Delcath Systems has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Delcath Systems, 2018, MAR 16, 2018, View Source [SID1234524864]).

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On March 16, 2018 Delcath Systems, Inc. (OTCQB:DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, reported that financial results for the twelve months ended December 31, 2017 (Press release, Delcath Systems, MAR 16, 2018, View Source;p=RssLanding&cat=news&id=2338487 [SID1234524857]).

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Highlights from the fourth quarter of 2017 and recent weeks include:

Revenue from European sales for 2017 increased 35% to $2.7 million from $2.0 million in 2016;
Satisfaction of all obligations under the privately placed senior secured convertible notes issued to two institutional investors in June 2016;
Completed a $5.0 million capital raise in February 2018;
Modified the Special Protocol Agreement (SPA) with the U.S. Food and Drug Administration (FDA) for the Company’s Phase 3 clinical trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) to treat patients with hepatic dominant ocular melanoma (OM);
Announced that the independent Data Safety Monitoring Board (DSMB) of the Phase 3 FOCUS clinical trial recommended that the study continue without modification; Reported the 500th CHEMOSAT treatment in Europe;
Announced results from a multi-center analysis of Delcath’s Percutaneous Hepatic Perfusion (PHP) therapy in the peer-reviewed Journal of Surgical Oncology; largest data set outside of clinical trial showed manageable toxicity and overall median overall survival of 15.3 months, and;
Secured a commercial supply of melphalan through an agreement with Tillomed Laboratories for use with the company’s CHEMOSAT Delivery System for Melphalan, where it is marketed in Europe for the treatment of a wide range of cancers of the liver.
Management Commentary

"For much of the second half of 2017 and recent weeks, our focus has been on easing the cash constraints and other restrictions related to our capital structure," said Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath. "These limitations necessitated a series of transactions during the second half of 2017 and the early weeks of 2018 that have permitted us to exit our 2016 Convertible Note, invest in our clinical development program, and advance our commercialization efforts for CHEMOSAT in Europe. We continue to work to resolve the remaining issues and to secure new equity financing under less dilutive terms to execute our plan and create value for our shareholders."

"Despite cash constraints, total revenues for fiscal year 2017 increased 35% over the prior year, continuing the steady growth in our core European markets. This growth was supported by the establishment of ZE diagnostic-related (DRG) reimbursement for CHEMOSAT in Germany, which we are leveraging to obtain market access and reimbursement in other regions such as the United Kingdom and the Netherlands. In the Netherlands, Dutch Health Authorities have included CHEMOSAT treatment in their published guidelines for OM liver metastases. We are hopeful that inclusion in the national guidelines and the support of clinicians treating patients with CHEMOSAT will support an application for reimbursement in this market. Since launching CHEMOSAT in Europe, over 500 commercial CHEMOSAT procedures have been performed.

"In our clinical development program, we achieved an important milestone in December 2017 when the independent DSMB for our Phase 3 FOCUS clinical trial for patients with hepatic dominant OM completed a pre-specified review of safety data and recommended that the study continue without modification. This confirms our own observations of the improvements in the safety profile of PHP therapy based on prior research and our commercial experience with CHEMOSAT in Europe. We were also happy to announce a SPA modification agreement with the FDA to revise the FOCUS trial’s eligibility criteria to permit a greater extent of extra-hepatic disease by removing the size restriction, number and location of extra-hepatic lesions, in conjunction with a treatment plan for the extra-hepatic metastases. We requested this protocol modification to improve patient access to this important clinical trial for appropriately selected patients. In an ultra-orphan indication like OM, striking the appropriate balance between eligibility criteria and patient access can be a challenge. We are pleased that the FDA agreed to this modification, and hope that once approved by the European Competent Authorities, ethics boards and institutional review boards of our participating clinical trial sites, this protocol modification will help accelerate enrollment in this registration trial.

"Enrollment in our FOCUS Phase 3 Trial has been slower than anticipated, and our ability to take proactive steps to support enrollment was limited by the cash constraints we operated under in 2017. With the rollout of the SPA protocol modification to participating centers underway, we hope to accelerate enrollment in 2018 and expect to update our enrollment projections in the second half of this year. Any impact on enrollment from the SPA modification is not expected to be immediate, and it is unlikely that enrollment for this trial will be completed in time to submit an NDA to the FDA in 2019.

"For our pivotal trial in intrahepatic cholangiocarcinoma (ICC), we continue to work with potential trial sites with a view to opening the trial in the first half of 2018. Our ICC pivotal trial is based on the prior work done in our Phase 2 trial program in hepatocellular carcinoma (HCC) and ICC, which had the objective of identifying an efficacy signal worthy of further clinical investigation. This objective was met by the retrospective data collection performed by European investigators last year, which informed our development path for ICC. We have closed enrollment in the Phase 2 trials to devote available resources to the FOCUS Trial and the planned ICC pivotal trial.

"Though the recent months have been financially difficult, we remain committed to advancing our clinical and commercial programs. We are continuously working to improve our ability to operate so we can realize the potential of PHP therapy and return value to our shareholders," concluded Dr. Simpson.

