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Anthera Pharmaceuticals Provides Business Update and Reports 2016 Second Quarter Financial Results

On August 9, 2016 Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) reported a business update and reported financial results for the second quarter ended June 30, 2016 (Filing, Q2, Anthera, 2016, AUG 9, 2016, View Source [SID:1234514412]).

Recent Developments and Business Highlights:

Sollpura (liprotamase) – Exocrine Pancreatic Insufficiency ("EPI")

o Phase 3 SOLUTION Clinical Study Enrollment Target of 126 Patients Met

We met the enrollment target in our Phase 3 SOLUTION clinical study evaluating the efficacy and safety of the capsule formulation of Sollpura to treat exocrine pancreatic insufficiency in patients with cystic fibrosis in early August. We expect to report topline efficacy data in the fourth quarter of 2016. For more information on the SOLUTION clinical study, please visit View Source study/.

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o Initiated SIMPLICITY Clinical Study with an Enrollment Target of 46 Patients

We began dosing patients in the SIMPLICITY clinical study which is evaluating the efficacy and safety of Sollpura supplied as a powder for oral solution. In this study, Sollpura is packaged in a convenient, easy-to-administer packet. The soluble dose form of all three digestive enzymes is mixed with water or apple juice. After an initial cohort of patients older than seven is treated for one week, this study will allow for administration of Sollpura powder for oral solution to pediatric patients ranging in age from 28 days to seven years. For more information on the study, please visit View Source

o Manufacturing Progressing to Support SIMPLICITY Study and Commercial Readiness

We successfully manufactured and released two sachet dosage strengths with a newly developed dry powder formulation for oral solution, enabling the initiation of the SIMPLICITY clinical study. We made progress with manufacturing technical transfer of all three enzymes to our contract manufacturers site. We completed demonstration batch manufacturing at commercial launch scale for lipase. Additionally, proof-of-concept was demonstrated for a high dose Lipase unit capsule – a further step towards reducing capsule burden in patients with EPI.

Blisibimod – Systemic Lupus Erythematosus ("SLE")

o Topline Data from Phase 3 CHABLIS-SC1 Clinical Study

We continue to collect and prepare final data from the Phase 3 CHABLIS-SC1 clinical study as the final patients continue treatment in the study. The last patient in the study received their final study dose on July 28th. As described in the protocol, patients are followed for eight weeks after their last dose at which time the final safety data is collected. Due to timing of this final visit, the company expects topline efficacy and safety data will be available prior to the annual American College of Rheumatology Annual Meeting in November. Topline data from the CHABLIS-SC1 will include the primary endpoint evaluation, a six-point reduction in the Systemic Lupus Erythematosus Responder Index (SRI-6) as well as safety and tolerability data from the study. For more information on the CHABLIS-SC1 study, please visit View Source

o Phase 3 CHABLIS 7.5 Clinical Study Initiated

CHABLIS 7.5, Anthera’s second Phase 3 clinical study successfully enrolled its first patient. This study will evaluate the efficacy and safety of blisibimod in patients who, despite corticosteroid use, continue to have clinically-active lupus (SLE) and the presence of anti-double-stranded DNA and low complement which are of known serological markers of lupus. For more information about the CHABLIS 7.5 study, visit View Source

Blisibimod – IgA Nephropathy

o Positive Trends Reported on Phase 2 BRIGHT-SC Clinical Study

In June 2016, interim data from the BRIGHT-SC study, which enrolled 57 patients, demonstrated a positive trend in lower proteinuria in blisibimod versus placebo treated patients. While the numerical reduction in proteinuria in blisibimod versus placebo treated patients at week 24 in the BRIGHT-SC study did not meet the predefined primary endpoint of complete or partial response, longer-term data from the study demonstrated an increasingly large separation in proteinuria favoring the blisibimod treated arm compared to placebo. Additionally, secondary biomarker data from the study, including changes in total B cell counts and changes in immunoglobulins IgA, IgG, and IgM, were highly consistent with previous studies with blisibimod and demonstrated marked reduction after 8 weeks on study. As a result of the increasing proteinuria effect after 24 weeks of dosing, and the demonstration of blisibimod’s effect on immunological markers relevant to IgA nephropathy including reductions of B cells, and immunoglobulins including IgA, IgG and IgM, we elected to continue the study until the last subject enrolled completes 48 weeks of evaluation. For more information about the BRIGHT-SC study, visit View Source

