Heat Biologics Completes Enrollment in Phase 2 Non-Small Cell Lung Cancer Trial

On July 9, 2019 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing therapies designed to activate a patient’s immune system against cancer, reported it has completed recruitment for enrollment in its Phase 2 study investigating HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo) or Merck’s pembrolizumab (Keytruda) (Press release, Heat Biologics, JUL 9, 2019, View Source [SID1234537431]). In total, approximately 120 patients have been enrolled in the trial.

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Lori McDermott, Heat’s VP of Clinical Development, said, "We are pleased to report that our Phase 2 enrollment targets were achieved on schedule. Last month, we reported promising interim results from the study showing that the addition of HS-110 to nivolumab may restore anti-tumor activity in patients whose disease has progressed after checkpoint inhibitor therapy. These results continue to support our mechanistic hypothesis that the broad, T-cell mediated immune response activated by HS-110 may improve clinical outcomes for those patients who are least likely to respond to a checkpoint inhibitor, including those whose disease has worsened during or after checkpoint inhibitor therapy."

Jeff Wolf, Heat’s CEO, commented, "We are pleased to achieve this important milestone and delighted with the patient mix which includes those whose disease has progressed after prior checkpoint inhibitor treatment failure. We look forward to reporting additional results later this year."

Genmab Commences Public Offering of American Depositary Shares (ADSs) in the United States

On July 9, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that it has commenced a public offering (the "Offering") of 27,800,000 ADSs (the "Firm ADSs"), representing 2,780,000 of its ordinary shares, pursuant to a registration statement on Form F-1, as amended, filed with the U.S. Securities and Exchange Commission (the "SEC") and has today filed a preliminary prospectus with the SEC in connection with the Offering (Press release, Genmab, JUL 9, 2019, View Source [SID1234537430]). In addition, Genmab has decided to grant the underwriters a 30-day option to purchase up to 4,170,000 additional ADSs, representing 417,000 ordinary shares (the "Option ADSs").

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ADSs are U.S. dollar-denominated negotiable instruments represented by American Depositary Receipts ("ADRs") issued by a depositary bank that facilitate U.S. trading and investment in shares of non-U.S. companies. The ADSs will be issued under Genmab’s existing ADR program, which is administered by Deutsche Bank Trust Company Americas. Each ADS represents one-tenth of one ordinary share of Genmab.

Genmab intends to use the net proceeds from the Offering to continue the development of its proprietary product candidates, to continue its pre-commercial activities, to continue building its commercial capabilities and to advance its earlier stage product candidates. The expected use of the net proceeds from the Offering represents Genmab’s intentions based upon its current plans and business conditions, which could change in the future as Genmab’s plans and business conditions evolve. Genmab cannot predict with certainty all of the particular uses of the net proceeds of the Offering or the amounts that it will actually spend on the uses set forth above.

Genmab’s ordinary shares are currently listed on Nasdaq Copenhagen under the symbol "GEN" and an application has been made to list the ADSs on the Nasdaq Global Select Market in the United States under the symbol "GMAB." It is expected that the ordinary shares underlying the ADSs will be admitted to trading and official listing on Nasdaq Copenhagen upon issuance. The filing of the preliminary prospectus and the application for listing on the Nasdaq Global Select Market has no implications for Genmab’s listing on Nasdaq Copenhagen in Denmark.

Genmab’s board of directors (the "Board") has in accordance with article 4A of Genmab’s articles of association exercised an authorization granted by Genmab’s annual general meeting held on April 10, 2018, to increase Genmab’s share capital by issue of up to 3,197,000 new shares underlying the ADSs (covering both the Firm ADSs and Option ADSs), of which 2,780,000 new shares (the "Firm Shares") will cover the Firm ADSs and up to 417,000 new shares will cover the Option ADS (the "Option Shares").

Pricing of the Offering is expected to take place during the week commencing July 15, 2019.

