On March 14, 2019 DXC Technology (NYSE: DXC) reported that it has received notice of an unsolicited "mini-tender" offer by TRC Capital Corporation to purchase up to two million shares of DXC’s common stock at a price of $63.63 per share in cash (Press release, DynPort Vaccine Company, MAR 14, 2019, View Source [SID1234534345]). The offering price is 4.56 percent below the closing price per share of DXC’s common stock on February 22, 2019, the last trading day before the tender offer commenced. The offer is for approximately 0.75 percent of the outstanding shares of DXC’s common stock.

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DXC does not endorse TRC Capital’s unsolicited mini-tender offer and recommends that stockholders reject the offer of TRC Capital and not tender their shares. DXC is not associated with TRC Capital, its mini-tender offer or the mini-tender offer documentation.

Mini-tender offers are not subject to many of the investor protections afforded to larger tender offers, including the filing of disclosure and other tender offer documents with the U.S. Securities and Exchange Commission (SEC) and other procedures mandated by U.S. securities laws.

The SEC has cautioned investors that some bidders making mini-tender offers at below-market prices are, "hoping that they will catch investors off guard if the investors do not compare the offer price to the current market price." The SEC’s guidance to investors on mini-tender offers is available at View Source TRC Capital has made many similar unsolicited mini-tender offers for shares of other public companies.

Stockholders should obtain current market quotations for their shares, consult with their broker or financial advisor, and exercise caution with respect to TRC Capital’s mini-tender offer. DXC recommends that stockholders who have not responded to TRC Capital’s offer take no action. Stockholders who have already tendered their shares may withdraw them at any time prior to 12:01 a.m., New York City time, on March 26, 2019, in accordance with TRC Capital’s offering documents.

DXC encourages brokers and dealers, as well as other market participants, to review the SEC’s letter regarding broker-dealer mini-tender offer dissemination and disclosure at View Source

DXC requests that a copy of this press release be included with all distributions of materials relating to TRC Capital’s mini-tender offer for shares of DXC common stock.

On March 14, 2019 VBL Therapeutics (Nasdaq: VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, reported that it will host a conference call and live audio webcast on Thursday, March 28th at 8:30am Eastern Time to report fiscal year ended December 31, 2018 financial results and to provide a corporate update (Press release, VBL Therapeutics, MAR 14, 2019, View Source [SID1234534346]).

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Thursday, March 28th @ 8:30am Eastern Time
From the US: 877-407-9208
International: 201-493-6784
Conference ID: 13687581
Webcast: View Source

On March 14, 2019 Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported financial results for the fourth quarter and full year ended December 31, 2018 and provided a corporate update (Press release, Harpoon Therapeutics, MAR 14, 2019, View Source [SID1234534357]).

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"The past year included achievement of significant clinical, scientific and operational milestones for Harpoon Therapeutics," said Gerald McMahon Ph.D., President and Chief Executive Officer of Harpoon Therapeutics. "T cell engagers are gaining momentum as exciting immuno-oncology therapies and Harpoon has built a proprietary TriTAC platform to take this approach to a new level. HPN424 has entered a Phase 1 clinical trial in prostate cancer and HPN536 is poised to enter clinical development for ovarian and other mesothelin (MSLN) expressing tumors in the near future, followed by HPN217 targeting B cell maturation antigen (BCMA) for the potential treatment of multiple myeloma. In addition, we successfully completed our initial public offering in February, an important milestone in the company’s history which further strengthened our balance sheet."

"Our scientific expertise has led to the discovery and development of three TriTACs on paths for clinical development. We are pleased to announce today that we have selected an additional drug candidate, targeting DLL3, for potential clinical development in small cell lung cancer," said Holger Wesche, Chief Scientific Officer of Harpoon. "This candidate, HPN328, has entered IND-enabling studies and we expect a Phase 1 trial to begin in 2020."

