Delcath Announces Second Quarter Financial Results

On August 16, 2016 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported financial results for the three and six months ended June 30, 2016 (Press release, Delcath Systems, AUG 16, 2016, View Source;p=RssLanding&cat=news&id=2195645 [SID:1234514611]).

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Highlights for the second quarter of 2016 and recent weeks include:

Issuance of $35 million in senior convertible notes to support Melphalan/HDS Phase 3 Focus Trial enrollment and CHEMOSAT European commercialization through the end of 2017;
Presentation of data from a large single hospital experience conducted at Southampton University Hospital in the United Kingdom at the 6th European Post-Chicago Melanoma/Skin Cancer Meeting, which demonstrated overall survival benefit using Delcath’s CHEMOSAT to treat metastatic uveal melanoma;
Acceptance of abstracts from two studies conducted in Germany using Delcath’s CHEMOSAT to treat patients with liver metastases for presentation as posters at the Cardiovascular and Interventional Radiology Society of Europe (CIRSE) Annual Meeting in September 2016;
Acceptance of a review of clinical research treatment outcomes using Melphalan Hydrochloride for Injection with the Delcath Hepatic Delivery System (Melphalan/HDS) in patients with hepatic metastases for publication in the prestigious journal, Cancer Control;
Promotion of John Purpura to Executive Vice President, Global Head of Operations from Executive Vice President-Regulatory Affairs and Quality Assurance; and
Launch of CHEMOSAT at the HM Sanchinarro University Hospital in Madrid.
"Throughout the second quarter we made considerable clinical and commercial progress advancing CHEMOSAT as an innovative new treatment option for primary and metastatic liver cancers," noted Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath. "Importantly, we secured $35 million in committed financing that provides us with the resources to advance our clinical development plan through to key inflection points while also supporting our commercialization programs in Europe.

"We were particularly pleased to have real-world data from Southampton University Hospital’s experience presented at the Melanoma/Skin Cancer meeting as the progression free and overall survival benefits observed in this study are dramatic, especially given the limited treatment options for patients suffering with these life-threatening cancers. These supportive data provide us with considerable confidence that similar results may be formally validated by our FOCUS Phase 3 Trial in hepatic dominant ocular melanoma that is currently underway in the U.S. and Europe. We look forward to additional presentations and publication of data in support of CHEMOSAT in the treatment of cancers of the liver during the second of half of the year.

"The addition of CHEMOSAT to centers in Spain and Turkey highlight our continued progress commercializing the system in Europe. We continue with negotiations to determine reimbursement levels for CHEMOSAT under the ZE national system in Germany and expect coverage levels to be defined later this year. We believe that favorable reimbursement levels will enhance growth in procedure volumes in Germany and provide important validation for reimbursement appeals in other markets in Europe.

"The advances we made during the first half of 2016 have positioned us to achieve important clinical inflection points in our FOCUS trial and our global Phase 2 program in HCC and ICC, as we work to expand global access to our CHEMOSAT for the benefit of patients suffering with primary and metastatic liver cancers," concluded Dr. Simpson.

Second Quarter Financial Results

Total revenues for the second quarter of 2016 and 2015 were $0.5 million. Selling, general and administrative expenses for the second quarter of 2016 were $2.3 million, compared with $2.5 million for the same period in 2016, primarily attributable to a reduction in depreciation and corporate expenses. Research and development expenses increased to $1.9 million for the 2016 second quarter from $1.5 million for the same period in 2015, primarily due to increased investment in clinical development initiatives, specifically the global Phase 3 FOCUS clinical trial.

Total operating expenses for the second quarter of 2016 increased to $4.2 million from $4.0 million for the same period in 2015. This reflects an increase in clinical development initiatives, partially offset by reductions in depreciation and corporate expenses.

The Company recorded a net loss for the three months ended June 30, 2016 of $6.7 million, an increase of $3.0 million from a net loss of $3.7 million for the same period in 2015. This was primarily driven by amortization of debt discounts related to the convertible note issued in June 2016 and a change in the fair value of the warrant liability, a non-cash item.

First Half Financial Results

Total revenues for the first half of 2016 and 2015 were $0.9 million. Selling, general and administrative expenses for the first six months of 2016 were $4.7 million, an improvement of $0.8 million or 15% from $5.5 million reported for the same period in 2015, primarily attributable to a reduction in facility expenses related to the lease restructurings. Research and development expenses during the first half of 2016 increased to $3.3 million compared with $2.4 million for the same period in 2015, primarily due to increased investment in clinical development initiatives.

Total operating expenses for the first half of 2016 were $8.0 million compared with $8.0 million for the same period in 2015.

