On November 13, 2019 Oncoceutics, Inc. reported that results from the second and third cohort of the Phase II trial for patients with recurrent glioblastoma treated with the company’s lead imipridone, ONC201, were recently published in the journal Neuro-Oncology (Press release, Oncoceutics, NOV 13, 2019, View Source [SID1234558331]). This manuscript represents the third publication among a series of reports demonstrating durable radiographic regressions with ONC201 in patients with H3 K27M-mutant glioma. The study (NCT02525692) also demonstrated that weekly oral administration of ONC201 given as a single agent was well-tolerated, achieved therapeutic intratumoral concentrations, and intratumoral pharmacodynamic activity in adult recurrent glioblastoma patients.

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ONC201 achieved intratumoral concentrations that exceeded preclinical efficacy thresholds and induced intratumoral biomarkers of pharmacodynamic signaling and apoptosis indicating target engagement. The radiographic regression of multi-focal, multi-recurrent disease with ONC201 administration in an adult recurrent H3 K27M-mutant glioblastoma patient remained durable for >1.5 years. No treatment modifications or discontinuations due to toxicity were observed, including those who underwent re-resection.

A previous publication on the first cohort of the study had demonstrated that ONC201 is well-tolerated in adult recurrent glioblastoma patients with every three-week dosing and achieved an objective radiographic response in a patient harboring the H3 K27M mutation that remained durable for >2.5 years. Other publications have reported radiographic regressions and clinical benefit in pediatric and adult H3 K27M-mutant diffuse midline glioma patients including those with diffuse intrinsic pontine glioma (DIPG).

High-grade glioma with the H3 K27M mutation is the lead indication for ONC201 and FDA has awarded Fast-Track designation to ONC201 for the treatment of adults with this disease who have recurred. The publication is supported by Small Business Innovation Research (SBIR) Fast-track and Bridge grants from the National Cancer Institute of the National Institutes of Health, as well as The Musella Foundation.

"These results indicate weekly ONC201 is very well tolerated and biologically active in a molecular subset of glioblastoma patients associated with biomarkers of dopamine receptor dysregulation," said Isabel Arrillaga-Romany, MD, PhD, Director of Neuro-Oncology Clinical Trials at Massachusetts General Hospital and the Principal Investigator and corresponding author of the study. "The durable regression observed in a 74-year old patient with sub-centimeter multi-focal, multi-recurrent H3 K27M-mutant glioma is particularly noteworthy given the development focus of ONC201 in this subset of brain tumors."

"Overall, the safety and efficacy results with ONC201 in recurrent glioblastoma are promising and unlike any other targeted agent we have evaluated thus far," said Patrick Y. Wen, MD, Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute and senior author and investigator of the study. "ONC201 continues to be promising as a single agent in molecular subsets of high-grade glioma and the intratumoral pharmacodynamic results suggest the activity of ONC201 may extend beyond H3 K27M-mutant gliomas to high-grade glioma subsets that also exhibit dopamine pathway dysregulation."

On November 13, 2019 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that the Italian Medicines Agency (AIFA) has approved rucaparib for reimbursement in Italy (Press release, Clovis Oncology, NOV 13, 2019, View Source [SID1234551135]). Rucaparib will soon be available as an option for monotherapy maintenance treatment for adults with relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy.3

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Rucaparib is indicated for eligible patients regardless of BRCA status, which means it can be prescribed for women who harbor a BRCA mutation or who are BRCA wild-type.3

"We very much welcome the arrival of the PARP inhibitor rucaparib, which offers a new treatment option after surgery and two lines of chemotherapy to all eligible women affected by relapsed ovarian cancer," declared Nicoletta Cerana, National President of Acto Onlus, the number one Italian network of patient associations involved in the fight against ovarian cancer and gynecological tumors. "Ovarian cancer is a highly lethal neoplasm which now, thanks to the PARP inhibitors, can finally be made chronic. Patients know this and are ready to embark upon the difficult journey towards chronicity. As an association, we therefore hope that rucaparib can be prescribed as soon as possible in all Italian regions."

