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Veracyte to Release Fourth Quarter and Full-Year 2019 Financial Results on February 25, 2020

On January 6, 2020 Veracyte, Inc. (Nasdaq: VCYT) reported that it will release its financial results for the fourth quarter and full-year 2019 after the close of market on Tuesday, February 25, 2020 (Press release, Veracyte, FEB 6, 2020, View Source [SID1234553956]). Company management will host a conference call and webcast to discuss its financial results and provide a general business update at 5:00 p.m. Eastern time on the same day.

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The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following conclusion of the live broadcast and will be accessible on the company’s website at View Source

Immunis.AI to Present at the BIO CEO & Investor Conference

On February 6, 2020 Immunis.AI, a privately held immunogenomics company with a patented liquid biopsy platform, reported that its President and Chief Executive Officer, Mark McDonough, will present at the BIO CEO & Investor Conference being held in New York City from February 10-11, 2020 (Press release, ImmunisAI, FEB 6, 2020, View Source [SID1234553955]).

Date: Tuesday, February 11th

Time: 10:00 AM

Track: Diagnostics

Venue: Ziegfeld Room, New York Marriott Marquis, 1535 Broadway, New York, NY 10036

To schedule a meeting with Mark McDonough during the conference, please contact [email protected].

CEL-SCI to Present at 2020 BIO CEO & Investor Conference

On February 6, 2020 CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy company, reported that Geert Kersten, Chief Executive Officer, will be presenting at the 2020 BIO CEO & Investor Conference in New York, NY on Monday, February 10, 2019 at 3:45 p.m (Press release, Cel-Sci, FEB 6, 2020, View Source [SID1234553954]).

A live audio webcast of the presentation will be available on CEL-SCI’s website at View Source A replay of the presentation will be available approximately 1 hour after the presentation and is accessible until May 12, 2020.

Now in its 22nd year, the BIO CEO & Investor Conference is one of the largest independent investor conferences focused on established and emerging publicly traded and select private biotech companies. Experience the best of biotech with two days of productive partnering meetings with institutional and early-stage investors, industry analysts, and senior biotechnology executives, in one location.

PHIO PHARMACEUTICALS ANNOUNCES CLOSING OF $1.74 MILLION REGISTERED DIRECT OFFERING PRICED AT-THE-MARKET

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.

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.

Celsion Corporation Announces DSMB has Confirmed Initial Safety of Weekly GEN-1 Dosing at 100 mg/m² in 15 Randomized Patients with Advanced Ovarian Cancer

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.

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.