On March 27, 2019 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported that it has commenced an underwritten public offering of $300,000,000 in shares of its common stock (Press release, Blueprint Medicines, MAR 27, 2019, View Source [SID1234534711]). In addition, Blueprint Medicines expects to grant the underwriters a 30-day option to purchase up to an additional $45,000,000 in shares of its common stock in connection with the public offering. All shares of common stock will be offered by Blueprint Medicines.

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Blueprint Medicines expects to use the net proceeds of the offering to further build its commercial infrastructure and operations in support of one or more anticipated commercial launches of its drug candidates, including potential commercial launches of avapritinib in the United States and Europe, subject to regulatory approval; to fund clinical trials for avapritinib in gastrointestinal stromal tumors (GIST) and systemic mastocytosis (SM), including its planned registration-enabling Phase 3 COMPASS-2L clinical trial for second-line GIST and its ongoing registration-enabling Phase 2 PIONEER clinical trial for indolent and smoldering SM, as well as future indication expansion clinical trials; to fund clinical trials for BLU-667 in RET-driven cancers, including its planned Phase 3 clinical trial for BLU-667 in first-line RET-altered non-small cell lung cancer (NSCLC) and its planned Phase 2 clinical trial for BLU-667 in combination with osimertinib in treatment-resistant, EGFR-mutant NSCLC harboring an acquired RET alteration; to fund a planned Phase 2a clinical trial for BLU-782 in patients with fibrodysplasia ossificans progressiva; to fund manufacturing costs for ongoing and anticipated drug development efforts for its most advanced drug candidates, including a potential commercial launch of avapritinib; and the balance, if any, to fund additional discovery research efforts, its other ongoing and planned clinical trials, working capital requirements and other general corporate purposes.

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 subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

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 copy of the 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 27, 2019 Innovus Pharmaceuticals, Inc. ("Innovus Pharma") (OTCQB: INNVD), an emerging commercial-stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men’s and women’s health and respiratory diseases, reported that it will release its annual 2018 calendar year financial results on Monday, April 1, 2019, after the close of the U.S. financial markets (Press release, Innovus Pharmaceuticals, MAR 27, 2019, View Source [SID1234534670]). The Company will host a conference call at 4:15 p.m. ET/1:15 p.m. PT on the same day to discuss the financial results and recent business developments.

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To participate in the call, please dial 1-877-883-0383 for domestic callers or 1-412-902-6506 for international callers or 1-877-885-0477 for Canadian callers and Participant Elite Entry Number: 7875805.

A replay of the call will be available for 30 days. To access the replay, dial 1-877-344-7529 domestically or 1-412-317-0088 internationally or 1-855-669-9658 for Canada and reference Conference ID: 10129968.

The replay will be available shortly after the end of the conference call.

On March 27, 2019 Epigenomics AG (FSE: ECX, OTCQX: EPGNY; the "Company") reported the financial results (according to IFRS) for the year ended December 31, 2018 (Press release, Epigenomics, MAR 27, 2019, View Source [SID1234534692]).

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KEY HIGHLIGHTS

Financial

– Total revenue of EUR 1.5 million and EBITDA (before share-based payment expenses) of EUR -11.4 million (compared to 2017: EUR 1.9 million and EUR -9.4 million, respectively).

– Liquidity of EUR 17.1 million (incl. marketable securities) at year-end following a successful capital raise in October 2018 (December 31, 2017: EUR 13.7 million)

Corporate

– In December 2018, Centers for Medicare & Medicaid (CMS), the U.S. National Health Insurance, published its official Clinical Lab Fee Schedule (CLFS) 2019, which includes the final reimbursement rate of USD 192.00 for the Epi proColon blood test.

– Epigenomics AG obtains CE Mark for blood test to aid in detecting liver cancer among patients with cirrhosis, which will be commercialized under the brand name HCCBloodTest.

