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 (*).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

Legal warning
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction….

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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 INmune Bio, Inc., a cancer immunotherapy company focused on developing therapies that harness the patient’s innate immune system to attack their cancer, reported that RJ Tesi, M.D., CEO and President of the Company, will present a company overview at the upcoming National Investment Banking Association Conference, with details as follows (Press release, INmune Bio, OCT 30, 2018, View Source [SID1234530395]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

National Investment Banking Association 145th Investment Conference

Date and Time: Thursday November 1, 2018 at 9:30 a.m. Eastern time
Venue: Crowne Plaza Times Square, New York City

On October 30, 2018 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company generated revenue of $118.3 million and screened approximately 241,000 people with Cologuard during the quarter ended September 30, 2018 (Press release, Exact Sciences, OCT 30, 2018, View Source [SID1234530394]). Third-quarter 2018 revenue and Cologuard test volume grew by 63 percent and 49 percent, respectively, from the same period of 2017.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"The Exact Sciences team delivered another strong quarter, highlighted by significantly increased patient access to Cologuard with no out-of-pocket cost and continued progress toward our 2018 priorities," said Kevin Conroy, chairman and CEO of Exact Sciences. "We are enthusiastic about our partnership with Pfizer and launched Cologuard to their internal medicine team in early October. We look forward to working with such a tremendous partner in the fight against colon cancer."

Third-Quarter 2018 Financial Results

For the three-month period ended September 30, 2018, as compared to the same period of 2017 (where applicable):

Revenue was $118.3 million, an increase of 63 percent, and test volume was 241,000, an increase of 49 percent
Average recognized revenue per test was $492, an improvement of 9 percent
Average cost per test was $125, an improvement of 3 percent
Gross margin was 75 percent, an increase of 320 basis points
Operating expenses were $129.2 million, an increase of 61 percent
Net loss was $45.4 million or $0.37 per share, compared to $26.9 million or $0.23 per share
Non-cash interest expense related to convertible debt was $8.4 million, or $0.07 per share
Cash utilization was $36.9 million, compared to $21.7 million
Cash, cash equivalents and marketable securities were $1.2 billion at the end of the quarter
More than 11,000 healthcare providers ordered their first Cologuard test during the third quarter, and nearly 132,000 have ordered since the test was launched
2018 Outlook

The company anticipates revenue of $435-$440 million for 2018, an increase from prior guidance of $420-$430 million
The company’s guidance for revenue is a forward-looking statement. It is subject to various risks and uncertainties that could cause the company’s actual results to differ materially from the anticipated targets. There can be no assurance the company will meet these financial projections. See the cautionary information about forward-looking statements in the "Safe Harbor Statement" section of this press release.

Third-Quarter Conference Call & Webcast

Company management will host a conference call and webcast on Tuesday, Oct. 30, 2018, at 5 p.m. ET to discuss third-quarter 2018 results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 877-201-0168 and international callers should dial +1-647-788-4901.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 6870368. The webcast, conference call and replay are open to all interested parties.

About Cologuard

Cologuard was approved by the FDA in August 2014 and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2014) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx Only.

On October 30, 2018 Shanghai Fosun High Technology (Group) Co., Ltd. ("Fosun High Technology"), a subsidiary of Fosun International Limited (the "Company"), which has issued medium-term notes in February 2018, April 2018, July 2018 and September 2018 respectively, and super commercial paper in June 2018 in the China’s interbank bond market, published its 2018 third quarter report (the "Report") on 30 October 2018, in accordance with the relevant regulations in China (Press release, Fosun Pharma, OCT 30, 2018, View Source [SID1234530388]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The board of directors of the Company (the "Board") would like to draw the attention of its shareholders and the investment public to the following unaudited principal consolidated financial data of Fosun High Technology for the nine months ended 30 September 2018 as set out below in the Report:

Unit: Thousand Yuan Currency: RMB
As at the end of
this reporting period As at the end of last year
Increase/decrease as at
the end of this reporting
period as compared
with the end of last year
(%)
Total assets 288,748,478 236,798,051 21.94%
Equity attributable to
owners of the parent 53,614,661 50,089,794 7.04%
From the beginning of
2018 up to the end of
this reporting period
From the beginning of
last year up to the end of
the same reporting period
of last year
Increase/decrease as
compared with the
same period of last year
(%)
Revenue from operation 34,250,739 23,433,701 46.16%
Profit attributable to
owners of the parent 3,863,135 3,601,006 7.28%