On June 8, 2020 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company" or "Pulse Biosciences"), a novel bioelectric medicine company, reported preliminary results of its rights offering, which expired at 5:00 p.m. Eastern Time on June 8, 2020 (the "Expiration Date") (Press release, Pulse Biosciences, JUN 8, 2020, View Source [SID1234560918]).

In accordance with the pricing structure described in the prospectus relating to the rights offering, the final subscription price for the units offered (the "Units") is $7.01 per Unit, which is the initial price established at commencement of the rights offering. Each Unit consisted of one share of the Company’s common stock, par value $0.001 per share, and 0.15 warrants to purchase shares of common stock. Each warrant will be exercisable for one share of the Company’s common stock at an exercise price that shall be equal to $7.01, the subscription price for the Units. Warrants are exercisable immediately and expire on the fifth anniversary of the completion of this rights offering.

Based on a preliminary tabulation by Broadridge Corporate Issuer Solutions, Inc. (the "Subscription Agent"), as of the Expiration Date, the Company received basic subscriptions and over-subscriptions exceeding the maximum number of up to 4,279,600 Units offered in the rights offering. Available Units will be allocated proportionately among rights holders who exercised their over-subscription right based on the number of Units each rights holder subscribed for under their basic subscription rights, in accordance with the procedures described in the prospectus relating to the rights offering. The common stock and warrants comprising the Units will separate upon the closing of the rights offering and will be issued individually. The Company expects the Subscription Agent to distribute such shares and warrants, as well as the sale proceeds, on or about June 11, 2020.

The Company will receive aggregate gross proceeds from the rights offering of $30 million, excluding proceeds of up to $4.5 million from the exercise of warrants issued in the rights offering (if any such exercises occur). The results of the rights offering are preliminary and subject to change pending finalization of subscription procedures by the Subscription Agent.

A registration statement, as amended, relating to the Units was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on May 8, 2020. A prospectus relating to the offering was filed with the SEC on May 14, 2020 and is available on the SEC’s website. Subscription rights that were not exercised by 5:00 p.m. Eastern Time on June 8, 2020 have expired.

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On June 8, 2020 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it has rescheduled its investor conference call to discuss data presented at the European Hematology Association (EHA) (Free EHA Whitepaper) EHA (Free EHA Whitepaper)25 Virtual Congress to 12 June 2020 at 7:30 am EDT, 12:30 pm BST (Press release, Autolus, JUN 8, 2020, View Source [SID1234560937]). This call was previously announced and scheduled for 15 June 2020.

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On the call Dr. Christian Itin, chairman and chief executive officer, along with the AUTO1 and AUTO3 clinical teams, will discuss presentations related to the company’s AUTO1 and AUTO3 programs, CAR T cell therapies being investigated in Phase 1/2 studies of adult Acute Lymphocytic Leukemia (ALL) and relapsed/refractory Diffuse Large B Cell Lymphoma (DLBCL), respectively.

Investor call on Friday June 12, 2020

Management will host a conference call and webcast at 7:30 am EDT/12:30 pm BST to discuss the EHA (Free EHA Whitepaper) data. To listen to the webcast and view the accompanying slide presentation, please go to: View Source

On June 8, 2020 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that it will host a key opinion leader (KOL) call on intratumoral therapy with self-delivering RNAi at 8 a.m. ET on Friday, June 12, 2020 (Press release, Phio Pharmaceuticals, JUN 8, 2020, View Source [SID1234560902]).

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The call will feature a presentation by KOL Professor Caroline Robert, M.D., Ph.D., of the Gustave Roussy Institute, on the promising new avenues to treat melanoma patients. Surgery combined with adjuvant immunotherapy remains the current standard of care for locally advanced melanoma, however, it is associated with both a high risk of recurrence and significant drug toxicities. Due to these risks, there has been increased interest in novel treatment options such as neoadjuvant immunotherapy and intratumoral immunotherapy. The presentation will include the scientific and clinical rationale for intratumoral neoadjuvant therapy and the role that INTASYL technology can play in such therapeutic approaches. Dr. Robert will also provide an overview of the design for a planned study for the neoadjuvant use of PH-762 administered by intratumoral injection in patients with advanced resectable melanoma. Dr. Robert will be available to answer questions at the conclusion of the call.

In addition, the Phio management team will provide a corporate update on its PH-762 pipeline product as it relates to the planned clinical study. The Company will also discuss recently published data exemplifying that INTASYL based products are ideally suited for novel therapeutic approaches such as neoadjuvant intratumoral immunotherapy.

KOL Call Details:

Topic:

Intratumoral neoadjuvant therapy with self-delivering RNAi

KOL (speaker):

Professor Caroline Robert, M.D., Ph.D., Head of the Dermatology Unit at Gustave
Roussy and co-director of the Melanoma Research Unit at INSERM 981 Paris-Sud
University

Date:

Friday, June 12th @ 8am Eastern Time

Dial-in numbers:

1-877-407-4018 (U.S. domestic) / 1-201-689-8471 (international)

Conference ID:

13703530

Webcast:

Click Here for Webcast

Caroline Robert, M.D., Ph.D., is the Head of the Dermatology Unit at Gustave Roussy and co-director of the Melanoma Research Unit at INSERM 981 Paris-Sud University. She trained at the Paris V University, France, and completed a research fellowship at Harvard, Brigham & Women’s hospital in Cancer Immunology and Immunotherapy. She chaired the melanoma group of the European Organization for the Research and Treatment of Cancer (EORTC) from 2014 to 2017 and she is a board member for the European Association of Onco-Dermatology (EADO), the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper), the European Association of Dermato-Venereology (EADV) the French society of Dermatology and Venereology (SFD), the American Society of Oncology (ASCO) (Free ASCO Whitepaper) and the American Association of Clinical Research (AACR) (Free AACR Whitepaper). Her main focuses of interest are clinical and translational research on melanoma, immunotherapy and targeted therapy, as well as the study of the cutaneous adverse events of anticancer agents. Dr. Robert has coordinated many national and international clinical trials of targeted therapy and immunotherapy for melanoma patients, from phase I to III. She has authored more than 325 articles in peer-reviewed scientific journals, including several publications on new treatments for metastatic melanoma. Her recent work has focused on identification of new biomarkers for immunotherapy and targeted therapies of patients with melanoma.

