On June 26, 2020, Veru Inc. (the "Company") reported that it entered into a common stock purchase agreement (the "Purchase Agreement") with Aspire Capital Fund, LLC, an Illinois limited liability company ("Aspire Capital"), which provides that, upon the terms and subject to the conditions and limitations set forth therein, the Company has the right, from time to time in its sole discretion during the 36-month term of the Purchase Agreement, to direct Aspire Capital to purchase up to $23.9 million of the Company’s common stock (the "Common Stock") in the aggregate (Filing, 8-K, Veru, JUN 26, 2020, View Source [SID1234561499]). Upon execution of the Purchase Agreement, the Company issued and sold to Aspire Capital under the Purchase Agreement 1,644,737 shares of Common Stock at a price per share of $3.04, for an aggregate purchase price of $5,000,000 (the "Initial Purchase Shares"). Based on information currently available including giving effect to the sale of the Initial Purchase Shares to Aspire Capital under the Purchase Agreement, the Company expects its cash and cash equivalents as of June 30, 2020 to be approximately $13.5 million, compared to $2.6 million as of March 31, 2020.

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Concurrently with entering into the Purchase Agreement, the Company also entered into a registration rights agreement with Aspire Capital (the "Registration Rights Agreement"), pursuant to which the Company agreed to file with the Securities and Exchange Commission (the "SEC") one or more registration statements (each, a "Registration Statement") as necessary to register for sale under the Securities Act of 1933, as amended (the "Securities Act"), the Initial Purchase Shares, the Commitment Shares (as defined below) and the additional shares of Common Stock that may be issued to Aspire Capital under the Purchase Agreement. The Company has filed with the SEC a prospectus supplement to the Company’s effective shelf registration statement on Form S-3 (File No. 333-221120) registering all of the shares of Common Stock that may be offered to Aspire Capital from time to time under the Purchase Agreement.

Under the Purchase Agreement, on any trading day selected by the Company, the Company has the right, in its sole discretion, to present Aspire Capital with a purchase notice (each, a "Purchase Notice"), directing Aspire Capital (as principal) to purchase up to 200,000 shares of Common Stock per business day at a per share price (the "Purchase Price") equal to the lesser of the lowest sale price of the Common Stock on the purchase date or the arithmetic average of the three lowest closing sale prices for the Common Stock during the ten consecutive trading days ending on the trading day immediately preceding the purchase date.

In addition, on any date on which the Company submits a Purchase Notice to Aspire Capital in an amount equal to 200,000 shares of Common Stock and the closing sale price of the Common Stock is equal to or greater than $0.50 per share, the Company also has the right, in its sole discretion, to present Aspire Capital with a volume-weighted average price purchase notice (each, a "VWAP Purchase Notice") directing Aspire Capital to purchase shares of Common Stock equal to up to 30% of the aggregate shares of the Common Stock traded on its principal market on the next trading day (the "VWAP Purchase Date"), subject to a maximum number of shares of Common Stock the Company may determine. The purchase price per share pursuant to such VWAP Purchase Notice is generally 97% of the volume-weighted average price for the Common Stock traded on its principal market on the VWAP Purchase Date.

The Purchase Price will be adjusted for any reorganization, recapitalization, non-cash dividend, stock split, or other similar transaction occurring during the period(s) used to compute the Purchase Price. The Company may deliver multiple Purchase Notices and VWAP Purchase Notices to Aspire Capital from time to time during the term of the Purchase Agreement, so long as the most recent purchase has been completed.

The Purchase Agreement provides that the Company and Aspire Capital shall not effect any sales under the Purchase Agreement on any purchase date where the closing sale price of the Common Stock is less than $0.25 per share. There are no trading volume requirements or restrictions under the Purchase Agreement, and the Company will control the timing and amount of sales of shares of Common Stock to Aspire Capital. Aspire Capital has no right to require any sales by the Company, but is obligated to make purchases from the Company as directed by the Company in accordance with the Purchase Agreement. There are no limitations on use of proceeds, financial or business covenants, restrictions on future fundings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement. In consideration for entering into the Purchase Agreement, concurrently with the execution of the Purchase Agreement, the Company issued to Aspire Capital 212,130 shares of Common Stock (the "Commitment Shares"). The Purchase Agreement may be terminated by the Company at any time, at its discretion, without any cost to the Company. Aspire Capital has agreed that neither it nor any of its agents, representatives and affiliates shall engage in any direct or indirect short-selling or hedging of the Common Stock during any time prior to the termination of the Purchase Agreement. Any proceeds the Company receives under the Purchase Agreement are expected to be used for working capital and general corporate purposes, which may include research and development, clinical trial and marketing expenditures.

