On May 3, 2022 Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company" or "We") (OTCQB:OTLC), reported the appointment of Dr. Fatih Uckun as its Chief Medical Officer (Press release, Oncotelic, MAY 3, 2022, View Source [SID1234613416]). Dr. Uckun will be responsible for execution of internal company led registrational trials.

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 addition of Dr. Uckun to our executive team, comes at a critical time for Oncotelic. We have made significant inroads toward our goal of developing OT-101 as treatment for difficult to treat cancers," said Dr. Vuong Trieu, CEO and Chairman. "Dr. Uckun is one of the highest caliber physician scientists. His deep knowledge in clinical oncology and vast experience in translational research for successful applications of immunotherapy in oncology, especially for difficult to treat cancer subtypes will be invaluable, as we further advance OT-101 and the rest of our product portfolio."

"With the completion of the joint venture with Dragon Overseas Capital Limited for OT-101, we will be initiating OT-101 registration trials against difficult to treat cancers such as DIPG and pancreatic cancers", said Dr. Fatih Uckun, CMO. "I look forward to engaging the global oncology community in bringing OT-101 to these patients."

About Dr. Uckun

Dr. Uckun is an elected Member of the American Society for Clinical Investigation (ASCI), an honor society for physician-scientists, and an active member of several professional organizations. He received numerous awards for his work on monoclonal antibodies, recombinant cytokines and fusion proteins, radiation sensitizers, kinase inhibitors and targeted therapeutics for difficult-to-treat cancers, including the Stohlman Memorial Award of the Leukemia Society of America, the highest honor given to a Leukemia Society Scholar.

Prior to joining Oncotelic, Dr. Uckun served as Chief Medical Officer and Chief Scientific Officer of Reven Pharmaceuticals (from 2020 to 2022), Chief Medical Officer of Ares Pharmaceuticals (from 2017 to 2022), Chief Clinical Advisor of Aptevo Therapeutics (2021), Vice President and Clinical Strategy Lead, Oncology-Hematology of Worldwide Clinical Trials (2020), Chief Medical Officer of Mateon and Oncotelic (2019-2020), and Executive Medical Director and Strategy Lead in Global Oncology and Hematology at Syneos Health (from 2017 to 2018). Prior to this, he was Vice President of Research and Clinical Development at Nantkwest, Chief Scientific Officer of Jupiter Research Institute and, before that, held senior-level scientific and research positions at Parker Hughes Institute and its cancer center, Paradigm Pharmaceuticals, and the Children’s Cancer Study Group.

Dr. Uckun earned his doctoral degrees at the University of Heidelberg, Germany where he also served as an active member of the autologous bone marrow transplant and peripheral stem cell transplant clinical research teams of the Tumor Center. Dr. Uckun completed his residency training in pediatrics, clinical fellowship training in Hematology/Oncology/Blood and Bone Marrow Stem Cell Transplantation as well as postdoctoral research training in immunology at the University of Minnesota. Dr. Uckun has more than 30 years of professional experience in developmental therapeutics with a special emphasis on targeted therapeutics/precision medicines and biopharmaceuticals. He has published more than 500 peer-reviewed papers, authored numerous review articles and book chapters and and is an inventor on numerous patents.

Dr. Uckun worked as a Professor of Therapeutic Radiology-Radiation Oncology, Pharmacology, and Pediatrics as well as Director of the Biotherapy Institute at the University of Minnesota (1986-1997), where he became the first recipient of the Endowed Hughes Chair in Biotherapy, and as a Professor of Pediatrics and Head of Translational Research in Leukemia and Lymphoma of the Children’s Center for Cancer and Blood Diseases at the University of Southern California (2009-2015). From 2012-2015, Dr. Uckun served as chair of the Biotargeting Working Group and a Member of the Coordination and Governance Committee of the NCI Alliance for Nanotechnology in Cancer.

On May 3, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported financial results for the first quarter ended March 31, 2022 (Press release, Veracyte, MAY 3, 2022, View Source [SID1234613409]).

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!

