On October 30, 2018 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel medical therapy company bringing to market its proprietary Nano-Pulse Stimulation (NPS) platform, reported recent corporate developments and financial results for the three- and nine-month periods ended September 30, 2018 (Press release, Pulse Biosciences, OCT 30, 2018, View Source [SID1234530396]).

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Recent Developments

Completion of enrollment and patient treatments in the Company’s NPS clinical study for the treatment of Sebaceous Hyperplasia (SH)

Study enrollment and patient treatments were completed in the Company’s multi-center study to evaluate the safety and efficacy of NPS for the treatment of Sebaceous Hyperplasia, a common but difficult-to-treat facial lesion.

Preliminary data on the first 79 of 226 (35%) treated lesions indicate excellent safety and efficacy results to date with no adverse events and over 95% of treated lesions rated as clear or mostly clear after 60-day follow-up.

Patient follow-up visits scheduled to be completed during the fourth quarter with study data available by the end of 2018.

Initiation of a clinical feasibility study using NPS to treat patients with cutaneous warts.

First patient enrollment and treatment in the Company’s feasibility study that includes up to 20 subjects at the prestigious Scripps Clinic in San Diego, CA. Patient enrollment commenced October 2018. Treatment and follow-up are expected to be completed during the first quarter of 2019.

Continued enrollment in NPS Basal Cell Carcinoma (BCC) Biomarker Study

First patient enrolled and treated in the Company’s multi-center "treat and resect" study evaluating local lesion effect and immune response changes to NPS. Study enrollment is progressing and is expected to be completed by the end of 2018 with data available during the first quarter of 2019.

Clinical introduction of the CellFX System, the Company’s next generation Nano-Pulse Stimulation system.

Designed with commercial intent for office, outpatient, or hospital setting;

Simple and intuitive system design suitable across multiple clinical applications;

Integrated networking capability for a per-click revenue model; and

Single-patient-use applicator available with a variety of tip sizes for different applications.

"We’re pleased with the continued and significant progress we’ve made and are making towards bringing our NPS platform closer to commercialization," said Darrin Uecker, Pulse Biosciences’ President and Chief Executive Officer. "Our data continues to demonstrate safety and efficacy allowing us the opportunity to move forward with our plans to target the cash paying aesthetic dermatology market while we continue to make progress in longer-term opportunities."

Financial Highlights

Cash, cash equivalents, and investments totaled $21.0 million at September 30, 2018, compared to $38.1 million at December 31, 2017. Cash use totaled $6.5 million for the third quarter of 2018 compared to cash use of $3.9 million for the fourth quarter of 2017. Cash use for 2018 is currently anticipated to total approximately $24 million.

Operating expenses for the three-month period ended September 30, 2018 totaled $10.9 million, compared to $7.5 million for the three-month period ended September 30, 2017. Operating expenses for the three-month period ended September 30, 2018 included non-cash stock-based compensation of $3.4 million, compared to non-cash stock-based compensation of $3.4 million for the three-month period ended September 30, 2017.

Operating expenses for the nine-month period ended September 30, 2018 totaled $28.9 million, compared to $17.0 million for the nine-month period ended September 30, 2017. Operating expenses for the nine-month period ended September 30, 2018 included non-cash stock-based compensation of $10.0 million, compared to non-cash stock-based compensation of $6.4 million for the nine-month period ended September 30, 2017.

Conference Call Details

Pulse Biosciences will host an investor call on October 30, 2018, at 1:30 p.m. PDT / 4:30 p.m. EDT. The telephone dial-in number for the call is (844) 494-0190 (U.S. toll-free) or (508) 637-5580 (international) using Conference ID 2098843. Listeners will also be able to access the call via webcast available on the Investors section of the Company’s website at www.pulsebiosciences.com.

