On October 23, 2020, Plus Therapeutics, Inc. (the "Company") reported that it entered into an Equity Distribution Agreement (the "Distribution Agreement") with Canaccord Genuity LLC (the "Agent"), pursuant to which the Company may issue and sell, from time to time, shares of its common stock having an aggregate offering price of up to $10,000,000 (the "Shares"), depending on market demand, with the Agent acting as an agent for sales (Filing, 8-K, PLUS THERAPEUTICS, OCT 23, 2020, View Source [SID1234572295]). Sales of the Shares may be made by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended (the "Securities Act"), including, without limitation, sales made directly on or through the NASDAQ Capital Market. The Agent will use its commercially reasonable efforts to sell the Shares requested by the Company to be sold on its behalf, consistent with the Agent’s normal trading and sales practices, under the terms and subject to the conditions set forth in the Distribution Agreement. The Company has no obligation to sell any of the Shares. The Company may instruct the Agent not to sell the Shares if the sales cannot be effected at or above the price designated by the Company from time to time and the Company may at any time suspend sales pursuant to the Distribution Agreement.

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The Company will pay the Agent a commission of up to 3.0% of the gross proceeds from the sale of Shares by the Agent under the Distribution Agreement. The Company has also agreed to reimburse the Agent for its reasonable documented out-of-pocket expenses, including fees and disbursements of its counsel, in the amount of $50,000. In addition, the Company has agreed to provide customary indemnification rights to the Agent.

The Offering will terminate upon the earlier of (1) the issuance and sale of all shares of the Company’s common stock subject to the Distribution Agreement, or (2) the termination of the Distribution Agreement as permitted therein, including by either party at any time without liability of any party.

Any sales of Shares under the Distribution Agreement will be made pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-249410), including the related prospectus, filed with the Securities and Exchange Commission (the "SEC") on October 9, 2020 and declared effective on October 19, 2020, as supplemented by the prospectus supplement dated October 23, 2020, and any applicable additional prospectus supplements related to the Offering that form a part of the Registration Statement. The aggregate market value of Shares eligible for sale in the Offering and under the Distribution Agreement will be subject to the limitations of General Instruction I.B.6 of Form S-3, to the extent required under such instruction. The prospectus supplement filed with the SEC on October 23, 2020 is only offering Shares having an aggregate offering price of $4,960,000 million. The Company will be required to file another prospectus supplement in the event it determines to offer more than $4,960,000 million of Shares in accordance with the terms of the Distribution Agreement, to the extent then permitted under General Instruction I.B.6 of Form S-3. The Company intends to use the net proceeds from this offering for general corporate purposes and for working capital.

The foregoing description of the Distribution Agreement does not purport to be complete and is qualified in its entirety by reference to the Distribution Agreement, which is filed as Exhibit 1.1 to this report and is incorporated herein by reference. A copy of the legal opinion of Pillsbury Winthrop Shaw Pittman LLP regarding the legality of the issuance and sale of the Shares is filed as Exhibit 5.1 to this report and is incorporated by reference herein.

On October 23, 2020 Quirem Medical reported a first clinical QuiremSpheres patient procedure took place with a patient dose prepared using a novel hotlab manufacturing process design, developed together with VANDERWILT Techniques (Press release, Quirem Medical, OCT 23, 2020, View Source [SID1234571203]). The new process improves radiation safety for the hotlab operators and limits the production time, preparing for further scaling-up of the production of QuiremScout and QuiremSpheres. QuiremScout is an innovative product for screening liver cancer patients before they are treated with QuiremSpheres. QuiremSpheres is a CE-marked medical device indicated for treatment of unresectable liver tumors.

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"Quirem Medical and VANDERWILT Techniques have a long-standing strategic partnership during which VANDERWILT has proven to be instrumental in the optimization of the hotlab processing steps. The effectuation of this latest process innovation, including bespoke instruments and tooling, is a new milestone. It supports our hotlab operators in their daily operations, minimizing processing time while reducing dose exposure significantly." says Stuart Koelewijn, Hotlab Operations Manager of Quirem Medical BV.

"We see a strongly increasing demand for our products throughout Europe and beyond. VANDERWILT has proven to be a reliable and innovative partner to us, while we are constantly improving our internal processes to match the increasing demand and to prepare for the global expansion of our business." says Jan Sigger, CEO of Quirem Medical BV.

On October 23, 2020 IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQX:IGXT) (the "Company" or "IntelGenx") reported that it has closed a private placement (the "Offering") to certain investors in the United States of U.S.$532,000 principal amount of 8% convertible notes due October 15, 2024 (the "Notes") (Press release, IntelGenx, OCT 23, 2020, View Source [SID1234569224]). The Notes will bear interest at a rate of 8% per annum, payable quarterly, and will be convertible into shares of common stock of the Company (the "Shares") beginning 6 months after their issuance at a price of U.S.$0.18 per Share. The Offering represents a second tranche of the Notes. As previously announced, the Company closed an offering of an additional $1.2 million of Notes on October 15, 2020.

