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On February 7, 2019 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel medical therapy company bringing to market its proprietary CellFX System, reported recent corporate developments, and financial results for the quarter and year-ended December 31, 2018 (Press release, Pulse Biosciences, FEB 7, 2019, View Source [SID1234533132]).

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The Company also announced today treatment of the first of up to 20 patients in a clinical feasibility study to evaluate the CellFX System for acne on the back. This study leverages the unique mechanism of action of the CellFX System in order to target sebaceous glands deep in the dermis, as demonstrated in the previously announced clinical study evaluating NPS for the treatment of facial sebaceous hyperplasia (SH).

Recent Corporate Developments

Demonstrated efficacy of over 99.5% of Sebaceous Hyperplasia (SH) lesions treated with Nano-Pulse Stimulation (NPS) in a clinical feasibility study, the second successful study of a dermatologic application of the Company’s NPS technology platform.
99.5% of the treated lesions were assessed as clear or mostly clear by investigators at the 60-day post-treatment follow-up evaluation.
92% (n=203) of treated lesions were assessed as clear or mostly clear after a single NPS treatment.
Patients rated 78% of lesion outcomes as satisfied or mostly satisfied at study end.
The study data has been accepted for presentation at the upcoming American Academy of Dermatology Annual Meeting by Dr. Girish Munavalli, one of the study’s principal investigators.
Successfully completed a $45 million rights offering, an important financial milestone enabling Pulse Biosciences to accelerate its progress towards commercialization of the CellFX System.
Appointed key personnel focusing on CellFX commercialization:
Promotion of Edward Ebbers to Executive Vice President and General Manager, Dermatology. Mr. Ebbers brings over 35 years of leadership and management experience with major dermatology, pharmaceutical and medical device companies, including extensive experience introducing products with utilization-based revenue models in the private pay aesthetic dermatology market.
Addition of Robert Tyson as Vice President of Sales, North America. Mr. Tyson brings a proven track record as a sales leader with over 20 years of medical technology experience.
"We are pleased with our accomplishments over the past year in advancing our proprietary CellFX System and look forward to achieving key commercialization milestones in 2019," said Darrin Uecker, Pulse Biosciences’ President and Chief Executive Officer.

Acne Clinical Feasibility Study

The objective of the acne clinical feasibility study announced today is to treat up to 20 patients between the ages of 18 and 80 to evaluate the reduction in number and severity of back acne eruptions post CellFX procedures through comparison of the treated to non-treated areas 90-days after the last procedure. Mark Nestor, MD, PhD, managing partner of Skin and Cancer Associates, and Brian Berman, MD, PhD, director of the Center for Clinical and Cosmetic Research in Miami and a past Vice President of the American Academy of Dermatology, are the principal investigators on the study.

"We are very excited to enroll our first back acne patient as chronic acne eruptions can be very difficult to control, and compliance with ongoing use of oral or topical therapies can be problematic," said clinical investigator Brian Berman, MD. "Through this rigorous study, we expect to achieve a meaningful reduction in the number and severity of acne lesions treated with the CellFX System."

Fourth Quarter and Full Year 2018 Financial Highlights

Cash, cash equivalents, and investments totaled $59.6 million at December 31, 2018, compared to $38.1 million at December 31, 2017. Cash use totaled $6.4 million for the fourth quarter of 2018 compared to cash use of $3.9 million for the fourth quarter of 2017. Cash use for 2018 totaled $23.5 million.

Operating expenses for the three-month period ended December 31, 2018 totaled $9.1 million, compared to $8.8 million for the three-month period ended December 31, 2017. Operating expenses for the three-month period ended December, 2018 included non-cash stock-based compensation of $2.4 million, compared to non-cash stock-based compensation of $4.5 million for the three-month period ended December 31, 2017.

Operating expenses for the fiscal year ended December 31, 2018 totaled $38.0 million, compared to $25.8 million for the fiscal year ended December 31, 2017. Operating expenses for the fiscal year ended December 31, 2018 included non-cash stock-based compensation of $12.3 million, compared to non-cash stock-based compensation of $10.9 million for the fiscal year ended December 31, 2017.

