On September 27, 2018 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) reported it has entered into a strategic licensing and collaboration agreement with Novartis to manufacture and supply the CAR-T cell therapy Kymriah (tisagenlecleucel) in China (Press release, Cellular Biomedicine Group, SEP 27, 2018, View Source [SID1234529612]). Novartis will be the exclusive holder of the marketing license.

Upon the closing of the licensing and collaboration agreement, CBMG – a clinical-stage biopharmaceutical firm engaged in the development of immunotherapies for cancer and stem cell therapies for degenerative diseases – will receive $40 million in an equity purchase from Novartis at $27.43/share for approximately 9% equity. Novartis will receive certain royalty-free intellectual property worldwide rights to certain CBMG CAR-T related technology. CBMG will receive a single-digit escalating percentage collaboration payment based on net product sales. CBMG will receive a mark-up from Novartis on the manufacturing cost. CBMG will take the lead in the manufacturing process, and Novartis will lead distribution, regulatory and commercialization efforts in China.

"This collaboration with Novartis reflects our shared commitment to bringing the first marketed CAR-T cell therapy Kymriah, a transformative treatment option currently approved in the United States, European Union and Canada for two difficult-to-treat cancers, to China where the number of patients in need remains the highest in the world," said Tony Liu, Chief Executive Officer, CBMG. "Together with Novartis, we hope to bring the first CAR-T cell therapy to patients in China. In addition, we continue to focus on developing CBMG’s pipeline of immuno-oncology assets."

"Novartis is committed to bringing new hope to children and adults who are suffering from aggressive forms of blood cancer and currently have limited therapeutic options. We are proud to collaborate with CBMG in China to expand our Kymriah manufacturing capabilities and the potential to facilitate safe and seamless delivery of this innovative, one-time treatment to patients in need," said Pascal Touchon, Senior VP and Global Head, Cell & Gene, Novartis Oncology.

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On September 27, 2018 Geron Corporation (Nasdaq: GERN) reported that Janssen Biotech, Inc. (Janssen) has terminated the 2014 Collaboration and License Agreement (CLA) with the Company (Press release, Geron, SEP 27, 2018, http://ir.geron.com/news-releases/news-release-details/geron-announces-discontinuation-imetelstat-collaboration-janssen [SID1234532272]). Janssen stated in their press release issued today that they made this decision as the result of a strategic portfolio evaluation and prioritization of assets within their portfolio. As such, Geron has regained the global rights to develop and commercialize imetelstat, a first-in-class telomerase inhibitor.

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"We are grateful for the collaboration with Janssen, who successfully managed two Phase 2 trials of imetelstat," said John A. Scarlett, M.D., Geron’s President and Chief Executive Officer. "We believe the clinical results from IMbark provide valuable insights into the potential future development of imetelstat for an underserved relapsed and refractory myelofibrosis patient population. We also believe the combined data of 38 patients from the initial and expansion cohorts for the target patient population from the Phase 2 portion of IMerge support further development of imetelstat, and we are therefore prioritizing the initiation of the Phase 3 portion of IMerge."

Under the terms of the CLA, the effective date of the termination is September 28, 2018, after which the licensed rights to the imetelstat program, including intellectual property rights generated under the collaboration, return to Geron without any continuing economic obligations to Janssen, and Janssen has no further obligations to fund any of the current ongoing imetelstat clinical trials.

Transition of the imetelstat program to Geron is expected to occur over approximately 12 months with operational support from Janssen, including the orderly transfer of all ongoing clinical, regulatory, medical affairs, manufacturing and preclinical activities to Geron. In addition, Janssen is expected to supply imetelstat to Geron for up to 24 months during a transition period for clinical manufacturing.

Patients currently enrolled in the ongoing imetelstat clinical trials in myelofibrosis (IMbark) and myelodysplastic syndromes (IMerge) will continue to be supported through the respective trial protocols, including treatment and follow-up.

Expanded Phase 2 Portion of IMerge Data Snapshot Highlights

IMerge is a two-part clinical trial evaluating imetelstat in transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS) who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA).

The first part of the trial was originally designed as a Phase 2, open-label, single-arm trial to assess the efficacy and safety of imetelstat. The second part of the trial is planned as a Phase 3 double-blind, randomized, placebo-controlled trial in approximately 170 patients. The primary efficacy endpoint is the rate of red blood cell transfusion independence, or RBC-TI rate, lasting at least 8 weeks. Key secondary endpoints include the RBC-TI rate lasting at least 24 weeks, amount and relative change in red blood cell transfusions and hematologic improvement.