First quarter 2019

– On January 7, 2019, the Company announced positive results from a microsimulation model for the Epi proColon blood test. Microsimulation models are utilized by various screening guideline groups in the U.S. to aid in the development of screening recommendations.

– Reintroduction of the bi-partisan "Donald Payne Sr. Colorectal Cancer Detection Act" (HR 1765) to the U.S. House of Representatives at the end of March 2019 as a necessary step on the legislative path to reimbursement.

Greg Hamilton, Chief Executive Officer of Epigenomics AG: "In the past fiscal year, we achieved some critical milestones including the reimbursement rate for Epi proColon of USD 192.00 per test, completion of the microsimulation model, CE marking of our HCCBloodTest for liver cancer and a successful capital raise. While we did not receive Medicare coverage in 2018, we made progress on both the legislative and NCD paths. We believe we are positioned to receive a positive coverage decision in 2019, which will be a turning point for Epigenomics".

Financial results 2018

– Total revenue was EUR 1.5 million in fiscal year 2018 (2017: EUR 1.9 million). The decrease is due to a reduction of EUR 0.6 million in licensing revenue attributed to the one-time patent sale in Q4 of 2017. This decline in licensing revenue was partly offset by an increase of 47% in product revenue.

– Operating loss (EBIT) amounted to EUR -12.9 million in 2018 (2017: EUR -10.3 million), the net loss for the year to EUR -12.7 million (2017: EUR -10.2 million). The change from 2017 was driven primarily through an increase in R&D of EUR 2.1 million attributed mainly to the post approval study. The loss per share rose to EUR -0.47 (2017: EUR -0.44).

– Cash consumption decreased to EUR 9.6 million (2017: EUR 10.1 million). With a cash inflow from financing activities of EUR 13.3 million (2017: EUR 11.5 million), net cash flow was EUR 3.6 million (2017: EUR 1.4 million).

– The Company’s liquidity (including marketable securities) increased to EUR 17.1 million at year-end 2018 (Dec. 31, 2017: EUR 13.7 million).

Outlook 2019

Revenue

– We estimate increased U.S. test volume demand based upon the new reimbursement rate of USD 192.00. As a result, the Company expects revenue in 2019 within the range of EUR 3.0 million to EUR 6.0 million even without Medicare coverage.

EBITDA

– For 2019, we expect EBITDA before share-based payment expenses to remain unchanged from the previous year’s guidance in a range of EUR -11.5 million to EUR -14.0 million.

Cash consumption

– Based on the Company’s 2019 business plan, we expect cash consumption to be in line with our EBITDA guidance (before share-based payment expenses).

– The Company’s financial position was significantly strengthened by the successful capital increase in October 2018. The 2018 financial year was concluded with cash and cash equivalents and marketable securities in the amount of EUR 17.1 million, which means that our financial resources are sufficient at our projected cash consumption rate to support the Company’s operations well into 2020.

Further information

The annual report 2018 can be downloaded from the Epigenomics Website at: View Source

Conference call for analysts and investors

Epigenomics AG will host a conference call for analysts and investors today at 2.30 pm (CET) / 9:30 am (EDT). The webcast can be accessed on the company’s website: View Source

The dial-in numbers for the conference call are:

Dial-in number within Germany: +49 30 8687 1728
Dial-in number within the UK: +44 1635 598 062
Dial-in number within the U.S.A.: +1 516 269 8983

Participants are kindly requested to dial in 10 minutes prior to the start of the call.

An audio replay of the conference call will be provided on Epigenomics’ website subsequently.

On March 27, 2019 BioLineRx Ltd. (NASDAQ: BLRX) (TASE:BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported that hematopoietic stem cells (HSCs) mobilized by BL-8040 in combination with granulocyte colony-stimulating factor (G-CSF) were successfully engrafted in all 11 patients participating in the Part 1, lead-in period of the GENESIS trial, a double-blind, placebo-controlled Phase 3 trial comparing BL-8040 and G-CSF to G-CSF alone, in mobilization of HSCs for autologous transplantation in multiple myeloma patients (Press release, BioLineRx, MAR 27, 2019, View Source;p=irol-newsArticle&ID=2392451 [SID1234534671]). These data follow previously announced successful mobilization data which led the Data Monitoring Committee (DMC) to recommend proceeding to the randomized placebo-controlled Part 2 of the study.