On October 30, 2018 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to the Company’s lead product candidate, UGN-101, (mitomycin gel) for instillation (Press release, UroGen Pharma, OCT 30, 2018, View Source [SID1234530412]). UGN-101 is currently in Phase 3 development for the treatment of patients with low-grade upper tract urothelial cancer (LG UTUC). Breakthrough Therapy Designation is designed to expedite the development and review of new drugs to treat serious or life-threatening conditions, so patients may have access to therapies through FDA approval as soon as possible. The FDA previously granted both Orphan Drug and Fast Track designations to UGN-101 for the treatment of LG UTUC.

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"We are very excited about receiving the Breakthrough Therapy Designation for UGN-101 and the potential to deliver this far less invasive, organ-sparing therapy option to patients," said Ron Bentsur, Chief Executive Officer of UroGen. "We look forward to working with the FDA as we prepare to initiate a rolling submission of the UGN-101 New Drug Application (NDA) later this year, with the potential to become the first drug ever approved as frontline treatment of LG UTUC."

"UGN-101 was developed to provide an effective alternative to current treatment options, that avoids the risks of surgery, anesthesia, and the deleterious effects of kidney removal," said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. "The Breakthrough Therapy Designation confirms that UGN-101 represents a novel and effective approach to treat this devastating disease, and we look forward to close collaboration with the FDA as we bring this potentially transformative therapy to patients with LG UTUC as quickly as possible."

In the United States, approximately 6,000 to 8,000 patients present with new or recurrent LG UTUC every year1, and nearly 14,500 people are currently living with low-grade LG UTUC. LG UTUC is a rare malignant tumor of the cells lining the urinary tract. It most commonly presents in the elderly who also suffer from comorbid conditions such as hypertension, diabetes, obesity and the metabolic syndrome. There is a clear unmet medical need to provide effective, organ-sparing therapy for these patients because the current standard of care imposes significant burdens on both patients and the healthcare system. Patients diagnosed with LG UTUC typically face either complete removal of the kidney and/or partial removal of the ureter. In selected patients who present with a limited tumor burden, repetitive endoscopic tumor resection is employed when feasible. These interventions are surgical in nature and require anesthesia; and these procedures are associated with the typical risks for this patient population, including bleeding, infection, injury to adjacent organs, and the potential long-term morbidity associated with kidney removal. Due to the anatomy and physiology of the upper urinary tract and renal pelvis, organ-sparing endoscopic tumor resection is often challenging, leading to high rates of recurrence. Although the administration of water-based drug solutions has been used following surgery to treat patients with LG UTUC, evidence of the therapeutic benefit of this approach is lacking and none of these products have been approved for frontline therapy. Continuous urine flow and the inability of the upper urinary tract to retain a liquid volume under normal circumstances results in limited exposure of target tissue to aqueous medications. No therapeutic agent has ever been approved to treat LG UTUC.

The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates that use of the drug may result in substantial improvement on at least one clinically significant endpoint over available therapy. The Breakthrough Therapy Designation for UGN-101 is supported by data from the ongoing Phase 3 OLYMPUS clinical trial of UGN-101 for the non-surgical treatment of LG UTUC. Results from an interim analysis presented in May, 2018 showed a complete response (CR) rate of 59 percent (20 out of the interim analysis intent to treat population of 34 patients) who were evaluated for primary disease evaluation (PDE, or the primary endpoint). In addition, 15 percent (five of 34 patients) achieved a partial response. At the time of the interim analysis presentation, of the 20 patients who achieved a CR, 13 patients had reached three-month follow-up, and all remained in CR. Four of these 13 patients had reached six-month follow-up and one of the 13 patients had reached nine-month follow-up, and all remained in CR. UGN-101 appeared to be well-tolerated with most treatment-emergent adverse events characterized as mild or moderate and transient.

About UGN-101

UGN-101 (mitomycin gel) for instillation is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of low-grade (LG) upper tract urothelial cancer (UTUC). Utilizing the RTGel technology platform, UroGen’s proprietary sustained release, hydrogel-based formulation, UGN-101 is designed to enable longer exposure of mitomycin to the urinary tract tissue, thereby potentially enabling the treatment of tumors by non-surgical means. UGN-101 is delivered to patients using standard intravesical catheters.

