MacroGenics Announces Date of Second Quarter 2020 Financial Results Conference Call

On July 23, 2020 MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the Company will release its financial results for the second quarter 2020 after the market closes on Thursday, July 30, 2020 (Press release, MacroGenics, JUL 23, 2020, View Source [SID1234562291]). MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Thursday, July 30, 2020 at 4:30 p.m. ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID 3236629.

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The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

Infinity Announces the Date of Its Second Quarter Financial Results Conference Call and Webcast

On July 23, 2020 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that it will host a conference call on July 30, 2020 at 4:30 p.m. ET to review its second quarter 2020 financial results and provide an update on the company (Press release, Infinity Pharmaceuticals, JUL 23, 2020, View Source [SID1234562290]).

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A live webcast of the conference call can be accessed in the Investors/Media section of Infinity’s website at www.infi.com. To participate in the conference call, please dial (877) 316-5293 (domestic) and (631) 291-4526 (international) five minutes prior to start time. The conference ID number is 7893533. An archived version of the webcast will be available on Infinity’s website for 30 days.

Genocea Provides Second Quarter 2020 Corporate Update

On July 23, 2020 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported its operating and financial results for the second quarter ended June 30, 2020 (Press release, Genocea Biosciences, JUL 23, 2020, View Source [SID1234562289]). Genocea had an active and productive second quarter, demonstrating important progress across the Company:

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GEN-009
•On July 30, 2020, the Company plans to present initial clinical data on the first 5 patients from Part B with Dr. Maura L. Gillison, MD, PhD, Professor of Medicine, Department of Thoracic/Head and Neck Medical Oncology at MD Anderson Cancer Center. Part B of the study is exploring the combination of GEN-009 and immune checkpoint inhibitor-based regimens in advanced solid tumors.
•Presented long-term follow-up data from Part A of the ongoing Phase 1/2a clinical trial at ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program that evaluates eight participants for duration of immune responses and clinical outcomes.
◦Seven out of eight patients treated on Part A of the study are without disease progression at one-year median follow-up.
◦ATLAS-identified neoantigens generate broad, sustained T cell responses starting after only 4 weeks and lasting for up to 1 year after the last vaccination.

GEN-011
•Hosted a virtual KOL symposium introducing GEN-011 – a neoantigen cell therapy that uses peripheral blood T cells and is powered by ATLAS to target the right tumor neoantigens. The event featured commentary from Dr. Eric Tran, Assistant Member at the Earle A. Chiles Research Institute in the Providence Cancer Institute and members of the Genocea management team on GEN-011 as a new category of T cell therapy designed to improve on current limitations of TIL therapy.
•Filed an Investigational New Drug (IND) application to initiate a Phase 1/2a clinical study of GEN-011 evaluating patient safety, T cell proliferation and persistence, and clinical activity. The trial expects to enroll up to 24 patients and will assess GEN-011 in a range of tumor types, with a focus on patients who have failed standard-of-care checkpoint inhibitor therapy. The Company has received verbal notification from the U.S. Food and Drug Administration (FDA) that the agency has completed its review of the Company’s IND for GEN-011. In this verbal feedback, the FDA informed Genocea that it is placing the IND on clinical hold until it receives additional information pertaining to certain third-party reagents used in the GEN-011 manufacturing process. These reagents are not a component of the final cell therapy product. The Company expects to receive official written communication from the FDA regarding the hold and the FDA’s position in the near future and plans to work with the FDA to resolve their questions as quickly as possible.

Private Placement
•On July 22, 2020 the Company entered into a private placement led by an undisclosed leading U.S. public investment fund specializing in life sciences as well as certain existing and new investors providing for the purchase of up to approximately $80 million of its common stock and warrants to purchase shares of Genocea common stock (before deducting fees to the placement agent and other offering expenses payable by Genocea). Genocea will offer 21.4 million shares of common stock and 12.2 million pre-funded warrants to purchase common stock, along with accompanying warrants to purchase one share of common stock for each share of common stock or pre-funded warrant purchased by an investor. The warrants will be exercisable immediately upon issuance, in whole or in part, at an exercise price of $2.25 per share and will have a 4-year term. The closing of the private placement is expected to occur on or about July 24, 2020, subject to customary closing conditions.

Shionogi Material Transfer Agreement ("MTA")
•Entered into an MTA and exclusive license option with Shionogi & Co., Ltd. ("Shionogi") to develop a novel HSV-2 vaccine using Genocea’s proprietary HSV-2 antigens from the GEN-003 program, which the company discontinued in 2017. As part of this agreement, the Company received $2 million for the exclusive option to evaluate the HSV-2 antigens and to negotiate a license prior to expiration of the MTA. Upon exercise of Shionogi’s option, terms of the license are expected to include an upfront payment, regulatory and sales milestones, as well as tiered royalties. Final terms of the license agreement will be based on results of the MTA evaluation and overall diligence. If licensed, Shionogi will assume responsibility for global development and commercialization of the HSV-2 vaccine product.