The Company recorded a net loss for the six months ended June 30, 2016 of $8.5 million, an increase of $1.3 million from a net loss of $7.2 million for the six months ended June 30, 2015. This was primarily driven by amortization of debt discounts related to the convertible note issued in June 2016 and a change in the fair value of the warrant liability, a non-cash item.

Balance Sheet Highlights

As of June 30, 2016, Delcath had cash and cash equivalents of $7.5 million, compared with $12.6 million as of December 31, 2015. During the first half of 2016, the Company used $7.0 million in cash to fund its operating activities. In June 2016, Delcath issued $35.0 million of senior convertible notes and related common stock purchase warrants. As a result, Delcath believes it has sufficient capital to fund its operating activities through the end of 2017.

Abeona Therapeutics Announces Second Quarter 2016 Financial Results and Recent Clinical Highlights

On August 16, 2016 Abeona Therapeutics Inc. (NASDAQ: ABEO) a clinical-stage biopharmaceutical company focused on delivering gene and plasma-based therapies for life-threatening rare diseases, reported financial results for the second quarter (Press release, Abeona Therapeutics, AUG 16, 2016, View Source;p=RssLanding&cat=news&id=2195628 [SID:1234514594]). The Company will provide investors an update on recent and ongoing business activities and an overview of its 2Q16 financials on, Wednesday, August 17th, at 10:00 am (Eastern). Interested parties are invited to participate in the call by dialing 877-269-7756 (toll free domestic) or 201-689-7817 (international).

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"The second fiscal quarter of 2016 brought significant advancements in our goal of building a strong leadership position in the development of innovative therapies for rare diseases," stated Steven H. Rouhandeh, Executive Chairman. "We are excited about the initial biopotency signals seen in our Sanfilippo Type A clinical trial, and are looking forward to advancing multiple important new therapeutic candidates for the treatment of epidermolysis bullosa (EB), as announced last week. We thank our collaborators, shareholders and staff for their ongoing commitment and support as we move these therapies further into clinical development."

Timothy J. Miller, Ph.D, stated, "Abeona achieved many important regulatory and clinical milestones in the second quarter of 2016. The milestones include the dosing of the first patient in our Phase 1/2 clinical trial with ABO-102 for patients with Sanfilippo syndrome type A, the FDA allowance of our Phase 1/2 clinical study in Sanfilippo syndrome type B (MPS IIIB), and, most recently, the European regulatory approval for our MPS IIIA Phase 1/2 clinical study to be conducted at Cruces University Hospital in Bilbao, Spain. Additionally, we are excited about our new collaboration with the EB Research Partnership, EB Medical Research Foundation and Stanford University to accelerate up to three new promising EB product candidates toward commercialization."

Recent Abeona Operating Highlights

On May 17, 2016, Abeona announced that the first patient in its Phase 1/2 trial for ABO-102 (AAV-SGSH), a single treatment gene therapy strategy for patients with Sanfilippo syndrome type A (MPS IIIA), has been enrolled at Nationwide Children’s Hospital in Columbus, Ohio.
On May 24, 2016, Abeona announced the FDA Allowance of its Investigational New Drug (IND) for a Phase 1/2 clinical study with ABO-101 (AAV-NAGLU) for patients with Sanfilippo syndrome type B (MPS IIIB).
On August 2, 2016, Abeona provided an update on the initial subjects enrolled in this trial, stating that ABO-102 had been well tolerated with no safety or tolerability concerns identified through 30-days post-injection, and that encouraging signs of early biopotency had been observed in urinary and CSF GAG (heparan sulfate) measurements as well as potential disease-modifying effects in the liver and spleen.
On August 4, 2016, the Company announced it had received European regulatory approval by the Agencia Espanola de Medicamentos y Productos Sanitarios for its Phase 1/2 trial for ABO-102 (AAV-SGSH) to be conducted at Cruces University Hospital (Bilbao, Spain).
On August 9, 2016, Abeona announced a collaboration with the EB Research Partnership, EB Medical Research Foundation and Stanford University for the development of treatments for recessive dystrophic epidermolysis bullosa (RDEB). Clinical results for the lead EB program (EB-101) were recently presented at the opening Plenary Session of the Society for Investigative Dermatology in May 2016, and Investigators at Stanford are recruiting patients for a Phase 2 clinical trial of EB-101 in adolescents age 13 and older to determine the effect of type VII collagen gene corrective grafts on wound healing efficacy.
Second Quarter Summary Financial Results

Cash Position : Cash, cash equivalents and marketable securities as of June 30, 2016 were $34.3 million, compared to $37.4 million as of March 31, 2016. Net cash used in operating activities in the Six Months Ended June 30, 2016 was $5.6 million as compared to $5.0 million in the same period in 2015, an increase of $0.6 million.
Revenues : Revenues were $214 thousand for the second quarter of 2016, compared to $282 thousand in in the second quarter of 2015. Revenues consisted of a combination of royalties from marketed products, primarily MuGard, and recognition of deferred revenues related to upfront payments from early license agreements.
Loss per share : Loss per share was $0.20 for the second quarter of 2016, compared to a loss per share of $0.16 in comparable period in 2015.