"I am extremely pleased with our team’s strong results in the first quarter," said Marc Stapley, Veracyte’s chief executive officer. "Last year we assembled the critical elements needed to drive near and long-term growth, including our acquisitions of Decipher Biosciences and HalioDx, complementing our prior acquisition of the nCounter diagnostic platform. We opened this year with the organization re-aligned to fully execute our strategic plan initiatives. With our innovative lab-based business and international reach, enabled by the automated nCounter platform, we are positioned to achieve our vision of improving outcomes for patients all over the world."

Key Business Highlights:

Increased first quarter total revenue by 85% to $67.8 million, compared to the first quarter of 2021;
Grew test volumes to 23,245, an increase of 61% compared to the first quarter of 2021;
Announced that new, expanded data will be presented at the upcoming American Thoracic Society (ATS) 2022 International Conference on the Percepta Nasal Swab test’s performance in current and former smokers with lung nodules, regardless of their smoking history burden;
Announced that three abstracts will be presented at the upcoming American Urological Association conference highlighting new data on the genomic underpinnings of prostate and bladder cancers, derived from analyses of the Decipher GRID database;
Introduced the Veracyte Biopharma Atlas, a unique pan-cancer database of comprehensive biomarkers linked to clinical outcome data leveraging Veracyte’s unique multi-omic and immuno-oncology capabilities, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April;
Announced that an updated clinical practice guideline, as well as a review article and separate commentary, were published in journals of the American Thoracic Society and highlight the role of the Envisia Genomic Classifier in the diagnosis of idiopathic pulmonary fibrosis (IPF); and
Ended the first quarter of 2022 with cash and cash equivalents of $163.6 million.
First Quarter 2022 Financial Results

Total revenue for the first quarter of 2022 was $67.8 million, compared to $36.7 million in the first quarter of 2021. Testing revenue was $56.0 million, an increase of 69% compared to $33.1 million in the first quarter of 2021 driven by the strong performance of our Decipher urology portfolio. Product revenue was $3.0 million, a decrease of 3% compared to $3.1 million in the first quarter of 2021 as volume growth was offset by an approximately 5% currency headwind due to a decline in exchange rates. Biopharmaceutical and other revenue was $8.8 million, an increase of $8.2 million compared to $0.6 million in the first quarter of 2021, driven primarily by the contribution of the HalioDx acquisition.

Total gross margin for the first quarter of 2022, including the amortization of acquired intangible assets, was 58%, compared to 62% in the first quarter of 2021. Non-GAAP gross margin, excluding the amortization of acquired intangible assets and other acquisition related expenses was 65%, compared to 66% in the first quarter of 2021.

Operating expenses, excluding cost of revenue, were $54.4 million, a decrease of 20% compared to the first quarter of 2021. Non-GAAP operating expenses, excluding the cost of revenue, amortization of acquired intangible assets and other acquisition related expenses, were $49.1 million compared to $31.9 million in the first quarter of 2021.

First quarter 2022 net loss was $14.5 million, an improvement of 65% compared to the first quarter of 2021. Basic and diluted net loss per common share was $0.20, an improvement of 70% compared to the first quarter of 2021. Net cash used by operating activities in the first quarter of 2022 was $8.9 million, an improvement of $31.7 million compared to the first quarter of 2021.

A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Note Regarding Use of Non-GAAP Financial Measures."

2022 Financial Outlook

The company is currently projecting full year 2022 total revenue of $265 million to $275 million, representing year-over-year growth of 21% to 25% compared to the prior year. This compares to our prior 2022 total revenue guidance of $260 million to $275 million.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

On May 3, 2022 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that it will report first quarter 2022 financial results on Tuesday, May 10, 2022, prior to the open of the market (Press release, UroGen Pharma, MAY 3, 2022, View Source [SID1234613408]). The announcement will be followed by a live audio webcast and conference call at 10:00 AM Eastern Time.

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!

Audio Webcast

The webcast will be made available on the Investors section of the Company’s website at View Source Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

On May 3, 2022 Tubulis reported the successful completion of a €60 million (USD $63 million) Series B financing led by Andera Partners with participation from new investors Evotec and Fund+ (Press release, Tubulis, MAY 3, 2022, View Source [SID1234613407]). All existing investors also participated in the round, including Bayern Kapital (with Wachstumsfonds Bayern 2), BioMedPartners, coparion, High-Tech Gründerfonds (HTGF), OCCIDENT and Seventure Partners. The new capital will be used to advance Tubulis’ proprietary pipeline of uniquely assembled antibody drug conjugates (ADCs), towards clinical evaluation as well as introduce programs addressing a range of solid tumor indications. The proceeds will enable the company to deliver the true therapeutic potential of ADCs through further innovation of novel payload classes and identification of new cancer targets.

