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Hansa Biopharma to Host Conference Call to Provide Year-End report 2019 and Business Update

On January 22, 2020 Hansa Biopharma reported that it will publish its Year-End report 2019 at 8:00 a.m. CET on February 6, 2020 (Press release, Hansa Biopharma, JAN 22, 2020, https://www.prnewswire.com/news-releases/hansa-biopharma-to-host-conference-call-to-provide-year-end-report-2019-and-business-update-300990986.html [SID1234553428]). All interested parties are invited to participate in a telephone conference, which will include a presentation of the interim results and a business update, on the same date at 2:00 p.m. CET. The event will be hosted by Hansa Biopharma’s CEO, Søren Tulstrup, and CFO, Donato Spota, and the presentation will be held in English.

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Slides used in the presentation will be live on the company website during the call under "Events & Webcast," and will also be made available online after the call.

INHIBITOR Therapeutics Receives prostate cancer IND Clearance from FDA

On January 22, 2020 INHIBITOR Therapeutics, Inc. (OTCQB: INTI), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapeutics to inhibit progression of cancerous and non-cancerous proliferation disorders, reported that the company has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate an IND-opening clinical study as a two-part, multi-center, randomized, double-blind, placebo-controlled, Phase 2b clinical trial that will evaluate the efficacy and safety of SUBA-Itraconazole capsules dosed in combination with docetaxel and prednisone in patients with metastatic castrate resistant prostate cancer (mCRPC) (Press release, Inhibitor Therapeutics, JAN 22, 2020, View Source [SID1234553427]).

The Phase 2b trial is named PREDICT (Prostate Response Evaluating Docetaxel Itraconazole Combination Therapy). The PREDICT trial is expected to be carried out across approximately 35 sites in six countries in North America, Western Europe and Eastern Europe.

Approximately 23,000 men in the U.S. are diagnosed each year with late-stage mCRPC that no longer responds well to androgen deprivation therapy (ADT) or previous treatment with chemotherapy or newer stand-alone anti-androgen therapies such as abiraterone, enzalutamide or apalutamide. SUBA-Itraconazole will be tested to determine its potential to address an unmet need in these patients, who exhibit disease progression or who have discontinued the other therapies due to toxicity or other reasons.

Nicholas J. Virca, INHIBITOR’s President and CEO, said: "Following a face-to-face End-of-Phase-2 meeting with FDA last October and our submission of an IND application thereafter, I am pleased to announce that we have received IND clearance for our PREDICT trial. FDA confirmed that we can follow the 505(b)(2) regulatory pathway and, assuming positive results demonstrating an improvement in radiographic progression-free survival (rPFS) as our primary endpoint, also indicated that the general design and planned analysis of our study would adequately address the objectives necessary to support an eventual New Drug Application (NDA) submission for this indication. FDA also indicated that the final analysis of the key secondary endpoint of overall survival (OS) can occur following submission of the NDA for approval in the United States."

Mr. Virca continued: "I would once again like to acknowledge the efforts of our regulatory and clinical team members during 2019 to achieve this level of progress for our SUBA-Itraconazole Prostate program. We look forward to further updating our shareholders as we take subsequent steps to move this program into the clinic."

About Itraconazole in Prostate Cancer

In late-stage prostate cancer, up-regulation of the Hedgehog pathway in cells results in oncogene expression, which can interfere with the binding of ADT drugs to the androgen receptor (AR), causing biochemical resistance leading to mCRPC. Itraconazole acts on the essential Hedgehog signaling pathway component called smoothened (SMO) in human cells in a different manner than the FDA-approved drug vismodegib by preventing the ciliary accumulation of SMO normally caused by the Hedgehog pathway. Itraconazole also has a much shorter half-life than vismodegib, which may be the reason it appears to have fewer side effects than what has been reported for vismodegib in recent publications regarding its use in treating basal cell carcinoma. Thus, INHIBITOR believes that itraconazole may be more suitable than vismodegib for use in combination with chemotherapy due to its lower toxicity profile. Itraconazole has been tested as a treatment for mCRPC in a multi-institutional Phase 2 trial led by a prominent U.S. university and published in 2013. This trial showed that 90% of men with prostate specific antigen (PSA)-doubling times of less than 6 months, who achieved therapeutic levels of itraconazole, showed promising PSA reductions that correlated significantly with rPFS. INHIBITOR also believes that the improved bioavailability of SUBA-Itraconazole may provide additional benefits to prostate cancer patients in two ways: 1) by achieving higher therapeutic levels of itraconazole at lower doses than those reported in the 2013 Phase 2 study, which used the generic formulation of the drug, and 2) by reducing the dose of chemotherapy based on enhanced uptake of docetaxel in the presence of itraconazole.

No assurances can be given, however, that the clinical study referenced herein will be found by FDA to be sufficient for an NDA filing or, even if the NDA is accepted for filing, that the NDA will ultimately be approved by FDA.