2017 Financial Results

Total revenue for the year ended December 31, 2017 of $2.7 million was an increase of 35% when compared to the $2.0 million total for 2016. The increase is the result of greater product sales in Europe in 2017 as Delcath continued to see increased market acceptance of its product, particularly in Germany where the establishment of the ZE code contributed to an increase in treatments.

Research and development (R&D) expenses for 2017 increased to $10.5 million from $8.4 million for the prior year, largely as a result of costs associated with the Company’s ongoing Phase 3 FOCUS Trial. Selling, general and administrative expenses for 2017 increased to $9.7 million from $9.4 million in 2016, primarily due to an increase in Delaware corporate taxes, independent audit fees, and costs associated with the Company’s efforts to secure approval for a reverse stock split.

For the year ended December 31, 2017, derivative instrument income increased to $15.1 million from $12.8 million for the year ended December 31, 2016. The increase of $2.3 million is due to the issuance of the November 2017 warrants and the subsequent mark-to-market adjustment at December 31, 2017.

The Company had a net loss for the year ended December 31, 2017 of $45.1 million, an increase of $27.1 million, or 151.1%, compared to the net loss of $18.0 million for the same period in 2016. Approximately $2.3 million is related to an increase in operating expenses primarily related to increased investment in clinical trial initiatives. The balance of the increase is related to several non-cash items, including a $7.4 million increase in interest expense primarily related to the amortization of debt discounts and a $29.9 million loss on the settlement of the convertible note debt, which was partially offset by a $2.3 million change in the fair value of the warrant liability and a $9.6 million gain on the extinguishment of the June 2016 Series C Warrants.

The 2016 net loss included a $14.3 million increase in interest expense primarily related to the amortization of debt discounts and a $1.4 million increase in operating expenses primarily related to increased investment in clinical trial initiatives. This was offset by a $12.2 million change in the fair value of the warrant liability, a non-cash item, and a $0.2 million improvement in gross profit due to increased sales.

Balance Sheet Highlights

As of December 31, 2017, Delcath had cash and cash equivalents of $4.0 million, compared with $4.4 million as of December 31, 2016. During 2017 the Company used $15.4 million of cash to fund operating activities.

On February 9, 2018, the Company closed a registered offering of 212.0 million shares of common stock, 38.0 million pre-funded warrants to purchase 38.0 million shares of common stock and warrants to purchase an aggregate of 500.0 million shares of common stock for total gross proceeds of approximately $5.0 million.

Delcath believes it has sufficient capital and access to committed capital to fund its operating activities through May of 2018.

Geron has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Geron, 2018, MAR 16, 2018, View Source [SID1234524865]).

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On March 16, 2018 Geron Corporation (Nasdaq:GERN) reported financial results for the fourth quarter and year ended December 31, 2017 and recent events (Press release, Geron, MAR 16, 2018, View Source;p=RssLanding&cat=news&id=2338516 [SID1234524858]).

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Fourth Quarter and Year-End 2017 Results

For the fourth quarter of 2017, the company reported a net loss of $7.4 million, or $0.05 per share, compared to $8.5 million, or $0.05 per share, for the comparable 2016 period. For 2017, the company reported a net loss of $27.9 million, or $0.18 per share, compared to $29.5 million, or $0.19 per share, for 2016. The company ended 2017 with $109.2 million in cash and investments.

Revenues for the fourth quarter of 2017 were $191,000 compared to $94,000 for the comparable 2016 period. Revenues for 2017 were $1.1 million compared to $6.2 million for 2016. Revenues in 2016 included the full recognition of an upfront payment of $5.0 million from Janssen Pharmaceuticals, Inc. under a license agreement that was signed in September 2016 for certain rights to specialized oligonucleotide backbone chemistry and novel amidates.

Total operating expenses for the fourth quarter of 2017 were $8.0 million compared to $8.9 million for the comparable 2016 period. Total operating expenses for 2017 were $30.3 million compared to $36.8 million for 2016.

Research and development expenses for the fourth quarter of 2017 were $2.5 million compared to $4.1 million for the comparable 2016 period. Research and development expenses for 2017 were $11.0 million compared to $18.0 million for 2016. The decrease in research and development expenses in 2017 compared to 2016 primarily reflects lower costs for the company’s proportionate share of clinical development expenses under the imetelstat collaboration with Janssen Biotech, Inc. and reduced personnel related expenses.

General and administrative expenses for the fourth quarter of 2017 were $5.5 million compared to $4.8 million for the comparable 2016 period. General and administrative expenses for 2017 were $19.3 million compared to $18.8 million for 2016. The increase in general and administrative expenses in 2017 compared to 2016 primarily reflects higher non-cash stock-based compensation expense and increased consulting costs, partially offset by lower legal costs.

Interest and other income for the fourth quarter of 2017 was $375,000 compared to $321,000 for the comparable 2016 period. Interest and other income for 2017 was $1.4 million compared to $1.2 million for 2016. The increase in interest and other income for 2017 compared to 2016 primarily reflects higher yields on the company’s marketable securities portfolio.