Approximately 5,000 women are diagnosed with ovarian cancer in Italy every year, which equates to roughly 14 every day, and accounts for about 30 percent of all malignant tumors of the female reproductive system.4,5 In addition, approximately 25 percent of patients harbor a BRCA1/2 mutation correlating to responsiveness to therapy, while the majority of women who are diagnosed are BRCA wild-type will have a worse prognosis and limited therapeutic options.5,6,7 Despite advancements in treatment and care, more than 3,000 women still die each year.4 The 5-year survival rate for ovarian cancer in Italy is only 39 percent, falling to 31 percent at 10 years.5 Of those treated with surgery and first line chemotherapy, approximately 70 percent of patients will relapse within the first three years.8

"On a personal level, I am very pleased to be able to offer rucaparib to Italian patients as well, as this represents an important innovation," said Nicoletta Colombo, Director of the Oncological Gynecology Program of the European Institute of Oncology in Milan and Associate Professor at the University of Milano-Bicocca. "In the ARIEL3 study, in fact, rucaparib doubled disease-free time after a second line of chemotherapy compared to placebo and with a manageable tolerability profile despite a study population very similar to clinical practice, regardless of the BRCA mutation."

The European Union (EU) authorization is based on data from the pivotal phase 3 ARIEL3 clinical trial, which found that rucaparib significantly improved PFS in all ovarian cancer patient populations studied.1 ARIEL3 successfully achieved its primary endpoint of extending investigator-assessed PFS versus placebo in all patients treated (intention-to-treat, or ITT), population, regardless of BRCA status (median 10.8 months vs 5.4 months).1,2 In addition, it successfully achieved the key secondary endpoint of extending PFS by independent radiological review versus placebo in all patients treated (ITT), regardless of BRCA status (median 13.7 months vs 5.4 months).2 The overall safety profile of rucaparib is based on data from 937 patients with ovarian cancer treated with rucaparib monotherapy in clinical trials.2

"In ovarian cancer, around 80 percent of cases involve women without a BRCA mutation and are characterized by a particularly poor prognosis," explains Professor Sandro Pignata, Director of Medical Oncology of the Urogynecology Department at the National Oncological Institute Pascale Foundation cancer center in Naples, Scientific Coordinator of the Campania Region Oncology Network and President of the MITO Research Group. "The fact that rucaparib is a reimbursable drug makes it an important new treatment option, even for these patients who still too often do not receive safe and effective maintenance therapy."

"The reimbursement of Rubraca in Italy is an important step in the ovarian cancer treatment pathway, as it has shown to be effective across a broad population of women with relapsed ovarian cancer," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We are working to make Rubraca available to as many eligible patients as possible across Europe, and we look forward to additional country launches in the coming months."

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 that is being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancer (mCRPC), as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

Rubraca (rucaparib) European Union (EU) authorized use and Important Safety Information

Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

Rubraca is indicated as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with ≥2prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

Efficacy of Rubraca as treatment for relapsed or progressive EOC, FTC, or PPC has not been investigated in patients who have received prior treatment with a PARP inhibitor. Therefore, use in this patient population is not recommended.

Rubraca (rucaparib) European Union (EU) authorized use and Important Safety Information

Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

Rubraca is indicated as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with ≥2prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

Efficacy of Rubraca as treatment for relapsed or progressive EOC, FTC, or PPC has not been investigated in patients who have received prior treatment with a PARP inhibitor. Therefore, use in this patient population is not recommended.

Summary warnings and precautions:

Hematological toxicity

During treatment with Rubraca, events of myelosuppression (anemia, neutropenia, thrombocytopenia) may be observed and are typically first observed after 8–10 weeks of treatment with Rubraca. These reactions are manageable with routine medical treatment and/or dose adjustment for more severe cases. Complete blood count testing prior to starting treatment with Rubraca, and monthly thereafter, is advised. Patients should not start Rubraca treatment until they have recovered from hematological toxicities caused by previous chemotherapy (CTCAE grade ≥1).

