On April 10, 2020 Pelican Therapeutics, Inc. ("Pelican"), reported that it was awarded $15.2 million to fund preclinical and certain clinical activities from Cancer Prevention Institute of Texas (CPRIT) grant (the "CPRIT Grant") (Filing, 8-K, Heat Biologics, APR 10, 2020, View Source [SID1234556244]). The CPRIT Grant is subject to customary CPRIT funding conditions.

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The CPRIT Grant initially covered a three-year period from June 1, 2017 through May 31, 2019. On April 12, 2019, CPRIT notified Pelican that it agreed to a six-month extension of time in order to conclude the approved scope of work, such that the completion date was extended from May 31, 2019 to November 30, 2019. On November 20, 2019, CPRIT notified Pelican that it agreed to a six-month extension of time in order to conclude the approved scope of work, such that the completion date was extended from November 30, 2019 to May 30, 2020. On April 9, 2020, CPRIT notified Pelican that it agreed to a six-month extension of time in order to conclude the approved scope of work, such that the completion date was extended from May 30, 2020 to November 30, 2020. All other terms and conditions of the CPRIT arrangement remained the same.

On April 9, 2020 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it recently participated in a constructive meeting with the U.S. Food and Drug Administration (FDA) as scheduled, to discuss the clinical section of the New Drug Application (NDA) for oral paclitaxel and encequidar for the treatment of metastatic breast cancer (Press release, Athenex, APR 9, 2020, View Source [SID1234573880]). The Company is on track to submit the NDA in accordance with the FDA’s guidance, and will provide a further update when the FDA’s official response to the filing becomes available.

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On April 9, 2020 Notable, a technology leader redefining cancer treatment through rapid drug development via a clinically validated platform, reported its board has appointed veteran life science executive Laurie Heilmann as Chief Executive Officer (Press release, Notable Labs, APR 9, 2020, View Source [SID1234556909]). She succeeds founder Matt De Silva who will remain a member of Notable’s Board of Directors and continue to serve as the company’s Executive Chairman.

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"Laurie has a proven track record transforming life science startups into established global brands. We are delighted to welcome her to the team during this critical inflection point in our trajectory," said Matt De Silva, Founder and Executive Chairman. "Notable’s experienced and diverse team has spent over five years focused on developing our clinical platform and building partnerships with top academic institutions and leading pharmaceutical companies. We will continue to expand the reach of our technology to power functional precision medicine with Laurie at the helm."

Heilmann brings more than 30 years of executive leadership experience. She joins Notable from CrownBio, where she served as President of Global Life Science and Diagnostic Solutions and led the strategic development and commercialization of products and services to treat oncology, cardiovascular, and metabolic diseases. Her efforts helped transform the company into a prominent global player in the pre-clinical oncology, cardiovascular, and metabolic disease markets. Prior to CrownBio, Laurie held leadership roles at Strong-Bridge Consulting, Image Metrix-American College of Radiology and the Ockham Development Group.

"It’s an exciting time to join the talented team at Notable. As the company enters the next stage of growth we will focus on advancing the awareness of our scientific technology platform and continue our revolutionary innovation in functional precision medicine," said Laurie Heilmann, CEO of Notable. "I look forward to advancing the incredible work that Matt and the Notable team has accomplished to accelerate drug discovery for cancer patients."

Notable’s automated technology platform is built to help predict patient responses to cancer treatment therapies in as little as seven days. As a precision oncology company, Notable matches patients with effective therapies and accelerates the drug development process for novel therapeutics. The company can help patients and their physicians make better-informed decisions about which treatments and clinical trials might be most effective. A feasibility study conducted at the Stanford University School of Medicine demonstrated that Notable achieved an 84 percent overall accuracy rate in retrospectively predicting patient therapeutic responses. The most recent data from this collaboration was presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December of 2019.

On April 9, 2020 Rexahn Pharmaceuticals terminated a nearly two-year-old agreement with Merck that paired the company’s experimental phosphorylated-p68 inhibitor with Keytruda as a potential treatment for metastatic triple-negative breast cancer (Press release, Merck & Co, APR 9, 2020, View Source [SID1234556249]).