Summary of Financial Results

· Cash Position. We ended the second quarter of 2016 with cash and cash equivalents totaling $28.5 million, compared to $47.0 million as of December 31, 2015. The decrease in cash was mainly attributable to research, development and operating expenses during the six months ended June 30, 2016.
· R&D Expense. Research and development expenses for the three and six months ended June 30, 2016 totaled $12.0 million and $21.6 million, respectively, compared to $8.5 million and $14.5 million for the corresponding periods in 2015. The increase is mainly attributable to higher clinical development expenses resulting from the acceleration of patient enrollment in the SOLUTION clinical study, the initiation of the SIMPLICITY clinical study, manufacturing scale-up costs associated with Sollpura, and the initiation of the CHABLIS-7.5 clinical study in severe lupus patients.
· G&A Expense. General and administrative expenses for the three and six months ended June 30, 2016 totaled $2.6 million and $4.8 million, respectively, compared to $1.7 million and $3.6 million for the corresponding periods in 2015. The increase is primarily due to higher non-cash stock-based compensation expense of $0.6 million and $0.9 million, respectively, recognized during the three and six months ended June 30, 2016.
· Research Award. A research award, granted to us in March 2015 by the Cystic Fibrosis Foundation Therapeutics, Inc. and recorded as an offset to operating expense, totaled $261,000 for the three and six months ended June 30, 2016. The amount of research award recognized represents the value prescribed to the milestones that we achieved under the award agreement during the current period. There were no research award amounts recorded during the comparative period in 2015.
· Net Loss. Net loss for the three and six months ended June 30, 2016 was $14.3 million, or $0.35 per basic and diluted share and $26.1 million, or $0.64 per basic and diluted share, respectively, compared to $8.9 million, or $0.25 per basic and diluted share and $16.6 million, or $0.52 per basic and diluted share for the corresponding periods in 2015.

GTx Provides Corporate Update and Reports Second Quarter 2016 Financial Results

On August 9, 2016 GTx, Inc. (Nasdaq: GTXI) reported financial results for the second quarter ended June 30, 2016 and highlighted upcoming milestones (Press release, GTx, AUG 9, 2016, View Source;p=RssLanding&cat=news&id=2194053 [SID:1234514411]). The Company is currently enrolling patients in three Phase 2 clinical trials: two trials evaluating enobosarm as a potential treatment for women with advanced breast cancer, and another assessing enobosarm as a potential treatment for stress urinary incontinence in postmenopausal women.

"We have maintained considerable momentum in our lead enobosarm programs as well as our emerging SARD program. In the coming months, I look forward to reporting preliminary data from our two Phase 2 clinical trials of enobosarm in women with advanced breast cancer, which should enable us to determine if the clinical benefit response will permit each trial to advance to the second and final stage of the trial," said Dr. Robert J. Wills, Executive Chairman of GTx. "In addition, the clinical trial of enobosarm to treat stress urinary incontinence in postmenopausal women has continued to enroll and we expect data from this trial during the first half of 2017."

Corporate Highlights and Anticipated Milestones

Enobosarm in Breast Cancer: The Company’s lead product candidate, a selective androgen receptor modulator (SARM), is being developed as a targeted treatment for two advanced breast cancer indications: (i) estrogen receptor positive (ER+) and androgen receptor positive (AR+) breast cancer, and (ii) AR+ triple negative breast cancer (TNBC). For both clinical trials, the primary efficacy endpoint is a determination of clinical benefit, which is defined as a complete response, partial response or stable disease.