Supportive care and institutional guidelines should be implemented for the management of low blood counts for the treatment of anemia and neutropenia. Rubraca should be interrupted or dose reduced according to Table 1 (see Posology and Method of Administration [4.2] of the Summary of Product Characteristics [SPC]) and blood counts monitored weekly until recovery. If the levels have not recovered to CTCAE grade 1 or better after 4 weeks, the patient should be referred to a hematologist for further investigations.

MDS/AML

MDS/AML, including cases with fatal outcome, have been reported in patients who received Rubraca. The duration of therapy with Rubraca in patients who developed MDS/AML varied from less than 1 month to approximately 28 months.

If MDS/AML is suspected, the patient should be referred to a hematologist for further investigations, including bone marrow analysis and blood sampling for cytogenetics. If, following investigation for prolonged hematological toxicity, MDS/AML is confirmed, Rubraca should be discontinued.

Photosensitivity

Photosensitivity has been observed in patients treated with Rubraca. Patients should avoid spending time in direct sunlight because they may burn more easily during Rubraca treatment; when outdoors, patients should wear a hat and protective clothing, and use sunscreen and lip balm with sun protection factor of 50 or greater.

Gastrointestinal toxicities

Gastrointestinal toxicities (nausea and vomiting) are frequently reported with Rubraca, and are generally low grade (CTCAE grade 1 or 2), and may be managed with dose reduction (refer to Posology and Method of Administration [4.2], Table 1 of the SPC) or interruption. Antiemetics, such as 5-HT3 antagonists, dexamethasone, aprepitant and fosaprepitant, can be used as treatment for nausea/vomiting and may also be considered for prophylactic (i.e. preventative) use prior to starting Rubraca. It is important to proactively manage these events to avoid prolonged or more severe events of nausea/vomiting which have the potential to lead to complications such as dehydration or hospitalization.

Embryofetal toxicity

Rubraca can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings from animal studies. In an animal reproduction study, administration of Rubraca to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicity at exposures below those in patients receiving the recommended human dose of 600 mg twice daily (see Preclinical Safety Data [5.3] of the SPC).

Pregnancy/contraception

Pregnant women should be informed of the potential risk to a fetus. Women of reproductive potential should be advised to use effective contraception during treatment and for 6 months following the last dose of Rubraca (see section 4.6 of the SPC). A pregnancy test before initiating treatment is recommended in women of reproductive potential.

On November 12, 2019 Oncology Venture A/S ("OV" or the Company) reported an update on the progress of its planned Phase 2 clinical trial for IXEMPRA (Ixabepilone) for the treatment of breast cancer (Press release, Oncology Venture, NOV 13, 2019, View Source [SID1234551165]).

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OV holds an exclusive option to in-license the European rights to IXEMPRA (ixabepilone) from the pharmaceutical company R-Pharm U.S., LLC, which previously acquired global rights to the drug from Bristol-Myers Squibb (BMS). The drug is approved in the USA since 2007 for the treatment of breast cancer. OV has recently announced this drug as one of its top priority programs.

The Company is currently advancing a protocol to evaluate IXEMPRA for the treatment of newly diagnosed breast cancer (neoadjuvant setting) in a DRP-guided Phase 2 clinical trial, with sites planned in Europe. The Company’s protocol aims towards an enrollment target of nearly 40 patients. Through use of DRP patient selection, OV aims to provide a superior clinical benefit, to breast cancer patients receiving IXEMPRA, as compared to other approved therapy options. Enrollment of patients is expected in 1H 2020

Steve R. Carchedi, CEO of Oncology Venture, commented "We are pleased to announce the ongoing progress of our planned Phase 2 clinical trial for IXEMPRA, one of our top priority pipeline programs. Phase 2 development of this asset in EU positions us to advance the drug to market and commercialization in both of these top, global oncology markets. The potential approval and use of microtubulin inhibitors, such as IXEMPRA in the front-line setting for breast cancer is an exciting therapeutic area. We are confident our Phase 2 study will prove the merits of this drug, together with its DRP companion diagnostic, as we advance towards approval and commercialization of this priority asset in our pipeline."

