On March 28, 2019 Nordic Nanovector ASA (OSE: NANO) reported that members of its senior management team will participate and present at the following upcoming investor conferences during April (Press release, Nordic Nanovector, MAR 28, 2019, View Source [SID1234553454]):

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DNB’s 15th Annual Small & Medium Enterprises (SME) Conference in Oslo on 4 April
The 12th Kempen Life Sciences Conference in Amsterdam on 16-17 April
The company presentation will be available on the investors and media page on the first day of the conference.

For further information, please contact:

IR enquiries

Malene Brondberg, VP Investor Relations and Corporate Communications

Cell: +44 7561 431 762

Email: [email protected]

Media Enquiries

Mark Swallow/David Dible (Citigate Dewe Rogerson)

Tel: +44 207 638 9571

Email: [email protected]

On March 28, 2019 ESSA Pharma Inc. (TSX-V: EPI;Nasdaq: EPIX), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported the nomination of EPI-7386 as the lead clinical candidate for the treatment of metastatic castration-resistant prostate cancer ("mCRPC") (Press release, ESSA, MAR 28, 2019, View Source [SID1234539332]). EPI-7386 is a novel drug candidate that inhibits the N-terminal domain of the androgen receptor. Through this novel mechanism of action, EPI-7386 displays activity in vitro in numerous prostate cancer models including models where current antiandrogens are inactive. Compared to ESSA’s first generation compound, ralaniten acetate, EPI-7386 is significantly more potent, metabolically stable and more effective in preclinical studies. In addition, EPI-7386 has demonstrated a favorable tolerability profile in all animal studies of the compound conducted to date. IND-enabling studies are currently underway, and ESSA expects to enter clinical studies with EPI-7386 in the first quarter of 2020.

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As recently presented at the 2019 Genitourinary Cancers Symposium, EPI-7386 demonstrates in vitro cellular potency against the androgen receptor in a similar range to the leading antiandrogens, bicalutamide and enzalutamide. Importantly, EPI-7386 shows activity in numerous in vitro models of antiandrogen resistance driven by the AR-V7 splice variant of the androgen receptor while enzalutamide is inactive. In addition, EPI-7386 is metabolically stable in liver microsome and hepatocyte preparations and shows a favorable pharmacokinetic profile in mice, exhibiting significant exposure and a long half-life. Lastly, EPI-7386 (60 mg/kg) displayed comparable activity to enzalutamide (30 mg/kg) in a prostate cancer LNCaP xenograft mouse model in which enzalutamide mouse exposure was estimated to be twice the clinical exposure of enzalutamide in humans.

"We are excited to announce the nomination of EPI-7386 as our lead clinical candidate for the treatment of mCRPC," said David Parkinson, President and Chief Executive Officer of ESSA. "EPI-7386 represents a novel approach to targeting the androgen receptor, one of the most validated targets in oncology. We look forward to bringing this novel drug candidate to patients with mCRPC who have no other treatment options."

On March 28, 2019 Forty Seven Inc. (NASDAQ:FTSV), a clinical-stage, immuno-oncology company focused on developing therapies to activate macrophages in the fight against cancer, reported financial results for the fourth quarter and full year ended December 31, 2018 and provided a business update (Press release, Forty Seven, MAR 28, 2019, View Source [SID1234534785]).

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"Our ultimate goal at Forty Seven is to enable more patients to defeat their cancers by delivering a new class of therapies, which take advantage of the innate immune system as a powerful therapeutic target," said Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of Forty Seven, Inc. "In 2018, we made important strides toward achieving this goal, announcing proof-of-concept data for 5F9 in a range of difficult-to-treat cancers and demonstrating its best-in-class safety profile, which is enabled by our proprietary priming and maintenance dosing regimen. In addition, we expanded our pipeline with FSI-189 and FSI-174, reinforced our intellectual property portfolio, and strengthened our corporate position, hiring Ann Rhoads as Chief Financial Officer, adding Kristine Ball and Ian Clark to our Board of Directors, creating a world-class Scientific Advisory Board and successfully completing our initial public offering.

