On May 4, 2022 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that the Company has engaged Wolfram C. M. Dempke, MD, PhD, MBA, MRCP as its EU Chief Medical Officer and part-time contractor for its European clinical trials (Press release, Moleculin, MAY 4, 2022, View Source [SID1234613539]).

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Dr. Dempke currently serves as the Vice President, Scientific Solutions: Hematology & Oncology, at Worldwide Clinical Trials. He holds oncology/hematology society memberships in the U.S. and Europe. He has published five textbooks and more than 150 peer-reviewed papers. Dr. Dempke continues to teach classes in the Munich University Medical Oncology department, Germany, and he even continues to see patients on a monthly basis.

Walter Klemp, President and Chief Executive Officer of Moleculin commented, "As we look to commence our clinical studies in Europe, we believe Dr. Dempke will be a tremendous asset. Over the course of his career, he has played a key role in clinical oncology programs and made noteworthy contributions to the industry and academia. We are honored and pleased to have his leadership and guidance for our European clinical teams and help to drive these important programs forward."

"There remains critical unmet needs across a number of oncology indications. I have dedicated my career to advancing innovative therapeutics that have the potential to provide patient benefit and make a positive impact in the treatment of cancer. After overseeing developments in the hem/onc space for more than 30 years, we are clearly committed to our patients to bring drug candidates like annamycin, which has the potential to become a game changer in anthracycline development in the future to the market. Thus, I am pleased to join the Moleculin team and help to advance their broad portfolio of drug candidates targeting highly resistant tumors and viruses. I am excited for the initiation of clinical studies in Europe and further advancing development of these important assets to meet unmet needs in the space," added Dr. Dempke.

Prior to his current role, Dr. Dempke served as the External Expert at Novartis Oncology Global Clinical Development (NSCLC) (Basel, Switzerland), where he was responsible for the development of capmatinib (c- MET inhibitor), nazartinib (EGFRmut inhibitor), and novel compounds in Phase 1. Prior to that, he served as the Executive Medical Director Global Clinical Development (Head of Global Clinical Development in EU) at Incyte Biosciences; Head, Global Medical Affairs for EUSA Pharma; and as Executive Medical Director for Kyowa Kirin Pharmaceutical Development Ltd., where he was responsible for the global clinical development (Phase 1-3) in the therapeutic area of leukaemias and lymphomas (antibodies). This included the development of Phase 1/2 trials for an anti-CD123 antibody in AML, first-in-human studies with novel immune-oncology drugs (immune checkpoint antibodies) and support for the EMA submission of mogamulizumab based on the Phase 3 trial results. Additionally he served as the Executive Medical Director and Global Clinical Lead (Global Medical Oncology) at AstraZeneca. During his tenure there, he was responsible for the global clinical development in the therapeutic area of NSCLC and ovarian cancer (antibodies, TKIs). This included the responsibility for the FDA submission and re-launch of gefitinib in the US (NSCLC), the development of durvalumab for NSCLC (Phase 1/2) and the design and execution of Phase 2/3 trials for a novel wee-1 inhibitor in ovarian carcinomas. Other career appointments include Head of the Department of Haematology, Oncology and Gastroenterology at the Elbland Clinic Holding; Head of Global Medical Affairs Oncology at MerckSerono; Lead Medical Science Manager Oncology at Bristol-Myers Squibb and thereafter promoted as TA Head Oncology; Executive Medical Director of the TTG Bochum; Head of the Medical Oncology Department of the General Hospital Goch; Deputy Head and Acting Representative of the Medical Clinic IV (Haematology and Oncology) at the University of Halle; and Deputy Head of the Haematology Departments at Elisabeth Hospital in Germany.

On May 4, 2022 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported that it will announce first quarter 2022 financial results on Wednesday, May 11, 2022 (Press release, Cyclacel, MAY 4, 2022, View Source [SID1234613558]). The company will host a conference call and live webcast at 4:30 p.m. Eastern Daylight Time on the same day.

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For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

On May 4, 2022 Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company") reported financial results for the first quarter of 2022 ended March 31, 2022 and provided a corporate update (Press release, Protagonist, MAY 4, 2022, View Source [SID1234613575]).

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"This has been a period of important clinical results and strategic focus," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer of Protagonist. "Today, we reaffirm rusfertide as the primary focus of our organization’s resources, time, and attention. This prioritization is based on the compelling data we have obtained to date and the potential of this therapeutic peptide to transform the treatment of patients with polycythemia vera. We are committed to the execution of all critical activities related to the successful completion of the Phase 3 VERIFY study. We look forward to a productive ongoing dialogue with regulators, and sharing important data from our ongoing rusfertide studies at upcoming medical meetings."

Dr. Patel continued: "Recently, we released topline data from the Phase 2 IDEAL study of PN-943, our oral, gut-restricted alpha-4 beta-7-integrin antagonist drug candidate in development for ulcerative colitis. We are pleased and encouraged with the positive results across different measures in the lower dose arm, and are scheduled for an oral presentation at the Digestive Disease Week (DDW) conference later this month. Based on the consistency of our results with previous studies with other agents that target the integrin-MadCAM pathway, and the strong concordance across different measures in the lower dose arm of this Phase 2 study, we believe that PN-943 may represent a substantial commercial opportunity and merits further clinical development. We intend to pursue further clinical development in collaboration with a large pharma partner or through a structured financing arrangement. We have now formally engaged PJT Partners to facilitate a collaboration arrangement with a pharmaceutical company. In addition to commercialization capabilities, we believe that a partner can add the financial and development resources required to maximize the potential benefit to patients that could be provided by this important therapeutic candidate. At the current time, our planned expenses for PN-943 are related to finalizing the Phase 3 study design with regulators and completing the ongoing manufacturing of clinical trial materials to support study initiation. We expect these activities to have a minimal impact on our cash resources and we retain our prior guidance of cash runway through the end of 2024."

