ESSA Pharma Enters into At-The-Market Equity Offering Sales Agreement

On April 13, 2020 ESSA Pharma Inc. ("ESSA", or the "Company") (Nasdaq: EPIX, TSX-V: EPI), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported that it has entered into an Open Market Sale AgreementSM (the "ATM Sales Agreement") with Jefferies LLC, effective as of April 13, 2020 (Press release, ESSA, APR 13, 2020, View Source [SID1234556265]). Under the ATM Sales Agreement, ESSA may sell its common shares in the capital of the Company from time to time for up to US$35.0 million in aggregate sales proceeds in "at-the-market" transactions. No offers or sales of common shares will be made in Canada, to anyone known by Jefferies, LLC to be a resident of Canada or on or through the facilities of the TSX Venture Exchange ("TSXV") or other trading markets in Canada.

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Before you invest in the securities offered, you should read the prospectus supplement relating to and describing the terms of the offering and the related registration statement on Form F-3 and other documents that ESSA has filed with the Securities and Exchange Commission (the "SEC") for more complete information about ESSA and the offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the prospectus supplement relating to the offering may be obtained, when available, from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, telephone: 1-877-821-7388 or by emailing [email protected].

The offering described herein remains subject to the approval of the TSXV.

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

Verastem Oncology Announces Presentation of Clinical Data from Investigator-initiated RAF/MEK and FAK Combination Study in KRAS Mutant Solid Tumors at the American Association for Cancer Research 2020 Virtual Annual Meeting

On April 13, 2020 Verastem, Inc. (Nasdaq:VSTM) (also known as Verastem Oncology), a biopharmaceutical company committed to developing and commercializing new medicines for patients battling cancer, reported that an abstract highlighting preliminary results from the ongoing investigator-initiated clinical study investigating VS-6766, its RAF/MEK inhibitor, in combination with defactinib, its FAK inhibitor, in patients with KRAS mutant advanced solid tumors has been selected for a virtual poster presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2020 Virtual Annual Meeting I, taking place April 27-28, 2020 (Press release, Verastem, APR 13, 2020, View Source [SID1234556264]).

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This ongoing study is an open label, dose escalation and expansion study. The expansion cohorts are currently ongoing in patients with KRAS mutant advanced solid tumors, including low grade serous ovarian cancer (LGSOC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). Following the virtual data presentation, Verastem Oncology will host an investor conference call to discuss the presented data. The exact date and time of the investor conference call will be announced soon.

"These early clinical results led to our decision to in-license VS-6766 earlier this year and accelerate development of this exciting combination program for patients with KRAS mutant cancers," said Brian Stuglik, Chief Executive Officer of Verastem Oncology. "The synergy between VS-6766 and defactinib has been encouraging and we look forward to sharing the data with the medical and scientific communities later this month."

Verastem Oncology plans to initiate discussions with regulatory authorities during the first half of 2020, with the goal of commencing a registration-directed trial investigating the VS-6766/defactinib combination as soon as possible.

Other Abstracts Selected for Presentation at AACR (Free AACR Whitepaper) 2020 Virtual Meeting I

Two additional abstracts also selected for presentation at the April virtual meeting include: updated data from an ongoing Investigator-initiated Phase 1 study investigating defactinib in combination with pembrolizumab and gemcitabine in patients with advanced pancreatic ductal adenocarcinoma (PDAC) (Wang-Gilliam, et al); and preclinical research describing the synergistic antitumor efficacy of duvelisib, the Company’s oral inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, in combination with PD-1 blockade in solid tumor and lymphoma models.