Dr. McCamish continued, "As we move into 2019, we are building on this forward momentum, with a particular focus on executing our clinical plans. We expect to generate meaningful data across multiple programs this year, beginning with updated clinical data from our Phase 1b/2 trial of 5F9 plus rituximab in r/r NHL and our Phase 1b trial of 5F9 as a monotherapy and in combination with azacitidine in AML and MDS, all expected in the second quarter. We are also advancing four additional trials with 5F9 and expect to provide updated data in ovarian and colorectal cancer in the fourth quarter, while conducting investigational new drug-application enabling studies for FSI-189, an anti-SIRPα antibody, and FSI-174, an anti-cKIT antibody."

Fourth Quarter and Recent Business Highlights:

Pipeline:

In January 2019, Forty Seven announced FSI-174, an anti-cKIT antibody, as its third development candidate. Forty Seven plans to develop FSI-174 in combination with anti-CD47 antibodies as a non-toxic transplant conditioning regimen, as well as a treatment for targeted hematologic malignancies.

In December 2018, Forty Seven presented preclinical data at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, providing additional mechanistic insight into why its proprietary 5F9 priming and maintenance dosing strategy mitigates the on-target anemia caused by the clearance of aged red blood cells (RBCs). The data show that the initial priming dose of 5F9 results in a near complete loss of CD47 on surviving, younger RBCs, making these cells less susceptible to phagocytosis and decreasing the risk of CD47 antibody-induced anemia during subsequent maintenance dosing.

O: 650-352-4150 F: 650-618-2308 W: fortyseveninc.com A: 1490 O’Brien Drive, Suite A, Menlo Park, CA 94025, United States

Helping Patients Defeat Their Cancer

Also at ASH (Free ASH Whitepaper), Forty Seven presented new preclinical data supporting the development of 5F9 and azacitidine for the treatment of AML. The data show that the combination of 5F9 and azacitidine increases the phagocytic elimination of AML blast cells by human macrophages in vitro, enhances clearance of AML in vivo, and prolongs survival compared to single-agent treatment with either 5F9 or azacitidine alone.

In November 2018, Forty Seven announced that proof-of-concept data from the Phase 1b portion of its Phase 1b/2 clinical trial evaluating 5F9 in combination with rituximab in patients with r/r NHL were published in the New England Journal of Medicine.

Key Upcoming Milestones:

The company expects to achieve the following milestones by the end of 2019:

Report data from the Phase 1b/2 trial of 5F9 in combination with rituximab in patients with r/r NHL, including safety, efficacy and duration of response across various dosing cohorts, in the second quarter.

Report data from the Phase 1b trial of 5F9 as a monotherapy and in combination with azacitidine in patients with AML and MDS, including safety and initial efficacy data, in the second quarter.

Report data from the Phase 1b trial of 5F9 in combination with avelumab in patients with ovarian cancer in the fourth quarter.

Report data from the Phase 1b trial of 5F9 in combination with cetuximab in patients with colorectal cancer in the fourth quarter.

Report preclinical data and complete IND-enabling studies for FSI-174 in the second half.

Completing IND-enabling studies for FSI-189 in the second half.

Fourth Quarter and Full Year 2018 Financial Results:

Cash Position: As of December 31, 2018, cash, cash equivalents and short-term investments were $139.0 million, as compared to $88.1 million as of December 31, 2017. This increase reflects net proceeds of $116.3 million from Forty Seven’s initial public offering of common stock, which closed in July 2018. The company expects that its cash, cash equivalents and short-term investments will fund operating expenses and capital expenditure requirements through the first half of 2020.