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The Company intends to use the proceeds of the Offering for working capital purposes.

In connection with the Offering, the Company paid to an agent a cash commission of approximately U.S.$37,000 in the aggregate and issued non-transferable warrants to the agent (the "Agent’s Warrants"), entitling the holder to purchase 212,800 common shares at a price of U.S.$0.18 per Share until October 15, 2022.

The TSX Venture Exchange (the "TSXV") has conditionally approved the listing of the Shares issuable upon conversion of the Notes, as well as the Shares issuable upon exercise of the Agent’s Warrants. Listing on the TSXV will be subject to the Company fulfilling all of the listing requirements of the TSXV within 15 days of the closing of the Offering.

This press release does not constitute an offer to sell, or a solicitation of an offer to buy, securities in any jurisdiction where not permitted by law. Any securities described in this announcement have not been registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), or any state securities laws, and may not be offered or sold in the United States, or to, or for the account or benefit of a "U.S. person" as defined in Regulation S under the U.S. Securities Act, except in transactions exempt from, or not subject to, registration under the U.S. Securities Act and applicable state securities laws.

The Notes were distributed pursuant to the prospectus exemption of section 12 of the Securities Act (Québec) for distribution of securities to persons established outside Québec.

On 23 October 2020 In the virtual 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) symposium on Molecular Targets and Cancer Therapeutics, Dr Marie Morfouace PhD, EORTC Translational Scientist, reported that it will present results of study using EORTC SPECTA, a molecular and biological research platform (Press release, EORTC, OCT 23, 2020, View Source [SID1234568964]). The platform detected genetic alterations in rare cancers, which could be potential targets for therapy.

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Rare cancers can include more than 300 different types of cancers and may affect all organs. Even though they represent 20% of all adult cancers, they account for more than 30% of cancer mortality. They are clearly under-represented in clinical research programmes, especially in research programmes exploring genomic alterations of cancer.

The EORTC and EURACAN developed a collaborative clinical research project called "Arcagen." This project aims to recruit 1,000 patients with rare cancer and perform a molecular profiling, using the Foundation Medicine tests. This feasibility study presents results from 87 patients from three French sites were analysed.

Forty-one patients were diagnosed with sarcoma, 9 with ovarian Yolk Sac Tumour (YST), 14 with rare head and neck cancers and 13 with thymic cancer. Male to female ratio was almost 1:1 (38 male and 35 female) and the median age at diagnosis was 48 years (range 28–85).

89% of patients had reportable genomic alterations. The most common alterations were linked to the cell cycle regulation, in particular in sarcoma and rare head and neck tumours (TP53, RB1 as well as CDKN2A/B deletions or MDM2 amplification). Multiple single-nucleotide variants (SNVs) were detected in the RAS/RAF family, and could be of notable interest in the YST and thymic tumours. The TMB status was globally low across all samples with a median of 3 Must/MB (range).

Only 5.1% of tumours had mutations that were directly targetable with approved agents: NTRK fusion (n = 1; sarcoma), EGFR 20 insertion (n = 1; head and neck tumour) and FGFR fusion/amplification (n = 2; sarcoma). However, regarding global action ability (independently of disease type), we could recommend a targeted treatment for 39% of the patient population (n = 30) such as CDK4/6 inhibitors, RTKI, PARPi, mTOR inhibitors, and immune checkpoint inhibitors.

The pilot study highlights a need for specific research on rare cancers to find driver alterations and develop adequate therapies and the feasibility of enrolling patients with rare cancers. Prospective recruitment is ongoing for this project. The possibility of liquid biopsy was added to optimize the success rate for molecular analysis for all patients. When failure occurs on the tumor tissue molecular analysis, a blood draw can be performed and analysed using the FoundationOne Liquid CDx.

Marie Morfouace says "The pilot study shows that comprehensive molecular characterization of rare tumors is important , since the molecular landscape of these tumors is much less known than more common cancers. The data shows that fewer actionable targets and therapeutic options are available to patients with rare adult cancers vs more common cancers (60% vs 25%), and highlight the need for research on rare cancers."

"The EORTC SPECTA platform is important in enabling research is this scientific, technical, operational, and geographic scope. Reliable multi-test, multi-tumour, multi-country research needs a level of harmonisation and control that can only happen with the use of a large research platform such as SPECTA," says Dr Vassilis Golfinopoulos MD, EORTC HQ director. "Acknowledging that development scientific knowledge needs large-scale collaboration, EORTC promptly makes SPECTA available for ARCAGEN and other suitable research initiative."

This study conducted with the support of a grant from Roche.