OncoGenex Announces Results from the Phase 3 AFFINITY Trial of Custirsen in Men with Metastatic Castrate-Resistant Prostate Cancer

On August 16, 2016 OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) reported results from the final analysis of AFFINITY, the Phase 3 trial of custirsen in men with metastatic castrate-resistant prostate cancer (CRPC) whose disease has progressed after treatment with docetaxel (Press release, OncoGenex Pharmaceuticals, AUG 16, 2016, View Source [SID:1234514590]). The trial did not meet the primary endpoint of demonstrating a statistically significant improvement in overall survival for patients treated with custirsen in combination with cabazitaxel/prednisone compared to cabazitaxel/prednisone alone.

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The adverse events were consistent with those observed in previous trials of custirsen in metastatic CRPC. The final data will be submitted as a late-breaking abstract to the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress 2016.

"We are obviously disappointed that custirsen was unable to demonstrate a survival benefit in prostate cancer. We would like to thank the patients who participated in the AFFINITY trial and their caregivers, as well as the investigators and their teams for their commitment to improving cancer care for patients who are in desperate need of new treatment options," said Scott Cormack, President and CEO of OncoGenex.

As a result of these data and previous custirsen findings, OncoGenex plans to initiate discussions with the U.S. Food and Drug Administration (FDA) to evaluate options related to an early analysis of the Phase 3 ENSPIRIT trial investigating custirsen in combination with docetaxel as second-line chemotherapy in patients with non-small cell lung cancer (NSCLC).

"Given that the ENSPIRIT trial has nearly completed enrollment and we believe there are likely a sufficient number of events to determine the effect of custirsen in NSCLC, we are eager to expedite the final data analysis, which would allow us to conserve resources and fully understand the value of the asset as we evaluate our alternatives to maximize shareholder value," said Cormack.

OncoGenex has engaged MTS Health Partners, LP as its advisor to assist with the exploration of strategic alternatives.

Conference Call Details
OncoGenex will host a conference call at 7:30 a.m. Eastern Time today, Tuesday, August 16, 2016, to discuss today’s news. A live event will be available on the Investor Relations section of the OncoGenex website at www.OncoGenex.com. Alternatively, visitors may access the live conference call by dialing (877) 606-1416 (U.S. & Canada) or (707) 287-9313 (International). A webcast replay will be available approximately two hours after the call and will be archived on www.OncoGenex.com for 90 days.

About the AFFINITY Trial
The Phase 3 AFFINITY trial was an international, randomized, open-label study designed to evaluate whether custirsen, when combined with cabazitaxel, could improve survival outcomes for patients with metastatic CRPC whose disease has progressed after treatment with docetaxel.

Patients received cabazitaxel in combination with weekly custirsen or cabazitaxel alone, and treatment continued until disease progression, unacceptable toxicity or completion of 10 cycles. The AFFINITY trial enrolled 634 men with metastatic CRPC at 95 sites throughout North America, Europe, Russia and Australia. For more information on the AFFINITY trial, please visit ClinicalTrials.gov (NCT01578655).

About ENSPIRIT Trial
The Phase 3 ENSPIRIT trial is an international, randomized, open-label trial designed to evaluate custirsen for the treatment of advanced or metastatic NSCLC in 700 patients who have progressed after initial chemotherapy treatment. The trial is investigating if combining custirsen with docetaxel, a standard second-line NSCLC chemotherapy, has the potential to improve survival outcomes compared to docetaxel alone in these patients. ENSPIRIT is expected to enroll patients at approximately 50 sites globally. For more information on the ENSPIRIT trial, please visit ClincalTrials.gov (NCT01630733).

About Custirsen
Custirsen is a highly specific clusterin inhibitor designed to improve survival in patients with advanced cancer by disabling a fundamental cellular repair mechanism used by tumor cells. Custirsen binds to clusterin mRNA to block the production of clusterin protein and has enhanced the tumor cell destructive effects of multiple anti-cancer therapies across a variety of tumor models. By inhibiting clusterin, custirsen is designed to alter tumor dynamics by slowing tumor growth and inhibiting tumor resistance to partner treatments, so that the benefits of therapy, including survival, may be extended.

10-Q – Quarterly report [Sections 13 or 15(d)]

Oncbiomune has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, OncBioMune Pharmaceuticals, 2017, AUG 15, 2016, View Source [SID1234522114]).

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10-Q – Quarterly report [Sections 13 or 15(d)]

Syros Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Syros Pharmaceuticals, 2017, AUG 15, 2016, View Source [SID1234521295]).

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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

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