On November 13, 2019 Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of targeted immunotherapies using fully human monoclonal antibodies (mAbs) to treat life-threatening bacterial infections, reported financial and corporate results for the third quarter ended September 30, 2019 (Press release, Aridis Pharmaceuticals, NOV 13, 2019, View Source [SID1234551227]).

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Third Quarter Highlights and Recent Developments

Advanced Phase 3 global clinical trial of AR-301 in patients with ventilator associated pneumonia (VAP) and remain on track to announce top line data expected in early 2021.
Executed an equity purchase agreement with Serum Institute BV (SIBV), an affiliate of the Serum Institute of India, Ltd. (SIIL), whereby SIBV invested $10 million into Aridis.
Executed license agreement with Serum AMR (SAMR), another affiliate of SIIL, for rights to multiple products and utilization of MabIgX platform technology (transaction included a $15M upfront payment).
Received Orphan Drug Designation (ODD) from The European Medicines Agency (EMA) for AR-501, an inhalable therapy for the treatment of chronic lung infections in cystic fibrosis patients.
Continued enrolling AR-501’s Phase 1/2a clinical trial with top-line data expected in Q1 2020 (healthy subjects), and in Q2 2021 (cystic fibrosis subjects).
Enhanced leadership team with key appointments including infectious disease expert, Dr. Paul Mendelman as Interim Chief Medical Officer.
Presented posters at the Infectious Disease Society of America’s (IDSA) IDWeek 2019 on AR-105 and AR-501.
Announced results from AR-105’s global Phase 2 clinical trial for the treatment of VAP caused by Pseudomonas aeruginosa (P. aeruginosa).
"The major emphasis for the period was laying the foundation for our long-term growth strategy as we head into the final quarter of 2019, and the new year. While we are certainly disappointed by AR-105’s Phase 2 clinical trial result, our intense post-data analysis gives us conviction that the ongoing phase 3 study for AR-301 in S. aureus VAP is being conducted with utmost rigor and scrutiny incorporating lessons learned from AR-105 to bring this drug to market. Similarly, we remain confident in the design and execution of the ongoing phase 1/ 2 trial for AR-501 targeting infections in cystic fibrosis patients," commented Vu Truong, Ph.D., Chief Executive Officer of Aridis Pharmaceuticals.

"I’m especially pleased with the recent addition to management of Dr. Paul Mendelman who brings renowned infectious disease expertise to the team and is already impacting the data analysis of the AR-105 clinical trial as well as management of our ongoing Phase 3 clinical trial for AR-301 and Phase 1/2a clinical trial for AR-501 programs. Moving forward, we are now well positioned to execute on our clinical development strategy and to commence in earnest corporate development activities for the MabIgX platform," continued Dr. Truong.

Clinical Program Update

AR-301: During the third quarter, Aridis continued enrolling its Phase 3 global clinical trial for AR-301, which targets gram-positive S. aureus in critically ill VAP patients. The trial, which was initiated in the first quarter of 2019, is expected to enroll 240 patients at approximately 125 clinical centers in 20 countries. Interim data is expected in early 2020 and top line data is expected in early 2021. Participating centers in all countries are following the same stringent clinical protocols and procedures for critically ill VAP patients, as is standard in the U.S. and Europe. The trial represents the first ever Phase 3 superiority clinical study evaluating immunotherapy with a fully human monoclonal antibody to treat acute pneumonia in the intensive care unit setting. Details of the study can be viewed on www.clinicaltrials.gov using identifier NCT03816956.

AR-301 is a fully human monoclonal IgG1 antibody specifically targeting gram-positive S. aureus alpha-toxin. It has been shown in vitro to protect against alpha-toxin mediated destruction of host cells, thereby potentially preserving the human immune response. AR-301’s mode of action is independent of the antibiotic resistance profile of S. aureus and it is active against infections caused by both MRSA (methicillin resistant S. aureus) and MSSA (methicillin sensitive S. aureus).