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"Autologous HSC transplantation in multiple myeloma has been shown to improve overall survival compared to conventional chemotherapy. However, the effectiveness of the treatment relies, in part, upon the ability to collect an adequate amount of HSCs, typically obtained from peripheral blood," explained Dr. John F. DiPersio, Chief, Division of Oncology at the Washington University School of Medicine, and lead investigator of the study. "Current practice involves mobilizing HSCs from the bone marrow to the peripheral blood, after which the cells are collected by apheresis. Results so far show that mobilizing HSCs with a single BL-8040 dose combined with G-CSF is highly effective compared to using G-CSF alone, which typically requires up to 8 injections and multiple apheresis days. Furthermore, engraftment of the cells in all evaluable patients was successful. This is a very encouraging result which, if corroborated in the placebo-controlled part of the trial, will be of great value to patients as well as to the medical community."

The results, detailed in an abstract titled GENESIS – A Phase III Randomized Double-Blind, Placebo-Controlled Trial, Evaluating Safety and Efficacy of BL-8040 and G-CSF in Mobilization of HSCs for Autologous Transplantation in Multiple Myeloma were presented in an oral presentation at the 45th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT 2019), today, March 27, 2019, in Frankfurt, Germany.

Results of the first 11 patients show that 9/11 patients (82%) reached the primary endpoint threshold of ≥ 6×106 CD34 cells/kg with only one dose of BL-8040 and in up to 2 apheresis sessions. Furthermore, 7/11 patients (64%) reached the threshold of ≥ 6×106 CD34 cells/kg in a single apheresis session only. In addition, all 11 patients reached the desired threshold in 4 or less apheresis days, and for all patients with available data (9/11), successful engraftment with BL-8040 mobilized HSCs was observed, with time to engraftment and graft durability comparable to standard of care mobilization regimens.

About the GENESIS Study
The GENESIS study is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study, evaluating the safety, tolerability and efficacy of BL-8040 in combination with G-CSF, compared to placebo and G-CSF, for the mobilization of CD34 HSCs for autologous transplantation in multiple myeloma patients. The placebo-controlled part is designed to include 177 patients in more than 25 centers. Treatment will include 5 days of G-CSF, with a single dose of BL-8040 or placebo on day 4, and with the option to expand treatment to up to 8 days of G-CSF and up to 2 doses of BL-8040. Apheresis for collection of CD34 cells will be performed on day 5. An additional 3 apheresis sessions may be conducted if needed in order to reach the goal of ≥ 6×106 mobilized CD34 cells/kg.

The primary objective of the study is to demonstrate the superiority of a single dose of BL-8040 in combination with G-CSF, over placebo and G-CSF, in the mobilization of ≥ 6×106 CD34 cells/kg in up to 2 apheresis sessions, in preparation for autologous stem cell transplantation in multiple myeloma patients. Secondary objectives include time to engraftment of neutrophils and platelets, durability of the engraftment, as well as safety and other efficacy parameters.

About BL-8040
BL-8040 is a short synthetic peptide for stem cell mobilization and for treatment of hematological malignancies and solid tumors. It functions as a high-affinity best-in-class antagonist for CXCR4, a chemokine receptor that is directly involved in the retention of stems cells in the bone marrow, as well as tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity.

HSCs express CXCR4 and are retained in the protective bone marrow niche via binding to CXCL12 (also known as SDF-1). Blocking of the CXCR4-SDF1 interaction by BL-8040 leads to the mobilization of HSCs into the peripheral blood. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of HSCs.