If all the Firm Shares and all the Option Shares are subscribed for, the Firm Shares will represent 4.3% of Genmab’s share capital and the Option Shares will represent 0.6%.

The Board has not yet finally decided whether to complete the Offering and whether to proceed with the listing. Even if the Board determines to complete the Offering, the Offering may not be consummated. Neither the timing, number of Firm ADSs and Option ADSs, number of underlying ordinary shares of Genmab nor the price of the ADSs and thereby the subscription price of the underlying ordinary shares have been finally determined. If consummated, the final price per ADS (and thereby the subscription price per underlying share) will be determined following a book-building process.

A registration statement relating to the ADSs referred to herein has been filed with the SEC but has not yet been declared effective. These ADSs may not be sold nor may offers to buy these ADSs be accepted prior to the time such registration statement becomes effective. The securities referred to in this Company Announcement are to be offered only by means of a prospectus.

BofA Merrill Lynch, Morgan Stanley and Jefferies are acting as joint book-running managers for the proposed Offering. Guggenheim Securities and RBC Capital Markets are acting as joint lead-managers and Danske Markets, H.C. Wainwright & Co. and Kempen are acting as co-managers for the proposed Offering.

A copy of the preliminary prospectus relating to the Offering may be may be obtained from BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email: [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone: 1-877-821-7388, or by email: [email protected]. Copies of the preliminary prospectus related to the Offering are also available at www.sec.gov. No Danish prospectus will be issued or offered.

This Company Announcement does not constitute an offer to sell nor a 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.

Exact Sciences to host annual meeting, second-quarter 2019 results webcasts and calls

On July 9, 2019 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company will host webcasts and conference calls of its annual stockholders meeting and its second-quarter 2019 financial results (Press release, Exact Sciences, JUL 9, 2019, View Source [SID1234537429]).

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Annual Meeting of Stockholders Webcast & Conference Call Details

Date:

Thursday, July 25, 2019

Time:

11 a.m. ET, 10 a.m. CT

Webcast:

The live webcast can be accessed at www.exactsciences.com

Telephone:

Domestic callers, dial 877-201-0168

International callers, dial +1 647-788-4901

Access code for both domestic and international callers: 2171853

Exact Sciences Corporation Logo (PRNewsfoto/EXACT SCIENCES CORP)
The company plans to release its second-quarter 2019 financial results after the close of the U.S. financial markets on July 30, 2019. Following the release, company management will host a webcast and conference call at 5 p.m. ET to discuss financial results and business progress.

Second-Quarter 2019 Webcast & Conference Call Details

Date:

Tuesday, July 30, 2019

Time:

5 p.m. ET, 4 p.m. CT

Webcast:

The live webcast can be accessed at www.exactsciences.com

Telephone:

Domestic callers, dial 877-201-0168

International callers, dial +1 647-788-4901

Access code for both domestic and international callers: 8288326

An archive of the webcast will be available at www.exactsciences.com. A replay of the annual meeting and second-quarter conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The annual meeting replay can be accessed with the code 2171853. The access code for the second-quarter replay is 8288326. The webcast, conference call and replays are open to all interested parties.

CytomX Therapeutics Announces Second Target Selection and Program Initiation with AbbVie Under Ongoing, Multi-Program Strategic Oncology Collaboration

On July 9, 2019 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported the second target selection by its partner AbbVie under the companies’ 2016 Discovery Collaboration and Licensing Agreement to discover and develop Probody drug conjugates ("PDC") (Press release, CytomX Therapeutics, JUL 9, 2019, View Source [SID1234537428]). The target selection triggers a $10 million payment to CytomX from AbbVie. This is the second of two research targets available to AbbVie under the agreement. The companies are also advancing a clinical-stage asset, CX-2029, under a global co-development and licensing agreement.

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"The initiation of this additional program with AbbVie and the associated milestone payment reflects the growing strength of clinical proof of concept CytomX has achieved in support of the Probody platform. It also further underscores the potential of our unique technology to make meaningful differences for cancer patients. We are excited to start this new program with our AbbVie colleagues," said Sean McCarthy D.Phil., president, chief executive officer and chairman of CytomX Therapeutics.

