On March 12, 2020 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported financial results for the full year ended December 31, 2019 (Press release, TapImmune, MAR 12, 2020, View Source [SID1234555494]).

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"With a clear path forward for our Phase 2 trial in AML patients with our novel T cell therapy, and the cash resources needed to advance our studies, 2020 is shaping up to be a busy and productive year for our Company," said Peter L. Hoang, President & CEO of Marker Therapeutics. "Based on promising results observed with our MultiTAA T cell therapy across various forms of cancer in investigator-sponsored trials, we are also evaluating opportunities for additional Marker-sponsored trials."

PROGRAM UPDATES

Multi-Antigen Targeted (MultiTAA) T Cell Therapies

Marker Prepares to Initiate Phase 2 AML Trial

In February 2020, the Company announced an updated study protocol for its Phase 2 clinical trial of MultiTAA T cell therapy in post-allogeneic hematopoietic stem cell transplant patients with acute myeloid leukemia (AML) in both the adjuvant and active disease setting. Under an amended trial design, the U.S. Food and Drug Administration (FDA) has permitted the trial to move forward with the safety lead-in. During the second half of 2020, Marker expects to complete enrollment of the first three patients and to submit the information required by the FDA to lift a partial clinical hold during the second half of 2020. The Company does not currently expect the partial clinical hold to significantly impact site or patient enrollment.

Investigator-Sponsored Trials with MultiTAA T Cell Therapy Continue to Generate Positive Results

Marker previously reported interim data from an ongoing Phase 1/2 clinical trial of MultiTAA T cell therapy for the treatment of patients with pancreatic adenocarcinoma being conducted by its partners at the Baylor College of Medicine (BCM). In this trial, the modified T cells exhibited activity against both targeted tumor-associated antigens (TAA) and non-targeted TAAs, indicating induction of antigen spreading. To date, there has not been any cytokine release syndrome or neurotoxicity observed in this trial.

T Cell-Based Vaccines

Phase 2 Triple Negative Breast Cancer Trial Progressing

Marker’s T cell-based vaccine program in triple negative breast cancer has delivered the following results as of September 30, 2019:

·Based on a preliminary analysis of 34 patients enrolled in the triple negative breast cancer trial, 31 patients showed meaningful immune response to vaccine treatment;

·Of 80 patients treated at 11 clinical sites, 16 have shown disease progression following treatment with TPIV200.

Phase 2 Platinum-Sensitive Advanced Ovarian Cancer Trial

·As previously announced, Marker has discontinued the development of TPIV200 in patients with platinum-sensitive advanced ovarian cancer based on an unblinded review of interim results from the trial conducted by the Data Safety Monitoring Board (DSMB). While the DSMB did not express safety concerns, Marker elected to discontinue the trial as it did not meet the threshold for probability of clinical benefit based upon the Company’s pre-specified criteria.

FINANCING UPDATE

·On March 2, 2020, Marker announced that the Company entered into a Common Stock Purchase Agreement of up to $30 million with Aspire Capital Fund, LLC, a Chicago-based institutional investor and long-term Marker shareholder.

FULL YEAR 2019 FINANCIAL RESULTS

Cash Position and Guidance: At December 31, 2019, Marker had cash and cash equivalents of $43.9 million. The Company believes that the financial flexibility provided by the Aspire transaction will enable the cash runway to extend beyond the second quarter of 2021.

R&D Expenses: Research and development expenses were $12.8 million for the year ended December 31, 2019 compared to $8.0 million for the year ended December 31, 2018. The increase was primarily attributable to increases in personnel-related expenses relating to the build-up of Marker’s internal infrastructure, an increase in clinical consulting and professional expenses relating to preparation of the AML trial, an increase in process development expenses, offset by a decrease in clinical trial expenses due to the stages of ongoing clinical trials and the decreased number of active patients in such trials.

G&A Expenses: General and administrative expenses were $10.0 million for the year ended December 31, 2019, compared to $24.4 million for the year ended December 31, 2018. The decrease was primarily attributable to a decrease of $12.8 million in stock-based compensation expenses due to executive stock option grants issued in fiscal year 2018, as well as a decrease in merger-related expenses during fiscal year 2019, offset by increased expenses in headcount-related and legal and other professional expenses.

Net Loss: Marker reported a net loss of $21.4 million for the year ended December 31, 2019, compared to a net loss of $148.0 million for the year ended December 31, 2018.

On March 12, 2020 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, reported that the Company will report full year 2019 financial and operating results on the evening of Tuesday, March 24, 2020 (Press release, Celyad, MAR 12, 2020, View Source [SID1234555510]).

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Following the press release, Celyad management will host a conference call on Wednesday, March 25 at 1 p.m. CET / 8 a.m. ET to discuss full year 2019 results and provide an update on the Company’s recent progress and upcoming milestones.

Participants may access the conference call by dialing +44 (0) 2071 928501. The conference ID for the call is 1392585. Alternatively, participants may access the conference call by dialing the following local numbers: Belgium 02 401 70 35, France 01 76 72 89 28, Netherlands 020 7188527 and United States 1 917 720 0181.

To access the subsequent archived recording, visit the "Events & Webcasts" section of the Celyad website.

Additionally, in consideration of growing concerns over the spread of coronavirus disease, COVID-19, the Company has decided to postpone its upcoming Research & Development Day, previously scheduled for March 18th, until later in the year.