In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells and immune-cells, sensitization of cancer cells to chemo- and bio-based anti-cancer therapies, and direct anti-cancer effect by inducing programmed cell death (apoptosis). BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

On March 26, 2019 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its financial results for the fourth quarter and year ended December 31, 2018 (Press release, Curis, MAR 26, 2019, View Source [SID1234534631]).

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"2018 was a pivotal year for Curis as we transitioned from a company broadly engaged in discovery research and pipeline expansion into a company singularly focused on clinical execution," said James Dentzer, President and Chief Executive Officer of Curis. "We now have three novel programs in the clinic, all potential blockbusters and all with significant data catalysts expected in 2019."

Dentzer continued, "With our recently announced agreement with Oberland Capital, we secured the financial flexibility needed to ensure we can continue to move forward aggressively in our clinical execution on all three programs and produce the data readouts everyone is so excited to see.

"As we move through 2019, we are focused on the development of first-in-class and best-in-class precision medicines that we hope will transform the lives of patients," he concluded.

Full Year and Fourth Quarter 2018 Financial Results

For the year ended December 31, 2018, Curis reported a net loss of $32.6 million, or $0.98 per share on both a basic and diluted basis, as compared to a net loss of $53.3 million, or $1.79 per share on both a basic and diluted basis in 2017. For the fourth quarter of 2018, Curis reported a net loss of $5.9 million or $0.18 per share on both a basic and diluted basis, as compared to a net loss of $8.0 million, or $0.24 per share on both a basic and diluted basis for the same period in 2017.

Revenues for the year ended December 31, 2018, were $10.4 million as compared to $9.9 million for the same period in 2017. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge. Revenues for the fourth quarters of 2018 and 2017 were $2.8 million and $3.3 million, respectively.

Operating expenses for the year ended December 31, 2018 were $39.8 million as compared to $59.7 million for the same period in 2017. Operating expenses for the fourth quarter of 2018 were $7.9 million, as compared to $10.4 million for the same period in 2017, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.6 million for the year ended December 31, 2018 as compared to $0.5 million for the same period in 2017. Cost of royalty revenues were $0.1 million for the fourth quarter of 2018, as compared to $0.2 million for the same period in 2017.

Research and Development Expenses. Research and development expenses were $24.4 million for the year ended December 31, 2018, as compared to $45.1 million for the same period in 2017. The decrease was primarily due to aggregate payments to Aurigene of $7.5 million, for an exclusivity option that was paid in 2017 as well as decreased costs related to ongoing clinical activities for CA-170. These costs included decreased clinical site, patient, clinical research organization, formulation and manufacturing and consulting costs for our ongoing Phase 1 clinical trial. Employee-related expenses decreased over the prior year period primarily due to a reduction in headcount that occurred in the fourth quarter of 2018. Research and development expenses were $4.7 million for the fourth quarter of 2018 as compared to $6.9 million for the same period in 2017.

General and Administrative Expenses. General and administrative expenses were $14.8 million for the year ended December 31, 2018 as compared to $14.1 million for the same period in 2017. The increase in general and administrative expenses was driven primarily by higher legal, professional and consulting services and other administrative expenses, partially offset by lower stock-based compensation for the period. General and administrative expenses were $3.0 million for the fourth quarter of 2018, as compared to $3.3 million for the same period in prior 2017.

Other expense, net, was $3.2 million for the year ended December 31, 2018, as compared to $3.6 million for the same period in 2017. Other expense, net primarily consisted of interest expense related to the debt obligations of Curis Royalty (a wholly owned subsidiary of Curis). The decrease in interest expense in the current year was related to a lower principal balance on Curis Royalty’s outstanding debt with HealthCare Royalty, which was refinanced in the first quarter of 2017. Other expense, net was $0.8 million and $0.9 million for the fourth quarter of 2018 and 2017, respectively.