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Rexahn disclosed the decision in a filing with the U.S. Securities and Exchange Commission this week, Seeking Alpha first reported. Rexahn said it notified Merck on April 7 of its decision to discontinue the development of RX-5902 for the treatment of metastatic triple-negative breast cancer. The two companies initially struck the agreement in 2018. At the time the deal was struck, Rexahn’s RX-5902 was already being studied as a monotherapy for triple-negative breast cancer. The companies intended to pair Keytruda with RX-5902 to treat patients with metastatic TNBC who have progressed following at least one prior treatment. Rexahn was intended to be the sponsor of the Phase II study.

In preclinical studies, RX-5902 had been shown to inhibit the growth and proliferation of multiple human cancer cell lines, including triple-negative breast cancer, decrease tumor growth in patient-derived xenograft models and potentiate the activity of immune checkpoint inhibitors and other anti-tumor agents, Rexahn said at the time of the deal.

In its disclosure this week, Rexahn provided little reason for the discontinuation of the Phase II program. The company said it had previously disclosed that it was evaluating the development strategy for RX-5902, including whether to proceed with the trial. In September, Rexahn announced it was exploring strategic alternatives to enhance shareholder value. Those options included the potential sale or licensing of assets. In that announcement, Rexahn said it would not disclose any developments of its strategy until "the evaluation of strategic alternatives has been completed or the board of directors has concluded that disclosure is appropriate or legally required."

While Rexahn has been somewhat silent on the state of its exploration of strategic alternatives, the company has continued to conduct business. In an SEC filing last month, the company said it amended its 2019 license agreement for its oncology asset RX-3117 with BioSense Global to use in Singapore, China, Hong Kong, Macau and Taiwan. BioSense initially aimed at developing the cancer treatment for China.

In February, Rexahn entered into a licensing agreement with China-based Zhejiang HaiChang Biotechnology for RX-0201, an asset that is a "nano-liposomal formulation of RX-0201 known as RX-0301, and RX-0047, a proprietary compound currently in preclinical development." HaiChang intends to develop one product comprising RX-0301 and one product comprising RX-0047, Rexahn said in the filing. Under terms of the deal, Rexahn could earn nearly $100 million if certain developmental and regulatory milestones are met.

On April 9, 2020 Ryvu Therapeutics (WSE:RVU), a clinical-stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology, reported its annual 2019 financial results and provided a corporate update (Press release, Ryvu Therapeutics, APR 9, 2020, View Source [SID1234556243]).

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Major Achievements

In March 2019, the U.S. Food and Drug Administration (FDA) has cleared Ryvu’s IND application to conduct a Phase 1b study of selective CDK8 inhibitor SEL120 in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS). The first patient enrolled in the Phase 1b study of SEL120, was dosed in September 2019 and the clinical trial is currently open at six sites in the U.S.
In April 2019 Ryvu presented data from multiple oncology programs at the 2019 AACR (Free AACR Whitepaper) Annual Meeting. Poster presentations included SEL120, novel dual A2A/A2B adenosine receptor antagonists and next-generation small molecule direct STING agonists.
In June 2019 posters on the dual PIM/FLT3 inhibitor SEL24/MEN1703 were presented at the 24th EHA (Free EHA Whitepaper) Congress and ASCO (Free ASCO Whitepaper) Annual Meeting.
In August 2019, Setareh Shamsili, M.D., Ph.D. joined Ryvu Therapeutics as the Chief Medical Officer, and in October 2019 was appointed to the Executive Management Board. Dr. Shamsili, a seasoned veteran, brings more than 20 years of clinical oncology and drug development experience to Ryvu.
The corporate split between Ryvu Therapeutics and the Selvita CRO division has been completed, with both companies trading independently on the Warsaw Stock Exchange as of October 16, 2019. During the split each Ryvu shareholder received one Selvita share in addition to each Ryvu share they already held. As of April 7, 2020 the market capitalization of spin-off company reached USD 129 million, up from USD 69 million reference level on the day of the split.
In November 2019, Ryvu presented two poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting: the novel, dual A2A/A2B antagonist immunometabolism program, and the small molecule, direct STING agonists immuno-oncology program.
In December 2019, Ryvu presented progress in translational, preclinical studies and introduction to a Phase Ib clinical trials for SEL120, at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.
Also in December 2019, Ryvu was awarded a grant funding by the Polish National Centre for Research and Development for advancing research on targeted oncology therapies based on the synthetic lethality concept. This provides Ryvu with almost USD 8.3 million of non-dilutive financing. The agreement was signed in February 2020.
Early R&D portfolio has matured to advance projects into clinical development in upcoming years. A preclinical candidate for the A2A/A2B project was selected and non-GLP Tox studies initiated. The STING agonist program advanced to the lead stage with planned preclinical stage in 2020.
Most important milestones in 2020, before the report date

