NuCana Receives Orphan Drug Designation from the U.S. Food and Drug Administration for Acelarin® for the Treatment of Biliary Tract Cancer

On June 12, 2019 NuCana plc (NASDAQ: NCNA) reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the Company’s investigational drug, Acelarin (NUC-1031), for the treatment of biliary tract cancer (Press release, Nucana BioPharmaceuticals, JUN 12, 2019, View Source [SID1234537054]). Acelarin is a new chemical entity and is NuCana’s ProTide transformation of gemcitabine.

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"We are pleased to have received orphan drug designation from the FDA for Acelarin in biliary tract cancer," said Hugh Griffith, NuCana’s Founder and Chief Executive Officer. "There is a high unmet need for patients suffering from this cancer type. Our Phase Ib study of Acelarin combined with cisplatin showed an approximate doubling of the response rate expected with the standard of care, gemcitabine plus cisplatin, with several patients achieving significant reductions in their tumor volume as well as further tumor shrinkage over time. We believe Acelarin represents a potential significant advance in biliary tract cancer and we remain on track to open our global Phase III study in combination with cisplatin as a front-line treatment for patients with advanced biliary tract cancer in 2019."

Orphan drug designation is granted by the FDA to drugs that are defined as those intended for the treatment, prevention or diagnosis of rare diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug designation provides certain benefits and incentives that may include tax credits towards the cost of clinical trials and prescription drug user fee waivers.

About Biliary Tract Cancer

Biliary tract cancer is a form of cancer that develops in the bile duct system, which connects the liver, gallbladder, and small intestine, moving bile – a fluid that helps digest fats – to the small intestine. Approximately 178,000 new cases of biliary tract cancer are diagnosed each year worldwide, with more than 12,000 of those diagnoses in the United States.

The focus of ASCO 2019

The ASCO (Free ASCO Whitepaper) 2019 Annual Meeting bills itself as the world’s premier oncology event. 1stOncology provides all its users with a detailed guide to the new technologies, drugs, targets, start-ups, clinical results etc. emerging from this meeting. We’ve now made this guide open to all for 48h of free access, complete with all LBA’s from ASCO (Free ASCO Whitepaper).

This year we saw a major interest amongst Immunotherapies and Protein Kinase Inhibitors.

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Ayala Pharmaceuticals to Present at Raymond James Life Sciences and MedTech Conference

On June 11, 2019 Ayala Pharmaceuticals, Inc., a clinical-stage company developing medicines for cancers that are genetically defined, reported that Roni Mamluk, Ph.D., Chief Executive Officer of Ayala, will present at the Raymond James Life Sciences and MedTech Conference being held June 18-19 in New York, NY (Press release, Ayala Pharmaceuticals, JUN 11, 2019, View Source [SID1234536993]).

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Event: Raymond James Life Sciences and MedTech Conference
Date: Tuesday, June 18
Time: 1:15 p.m. ET
Location: New York, NY

The audio webcast of the presentation will be available live on the Wall Street Webcasting website at View Source The presentation will be accessible for 30 days.

Delmar Pharmaceuticals Updates The Terms Of Previously Announced Rights Offering

On June 11, 2019 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported that it has adjusted certain pricing information and key dates for its previously announced rights offering (Press release, DelMar Pharmaceuticals, JUN 11, 2019, View Source [SID1234536994]). The subscription period for the rights offering will now expire at 5:00 PM Eastern time on June 25, 2019, unless extended by the Company.

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The unit pricing remains $1,000 per unit, consisting of one share of Series C Convertible Preferred Stock with a stated value of $1,000 (and immediately convertible into shares of DelMar’s common stock) and warrants to purchase DelMar’s common stock. The Series C Convertible Preferred Stock conversion price will now be $3.10 and each unit will now consist of 209 warrants to purchase DelMar’s common stock at an adjusted exercise price of $3.10 per share. The warrants will still be exercisable for five (5) years after the date of issuance and shall be redeemable as described in the preliminary and final prospectus, when available.

If exercising subscription rights through a broker, dealer, bank or other nominee, rights holders should promptly contact their nominee and submit subscription documents and payment for the units subscribed for in accordance with the instructions and within the time period provided by such nominee. The broker, dealer, bank or other nominee may establish a deadline before June 25, 2019, by which instructions to exercise subscription rights, along with the required subscription payment, must be received.

All record holders of rights that wish to participate in the rights offering must deliver a properly completed and signed subscription rights statement, together with payment of the subscription price for both basic subscription rights and any over subscription privilege election for delivery no later than 5:00 PM Eastern Time on June 25, 2019 to the Subscription Agent:

By mail:

By hand or overnight courier:

Broadridge Corporate Issuer Solutions, Inc.

Attn: BCIS Re-Organization Dept.

P.O. Box 1317

Brentwood, New York 11717-0693

(888) 789-8409 (toll free)

Broadridge Corporate Issuer Solutions, Inc.

Attn: BCIS IWS

51 Mercedes Way

Edgewood, New York 11717

(888) 789-8409 (toll free)

Under the rights offering, DelMar distributed one non-transferable subscription right for each share of common stock and each participating warrant held on the record date. The subscription rights are exercisable for up to an aggregate of $1.9 million of units on a pro rata basis if subscriptions are received in excess of that threshold.

Holders who fully exercise their basic subscription rights will be entitled, if available, to subscribe for an additional amount of units that are not purchased by other holders, on a pro rata basis and subject to the $1.9 million aggregate offering threshold and other ownership limitations.

DelMar has engaged Maxim Group LLC and Dawson James Securities Inc. as co-dealer-managers in the rights offering. Questions about the rights offering or requests for copies of the preliminary and final prospectuses, when available, may be directed to Maxim Group LLC at 405 Lexington Avenue, New York, NY 10174, Attention Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission (the "SEC") and became effective on May 28, 2019, and is available on the SEC’s website located at View Source Additionally, a post-effective amendment to the registration statement was filed on June 10, 2019 for pricing and other adjustments discussed above. The rights offering is being made only by means of a written prospectus. A copy of the prospectus for the rights offering may be obtained, when available, from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention Syndicate Department, email: [email protected] or telephone (212) 895-3745. Investors may also obtain these documents at no cost by visiting the SEC’s website at View Source

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will 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 registration or qualification under the securities laws of any such state or jurisdiction.

Jounce Therapeutics to Present at Upcoming Investor Conferences in June

On June 11, 2019 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that Jounce management will present at two upcoming investor conferences (Press release, Jounce Therapeutics, JUN 11, 2019, View Source [SID1234536995]):

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Raymond James Life Sciences and MedTech Conferenceat 1:50 p.m. ET on Tuesday, June 18, 2019 in New York, NY
JMP Securities Life Sciences Conferenceat 11:00 a.m. ET on Wednesday, June 19, 2019 in New York, NY
A live webcast of each presentation will be available by visiting "Events and Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. A replay of each webcast will be archived for 30 days following the presentations.