ER+/AR+ breast cancer: We currently expect to have sufficient data from the first stage of this open-label, Phase 2 clinical trial of enobosarm in women with metastatic or locally advanced, ER+/AR+ breast cancer before the end of 2016 to allow us to make a determination as to whether we will enroll additional patients in each of the two study cohorts for the second stage of the trial. While the first stage of the trial will evaluate 18 patients for each of the two dosing arms, 9 mg and 18 mg of enobosarm, the trial is designed to enroll up to 118 patients in total in order to obtain data from 88 evaluable patients (44 evaluable patients in each dose group) to assess the primary efficacy objective of clinical benefit response following 24 weeks of treatment.
AR+ TNBC: We expect to have sufficient data from the first stage of this open-label, proof-of-concept Phase 2 clinical trial of 18 mg of enobosarm in women with advanced AR+ TNBC by the end of 2016 to allow us to make a determination as to whether we will continue enrolling patients into the second stage of the trial. While the first stage will include 21 evaluable patients, the trial is designed to enroll up to 55 patients in total in order to obtain data from 41 evaluable patients to assess the primary efficacy objective of clinical benefit response following 16 weeks of treatment.
SARMs in Non-Oncologic Indications: The Company is exploring SARMs as potential treatments for both stress urinary incontinence (SUI) and Duchenne muscular dystrophy (DMD), a rare disease characterized by progressive muscle degeneration and weakness.

SUI: Enrollment in the Phase 2 proof-of-concept clinical trial of 3 mg of enobosarm in postmenopausal women with SUI is ongoing. This trial, in up to 35 women, is the first clinical trial to evaluate a SARM for SUI. Data from the trial is expected during the first half of 2017, at which point we plan to determine if continued development of enobosarm or another of our SARM compounds in SUI is warranted.
DMD: Preclinical studies have continued to confirm beneficial effects from SARMs in mice genetically altered to simulate DMD, compared to control groups. The Company continues to advance its preclinical initiatives while pursuing a potential strategic collaboration with biopharma companies experienced in orphan drug development.
SARDs in Prostate Cancer: our Selective Androgen Receptor Degrader (SARD) technology is being evaluated as a potentially novel treatment for men with castration-resistant prostate cancer (CRPC), including those who do not respond or are resistant to currently approved therapies. The Company believes that its SARD compounds will degrade multiple forms of the androgen receptor, including AR splice variants, such as AR-V7, along with mutant versions of the receptor.

CRPC: Lead SARD compounds are undergoing required preclinical development, including formulation and metabolism studies. The Company’s plan is to initiate its first human clinical trial with a SARD in 2017.
Second Quarter 2016 Financial Results

As of June 30, 2016, cash and short-term investments were $19.8 million compared to $29.3 million at December 31, 2015.
Research and development expenses for the quarter ended June 30, 2016 were $4.1 million compared to $3.0 million for the same period of 2015.
General and administrative expenses were $2.0 million for both the quarter ended June 30, 2016 and June 30, 2015.
The net loss for the quarter ended June 30, 2016 was $6.1 million compared to a net loss of $48.0 million for the same period in 2015. The second quarter of 2015 included a non-cash loss of $43.0 million due to the change in fair value of the Company’s warrant liability. During the first quarter of 2016, the Company recorded a non-cash reclassification of this warrant liability to stockholders’ equity due to the modification of these warrants. No adjustments to the fair value of these warrants are required subsequent to the first quarter of 2016.
The net loss for the six months ended June 30, 2016 was $4.0 million compared to a net loss of $50.3 million for the same period of 2015. The six months ended June 30, 2016 included a non-cash gain of $8.2 million due to the change in the fair value of the Company’s warrant liability, recorded during the first quarter of 2016. The six months ended June 30, 2015 included a non-cash loss of $40.4 million due to the change in fair value of the Company’s warrant liability.
GTx had approximately 141.7 million shares of common stock outstanding as of June 30, 2016. Additionally, there remain warrants outstanding to purchase approximately 64.3 million shares of GTx common stock at an exercise price of $0.85 per share.