2018 Business Highlights

Advanced our lead TriTAC product candidate, HPN424 into a Phase 1 clinical trial in prostate cancer. Utilizing its proprietary TriTAC platform, Harpoon has developed HPN424, a half-life extending T cell engager specifically designed to target prostate specific membrane antigen, or PSMA, for the treatment of prostate cancer. PSMA is present in 80-95% of patients with advanced prostate cancer. In July, Harpoon filed an IND for HPN424 and in August, commenced a Phase 1 trial. The Phase 1 trial is designed to enroll patients with progressive metastatic castration-resistant prostate cancer (mCRPC) in two parts, dose escalation and dose expansion. The company is currently enrolling patients in the dose escalation part of the trial.
Advanced two additional TriTAC product candidates, creating a robust development pipeline. The company’s proprietary TriTAC platform was designed to advance the therapeutic potential of T cell engagers, with a proprietary half-life extended format. Harpoon achieved multiple development milestones with its TriTAC pipeline in 2018 and intends to have four TriTACs in on-going clinical trials by the end of 2020.
HPN536 is a mesothelin-targeting TriTAC, designed as a potential therapy for ovarian cancer and other solid tumors. Mesothelin, a clinically validated target, is expressed on malignant cells of ovarian cancer, mesothelioma, pancreatic carcinoma, non-small cell lung cancer and triple-negative breast cancer, among others. Harpoon submitted the IND for HPN536 in December and received FDA clearance in January 2019. Harpoon anticipates a Phase 1/2a trial will commence in the first half 2019.
HPN217 is a TriTAC that targets BCMA and is in preclinical development for the potential treatment of multiple myeloma. At the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, the company released new preclinical data for HPN217 which demonstrated BCMA- and T cell-dependent antitumor activity in tissue culture and in xenografts modeling multiple myeloma and lymphoma. Harpoon expects to file an IND for HPN217 later this year.
Harpoon raised approximately $89.7 million in two financings in 2018. In November, the company closed a Series C equity financing, receiving $69.7 million in net proceeds. In July, in connection with the successful filing of the IND for HPN424, Harpoon received $20.0 million in net proceeds for closing the second tranche of its Series B equity financing.
Harpoon broadened its leadership team, adding expertise to support clinical development and public company readiness. Additions in 2018 included the appointments of Georgia Erbez as Chief Financial Officer and Natalie Sacks, M.D., as Chief Medical Officer. Holger Wesche, Ph.D., was promoted to Chief Scientific Officer. The leadership team at Harpoon has proven expertise in drug development, spanning early-stage development of oncology therapies through commercialization.
Expanded the board with the appointment of three independent directors: Jonathan Drachman, M.D., former Chief Medical Officer, Seattle Genetics; Scott Myers, Chairman and Chief Executive Officer, Rainier Therapeutics; and Julie Eastland, Chief Business and Financial Officer, Rainier Therapeutics. These board members, along with the existing directors, provide a wealth of experience in drug development, financial strategy and business development.
Recent Developments

In January 2019, Harpoon announced preliminary data for HPN424 that suggested HPN424 activated T cells in a manner that is consistent with target engagement. In addition, early evidence suggested that there was sufficient drug exposure during the treatment course to support once-weekly dosing. Side effects were consistent with T cell activation and were managed clinically.
In February 2019, Harpoon successfully completed its initial public offering, raising net proceeds of approximately $70.7 million.
Harpoon reported the designation of its fourth TriTAC in development, HPN328, for the potential treatment of small cell lung cancer (SCLC). HPN328 targets DLL3, a protein highly expressed in a majority of SCLC tumors but not in normal tissue. This selective expression makes DLL3 an attractive drug target for T cell engagers. Harpoon is currently conducting IND-enabling studies and expects to initiate a Phase 1 clinical trial of HPN328 in 2020.
Anticipated Milestones

Harpoon plans to have three TriTAC product candidates in the clinic by the end of 2019, with a fourth expected in 2020, as follows:

HPN424 – present additional Phase 1 data in the second half of 2019 at a medical conference
HPN536 – initiate Phase 1/2a trial in the first half of 2019
HPN217 – initiate Phase 1 trial in the second half of 2019
HPN328 – initiate Phase 1 trial in 2020
Fourth Quarter and Full Year 2018 Financial Results