On June 8, 2020 Helsinn, a Swiss pharmaceutical group focused on building quality cancer care and rare diseases products, reported that on April 1, 2020 the U.S. Food and Drug Administration (FDA) completed the review of the Investigational New Drug (IND) application for TAS0953/HM06 and released a "Study May Proceed" letter for the Phase 1/2 Study of TAS0953/HM06 in Patients with Advanced Solid Tumors with RET Gene Abnormalities (Press release, Helsinn, JUN 8, 2020, View Source [SID1234560919]).

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The study is intended to be conducted globally and is due to commence in the third quarter of 2020.

TAS0953/HM06 is being developed together with its partner Taiho Pharmaceutical Co., Ltd. In 2017, Helsinn and Taiho signed a global co-development and commercialization agreement for TAS0953/HM06.

TAS0953/HM06 is an investigational oral treatment which inhibits several RET abnormalities identified as oncogenic driver alterations in NSCLC, papillary and medullary thyroid cancers, and several other tumor types. This innovative drug candidate offers several differentiating features as compared to other RET inhibitors.

Sergio Cantoreggi, Group Chief Scientific Officer and Head of R&D at Helsinn, commented: "Helsinn and Taiho have been working closely together as part of a global development partnership and we’re delighted to have reached this latest milestone that will allow us to start treating patients with TAS0953/HM06 in a Phase 1/2 clinical trial starting in the next quarter. We are excited by the potential of TAS0953/HM06 to treat NSCLC and other tumors which harbor RET abnormalities and look forward to working with Taiho to progress the treatment through the clinic."

TAS0953/HM06 is an investigational agent and is not approved for commercial use in any country.

About TAS0953/HM06

TAS0953/HM06 is an oral RET inhibitor in development for advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) and other tumors which express RET gene abnormalities. Preclinical data showed several differentiating features in comparison to other targeted therapies acting on RET abnormalities.

Taiho and Helsinn signed a co-development and commercialization agreement for TAS0953/HM06 in 2017 and will continue to pursue together all preclinical, clinical and CMC developments. This alliance also includes efforts to reach as many patients as possible around the world through their own commercial infrastructures or through valued partners.

About RET abnormalities in NSCLC and other cancers1

RET kinase abnormalities have been identified as targetable oncogenic drivers in NSCLC, papillary and medullary thyroid cancers, and several other tumor types. In NSCLC, RET fusions are more common in younger patients with no prior history of smoking and in those with adenocarcinomas, however the underlying mechanisms remain unknown.

1Helsinn and Taiho research and analysis of ASCO (Free ASCO Whitepaper) 2018; ASCO (Free ASCO Whitepaper) 2019; Cancer Biol Ther 2015; Cell Rep 2017; JCO 2018; Johns Hopkins 2019; Nat Med 2012; Nat Rev Clin Oncol 2018; OMIM; Onco Targets Ther 2019

On June 8, 2020 Oasmia Pharmaceutical AB reported that partnered with the Swiss Group for Clinical Cancer Research (SAKK) to conduct the first clinical trial of Oasmia’s docetaxel micellar compound in advanced prostate cancer (Press release, Oasmia, JUN 8, 2020, View Source [SID1234560887]). Prostate cancer in men is a significant health problem worldwide and is a leading cause of cancer death in men. Oasmia’s docetaxel micellar formulation uses Oasmia’s proprietary solubility technology platform enabling the intravenous administration of water-insoluble compounds without traditional solubility enhancers. Oasmia’s solubility technology platform has been utilized in another product, Apealea, which has obtained Marketing Authorization in the EU in 2018, in combination with carboplatin for the treatment of adult patients with first relapse of platinum-sensitive ovarian cancer.

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Docetaxel (INN) is a widely approved anticancer drug with proven activity against a wide range of solid malignancies and represents a standard of care option for advanced prostate cancer. The new Oasmia formulation of docetaxel, to be investigated in this clinical trial, docetaxel micellar, is intended to improve the solubility of docetaxel and avoid the mandatory use of steroid pre-medication.

The Executive Board of SAKK was unanimous in making the decision to carry out the clinical trial. In view of the urgent need for new treatment options in this disease stage, affecting many men all over the world, several Swiss qualified hospital centres have confirmed their participation in this initial study in patients suffering from advanced prostate cancer.

Pursuant to the collaboration agreement, SAKK is the legal sponsor of the project and responsible to conduct the phase 1B trial in accordance with the protocol and applicable rules and regulations. Oasmia’s main role in the project is to supply its formulation of docetaxel and carry the cost of the trial, which are deemed not material to Oasmia.

Prof.Dr. med. Markus Jörger MD-PhD, President of the SAKK Project Group "Developmental Therapeutics", commented on the trial: "The investigational drug docetaxel micellar may be a promising alternative to solvent-based docetaxel formulations in advanced prostate cancer, to avoid mandatory use of steroid premedication".

Francois Martelet, M.D., CEO of Oasmia, comments: "We are pleased to enter into this agreement. It provides an cost-efficient opportunity to test our formulation in collaboration with SAKK, an organization with extensive clinical trial experience, and take us further in our goal to develop new drugs based on our proprietary technology platform XR17."