In the original Phase 2 portion of IMerge, 32 patients were enrolled, of which a subset of 13 patients had not received prior treatment with either a hypomethylating agent (HMA) or lenalidomide and did not have a del(5q) chromosomal abnormality.

As reported at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress in June 2018, the initial cohort of 13 patients showed an increased durability and rate of transfusion independence compared to the overall trial population (≥8-week RBC-TI rate: 54% vs. 34%). Based on these data from the initial cohort, enrollment into the Phase 2 portion of IMerge was expanded to include an additional 25 patients (expansion cohort) who are non-del(5q) and naïve to HMA and lenalidomide treatment in order to increase the clinical experience and confirm the benefit-risk profile of imetelstat dosed at 7.5 mg/kg every four weeks in this target patient population.

To align with the completion of the IMbark primary analysis and their decision about the collaboration, Janssen conducted an initial data review of the expansion cohort, which they called a data snapshot. This data snapshot represented an early look at the expansion cohort since the median follow-up was less than half the time the 13-patient initial cohort had been followed when their data were first reported. The median baseline RBC transfusion burden for the expansion cohort (n=25) was 8.0 units/8 weeks, compared to 6.0 units for the initial 13-patient cohort.

In the data snapshot for the expansion cohort (n=25), the ≥8-week RBC-TI rate was 28%. Combining the expansion cohort with the 13-patient initial cohort for the target patient population (n=38), the ≥8-week RBC-TI rate was 37%. As of the data snapshot, sufficient time had not elapsed in the expansion cohort to assess the ≥24-week RBC-TI rate.

The safety profile from the additional enrolled patients was consistent with the safety profile from the original 32 patients, as well as with other clinical trials of imetelstat in hematologic myeloid malignancies. No new safety signals were identified. The most common adverse events were cytopenias.

Geron believes the combined data from the initial and expansion cohorts for the target patient population (n=38) support initiating the Phase 3 portion of IMerge to address an unmet medical need for patients who have failed ESAs and for whom currently available therapies show only modest efficacy.

Janssen submitted detailed results from the combined initial and expansion cohorts for the target patient population (n=38) in the Phase 2 portion of IMerge as an abstract for potential presentation at the 60TH Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper). If the abstract is accepted for presentation at ASH (Free ASH Whitepaper), Geron expects more mature data from the target patient population in the Phase 2 portion of IMerge to be included in the ASH (Free ASH Whitepaper) presentation. The Company also expects final data from the Phase 2 portion of IMerge to be available in 2019 and anticipates submitting such final data for presentation at a future medical conference in 2019.

Phase 3 Development Plan for Lower Risk MDS

Based on the combined data from the initial and expansion cohorts for the target patient population in the Phase 2 portion of IMerge, Geron plans to initiate the Phase 3 portion of IMerge after the sponsorship of the ongoing imetelstat clinical trials has been transferred from Janssen to Geron. Geron anticipates patient screening and enrollment for the Phase 3 portion of IMerge to begin by mid-year of 2019. In addition, Geron has engaged a global contract research organization (CRO) to support imetelstat clinical development.

IMbark Protocol-Specified Primary Analysis Highlights

IMbark was designed as a Phase 2 clinical trial to evaluate two starting dose levels of imetelstat (either 4.7 mg/kg or 9.4 mg/kg administered by intravenous infusion every three weeks) in approximately 200 patients with Intermediate-2 or High-risk myelofibrosis (MF) who have relapsed after or are refractory to prior treatment with a JAK inhibitor.

The co-primary efficacy endpoints for the trial are spleen response rate, defined as the proportion of patients who achieve a ≥35% reduction in spleen volume assessed by imaging; and symptom response rate, defined as the proportion of patients who achieve a ≥50% reduction in Total Symptom Score, at 24 weeks. Key secondary endpoints are safety and overall survival.

For the 9.4 mg/kg dosing arm (n=59), highlights from the primary analysis included a spleen response rate of 10% and a symptom response rate of 32%. No patients achieved complete remission, and one patient achieved partial remission. The safety profile was consistent with prior clinical trials of imetelstat in hematologic malignancies, and no new safety signals were identified. The most common adverse events were cytopenias. At the time of the primary analysis, median overall survival had not been reached after 23 months of median follow-up.