Inhibigens
•Presented preclinical data at the AACR (Free AACR Whitepaper) Virtual Annual Meeting II that furthers understanding of inhibitory antigen (InhibigenTM) function and builds on previous research demonstrating that the presence of an Inhibigen in an otherwise protective immunotherapy can be detrimental to anti-tumor responses.
◦Inhibigens were found to alter the tumor microenvironment and drive tumor hyperprogression and also abolished both global and tumor antigen-specific T cell activity to beneficial anti-tumor antigens.
◦Findings suggest that Inhibigens must be identified and excluded from the rational design of cancer immunotherapies to achieve more favorable patient outcomes.

"We continue to advance our clinical programs for patients living with cancer," said Chip Clark, President and Chief Executive Officer, Genocea. "I am pleased by our ability to remain on track during these uncertain times, meeting our highest priority milestones and working to deliver on the promise of developing effective immunotherapies through our unique and differentiated approach."

Second Quarter 2020 Financial Results
•Cash position: As of June 30, 2020, cash and cash equivalents were $22.1 million versus $40.1 million as of December 31, 2019.
•Research and Development (R&D) expenses: R&D expenses were $8.6 million for the quarter ended June 30, 2020, compared to $6.8 million for the same period in 2019.
•General and Administrative (G&A) expenses: G&A expenses were $3.5 million for the quarter ended June 30, 2020, compared to $3.2 million for the same period in 2019.
•Net loss: Net loss was $11.3 million for the quarter ended June 30, 2020, compared to $6.5 million for the same period in 2019.

Guidance
Genocea expects that its existing cash and cash equivalents inclusive of the private placement proceeds are sufficient to support its operations to mid-2022.

Conference Call
Genocea will host a conference call and webcast today at 8:30 a.m. EDT. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 8894505. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at View Source A webcast replay of the conference call

will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

GEN-009 Clinical Update Registration
Genocea will present a clinical update on GEN-009 on Thursday, July 30 at 8 a.m. EDT. Interested participants may access this event by registering here.

Corcept Therapeutics Completes Enrollment in Controlled, Phase 2 Trial of Relacorilant Plus Nab-Paclitaxel in Patients with Metastatic Ovarian Cancer

On July 23, 2020 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported the completion of enrollment in its controlled, Phase 2 trial of relacorilant combined with nab-paclitaxel (Abraxane) in patients with metastatic, platinum-resistant ovarian cancer (Press release, Corcept Therapeutics, JUL 23, 2020, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-completes-enrollment-controlled-phase-2 [SID1234562288]).

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"We achieved this milestone thanks in part to the hard work and enthusiasm of our clinical investigators," said Andreas Grauer, MD, Corcept’s Chief Medical Officer. "Data from our open-label, Phase 1/2 trial were very promising.1 We expect to have results from this larger, controlled trial in the first half of next year."

The trial has enrolled 177 patients at 28 sites in the United States, Canada and Europe. Participants were randomly assigned to receive either relacorilant in combination with nab-paclitaxel or nab-paclitaxel alone. The trial’s primary endpoint is progression free survival, with secondary endpoints including objective response rate and duration of objective response.2

About Relacorilant

Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor, the receptor for cortisol which is activated when cortisol levels are high. Relacorilant does not bind to the body’s other hormone receptors. Corcept is studying relacorilant as a potential treatment for a variety of serious disorders, including Cushing’s syndrome and advanced adrenal, ovarian and pancreatic cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents. Relacorilant has received orphan drug designation in the United States for the treatment of Cushing’s syndrome and pancreatic cancer.

Clovis Oncology to Announce Second Quarter 2020 Financial Results and Host Webcast Conference Call on August 6

On July 23, 2020 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that it will announce its second quarter 2020 financial results on Thursday, August 6, 2020, after the close of the U.S. financial markets (Press release, Clovis Oncology, JUL 23, 2020, View Source [SID1234562287]). Clovis’ senior management will host a conference call and live audio webcast at 4:30 p.m. ET to discuss the company’s results in greater detail.

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The conference call is being webcast and can be accessed from the Clovis Oncology website at www.clovisoncology.com. A replay of the webcast will be available for 30 days.

Conference Call Details

Clovis will hold a conference call to discuss second quarter 2020 results on Thursday, August 6 at 4:30 p.m. ET. The conference call will be simultaneously webcast on the Company’s web site at www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: U.S. participants (877) 698-7048, International participants (647) 689-5448, conference ID: 7155799.