On February 6, 2020 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported the closing of its previously announced registered direct offering of 197,056 shares of common stock, at a purchase price of $8.83 per share, priced at-the-market under Nasdaq rules (Press release, Phio Pharmaceuticals, FEB 6, 2020, View Source [SID1234553953]). Additionally, the Company issued to the investors unregistered warrants to purchase up to an aggregate of 197,056 shares of common stock.

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

The warrants have an exercise price of $8.71 per share of common stock, are exercisable immediately and will expire five and one-half years following the date of issuance.

Gross proceeds to Phio, before deducting placement agent fees and other offering expenses, are approximately $1.74 million. The Company intends to use the net proceeds from the offering to fund the development of its immuno-oncology programs, other research and development activities and for general working capital needs.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) were offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-224031) previously filed with the Securities and Exchange Commission (the "SEC") on March 29, 2018 and declared effective by the SEC on April 6, 2018. A final prospectus supplement and accompanying prospectus relating to the shares of common stock being offered were filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 6, 2020 Celsion Corporation (NASDAQ: CLSN) reported that the independent Data Safety Monitoring Board (DSMB) has completed its initial safety review of data from the first fifteen patients treated with the first four neoadjuvant doses of GEN-1 at 100 mg/m² in the ongoing Phase I/II OVATION 2 Study (Press release, Celsion, FEB 6, 2020, View Source [SID1234553952]). As requested by the U.S. Food and Drug Administration (FDA), a follow-on Phase 1 review by the DSMB will evaluate the safety of GEN-1 in up to 17 weekly doses before initiating the Phase 2 portion of the Study. The OVATION 2 Study combines GEN-1, the Company’s IL-12 gene-mediated immunotherapy, with neoadjuvant chemotherapy (NACT), a standard of care for newly diagnosed patients with Stage III and IV ovarian cancer. Following NACT, patients undergo interval debulking surgery (IDS) followed by three additional cycles of chemotherapy.

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The OVATION 2 Study is an open label, 130 patient, 1 to 1 randomized Phase II trial, 80% powered to show the equivalent of a 33% improvement in progression-free survival (PFS), the primary endpoint, when comparing the treatment arm (NACT + GEN-1) with the control arm (NACT alone). GEN-1, is a formulation of Celsion’s proprietary, synthetic, non-viral cell transfection platform TheraPlas, incorporating, DNA plasmids coded for the inflammatory protein, interleukin-12 (IL-12). Cell transfection is followed by persistent, local secretion of the IL-12 protein, expected at therapeutic levels.

The OVATION 2 Study builds on promising clinical and translational research data from the Phase IB OVATION I Study, in which enrolled patients received escalating weekly doses of GEN-1 (from 36 mg/m² to 79 mg/m²) for a total of eight treatments in combination with NACT, followed by IDS. These data from the OVATION I Study were presented at the ASCO (Free ASCO Whitepaper)-SITC Clinical-Oncology Symposium by Dr. Premal H. Thaker, M.D., M.S. on May 4, 2019 and can be reviewed here. In addition to exploring a higher dose of GEN-1 in the OVATION 2 Study, patients will continue to receive GEN-1 after their IDS in combination with adjuvant chemotherapy.

"This latest DSMB review of GEN-1 at 100 mg/m² confirmed that there were no dose limiting toxicities detected in any of the six evaluable patients (those patients who received at least four doses of GEN-1) and that intraperitoneal GEN-1 administration is well tolerated even when given with standard NACT," said Nicholas Borys, M.D., executive vice president and chief medical officer of Celsion. "Of the fifteen patients treated in the Phase I portion of the OVATION 2 Study, nine patients were treated with GEN-1 plus NACT and six patients were treated with NACT only. After the final six patients in the Phase I portion of the Study have completed their interval debulking surgery, we will be reporting surgical results and overall tumor response rates for all fifteen patients from the Phase I portion of the trial later this quarter."

Dr. Borys concluded, "We anticipate that the Phase II portion of the OVATION 2 Study will begin enrolling patients at more than 25 clinical sites in the U.S. and Canada beginning in the second quarter of 2020. As requested by the FDA, a follow-on safety review will be conducted by the DSMB after all the patients have concluded their chemotherapy dosing. The Study protocol allows for up to 17 doses of GEN-1. Our goal is to complete enrollment of all patients in the OVATION 2 Study by the first quarter of 2021."

The OVATION 2 Study is supported with promising clinical and translational data from the Company’s prior Phase Ib OVATION I Study. In addition to a 100% objective response rate (complete response + partial response) observed in all 9 patients at the two highest dose cohorts, translational research data demonstrates that GEN-1 is biologically active, producing therapeutic levels of IL-12 cytokines and positively impacting T-cell population in the tumor.

On February 6, 2020 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, reported that it has entered into definitive agreements with institutional investors to purchase an aggregate of up to 7,500,000 shares and warrants to purchase 5,625,000 shares of common stock at a combined public offering price of $0.80 per share and related warrant in a registered direct offering (Press release, Moleculin, FEB 6, 2020, View Source [SID1234553951]).

