Ellipses Pharma to Present Clinical Updates at Leading U.S. Breast and Blood Cancer Conferences

On November 21, 2022 Ellipses Pharma Limited ("Ellipses"), a global drug development company focused on accelerating the development of new oncology treatments, reported that it will be presenting clinical updates covering two of its assets at the San Antonio Breast Cancer Symposium (SABCS), taking place between 6 – 10 December 2022 in San Antonio, Texas, and at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, from 10 – 13 December 2022 in New Orleans, Louisiana (Press release, Ellipses Pharma, NOV 21, 2022, View Source [SID1234624297]).

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At SABCS, a ‘Trial in Progress’ poster that details the design of a Phase 1 / 2 trial of vosilasarm (EP0062) will be presented. EP0062 is a selective androgen receptor modulator currently under development for the treatment of AR+/HER-/ER+ advanced breast cancer.

At ASH (Free ASH Whitepaper), Ellipses’ preliminary results of the dose escalation part of the Phase 1 / 2a first-in-human study of EP0042 in patients with acute myeloid leukaemia (AML) will be presented. EP0042 is a dual FLT3 and aurora kinase inhibitor. The trial is investigating the use of EP0042 as both a monotherapy and in combination with existing therapies.

Dr Rajan Jethwa, CEO of Ellipses Pharma, said:
"Ellipses is committed to developing novel cancer treatments at pace and getting them to patients. Presenting the design of Ellipses’ first trial of EP0062, and the preliminary findings of the EP0042 trial at two of the world’s leading oncology conferences is a significant step closer to delivering on that goal. We are proud of the work our dedicated team has delivered to make these trials happen and bring such potentially exciting data to light."

Professor Sir Christopher Evans, Chairman of Ellipses Pharma, said:
"The presentation of these two posters is testament to the potential of the promising assets in Ellipses’ pipeline and demonstrates the progress we have made towards our goal of accelerating the development of much-needed cancer treatments."

Oncotelic Reports Q3 2022 Compared to Q3 2021 Financial Results

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.

EDAP to Present at the Piper Sandler 34th Annual Healthcare Conference

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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Leap Therapeutics to Participate at the Piper Sandler 34th Annual Healthcare Conference

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.

Sensei Biotherapeutics Announces Collaboration with Washington University, St. Louis to Support Development of SNS-101, a Conditionally Active VISTA-blocking Antibody

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.