AR-501: During the third quarter, Aridis continued enrolling patients in its Phase 1/2a clinical trial of this inhalable formulation of gallium citrate being evaluated for the treatment of chronic lung infections associated with cystic fibrosis. The single ascending dose cohorts of healthy subjects have completed dosing and the safety monitoring committee has recommended proceeding into the multiple ascending dose cohorts. The Company expects to report data from the Phase 1 portion of the trial which consists of healthy subjects in Q1 2020 and the Phase 2a segment with cystic fibrosis subjects in Q2 2021.

AR-501, which is being developed in collaboration with the Cystic Fibrosis Foundation (CFF), has been granted by the U.S. Food and Drug Administration (FDA) both Fast Track and Qualified Infectious Disease Product Designation (QIDP) designations. In addition, during the third quarter (July 19th), the EMA granted the program Orphan Drug Designation (ODD). The FDA had granted ODD status to AR-501 in June 2019.

Details of the Phase 1/2a clinical trial, which is a randomized, double-blinded, placebo controlled single and multiple dose-ascending trial investigating the safety and pharmacokinetics of inhaled AR-501 in healthy volunteers and cystic fibrosis patients with chronic bacterial lung infections, can be viewed on www.clinicaltrials.gov using identifier NCT03669614. The study is expected to accrue 48 healthy adult volunteers and 48 cystic fibrosis patients from approximately 15 sites in the U.S.

AR-105: During the third quarter (September 3, 2019), Aridis reported results for its global Phase 2 clinical trial evaluating AR-105, a fully human IgG1 monoclonal antibody for the treatment of VAP caused by gram-negative Pseudomonas aeruginosa (P. aeruginosa). The completed study did not meet its primary endpoint of demonstrating superiority in clinical cure rates on Day 21 compared to placebo. Furthermore, there was a statistically significant imbalance in all-cause mortality, as well as serious adverse event (SAE) rates between treatment groups that favored placebo. However, no SAE or mortality in the study was deemed to be drug related by the study investigators or the study’s data monitoring committee. AR-105 has a different mechanism of action, directed at a different bacterium, and evaluated in a different patient population as compared to AR-301. While no further development resources will be allocated towards AR-105, the Company will continue to analyze the full data set to better understand the top-line results.

Throughout the third quarter, Aridis continued to attend investor and medical conferences and recently presented two posters at the Infectious Disease Society of America’s (IDSA) IDWeek 2019, which took place on October 2nd-6th in Washington, DC. Both posters, "Pre-Clinical and Phase I Safety Data for Anti-Pseudomonas aeruginosa Human Monoclonal Antibody AR-105," and "In Vitro and In Vivo Non Clinical Efficacy of AR-501 (Gallium Citrate)," were presented on October 3, 2019.

Infectious Disease Specialist CMO Appointment: A recent key highlight occurred on October 11, 2019, when Aridis announced the appointment of Paul Mendelman, MD, as interim Chief Medical Officer, replacing Dr. Wolfgang Dummer who departed the company for personal reasons. Dr. Mendelman brings to Aridis a prolific career in infectious diseases across industry and academia spanning over 30 years with board certification in pediatrics and pediatric infectious diseases. He has held senior clinical development positions at leading companies such as Takeda Vaccines (Vice President, Medical), MedImmune (Vice President & Therapeutic Area Leader, Clinical Development), and Merck (Director, Clinical Research Infectious Diseases). From 1996 to 2005, he managed the clinical development group for FluMist, the live attenuated intranasal influenza vaccine, licensed initially in the U.S. for the 2003-04 season. The Company also promoted Lynne Deans to the position of Vice President, Clinical Operations. Ms. Deans has over 30 years of experience in clinical operations and has held senior director of clinical operations positions in infectious diseases focused companies such as Cerexa, PaxVax, and Kalobios.