Fourth Quarter 2017 and Recent Events

IMerge

IMerge is the ongoing Phase 2/3 clinical trial of imetelstat in red blood cell (RBC) transfusion-dependent patients with lower risk myelodysplastic syndromes (MDS) who are refractory or resistant to treatment with an erythropoiesis stimulating agent (ESA).

Medical Conference Presentation. At the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2017, preliminary data as of October 2017 were presented from the first 32 patients enrolled in Part 1 of IMerge. The data showed that among the subset of 13 patients who had not received prior treatment with either lenalidomide or a hypomethylating agent (HMA) and did not have a deletion 5q chromosomal abnormality (non-del(5q)), 54% achieved RBC transfusion-independence (TI) lasting at least 8 weeks, including 31% who achieved a 24-week RBC-TI. In the overall trial population, the rates of 8- and 24-week RBC-TI were 38% and 16%, respectively. Cytopenias, particularly neutropenia and thrombocytopenia, were the most frequently reported adverse events, which were predictable, manageable and reversible. Imetelstat presentations are available through the Publications page in the R&D section of Geron’s website at www.geron.com/r-d/publications.

"With the preliminary data from IMerge presented at ASH (Free ASH Whitepaper), we now have clinical data in three blood cancers, ET, MF and MDS, where imetelstat exhibits potential disease modifying activity by inhibiting the progenitor cells of the malignant clones that drive the underlying diseases," said John A. Scarlett, M.D., Geron’s President and Chief Executive Officer.

Investor Event. Geron hosted an analyst and investor meeting in December 2017 during which an IMerge clinical investigator presented and discussed the data presented at ASH (Free ASH Whitepaper), as well as a description of the unmet medical need in lower risk MDS. The archived webcast of the presentation is available for replay through the Investors section of Geron’s website under Events.

Clinical Development. Based on the preliminary data from the 13-patient subset, Janssen expanded Part 1 of IMerge to enroll approximately 20 additional patients who were naïve to lenalidomide and HMA treatment and non-del(5q) to increase the experience and confirm the benefit-risk profile of imetelstat in this refined target patient population. The first patient in the expanded Part 1 was dosed in November 2017 and enrollment was completed in February 2018.

Regulatory Designation. In October 2017, the United States Food and Drug Administration (FDA) granted Fast Track designation to imetelstat for the potential treatment of adult patients with transfusion-dependent anemia due to Low or Intermediate-1 risk MDS who are non-del(5q) and who are refractory or resistant to treatment with an ESA. Janssen sponsored the application for Fast Track designation using preliminary data from IMerge.

IMbark

IMbark is the ongoing Phase 2 clinical trial to evaluate two doses of imetelstat in intermediate-2 or high-risk myelofibrosis (MF) patients who are refractory to or have relapsed after treatment with a JAK inhibitor.

Clinical Development. Janssen completed a third internal data review of IMbark in March 2018, based on a January 2018 data cut, to enable a protocol amendment to allow the long-term treatment and follow up of patients, including for survival, and the Collaboration’s Joint Steering Committee (JSC) made the following observations and implemented the following actions:

The safety profile was consistent with prior clinical trials of imetelstat in hematologic malignancies, and no new safety signals were identified.

Outcome measures for efficacy, including spleen volume responses and reductions in Total Symptom Score remain consistent with the prior data reviews.

With a median follow up of approximately 19 months, the median overall survival has not been reached in either dosing arm.

The trial is officially being closed to new patient enrollment. More than 100 patients have been enrolled in IMbark to date, which is expected to be adequate to assess overall survival. Patients who remain in the treatment phase may continue to receive imetelstat, and until the primary analysis, all safety and efficacy assessments are being conducted as planned in the protocol, including following patients, to the extent possible, until death to enable an assessment of overall survival.

Based on the rate of deaths occurring in the trial, the protocol-specified primary analysis, which includes an assessment of overall survival, will begin by the end of the second quarter of 2018.

Upon the protocol-specified primary analysis, the main trial will be completed. The IMbark protocol is being amended to establish an extension phase of the trial to enable patients remaining in the treatment phase to continue to receive imetelstat treatment per investigator discretion. During the extension phase, standard data collection will primarily consist of safety information.
Upcoming 2018 Events

Following completion of the IMbark protocol-specified primary analysis, Janssen must notify Geron whether it elects to maintain the license rights and continue the development of imetelstat in any indication (Continuation Decision). Geron expects the protocol-specified primary analysis for IMbark to begin by the end of the second quarter of 2018. As such, the company expects the Continuation Decision to occur by the end of the third quarter of 2018.

Conference Call and Webcast

At 8:30 a.m. ET on March 19, 2018, Geron’s management will host a conference call to discuss the company’s fourth quarter and annual results as well as recent company events.

Participants can access the conference call live via telephone dialing 877-303-9139 (U.S.); 760-536-5195 (international). The conference ID is 3564078. A live audio-only webcast is also available through the Investors section of our website at www.geron.com or at View Source The audio webcast of the conference call will be available for replay approximately one hour following the live broadcast through April 20, 2018.

Abeona Therapeutics has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Abeona Therapeutics, 2018, MAR 16, 2018, View Source [SID1234524866]).

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