CardioFocus® Names Burke T. Barrett As Chief Executive Officer

On January 22, 2020 CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), reported that the company’s Board of Directors has promoted Burke T. Barrett to the position of Chief Executive Officer (CEO), effective January 19, 2020 (Press release, CardioFocus, JAN 22, 2020, View Source [SID1234553426]). Mr. Barrett previously served as CardioFocus’ President and Chief Operating Officer (COO).

"The Board of Directors are proud to announce Burke’s promotion to CEO," said Paul LaViolette, Executive Chairman of CardioFocus. "From the outset, Burke has played an integral role in the development of the HeartLight platform as well as CardioFocus as a company. He is intimately familiar with our technology, employees, investors, customers, regulators, vendors and distributors, and is the perfect person to lead the company as we introduce the breakthrough HeartLight X3 System to the global AFib market."

"I am as excited as ever about the future of CardioFocus given the impressive clinical and commercial results coming out of Europe with our HeartLight X3 System," said Mr. Barrett. "We are pleased to showcase the System at the 25th Annual International AF Symposium being held in Washington D.C. this week and plan to provide an update about the regulatory path and timeline for introduction of the System into the U.S. market in the coming weeks."

Mr. Barrett has over 30 years of experience in the medical device industry. He joined CardioFocus in 2002, and during his more than 15 years with the company has held roles of increasing responsibility from Vice President through to President and COO. Prior to joining CardioFocus, Mr. Barrett was Vice President of Clinical Operations at Cyberkinetics Neurotechnology Systems, Inc., a public medical device company that achieved first-in-man success in novel, implantable brain-computer interfaces. He also served at Cyberonics as the Vice President, Business and Technology Development. Previously, Mr. Barrett held positions in business development, clinical & regulatory affairs, and quality auditing at Biofield Corporation, Dornier Medical Systems, and Bausch & Lomb. Mr. Barrett is a co-inventor on numerous issued and pending patent applications. From 2010-2013 he served as the industry representative on the Food and Drug Administration’s (FDA) Circulatory Systems Device Advisory Panel. He received bachelor’s degrees in chemical engineering and chemistry from Syracuse University and a Master of Business Administration from Kennesaw University in Atlanta.

Aethlon Medical Announces Completion of $3.77 Million Registered Direct Offering

On January 22, 2020 Aethlon Medical, Inc. (Nasdaq:AEMD) ("Aethlon" or the "Company"), a medical device technology company focused on developing products to diagnose and treat life and organ threatening diseases, reported the completion of its previously announced registered direct offering of 1,885,378 shares of its common stock, at a purchase price per share of $2.00, priced at-the-market under Nasdaq rules (Press release, Aethlon Medical, JAN 22, 2020, View Source [SID1234553425]). Additionally, Aethlon issued to the purchasers unregistered warrants to purchase up to 942,689 shares of common stock. The warrants have an exercise price of $2.75 per share of common stock, are exercisable immediately and will expire five and one-half years from the issuance date.

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

The gross proceeds to Aethlon, before deducting placement agent fees and other offering expenses, are approximately $3.77 million.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) were offered by Aethlon pursuant to a "shelf" registration statement on Form S-3 that was originally filed on May 10, 2019 and declared effective by the Securities and Exchange Commission ("SEC") on August 1, 2019 and the base prospectus contained therein (File No. 333-231397). The offering of the shares of common stock was made by means of a prospectus supplement that forms part of the registration statement. A final prospectus supplement and accompanying base prospectus relating to the shares of common stock being offered were filed with the SEC. Electronic copies of the final prospectus supplement and accompanying base 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 a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction.

Seneca Biopharma Announces Closing of Exercise of Warrants for $7.55 Million Gross Proceeds

On January 22, 2020 Seneca Biopharma, Inc. (Nasdaq: SNCA), a clinical-stage biopharmaceutical company developing novel treatments for various diseases of high unmet medical need, reported the closing of the previously announced agreement by several accredited investors to exercise certain warrants to purchase up to an aggregate of 5,555,554 shares of common stock having an exercise price of $2.70 issued by the company on July 30, 2019, at a reduced exercise price of $1.36 per share (Press release, Seneca Biopharma, JAN 22, 2020, View Source [SID1234553424]).

The shares of common stock issuable upon exercise of the warrants were registered pursuant to a registration statement on Form S-1 (File No. 333-232273) which became effective by the Securities and Exchange Commission (SEC) on July 25, 2019. The gross proceeds to the company from the exercise of the warrants are approximately $7.55 million, prior to deducting placement agent fees and estimated offering expenses.

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

In consideration for the immediate exercise of the warrants for cash, the exercising holders received new unregistered warrants to purchase shares of common stock in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act"). The warrants will be exercisable into an aggregate of up to 5,555,554 shares of common stock, at an exercise price of $1.23 per share, 2,777,777 of which have a term of exercise equal to two years and 2,777,777 of which have a term of exercise equal to five years.

Seneca intends to use the net proceeds from the offering as working capital for general business purposes, including continued development of SNCA’s stem cell assets and seeking partnership opportunities, as well as pursuing the in-licensing or acquisition of new innovative medicines to strengthen the company’s pipeline.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the 1933 Act and, along with the shares of common stock issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. The company agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants.

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.