First Quarter 2022 Recent Developments and Upcoming Milestones

Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood Disorders

Protagonist activated sites and initiated patients screening for VERIFY, a single, global Phase 3 randomized, placebo-controlled trial evaluating the efficacy and safety of a once weekly, subcutaneously self-administered dose of rusfertide in PV. We expect enrollment completion in 1H 2023.
Patient enrollment has been completed in the ongoing Phase 2 REVIVE study of rusfertide in PV.
Highlights of the resumed and ongoing Phase 2 REVIVE study will be shared as an oral presentation at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Q2. Ronald Hoffman, M.D., will give the presentation.
The Company has submitted a formal response to the U.S. Food and Drug Administration (FDA) to support retention of rusfertide’s Breakthrough Therapy Designation (BTD) status, following a letter received from FDA indicating its intent to rescind BTD for this drug candidate.
Data from an open-label Phase 2 clinical trial of rusfertide in hereditary hemochromatosis (HH) were presented at The Liver Meeting in November 2021, hosted by the American Association for the Study of Liver Diseases. The Company plans to identify potential next steps in 1H 2022 to advance the program.
PN-943: Oral, gut-restricted, alpha-4-beta-7 Integrin Antagonist for Ulcerative Colitis (UC)

The Company shared topline results from the Phase 2 IDEAL study evaluating PN-943 in moderate-to-severe UC. In the twice-daily I50 mg dose arm (lower dose), PN-943 achieved 27.5% clinical remission with a delta of 13% versus placebo, with strong concordance across several key proxies including histological and endoscopic endpoints for efficacy. The higher dose arm, 450 mg BID, did not differentiate from placebo.
Consistent with the goals of a Phase 2 study and based on the safety and efficacy data from the 150 mg BID arm, IDEAL achieved clinical proof-of-concept and validation for an oral, gut-restricted approach for ulcerative colitis via blockade of the alpha-4-beta-7-integrin pathway.
The Company has formally engaged PJT Partners to explore potential collaborations with large pharmaceutical companies with commercial expertise and financial resources sufficient to support global registrational studies and commercialization of PN-943.
The results of the IDEAL study have been selected for an oral presentation at Digestive Disease Week (DDW) 2022.
Presentation Title: "The IDEAL Study: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Safety and Efficacy of the Oral α4β7 Integrin Peptide Antagonist PN-943 in Patients with Moderate to Severe Ulcerative Colitis (3754345).
Presentation Date and Time: May 24, 2022; 8:15 a.m. to 8:30 a.m. PDT
Presenter: Bruce Sands, M.D., M.S., Icahn School of Medicine at Mount Sinai.
PN-235: Oral IL-23 Receptor Antagonist

In March 2022, Protagonist qualified for a $25 million milestone in connection with the dosing of a third patient in FRONTIER 1, a Phase 2b study of PN-235, sponsored by Janssen Biotech. PN-235 is a second-generation oral peptide IL-23 receptor antagonist being developed under the worldwide license and collaboration agreement with Janssen. The Company received the $25 million in April 2022.
The Company is also eligible for a $10 million milestone in connection with the start of the second indication-based Phase 2 study. PN-235 is expected to advance into Phase 2 clinical studies in inflammatory bowel diseases in 2023.
First Quarter 2022 Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2022 were $305.3 million. The Company expects current cash, cash equivalents and marketable securities to be sufficient to fund its planned operating and capital expenditures through the end of 2024.
License and Collaboration Revenue: License and collaboration revenue was $25.7 million for the first quarter of 2022 compared to $6.2 million for the same period of 2021. The increase was primarily due to the $25.0 million milestone we became eligible to receive in March 2022 upon the dosing of the third patient in the Janssen Frontier 1 study of PN-235, which resulted in increases in transaction price and proportional performance under the Janssen license and collaboration agreement.
Research and Development ("R&D") Expenses: R&D expenses for the first quarter of 2022 were $36.3 million as compared to $24.2 million for the same period of 2021. The increase was primarily due to costs associated with advancing our pipeline assets rusfertide and PN-943, including current and planned Phase 3 clinical trials.
General and Administrative ("G&A") Expenses: G&A expenses for the first quarter 2022 were $10.5 million, as compared to $6.0 million for the same period of 2021. The increase was primarily due to personnel and other expenses to support the growth of our business.
Net Loss: The first quarter 2022 net loss was $20.9 million, or a net loss of $0.43 per share, compared to the first quarter of 2021 net loss of $24.0 million, or a net loss of $0.54 per share.

On May 4, 2022 Onconova Therapeutics, Inc. (NASDAQ: ONTX), ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that the Company intends to release its first quarter 2022 financial results on Wednesday, May 11, 2022 (Press release, Onconova, MAY 4, 2022, View Source [SID1234613689]). Management plans to host a conference call and live webcast at 4:30 p.m. ET on the same day to discuss these results and provide an update on its pipeline programs.

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Conference Call and Webcast Information

Interested parties who wish to participate in the conference call may do so by dialing (855) 428-5741 for domestic and (210) 229-8823 for international callers and using conference ID 7369861.

Those interested in listening to the conference call via the internet may do so by visiting the investors and media page on the company’s website at www.onconova.com and clicking on the webcast link. In addition to the live webcast, a replay will be available on the Onconova website for 90 days following the call.

United Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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