On May 1, 2020 Genmab A/S (Nasdaq: GMAB) reported that the U.S. Food and Drug Administration (U.S. FDA) has approved the use of the subcutaneous formulation of daratumumab, DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) (Press release, Genmab, MAY 1, 2020, View Source [SID1234556910]). The Biologics License Application (BLA) for this formulation was submitted by Genmab’s licensing partner, Janssen Biotech, Inc. (Janssen) in July 2019. DARZALEX FASPRO is approved for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant (ASCT); in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. DARZALEX FASPRO is a fixed-dose formulation that can be administered over approximately three to five minutes, significantly less time than intravenous DARZALEX, which is given over several hours. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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The approval was based on data from two studies: the Phase III non-inferiority COLUMBA (MMY3012) study, which compared the subcutaneous formulation of daratumumab to the intravenous formulation in patients with relapsed or refractory multiple myeloma and data from the Phase II PLEIADES (MMY2040) study, which is evaluating subcutaneous daratumumab in combination with different standard multiple myeloma treatment regimens. The topline results from the COLUMBA study were announced in February 2019 and subsequently presented in oral sessions at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the 24th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress. An update of the COLUMBA data as well as data from the PLEIADES study were presented during poster sessions at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2019.

"The approval of the subcutaneous formulation of daratumumab, DARZALEX FASPRO, is a landmark event in the development of daratumumab. Not only is it now the first and only subcutaneous CD38 antibody approved for the treatment of multiple myeloma, the subcutaneous administration of DARZALEX FASPRO considerably reduces treatment burden, as the fixed-dose injection is administered in approximately three to five minutes, offering patients a more convenient treatment experience. As seen in the pivotal study supporting the approval, this reduction in infusion time from hours to minutes led to higher satisfaction levels for patients and in addition, infusion-related reactions were both mild and significantly reduced with this formulation of daratumumab. We are very much looking forward to the launch of DARZALEX FASPRO in the U.S. and the potential for positive impact it will have on the lives of the patients receiving the drug," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About the COLUMBA (MMY3012) study
The Phase III trial (NCT03277105) is a randomized, open-label, parallel assignment study that included 522 adults diagnosed with relapsed and refractory multiple myeloma. Patients were randomized to receive either: subcutaneous (SC) daratumumab, as 1,800 mg daratumumab with rHuPH20 2,000 U/mL once weekly in Cycle 1 and 2, every two weeks in Cycles 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study; or 16 mg/kg IV daratumumab once weekly in Cycle 1 and 2, every two weeks in Cycles 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The co-primary endpoints of the study are overall response rate and Maximum trough concentration of daratumumab (Ctrough; defined as the serum pre-dose concentration of daratumumab on Cycle 3 Day 1).

About the PLEIADES (MMY2040) study
The Phase II trial (NCT03412565) is a non-randomized, open-label, parallel assignment study that includes 265 adults either newly diagnosed or with relapsed or refractory multiple myeloma. Patients with newly diagnosed multiple myeloma are being treated with 1,800 mg SC daratumumab in combination with either bortezomib, lenalidomide and dexamethasone (D-VRd) or bortezomib, melphalan and prednisone (D-VMP). Patients with relapsed or refractory multiple myeloma are being treated with 1,800 mg SC daratumumab plus lenalidomide and dexamethasone (D-Rd). An additional cohort of patients with relapsed and refractory multiple myeloma treated with daratumumab plus carfilzomib and dexamethasone (D-Kd) was subsequently added to the study. The primary endpoint for the D-VMP, D-Kd and D-Rd cohorts is overall response rate. The primary endpoint for the D-VRd cohort is very good partial response or better rate.

About DARZALEX(daratumumab)
DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant (ASCT); in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for ASCT; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for ASCT; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in Europe: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for ASCT; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for ASCT; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for ASCT; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy2. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for ASCT; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for ASCT; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit www.DARZALEX.com.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. DARZALEX FASPRO is the first subcutaneous CD38-directed antibody approved in the U.S. for the treatment of multiple myeloma.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resul cvfting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,2,3,4,5,6

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

On May 1, 2020 Veracyte, Inc. (Nasdaq: VCYT) reported that the company has launched "More About You," a web-based campaign that is designed to educate patients about thyroid nodules, and empower them to both engage in conversations with their physicians and ask for molecular testing when appropriate (Press release, Veracyte, MAY 1, 2020, View Source [SID1234556902]). The campaign centers on the company’s new website, www.AskForAfirma.com, and addresses critical challenges that patients with potentially cancerous thyroid nodules experience during their diagnostic journey.

