On August 21, 2020 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported that leadership will present at the 2020 Cross-Border Healthcare Webinar Series on Wednesday, August 26, 2020 (Press release, TYME, AUG 21, 2020, View Source [SID1234563956]). The Company will present its corporate overview with a focus on:

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Growth opportunities driven by advances in the science of cancer metabolism
Recently launched pivotal and late-stage trials in pancreatic cancer and a Phase II trial in high-risk sarcoma
Plans for expanding clinical programs for its lead candidate SM-88 (racemetyrosine) in prostate, breast and hematological cancers
Potential for development and commercialization of SM-88 and TYME-18 in Asia
Event: 2020 Virtual CHINABIO Partnering Forum

Topic: Evolving Science & Development of Cancer Metabolism-Based Therapies

Presentation Date: Wednesday, August 26, 2020

The presentation will be accessible on the events page under the investor relations section of Tyme Technologies’ website at www.tymeinc.com. There are no planned webcasts for this event.

About SM-88

SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events. Learn more.

About TYME-18

TYME-18 is composed of a proprietary surfactant delivery agent with a specific sulfonic acid component. It is designed for intra-tumoral administration of difficult to treat tumors and leverages the acidic tumor microenvironment and signaling pathways to kill cancer cells. TYME-18 is distinct in composition, but like SM-88, aims to leverage susceptibilities of a cancer that are related to its altered metabolism. Initial preclinical data for TYME-18 in animal tumor models demonstrate rapid and complete tumor regression, with no reported local or systemic toxicities. TYME-18 continues to be studied as a potential therapy for difficult to treat tumors that may not be eligible for surgical or other interventions. Learn more.

About TYME-88-Panc Pivotal Trial

The TYME-88-Panc pivotal trial applies the latest advances in the field of cancer metabolism by evaluating the efficacy and safety of an oral investigational compound that targets the metabolic mechanisms of the disease at its source. A prospective, open label pivotal trial in metastatic pancreatic cancer for patients who have failed two lines of any prior systemic therapy. The trial is designed to evaluate the safety and efficacy of SM-88 used with MPS (methoxsalen, phenytoin and sirolimus) in advanced pancreatic cancer and will measure multiple endpoints, including overall survival, progression free survival, relevant biomarkers, quality of life, safety, and overall response rate. Learn more.

On August 21, 2020 Ultimovacs ASA ("Ultimovacs", ticker ULTIMO), a pharmaceutical company developing novel immunotherapies against cancer, reported its second quarter 2020 results (Press release, Ultimovacs, AUG 21, 2020, View Source [SID1234563955]). A presentation by the company’s management team will take place today on a webcast at 09:00 CEST.

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The presentation can be followed as a live webcast (access through the link https://channel.royalcast.com/webcast/hegnarmedia/20200821_4/) which will also be available on our website.

Highlights for the second quarter of 2020:

The first patient in the INITIUM trial was enrolled in June, and a total of three patients have been enrolled as per reporting date. The first site in the INITIUM trial opened for patient inclusion in May. The INITIUM trial is a randomized, comparative, multi-center Phase II trial for evaluating UV1 as a treatment for first-line patients with metastatic malignant melanoma.
Similarly, the first patient in the NIPU trial was enrolled in June, and four patients are enrolled as per reporting date. The NIPU trial is a randomized, comparative, multi-center Phase II trial in which UV1 is investigated as a second-line treatment in mesothelioma.
In the US based Phase I trial in malignant melanoma, patient enrollment is now completed with all 10 patients in cohort 2 (dose finding GM-CSF) included. No unexpected safety issues have been observed to date.
The Covid-19 situation has so far had limited impact regarding site openings and patient inclusion. The longer-term effect of the pandemic on the biotech industry and the general ability to conduct clinical trials is still uncertain.
In May 2020, Ultimovacs announced a collaboration with a non-specified big pharma company and a leading European oncology clinical trial group to evaluate UV1 in a third Phase II clinical trial. More information is expected to be disclosed during the third quarter of 2020.
A private placement of new shares to fund the above-mentioned clinical trial was successfully completed in May 2020, raising gross proceeds of MNOK 160.
Carlos de Sousa was appointed the new CEO of Ultimovacs ASA effective 1 June 2020.
Cash flow from operations was MNOK -33.2 in Q2-20. With the proceeds from the private placement in May 2020, total cash and cash equivalents increased by MNOK 115.2 during Q2-20 and amounted to MNOK 483.2 as per 30 June 2020.
The report and presentation are also available on the company website: www.ultimovacs.com/investors/reports-and-presentations

On August 21, 2020 Allergan reported As part of its safety surveillance efforts, the FDA has published new data on harmful side effects associated with breast implants, including certain cases of cancer as well as what patients have termed "breast implant illness"—a collection of symptoms that can include fatigue, memory loss, confusion, rashes and joint pain (Press release, Allergan, AUG 21, 2020, View Source [SID1234563954]).