Corporate Update:

A key highlight during the third quarter was the execution of a license agreement with SAMR, an affiliate of SIIL. The agreement provides SAMR with the right to in-license Aridis’ clinical stage programs AR-301(VAP), AR-105 (VAP) and AR-101 (hospital acquired pneumonia (HAP)). These license rights will be exclusive and to a limited territory which includes markets outside of the U.S., Europe, Canada, UK, China, Australia, New Zealand and Japan. Also, the agreement includes an exclusive, worldwide license (excluding China) to AR-201, a preclinical fully human mAb for the prevention of respiratory syncytial virus (RSV). In addition, SAMR may elect to collaborate with Aridis to utilize MabIgX to identify and advance up to five SAMR wholly-owned programs. MabIgX is Aridis’ proprietary technology platform to rapidly identify rare, potent antibody-producing B-cells from patients who have successfully overcome an infection to produce mAbs.

Under the terms of the Agreement, Aridis received a $15M upfront payment and will be eligible to receive as much as $42.5 million in future milestone payments for achieving product development and commercial objectives, along with royalties on net sales. The consummation of this transaction follows an equity purchase agreement with SIBV, another affiliate of SIIL, which occurred in July 2019 whereby SIBV invested $10 million into Aridis.

"We continued to make major strides in corporate development with a key pharmaceutical alliance, which also improves our balance sheet. SIIL is the world’s largest vaccine manufacturer by dose units and a significant monoclonal antibody development and manufacturing company. This combined product and technology license is a testament to the quality of our pipeline and groundbreaking MabIgX platform for identifying rare, potent antibody-producing B-cells from patients who have successfully overcome an infection to produce mAbs," concluded Dr. Truong.

Fiscal 2019 Third Quarter Results:

Cash: Total cash and cash equivalents as of September 30, 2019 was $17.3 million. In addition, in October 2019 the Company received $10 million, the balance due on the upfront payment from SAMR upon the execution of license agreement referred to above.
Revenues: Total revenues for the quarter ended September 2019 was zero, a decrease of $1.0 million over the same period in 2018 when a $1.0 million milestone payment was recognized from the CFF associated with its grant to fund the AR-501 Phase 1/2a clinical trial.
Research and Development Expenses: Research and development expenses for the quarter ended September 30, 2019 were $6.0 million, a decrease of $0.9 million over the same period in 2018 due primarily to a decrease in spending on clinical trial activities and drug manufacturing for our AR-105 program, which was recently completed, partially offset by an increase in spending on clinical trial activities for both our AR-301 Phase 3 and the AR-501 Phase 1/2a programs.
General and Administrative Expenses: General and administrative expenses for the quarter ended September 30, 2019 were $1.4 million, an increase of $0.6 million over the same period in 2018 due primarily to an increase in personnel related expenses, including stock-based compensation, an increase in patent related fees and an increase in directors’ and officers’ liabilities insurance expense.
Interest and Other Income, net: Interest and other income, net for the quarter ended September 30, 2019 was $90,000, a decrease of $29,000 over the same period in 2018. This decrease was due primarily to a lower average cash balance.
Change in Fair Value of Warrant Liability: As a result of all warrants to purchase preferred stock being converted into warrants to purchase common stock upon our IPO in August 2018, there was no warrant liability recorded at the end of the third quarter of 2019. There was a $1.4 million loss attributed to an increase in the fair value of the warrant liability in the third quarter of 2018.
Net Loss: The net loss available to common shareholders for the quarter ended September 30, 2019 was $7.6 million, or ($0.87) per share, compared to a net loss available to common shareholders of $7.9 million, or ($1.97) per share, for the quarter ended September 30, 2018. It should be noted that there were 166,373 common shares outstanding during the third quarter of 2018 and until the completion of the Company’s IPO in August 2018. Moreover, there were convertible preferred shares outstanding until the time of the IPO which earned dividends that were distributed as additional shares of preferred stock. All preferred shares were converted to common stock upon the completion of the IPO on August 16, 2018. As a result, the weighted average common shares outstanding for the third quarter of 2018 was 4.0 million. At September 30, 2019, the weighted average common shares outstanding for the third quarter of 2019 was 8.7 million.