Details for the AACR (Free AACR Whitepaper) 2020 Virtual Meeting I presentations are as follows:

Title: Phase 1 study of the combination of a RAF-MEK inhibitor CH5126766 and FAK inhibitor defactinib in an intermittent dosing schedule with expansions in KRAS mutant cancers
Lead author: Udai Banerji, Institute of Cancer Research and The Royal Marsden
Poster #: CT143
Session: VPO.CT01 – Phase I Clinical Trials
Date and Time: Monday, April 27, 2020; 9:00 a.m. to 6:00 p.m. ET
URL: View Source!/9045/presentation/10642

Title: Phase 1 study of defactinib combined with pembrolizumab and gemcitabine in patients with advanced cancer: Experiences of pancreatic ductal adenocarcinoma (PDAC) patients
Lead author: Andrea Wang-Gilliam, Washington University in St. Louis
Poster #: CT118
Session: VPO.CT01 – Phase I Clinical Trials
Date and Time: Monday, April 27, 2020; 9:00 a.m. to 6:00 p.m. ET
URL: View Source!/9045/presentation/10617

Title: Synergistic antitumor efficacy of the dual PI3K-δ/PI3K-γ inhibitor duvelisib with PD-1 blockade in solid tumor and lymphoma models
Lead author: Jonathan Pachter, Verastem Oncology
Abstract #: CT045
Session: VCTPL04 – Immunotherapy Clinical Trials 2
Date and Time: Tuesday, April 28, 2020; 3:15 – 3:25 p.m. ET
URL: View Source!/9045/presentation/10754

About VS-6766

VS-6766 (formerly known as CH5126766, CKI27 and RO5126766) is a unique inhibitor of the RAF/MEK signaling pathway. In contrast to other MEK inhibitors in development, VS-6766 blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows VS-6766 to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors. The combination of VS-6766 and the focal adhesion kinase (FAK) inhibitor defactinib is currently being investigated in a Phase 1 dose escalation and expansion study. The expansion cohorts are currently ongoing in patients with KRAS mutant advanced solid tumors, including low grade serous ovarian cancer (LGSOC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).3 The ongoing clinical study of the VS-6766/defactinib combination is supported by single-agent Phase 2 studies which investigated defactinib in KRAS mutant NSCLC4 and VS-6766 in KRAS mutant NSCLC and LGSOC.5

About Defactinib

Defactinib is an oral small molecule inhibitor of FAK and PYK2 that is currently being evaluated as a potential combination therapy for various solid tumors. The Company has received Orphan Drug designation for defactinib in ovarian cancer and mesothelioma in the US, EU and Australia. Preclinical research by Verastem Oncology scientists and collaborators at world-renowned research institutions has described the effect of FAK inhibition to enhance immune response by decreasing immuno-suppressive cells, increasing cytotoxic T cells, and reducing stromal density, which allows tumor-killing immune cells to enter the tumor.1,2 Additionally, in both preclinical and clinical studies, FAK activation has been shown to occur as a potential resistance mechanism in response to MEK inhibitor treatment, and synergy of a FAK inhibitor with a RAF/MEK inhibitor has been shown in several preclinical models. The combination of defactinib and VS-6766 is currently being investigated in a Phase 1 dose escalation and expansion study. The expansion cohorts are currently ongoing in patients with KRAS mutant advanced solid tumors, including low grade serous ovarian cancer (LGSOC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).3 The ongoing clinical study of the VS-6766/defactinib combination is supported by single-agent Phase 2 studies which investigated defactinib in KRAS mutant NSCLC4 and VS-6766 in KRAS mutant NSCLC and LGSOC.5 Defactinib is also in clinical testing in combination with pembrolizumab for treatment of patients with pancreatic cancer, NSCLC and mesothelioma.6

About COPIKTRA (duvelisib)

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.7,8,9 COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status and Orphan Drug Designation, and is being investigated in combination with other agents through investigator-sponsored studies.10 For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

SCYNEXIS and Aspire Capital Enter into $20 Million Common Stock Purchase Agreement

On April 13, 2020 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, reported that it has entered into a Common Stock Purchase Agreement ("Purchase Agreement") of up to $20 million with Aspire Capital Fund, LLC ("Aspire Capital") (Press release, Scynexis, APR 13, 2020, View Source [SID1234556263]).

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Under the terms of the agreement, SCYNEXIS has the right to sell to Aspire Capital, from time to time and in its sole discretion, up to $20 million in shares of SCYNEXIS’s common stock over the next 30 months, subject to certain limits.