Ionis Pharmaceuticals Reports Financial Results and Highlights for Second Quarter 2016

On August 9, 2016 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) reported that its financial results for the first half of 2016 were in line with the Company’s expectations and the Company is on track to meet its pro forma NOL and cash guidance for the year (Press release, Ionis Pharmaceuticals, AUG 9, 2016, View Source;p=RssLanding&cat=news&id=2194067 [SID:1234514400]).

Ionis Pharmaceuticals (PRNewsFoto/Ionis Pharmaceuticals, Inc.)
"The recent announcement to file for regulatory approval of nusinersen based on positive results from an interim analysis of the Phase 3 ENDEAR study was an important next step in our goal to bring this potentially transformational medicine to the patients who desperately need it as quickly as possible. This is the first time a potential treatment for infantile-onset SMA has demonstrated a clinical benefit in a controlled clinical study," said B. Lynne Parshall, chief operating officer of Ionis Pharmaceuticals. "We are excited about the opportunity we now have to accelerate the advancement of nusinersen into regulatory review. We and Biogen are well along in preparing the U.S. and E.U. regulatory dossiers, and Biogen plans to file marketing applications in the U.S. and E.U. in the next few months, with other countries to follow. We are very pleased that our interactions with the FDA remain very constructive as we and Biogen continue to explore possible expedited mechanisms to accelerate the regulatory review timeline."

Biogen has exercised its option to license nusinersen and will be responsible for all development, regulatory and commercialization activities and costs going forward. Over the next several months, Ionis will be working closely with Biogen to transition patients in the ENDEAR and EMBRACE studies to an open-label study that will allow all patients in these studies to have access to nusinersen. Once these patients have been transitioned into an open-label study, Biogen plans to open an expanded access program to make nusinersen available to eligible patients with infantile-onset SMA (consistent with type 1). Ionis will continue to conduct the Phase 3 CHERISH study in childhood-onset SMA patients. Biogen will also continue to conduct the NURTURE study in pre-symptomatic SMA infants.

"We believe that Biogen is the right company to bring nusinersen to patients with this devastating disease. They understand the unique needs of the SMA community and the impact SMA has on patients and their families. Importantly, Biogen has the global commercial infrastructure and expertise needed to successfully launch and commercialize nusinersen. Nusinersen is the first antisense drug from our neurological disease collaboration with Biogen that we expect to advance to regulatory review, and we are excited about the possibility of bringing other therapies to patients with severe neurological diseases with limited or no treatment options," continued Ms. Parshall.

Financial Results

"We finished the second quarter in a strong financial position. In the first half of this year, we earned $75 million of revenue, including more than $15 million in milestone payments, the majority of which were related to the progression of our Phase 3 program for nusinersen, and $15 million from Kastle when Kastle acquired the global rights to develop and commercialize KYNAMRO. Consistent with the guidance we have provided, we expect our revenue to be significantly higher in the second half of this year. We are well on our way to achieving our second half projections with the revenue we have already earned in the third quarter from the nusinersen and Janssen license fees, which total $85 million," said Elizabeth L. Hougen, chief financial officer of Ionis Pharmaceuticals.

"We have continued to advance our Phase 3 programs and to prepare to commercialize volanesorsen through Akcea while prudently managing our expenses. As a result, we finished the first half of 2016 with a GAAP loss from operations of $104 million, which included nearly $40 million in non-cash compensation expense related to equity awards, that when excluded, resulted in a pro forma net operating loss of $64 million. We also ended the first half of this year with more than $660 million in cash. Neither our operating loss nor our cash balance at June 30th included the $85 million in license fees we have earned already in the third quarter. We are on track to meet our guidance of a pro forma NOL in the low $60 million range and a year-end cash balance in excess of $600 million. Importantly, with the projected accelerated timeline for approval of nusinersen, we have the opportunity to begin earning commercial revenue next year," concluded Ms. Hougen.