Harpoon Therapeutics ended 2018 with $89.5 million in cash and cash equivalents compared to $29.4 million as of December 31, 2017. Net cash provided by financing activities for the year ended December 31, 2018 was $88.3 million, primarily comprised of $69.7 million in net cash proceeds received from the November 2018 issuance of Series C convertible preferred stock and $20.0 million in net cash proceeds received from the July 2018 issuance of Series B convertible preferred stock as a result of the IND filing for HPN424. Net cash used in operations for the year ended December 31, 2018 was $27.1 million.
Net loss for the fourth quarter ended December 31, 2018 was $9.7 million compared to $4.9 million for the fourth quarter ended December 31, 2017. Net loss for the year ended December 31, 2018 was $27.4 million, compared to $16.8 million for the prior year.
Revenue for the fourth quarter ended December 31, 2018 was $1.1 million compared to $0.7 million for the fourth quarter ended December 31, 2017. Revenue for the year ended December 31, 2018 was $4.8 million, compared to $0.7 million for the prior year. During both periods, the revenue primarily consisted of the amortized portion of the deferred $17.0 million upfront payment received in October 2017 under a collaboration agreement with AbbVie.
Research and development expense for the fourth quarter ended December 31, 2018 was $8.7 million compared to $4.8 million for the fourth quarter ended December 31, 2017. R&D expense for the year ended December 31, 2018 was $26.4 million, compared to $13.6 million for the prior year. The increases in both comparative periods were primarily due to clinical development expenses and an increase in personnel-related expenses, including conducting preclinical studies, initiating the first clinical trial for lead product candidate, HPN424, and manufacturing activities for four TriTAC product candidates in various stages of development.
General and administrative expense for the quarter ended December 31, 2018 was $2.2 million compared to $0.9 million for the quarter ended December 31, 2017. General and administrative expenses for the year ended December 31, 2018 were $6.1 million, compared to $3.6 million for the prior year. The increases over both comparative periods were primarily due to an increase in consulting and accounting services related to quarterly reviews and year-end audits and an increase in headcount.
Conference Call Information

Harpoon will host a conference call and live audio webcast this afternoon at 1:30 p.m. PT / 4:30 p.m. ET to discuss the fourth quarter and full year 2018 financial results and provide a corporate update.

The live call may be accessed by dialing 866-951-6894 for domestic callers and 409-261-0624 for international callers and using conference ID: 2497976. A live webcast of the call will be available online from the investor relations section of the Harpoon Therapeutics website at View Source

An archived replay of the webcast will be available on Harpoon Therapeutics’ website shortly after the conference call.

On March 14, 2019 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a clinical-stage pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for selinexor (Press release, Karyopharm, MAR 14, 2019, View Source [SID1234534323]). The NDA, which is currently under Priority Review by the FDA, is seeking accelerated approval for selinexor in combination with dexamethasone for the treatment of patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor (PI), one immunomodulatory agent (IMiD), and one anti-CD38 monoclonal antibody. The previously disclosed April 6, 2019 PDUFA date has been extended by three months to July 6, 2019.

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On February 26, 2019, the FDA’s Oncologic Drugs Advisory Committee (ODAC) met to discuss the selinexor NDA and voted 8 to 5 recommending that the FDA wait for the results from Karyopharm’s randomized, open-label, Phase 3 BOSTON study evaluating selinexor in patients with relapsed or refractory multiple myeloma, before making a final decision regarding approval. Although the FDA considers the recommendation of this panel, the final decision regarding the approval of the product is made by the FDA solely, and the recommendations by the panel are non-binding.

Following the ODAC meeting, at the FDA’s request, Karyopharm submitted additional, existing clinical information as an amendment to the NDA, which allowed the FDA to extend the PDUFA action date by three months. "We look forward to the continued collaboration with FDA in trying to meet the needs of patients with relapsed refractory multiple myeloma," said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm.

About Selinexor

Selinexor is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. In 2018, Karyopharm reported positive data from the Phase 2b STORM study evaluating selinexor in combination with low-dose dexamethasone in patients with triple class refractory multiple myeloma who have been previously exposed to all five of the most commonly prescribed anti-myeloma therapies currently available. Selinexor has been granted Orphan Drug Designation in multiple myeloma and Fast Track designation for the patient population evaluated in the STORM study. Karyopharm’s New Drug Application (NDA) has been accepted for filing and granted Priority Review by the FDA, and oral selinexor is currently under review by the FDA as a possible new treatment for patients with triple class refractory multiple myeloma. The Company has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval and was granted accelerated assessment. Selinexor is also being studied in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). In 2018, Karyopharm reported positive top-line results from the Phase 2b SADAL study evaluating selinexor in patients with relapsed or refractory DLBCL after at least two prior multi-agent therapies and who are ineligible for transplantation, including high dose chemotherapy with stem cell rescue. Selinexor has received Fast Track designation from the FDA for the patient population evaluated in the SADAL study. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade (bortezomib) and low-dose dexamethasone (BOSTON), as a potential backbone therapy in combination with approved therapies (STOMP), in liposarcoma (SEAL), and an investigator-sponsored study in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

On March 14, 2019 Constellation Pharmaceuticals presented a presentation named "March 2019 Developing Next-Generation Epigenetic Treatments for Cancer Patients Corporate Overview" (Presentation, Constellation Pharmaceuticals, MAR 14, 2019, View Source [SID1234534382]).

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