The extension phase of IMbark is ongoing to allow the long-term treatment and follow-up of patients. Data collection during this phase will consist of serious adverse events and survival.

Janssen submitted detailed results from the IMbark primary analysis as an abstract for potential presentation at the 60TH Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper). If the abstract is accepted for presentation at ASH (Free ASH Whitepaper), Geron expects more mature data from the extension phase of IMbark to be included in the ASH (Free ASH Whitepaper) presentation.

Geron intends to discuss the results of the IMbark primary analysis, including the assessment of overall survival as it compares to historical data, with experts in myelofibrosis, as well as regulatory authorities. The Company believes feedback from these discussions will provide important information on the scope and design of any potential future clinical trials for imetelstat in Intermediate-2 or High-risk MF patients who have relapsed after or are refractory to prior treatment with a JAK inhibitor.

Revised Financial Guidance

As a result of the termination of the CLA and Geron’s decision to continue the development of imetelstat independently, the Company has revised its financial projections and now anticipates 2018 operating expenses to be approximately $37 million (previously $30 million). The Company expects its operating expenses to increase as it hires additional personnel and external service providers to support the development of imetelstat. As of August 31, 2018, the Company had approximately $183 million in cash and marketable securities which is expected to be sufficient to support its plans to initiate the Phase 3 portion of IMerge in 2019.

Conference Call

Geron will host a conference call to discuss its future development plans for imetelstat at 8:00 a.m. ET on Thursday, September 27, 2018.

Participants may access the conference call live via telephone by dialing domestically +1 (877) 303-9139 or internationally +1 (760) 536-5195. The passcode is 7987354. A live, listen-only webcast will also be available on the Company’s website at www.geron.com/investors/events. If you are unable to listen to the live call, an archived webcast will be available on the Company’s website for 30 days.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Early clinical data suggest imetelstat may have disease-modifying activity through the suppression of malignant progenitor cell clone proliferation, which allows potential recovery of normal hematopoiesis. Ongoing clinical studies of imetelstat include a Phase 2/3 trial called IMerge in lower risk myelodysplastic syndromes (MDS) and a Phase 2 trial called IMbark in Intermediate-2 to High risk myelofibrosis. Imetelstat received Fast Track designation from the United States Food and Drug Administration for the treatment of patients with transfusion-dependent anemia due to lower risk MDS who are non-del(5q) and refractory or resistant to an erythroid stimulating agent.

On September 27, 2018 AngioDynamics, Inc. (NASDAQ:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported financial results for the first quarter of fiscal year 2019, which ended August 31, 2018 (Press release, AngioDynamics, SEP 27, 2018, View Source [SID1234529629]).

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"Our operating and financial accomplishments during the first quarter reflect our ongoing commitment to building a more cohesive, patient-focused product portfolio. As evidenced by our two recent acquisitions, we are making progress on our portfolio optimization efforts with a focus on the continuum of care within oncology, as well as on disruptive and differentiated technologies," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "Our first quarter results give us continued confidence in meeting our financial goals for fiscal 2019."

First Quarter 2019 Financial Results

Net sales for the first quarter of fiscal 2019 were $85.3 million, compared to $85.4 million a year ago. During the quarter, growth in the Company’s Vascular Access business was offset by declines in its Oncology business, while Vascular Interventions and Therapies (VIT) sales were flat.

Currency did not have a significant impact on the Company’s sales in the quarter.

Oncology net sales were $11.6 million, a decrease of 6.1% from $12.3 million a year ago, as NanoKnife disposable growth was more than offset by decreases in sales of Radiofrequency Ablation and timing effects of Microwave products. The comparison of year-over-year results within the Company’s Oncology business was negatively impacted by the timing of the prior-year Acculis Microwave abalation system market withdrawal. Excluding the impact of this transition from the Company’s Acculis Microwave product to its Solero Microwave product, the Oncology business grew 7.5% year over year.
VIT net sales in the first quarter of fiscal 2019 were $50.0 million, compared to $49.9 million a year ago, as growth in Fluid Management, Angiographic Catheters, and AngioVac was offset by declines in the Venous Insufficiency business.
Vascular Access net sales were $23.8 million, an increase of 2.4% from $23.2 million a year ago, as growth in Ports, Dialysis, and Midline products was partially offset by a decline in sales of PICCs.
U.S. net sales in the first quarter of fiscal 2019 were $67.7 million, a decrease of 1.8% from $68.9 million a year ago, and International net sales were $17.7 million, an increase of 7.1% from $16.5 million a year ago.

