On August 28, 2019 Varian (NYSE: VAR) has reported it completed the installation of the cyclotron for its ProBeam Compact single-room proton therapy system at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine — part of the University of Miami Health System (Press release, Varian Medical Systems, AUG 28, 2019, View Source [SID1234539064]). The cyclotron is a particle accelerator and a significant piece of the equipment in the ProBeam proton therapy system. The Center is scheduled to begin patient treatment in the summer of 2020.

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Proton therapy is an advanced form of cancer care. It uses protons, accelerated to about two-thirds the speed of light, or more than 100,000 miles per second, to destroy cancer cells, while minimizing exposure to nearby healthy tissues. The Varian ProBeam Compact system is the only single room system capable of fully rotational intensity modulated proton therapy (IMPT). Treatments can be delivered with an unmatched combination of speed, flexibility and cost efficiency.

The full-featured ProBeam Compact system includes the cyclotron, Varian’s unique pencil-beam scanning technology for intensity modulated proton therapy (IMPT), a fully rotational gantry, robotic patient positioning tools, and a comprehensive suite of motion management tools. It includes integrated cone beam CT imaging for positioning the patient based on high quality anatomical images with excellent soft tissue resolution.

"We selected Varian as our partner because we wanted a company that understood our mission to reduce the human burden from cancer through research, education, prevention, and the delivery of quality patient care," said Dr. Stephen D. Nimer, director of Sylvester. "We are excited to bring innovative cancer treatments to patients in our state and region. They will benefit from having access to therapies that provide superior dose distribution, spare healthy surrounding tissue and most importantly, give our patients a better quality of life during and after treatment. With Varian’s help, we are treating cancer more effectively and efficiently."

"We look forward to continuing this partnership and making this advanced cancer fighting technology available to more patients in Florida," said Kolleen Kennedy, president, Proton Solutions and chief growth officer, Varian. "This advanced treatment technology has the potential to offer new hope to many cancer patients across the state and the country."

For more information on ProBeam and its Compact single-room configuration, visit: www.varian.com/probeamcompact

On August 28, 2019 Theravance Biopharma, Inc. (NASDAQ: TBPH) reported that members of management will participate in fireside chats at two upcoming investor conferences (Press release, Theravance, AUG 28, 2019, View Source [SID1234539080]):

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14th Annual Wells Fargo Securities Healthcare Conference on Wednesday, September 4, 2019 at 1:15 p.m. ET. The conference will be held September 4-5 at The Westin Copley Place Boston.
Morgan Stanley 17th Annual Global Healthcare Conference on Monday, September 9, 2019 at 11:05 a.m. ET. The conference will be held September 9 – 11 at the Grand Hyatt New York.
A live broadcast will be available by visiting the Investor Relations section of Theravance Biopharma’s website at www.theravance.com, under the Presentations & Events tab. Listeners are encouraged to visit the site at least 15 minutes prior to the scheduled presentation to register, download and install any necessary audio software. Audio replays will be available for 30 days following the presentation.

On August 28, 2019 Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported that members of its senior management team will participate in the upcoming investor conferences (Press release, Arena Pharmaceuticals, AUG 28, 2019, View Source [SID1234539098]):

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Wells Fargo Global Healthcare Conference – Presenting on Wednesday, September 4, at 8:30 AM EDT in Boston
Citi Biotech Conference – Hosting investor meetings on Thursday, September 5, in Boston
A live audio webcast of the Wells Fargo presentation will be available under the investor relations section of Arena’s website at www.arenapharm.com. A replay of the presentation will be available for 30 days following the events.

On August 28, 2019 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in therapeutic ultrasound, reported financial results for the second quarter of 2019 and provided an update on strategic and operational developments (Press release, EDAP TMS, AUG 28, 2019, View Source [SID1234539117]).

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Marc Oczachowski, EDAP’s Chief Executive Officer, said: "We are very pleased with our second quarter results that demonstrated another period of robust HIFU revenue growth, significant gross margin expansion and profitability. We have now posted three consecutive profitable quarters, and we are confident that this type of growth and consistency in our results could be maintained going forward. We were very pleased with the American Medical Association’s decision in June to accept our request for a Category 1 CPT code that will facilitate reimbursement for the ablation of malignant prostate tissue with HIFU technology. This is an important milestone for the adoption curve of HIFU technology, and, we believe will help our customers gain confidence in implementing next generation prostate cancer therapy programs. Importantly, we are still in the early stages of our Focal One marketing and sales development efforts, and as these activities continue, we expect to see continued robust expansion of our pipeline of sales prospects. We look forward to providing further updates on our progress in the coming months."

