against the Company, as well as related claims and counterclaims.
Year-to-Date

Net loss and net loss per share for the nine months ended September 30, 2016 were $39.1 million and $1.92, respectively, compared to $27.3 million and $1.45, respectively, for the same period in 2015.
Revenue for the nine months ended September 30, 2016 was $11.2 million and was attributable primarily to $7.0 million in license revenue associated with Immune Design’s collaboration with Sanofi, $1.2 million in product sales to collaboration partner Sanofi, and $3.0 million in collaboration revenue associated with the Sanofi G103 (HSV2 therapeutic vaccine) collaboration. Revenue for the nine months ended September 30, 2015 was $8.4 million and was attributable primarily to $3.5 million in license revenue associated with Immune Design’s collaboration with Sanofi, $0.9 million in product sales to collaboration partners MedImmune and Sanofi, and $3.9 million in collaboration revenue associated with the Sanofi G103 (HSV2 therapeutic vaccine) collaboration.
Research and development expenses for the nine months ended September 30, 2016 were $33.1 million compared to $24.2 million for the same period in 2015. The $8.9 million increase was primarily attributable to continuing advancement of Immune Design’s ongoing research and development programs, including ongoing Phase 1 and Phase 2 clinical trials and an increase in personnel-related expenses to support the company’s advancing research and clinical pipeline.

General and administrative expenses for the nine months ended September 30, 2016 were $17.4 million, compared to $11.1 million for the same period in 2015. The $6.3 million increase was primarily attributable to the settlement and license agreements with TVS entered into in October 2016 involving the acquisition of certain present and future intellectual property rights from TVS and resolving the litigation initiated by TVS in July 2014 against the Company, as well as related claims and counterclaims.

On November 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 nine months ended September 30, 2016 (Press release, Sophiris Bio, NOV 9, 2016, View Source [SID1234516726]).

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Business Highlights:

On August 26, 2016, the Company announced the closing of a public offering in which the Company raised net proceeds of $27.4 million. The Company plans to use the proceeds from this offering to fund a Phase 2b clinical trial for the treatment of localized prostate cancer and working capital and general corporate purposes, which may include research and development expenses, general and administrative expenses and manufacturing expenses.
During the third quarter of 2016, the Company received proceeds of $1.7 million from the exercise of warrants and stock options.
In September 2016, the Company repaid the outstanding principal balance of the loan with Oxford Finance LLC with a total payment of $4.2 million.
On October 12, 2016 the Board of Directors of Sophiris Bio Inc. approved the appointment of Allison Hulme, Ph.D., the Company’s chief operating officer and head of research and development, as a director of the Company.
"Sophiris has been successful in building on a series of positive clinical milestones that we believe will enable us to further the development of topsalysin," said Randall Woods, president and CEO of Sophiris Bio. "In the wake of announcing positive data from our Phase 2a proof-of-concept study in localized prostate cancer as well as from our Phase 3 trial in BPH that met its primary endpoint, the Company was able to raise additional funds in the public market in the third quarter to strengthen our balance sheet and enable us to fund an additional clinical trial. Over the past quarter, we have made significant progress in preparing to initiate a Phase 2b clinical trial of topsalysin for the treatment of localized prostate cancer, which is expected to report initial results by the end of 2017."

Financial Results:

At September 30, 2016, we had cash, cash equivalents and securities available-for-sale of $31.3 million and net working capital of $29.8 million. We expect that our cash and cash equivalents will be sufficient to fund our operations into the second quarter of 2018. At this point in time we do not plan on pursuing a second Phase 3 trial in BPH unless we obtain additional financing.

For the three months ended September 30, 2016

The Company reported a net loss of $4.3 million ($0.17 per share) for the three months ended September 30, 2016 compared to a net loss of $3.7 million ($0.22 per share) for the three months ended September 30, 2015.

Research and development expenses

Research and development expenses were $0.6 million for the three months ended September 30, 2016, compared to $2.6 million for the three months ended September 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 localized prostate cancer both of which were completed prior to the third quarter.

General and administrative expenses

General and administrative expenses were $3.0 million for the three months ended September 30, 2016 compared to $0.9 million for the three months ended September 30, 2015. The increase is primarily due to the inclusion of $1.4 million in offering expenses which were allocated to the fair value of the warrants issued in our public offering in August 2016. The balance of the offering expenses were recorded as a reduction to equity. The increase was also related to an increase in personnel related costs and professional services.

Loss on revaluation of warrant liability.

Loss on revaluation of the warrant liability was $0.3 million for the three months ended September 30, 2016. The non-cash loss is associated with the change in the fair value of our warrant liability.

For the nine months ended September 30, 2016

The Company reported a net loss of $10.6 million ($0.51 per share) for the nine months ended September 30, 2016 compared to a net loss of $11.7 million ($0.69 per share) for the nine months ended September 30, 2015.

Research and development expenses

Research and development expenses were $2.5 million for the nine months ended September 30, 2016 compared to $8.2 million for the nine months ended September 30, 2015. The decrease in research and development costs are primarily attributable to a decrease of $5.2 million in the costs associated with the Company’s completed Phase 3 PLUS-1 clinical trial of topsalysin for the treatment of BPH and to a lesser extent a decrease in costs associated with our Phase 2a proof of concept clinical trial for localized prostate cancer and manufacturing activities for topsalysin.

General and administrative expenses

General and administrative expenses were $5.6 million for the nine months ended September 30, 2016 compared to $3.0 million for the nine months ended September 30, 2015. The increase is primarily due to the inclusion of $1.6 million in offering costs which were allocated to the warrants issued in connection with our offerings which closed in May and August of 2016. The increase, to a lesser extent, is due to an increase in personnel, legal, accounting, consulting and professional services. These increases were partially offset by a decrease in non-cash stock-based compensation expense.

Loss on revaluation of warrant liability.

Loss on revaluation of the warrant liability was $2.0 million for the nine months ended September 30, 2016. The non-cash loss is associated with the change in the fair value of our warrant liability.

Valeant has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Valeant, NOV 9, 2016, View Source [SID1234516648]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!