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The agency’s analysis covers medical device reports through the latter half of 2019, adding 160 new cases and three deaths due to breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, a cancer of the immune system typically found in the scar tissue and fluid surrounding an implant.

This brings the FDA’s worldwide total up to 733 cases and 36 deaths, including 620 cases tied to implants manufactured by Allergan, the agency said.

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In late July 2019, Allergan launched a global recall of its textured breast implants—including in its Biocell and Natrelle product lines of saline- and silicone-filled implants and tissue expanders—after the FDA saw a spike in BIA-ALCL cases, which the agency has been tracking since 2011.

While the overall incidence of BIA-ALCL is low, the cancer can be fatal if not diagnosed and treated early, according to the FDA, such as with surgery to remove the implant and the surrounding scar tissue or with radiation and chemotherapy.

RELATED: Allergan receives FDA warning over recalled breast implant safety studies

"The FDA has been diligently monitoring adverse events associated with breast implants for decades and has been working to better understand the quality of life and satisfaction a breast reconstruction patient may experience in order to refine our evaluation of breast implant benefits and risks," said Binita Ashar, director of the agency’s Office of Surgical and Infection Control Devices.

Meanwhile, reports of the systemic signs and symptoms referred to as breast implant illness totaled nearly 2,500 across the 12 months from November 2018 to October 2019, the FDA said.

RELATED: FDA sends warning letters to breast implant manufacturers as safety probe continues

That’s a steep jump from the 1,080 reports the agency received over the decade-plus spanning January 2008 to October 2018. The FDA attributes the increase in part to growing awareness of the condition driven by the press, social media and the agency’s public meetings on the subject.

According to the FDA, the top 10 most common symptoms reported by patients with breast implants include fatigue (49%), brain fog (25%), joint pain (25%), anxiety (24%), hair loss (21%), depression (19%), rash (18%), autoimmune diseases (18%), inflammation (18%) and weight problems (18%).

"While the FDA doesn’t have definitive evidence demonstrating breast implants cause these symptoms, the current evidence supports that some patients experience systemic symptoms that may resolve when their breast implants are removed," the agency said.

On August 21, 2020 Oncology Venture A/S (Nasdaq First North Stockholm: OV.ST) ("OV" or the "Company") reported that it has called upon Global Corporate Finance (GCF) to invest in the Company in a directed share issue in accordance with the Company’s share subscription agreement with GCF (Press release, Oncology Venture, AUG 21, 2020, View Source [SID1234563940]). A total of 5,980,020 shares at a price per share of SEK 1.3420441 is issued to Global Corporate Finance.

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The share price is fixed at SEK 1.3420441 per share of nominal DKK 0.05 share and has been calculated as 95% of the daily volume weighted average price (VWAP) of the Company’s shares for the five (5) consecutive trading days following 11 August 2020, the date of the draw down notice from OV.

The registered share capital of Oncology Venture will after the conversion be nominal DKK 9,587,717.55 divided into 191,754,351 shares of nominal DKK 0.05 each.

The investment is the second investment tranche Oncology Venture has requested from Global Corporate Finance (New York City, NY, U.S.). Oncology Venture may call upon up to a total investment of SEK 50 million in a series of tranches, no single tranche may exceed SEK 10 million.

For further information on the conditions and structure of the financing agreement; please, refer to the press release concerning the agreement published by Oncology Venture on May 6, 2020.

On August 21, 2020 Kintara Therapeutics, Inc. (formerly DelMar Pharmaceuticals, Inc.) ("Kintara" or the "Company") (Nasdaq: KTRA) reported that it has entered into definitive agreements with investors providing for the sale and issuance of up to 2,435 shares of its Series C Convertible Preferred Stock (the "Preferred Stock") at a purchase price of $1,000 per share in a private placement offering priced at-the-market under the rules of the Nasdaq Stock Market (Press release, Kintara Therapeutics, AUG 21, 2020, View Source [SID1234563939]). The Preferred Stock is convertible into shares of Kintara common stock at a conversion price of $1.214 per share. The offering is expected to result in gross proceeds to Kintara of up to approximately $2.4 million which is in addition to the $19.6 million previously announced. The Preferred Stock accrues dividends as previously announced.

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The private placement is expected to close on or about August 24, 2020, subject to the satisfaction of customary closing conditions.

The Company intends to use the net proceeds from the offering for the previously announced registration study for VAL-083 in newly diagnosed and recurrent glioblastoma multiforme (GBM), the 15-patient REM-001 confirmatory lead-in study intended to continue seamlessly into a full Phase 3 pivotal study for Cutaneous Metastatic Breast Cancer (CMBC), and for working capital. Also, as previously disclosed, the GBM trial will be executed through the Company’s partnership with Global Coalition for Adaptive Research (GCAR) through the Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) Study, an adaptive clinical trial platform in GBM.

The shares of Preferred Stock described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "Act"), and, along with the common shares issuable upon their exercise or payable as dividends pursuant to the Preferred Stock, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.