Leap Therapeutics Announces Closing of Previously Announced Equity Financing

On January 7, 2020 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported the closing of its previously announced equity financing to issue 1,421,801 shares of newly designated Series A mandatorily convertible preferred stock to a lead institutional investor, at a price of $10.54 per share, and an aggregate of 1,137,442 shares of newly designated Series B mandatorily convertible preferred stock to BeiGene and Perceptive Advisors, at a price of $10.55 per share (Press release, Leap Therapeutics, JAN 7, 2020, View Source [SID1234552783]). The preferred stock price reflects a common stock equivalent price of $1.055 per share, the closing price for Leap’s common stock on the Nasdaq Global Market on the day of pricing, January 2, 2020 and, in the case of the Series A mandatorily convertible preferred stock, reflects a per share reduction equal to the exercise price of the pre-funded warrant issued upon conversion of the Series A mandatorily convertible preferred stock. The holder of Series A mandatorily convertible preferred stock also received a share of a newly designated special voting preferred stock that will entitle it to elect one member of Leap’s Board of Directors.

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Upon approval by the stockholders of Leap, the Series A mandatorily convertible preferred stock will automatically convert into pre-funded warrants to purchase 14,218,010 shares of common stock and the Series B mandatorily convertible preferred stock will automatically convert into 11,374,420 shares of common stock, plus that number of additional shares of common stock representing payment of an 8% per annum accruing dividend on each share of preferred stock as of the conversion date. Upon stockholder approval and conversion of the preferred stock, the investors will also receive warrants to purchase up to an equal number of shares of common stock at an exercise price of $2.11 per share. The aggregate gross proceeds to Leap from this offering are approximately $27 million, before deducting placement agent fees and estimated offering expenses payable by Leap, and excluding proceeds from the exercise of any warrants.

Raymond James & Associates, Inc. was the placement agent for the equity financing.

The securities sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from such registration requirements. Leap has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon conversion of the preferred stock and exercise of the warrants issued in the private placement.

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

Context Therapeutics to Present at Biotech Showcase 2020

On January 7, 2020 Context Therapeutics, a clinical-stage biopharmaceutical company dedicated to advancing medicines for hormone driven cancers, reported that chief executive officer Martin Lehr will deliver a corporate presentation at Biotech Showcase 2020, being held January 13-15, 2020, at the Hilton San Francisco Union Square in San Francisco (Press release, Context Therapeutics, JAN 7, 2020, View Source [SID1234552782]).

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During the presentation, Mr. Lehr will provide updates on Context’s lead clinical program, onapristone extended release (onapristone ER), including the Company’s ongoing Phase 2 study (ONWARD 220) evaluating onapristone ER alone in patients with progesterone receptor positive (PR+) rare ovarian and endometrial cancers, and pending combination trials in ER+,PR+,HER2- breast cancer.

Details for this presentation are as follows:

Time/Date: 4:30 p.m. PT on Tuesday, January 14, 2020

Location: Hilton San Francisco, Union Square

Room: Franciscan D (Ballroom Level)

To schedule a meeting with the Context management team, please email [email protected].

About Onapristone ER
Onapristone ER (onapristone extended release) is a potent and specific antagonist of the progesterone receptor that is orally administered. Currently, there are no approved therapies that selectively target PR+ cancers. Preliminary preclinical and clinical data suggest that onapristone ER has anticancer activity by inhibiting progesterone receptor binding to chromatin, downregulating cancer stem cell mobilization and blocking immune evasion. Onapristone ER is currently the subject of an ongoing Phase 2 clinical trial in progesterone receptor positive ovarian cancer. Additional Phase 2 clinical trials in breast and endometrial cancers will initiate in 2020. Onapristone ER is an investigational drug that has not been approved for marketing by any regulatory authority.

Avidity Biosciences Announces Presentation at the 38th Annual J.P. Morgan Healthcare Conference

On January 7, 2020 Avidity Biosciences (Avidity) reported that it will present at the 38th Annual J.P. Morgan Healthcare Conference being held January 13-16, 2020 in San Francisco, CA (Press release, Avidity Biosciences, JAN 7, 2020, View Source [SID1234552781]).

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Sarah Boyce, President and CEO of Avidity, will present an overview of the company’s novel approach to treating rare muscle disorders and other serious diseases using Avidity’s proprietary Antibody-Oligonucleotide Conjugates (AOCs). Avidity’s AOCs combine the tissue selectivity of monoclonal antibodies with the specificity of oligonucleotide-based therapeutics to modulate disease-related RNAs in many cell types and tissues. This presentation follows the close of a successful $100 million Series C in 2019 that will fund development activities and expansion of the Avidity platform to other tissues and organs.