R&D Expenses: R&D expenses were $13.9 million for the fourth quarter of 2018 and $56.7 million for the full year ended December 31, 2018, as compared to $10.0 million for the fourth quarter of 2017 and $37.2 million for the full year ended December 31, 2017. This increase was primarily due to an increase in third party costs associated with the continued advancement of the company’s clinical development efforts, an increase in personnel-related costs, including stock-based compensation, and non-recurring upfront payments of $8.8 million associated with two licensing deals. This increase was partially offset by $5.3 million in grant funding and cost sharing from the California Institute of Regenerative Medicine, the Leukemia and Lymphoma Society, and Merck KGaA.

G&A Expenses: G&A expenses were $3.8 million for the fourth quarter of 2018 and $15.4 million for the full year ended December 31, 2018, as compared to $2.6 million for the fourth quarter of 2017 and $8.1 million for the full year ended December 31, 2017. This increase was primarily due to an increase in personnel-related costs and expenses incurred in connection with operating as a public company.

Net Loss: Net loss was $17.2 million for the fourth quarter of 2018 and $70.4 million for the full year ended December 31, 2018, or a net loss per share of $0.56 and $3.75, respectively, as compared to $12.3 million for the fourth quarter of 2017 and $44.9 million for the full year ended December 31, 2017, or a net loss per share of $1.88 and $6.94, respectively.

O: 650-352-4150 F: 650-618-2308 W: fortyseveninc.com A: 1490 O’Brien Drive, Suite A, Menlo Park, CA 94025, United States

Helping Patients Defeat Their Cancer

Conference Call Information:

Forty Seven will host a live conference call and webcast at 4:30 p.m. ET today to discuss fourth quarter and full year 2018 financial results and recent business activities. The conference call may be accessed by (866) 953-0780 (domestic) or (630) 652-5854 (international) and referring to conference ID 1089506. A webcast of the conference call will be available in the Investors section of the Forty Seven website at View Source The archived webcast will be available on Forty Seven’s website approximately two hours after the conference call and will be available for 30 days following the call.

On March 28, 2019 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported the pricing of an underwritten public offering of 4,054,054 shares of its common stock at a public offering price of $74.00 per share, before underwriting discounts and commissions (Press release, Blueprint Medicines, MAR 28, 2019, View Source [SID1234534760]). In addition, Blueprint Medicines has granted the underwriters a 30-day option to purchase up to an additional 608,108 shares of its common stock at the public offering price, less underwriting discounts and commissions. All shares of common stock were offered by Blueprint Medicines.

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Goldman Sachs & Co. LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering. Guggenheim Securities, LLC and Wedbush Securities Inc. are acting as co-lead managers for the offering. The offering is expected to close on or about April 2, 2019, subject to the satisfaction of customary closing conditions.

A registration statement on Form S-3 (File No. 333-216573) relating to these securities has been previously filed with the Securities and Exchange Commission (SEC) and has become effective. This press release shall not constitute an offer to sell or a 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.

The offering will be made only by means of a prospectus. A preliminary prospectus supplement describing the terms of the offering has been filed with the SEC and forms a part of the effective registration statement. A copy of the final prospectus supplement relating to the offering will be filed with the SEC and may be obtained, when available, from Goldman Sachs & Co. LLC by mail at Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, by fax at (212) 902-9316, or by email at [email protected], or from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (631) 274-2806, or by fax at (631) 254-7140.

On March 28, 2019 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell product candidates, reported full year 2018 consolidated financial results prepared in accordance with IFRS (Press release, Celyad, MAR 28, 2019, View Source [SID1234534759]).

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Christian Homsy, CEO of Celyad: "In 2018, we identified several significant opportunities to drive long-term growth by focusing our clinical pipeline on the development of CAR-T cell product candidates. This includes the ongoing program for our lead product candidate CYAD-01 as well as our non-gene edited allogeneic candidate CYAD-101. Following encouraging preliminary data from the THINK trial evaluating CYAD-01 as a monotherapy for the treatment of relpased / refactory acute myeloid leukemia (r/r AML) patients, our clinical hematological program for CYAD-01 now includes multiple approaches for evaluating CYAD-01 including the THINK schedule optimization cohorts as well as our DEPLETHINK trial. We look forward to providing clinical updates from both the Phase 1 THINK and DEPLETHINK trials throughout 2019."