On October 30, 2018 Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing innovative gene therapy products for patients living with serious, life-threatening rare diseases, reported that it will host a conference call and webcast to report its third quarter 2018 financial results and provide a corporate update on Tuesday, November 6, 2018 (Press release, Audentes Therapeutics, OCT 30, 2018, View Source [SID1234530357]).

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The conference call will be held at 4:30 pm EST, after the market closes. To access a live webcast of the conference call, please visit the Events & Presentations page within the Investor + Media section of the Audentes website at www.audentestx.com. Alternatively, please call (833) 659-8620 (U.S.) or (409) 767-9247 (international) and dial the conference ID# 1473209 to access the call.

A replay of the live webcast will be available on the Audentes website for approximately 30 days

On October 30, 2018 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported third quarter 2018 financial results on Tuesday, November 6, 2018, after the close of U.S. markets (Press release, CytomX Therapeutics, OCT 30, 2018, View Source [SID1234530374]). Following the announcement, the Company will host a conference call beginning at 5:00 p.m. ET to discuss its results.

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Participants may access the live audio webcast of the teleconference from the Investor Relations section of CytomX’s website at View Source Please access the website 15 minutes prior to the start of the call to download and install any necessary audio software.

Audio Conference Call:

U.S. Dial-in Number: (877) 809-6037

International Dial-in Number: (615) 247-0221

Conference ID: 9616738
An archived webcast replay will be available on the Company’s website from November 6, 2018, until November 13, 2018.

On October 30, 2018 PharmaMar Group (MSE: PHM) reported total revenues of €133 million in the first nine months of 2018 (Press release, PharmaMar, OCT 30, 2018, View Source [SID1234530397]). This figure represents an increase of 7% with respect to the same period of the previous year. Oncology sales in the first nine months of the year totaled €57.4 million, compared to €64.6 million in the same period of 2017. This difference is mainly due to two factors: first, the effect of the sale of Yondelis raw materials to our partners Janssen Products and Taiho Pharmaceutical, of which €2.5 million were sold in 2017; and second, the erosion of Yondelis prices in some European countries. Revenue from royalties and licenses and other development agreements totaled €27 million in the first nine months of 2018, compared to €11 million in the same period last year. This increase is due to the recognition in the income statement of €15 million as a result of the early termination of the license agreement of Chugai Pharmaceuticals Co., in 2018. This termination also generated revenues of €3 million. Sales in the consumer chemicals sector in the first nine months of 2018 were €44.6 million, an increase of 1.7% over the same period last year (*).

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R&D expenditure through the end of the third quarter of 2018 was €57 million, compared to €56.5 million in the first nine months of 2017. In July, PharmaMar reached the target recruitment of 600 patients for the Phase III ATLANTIS trial with Zepsyre (lurbinectedin) in combination with doxorubicin compared to topotecan or CAV for the treatment of relapsed small-cell lung cancer, the results of which are expected by the end of 2019. Also with regard to lurbinectedin, for the treatment of relapsed small-cell lung cancer, an open label monotherapy phase II trial is being
carried out, the preliminary results of which were presented in June 2018 at the ASCO (Free ASCO Whitepaper) congress in Chicago. We anticipate target enrolment of 100 being reached this quarter with data reading out in the first half of 2019.

In addition, with regard to Sylentis, the HELIX phase III trial in dry eye disease has recently completed recruitment.
As a result, the Group’s adjusted EBITDA for the first nine months of 2018 was €2.2 million compared to € -6.0(*) million in the same period of the previous year and the Group recorded an attributable net profit of €5 million compared to a loss of € -14 million in the same period of the previous year. *In order to make both periods comparable, the results to September 2017 have been adjusted taking into account the discontinued operation due to the sale of Xylazel announced on September 20, 2018.

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