32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, 24-25 October 2020, Virtual conference

Poster presentation
Abstract number: 123
Arcagen: Molecular profiling of rare cancer patients – analysis of the pilot study (87 patients)

Morfouace1, I. Ray-Coquard2, N. Girard3, A. Stevovic1, I. Treilleux2, P. Meeus2, S. Aust2, A. Floquet4, S. Croce4, M. Seckl5, J. Gietema6, M. Caplin7, C. de la Fouchardiere2, L. Licitra8, H. Kapiteijn9, S. Piperno Neumann3, A. Idbaih10, J.Y. Blay2, On behalf of EURACAN.

1EORTC, TRU, Brussel, Belgium; 2Centre Léon Bérard, Lyon, France; 3Institut Curie, na, Paris, France; 4Institut Bergonié, Bordeaux, France; 5Imperial College, London, United Kingdom; 6University Medical Centre, Groningen, Netherlands; 7Royal Free London NHS Trust, London, United Kingdom; 8Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; 9Leiden University Medical Centre, Leiden, Netherlands; 10Sorbonne Université and AP-HP, Paris, France

On October 23, 2020 Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC, Nasdaq:CYCCP) ("Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported the appointment of Mark Kirschbaum, M.D. as Senior Vice President & Chief Medical Officer (CMO) (Press release, Cyclacel, OCT 23, 2020, View Source [SID1234568954]). Dr. Kirschbaum is a highly experienced hematologist/oncologist with over 30 years of experience in molecular medicine, new drug development, clinical trial design and patient care. He has management experience in both academic research and clinical and pharmaceutical settings. As CMO, he will be responsible for advancing Cyclacel’s pipeline and will lead clinical strategy, patient safety, and medical affairs.

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"We are delighted to welcome Mark to the Cyclacel team," said Spiro Rombotis, Cyclacel’s President & Chief Executive Officer. "Recent data with fadraciclib, our CDK2/9 inhibitor, and CYC140, our PLK1 inhibitor, support further clinical development of these agents in both liquid and solid cancers. Mark’s extensive hematology and oncology experience in clinical practice, experimental therapeutics and industry drug development will be essential as we advance these and our other clinical development programs with the aim of helping patients with unmet medical needs."

"Cyclacel’s biomarker-driven approach to drug development has produced a growing and diversified clinical pipeline with the potential to target a broad range of malignancies," said Dr. Kirschbaum. "I am excited to join the Cyclacel team at this point in its evolution to help build an innovative pipeline addressing the rising problem of cancer resistance and to achieve our clinical milestones."

Dr. Kirschbaum will report to Spiro Rombotis, President and Chief Executive Officer. He will be based in the Company’s Berkeley Heights, NJ office.

Most recently, Dr. Kirschbaum served as Vice President, Hematology/ Oncology at ArQule Inc., (recently acquired by Merck & Co.) where he managed the development of their BTK inhibitor ARQ531 for hematological indications, including CLL. Prior to ArQule, he was Senior Medical Director with global clinical development responsibilities at Daiichi-Sankyo, Taiho Pharmaceuticals and BeiGene, USA, where he led the clinical development of novel compounds including inhibitors of EZH2/1, HSP-90, HER2/3 and BTK in various solid tumors and hematological malignancies.

Before working in the biopharmaceutical industry, Dr. Kirschbaum served as Professor of Medicine, Director of Experimental Therapeutics, Hematology at the Monter Cancer Center/NSLIJHS; Professor of Medicine, Director Hematologic Malignancies at Penn State, Hershey Cancer Center, Director of Experimental Therapeutics, Nevada Cancer Institute, and Director, New Drug Development at the City of Hope National Cancer Center, and Attending Senior Physician, Department of Hematology and Department of Bone Marrow Transplantation, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.

He has earned a B.A. from Yeshiva University in New York and his M.D. from SUNY–Health Sciences Center in Brooklyn. He did his Residency in Internal Medicine at Kings County Hospital Center in New York. He also held a Research Fellowship in Oncology at Fred Hutchinson Cancer Research Center in Seattle and worked as a physician scientist at Hadassah University Hospital and the Weizmann Institute of Science in Israel.

Cyclacel also announced that the Compensation Committee of its Board of Directors authorized the grant to Dr. Kirschbaum of non-qualified stock options to purchase up to 120,000 shares of the Company’s common stock, effective as of the first day of his employment as an inducement to Dr. Kirschbaum to commence employment with Cyclacel. The award was granted under Cyclacel’s 2020 Inducement Equity Incentive Plan which Cyclacel’s Board of Directors adopted to facilitate the granting of equity awards to new employees in accordance with NASDAQ Listing Rule 5635(c)(4).

The inducement grant is exercisable at a price of $3.77 per share, which is the closing price per share of Cyclacel’s common stock as reported by NASDAQ on October 23, 2020. The stock option shall vest over three years, with one third of the award vesting on October 23, 2021, and the remainder vesting ratably at the end of each subsequent month thereafter, subject to Dr. Kirschbaum’s continued employment with Cyclacel through each applicable vesting date. The option has a ten-year term and is subject to the terms and conditions of a stock option agreement.