All pro forma amounts referred to in this press release exclude non-cash compensation expense related to equity awards. Please refer to the reconciliation of GAAP to pro forma measures, which is provided later in this release.

Revenue

Ionis’ revenue for the three and six months ended June 30, 2016 was $38.5 million and $75.3 million, compared to $120.4 million and $183.0 million for the same periods in 2015. Ionis’ revenue in the first half of 2016 consisted of the following:

$15 million from Kastle Therapeutics in an upfront payment for KYNAMRO;
$14.5 million from Biogen for advancing the Phase 3 program for nusinersen and advancing IONIS-BIIB4Rx;
$1.5 million from GSK for advancing IONIS-HBV-LRx; and
$44.3 million primarily from the amortization of upfront fees and manufacturing services Ionis performed for its partners.
Ionis’ revenue in the first half of 2015 included $91.2 million in connection with the exclusive license agreement with Bayer, $56.8 million in milestone payments from partnered programs and $35.0 million, primarily from the amortization of upfront fees and manufacturing services Ionis performed for its partners.

Ionis’ revenue fluctuates based on the nature and timing of payments under agreements with its partners and consists primarily of revenue from the amortization of upfront fees, milestone payments and license fees. Already in the third quarter of 2016, Ionis has earned $85 million in license fee revenue consisting of $75 million from Biogen for nusinersen and $10 million from Janssen for the Company’s first oral antisense drug designed to act locally in the GI tract.

Operating Expenses
Ionis’ operating expenses included costs to support the Company’s five ongoing Phase 3 studies and three open-label extension studies related to its Phase 3 programs for nusinersen, IONIS-TTRRx and volanesorsen. In addition, Akcea continued to build its operations in preparation for the commercial launch of volanesorsen. As such, Ionis’ operating expenses increased for the three and six months ended June 30, 2016 and on a GAAP basis were $87.4 million and $178.9 million, respectively, and on a pro forma basis, were $68.1 million and $139.6 million, respectively. This is compared to GAAP operating expenses of $75.8 million and $147.7 million and pro forma operating expenses of $62.2 million and $120.8 million for the same periods in 2015. In addition, Ionis’ operating expenses on a GAAP basis increased due to an increase in non-cash compensation expense that resulted from an increase in the exercise price of the stock options the Company has granted over the past several years.

Net Income (Loss)
Ionis reported a net loss of $56.9 million and $119.8 million for the three and six months ended June 30, 2016, respectively, compared to net income of $35.6 million and $18.9 million for the same periods in 2015. Basic net loss per share for the three and six months ended June 30, 2016 was $0.47 and $0.99, respectively, compared to basic net income per share of $0.30 and $0.16 for the same periods in 2015. Diluted net loss per share for the three and six months ended June 30, 2016 was $0.47 and $0.99, respectively, compared to diluted net income per share of $0.29 and $0.15 for the same periods in 2015. Ionis had a net loss for the three and six months ended June 30, 2016 compared to net income for the same periods in 2015 primarily due to variations in the timing of revenue from license fees and milestone payments. For example, in the second quarter of 2015, the Company recognized $91.2 million in revenue related to its exclusive license agreement with Bayer.

Balance Sheet
As of June 30, 2016, Ionis had cash, cash equivalents and short-term investments of $664.1 million compared to $779.2 million at December 31, 2015. Ionis’ cash balance decreased in the first half of 2016 primarily due to spending to support the Company’s ongoing Phase 3 programs for nusinersen, IONIS-TTRRx and volanesorsen. Ionis’ working capital was $586.9 million at June 30, 2016 compared to $688.1 million at December 31, 2015. The decline in Ionis’ working capital was a result of the cash used in operations and a decline in the Company’s investment in Regulus Therapeutics resulting from a decline in Regulus’ share price. Ionis’ cash balance at June 30, 2016 did not include $85 million, comprised primarily of the $75 million from Biogen for the license of nusinersen, which it will add to its balance sheet in the third quarter.

Eagle Pharmaceuticals, Inc. Reports Second Quarter 2016 Results

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:

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.