The foregoing is a summary description of certain terms of the Purchase Agreement and the Registration Rights Agreement and, by its nature, is incomplete. Copies of the Purchase Agreement and Registration Rights Agreement are filed herewith as Exhibits 10.1 and 10.2, respectively, to this report and are incorporated herein by reference. All readers are encouraged to read the entire text of the Purchase Agreement and the Registration Rights Agreement.

On June 26, 2020 Bristol Myers Squibb (NYSE: BMY) and Acceleron Pharma Inc. (NASDAQ: XLRN) reported that the European Commission (EC) has approved Reblozyl (luspatercept) for the treatment of: Adult patients with transfusion-dependent anemia due to very low-, low- and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response or are ineligible for erythropoietin-based therapy (Press release, Bristol-Myers Squibb, JUN 26, 2020, View Source [SID1234561496]).

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Adult patients with transfusion-dependent anemia associated with beta thalassemia.
"Dependence on blood transfusions caused by anemia in hematologic malignancies like MDS can often mean frequent and lengthy hospital visits, which can pose additional health risks and affect patients’ quality of life," said Uwe Platzbecker, M.D., lead investigator of the MEDALIST study, Head of Clinic and Policlinic for Hematology and Cell Therapy, Leipzig University Hospital. "Today’s approval of Reblozyl provides healthcare professionals with a new therapy that has been shown to significantly reduce the number of red blood cell transfusions needed by MDS patients and, in some cases, helped them to achieve transfusion independence."

"While beta thalassemia remains an orphan disease, the lifelong blood transfusions often needed by patients can have a significant impact on the limited blood supply in their communities, and there are few treatment alternatives," said Maria Domenica Cappellini, M.D., lead investigator of the BELIEVE study, Professor of Medicine, University of Milan, Fondazione IRCCS Ca Granda. "The European Commission’s approval of Reblozyl provides eligible adult patients with beta thalassemia a new, much needed treatment option for their anemia, and with it, the possibility of becoming less dependent on red blood cell transfusions."

Reblozyl is the first and only erythroid maturation agent approved in the European Union, representing a new class of therapy for eligible patients. This approval is based on data from the pivotal Phase 3 MEDALIST and BELIEVE studies, evaluating the ability of Reblozyl to effectively address anemia associated with MDS and beta thalassemia, respectively.

"Across the EU, 25 million blood transfusions occur every year, some of which are needed by patients with anemia due to hematologic diseases like MDS and beta thalassemia," said Diane McDowell, M.D., vice president, Hematology Global Medical Affairs, Bristol Myers Squibb. "Reblozyl has the potential to address the ineffective erythropoiesis associated with MDS and beta thalassemia, decrease patients’ dependence on red blood cell transfusions and impact the underlying consequences of the high burden of anemia for these patients. Alongside our partners at Acceleron, we recognize the continuing need in disease-related anemias and are committed to working collaboratively with European health authorities to make Reblozyl available to these patients as quickly as possible."

About MEDALIST

MEDALIST is a Phase 3, randomized, double-blind, placebo-controlled, multi-center study evaluating the safety and efficacy of Reblozyl plus best supportive care (BSC) versus placebo plus BSC in adults with IPSS-R-defined very low-, low- or intermediate-risk non-del(5q) MDS. All patients were RBC transfusion-dependent and were either refractory or intolerant to prior erythropoiesis stimulating agent (ESA) therapy, or were ESA naïve and unlikely to respond due to endogenous serum erythropoietin levels of ≥ 200 U/L, and had no prior treatment with disease modifying agents.

The trial showed a statistically significant improvement in RBC transfusion burden with Reblozyl, the study’s primary endpoint, with 37.9% of patients treated with Reblozyl achieving independence from RBC transfusions for at least eight weeks during the first 24 weeks of the trial compared to 13.2% of patients on placebo. The trial also met the secondary endpoint of transfusion independence for at least 12 weeks within the first 24 and 48 weeks of the study, which was achieved in a significantly greater proportion of patients receiving Reblozyl versus placebo.

The majority of treatment-emergent adverse events (TEAEs) were Grade 1-2. Grade 3 or 4 TEAEs were reported in 42.5% of patients who received Reblozyl and 44.7% of patients who received placebo. Discontinuation due to an adverse reaction (Grades 1-4) occurred in 4.5% of patients who received Reblozyl. The most common (>10%) all-grade adverse reactions included fatigue, musculoskeletal pain, dizziness, diarrhea, nausea, hypersensitivity reactions, hypertension, headache, upper respiratory tract infection, bronchitis and urinary tract infection.