Conference Call Details

Pulse Biosciences will host an investor call on February 7, 2019, 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 5196202. 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 February 7, 2019 Median Technologies (Paris:ALMDT), The Imaging Phenomics Company reported preliminary and unaudited financial results for the full year 2018, a year of successful transition that has led to the reconfiguration of the company into two separate business units, iCRO and iBiopsy, and to the realignment of its workforce and business activities with clarified strategic objectives (Press release, MEDIAN Technologies, FEB 7, 2019, View Source [SID1234533131]).

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During 2018, Median increased its focus on its iBiopsy platform, its next generation of medical imaging platform based on best-in-class technology, including image processing, cloud computing and artificial intelligence to improve targeting of current patient treatments, enhancing diagnostics and accelerating the development of next generation therapies. With the unprecedented growth in healthcare data, the iBiopsy platform’s imaging, analytical and machine learning functionalities will permit healthcare providers to derive insights from multi-omics data to reduce healthcare costs, develop personalized medicine, and manage patient care proactively. Median Technologies has grouped all of its science and development activities into its iBiopsy business unit. The iBiopsy business unit represented more than 40% of the company’s overall headcount as of December 31, 2018.

In 2018, the company’s revenues were generated by the iCRO business unit. Median decided to focus the majority of its iCRO activities on the high growth Chinese market and closed certain non-profitable activities. The restructuring of the iCRO business unit has allowed the company to dramatically reduce costs, improve margins and Median is targeting breakeven in 2019 for this part of the business. Even though 2018 company’s revenues were €6.3m, a decrease of 17.5% compared to 2017, the iCRO business is now not only stable but should see strong growth through conversion of it increased backlog and as part of this its focus on the Chinese market.

As of December 31, 2018, the company’s order backlog was €23.7m, an increase of 10.8% compared to the backlog on June 30, 2018. During the second half of the year, Median signed up many of the leading Chinese pharmaceutical companies including major contracts for phase III clinical trials. The Chinese market is experiencing extremely strong growth given that Chinese pharmaceutical companies have been able to raise substantial amounts of funding for clinical trials through successful IPO’s. Median has benefited in China from the fact that there are no legacy or established relationships with local or International iCROs competing with the company; consequently, Median has experienced a strong market penetration by demonstrating a high quality of customer service. Median expects this growth to continue over the next few years and the company should gain further repeat business from existing customers. At the end of 2018, 39.2% of the order backlog was coming from Chinese business vs 5.4% in 2017. Over 75% of 2018 gross new business originated from China. Median’s strategic Chinese investor, Furui Medical Science Company, has been instrumental in supporting the growth in the Chinese market.

The company’s cash and cash equivalents were €12.7m as of December 31, 2018. The strategic restructuring into two business units and an increased focus on high growth and profitable markets has enabled the cash burn to decrease substantially during the second semester of 2018 with a cash burn of €5.8m versus €9.8m during the first semester of 2018. Excluding exceptional charges related to the company’s organizational changes, the cash burn would have decreased even more.

"In 2018 we have repositioned our iCRO business to allow Median to deliver on its promise of sustained profitable growth. We expect good growth in the years to come particularly in China and the rest of the Asia-Pacific region", said Fredrik Brag, CEO, Chairman and co-founder of Median Technologies. "Healthcare is being transformed by AI and cloud computing and as a technology company Median is very well positioned to profit from these disruptive changes in the delivery of healthcare through its groundbreaking iBiopsy imaging phenomics platform. In 2018 a new breed of data driven technology companies have emerged in the US and even though they are at an early stage of development, they have attracted large amounts of funding and generated significant market value based on the projected impact on drug development and patient treatment. We fully expect to leverage our unique technology in this rapidly emerging market and we look forward to a very exciting 2019".

The Company expects to announce full 2018 financial results on April 11, 2019, after market close.