"In addition, we have advanced our shRNA platform to design novel preclinical CAR-T product candidates including our next-generation NKG2D-based CAR-T, CYAD-02, and our CYAD-200 series of non-gene edited allogeneic CAR-T candidates. We look forward to advancing multiple shRNA-based CAR-T product candidates towards the clinic in 2020."

Full Year 2018 and Recent Business Highlights

CYAD-01 – Autologous NKG2D-based CAR-T
Hematologic malignancies (r/rAML/MDS)

THINK Phase 1 trial, evaluating CYAD-01 without preconditioning chemotherapy, showed 40% (four out of ten) of patients with AML/MDS achieved a complete response.

Further development to assess a more frequent dosing schedule of CYAD-01 without preconditioning chemotherapy for the treatment of r/r AML is ongoing.

Cohort 1 of the DEPLETHINK Phase 1 trial, which is anopen-label, dose-escalation trial with a single injection of CYAD-01 following standard CyFlu preconditioning, demonstrated that CYAD-01 is well-tolerated, with no dose-limiting toxicity or treatment-related grade 3 or above adverse events (AEs) observed in patients with r/r AML.

Solid tumors (mCRC):

The concurrent treatment of CYAD-01 with FOLFOX chemotherapy in the first cohort of the trial was well tolerated, with no occurrence of serious AEs (SAEs) nor increase in the rate of treatment-related AEs. In addition, initial data from the THINK CyFlu cohort (single injection of CYAD-01 following treatment with CyFlu) showed that treatment is well tolerated with no occurrence of SAEs nor an increase in the treatment-related AEs rate. In addition, preliminary translational data suggest an improvement in the cell expansion of CYAD-01 induced by the CyFlu preconditioning.

CYAD-101 – Allogeneic NKG2D-based CAR-T
In 2018 the Company initiated the open-label, dose escalation alloSHRINK trial evaluating the non-gene edited allogeneic CAR-T therapy, CYAD-101, administered concurrently with FOLFOX chemotherapy in the treatment of patients with unresectable metastatic colorectal cancer (mCRC).

Novel, next-generation, shRNA platform
In March 2019, Celyad held a Research & Development Day in New York highlighting its pipeline of preclinical CAR-T product candidates candidates for the treatment of hematological malignancies and solid tumors, based on its short hairpin RNA (shRNA) platform

Autologous settings: CYAD-02 is a next-generation autologous NKG2D-based CAR-T candidate incorporating shRNA technology to target NKG2D ligands MICA/MICB. Preclinical AML models for CYAD-02 show an encouraging increase in in vitro proliferation and in vivo persistence and anti-tumor activity leading the company to plan to submit an Investigational New Drug (IND) application for CYAD-02 in the first half 2020.

Allogeneic settings: In vivo data demonstrate that shRNA targeting of CD3ζ by shRNA protects against graft-versus-host disease (GvHD) to a level equivalent to CRISPR-Cas9 based knock-out , as well as a significant increase in persistence of allogeneic T cells using shRNA targeting when compared to CRISPR-Cas9 gene-editing technologies.