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"Our research shows that patients today have limited awareness that their thyroid nodule fine needle aspiration biopsy results may be indeterminate. This can negatively impact their ability to receive advanced testing and personalized care," said John Hanna, chief commercial officer of Veracyte. "Our goal is to help educate patients so that they can have more productive conversations with their physicians about their thyroid nodules and ensure they understand their diagnostic options, including molecular testing."

Veracyte’s new website features information about what patients can expect when undergoing thyroid nodule evaluation, what the possible results could be and what they mean. It also provides questions for patients to ask their physicians once a thyroid nodule has been detected. In addition, the site includes information about Afirma genomic testing, which the company estimates has helped over 160,000 patients avoid unnecessary diagnostic surgery or receive more informed treatment based on the genomic makeup of their thyroid nodules. Veracyte will communicate information about the campaign and website to patients and physicians via online, social media and other channels.

About Thyroid Nodules

Each year in the United States, more than 565,000 fine needle aspiration biopsies are performed to assess patients with potentially cancerous thyroid nodules. Up to 30 percent of the results are indeterminate and physicians have traditionally recommended thyroid surgery for a more definitive diagnosis. Following surgery, however, 70 to 80 percent of patients’ nodules are diagnosed as benign, meaning the surgery was unnecessary. Such surgery is invasive, costly and often leads to the need for lifelong daily thyroid hormone replacement drugs.

On May 1, 2020 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company" or "Pulse Biosciences"), a novel bioelectric medicine company, reported that it has updated the structure, key dates and pricing terms for its previously-announced rights offering (Press release, Pulse Biosciences, MAY 1, 2020, View Source [SID1234556901]).

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The Company intends to issue non-transferable subscription rights to its stockholders of record as of 5:00 p.m. Eastern Time on May 14, 2020 (the "Record Date") to purchase up to $30,000,000 of units (the "Units," and each, a "Unit"). Each Unit shall consist of one share of the Company’s common stock, par value $0.001 per share (the "Common Stock") and 0.15 warrants to purchase shares of Common Stock. Each warrant will be exercisable for one share of Common Stock at an exercise price that shall be equal to the subscription price for the Units. The Common Stock and the warrants comprising the Units will separate upon the closing of the rights offering and will be issued separately; however, they may only be purchased as a Unit and the Unit will not trade as a separate security.

Following the Record Date, the Company intends to mail to stockholders of record on the Record Date a prospectus and related documents for use in exercising subscription rights. The subscription rights will expire and have no value if they are not exercised prior to 5:00 p.m. Eastern Time on June 8, 2020 (the "Expiration Date").

Pursuant to the rights offering, Pulse Biosciences is distributing at no charge to the holders of its Common Stock, non-transferable subscription rights to purchase up to $30,000,000 of Units at a subscription price per Unit equal to the lesser of (i) $7.01, the closing price of the Common Stock on April 23, 2020 (the "Initial Price") or (ii) the volume weighted average price of the Common Stock for the five-trading day period through and including the Expiration Date (the "Alternate Price").

Stockholders wishing to exercise subscription rights must timely pay $7.01 per Unit, the Initial Price, for the full number Units they wish to acquire. If the Alternate Price is lower than the Initial Price on the Expiration Date, any excess subscription amounts paid by a subscribing holder will be applied towards the purchase of additional Units in the rights offering, but the Company will not sell fractional Units. Stockholders who fully exercise their basic subscription rights will be entitled to subscribe for additional Units that are not purchased by other stockholders, on a pro rata basis and subject to availability.