The preliminary results set forth above are based on management’s initial review of the Company’s operations for the year ended December 31, 2018 and are subject to revision based upon the Company’s year-end closing procedures and upon the completion and external audit of the Company’s year-end financial statements. Actual results may differ materially from these preliminary results as a result of the completion of year-end closing procedures, final adjustments and other developments arising between now and the time that the Company’s financial results are finalized, and such changes could be material. In addition, these preliminary results are not a comprehensive statement of the Company’s financial results for the fourth quarter or full year ended December 31, 2018, should not be viewed as a substitute for full, audited financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the Company’s results for any future period.

On February 7, 2019 BioMotiv, a drug development accelerator associated with The Harrington Project for Discovery & Development, and researchers from Rutgers, The State University of New Jersey, reported the formation of a new biotech start-up, TamRx (Press release, BioMotiv, FEB 7, 2019, View Source [SID1234533130]). The new company will focus on the development of a novel family of small molecule inhibitors designed to block tumor growth and stimulate the immune system to fight various forms of cancer.

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"The potential held by this novel technology to both block tumor growth and elicit an anti-tumor immune response is very exciting," said Baiju R. Shah, CEO of BioMotiv. "We look forward to working with Drs. Birge, Welsh, and Peng as they advance their discoveries with the TamRx team."

The TamRx technology was developed by scientific founders Ray Birge of Rutgers New Jersey Medical School, William Welsh of Rutgers Robert Wood Johnson Medical School, Youyi Peng of Rutgers Cancer Institute of New Jersey, and other researchers. The technology blocks ligand (Gas6) binding, thereby inhibiting TAM (Tyro3, Axl, and Mertk)-mediated activation of cellular processes that may lead to aggressive growth and spread of tumors. In addition to blocking tumor growth and metastasis, the pan-TAM inhibitors work as anticancer agents to indirectly promote an anti-tumor immune response. The TamRx technology is expected to work in combination with immuno-oncology therapies—including checkpoint inhibitors—in a wide variety of cancers.

The TAM family of receptor tyrosine kinases are implicated in a wide spectrum of human cancers in which TAM over-expression is clinically-associated with both an aggressive tumor grade and poor survival outcomes. TamRx’s pipeline of small molecule inhibitors target the TAM-Gas6 interface. The TamRx inhibitors are advantageous due to their extracellular activity and ability to target all three receptors.

According to Drs. Birge, Welsh, and Peng, this new approach to fighting cancer and boosting the immune response shows promise to be a real game-changer in the oncology field. The Rutgers researchers are "excited to work with BioMotiv and the team at TamRx to advance this technology."

On February 7, 2019 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that it has closed its previously reported underwritten public offering of 28,000,000 American Depositary Shares ("ADSs"), each representing one of its ordinary shares, and warrants to purchase 28,000,000 ADSs, at a public offering price of $0.55 per ADS and accompanying warrant (Press release, BioLineRx, FEB 7, 2019, View Source;p=irol-newsArticle&ID=2386604 [SID1234533128]). The warrants are exercisable immediately, expire five years from the date of issuance and have an exercise price of $0.75 per ADS. The gross proceeds of the offering were $15.4 million, before deducting underwriting discounts and commissions and offering expenses payable by BioLineRx, and excluding the exercise of any warrants. All of the securities in the offering were sold by BioLineRx. BioLineRx anticipates using the net proceeds from the offering for general corporate purposes, which may include, but are not limited to, working capital and funding clinical trials.

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Oppenheimer & Co. Inc. acted as sole book-running manager for the offering. Maxim Group LLC acted as co-manager for the offering.

The securities described above were issued pursuant to a shelf registration statement (File No. 333-222332) that was previously filed with, and declared effective by, the Securities and Exchange Commission ("SEC"). A final prospectus supplement related to the offering has been filed with the SEC and is available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement may also be obtained from Oppenheimer & Co. Inc., 85 Broad St., 26th Floor, New York, New York 10004, Attention: Syndicate Prospectus Department, or by telephone: (212) 667-8055 or by email: [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.