On November 18, 2021 Sanofi reported an equity investment of $180 million and a new strategic collaboration with Owkin comprised of discovery and development programmes in four exclusive types of cancer, with a total payment of $90 million for three years plus additional research milestone-based payments (Press release, Sanofi, NOV 18, 2021, View Source [SID1234595762]). Owkin, an artificial intelligence (AI) and precision medicine company, builds best-in-class predictive biomedical AI models and robust data sets. With the ambition to optimize clinical trial design and detect predictive biomarkers for diseases and treatment outcomes, this collaboration will support Sanofi’s growing oncology portfolio in core areas such as lung cancer, breast cancer and multiple myeloma.

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!

To accelerate medical research with AI in a privacy-preserving way, Owkin has assembled a global research network powered by federated learning, which allows data scientists to securely connect to decentralized, multi-party data sets and train AI models without having to pool data. This approach will complement Sanofi’s emerging strength in oncology, as the company’s scientists apply cutting-edge technology platforms to design potentially life-transforming medicines for cancer patients worldwide.

"Owkin’s unique methodology, which applies AI on patient data from partnerships with multiple academic medical centers, supports our ambition to leverage data in innovative ways in R&D," said Arnaud Robert, Executive Vice President, Chief Digital Officer, Sanofi. "We are striving to advance precision medicine to the next level and to discover innovative treatment methods with the greatest benefits for patients."

Sanofi will leverage the comprehensive Owkin Platform, in order to find new biomarkers and therapeutic targets, building prognostic models, and predicting response to treatment from multimodal patient data. Sanofi’s investment will support Owkin’s development and goal to grow the world’s leading histology and genomic cancer database from top oncology centers.

"Owkin’s mission is to improve patient’s lives by using our platform to discover and develop the right treatment for every patient," said Thomas Clozel, M.D., Co-Founder and CEO at Owkin. "We believe that the future of precision medicine lies in technologies that can unlock insights from the vast amount of patient data in hospitals and research centers in a privacy-preserving and secure way. This landmark partnership with Sanofi will see federated learning used to create research collaborations at a truly unprecedented scale. The future of AI to transform how we develop treatments is incredibly bright, and we are proud to partner with Sanofi on this mission."

This collaboration agreement will allow Sanofi to work closely with Owkin in identifying new oncology treatments across four cancers.

"We look forward to working with our colleagues at Owkin to analyze data from hundreds of thousands of patients," said John Reed, M.D., Ph.D., Global Head of Research and Development, Sanofi. "Sanofi’s investment in the company includes a three-year agreement that will help discover and develop new treatments for non-small cell lung cancer, triple negative breast cancer, mesothelioma and multiple myeloma. This partnership will help accelerate our ambitious oncology program as we advance a rich pipeline of medicines to address unmet patient needs."

On November 17, 2021 Orange Grove Bio, a preclinical drug investment and development firm, and the University of Pittsburgh reported the establishment of a collaboration designed to advance the development and commercialization of novel therapeutics by supporting the translation of scientific discoveries made by researchers at the University of Pittsburgh (Press release, Orange Grove Bio, NOV 17, 2021, View Source [SID1234633191]). The newly established partnership will aim to cultivate the Pittsburgh biotech landscape by increasing entrepreneurship, education, and scientific translation of promising technologies. These efforts will be focused in the areas of oncology and autoimmune and inflammatory diseases.

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!

"University of Pittsburgh innovators have a strong track record of achieving impact for their research through commercial translation," said Joe Havrilla, Associate Vice Chancellor for Innovation and Entrepreneurship. "This new collaboration with Orange Grove Bio will allow us to further our commercialization efforts and we look forward to the positive impact it will have for our faculty and students and ultimately for patients."

Under terms of the partnership, Orange Grove Bio will provide commercialization guidance and support to the University of Pittsburgh Innovation Institute, an internship program for the university’s Ph.D. students, and educational seminars for primary investigators and researchers at the university. Additionally, as part of these activities, Orange Grove Bio’s head of chemistry, William H. Miller, Ph.D., has joined the University of Pittsburgh’s external advisory board for novel technologies.

