On November 21, 2022 Oncotelic Therapeutics, Inc (OTCQB:OTLC) ("Oncotelic", the "Company" or "We"), a developer of treatments for rare and orphan indications, including Parkinson’s Disease, PDAC, DIPG, and COVID-19, reported financial results for the three months ended September 30, 2022 ("Q3 2022") as compared to the three months ended September 30, 2021("Q3 2021") (Press release, Oncotelic, NOV 21, 2022, View Source [SID1234624295]). The financial results are based on the Quarterly Report on Form 10-Q as filed with the Securities and Exchange Commission on November 18, 2022.

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Highlights for Q3 2022 and thereafter:

We are starting to see the benefits of the JV transaction, between Dragon Overseas Limited ("Dragon") and us through the formation of GMP Biotechnology Limited ("GMP Bio" or "JV") being reflected in our financial results. The JV has absorbed our R&D expenditures as related to OT-101 and a majority of our G&A expenditures as well. Going forward this should permit us to continue our development efforts of OT-101, mainly through the JV at a significantly lower cost to us, explore potential partnering of our remaining pipeline products, as well as expanding our effort on COVID-19 alongside BARDA. As previously reported, the JV, or a subsidiary thereof, is still being planned to be taken into an initial public offering in Hong Kong or another exchange at a future point in time.

As reported in October 2022, the creation of our animal health division is a strategic move to explore and evaluate how we could potentially utilize technology, such as blockchain and DAO’s, to help bring new treatments to market for animal health.

Further, as reported in October 2022, Biomedical Advanced Research and Development Authority (BARDA) approved a contract to conduct a study with us for the development of OT-101 against long-term effects of respiratory distress post COVID-19. The scope of the study includes collecting the long-term clinical data on COVID-19 patients in Peru and Argentina where our C001-2020-01 trial was conducted and to demonstrate potential effectiveness of OT-101 against the long-term effects of respiratory distress post COVID-19. The data will be used to design the next clinical trial aiming at demonstrating effectiveness of OT-101 against COVID-19 and long-term COVID-19 for its marketing approval.

Going into the final stretch of the year through the first quarter of 2023, we are accelerating our clinical programs in multiple indications supported by various stakeholders, including our JV and key opinion leaders. These include pancreatic cancer, gliomas, mesotheliomas, and others. We are optimistic at what the future holds for us and are happy with what we have accomplished so far this year.

"2022 has been a good nine months for us, starting with the culmination of the joint venture with Dragon. We are starting to see a significant reduction in our expenses due to the shift of our expenses over to the JV, especially related to the development of OT-101. This cost reduction has not come at the expense of our clinical programs; indeed, we are expanding our clinical programs related to OT-101 along multiple fronts and through the JV," opined Amit Shah, CFO, Oncotelic.

"We are singularly focused on building shareholder value. Our $22.6 million investment in GMP Bio, at fair value, has increased our total assets value from $23.6 million at December 31, 2021 to $40.2 million at September 30. 2022 We are looking to build on the positive impacts of the JV, hopefully with additional partnering deals as well as building out the DAO for animal health. We thank our shareholders, stakeholders, patients and investigators in their continuing support and looking forward to positive growth momentum in the coming years," said Dr. Vuong Trieu, CEO and Chairman, Oncotelic.

In comparing the Company’s operating results for the three months ended September 30, 2022, and 2021, respectively, our net loss reduced by approximately $1.0 million. This was primarily due to our reduced operating expenses of approximately $1.2 million and reimbursement of expenses by a related party of approximately $0.2 million; offset by higher interest expense by approximately $0.2 million and PPP loan forgiveness of approximately $0.3 million from the three months ended September 30, 2021.

Our research and development expenses decreased by approximately $0.6 million primarily due to lower personnel expenses of approximately $0.3 million and lower clinical trial expenses related to OT-101 of approximately $0.3 million. Further, our general and administrative expenses decreased by approximately $0.6 million primarily due to reduced compensation expense of approximately $0.6 million. Our operating expenses were lower as we have successfully transferred a significant portion of our development expenses to our JV specifically for activities related to OT-101, including the initiation of new clinical trials. We expect our R&D and G&A expense to remain steady or reduce for the remainder of the year 2022.

On November 21, 2022 EDAP TMS SA (Nasdaq: EDAP) (the "Company"), a global leader in robotic energy-based therapies, reported that Marc Oczachowski, Chief Executive Officer, is scheduled to deliver a company presentation and host investor 1×1 meetings at the Piper Sandler 34th Annual Healthcare Conference, which is being held November 29 – December 1, 2022, in New York City (Press release, EDAP TMS, NOV 21, 2022, View Source [SID1234624293]).

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On November 21, 2022 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that Douglas E. Onsi, President and Chief Executive Officer, will participate in a fireside chat at the Piper Sandler 34th Annual Healthcare Conference, being held in New York on November 29-December 1, 2022 (Press release, Leap Therapeutics, NOV 21, 2022, View Sourcenews-releases/news-release-details/leap-therapeutics-participate-piper-sandler-34th-annual" target="_blank" title="View Sourcenews-releases/news-release-details/leap-therapeutics-participate-piper-sandler-34th-annual" rel="nofollow">View Source [SID1234624292]).

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The fireside chat will be webcast live and may be accessed on the Investors page of the company’s website at View Source, where a replay of the event will also be available for a limited time.

On November 21, 2022 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), an immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported it has entered into a Sponsored Research Agreement with Washington University in St. Louis, MO, to support development of SNS-101, a conditionally active VISTA-blocking antibody (Press release, Sensei Biotherapeutics, NOV 21, 2022, View Source [SID1234624291]).

