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Heron Therapeutics to Present at the Stifel 2019 Healthcare Conference

On November 13, 2019 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that Barry Quart, Pharm.D., President and Chief Executive Officer of Heron Therapeutics, will present at the Stifel 2019 Healthcare Conference on Tuesday, November 19, 2019 at 8:35 a.m. EST at the Lotte New York Palace hotel (Press release, Heron Therapeutics, NOV 13, 2019, View Source [SID1234551137]).

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A live webcast of the presentation will be available on the Company’s website at www.herontx.com in the Investor Resources section. A replay of the presentation will be archived on the site for 60 days.

Xencor to Present at Upcoming Investor Conferences

On November 13, 2019 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer, autoimmune disease, asthma and allergic diseases, reported that company management will participate in two upcoming conferences (Press release, Xencor, NOV 13, 2019, View Source [SID1234551136]):

Jefferies 2019 London Healthcare Conference
Date: Wednesday, November 20, 2019
Presentation Time: 3:20 p.m. GMT
Location: London
Piper Jaffray 31st Annual Healthcare Conference
Date: Tuesday, December 3, 2019
Presentation Time: 8:00 a.m. EST
Location: New York
Live webcasts of these presentations will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. A replay of the events will be posted on the Xencor website approximately one hour after the live events and will be available for 30 days following the presentations.

DCprime to Present Long-term Follow-up and Survival Data for Lead Relapse Vaccine Candidate DCP-001 in High-Risk AML and MDS Patients

On November 13, 2019 DCprime, the front-runner in the field of relapse vaccines, reported the presentation of updated clinical results for its lead product DCP-001 at the upcoming 61st Annual Meeting and Exposition of the American Society of Hematology (ASH) (Free ASH Whitepaper), December 7-10, 2019, Orlando, FL, USA (Press release, DCPrime, NOV 13, 2019, View Source [SID1234551134]). The long-term follow-up and survival data generated in the Phase 1 clinical trial with DCP-001 in patients with high-risk Acute myeloid leukemia (AML) or Myelodysplastic syndromes (MDS) demonstrate the potential to prolong relapse-free survival (RFS) and overall survival (OS) using an allogeneic, off-the-shelf cell-based vaccine in the post-remission setting. The full abstract is available via the ASH (Free ASH Whitepaper) Annual Meeting’s website.

"Our deep dive into the Phase 1 clinical trial results, which we will present in full at the upcoming ASH (Free ASH Whitepaper) Annual Meeting, confirms our thinking on when and how our cell-based vaccine DCP-001 can have the greatest impact on patients in the post-remission setting. Treated early and while still in remission, vaccination with DCP-001 can strengthen the immune system’s ability to sustainably control residual disease with one patient surpassing an overall survival of 6 years since inclusion in the trial," commented Erik Manting PhD, CEO of DCprime.

"The Phase 1 data have evolved since we last updated the clinical community and provide a strong rationale to further investigate the relapse vaccine approach. With the progress made in the clinical community to implement the assessment of minimal residual disease, or MRD, we have designed the currently active Phase 2 clinical trial for DCP-001 to look even more specifically into DCP-001’s ability to support a long-term immune control of the tumour," commented Jeroen Rovers MD PhD, CMO of DCprime.

In the Phase 1 clinical trial, seven out of twelve patients responded to treatment, the other five patients showed progressive disease. These five patients had relapsed or refractory disease at the start of vaccination with detectable circulating peripheral blasts. Moreover, they were vaccinated after induction and consolidation therapy with a median time between diagnosis and first vaccination of 611 days compared to 240 for the responding patients. Of the latter, all were in complete remission (CR) (n=5) or had morphologic marrow blast counts <10% (n=2) at the start of vaccination.