Stockholders may exercise their subscription rights by delivering documentation of their subscription and payment in the manner specified in the prospectus relating to the rights offering. Beneficial stockholders (i.e. stockholders whose shares are in a brokerage account), should exercise their subscription rights as indicated in the instructions provided by their broker-dealer. Procedures and dates set-forth by broker-dealers may differ from those in the offering documents. Investors wishing to participate in the rights offering are encouraged to contact their broker-dealer for further information.

Questions about the rights offering and requests for copies of the prospectus relating to the rights offering may be directed to Broadridge Corporate Issuer Solutions, Inc., the Company’s information, subscription and warrant agent for the rights offering, at the address and phone number provided at the end of this release.

A registration statement relating to the rights offering has been filed with the Securities and Exchange Commission (the "SEC") and but has not yet become effective. The securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. When available, a copy of the prospectus may be obtained at the website maintained by the SEC at www.SEC.gov.

On May 1, 2020 GlycoMimetics, Inc. (Nasdaq: GLYC) reported its financial results for the first quarter ended March 31, 2020 and highlighted recent company events (Press release, GlycoMimetics, MAY 1, 2020, View Source [SID1234556898]). Cash and cash equivalents at March 31, 2020 were $154.8 million.

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"During the quarter, patient enrollment continued on track in GlycoMimetics’ Phase 3 registration program evaluating uproleselan in relapsed/refractory acute myeloid leukemia (AML) as well as in our collaboration with the National Cancer Institute (NCI) on a multi-center clinical trial evaluating the drug candidate in newly diagnosed patients fit for chemotherapy. Enrollment slowed in April as a result of the COVID-19 pandemic, and we continue to actively monitor the situation. At this time it is too early for us to comment on the potential impact of the pandemic on completion of enrollment in either trial, or the potential impact on cash burn. In addition, we are working closely with Apollomics in the Greater China region to initiate the Apollomics-funded third registration trial for uproleselan," commented Rachel King, Chief Executive Officer.

"In early April, Pfizer transferred to us the rivipansel investigational new drug application (IND) as well as the study data set from its Phase 3 clinical trial evaluating the drug’s clinical effect in sickle cell vaso-occlusive crisis," continued Ms. King. "We can now move forward to fully review the data to determine the next steps, if any, to take with respect to the rivipansel program now that we have worldwide development and commercialization rights."

Operational Highlights

Uproleselan

GlycoMimetics’ pivotal Phase 3 trial in relapsed/refractory AML continued to activate clinical sites and enroll patients in the U.S., Australia and Europe through March 2020.

The COVID-19 pandemic has resulted in slowed clinical site initiation, patient recruitment and enrollment rates beginning in April 2020, which we continue to closely monitor for any potential material impact on our expected completion of enrollment. Investigators continued to enroll patients in the NCI-sponsored Phase 3 clinical trial designed to evaluate uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy, through March 2020.

GlycoMimetics and Apollomics announced an exclusive collaboration and license agreement for the development and commercialization of uproleselan and GMI-1687 in Mainland China, Hong Kong, Macau and Taiwan (Greater China).

GMI-1359

Duke University initiated a proof-of-concept Phase 1b study to evaluate GMI-1359 in patients with advanced breast cancer with bone metastases, and investigators dosed the first patient in January of this year. The trial is evaluating safety and pharmacodynamic biomarkers in individuals with hormone receptor positive metastatic breast cancer.

A new composition of matter and formulation patent was issued in the United States for GMI-1359, and the U.S. Food and Drug Administration (FDA) granted orphan drug and rare pediatric disease designations for the drug candidate for the treatment of osteosarcoma that may provide future development support and marketing protections.

Rivipansel

GlycoMimetics and Pfizer worked closely to prepare for the transfer back to GlycoMimetics of the rivipansel program following Pfizer’s April 2020 termination of the parties’ 2011 license agreement for clinical development and commercialization of rivipansel in sickle cell disease (SCD). The transfer, now complete, includes the return of all rights and licenses previously granted, as well as the rivipansel IND and the Phase 3 RESET study data set.

GlycoMimetics is committed to a detailed assessment of what, if any, next steps to take with respect to the rivipansel program after reviewing the Phase 3 clinical data.