Results of the MEDALIST trial were first presented during the Plenary Session of the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2018 (ASH Abstract #001) and were selected for the Best of ASH (Free ASH Whitepaper). The New England Journal of Medicine published the MEDALIST trial results in January 2020.

About MDS

MDS are a group of hematologic malignancies characterized by ineffective production of healthy red blood cells, white blood cells and platelets, which can lead to anemia and frequent or severe infections, and can progress to Acute Myeloid Leukemia (AML). People with MDS who develop anemia often require regular blood transfusions to increase the number of healthy red blood cells in circulation. Frequent transfusions are associated with an increased risk of transfusion reactions, infections and iron overload. There are approximately 50,000 patients with MDS in the EU5 countries (France, Germany, Italy, Spain and the United Kingdom).

About BELIEVE

BELIEVE is a Phase 3, randomized, double-blind, placebo-controlled multi-center study comparing Reblozyl plus BSC versus placebo plus BSC in adults who require regular RBC transfusions (6-20 RBC units per 24 weeks with no transfusion-free period greater than 35 days during that period) due to beta thalassemia.

The trial showed a statistically significant improvement in RBC transfusion burden during weeks 13 to 24 compared to the baseline 12-week interval prior to randomization (21.4% Reblozyl versus 4.5% placebo), meeting the study’s primary endpoint. The trial also met the secondary endpoint of transfusion burden reduction of at least 33% (with a reduction of at least two units) during weeks 37 to 48, which was achieved in a significantly greater proportion of patients receiving Reblozyl versus placebo. The trial also met an exploratory endpoint, with 70.5% of patients treated with Reblozyl achieving at least a 33% reduction in RBC transfusion burden of at least two units for any 12 consecutive weeks compared to the 12-week interval prior to treatment, compared to 29.5% of patients on placebo.

The majority of TEAEs were Grade 1-2. Discontinuation due to an adverse reaction (Grades 1-4) occurred in 5.4% of patients who received Reblozyl. The most common adverse reactions (>10%) were headache, bone pain, arthralgia, fatigue, cough, abdominal pain, diarrhea and dizziness.

Results of the BELIEVE trial were first presented at the ASH (Free ASH Whitepaper) Annual Meeting in December 2018 and selected for the Best of ASH (Free ASH Whitepaper). The New England Journal of Medicine published the BELIEVE trial results in March 2020.

About Beta Thalassemia

Beta thalassemia is an inherited blood disorder caused by a genetic defect in hemoglobin. The disease is associated with ineffective erythropoiesis, which results in the production of fewer and less healthy RBCs, often leading to severe anemia—a condition that can be debilitating and can lead to other complications for patients—as well as other serious health issues. Treatment options for anemia associated with beta thalassemia are limited, consisting mainly of frequent RBC transfusions that have the potential to contribute to iron overload, which can cause serious complications such as organ damage. Across the United States, Germany, France, Italy, Spain and the United Kingdom, there are approximately 17,000 patients with beta thalassemia.

About Reblozyl

Reblozyl (luspatercept-aamt), a first-in-class erythroid maturation agent, promotes late-stage red blood cell maturation in animal models. Bristol Myers Squibb and Acceleron are jointly developing Reblozyl as part of a global collaboration. Reblozyl is currently approved in the U.S. for the treatment of:

anemia in adult patients with beta thalassemia who require regular red blood cell transfusions, and
anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
Reblozyl is not indicated for use as a substitute for red blood cell transfusions in patients who require immediate correction of anemia.

U.S. Important Safety Information

WARNINGS AND PRECAUTIONS

Thrombosis/Thromboembolism

In adult patients with beta thalassemia, thromboembolic events (TEE) were reported in 8/223 (3.6%) REBLOZYL-treated patients. TEEs included deep vein thrombosis, pulmonary embolus, portal vein thrombosis, and ischemic stroke. Patients with known risk factors for thromboembolism (splenectomy or concomitant use of hormone replacement therapy) may be at further increased risk of thromboembolic conditions. Consider thromboprophylaxis in patients at increased risk of TEE. Monitor patients for signs and symptoms of thromboembolic events and institute treatment promptly.

