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NeuBase Therapeutics Announces Closing of Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On April 30, 2020 NeuBase Therapeutics, Inc. (Nasdaq: NBSE), a preclinical-stage biotechnology company focused on developing next generation therapies to treat rare genetic diseases caused by mutant genes, reported the closing of its previously announced underwritten public offering of 6,037,500 shares of its common stock (inclusive of 787,500 shares that were sold pursuant to the underwriters’ full exercise of their option to purchase additional shares of NeuBase’s common stock), at a price to the public of $6.00 per share (Press release, NeuBase Therapeutics, APR 30, 2020, View Source [SID1234556834]). The net proceeds to NeuBase from the offering are expected to be approximately $33.3 million, after deducting the underwriting discounts and commissions and other estimated offering expenses payable by NeuBase. NeuBase intends to use the net proceeds from this offering for working capital and general corporate purposes and to advance the development of its product candidates and expand its pipeline.

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Oppenheimer & Co. Inc. and BTIG acted as the joint book-running managers for the offering, and Chardan and National Securities Corporation, a wholly-owned subsidiary of National Holdings, Inc. (Nasdaq: NHLD), acted as the co-managers.

The securities described above were offered by NeuBase pursuant to a shelf registration statement on Form S-3 (File No. 333-220487) previously filed with the Securities and Exchange Commission (the "SEC") on September 15, 2017 and declared effective by the SEC on September 27, 2017. A final prospectus supplement and the accompanying prospectus relating to and describing the offering was filed with the SEC. Electronic copies of the preliminary prospectus supplement and, when available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained by visiting the SEC’s website at www.sec.gov or by contacting Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, by telephone at (212) 667-8055 or by e-mail at [email protected], or BTIG, LLC, Attention: Equity Capital Markets, 65 East 55th Street, New York, NY 10022, by telephone at (212) 593-7555 or by e-mail at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

Aeglea BioTherapeutics Announces Closing of Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On April 30, 2020 Aeglea BioTherapeutics, Inc. (Nasdaq:AGLE), a clinical-stage biotechnology company developing next-generation human enzyme therapeutics as solutions for rare and other high-burden diseases, reported the closing of its public offering of 15,442,303 shares of its common stock at a public offering price of $4.75 per share, which includes the exercise in full of the underwriters’ option to purchase 3,789,473 shares of common stock (Press release, Aeglea BioTherapeutics, APR 30, 2020, View Source [SID1234556833]). In addition, and in lieu of common stock, Aeglea sold to certain investors pre-funded warrants to purchase up to an aggregate of 13,610,328 shares of common stock at a purchase price of $4.7499 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.0001 per share exercise price for each such pre-funded warrant. The aggregate gross proceeds to Aeglea, before deducting underwriting discounts and commissions and estimated offering expenses payable by Aeglea, were approximately $138 million.

J.P. Morgan Securities LLC, Evercore Group L.L.C. and Piper Sandler & Co. acted as joint book-running managers in the offering. JonesTrading Institutional Services LLC and Needham & Company, LLC acted as co-managers.

The securities described above were offered by Aeglea pursuant to a registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering was made only by means of the written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering were filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying base prospectus may also be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by e-mail at: [email protected]; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Aeglea, 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.

Invitation to MorphoSys’ First Quarter 2020 Results Conference Call on May 7, 2020

On April 30, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) reported that it will publish its results for the first quarter of 2020 on May 6, 2020 at 10:00pm CEST (9:00pm BST; 4:00pm EDT) (Press release, MorphoSys, APR 30, 2020, View Source [SID1234556832]).

MorphoSys’ Management team will host a conference call and webcast on May 7, 2020 at 2:00pm CEST (1:00pm BST; 8:00am EDT) to present MorphoSys’ results for the first quarter and provide a financial and operational outlook for 2020.

Date of the conference call: Thursday, May 7, 2020
Time: 2:00pm CEST (1:00pm BST, 8:00am EDT)
Dial-in numbers:
Germany: +49 69 201 744 220
United Kingdom: +44 203 009 2470
USA: +1 877 423 0830
(all numbers reachable from any geography)
Participant PIN: 14809293#

Participants are kindly requested to dial in up to 10 minutes before the call to ensure a secure line and a prompt start.

The presentation slides and webcast link will be available at the Company’s website at View Source

A replay of the conference will also be available at the corporate website following the live event.

CHMP Issues Positive Opinion Recommending Subcutaneous Formulation of Daratumumab for the Treatment of Patients with Multiple Myeloma

On April 30, 2020 Genmab A/S (Nasdaq: GMAB) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending the use of the subcutaneous formulation of daratumumab for the treatment of adult patients with multiple myeloma in frontline and relapsed / refractory settings (Press release, Genmab, APR 30, 2020, View Source [SID1234556831]). The CHMP’s Positive Opinion for the subcutaneous formulation of daratumumab applies to all currently approved daratumumab indications in frontline and relapsed / refractory multiple myeloma settings. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

"We are very pleased with this Positive Opinion from the CHMP as it potentially brings the convenient dosing of subcutaneous daratumumab closer to becoming available for multiple myeloma patients in Europe," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The Marketing Authorization Application for this formulation was submitted to the EMA by Janssen Pharmaceutica NV in July 2019 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 certain standard multiple myeloma regimens. The topline results from the COLUMBA data 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. Updated data of the COLUMBA and the PLEIADES studies were presented during poster sessions at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2019.

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 1800 mg daratumumab with rHuPH20 2000 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; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; 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 autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; 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, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. 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.

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, resulting 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, NKT-cell lymphoma and T-cell 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.

IMV ANNOUNCES PROPOSED $22.3 MILLION PRIVATE PLACEMENT

On April 30, 2020 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company, reported its intention to complete a private placement (the "Private Placement") of 7,797,203 units of the Company (each, a "Unit") at the market price of Cdn$2.86 per Unit based on the volume-weighted average price calculated over the 5 days ending Friday, April 24, 2020 (Press release, IMV, APR 30, 2020, View Source [SID1234556830]).

With aggregate gross proceeds of approximately Cdn$22.3 million this non-brokered private placement is being co-led by Fonds de Solidarité FTQ, an existing investor, and Lumira Ventures, a new investor in the Company, along with participation by Altium Capital, also a new investor in IMV and including other institutional investors. The Company intends to use the net proceeds from the Private Placement for the clinical development of its lead candidate, DPX-Survivac, currently being assessed in advanced ovarian cancer, as well as in multiple clinical studies in combination with Merck’s Keytruda. The balance of the net proceeds will be used for general corporate purposes, including funding research and development, preclinical and clinical expenses, and corporate costs.

Each Unit will consist of one common share of the Company ("Common Share") and 0.35 of one common share purchase warrant (each whole common share purchase warrant, a "Warrant"). Each Warrant will have an exercise price of Cdn$3.72 and will be exercisable until 24 months after its issuance.

The Company anticipates that the Private Placement will close on or about May 7, 2020. The Private Placement is conditional upon the Company receiving the conditional approval of the Toronto Stock Exchange (the "TSX") to list the Common Shares underlying the Units and the Warrants on the TSX. Listing will be subject to satisfying all of the requirements of the TSX. The Private Placement is also subject to the requirements of the NASDAQ Stock Market ("NASDAQ").

All securities issued pursuant to the Private Placement will be subject to a four month and one day hold period in Canada in accordance with applicable securities laws.