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!

"This funding emphasizes that Tubulis is uniquely positioned to consolidate the findings of the last 20 years in the ADC field and translate this understanding into meaningful therapeutic benefits for patients. We have reached an important inflection point in the development of our platform technologies as well as our pipeline of highly novel protein-drug conjugates and we are now focused on unlocking new avenues in the treatment of solid tumors bringing safe and effective ADCs to patients," said Dominik Schumacher, PhD, CEO and co-founder of Tubulis. "With this capital in place, we will execute on our growth strategy, including important focus areas for our pipeline and for how we can apply our proprietary technologies, biologic insights and new mechanisms of action to enable the true therapeutic value inherent in targeted therapeutics."

In conjunction with the round, Sofia Ioannidou, PhD, Partner at Andera Partners, Thomas Hanke, PhD, EVP, Head of Academic Partnerships at Evotec as well as Jan Van den Bossche, Partner at Fund+ will join Tubulis’ Board of Directors consisting of Sebastian Pünzeler, PhD, Principal at coparion, Dominik Schumacher, PhD, CEO of Tubulis and Christian Grøndahl, MD, DVM, PhD, MBA, the Chairman of the Board. In addition, Valentin Piëch, PhD, Partner at BioMedPartners will take over the board seat from Michael Wacker, PhD, General Partner at BioMedPartners. Biographies for all board members can be found here.

"With its unique toolkit of proprietary technologies and its pipeline of differentiated ADC candidates, Tubulis holds a compelling position in the ADC field," stated Andera Partners’ Sofia Ioannidou, PhD. "We look forward to supporting this talented team in bringing innovative ADCs to patients and are confident that Tubulis has the potential to become a leader in the next era of ADC drug development."

Tubulis’ capability of creating a pipeline of antibody-drug conjugates is based on a diverse range of targeting molecules, novel payloads, and proprietary conjugation technologies. They enable the discovery of truly innovative ADCs that go beyond traditional payload classes and can increase antibody conjugation options via novel chemical groups leading to stable, high drug-to-antibody ratios. Tubulis has developed superior Topoisomerase-I linker-payloads with significantly improved pharmacokinetic properties and unique conjugation chemistry enabling access to a novel payload class that has been chemically challenging for conjugation in the past.

The company’s lead tumor-targeting assets build upon this technological breadth and are currently in preclinical development addressing several high unmet medical need indications. Tubulis’ pipeline also includes a program for hematological tumors, which is on the path towards IND-readiness. Tubulis remains focused on pairing novel payloads with disease-specific targets to tackle the five deadliest cancer indications globally.

Baker McKenzie (Julia Braun) served as counsel for new Series B investors and CMS (Stefan-Ulrich Müller) for Tubulis.

On May 3, 2022 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported that its license and development partner, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun"), presented at this year’s Chinese Society of Clinical Oncology (CSCO) Guideline Conference (April 23-24, 2022) Phase 1 data for its anti-HER2-ADC, A166 (Press release, Sorrento Therapeutics, MAY 3, 2022, View Source [SID1234613406]). To generate this site-specific third generation ADC, Kelun partnered with Levena Biopharma, a Sorrento company, which provided the proprietary ADC technologies for the generation and production of A166, including (1) a proprietary small molecule toxin, Duostatin-5, a tubulin inhibitor, (2) K-Lock, a site-specific conjugation chemistry and (3) an enzymatically cleavable linker. Compared to Kadcyla, the first Antibody-Drug Conjugate approved for the treatment of HER2-positive metastatic breast cancer, A166 demonstrated potentially better efficacy, as shown in the overall response rate (ORR) of 73.9% with A166 at 4.8mg/kg versus Kadcyla, which had an ORR of 31.3%, as well as the progression-free survival (PFS) of 12.3 months with A166 versus 6 months with Kadcyla.

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!