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Research will be conducted in the laboratory of Robert Schreiber, Ph.D., Professor of Pathology & Immunology and Director of the Center for Human Immunology and Immunotherapy Programs, to evaluate the underlying molecular mechanisms that enable SNS-101 to overcome myeloid cell-driven immunosuppression within the tumor microenvironment.

"In addition to a deep expertise in immuno-oncology, Dr. Schreiber and his team bring extensive knowledge of the cancer model system planned for these studies as well as access to molecular characterization tools," said Edward van der Horst, Ph.D., Senior Vice President, Biologics Discovery & Early Development, at Sensei Bio. "Together, we will leverage these attributes to better understand SNS-101’s ability to modulate the tumor microenvironment and potentially achieve tumor rejection where other checkpoint therapies have failed."

Said Dr. Schreiber, "We’re excited to partner with Sensei Bio to further our understanding of how to safely and effectively inhibit VISTA, a promising but challenging target in immuno-oncology. SNS-101 has the potential to unlock VISTA as a powerful immune checkpoint by exploiting the tumor microenvironment using pH-sensitive properties, delivering powerful anti-tumor activity without the negative effects that have thwarted past efforts."

Sensei continues to advance SNS-101 and remains on track to submit an Investigational New Drug application (IND) for SNS-101 in the first half of 2023. The company recently presented preclinical data for the program at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting.

Disclosure
Dr. Schreiber receives compensation as a member of Sensei Biotherapeutics’ Immuno-Oncology Advisory Board, and this financial relationship has been disclosed to Washington University in St. Louis in accordance with institutional policy.

On November 21, 2022 Teva Pharmaceutical Industries Ltd. ("Teva" or the "Company") (NYSE and TASE: TEVA), reported that the Company’s Board of Directors has appointed Richard Francis as President and Chief Executive Officer, effective January 1, 2023 (Press release, Teva, NOV 21, 2022, View Source [SID1234624290]). In order to facilitate an orderly transition, Kåre Schultz and the Teva Board of Directors have mutually agreed that Mr. Schultz will retire from his current position as Chief Executive Officer, effective December 31, 2022.

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Mr. Francis is a seasoned pharmaceutical executive bringing more than two and a half decades of experience to Teva, including five years as Chief Executive Officer of Sandoz and a member of the Novartis Executive Team. Prior to his role at Sandoz, Mr. Francis was a senior executive at Biogen for 13 years where he held a number of senior roles, including leading the U.S. business. He also oversaw the successful launch of Tecfidera in 2013. Mr. Francis is currently the CEO of Purespring Therapeutics, a pioneering gene therapy company focused on transforming the treatment of kidney diseases, and CEO of Forcefield Therapeutics, a pioneer of best-in-class therapeutics to protect heart function. He is also an operating partner for Syncona Investment Management Limited.

"It has been a great privilege to serve Teva as its CEO since 2017, and to work with our dedicated and talented team to improve the lives of patients," said Mr. Schultz. "We have positioned Teva as a leader in both our specialty and generics businesses, built a strong financial and operational foundation and enhanced our portfolio and pipeline. This is the right time for a transition, and Richard’s proven track record in the industry makes him the right person to serve as Teva’s next CEO."

"On behalf of the entire Board, I would like to thank Kåre for his dedication and contributions to Teva over the last five years," said Dr. Sol J. Barer, Chairman of Teva’s Board of Directors. "Under Kåre’s leadership, we have stabilized the business and undergone a significant operational transformation across our international footprint. The Company is now well positioned for an exciting future and, by leveraging Richard’s compelling track record of growing businesses in the life sciences, biologics and generic drug sectors, his entrepreneurial and pragmatic leadership style and emphasis on a collaborative and innovative culture, the Board and I are confident that Teva will build on this solid foundation. As a global enterprise, we look forward to furthering our mission to provide much needed medicines to even more patients around the world under Richard’s leadership. The Board is delighted to have found the ideal leader for the next phase in Teva’s exciting journey to return to growth and leadership."

"I have long been impressed with the value Teva provides to patients globally and I am honored to take on the role of leading this extraordinary company into the future," said Mr. Francis. "I look forward to leveraging my background and years of pharmaceutical experience to build on Teva’s strong fundamentals and to write the next exciting chapter for Teva, focusing on building a solid pathway to deliver long-term growth. I continue to see a bright future ahead for the Company and look forward to working closely with the Board, management team and talented employees to continue driving value creation for patients, employees, shareholders and other stakeholders."

About Richard Francis

Richard Francis is an operating Partner at Syncona, which focuses on founding, building and funding healthcare companies. Mr. Francis is the Chief Executive Officer of Syncona’s portfolio companies, Purespring Therapeutics, one of the first AAV gene therapy companies focused on the kidney globally, and Forcefield Therapeutics, a pioneer of best-in-class therapeutics to retain heart function via protection of cardiomyocytes.

Prior to his current roles, Mr. Francis spent five years as the Chief Executive Officer of Sandoz and a member of the Novartis Executive Team. During Mr. Francis’ time at Sandoz, he developed a transformative strategy to reshape the business by focusing the organization on key geographies, reshaping the portfolio and targeting efficiencies to drive growth and margin improvement. Mr. Francis held various leadership roles over a 13-year tenure at Biogen, including Senior Vice President of U.S. Commercial, Vice President / Senior Vice President of Global Commercial Strategy, Managing Director of Canada and Managing Director of the UK and Ireland. During his time at Biogen, Mr. Francis oversaw the growth of the U.S. Commercial business, driven by a strategic focus on commercial excellence. To that end, at Biogen, Mr. Francis led the successful launch of Tecfidera in 2013. Earlier in his career, Mr. Francis worked at Sanofi and Wyeth.

Mr. Francis holds a Bachelor of Arts in Economics from The Manchester Metropolitan University.