Hypertension

Hypertension was reported in 10.7% (61/571) of REBLOZYL-treated patients. Across clinical studies, the incidence of Grade 3 to 4 hypertension ranged from 1.8% to 8.6%. In patients with beta thalassemia with normal baseline blood pressure, 13 (6.2%) patients developed systolic blood pressure (SBP) ≥130 mm Hg and 33 (16.6%) patients developed diastolic blood pressure (DBP) ≥80 mm Hg. In adult patients with MDS with normal baseline blood pressure, 26 (29.9%) patients developed SBP ≥130 mm Hg and 23 (16.4%) patients developed DBP ≥80 mm Hg. Monitor blood pressure prior to each administration. Manage new or exacerbations of preexisting hypertension using anti-hypertensive agents.

Embryo-Fetal Toxicity

REBLOZYL may cause fetal harm when administered to a pregnant woman. REBLOZYL caused increased post-implantation loss, decreased litter size, and an increased incidence of skeletal variations in pregnant rat and rabbit studies. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the final dose.

ADVERSE REACTIONS

Beta Thalassemia

Serious adverse reactions occurred in 3.6% of patients on REBLOZYL. Serious adverse reactions occurring in 1% of patients included cerebrovascular accident and deep vein thrombosis. A fatal adverse reaction occurred in 1 patient treated with REBLOZYL who died due to an unconfirmed case of acute myeloid leukemia (AML)
Most common adverse reactions (at least 10% for REBLOZYL and 1% more than placebo) were headache (26% vs 24%), bone pain (20% vs 8%), arthralgia (19% vs 12%), fatigue (14% vs 13%), cough (14% vs 11%), abdominal pain (14% vs 12%), diarrhea (12% vs 10%) and dizziness (11% vs 5%)
Myelodysplastic Syndromes

Grade >3 (≥2%) adverse reactions included fatigue, hypertension, syncope and musculoskeletal pain. A fatal adverse reaction occurred in 5 (2.1%) patients
The most common (≥10%) adverse reactions included fatigue, musculoskeletal pain, dizziness, diarrhea, nausea, hypersensitivity reactions, hypertension, headache, upper respiratory tract infection, bronchitis, and urinary tract infection
LACTATION

It is not known whether REBLOZYL is excreted into human milk or absorbed systemically after ingestion by a nursing infant. REBLOZYL was detected in milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because many drugs are excreted in human milk, and because of the unknown effects of REBLOZYL in infants, a decision should be made whether to discontinue nursing or to discontinue treatment. Because of the potential for serious adverse reactions in the breastfed child, breastfeeding is not recommended during treatment and for 3 months after the last dose.

Please see full Prescribing Information and Summary of Product Characteristics for REBLOZYL

Bristol Myers Squibb: Advancing Cancer Research

At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase patients’ quality of life, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.

Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational chimeric antigen receptor (CAR) T-cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering potential new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.

On June 26, 2020 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) reported that it will be announcing its interim results for the six months ended June 30, 2020 on Thursday, July 30, 2020 at 12:00 noon British Summer Time (BST) (7:00 pm Hong Kong Time (HKT); 7:00 am Eastern Daylight Time (EDT)) (Press release, Hutchison China MediTech, JUN 26, 2020, https://www.chi-med.com/chi-med-to-announce-2020-half-year-financial-results/ [SID1234561495]).

Analysts and investors are invited to join a conference call and audio webcast presentation with Q&A, conducted by Chi-Med management.

The conference call and audio webcast will take place at 1:00 pm BST / 8:00 pm HKT / 8:00 am EDT on Thursday, July 30, 2020 and will be webcast live via the company website at www.chi-med.com/investors/event-information/. The presentation will be available for downloading before the conference call begins. Details of the conference call dial-in will be provided in the financial results announcement and on the company website. A replay will also be available on the website shortly after the event.

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On June 26, 2020 Artiva Biotherapeutics, Inc., an oncology company focused on developing and commercializing allogeneic natural killer (NK) cell therapies, reported the launch of the company with the close of a $78 million Series A financing (Press release, Artiva Biotherapeutics, JUN 26, 2020, View Source [SID1234561489]). The financing was co-led by 5AM Ventures, venBio Partners, and RA Capital Management, and joined by Medivate Partners and seed investors and strategic partners GC LabCell (Green Cross LabCell Corporation) (KRX: 144510) and GC (Green Cross Holdings Corporation) (KRX: 005250). Artiva will use the proceeds of this financing to develop off-the-shelf universal NK cells for use in combination with monoclonal antibody therapy and tumor targeting CAR-NK cell therapies.

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"We have seen tremendous breakthroughs in redirecting immune cells against cancer, but patient access to these therapies has been limited by safety, scale, manufacturing, logistics, and cost issues," said Tom Farrell, President and CEO of Artiva. "Our goal at Artiva is to do more, leveraging GC LabCell’s foundational work on true off-the-shelf NK cells into a pipeline of product candidates that are accessible to any cancer patient who may benefit."

