On June 16, 2020 HALO Diagnostics reported interim 10-year results from its Phase II 20-year clinical trial for prostate laser focal therapy in patients with localized prostate cancer (Press release, HALO Diagnostics, JUN 16, 2020, View Source [SID1234561161]). Over 170 men, 45-years or older diagnosed with low-to-intermediate risk or recurrent prostate cancer, volunteered to participate in the study . The results are impressive: less than 1% infection, less than 1% erectile dysfunction and less than 1% incontinence – compared to conventional whole gland prostatectomy which has a risk of up to 50% erectile dysfunction and 25% urinary incontinence. These results, along with a 100% prostate cancer-specific survival rate, are an encouraging development for men looking for a prostate cancer therapy option with a lower risk of side effects.

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Prostate cancer is the second leading cause of cancer death in men in the United States. It is estimated that over 191,000 men will be diagnosed with prostate cancer this year and more than 33,000 are expected to die.
Prostate cancer is the second leading cause of cancer death in men in the United States. It is estimated that over 191,000 men will be diagnosed with prostate cancer this year and more than 33,000 are expected to die.
Why is this study important to prostate cancer patients? "Magnetic resonance image (MRI)-guided laser focal therapy enables doctors to contour their approach to the areas of the prostate that needs to be treated, while creating safety boundaries around the areas that need to remain untouched," said Bernadette M. Greenwood, chief research officer of HALO Diagnostics. "This level of precision compared to other approaches, such as radical prostatectomy, radiation therapy and even other focal or targeted approaches like high-intensity focused ultrasound (HIFU), substantially lowers the risk of side effects, including urinary incontinence, impotence and decreased bowel function. Unlike other treatments, laser focal therapy does not limit the option to treat with radiation therapy or surgery if needed later."

The procedure is as follows: the laser focal therapy (also called LITT or FLA) is designed to destroy prostate tissue under MRI guidance using laser energy. The laser device is FDA 510(k) cleared for clinical use for soft tissue necrotization. The planning system is FDA 510(k) cleared for MRI-guided prostate biopsy. HALO Diagnostics is the first company in the world to combine these devices under IRB approved clinical trial NCT 02243033. The procedure is minimally invasive and ambulatory outpatient – no general anesthesia required.

"The purpose of this research, which began on May 24, 2010, is to investigate the safety and effectiveness of using MRI-guided laser focal therapy for prostate cancer and to evaluate oncologic control over 20 years," said Dr. John Feller, chief medical officer of HALO Diagnostics. "The interim Phase II results indicate a paradigm shift in the treatment of men with intermediate risk prostate cancer and those with biochemical recurrence. These results are not only an exciting development in the advancement of laser focal therapy for prostate cancer, but speak to the strength of our clinical team and our commitment to developing life changing patient experiences and outcomes."

Recruitment for the "Phase II Study to Evaluate Outpatient Magnetic Resonance Image-Guided Laser Focal Therapy for Prostate Cancer, a 20-Year Survival Study" will continue through the HALO Diagnostics’ Center of Innovation in Indian Wells and conclude once the study goal of 200 men has been achieved and evaluated for oncological control for a 20 year period. The trial details are listed on clinicaltrial.gov and the 10-year interim results were published in Journal of Urology on May 15, 2020.

On June 16, 2020 Centene Corporation (NYSE: CNC) reported it will participate in the one-day, virtual-only BMO Capital 2020 Prescriptions for Success Healthcare Conference (Press release, Centene , JUN 16, 2020, View Source [SID1234561160]).

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Centene will participate in a virtual format on Tuesday, June 23, 2020, at 8:30 a.m. Eastern Daylight Time (EDT). A simultaneous live audio webcast is available at: View Source

A webcast replay will be available afterwards via the Company’s website at www.centene.com under the Investors section.

On June 16, 2020 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical device technology company focused on unmet needs in global health, reported that it will issue financial results for its fourth quarter fiscal year 2020, ended March 31, 2020, at 4:15pm Eastern time on Thursday, June 25, 2020 (Press release, Aethlon Medical, JUN 16, 2020, https://www.prnewswire.com/news-releases/aethlon-medical-to-release-fourth-quarter-financial-results-and-host-conference-call-on-june-25-2020-301077496.html [SID1234561159]).

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Management will host a conference call on Thursday, June 25, 2020 at 4:30pm eastern time to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference by navigating to View Source Please note that registered participants will receive their dial in number upon registration.

Interested parties without internet access or unable to pre-register may dial in by calling:

PARTICIPANT DIAL IN (TOLL FREE): 1-844-836-8741
PARTICIPANT INTERNATIONAL DIAL IN: 1-412-317-5442
All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through July 2, 2020. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada Toll Free at 1-855-669-9658. The replay conference ID number is 10145174.

On June 16, 2020 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company pioneering a new class of oligonucleotide-based therapies called Antibody Oligonucleotide Conjugates (AOCs), reported the closing of its initial public offering of 16,560,000 shares of common stock, which includes the exercise in full by the underwriters of their option to purchase 2,160,000 additional shares, at a public offering price of $18.00 per share (Press release, Avidity Biosciences, JUN 16, 2020, View Source [SID1234561158]). The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Avidity, were approximately $298.1 million. Avidity’s common stock is listed on the Nasdaq Global Market under the ticker symbol "RNA".

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Cowen, SVB Leerink, Credit Suisse and Wells Fargo Securities acted as joint book-running managers for the offering.

Registration statements relating to the offering have been filed with the Securities and Exchange Commission (SEC) and became effective on June 11, 2020. A prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from Cowen and Company LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (833) 297-2926, or by email at [email protected]; or from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6218, or by email at [email protected]; or from Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, Eleven Madison Avenue, 3rd Floor, New York, NY 10010, or by telephone at (800) 221-1037, or by email at [email protected]; or from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, NY 10001, or by telephone at (800) 326-5897, or by email at [email protected].

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 offer or 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 June 16, 2020 IDEAYA Biosciences, Inc. (Nasdaq:IDYA) reported that it intends to offer and sell up to $60 million of shares of its common stock in an underwritten public offering (Press release, Ideaya Biosciences, JUN 16, 2020, View Source [SID1234561157]). In addition, IDEAYA intends to grant the underwriters a 30-day option to purchase up to $9 million of shares of its common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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IDEAYA intends to use the net proceeds of the offering, along with its existing cash, cash equivalents and short-term and long-term marketable securities to fund (i) preclinical and clinical development of IDE397, its MAT2A inhibitor development candidate, and other product candidates in its research pipeline targeting poly (ADP-ribose) glycohydrolase, or PARG, and a DNA Damage Target, or DDT, as well as its share of costs for targeting WRN under the previously announced Collaboration, Option and License Agreement with GSK, (ii) ongoing early clinical development of IDE196, its PKC inhibitor, and binimetinib, a MEK inhibitor to which Pfizer has exclusive rights in the U.S. and Canada, as combination therapy in metastatic uveal melanoma, or MUM and other solid tumors having GNAQ/11 hotspot mutations, as well as ongoing clinical trials evaluating IDE196 as monotherapy in such indications, (iii) biomarker research and development activities and (iv) working capital and other general corporate purposes.

J.P. Morgan, Citigroup and Jefferies are acting as joint book-running managers for the offering.

The securities described above are being offered by IDEAYA pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the U.S. Securities and Exchange Commission (the "SEC"). The offering will be made only by means of a written prospectus and a prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and 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. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may also be obtained by request from: J.P. Morgan, by mail at J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 866-803-9204, or by email at [email protected]; Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146; or Jefferies, by mail at Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-547-6340 or 877-821-7388, or by email at [email protected].

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.