Gross margin for the first quarter of fiscal 2019 expanded 380 basis points to 52.1% from 48.3% a year ago, largely as a result of ongoing operational improvements, the recently completed facility consolidation, and the expiration of a royalty arrangement in the second quarter of fiscal 2018.

The Company recorded a net loss of $0.5 million, or $(0.01) per share, in the first quarter of fiscal 2019. This compares to a net loss of less than $100,000, or $0.00 per share, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the first quarter of fiscal 2019 was $6.2 million, or $0.16 per share, compared to adjusted net income of $5.0 million, or $0.13 per share, in the first quarter of fiscal 2018.

Adjusted EBITDAS in the first quarter of fiscal 2019, excluding the items shown in the reconciliation table below, was $12.6 million, compared to $11.3 million in the first quarter of fiscal 2018.

In the first quarter of fiscal 2019, the Company used $8.9 million in operating cash flow and had capital expenditures of $0.7 million. As of August 31, 2018, the Company had $24.8 million in cash and cash equivalents and $91.3 million in debt, excluding the impact of deferred financing costs.

Fiscal Year 2019 Financial Guidance

The Company is updating its previously announced financial guidance to reflect the BioSentry and RadiaDyne acquisitions, as well as the payment made to the DOJ for previously disclosed legal matters. The Company now expects fiscal year 2019 net sales in the range of $354 to $359 million and free cash flow in the range of $26 to $31 million. Additionally, the Company continues to expect its adjusted earnings per share in the range of $0.82 to $0.86.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its first quarter 2019 results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or 1-201-689-8560 (international) and refer to the passcode 13683219.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Thursday, September 27, 2018, until 11:59 p.m. ET on Thursday, October 4, 2018. To hear this recording, dial 1-844-512-2921 (domestic) or 1-412-317-6671 (international) and enter the passcode 13683219.

Use of Non-GAAP Measures

Management uses non-GAAP measures to establish operational goals and believes that non-GAAP measures may assist investors in analyzing the underlying trends in AngioDynamics’ business over time. Investors should consider these non-GAAP measures in addition to, not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this news release, AngioDynamics has reported adjusted EBITDAS, adjusted net income, adjusted earnings per share and free cash flow. Management uses these measures in its internal analysis and review of operational performance. Management believes that these measures provide investors with useful information in comparing AngioDynamics’ performance over different periods. By using these non-GAAP measures, management believes that investors get a better picture of the performance of AngioDynamics’ underlying business. Management encourages investors to review AngioDynamics’ financial results prepared in accordance with GAAP to understand AngioDynamics’ performance taking into account all relevant factors, including those that may only occur from time to time but have a material impact on AngioDynamics’ financial results. Please see the tables that follow for a reconciliation of non-GAAP measures to measures prepared in accordance with GAAP.

On September 27, 2018 FLX Bio, Inc., a clinical-stage, biopharmaceutical company focused on the development of oral small-molecule drugs that target drivers of cancer and other immune-related disorders, reported that the first patient has been treated in its Phase 1/2 clinical trial of FLX475 in patients with various advanced cancers (Press release, FLX Bio, SEP 27, 2018, View Source [SID1234529630]). FLX475 is an oral, small molecule CCR4 antagonist that selectively inhibits migration of regulatory T (Treg) cells into the tumor microenvironment.

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"The dosing of our first patient with FLX475 is a significant milestone for FLX Bio as we continue to advance our novel therapeutic approach targeting the tumor microenvironment," said Brian Wong, M.D., Ph.D., CEO of FLX Bio. "Treg cells play fundamental roles in inhibiting the immune response to the tumor and are a major resistance mechanism to many cancer immunotherapies including PD-1 inhibitors. FLX475 represents a best-in-class approach to selectively decrease Treg numbers in the tumor thereby unlocking the antitumor immune response. In addition, our big data and proprietary informatics platform has revealed the tumor types most likely to respond to FLX475. We are excited to evaluate this new therapeutic modality in these enriched patient populations through our ongoing global Phase 1/2 clinical trial."

"FLX475 has demonstrated an excellent safety, pharmacokinetic and pharmacodynamic profile in a recently-completed study of healthy volunteers and we believe this compound holds tremendous promise for directly addressing the suppressive effects of Treg in the tumor microenvironment," said Bill Ho, M.D., Ph.D., Chief Medical Officer of FLX Bio. "Treatment with FLX475 should allow the selective blocking of tumor-associated Treg recruitment while sparing normal tissues and beneficial cells. This may offer a safer and more efficacious treatment alternative for patients with many different types of cancer, as compared to the several existing strategies used to suppress or deplete Treg cells."