This encouraged the company to develop three disruptive first-in-class non-gene-edited allogeneic CAR-T candidates from the CYAD-200 series leveraging the shRNA SMARTvector platform:

CYAD-211: B-cell maturation antigen (BCMA) targeting CAR-T therapy for the treatment of multiple myeloma, which is expected to enter the clinic by mid-2020
CYAD-221: CD19 targeting CAR-T therapy for the treatment of B-cell malignancies, which is expected to enter the clinic by late 2020
CYAD-231: Dual specific CAR-T targeting NKG2D and an undisclosed membrane protein, which is expected to enter the clinic by early 2021

Expected milestones for 2019

Additional data from the Phase 1 dose-escalation THINK trial for CYAD-01 in r/r AML or MDS patients, including initial data from the schedule optimization portion of the trial;
Enrollment completion and initial data from the Phase 1 dose-escalation DEPLETHINK trial evaluating CYAD-01 with preconditioning chemotherapy in r/r AML or MDS patients;
Acceleration of the development strategy and refinement of the regulatory pathway plan for CYAD-01 for the treatment of r/r AML or MDS patients, including the initiation of a potential Phase 2 clinical trial;
Advancement towards an IND application with the preclinical development of next-generation NKG2D-based CAR-T, CYAD-02 ; and
Further pursue the development of the proprietary non-gene edited allogeneic shRNA platform and progress towards IND applications for the CYAD-200 series of shRNA-based CAR-T candidates.

The Company’s license and collaboration agreements have generated a revenue of €3.1 million in 2018. This includes €2.4 million from the exclusive license agreement signed with Mesoblast Ltd. focused on the development and commercialization of Celyad’s intellectual property rights related to C-CathEZ, a proprietary intra-myocardial injection catheter, as well as €0.7 million from the non-clinical supply agreement with ONO Pharmaceutical Co., Ltd. with respect to the product candidate development of CYAD-101 for their licensed territories.

Research & Development expenses totaled €23.6 million and €22.9 million for 2018 and 2017, respectively. The increase in 2018 is mainly driven by the key clinical studies on CYAD-01 and CYAD-101.

General and Administrative expenses increased by €1.1 million, primarily driven by a non-cash expenses associated with the vesting of warrants.

The Company’s other expenses amount to €8.4 million and include non-cash expenses of €6.6 million relating to liability reassessment required by International Financial Reporting Standards (IFRS) related to the advancement in the Company’s NKG2D-based CAR-T candidates. Overall, non-cash expenses for 2018 totaled €10.2 million.

Therefore, Company’s operating loss of recurring operations (REBIT) increased to €38.2 million compared to €26.6 million for the year 2017. Net operational cash burn, which excludes non-cash effects, was €27.2 million in 2018 compared to €31.2 million in 2017.

Loss for the year 2018 amounts to €37.4 million versus a net loss of €56.4 million for 2017.

Cash, cash equivalents and short-term investments totaled €49.7 million as of December 31, 2018 compared to €33.9 million on December 31, 2017. The Company confirms its previous guidance that existing cash, cash equivalents and short-term investments should be sufficient to fund operating expenses and capital expenditure requirements, based on the current scope of activities, until mid-2020.

Annual Report 2018

The Annual Report for the year ended December 31, 2018 is published today, March 28, 2019, on the website of the Company. The statutory auditor, BDO Réviseurs d’Entreprises SCRL, has confirmed that the audit, which is substantially complete, has not to date revealed any material misstatement in the draft consolidated financial statements, and that the accounting data reported in the press release are consistent, in all material respects, with the draft consolidated financial statements from which it has been derived. On March 28, 2019, date of the release of the Annual Report, Celyad published a press release relating to the appointment of Mr. Filippo Petti as Chief Executive Officer of the Company effective on April 1, 2019. As a consequence of this publication, Celyad decided to issue a supplement to the Annual Report in order to keep the Annual Report up to the date of the convening notice to the 2019 annual shareholders’ meeting. This supplement will be published on the website of the Company within the next days.

Conference Call Details

A conference call will be held on Friday, 29 March 2019, at 1 p.m. CET / 8 a.m. EDT to review the financial and operating results for full year 2018. Please dial-in five to ten minutes prior to the call start time using the number and conference ID below: Standard International Dial-In Number: +44 (0) 2071 928000; Conference ID: 8745558