On January 20, 2021 MobileODT, a FemTech company producing the latest digital innovation in cervical screening, reported that it has been awarded a prestigious Small Business Innovation Research Authority grant of $2.3 million (Press release, MobileODT, JAN 20, 2021, https://www.mobileodt.com/press-releases/13493/ [SID1234574136]). This grant is presented by the United States National Cancer Institute (NCI) to leading companies that are technologically and clinically advanced to support the NCI’s goal of reducing suffering and death due to cancer. This grant is a tribute to the groundbreaking advances of MobileODT as an innovative company commercializing a novel cervical cancer screening technology utilizing complex machine learning (ML) and artificial intelligence (AI) algorithms. The company’s technology offers an alternative screening modality to the current standard-of-care with significantly improved accuracy. It allows for a broader range of physicians, to perform cervical cancer screening, while defining the actual status of the patient and reducing loss to follow-up.

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The grant was awarded to MobileODT to perform a large-scale clinical trial validating the efficacy of the company’s EVA VisualCheck (TM) AI technology, as a cervical screening Clinical Decision Support Tool at the Point of Care and providing results in under 60 seconds. The VisualCheck AI technology will be compared to standard of care methods such as Pap smear, and visual inspection of the cervix.

"This award offers MobileODT a great opportunity to independently validate it’s VisualCheck AI technology against the standard of care check with NIH quality" says David Levitz PhD. Principal Investigator of the study. The trial will commence in Q3 2021 and will be conducted in cooperation with the Basic Health International organization (BHI) on a population of 10,000 subjects.

"AI has a lot of potential to revolutionize care for women worldwide. We are excited to test the technology and validate its accuracy and clinical feasibility " says Miriam Cremer MD., MPH, Associate Professor of Obstetrics and Gynecology from Cleveland Clinic, one of the key researchers who will be leading the trial.

"We are honored to receive such a prestigious grant, especially from National Cancer Institute. It’s a recognition of the value that our technology is bringing to women’s health". Says Leon Boston, MobileODT CEO. "The results of the trial are especially important in light of the World Health Organization’s recent global strategic decision to accelerate the elimination of cervical cancer. We see these results bringing our technology to the forefront of women’s health".

On January 20, 2021 Aclaris Therapeutics, Inc. (Nasdaq:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported the pricing of its underwritten public offering of 5,483,714 shares of its common stock at a price to the public of $17.50 per share (Press release, Aclaris Therapeutics, JAN 20, 2021, View Source [SID1234574135]). In addition, Aclaris has granted to the underwriters a 30-day option to purchase up to 822,557 additional shares of common stock at the public offering price, less the underwriting discount. The gross proceeds from the offering to Aclaris are expected to be approximately $96.0 million, before deducting underwriting discounts and commissions and offering expenses, but excluding any exercise of the underwriters’ option. The offering is expected to close on or about January 22, 2021, subject to customary closing conditions.

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Cantor Fitzgerald & Co. and William Blair & Company, L.L.C. are acting as joint book-running managers for the offering. H.C. Wainwright & Co., LLC is acting as lead manager for the offering.

A shelf registration statement relating to this offering was filed with the Securities and Exchange Commission (SEC) on March 13, 2020 and declared effective by the SEC on April 29, 2020. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. A final prospectus supplement and accompanying prospectus will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 6th floor, New York, NY 10022; Email: [email protected]; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered 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.

On January 20, 2021 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that details of its plans to report fourth quarter 2020 financial results on February 3, 2021 (Press release, Ligand, JAN 20, 2021, View Source [SID1234574134]). Ligand’s CEO John Higgins, President and COO Matt Foehr and Executive Vice President and CFO Matt Korenberg will host the conference call.

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Fourth Quarter 2020 Earnings Conference Call

What:

Ligand conference call to discuss financial results and provide general business updates

Wednesday, February 3, 2021

Time:

8:30 a.m. Eastern time (5:30 a.m. Pacific time)

Webcast:

Live conference call webcast and replay accessible at www.ligand.com

On January 20, 2021 Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, reported that Jeff Wolf, Chief Executive Officer of Heat Biologics, will participate in a fireside chat at the B. Riley Securities Virtual Oncology Investor Conference (Press release, Heat Biologics, JAN 20, 2021, View Source [SID1234574130]).

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The Heat’s presentation will be webcast live at 11:30 a.m. EST on Thursday, January 21, 2021. The presentation will be open to registered conference attendees, institutional investors and investor relations professionals, who may register to view the live webcast at https://b-riley-oncology-investor-conference.events.issuerdirect.com/signup. After completion of the event, a replay of the presentation will be publicly available under the "Investors – News/Events" tab on the Heat Biologics website at www.heatbio.com.

On January 20, 2021 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported that the first patient has been dosed in a Phase 1 clinical trial evaluating FT-7051, a selective inhibitor of CBP/p300, a known co-activator of the androgen receptor (AR) in men with metastatic castration-resistant prostate cancer (mCRPC) (Press release, Forma Therapeutics, JAN 20, 2021, View Source [SID1234574129]).

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"While a patient with mCRPC may initially respond to standard anti-androgen therapies, a significant unmet need persists since nearly all patients ultimately become resistant to these treatments," said David N. Cook, Ph.D., chief scientific officer of Forma Therapeutics. "Initiating enrollment in this Phase 1 trial is an important step toward our goal of providing mCRPC patients with an additional therapeutic option to treat this severe illness."

Study Design

The Phase 1 trial is a multicenter, open-label evaluation of the safety and tolerability, preliminary anti-tumor activity (PSA and radiographic responses), and pharmacokinetics/pharmacodynamics (PK/PD) of FT-7051 in men with mCRPC who have progressed despite prior therapy and have been treated with at least one potent anti-androgen therapy. This is an adaptive trial design, intended to accelerate the escalation to potentially therapeutic doses and yield important safety information. More information about this trial may be accessed at Clinicaltrials.gov (identifier: NCT04575766).

About FT-7051

FT-7051 is a selective inhibitor of CREB-binding protein/E1A binding protein p300 (CBP/p300) and a co-activator of androgen receptor (AR). In prostate cancer cell lines in vitro, FT-7051 demonstrated inhibition of AR-dependent gene expression and reductions in androgen receptor expression. FT-7051 also demonstrated antiproliferative activity in AR-positive prostate cancer cell lines, including resistance variant AR-v7 positive models.

About Metastatic Castration-resistant Prostate Cancer

Prostate cancer is the second leading cause of cancer death for men in the U.S., and mCRPC is the most advanced form of this disease. Prostate cancer cell growth is driven by activity of the androgen receptor (AR). Primary treatments of mCRPC include therapies that reduce androgen synthesis or inhibit androgen binding and activation of the AR. Studies have shown that approximately 20% to 40% of mCRPC patients demonstrate primary resistance to enzalutamide and abiraterone acetate, two commonly used therapies, and virtually all patients who demonstrate initial clinical responses eventually acquire resistance. There are currently no approved therapies specifically aimed at mCRPC over-expressing AR variants, including AR-v7; therefore, a novel inhibitor of AR co-activator CBP/p300 may play a role in the suppression of mCRPC driven by AR aberrations.