The open-label, dose-escalation and cohort expansion Phase 1/2 study will enroll patients with multiple types of cancer at leading cancer centers across the United States, Australia and Asia. The trial will evaluate the safety and tolerability of FLX475 as a monotherapy and in combination with pembrolizumab. In addition, the study will evaluate changes in the tumor microenvironment and the antitumor activity of both monotherapy and combination therapy. Patients with tumors positive for the Epstein-Barr Virus (EBV), which has been shown to be an indicator of tumors with a higher number of Treg cells, will be enrolled in a biomarker-selected cohort. Tumors that can be positive for EBV include nasopharyngeal cancer and Hodgkin lymphoma. In addition, the company intends to enroll patients with tumors that express high levels of CCR4 receptor and ligands, which include non-small cell lung cancer, head and neck cancer, triple negative breast cancer, and cervical cancer. For more information please visit clinicaltrials.gov identifier NCT03674567.

About FLX475

FLX475 is a best-in-class oral, small molecule antagonist of CCR4. FLX Bio has completed a study of FLX475 in healthy volunteers, demonstrating that the compound is safe with excellent pharmacokinetic and pharmacodynamic properties. In preclinical studies, FLX475 inhibited tumor growth and increased tumor regression as a single agent. In addition, FLX475 enhanced the antitumor effects of various checkpoint inhibitors including anti-PD-L1 and anti-CTLA4 antibodies as well as immune agonists such as anti-4-1BB antibodies. FLX475 also has the potential to enhance cell-based immunotherapies such as CAR-T and cancer vaccines. Unlike antibodies to CCR4, FLX475 selectively blocks the recruitment of regulatory T cells to the tumor site and does not deplete cells beneficial to an antitumor response or regulatory T cells in healthy tissue such as blood, spleen and skin cells.

On September 27, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology and targeted cancer therapies, reported its update on the Phase 2 clinical trial of ProscaVax for early-stage prostate cancer (Press release, Oncbiomune, SEP 27, 2018, View Source [SID1234529910]). The Company is pleased to report that initial installments for the study have been made and the final preparations culminating in enrollment are being completed between Theradex Oncology, the Contract Research Organization overseeing the study, and the host hospital, Beth Israel Deaconess Medical Center, a teaching hospital of Harvard University Medical School in Boston, MA.

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ProscaVax is OncBioMune’s lead immunotherapy platform candidate consisting of a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF). Per study protocol, approximately 120 patients are expected to be enrolled. The patients will be in what is termed "active surveillance," a disease management option for patients with localized prostate cancer that elect to work with their doctor to monitor the disease for progression before taking more drastic intervention measures, such as surgery or radiotherapy. To the Company’s knowledge, the trial of ProscaVax is the first ever worldwide for a prostate cancer vaccine technology addressing the active surveillance patient population.

"Our excitement is growing as we draw closer to enrollment. We (our Company and the host hospital) have already fielded inquiries from prostate cancer patients interested in participating in the study, which is an encouraging sign about recruitment once the trial is opened," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "We think the interest is owed to the strong safety profile and meaningful immunological effect demonstrated in the Phase 1 study of ProscaVax in advanced-stage prostate cancer patients and the simple fact that there are no FDA-approved therapeutic options for the tens of thousands of active surveillance patients that want to be proactive in addressing their cancer. We believe that ProscaVax has a lot to offer these patients and potential future partners as the only vaccine of this type."

In preparation for the trial and other pipeline developments, the Company has taken measures to clean its balance sheet, including recently retiring $900,000 in convertible, floorless debt. Management is currently in negotiations with its lenders and accredited investors to secure additional funding structured under attractive terms, including preferred stock and fixed-rate convertible debentures.

About Prostate Cancer

According to the American Cancer Society (ACS), prostate cancer is the most common type of cancer in men other than skin cancer, with about 1 in 9 men diagnosed during their lifetime. ACS estimates that about 164,690 new cases of prostate cancer will be diagnosed during 2018 and approximately 29,430 men will die from the disease this year. Prostate cancer is the second leading cause of cancer death in men, trailing only lung cancer. Approximately 2.9 million men are living with prostate cancer today. The average age of diagnosis is 66, with the disease considered rare in men under the age of 40.