Second Quarter 2019 Results

Total revenue for the second quarter 2019 was EUR 12.5 million (USD 14.0 million), a 45.1% increase compared to EUR 8.6 million (USD 10.2 million) for the second quarter of 2018.

Total revenue in the HIFU business for the second quarter 2019 was EUR 4.6 million (USD 5.1 million), a 97.1% increase compared to EUR 2.3 million (USD 2.7 million) for the second quarter of 2018.

For the three months ended June 30, 2019, total revenue for the UDS division was EUR 7.9 million (USD 8.9 million), a 25.9% increase compared to EUR 6.3 million (USD 7.4 million) during the year-ago period.

Gross profit for the second quarter 2019 was EUR 6.3 million (USD 7.1 million), compared to EUR 3.6 million (USD 4.2 million) for the year-ago period. Gross profit margin on net sales was 50.7% in the second quarter of 2019, compared to 41.3% in the year-ago period.

Operating expenses were EUR 4.7 million (USD 5.3 million) for the second quarter of 2019, compared to EUR 4.6 million (USD 5.5 million) for the same period in 2018.

Operating profit for the second quarter 2019 was EUR 1.7 million (USD 1.9 million), compared to an operating loss of EUR 1.1 million (USD 1.3 million) in the second quarter of 2018.

Net income for the second quarter 2019 was EUR 1.4 million (USD 1.6 million), or earnings of EUR 0.05 per diluted share, as compared to a net loss of EUR 0.8 million (USD 0.9 million), or a loss of EUR 0.03 per diluted share in the year-ago period.

First six months 2019 Results

Total revenue for the first half of 2019 was EUR 22.6 million (USD 25.6 million), a 27.3% increase compared to EUR 17.8 million (USD 21.4 million) for the first half of 2018.

Total revenue in the HIFU business for the first six months of 2019 was EUR 8.4 million (USD 9.5 million), a 77.4% increase compared to EUR 4.8 million (USD 5.7 million) for the six months ended June 30, 2018.

For the six months ended June 30, 2019, total revenue for the UDS division was EUR 14.2 million (USD 16.0 million), a 9.0% increase compared to EUR 13.0million (USD 15.7 million) during the year-ago period.

Gross profit for the first half of 2019 was EUR 11.2 million (USD 12.6 million), compared to EUR 7.6 million (USD 9.1 million) for the year-ago period. Gross profit margin on net sales was 49.5% compared to 42.6% in the year-ago period.

Operating expenses were EUR 9.3 million (USD 10.5 million) for the first six months of 2019, compared to EUR 9.0 million (USD 10.9 million) for the same period in 2018.

Operating profit for the first half of 2019 was EUR 1.9 million (USD 2.1 million), compared to an operating loss of EUR 1.5 million (USD 1.8 million) in the first six months of 2018.

Net income for the first half of 2019 was EUR 1.7 million (USD 1.9 million), or earnings of EUR 0.06 per diluted share, as compared to a net loss of EUR 0.7 million (USD 0.8 million), or a loss of EUR 0.02 per diluted share in the year-ago period.

As of June 30, 2019, cash and cash equivalents, including short term investments, were EUR 16.3 million (USD 18.5 million).

Conference Call

An accompanying conference call and webcast will be conducted by management to review the results. The call will be held at 8:30am EDT on Thursday, August 29, 2019. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Call & Webcast
Thursday August 29th @ 8:30am Eastern Time
Domestic: 877-451-6152
International: 201-389-0879
Passcode: 13693076
Webcast: View Source

Following the live call, a replay will be available on the Company’s website, www.edap-tms.com under "Investors Information."

On August 28, 2019 Starpharma reported its annual report and financial results for the year ended 30 June 2019 (Press release, Starpharma, AUG 28, 2019, View Source [SID1234539065]).