"Researchers at the University of Pittsburgh are engaged in a wide range of cutting-edge research that has the potential to meaningfully impact human health," said Dr. Miller. "At Orange Grove, we want to do our part to support these ongoing research efforts and further develop the local biotech environment to enable the development and commercialization of these discoveries."

In addition to working closely with the technology transfer office and supporting educational initiatives, Orange Grove Bio will increase its on-the-ground presence by onboarding new team members from the Pittsburgh area, who will perform critical scientific and business functions.

Orange Grove Bio’s mission is to develop new therapeutic options for patients by harnessing the significant research potential found in universities across the United States. Orange Grove Bio fosters strong relationships with technology transfer offices outside of the traditional medical technology hubs of Boston and San Francisco. Collectively, Orange Grove Bio’s team possesses more than one hundred years of drug development and company creation experience, allowing it to build and finance innovative programs from the research and development stage to clinical trials.

"We believe that the University of Pittsburgh and its talented researchers are well positioned to serve as a hotbed for the incubation of innovative drug development companies capable of delivering the ground-breaking therapies of tomorrow," said Marc Appel, Orange Grove Bio’s chief executive officer. "We are committed to fostering and supporting this rich scientific ecosystem through collaboration with the University of Pittsburgh, academic researchers, and investors to drive the commercialization of novel therapies for patients."

On November 17, 2021 BeiGene reported that was approved to stage a $3 billion IPO on Shanghai’s STAR Exchange, the company’s third listing (Press release, BeiGene, NOV 17, 2021, View Source [SID1234595836]). Previously, the company completed an $182 million IPO on NASDAQ in 2016 and a $900 million Hong Kong IPO in 2018. It will be the first biopharma to list on the three exchanges. The China Securities Regulatory Commission (CSRC) signed off on the IPO this week, the last requirement for the process. Founded in 2010, BeiGene focuses on developing molecularly targeted and immuno-oncology drug candidates.

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!

On November 17, 2021 EDAP TMS SA (Nasdaq: EDAP) (the "Company"), a global leader in robotic energy-based therapies, reported that unaudited financial results for the third quarter of 2021 and provided an update on strategic and operational developments (Press release, EDAP TMS, NOV 17, 2021, View Source [SID1234595795]).

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!

Marc Oczachowski, EDAP’s Chairman and Chief Executive Officer, said: "We are pleased with the continued strong growth in U.S. HIFU treatment volumes, which increased 58% year-to-date over the comparable period in 2020. This is a very positive sign as it reflects the growing adoption of focal therapy by urologists. Regarding our third quarter revenue, the COVID-19 pandemic continued to weigh on hospital capital spending, and this was further impacted by several machine placements that were delayed until the early days of the fourth quarter due to logistical challenges that were exacerbated by the resurgence of the pandemic in many parts of the world. Our leading indicators are strong, we are well financed, and I believe we are well positioned to exit the year with renewed momentum."

Nine Months 2021 Results

Total revenue for the nine months ended September 30, 2021 was EUR 30.1 million (USD 35.9 million), an increase of 14.4% from total revenue of 26.3 million (USD 29.8 million) for the same period in 2020.

Total revenue in the HIFU business for the nine months ended September 30, 2021 was EUR 5.7 million (USD 6.8 million), a decline of 18.9% as compared to EUR 7.1 million (USD 8.0 million) for the nine months ended September 30, 2020.

Total revenue in the LITHO business for the nine months ended September 30, 2021 was EUR 7.7 million (USD 9.1 million), an decrease of 7.4% from EUR 8.3 million (USD 9.4 million) for the nine months ended September 30, 2020.

Total revenue in the Distribution business for the nine months ended September 30, 2021 was EUR 16.7 million (USD 19.9 million), a 52.4% increase compared to EUR 11.0 million (USD 12.4 million) for the nine months ended September 30, 2020.