About the Discovery Collaboration and Licensing Agreement

Under the terms of the April 2016 Discovery Collaboration and Licensing Agreement, AbbVie receives exclusive worldwide rights to develop and commercialize PDCs against up to two targets, which were selected in March 2017 and June 2019. In each case, CytomX is responsible for certain research and pre-clinical activities with AbbVie leading pre-clinical and clinical development and commercialization of products arising from the collaboration. CytomX received an upfront payment of $10 million for each target selection and is eligible to receive up to $275 million in development, regulatory and commercial milestone payments and royalties in the high single to low teens from commercial sales of any resulting PDCs.

About the CX-2029 Co-Development and Licensing Agreement

Pursuant to the April 2016 Co-Development and Licensing Agreement, CytomX and AbbVie are also co-developing CX-2029, a PDC against CD71. CD71, also known as transferrin receptor 1 ("TfR1"), is a cell surface protein that is essential for iron uptake in dividing cells, is highly expressed in a number of solid and hematologic cancers and has attractive molecular properties for efficient delivery of cytotoxic payloads to tumor cells. CytomX received an upfront payment of $20 million, is eligible to receive up to $470 million in development, regulatory and commercial milestone payments, pending the achievement of pre-determined outcomes. CytomX is responsible for research activities and leading early-stage clinical development of CX-2029. AbbVie will lead global commercial activities with CytomX eligible to receive a profit share in the U.S. and tiered double-digit royalties on net product sales outside of the U.S. CytomX retains an option to co-promote in the U.S. CytomX initiated PROCLAIM-CX-2029, a Phase 1 dose escalation trial, in June 2018.

BioNTech Raises USD 325 Million in an Upsized Series B Financing to Further Advance Individualized Immuno-Oncology Pipeline

On July 9, 2019 BioNTech SE, a clinical-stage biotechnology company focused on patient-specific immunotherapies for the treatment of cancer and other serious diseases, reported the completion of a USD 325 million Series B financing round, making it one of the largest single private funding rounds for a biotechnology company in European history (Press release, BioNTech, JUL 9, 2019, View Source [SID1234537427]). The fund raising was upsized and was led by Fidelity Management & Research Company with participation from both new and existing investors, including Redmile Group, Invus, MiraeAsset Financial Group, Platinum Asset Management, Jebsen Capital, Steam Athena Capital, BVCF Management and the Struengmann Family Office. Two-thirds of the funding came from new investors. The proceeds of the financing will support the continued advancement of BioNTech’s therapeutics pipeline and manufacturing infrastructure.

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"BioNTech has executed on a highly disruptive business strategy that aims to change the treatment paradigm for cancer patients," said Helmut Jeggle, Chairman of BioNTech. "We value the continued participation of our existing investors and welcome new investors to this powerful global syndicate representing North America, Asia and Europe."

Prof. Ugur Sahin, CEO and Co-Founder of BioNTech added: "This financing round is a significant milestone that recognizes our scientific and initial clinical track record to date. With our ongoing focus on bringing together transformative technologies, it is exciting to have the support from high-technology investors who see the accelerating convergence of biology with bioinformatics, robotics and artificial intelligence as an opportunity to develop more precise, efficacious and cost-effective individualized immunotherapies."

The funding follows the Series A financing of USD 270 million announced in January 2018, led by Redmile Group. The previous financings have enabled BioNTech to advance a pipeline of seven product candidates in eight ongoing clinical trials, to establish a second GMP manufacturing license for production of its individualized neoantigen specific immunotherapies and to expand its antibody platform, most recently, through the acquisition of a Phase I/IIa program against pancreatic cancer from MabVax Therapeutics Inc. In conjunction with the MabVax Therapeutics acquisition of assets, the company has also recently established its US research and development facility in San Diego, California.