Q2 2016 Financial Report

On August 9, 2016 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a clinical-stage biomedicine firm engaged in the development of immunotherapies for cancer and effective stem cell therapies for degenerative diseases, reported financial results and business highlights for the second quarter and six months ended June 30, 2016 (Press release, Cellular Biomedicine Group, AUG 9, 2016, View Source [SID:1234514395]).

"In the first half of 2016, we made several significant advancements towards the operating objectives for our dual technology platforms of immuno-oncology and stem cells," commented Tony (Bizuo) Liu, CBMG’s Chief Executive Officer. "The completion of a $43.13 million strategic investment has strengthened our capabilities to continue to invest in research and development, optimize our clinical process and expand our focus on the CAR-T pipeline. We anticipate in the coming quarters launching clinical trials in China on CAR-T CD19 and CD20 constructs and to further bolster our immuno-oncology pipeline. We have completed patient treatment in the Phase I trial of AlloJoinTM, our off-the-shelf allogeneic adipose-derived progenitor cell (haMPC) therapy for Knee Osteoarthritis (KOA) in China, and are encouraged to see no serious adverse events thus far. We continue to evaluate the feasibility of initiating a clinical study of AlloJoinTM under IND to support the same indication in the United States. As we look forward to the remainder of 2016, we will continue to prioritize our immuno-oncology and stem cell clinical pipelines for multiple indications that serve large addressable markets while facilitating future partnerships and collaborations that will enhance our ability to develop safe and effective therapies."

Second Quarter and First Half 2016 Financial Performance

1. Cash Position:Cash and cash equivalents as of June 30, 2016 were $47.5 million compared to $14.9 million as of December 31, 2015. This increase was due to a private placement financing in February and April 2016 for gross proceeds of approximately $43 million, offset by cash used in operating and investment activities.
2. Net Cash Used in Operating Activities:Net cash used in operating activities for the quarter and six months ended June 30, 2016 was $5.2 million and $8.8 million, respectively, compared to $3.3 million and $5.7 million for the same periods in 2015.
3. G&A Expenses: General and administrative expenses for the quarter and six months ended June 30, 2016 were $3.1 million and $5.8 million, respectively, compared to $3.8 million and $6.4 million for the same periods in 2015.
4. R&D Expenses: Research and development expenses for the quarter and six months ended June 30, 2016 were $3 million and $5.4 million respectively, compared to $1.3 million and $2.8 million for the same periods in 2015.
5. Net Loss:Net loss allocable to common stock holders for the quarter and six months ended June 30, 2016 was $7.2 million and $11.4 million respectively, compared to $5 million and $9.3 million for the same periods in 2015.

Recent Business and Technology Highlights

Completed treatment for eighteen patients in Phase I trial of AlloJoinTM haMPC therapy for Knee Osteoarthritis (KOA);
China Patent Office granted the Company’s patent application on genetically engineered anti-CD20 Chimeric Antigen Receptor-positive NKT cells, its production and application;
Advanced the Company’s cash position following the closing of an agreement with Wuhan Dangdai Science & Technology Industries Group Inc. to invest an aggregate of $43.13 million for 2.27 million shares of the Company’s common stock, representing a 16.2% post-money stake investment as of April 15, 2016;
Appointment of Dr. Zhou Hansheng as a member of the Board of Directors.
Pipeline Update

Conducted single-center Phase I trial of AlloJoinTM haMPC therapy for Knee Osteoarthritis (KOA) in China
Eighteen patients have received two dose intra-articular injections at three week intervals and have not been presented with any serious adverse events thus far
Patients will be monitored over the next 12 months for safety and efficacy signs
Phase I clinical research trial for AlloJoin is registered at ClinicalTrials.gov under the number NCT02641860
Anticipate announcement of sponsorship of multi-indication clinical studies with multiple institutions using CBMG’s CD19 and CD20 constructs and stem cell technologies by Q12017 after the technologies are optimized and manufacturing capabilities are in place
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