There are no warrants, options, financing swaps, derivatives or other securities associated with this Purchase Agreement. SCYNEXIS will control the timing and amount of sales of common stock to Aspire Capital, if any. There are no limitations on use of proceeds, financial or business covenants, restrictions on future financings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement. In addition, the Purchase Agreement may be terminated by SCYNEXIS at any time, at its discretion, without any cost to SCYNEXIS.

"We are excited to enter into this agreement with Aspire Capital, a well-established, healthcare-focused institutional investor. The deal provides us with significant flexibility to efficiently bolster our balance sheet and further support the advancement of ibrexafungerp’s clinical programs and commercialization preparedness," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "This agreement, coupled with our strong cash position entering 2020 and the $10 million in proceeds from our recent sale of convertible notes, positions us well as we look to achieve key milestones in 2020 and beyond."

"Ibrexafungerp is a promising novel antifungal with a recent series of positive clinical trial read-outs. Additionally, SCYNEXIS is on the cusp of an important catalyst with the pending release of top-line data from its second Phase 3 trial for the treatment of vaginal yeast infections," stated Steven G. Martin, managing member of Aspire Capital. "Aspire Capital is pleased to partner with SCYNEXIS at this transformational time for the company as it plans for NDA submission later this year and commercial launch in 2021."

As consideration for Aspire Capital’s obligation under the Purchase Agreement, SCYNEXIS issued 709,103 shares to Aspire Capital as a commitment fee. SCYNEXIS also entered into a registration rights agreement with Aspire Capital in connection with its entry into the Purchase Agreement. A complete and detailed description of the Purchase Agreement and the related registration rights agreement is set forth in SCYNEXIS’s Current Report on the Form 8-K filed today with the U.S. Securities and Exchange Commission (SEC).

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor will there be any sale of these securities in any state or other 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 other jurisdiction.

Seattle Genetics to Host Conference Call and Webcast Discussion of First Quarter 2020 Financial Results on April 30, 2020

On April 13, 2020 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that it will report its first quarter 2020 financial results on Thursday, April 30, 2020 after the close of financial markets (Press release, Seattle Genetics, APR 13, 2020, View Source [SID1234556262]). Following the announcement, company management will host a conference call and webcast discussion of the results and provide a general corporate update. Access to the event can be obtained as follows:

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LIVE access on Thursday, April 30, 2020
1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time

Telephone 888-220-8474 (domestic) or +1 720-452-9217 (international); conference ID 7835915
Webcast with slides available at www.seattlegenetics.com in the Investors section
REPLAY access

Telephone replay will be available beginning at approximately 4:30 p.m. PT on Thursday, April 30, 2020 through 5:00 p.m. PT on Sunday, May 3, 2020 by calling 888-203-1112 (domestic) or +1 719-457-0820 (international); conference ID 7835915
Webcast replay will be available on the Seattle Genetics website at www.seattlegenetics.com in the Investors section

IntegraGen Achieves CE Mark for Its MERCURY™ Cloud-based Software Tool Which Supports Molecular Tumor Profiling for Cancer Patients

On April 13, 2020 IntegraGen reported the company’s MERCURY cloud-based analytical software tool has achieved Conformité Européenne (CE) marking (Press release, Integragen, APR 13, 2020, View Source [SID1234556260]). This registration enhances the ability for IntegraGen sell MERCURY throughout the European Union (EU). MERCURY is utilized by researchers and clinicians to assist with the analysis of sequencing data derived from small and large gene sequencing panels as well as whole exome, RNA-Seq and whole genome sequencing.

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CE-IVD marking of MERCURY indicates that it meets the provisions of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. Click here to view MERCURY’s CE Declaration of Conformity certificate.

The cloud-based platform utilized by MERCURY also regularly undergoes independent verification of security, privacy, and compliance controls, achieving certifications in line with global standards. Learn more about how IntegraGen ensures the security and privacy of genomic data.