On November 13, 2019 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in therapeutic ultrasound, reported financial results for the third quarter and nine months of 2019 and provided an update on strategic and operational developments (Press release, EDAP TMS, NOV 13, 2019, View Source [SID1234551305]).

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Marc Oczachowski, EDAP’s Chief Executive Officer, said, "During the third quarter, we were able to sustain the sales momentum that carried us through the first half of the year. We sold an additional two Focal One units, including one to the world renowned Mayo Clinic bringing our year-to-date total to nine. At the same time, our pipeline continues to grow, particularly in the U.S., where we are still in the early stages of our hospital and physician education and outreach efforts. As a recognized leader in therapeutic ultrasound, we believe we have established a solid foundation from which to drive future growth."

Third Quarter 2019 Results

Total revenue for the third quarter 2019 was EUR 10.3 million (USD 11.3 million), a 26.7% increase compared to EUR 8.1 million (USD 9.5 million) for the third quarter of 2018.

Total revenue in the HIFU business for the third quarter 2019 was EUR 2.8 million (USD 3.1 million), a 44.4% increase compared to EUR 1.9 million (USD 2.3 million) for the third quarter of 2018.

For the three months ended September 30, 2019, total revenue for the UDS division was EUR 7.5 million (USD 8.3 million), a 21.2% increase compared to EUR 6.2 million (USD 7.2 million) during the year-ago period.

Gross profit for the third quarter 2019 was EUR 4.7 million (USD 5.1 million), compared to EUR 3.4 million (USD 3.9 million) for the year-ago period. Gross profit margin on net sales was 45.3% in the third quarter of 2019, compared to 41.5% in the year-ago period.

Operating expenses were EUR 4.4 million (USD 4.9 million) for the third quarter of 2019, compared to EUR 4.1 million (USD 4.7 million) for the same period in 2018.

Operating profit for the third quarter 2019 was EUR 0.3 million (USD 0.3 million), compared to an operating loss of EUR 0.7 million (USD 0.8 million) in the third quarter of 2018.

Net income for the third quarter 2019 was EUR 0.8 million (USD 0.9 million), or earnings of EUR 0.03 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.

First nine months 2019 Results

Total revenue for the first nine months of 2019 was EUR 32.9 million (USD 36.9 million), a 27.1% increase compared to EUR 25.9 million (USD 30.9 million) for the first nine months of 2018.

Total revenue in the HIFU business for the first nine months of 2019 was EUR 11.2 million (USD 12.6 million), a 67.8% increase compared to EUR 6.7 million (USD 8.0 million) for the nine months ended September 30, 2018.

For the nine months ended September 30, 2019, total revenue for the UDS division was EUR 21.7 million (USD 24.3 million), a 13.0% increase compared to EUR 19.2 million (USD 22.9 million) during the year-ago period.

Gross profit for the first nine months of 2019 was EUR 15.9 million (USD 17.8 million), compared to EUR 10.9 million (USD 13.0 million) for the year-ago period. Gross profit margin on net sales was 48.2% compared to 42.3% in the year-ago period.

Operating expenses were EUR 13.7 million (USD 15.4 million) for the first nine months of 2019, compared to EUR 13.1 million (USD 15.6 million) for the same period in 2018.

Operating profit for the first nine months of 2019 was EUR 2.1 million (USD 2.4 million), compared to an operating loss of EUR 2.2 million (USD 2.6 million) in the first nine months of 2018.

Net income for the first nine months of 2019 was EUR 2.5 million (USD 2.8 million), or earnings of EUR 0.08 per diluted share, as compared to a net loss of EUR 1.4 million (USD 1.6 million), or a loss of EUR 0.05 per diluted share in the year-ago period.

As of September 30, 2019, cash and cash equivalents were EUR 17.7 million (USD 19.3 million).

Conference Call

An accompanying conference call and webcast will be conducted by management to review the results. The call will be held at 8:30 am EDT on Wednesday November 14, 2019. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Call & Webcast
Thursday, November 14, 2019 @ 8:30am Eastern Time
Domestic: 877-451-6152
International: 201-389-0879
Passcode: 13695746
Webcast: View Source

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