Gross profit for the nine months ended September 30, 2021 was EUR 12.2 million (USD 14.6 million), compared to EUR 11.4 million (USD 12.8 million) for the year-ago period. Gross profit margin on net sales was 40.6% for the nine months ended September 30, 2021, compared to 43.2% for the comparable period in 2020. The decrease in gross profit year-over-year was due to lower sales effect on fixed costs, particularly in the HIFU business.

Operating expenses were EUR 14.3 million (USD 17.0 million) for the nine months ended September 30, 2021, compared to EUR 12.8 million (USD 14.5 million) for the same period in 2020.

Operating loss for the nine months ended September 30, 2021 was EUR 2.1 million (USD 2.5 million), compared to an operating loss of EUR 1.5 million (USD 1.6 million) for the nine months ended September 30, 2020.

Net loss for the nine months ended September 30, 2021 was EUR 0.7 million (USD 0.8 million), or EUR (0.02) per diluted share, as compared to a net loss of EUR 2.5 million (USD 2.8 million), or EUR (0.09) per diluted share in the year-ago period.

Third Quarter 2021 Results

Total revenue for the third quarter 2021 was EUR 9.4 million (USD 11.1 million), roughly flat with total revenue of EUR 9.4 million (USD 11.2 million) for the same period in 2020.

Total revenue in the HIFU business for the third quarter 2021 was EUR 1.9 million (USD 2.3 million), a decline of 25.6% as compared to EUR 2.6 million (USD 3.0 million) for the third quarter of 2020.

Total revenue in the LITHO business for the third quarter 2021 was EUR 2.5 million (USD 2.9 million), an increase of 3.0% from EUR 2.4 million (USD 2.9 million) for the third quarter of 2020.

Total revenue in the Distribution business for the third quarter 2021 was EUR 5.0 million (USD 5.9 million), a 13.4% increase compared to EUR 4.4 million (USD 5.2 million) for the third quarter of 2020.

Gross profit for the third quarter 2021 was EUR 3.6 million (USD 4.3 million), compared to EUR 4.0 million (USD 4.7 million) for the year-ago period. Gross profit margin on net sales was 38.4% in the third quarter of 2021, compared to 42.0% in the year-ago period. The decrease in gross profit year-over-year was due to lower sales effect on fixed costs, particularly in the HIFU business.

Operating expenses were EUR 5.5 million (USD 6.5 million) for the third quarter of 2021, compared to EUR 4.3 million (USD 5.0 million) for the same period in 2020.

Operating loss for the third quarter of 2021 was EUR 1.9 million (USD 2.2 million), compared to an operating loss of EUR 0.3 million (USD 0.3 million) in the third quarter of 2020.

Net loss for the third quarter of 2021 was EUR 1.0 million (USD 1.2 million), or EUR (0.03) per diluted share, as compared to a net loss of EUR 1.0 million (USD 1.2 million), or EUR (0.03) per diluted share in the year-ago period.

As of September 30, 2021, the company held cash and cash equivalents of EUR 45.4 million (USD $52.6 million), as compared to EUR 24.7 million (USD 30.2 million) as of December 31, 2020.

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 tomorrow, November 18, 2021. Please refer to the information below for conference call dial-in information and webcast registration.

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

On November 17, 2021 La Jolla Pharmaceutical Company (Nasdaq: LJPC) reported that it will commence a share repurchase plan for up to $10 million of the Company’s common stock. Repurchases may be made from time to time at the Company’s discretion (Press release, La Jolla Pharmaceutical, NOV 17, 2021, View Source [SID1234595790]). The plan has no time limit and can be discontinued at any time. There can be no assurance as to the timing or number of shares of any repurchases.

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 decision to repurchase shares reflects our confidence in our team and the ability to execute against our strategic initiatives for growth, which is supported by the strength of our balance sheet," said Larry Edwards, President and Chief Executive Officer of La Jolla.