While the median overall survival (OS) for the non-responders was 144 days, the median OS for the responding patients was 1,090 days, with a longest survivor of 2,160 days after vaccination. The median relapse-free survival in those patients who were in CR at vaccination was 420 days, ranging up to 1,849 days in the longest survivor. Patients in the responding group all had intermediate or high-risk disease, based on cytogenetics, indicating their poor prognosis based on the ELN risk classification for AML or the Revised International Prognostic Scoring System (IPSS-R) for MDS. In the responder group, two patients died early in complete remission due to infection at day 90 and 184, respectively. More details on patient characteristics and cytogenetics will be presented by Dr. Luca Janssen and Prof. Dr. Arjan van de Loosdrecht (PI) at ASH (Free ASH Whitepaper).

DCprime’s lead cancer relapse vaccine candidate DCP-001 is generated by transforming a proprietary leukemic cell, DCOne, into a whole cell-based cancer vaccine. Whereas the parental leukemic cells are poorly immunogenic, DCP-001 is highly immunogenic, making it an attractive cancer vaccine candidate. DCP-001 is currently being evaluated in an international Phase II trial in AML patients in complete remission and with presence of MRD who are ineligible for hematopoietic stem cell transplantations. First results of the (ADVANCE-II) trial are expected to become available in 2020.

Agios Announces Closing of Public Offering and Full Exercise of Option to Purchase Additional Shares

On November 13, 2019 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO) reported the closing of its previously announced underwritten public offering of common stock, including the exercise in full by the underwriters of their option to purchase an additional 1,237,500 shares at the public offering price of $31.00 per share (Press release, Agios Pharmaceuticals, NOV 13, 2019, View Source [SID1234551132]). The exercise of the option to purchase additional shares brought the total number of shares of common stock sold by Agios to 9,487,500 shares and increased the amount of gross proceeds, before underwriting discounts and expenses, to approximately $294.1 million.

J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC and Cowen and Company, LLC acted as joint book-running managers for the offering.

The shares were offered by Agios pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission ("SEC"). The offering was made only by means of a prospectus and prospectus supplement that form a part of the registration statement. The final prospectus supplement relating to, and describing the terms of, the offering has been filed with the SEC and is available on the SEC’s web site at www.sec.gov.

Copies of the final prospectus supplement and the accompanying prospectus relating to this offering can be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 866-803-9204; Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 866-471-2526, facsimile: 212-902-9316, e-mail: [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or 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.

Applied DNA Sciences Announces Pricing of Upsized $12.0 Million Underwritten Public Offering

On November 13, 2019 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company") a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing for product authenticity, traceability solutions and nucleic acid-based biotherapeutic research, reported the pricing of an underwritten public offering of 2,285,000 shares of its common stock and warrants to purchase up to an aggregate of 2,285,000 shares of common stock (Press release, Applied DNA Sciences, NOV 13, 2019, View Source [SID1234551131]). Each share of common stock is being sold together with one warrant to purchase one share of common stock at a combined effective price to the public of $5.25 per share and accompanying warrant. Gross proceeds, before underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $12.0 million, not including any amounts received upon exercise of the warrants.

The warrants will be immediately exercisable at a price of $5.25 per share of common stock and will expire five years from the date of issuance. The shares of common stock and the accompanying warrants, can only be purchased together in the offering, but will be issued separately. The offering is expected to close on or about November 15, 2019, subject to customary closing conditions.

Maxim Group LLC is acting as the book-running manager and Joseph Gunnar & Co. LLC is acting as a co-manager in connection with the offering.

Applied DNA has granted the underwriters a 45-day option to purchase up to an additional 342,750 shares of common stock and/or warrants to purchase up to 342,750 shares of common stock, at the public offering price less discounts and commissions.

The Securities and Exchange Commission (the "SEC") declared effective a registration statement on Form S-1 (File No. 333-233830) relating to these securities on November 13, 2019. A final prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at View Source The offering is being made only by means of a prospectus forming part of the effective registration statement. Electronic copies of the prospectus relating to this offering, when available, may be obtained from Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at (212) 895-3745. Before investing in this offering, interested parties should read in its entirety the registration statement that the Company has filed with the SEC, which provides additional information about the Company and this offering.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may 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.