First Quarter 2020 Financial Results

Cash position: As of March 31, 2020, GlycoMimetics had cash and cash equivalents of $154.8 million as compared to $158.2 million as of December 31, 2019. In January 2020, GlycoMimetics received an upfront cash payment of $9.0 million from Apollomics pursuant to the exclusive collaboration and license agreement for the development and commercialization of uproleselan and GMI-1687 in Greater China.

R&D Expenses: The Company’s research and development expenses increased to $12.7 million for the quarter ended March 31, 2020 as compared to $ 11.8 million for the first quarter of 2019. Clinical development expenses increased by $2.4 million based on the higher clinical costs related to the Company’s ongoing Phase 3 clinical trial of uproleselan in individuals with relapsed/refractory AML and the Phase 3 clinical trial being conducted by the NCI. In addition, personnel-related and stock-based

compensation expenses increased by $540,000 due to annual performance adjustments processed in the quarter ended March 31, 2020. These increases were offset in part by a $2.1 million decrease in manufacturing and formulation due to lower raw material expenses in the first quarter ended March 31, 2020 as compared to the first quarter ended March 31, 2019.

G&A Expenses: The Company’s general and administrative expenses increased to $4.4 million for the quarter ended March 31, 2020 as compared to $3.4 million for the first quarter of 2019. Personnel-related expenses increased by $684,000 due to additional general and administrative headcount and annual salary adjustments awarded in the first quarter of 2020. Patent, legal fees, consulting and other professional expenses, including director and officer’s insurance premiums, increased by $373,000 for the quarter ended March 31, 2020 as compared to March 31, 2019.

Shares Outstanding: Shares of common stock outstanding as of March 31, 2020 were 43,582,979.

The Company will host a conference call and webcast today at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 for domestic participants and (216) 562-0466 for international participants, with participant code 4567397. Participants are encouraged to connect 15 minutes in advance of the call to ensure that all callers are able to connect. A webcast replay will be available via the "Investors" tab on the GlycoMimetics website for 30 days following the call. A dial-in phone replay will be available for 24 hours after the close of the call by dialing (855) 859-2056 for domestic participants and (404) 537-3406 for international participants, participant code 4567397.

About Uproleselan and GMI-1687

Discovered and developed by GlycoMimetics, uproleselan and GMI-1687 are investigational, first-in-class, targeted inhibitors of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy Designation from the U.S. FDA for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed or refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better-than-expected remission rates and overall survival compared to historical controls, which have been derived from results from third-party clinical trials evaluating standard chemotherapy, as well as lower-than-expected induction-related mortality rates. Treatment in these patient populations was generally well-tolerated, with fewer than expected adverse effects.

GMI-1687 is a rationally designed, innovative antagonist of E-selectin that is potentially suitable for subcutaneous (SC) administration. When given by SC injection in preclinical models, GMI-1687 has been observed to have equivalent activity to uproleselan, but at an approximately 1,000-fold lower dose. GlycoMimetics believes that GMI-1687 could be developed as a potential life-cycle expansion to broaden the clinical usefulness of an E-selectin antagonist to conditions where outpatient treatment is preferred or required. GMI-1687 is currently undergoing IND-enabling studies.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion molecules involved in tumor trafficking and metastatic spread. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow such as AML and multiple myeloma or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer, as well as in osteosarcoma, a rare pediatric tumor. GMI-1359 has completed a Phase 1 clinical trial in healthy volunteers. The Duke University Phase 1b clinical study in breast cancer patients is designed to enable investigators to identify an effective dose of the drug candidate and to generate initial biomarker data around the drug’s activity. GMI-1359 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for the treatment of osteosarcoma, a rare cancer affecting about 900 adolescents a year in the United States.

On May 1, 2020 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported it will host a conference call to discuss the first quarter 2020 financial results and provide a corporate update on Thursday, May 7, 2020 at 4:30 p.m. Eastern/1:30 p.m. Pacific (Press release, Spectrum Pharmaceuticals, MAY 1, 2020, View Source [SID1234556896]).

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Conference Call and Webcast:

Thursday, May 7, 2020 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic: (877) 837-3910, Conference ID# 8470139

International: (973) 796-5077, Conference ID# 8470139

The conference call will also be available from the Investor Relations section of the company’s website at View Source and will be archived there shortly after the live event.