Artiva’s initial pipeline includes AB-101, a universal NK cell therapy for use in combination with monoclonal antibodies. The company plans to enter the clinic this year with AB-101 in combination with an anti-CD20 monoclonal antibody for the treatment of relapsed refractory B-cell lymphoma. The company is also advancing AB-201, a novel HER2-specific CAR-NK cell therapy for the treatment of HER2+ solid tumors, and AB-202, a CD19-specific CAR-NK cell therapy for the treatment of CD19+ B-cell malignancies. In each case, a large scale of production along with effective cryopreservation enables high and repeat dosing.

Scaling NK Cell Therapy for Cancer

Artiva’s pipeline of universal and targeted NK cell therapies leverages the innate anti-tumor biology and safety features of NK cells. The therapies are optimized for enhanced efficacy through chimeric antigen receptors (CARs), therapeutic antibody combination therapy, and genetic engineering. The pipeline leverages a manufacturing platform that supports large-scale production and cryopreservation of off-the-shelf allogeneic NK cell therapies and proprietary CAR-NK and NK-specific gene-editing technologies to augment therapeutic activity.

Artiva’s platform incorporates cell expansion, activation, and engineering technology developed and enhanced through mid-stage clinical trials by the company’s corporate partner, GC LabCell. Artiva has exclusive ex-Asia-Pacific license agreements with GC LabCell covering their core manufacturing and CAR technology and initial product candidates and an option to take exclusive ex-Asia-Pacific licenses to additional research candidates generated by GC LabCell, under the governance of a Joint Steering Committee.

"The inherent biology of natural killer cells holds enormous therapeutic potential for cancer therapy, but until Artiva, technological barriers held back their advancement," said 5AM Ventures partner Brian Daniels, M.D. "Artiva is systematically resolving the barriers to safe and effective NK cell therapies at a scale that enables broader access to potentially life-saving cancer treatments."

Leadership Team: Deep Cell Therapy and Oncology Experience

Artiva’s proven executive team brings deep, diverse cell therapy and oncology experience to research and advance a pipeline of NK and CAR-NK cell therapies to treat cancer.

On June 26, 2020 ERC Belgium, a clinical-stage biopharmaceutical company developing immunotherapies for the treatment of cancer, reported that it has submitted to the EMA its Marketing Authorization Application (MAA) for conditional approval of its lead product SITOIGANAP (ERC1671) to treat recurrent glioblastoma (GBM) (Press release, ERC Belgium, JUN 26, 2020, View Source [SID1234561485]).

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The MAA contains observations suggesting safety and efficacy of SITOIGANAP demonstrated from the interim data of a randomized double-blind phase II trial. The data show that administration of SITOIGANAP/GM-CSF/Cyclophosphamide combined with bevacizumab results in a clinically meaningful survival benefit with minimal toxicity.

The SITOIGANAP regimen presents unique advantages in comparison to historical controls and it significantly increased overall survival and median survival compared to controls. Moreover, current clinical data supports the safety of this product, with no severe adverse events observed; related side effects were grade 1 and 2 headache and local skin reactions.

Approximately 10% of the patients that received SITOIGANAP experienced total recovery and survived longer than 3 years when treated following GBM recurrence and after receiving standard of care. In contrast, no spontaneous remissions were observed in the control group, and all patients showed tumor progression.

Apostolos Stathopoulos, MD, PhD, President and CEO of ERC Worldwide commented, "We are excited to see such strong results from SITOIGANAP, especially the high number of patients going into remission. The beneficial advantage that we are bringing to patients suffering from this orphan disease like GBM is groundbreaking, especially being able to help those patients who have advanced to a stage without alternative therapeutic options."

About SITOIGANAP

SITOIGANAP is an advanced immunotherapy based on freshly extracted tumor cells and lysates that stimulates the patient’s immune system to recognize and reject cancer cells. The immunotherapy contains a combination of autologous tumor cells, and allogeneic tumor cells, generated from the glioma tumor tissues of three different donor cancer patients, and the lysates of all of these cells. Upon injection, this mixture stimulates the patient’s immune system to mount an immune response against the tumor cells, which may lead to their destruction.

SITOIGANAP is for patients suffering from a grade IV glioma (glioblastoma multiforme and gliosarcoma) when all other traditional treatments have failed. The response to SITOIGANAP is the same whether the MGMT promoter is methylated or unmethylated.

SITOIGANAP is currently in randomized, placebo-controlled Phase 2 clinical trials in the United States as part of combination treatment for glioblastoma multiforme and gliosarcoma.