On March 5, 2020 Menarini Group announced successful completion of Phase I clinical study of SEL24/MEN1703 in Acute Myeloid Leukemia, which entitled Ryvu to receive a USD 1.96 million milestone payment. According to the information from Menarini SEL24/MEN1703 will start enrolling patients in the dose expansion Phase 2 study in the US. and in Europe.
On March 25, 2020 the U.S. Food and Drug Administration (FDA) granted an orphan drug designation (ODD) to Ryvu’s SEL120, for the treatment of patients with acute myeloid leukemia (AML).
Throughout 2019, Ryvu presented at numerous investor conferences including: Annual J.P. Morgan Healthcare Conference, Solebury Trout Access event, JP Morgan Conference, H.C. Wainwright 21st Annual Global Investment Conference, Jefferies 2019 Healthcare Conference, UBS 2019 Global Healthcare Conference, Biotech Showcase 2019, Ipopema Biotech Day 2019, Erste Group – Innovation Conference 2019, GPW Innovation Day, 9th Central European Life Science Investment Conference and BIO-Europe 2019.

"The past year has been very productive for Ryvu Therapeutics. We have achieved numerous corporate, research and clinical milestones which set us on a great path into 2020. After the successful spinning out of the CRO activities and creating significant incremental value for Ryvu shareholders, we are operating now as a pure-play small molecule oncology therapeutics company," commented Pawel Przewiezlikowski, Chief Executive Officer of Ryvu.

"With first patients being treated in our Phase I study of SEL120, successful completion of Phase I by SEL24/MEN1703, exciting data for our STING agonist and A2A/A2B antagonist programs, as well as additional non-dilutive financing from grants, we are ready to continue with our mission to discover and develop drugs that will improve the lives of cancer patients and their families."

Ryvu Annual 2019, Financial Results under IFRS

Operating expenses were USD 5.0 million for the quarter ended Dec. 31, 2019, a decrease of USD 0.7 million, compared to USD 5.7 million for the same period ended Dec. 31, 2018. Revenues were USD 2.1 million for the quarter ended Dec. 31, 2019, compared to revenues of USD 3.3 million for the quarter ended Dec. 31, 2018. EBITDA excluding IFRS16 impact for the quarter ended Dec. 31, 2019, was USD 2.4 million, compared to USD 2.0 million for the quarter ended Dec. 31, 2018.

Operating expenses were USD 20.7 million for the twelve months ended Dec. 31, 2019, an increase of USD 4.6 million, compared to USD 16.1 million for the same period ended Dec. 31, 2018. Revenues were USD 8.9 million for the twelve months ended Dec. 31, 2019, compared to revenues of USD 10.2 million for the twelve months ended Dec. 31, 2018. EBITDA excluding IFRS16 impact for the twelve months ended Dec. 31, 2019, was USD 10.2 million, compared to USD 5.0 million for the twelve months ended Dec. 31, 2018.

At Dec. 31, 2019, Ryvu Therapeutics held USD 19.0 million in cash, cash equivalents, and short-term investments.