On March 12, 2020 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported pricing of a public offering of 20,000,000 units at a price to the public of $0.30 per unit, for gross proceeds of $6.0 million, before deducting placement agent fees and other offering expenses payable by Kitov (Press release, Kitov Pharmaceuticals , MAR 12, 2020, View Source [SID1234555545]). Each unit contains one American Depositary Shares ("ADS") (or ADS equivalent) and one warrant to purchase one ADS. Each ADS represents one ordinary share, no par value, of Kitov. The ADSs (or ADS equivalents) and warrants included in the units can only be purchased together in this offering, but will be issued separately and will be immediately separable upon issuance.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants will have an exercise price of $0.325 per ADS and will be exercisable at any time after the date of issuance and will expire five years from the date of issuance.

The closing of the sale of the securities is expected to take place on or about March 16, 2020, subject to satisfaction of customary closing conditions.

Kitov intends to use the net proceeds of this offering to fund the development of its oncology drug candidates, acquisition of new assets and for general working capital purposes.

The offering is being made under an effective registration statement on Form F-1 (File No. 333-235729) filed with the Securities and Exchange Commission (the "SEC") and declared effective on March 11, 2020. The offering is being made only by means of a prospectus forming part of the effective registration statement. The final terms of the offering will be disclosed in a final prospectus to be filed with the SEC and made available on the SEC’s website at www.sec.gov. When available, electronic copies of the final prospectus relating to the offering may also be obtained by contacting H.C. Wainwright & Co., 430 Park Avenue, New York, NY 10022, by telephone at (646) 975-6996 or by email at [email protected]. This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On March 12, 2020 The National Foundation for Cancer Research (NFCR)reported that it has recently been approved by the U.S. Food and Drug Administration (FDA) for the initiation of human clinical trials. The regulatory body accepted the Investigational New Drug (IND) application for ST-001, a unique intravenous (IV) nano-delivery system of the off-patent synthetic chemical compound fenretinide, for the experimental treatment of patients with T-cell non-Hodgkin’s lymphoma.

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Fenretinide is a small-molecule which past studies have shown to be both safe and have cancer mitigating qualities. However, heretofore it has not been approved as a cancer therapeutic, largely due to the challenges of delivering it in adequate doses to tumor cells.

The molecule is highly hydrophobic, meaning poorly soluble in water. Therefore, the clinical use of fenretinide as a cancer therapeutic by itself is limited—that is, unless delivered to cancer cells in a manner via which the molecule’s insolubility will no longer be problematic. Existing technology has not yet solved this problem.

However, funded in part by an NFCR grant, a unique nanoparticle-based IV delivery system has been developed which shows promise in being able to address the insolubility challenge and administer therapeutically effective high doses of fenretinide. Phase I clinical trials for its safety are expected to begin later this year at the Rush University Medical Center in Chicago.

NFCR’s translational research support helped advance the cancer treatment technology, developed by scientists including the U.S. National Cancer Institute’s Ralph Parchment, Ph.D., to this crucial IND acceptance stage. Additionally, optimism for the prospect of the upcoming trials’ successful outcome is justified by earlier research on fenretinide conducted and published by multiple scientists, including Dartmouth College’s Michael Sporn, M.D., a former NFCR project director, showing the drug to be safe in humans after long periods of use.

"The acceptance by the FDA of ST-001’s IND application underscores the importance of research—basic and translational—in the battle against not only lymphoma, but all forms of cancer," said NFCR President and CEO Sujuan Ba, Ph.D. "It’s only novel research that can result in game-changing treatments for patients."

On March 12, 2020 Tyligand Bioscience, Ltd., a leader in small molecule drug discovery and development, and Context Therapeutics LLC, a clinical stage biopharmaceutical company focused on hormone driven cancers, reported the signing of collaboration agreements for the development, manufacturing, registration and future commercialization of onapristone extended release (ER) (Press release, Tyligand Bioscience, MAR 12, 2020, View Source [SID1234644992]).

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Onapristone ER is currently being evaluated in patients with progesterone receptor positive (PR+) ovarian and endometrial cancers in the ongoing Phase 2 ONWARD 220 clinical trial. Initiation of additional Phase 2 clinical trials in ER+, PR+, HER2- breast cancer and endometrial cancers are planned for mid-2020.

Under the terms of the agreements, Tyligand will be solely responsible for the design and optimization of a novel manufacturing process for onapristone ER to meet Context’s development and future commercialization needs, and standards for quality, safety and cost. Upon completion of specific performance-based milestones, Tyligand will be granted the exclusive right and will be solely responsible for the development and commercialization of onapristone ER in China, Hong Kong and Macau (the "Territory"), and Context will be eligible to receive royalties on net sales of onapristone ER in the Territory. Context will retain rest of world rights to commercialize onapristone ER.

"We are thrilled to partner with Tyligand as we accelerate onapristone ER’s Phase 2 evaluation and prepare for Phase 3," said Martin Lehr, CEO of Context. "Tyligand is renowned for its expertise in process development and has strong networks with manufacturing and clinical capabilities in China and the U.S. Partnering with Tyligand will enable Context to optimize and efficiently scale our manufacturing and clinical capacity to support the evaluation and future commercialization of onapristone ER, our experimental oral therapy, to address the unmet need in treating patients with PR+ cancers."

"Even with the major advances in cancer therapies in recent years, treatment options for patients with hormone driven cancers remain limited," said Tony Zhang, CEO of Tyligand."Onapristone ER has the potential to be the first-in-class therapeutic agent specifically targeting progesterone receptors and the best-in-class treatment option for breast, endometrial and ovarian cancers. We are proud to partner with Context to develop onapristone ER and make this innovative medicine ultimately more accessible for patients around the world."