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

Each warrant will have an exercise price of $1.05 per share and is exercisable six months and one day after issuance. The warrants will expire five years from the date they first become exercisable. The shares of common stock and the related warrants can only be purchased together in this offering but will be issued separately and will be immediately separable upon issuance. The offering is expected to close on or about February 10, 2020, subject to customary closing conditions.

The gross proceeds of the offering are expected to be $6.0 million, prior to deducting the placement agent fees and other estimated offering expenses.

Oppenheimer & Co. Inc. is acting as the sole placement agent for the offering. Roth Capital Partners and Maxim Group LLC are acting as financial advisors to the Company.

The Company intends to use the net proceeds of the offering to fund its planned clinical trials, preclinical programs, for other research and development activities and for general corporate purposes.

The securities described above are being offered pursuant to a prospectus supplement and an accompanying prospectus forming part of a shelf registration statement on Form S-3 (No. 333-219434) previously filed with and declared effective by the Securities and Exchange Commission (SEC). A final prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, by telephone at (212) 667-8055, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 registration or qualification under the securities laws of any such state or jurisdiction.

On February 6, 2020 Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of immune reset to more patients, reported that the company is scheduled to participate in a fireside chat at the Guggenheim Healthcare Talks Oncology Day on Thursday, February 13th, 2020, at 11:00 a.m. ET at the St. Regis Hotel in New York, NY (Press release, Magenta Therapeutics, FEB 6, 2020, View Source [SID1234553950]).

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A live webcast of the fireside chat can be accessed on the Magenta Therapeutics website at View Source The webcast replay will be available for 90 days following the event.

On February 6, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported the presentation of preclinical data from its ROR1 chimeric antigen receptor T cell (CAR-T) program at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) – Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting in Orlando, Florida (Press release, Oncternal Therapeutics, FEB 6, 2020, View Source [SID1234553949]). A copy of the poster presentation is available online at www.oncternal.com.

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In preclinical studies, anti-ROR1 CAR-T constructs were evaluated in an animal model of human leukemia. A single dose of anti-ROR1 CAR T-cells expanded in treated animals and the chimeric T cells trafficked to the disease sites. By week four, leukemia cells were cleared from major tissue reservoirs, including bone marrow, kidneys and spleen. CAR-T cell-treated animals survived longer than 90 days compared to 21 days for animals in control groups. The CAR-T cells were highly active and detected in mouse tissues more than two months after injection.

This research effort was led by Professor Thomas J. Kipps, M.D., Ph.D., and Charles Prussack, Pharm.D., Ph.D., at the University of California San Diego (UC San Diego) under a research grant from the California Institute of Regenerative Medicine (CIRM).

"It is exciting to see the potent preclinical activity of the ROR1 CAR-T cell therapy and its selectivity in targeting tumors," said Thomas Kipps, M.D., Ph.D., Professor of Medicine, Evelyn and Edwin Tasch Chair in Cancer Research, and Deputy Director of Research Operations at the UC San Diego Moores Cancer Center. "This CAR-T cell product utilizes the ROR1 binding domain derived from cirmtuzumab (UC-961), a clinical stage antibody that is currently being evaluated in patients with hematological malignancies and solid tumors. The challenges of CAR-T therapies include patient relapses due to the loss of target antigen and safety issues due to targeting of normal cells expressing the antigen. Harnessing cirmtuzumab’s specificity for ROR1 expressed on cancer cells has the potential to improve CAR-T efficacy and safety, and address the high unmet medical need for treating patients with aggressive cancers."

"We are encouraged by the preclinical results of this ROR1 CAR-T program and look forward to advancing it to clinical testing, initially for treating patients with hematological cancers, potentially in the fourth quarter of this year," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO.

About ROR1 CAR-T

Oncternal Therapeutics is developing a ROR1-targeting (Receptor tyrosine kinase-like Orphan Receptor 1) chimeric antigen receptor T cell therapy (CAR-T) as a potential treatment for patients with aggressive hematological malignancies or solid tumors, in collaboration with the UC San Diego School of Medicine and the California Institute for Regenerative Medicine (CIRM). The Company’s CAR-T program is based on the binding domain of cirmtuzumab, which is an investigational, potentially first-in-class monoclonal antibody targeting ROR1. Cirmtuzumab is currently being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of patients with chronic lymphocytic leukemia, or CLL, or mantle cell lymphoma, or MCL, and in an investigator-initiated Phase 1 clinical trial in combination with paclitaxel for the treatment of women with metastatic or unresectable breast cancer.

ROR1 is a potentially attractive target for cancer therapy because it is an onco-embryonic antigen – not usually expressed on adult cells, and its expression confers a survival and fitness advantage when reactivated and expressed by tumor cells. Researchers at the UC San Diego School of Medicine discovered that targeting a critical epitope on ROR1 was key to specifically targeting ROR1 expressing tumors. This led to the development of cirmtuzumab, that binds this critical epitope of ROR1, which is highly expressed on many different cancers but not on normal tissues. Because the epitope of ROR1 recognized by cirmtuzumab appears to be restricted to tumor cells, a cirmtuzumab-based CAR-T may be selective in distinguishing cancer from normal tissues. Cirmtuzumab and ROR1 CAR-T cell therapy have not been approved by the U.S. Food and Drug Administration for any indication.