Presentation details are below:

Date: Wednesday, January 15th, 2020
Time: 10:30 am PT
Location: The Westin St. Francis Hotel, 335 Powell Street, San Francisco, CA

Advaxis Announces FDA Clearance of IND for ADXS-504 for Treatment of Prostate Cancer

On January 7, 2020 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the initiation of a Phase 1 clinical study of ADXS-504, the Company’s ADXS-HOT candidate for prostate cancer (Press release, Advaxis, JAN 7, 2020, View Source [SID1234552779]). ADXS-HOT is the Company’s off-the-shelf neoantigen clinical program targeting hotspot mutations that currently includes over ten cancer-type specific drug constructs in various stages of development.

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"With encouraging proof-of-concept data within our neoantigen program, we believe the ADXS-HOT program has potential to provide off-the-shelf, neoantigen targeted immunotherapies to a broad patient population," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "We are proud of the progress we have made to date with our HOT program, which includes advancing the clinical development of ADXS-503, our candidate for non-small cell lung cancer, while also seeking to launch our next clinical program, ADXS-504, in prostate cancer. We look forward to presenting immunogenicity and safety data from the first cohort from our lung program later this quarter."

Clovis Oncology Announces Product Revenues for the Fourth Quarter and Full Year 2019

On January 7, 2020 Clovis Oncology, Inc. (NASDAQ:CLVS) reported its preliminary, unaudited revenues for the fourth quarter and full year ended December 31, 2019 (Press release, Clovis Oncology, JAN 7, 2020, View Source [SID1234552778]). The financial information presented in this news release may be adjusted as a result of completion of customary quarterly review and audit procedures.

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Unaudited preliminary results include:

$38.3-$39.3M in Rubraca product revenues for the fourth quarter of 2019 compared to $37.6M for Q3 2019 and $30.4M for Q4 2018

$142.0-$143.0M in Rubraca product revenues for the FY2019 compared to $95.4M for FY2018

Clovis plans to discuss these results with investors this week at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco.

"We are very pleased with our sales performance in the fourth quarter and the momentum it provides us going into this year," said Patrick J. Mahaffy, CEO and President of Clovis Oncology. "In mid-November 2019, we submitted the supplemental New Drug Application (sNDA) for Rubraca in BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer, and also during the quarter announced the first reported human experience of FAP-2286 and launched Rubraca in England and Italy. With this progress, we are looking forward to an eventful 2020. Key milestones include additional EU country ovarian cancer launches for Rubraca, a potential U.S. Rubraca launch in prostate cancer, initial data for lucitanib combination studies, and a planned IND filing for FAP-2286 in the second half of the year."

Clovis Oncology to Present at 38th Annual J.P. Morgan Healthcare Conference on January 13, 2019

Clovis’ President and CEO, Patrick J. Mahaffy, will present at the 38th Annual J.P. Morgan Healthcare Conference to be held at the Westin St. Francis hotel in San Francisco on Monday, January 13 at 10:00 a.m. PT. A live webcast of the presentation and Q&A session can be accessed through the investor relations section of the Company’s website at clovisoncology.com. Following the live presentations, replays of the webcasts will be available on the Company’s website for 30 days.

Fourth Quarter and Full Year 2019 Financial Results Release Planned for February 24, 2020

The Company plans to report financial results for the fourth quarter and full year ended December 31, 2019 on Monday, February 24, 2020, after the close of the U.S. financial markets. Clovis’ senior management will host a conference call and live audio webcast at 4:30 p.m. ET to discuss the Company’s results in greater detail.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, and lung cancers. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

In the EU, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. This expands rucaparib’s indication beyond its initial marketing authorization in the EU granted in May 2018 and with this label expansion, rucaparib is now available to patients regardless of their BRCA mutation status. Rubraca is also approved in the EU for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

Rubraca is an unlicensed medical product outside of the U.S. and the EU.

About Lucitanib

Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/b) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs reverses this immunosuppression and can augment response to immunotherapy.

Lucitanib is an unlicensed medical product.

About FAP-2286

FAP-2286 is a preclinical candidate discovered by 3B Pharmaceuticals under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein alpha (FAP). FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas. Clovis will conduct the global clinical trials and holds U.S. and global rights, excluding Europe.

FAP-2286 is an unlicensed medical product.