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Financial Results

Cash position at 30 June of $41.3M
Net cash burn[1] of $10.1M (FY18: $9.9M)
Total revenue and other income of $2.7M (FY18: $5.0M)
Reported loss of $14.3M (FY18: $10.3M)
Receipt of $4.0M R&D tax incentive
Key activities

VivaGel

VivaGel BV launched in Europe by Mundipharma, under the brand name Betadine BVTM;
VivaGel BV launched in Australia by Aspen Pharmacare, under the brand name Fleurstat BVgel;
VivaGel BV was licensed to ITF Pharma, Inc. for the US for milestones of up to US$101 million in addition to escalating royalties;
First Asian regulatory approvals received for BetadineTM BV Gel;
VivaGel condom launched in Japan under Okamoto’s Zero Zero Three (‘003’) brand;
US FDA completed its review of the VivaGel BV NDA and advised it requires confirmatory clinical data prior to approval; and
Positive independent market research was conducted in the US for SPL7013 ophthalmic drops for viral conjunctivitis and a patent was granted for the product.
DEP drug delivery

Starpharma signed a Development and Option Agreement with AstraZeneca to progress the development of a DEP version of one of their major marketed oncology medicines;
First patent granted for Starpharma’s DEP dendrimers with AstraZeneca’s Bcl2/xL inhibitors, including AZD0466;
Clinical trials for DEP docetaxel (phase 2) and DEP cabazitaxel (phase 1 / 2) progressed well with new sites opened and cohorts expanded;
Approval to commence DEP irinotecan phase 1 / 2 trial;
DEP irinotecan, showed significant efficacy and safety benefits over leading colorectal cancer drugs irinotecan (Camptosar) and cetuximab (Erbitux), in the irinotecan-refractory HT-29 human colon cancer model;
DEP irinotecan showed impressive efficacy and safety benefits over standard irinotecan in combination with 5-FU in a human pancreatic cancer model;
DEP docetaxel and DEP cabazitaxel outperformed both gemcitabine and Abraxane in a human pancreatic cancer model; and
A range of DEP radiopharmaceutical and other DEP candidates are undergoing testing in a variety of models.
Starpharma CEO, Dr Jackie Fairley, commented: "Starpharma has achieved significant milestones across the business this year, including international product launches, new commercial deals, and trial progress for our three high-potential, clinical-stage DEP products. The company is in a strong financial position with more than $40 million in cash at bank. With our anticipated revenues from products on market and future launches, we are well placed for future growth".

Commenting further on the 2019 financial year’s achievements and outlook, Dr Fairley added: "During the year, VivaGel BV was launched in both Europe and Australia and we recently received the first Asian regulatory approvals for this breakthrough product. VivaGel BV has now been licensed for more than 160 countries and we look forward to further approvals and launches in the coming months across Mundipharma’s regions. We also negotiated an attractive licensing deal for VivaGel BV in the US with specialty pharmaceutical company, ITF Pharma, Inc., however the US regulator has requested confirmatory data and Starpharma is currently working to pursue approval as quickly as possible to bring this innovative product to the US market".

"In our DEP portfolio, we were delighted to add another commercial deal with AstraZeneca for a DEP version of one of their major marketed oncology products, and are excited for the first DEP IND to be filed by AstraZeneca for AZD0466. We also progressed with our own internal clinical DEP programs – reporting positive interim results for both DEP docetaxel and DEP cabazitaxel – and recently advanced our third internal DEP product, DEP irinotecan, into the clinic. We also added a suite of excellent preclinical data from our DEP platform, further demonstrating the versatility of our drug delivery technology, and we continued to build our pipeline of DEP candidates".

"In the year ahead, we look forward to our partner’s further launches of VivaGel BV and building sales momentum, while progressing our three clinical stage internal DEP products alongside AstraZeneca’s first DEP product, AZD0466. We also continue to explore the potential expansion opportunities for our clinical programs into new indications and combination therapies to build further value in our DEP products and to create the greatest potential for patient outcomes", concluded Dr Fairley.

Download ASX Announcement: Starpharma annual report and full year financial results (PDF, 4.5MB)

[1] Net cash burn is considered a non-IFRS value and has not been audited in accordance with Australian Accounting Standards. Net cash burn is calculated by the movement in cash and cash equivalents from 30 June 2018 to 30 June 2019.