As of December 31, 2018, Curis’ cash, cash equivalents, marketable securities and investments totaled $24.3 million and there were approximately 33.2 million shares of common stock outstanding. The previously announced sale of a portion of Erivedge royalties to Oberland Capital Management will provide net proceeds of approximately $30 million before closing costs and transaction fees.

Full Year 2018 and Recent Operational Highlights

Precision oncology, fimepinostat (HDAC/PI3K inhibitor):

Curis initiated its study of fimepinostat (a MYC inhibitor) with venetoclax (a BCL-2 inhibitor) combination regimen in diffuse large B-cell lymphoma (DLBCL), including patients with Double-Hit/Double-Expressor Lymphoma. In preclinical models, fimepinostat administered in combination with venetoclax resulted in an enhanced benefit relative to each agent alone.
In December 2018 at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s (ASH) (Free ASH Whitepaper) annual meeting, Curis presented a pooled analysis of patients with relapsed/refractory DLBCL treated with fimepinostat, including individuals with MYC-alterations that demonstrated the treatment’s safety and durable benefit in this patient population.
Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene collaboration):

In 2018, Curis initiated and continued to enroll patients with relapsed or refractory non-Hodgkin lymphoma in a Phase 1 dose escalation study. CA-4948 is designed to target cancers with MYD88 mutations present in various tumor cell lines including DLBCL, Waldenström’s macroglobulinemia (WM), and acute myeloid leukemia.
In December 2018, at the ASH (Free ASH Whitepaper) annual meeting, Curis presented preclinical results showing potent anti-tumor in vivo activity for CA-4948 as a single agent as well as an enhanced effect when combined with other agents supporting the potential for IRAK4-based combination regimens.
Immuno-oncology, CA-170 (VISTA / PDL1 antagonist; Aurigene collaboration):

In November 2018, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s Annual Meeting, Curis presented three posters providing an update to the ongoing CA-170 Phase 1 trial and preclinical support of VISTA’s role as an oncology target of interest. At the same conference, collaborator Aurigene presented a poster detailing key findings from its ongoing Phase 2 trial of CA-170 in patients with advanced solid tumors and Hodgkin lymphoma who are immunotherapy treatment-naïve.
In January 2019, Curis announced the first mesothelioma patient dosed in its ongoing Phase 1 CA-170 trial, which recently started to enroll patients with mesothelioma, following evidence supporting high levels of VISTA expression in mesothelioma tumor samples. Recent publications have identified VISTA as a possible resistance mechanism to treatment with anti-PD1 antibodies in several cancer indications.
Full Year 2018 and Recent Corporate Highlights

Curis announced a 1-for-5 reverse stock split that came into effect on May 29, 2018.
In May 2018, Curis appointed Robert Martell, M.D., Ph.D., a practicing oncologist, experienced drug developer and former CMO of Tesaro, as Head of Research and Development.
In September 2018, Curis announced the appointment of James Dentzer to the position of President and Chief Executive Officer.
In October 2018, Curis implemented a 27% reduction in headcount and a re-allocation of pre-clinical resources to strengthen focus on clinical development. The result of these changes reduced the forecasted cash burn from approximately $11 million to $8 million per quarter going forward.
In March 2019, Curis announced that it sold a portion of its Erivedge royalties to Oberland Capital for up to $135.7 million, including $65 million upfront and $70.7 million in future milestones.
2019 Data Catalysts

Curis expects to report initial data on the combination of fimepinostat and venetoclax regimen in patients with R/R DLBCL, including patients with DH/DE Lymphoma, in the second half of 2019.
Curis expects to report initial efficacy data from its CA-4948 dose escalation study in patients with D/DE DLBCL in mid-year 2019.
Curis expects to report initial efficacy data from its CA-170 Phase 1 trial in patients with mesothelioma (high VISTA expressors) in the second half of 2019.
Conference Call Information

Curis management will host a conference call today, March 26, 2019, at 4:30 p.m. ET, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial 1-888-346-6389 (from the United States) or 1-412-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed in the Investors section on the Curis website at www.curis.com.