On June 1, 2021 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported that Jeff Baxter, President and Chief Executive Officer, and David E. Anderson, Ph.D., Chief Scientific Officer, will participate in analyst-led fireside chats at the following upcoming investor conferences (Press release, VBI Vaccines, JUN 1, 2021, View Source [SID1234583322]):

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Jefferies Virtual Healthcare Conference

Analyst discussion to be held with Kelechi Chikere, Ph.D.

Date: Thursday, June 3, 2021
Time: 1-1:25 PM ET
Webcast Link: View Source
Raymond James Human Health Innovation Conference

Analyst discussion to be held with Steven Seedhouse, Ph.D.

Date: Wednesday, June 23, 2021
Time: 12-12:30 PM ET
Webcast Link: View Source
Live webcasts of the presentations will also be available on the Investors page of VBI’s website at: View Source A replay of each webcast will be archived on the Company’s website following the presentation.

On June 1, 2021 TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that the Independent Data Monitoring Committee for the ENVASARC pivotal trial has recommended that the trial will proceed as planned following the review of safety data from more than 20 patients enrolled into the trial to date (Press release, Tracon Pharmaceuticals, JUN 1, 2021, View Source [SID1234583321]). The safety data reviewed included data from more than 10 patients enrolled into cohort A of treatment with single agent envafolimab and more than 10 patients enrolled into cohort B of treatment with envafolimab and Yervoy (ipilimumab).

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"We are pleased with the recommendation of the Data Monitoring Committee to continue the ENVASARC pivotal trial as planned," said James Freddo, M.D., TRACON’s Chief Medical Officer, "Envafolimab has been well tolerated as a single agent and when combined with Yervoy in these patients with refractory sarcoma who are enrolled in the ENVASARC trial. Based on the current accrual rate, we expect the Data Monitoring Committee to review additional safety data in the third quarter and to review interim efficacy data in the fourth quarter of this year."

About Envafolimab

Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in pivotal trials. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the U.S. sponsored by TRACON, has been studied in a completed Phase 2 pivotal trial as a single agent in MSI-H/dMMR advanced solid tumor patients in China and is being studied in an ongoing Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China, with both Chinese trials sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. Alphamab Oncology and 3D Medicines submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer that was accepted for review in December 2020 and granted priority review in January 2021.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multi-center, open label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States that began dosing in December 2020. TRACON expects the trial to enroll 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy. The primary endpoint is ORR by blinded independent central review with duration of response a key secondary endpoint.

On June 1, 2021, Madrigal Pharmaceuticals, Inc. (the "Company") reported that it entered into a Sales Agreement (the "Sales Agreement") with Cowen and Company, LLC ("Cowen"), pursuant to which the Company may issue and sell through or to Cowen, acting as agent or principal, shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), from time to time having an aggregate sales price of up to $200,000,000 (the "ATM Offering") (Filing, 8-K, Synta Pharmaceuticals, JUN 1, 2021, View Source [SID1234583320]).

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Sales of the Common Stock, if any, under the Sales Agreement will be made by any method that is deemed to be an "at the market" offering as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended. The Company has no obligation to sell any of the Common Stock and may at any time suspend offers under the Sales Agreement or terminate the Sales Agreement pursuant to its terms.

Subject to the terms and conditions of the Sales Agreement, Cowen will use its commercially reasonable efforts to sell the shares of Common Stock from time to time, as the sales agent, based upon the Company’s instructions. The offering of shares of Common Stock pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of all Common Stock subject to the Sales Agreement or (ii) the termination of the Sales Agreement in accordance with its terms.

The foregoing description of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the Sales Agreement, a copy of which is incorporated herein by reference as Exhibit 1.1.

The Common Stock to be sold under the Sales Agreement, if any, will be issued and sold pursuant to the Company’s automatic shelf registration statement on Form S-3, which was filed with the Securities and Exchange Commission ("SEC") on June 1, 2021. On June 1, 2021, the Company filed a prospectus supplement with the SEC in connection with the offer and sale of the Common Stock pursuant to the Sales Agreement. This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Common Stock nor shall there be any sale of the Common Stock in any state or 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. The legal opinion of Hogan Lovells US LLP relating to the legality of the issuance and sale of the Common Stock pursuant to the ATM Offering is attached as Exhibit 5.1 to this Current Report on Form 8-K and is incorporated by reference herein.

On June 1, 2021 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it will present at the Goldman Sachs 42nd Annual Global Healthcare Conference at 1:20 p.m. Eastern Time on Tuesday, June 8, 2021 (Press release, Neurocrine Biosciences, JUN 1, 2021, View Source [SID1234583319]). Kevin Gorman, Chief Executive Officer, will present at the conference.

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The live presentation will be webcast and may be accessed on the Company’s website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

On June 1, 2021 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology reported the close of its $10 million financing round (Press release, Kineta, JUN 1, 2021, View Source;utm_medium=rss&utm_campaign=kineta-closes-10-million-financing-round-to-advance-anti-vista-immuno-oncology-program [SID1234583318]). Kineta is eligible to receive up to $25 million in additional financing prior to the end of 2021 to further advance the company’s pipeline of novel immunotherapies. The financing from a syndicate of investors was led by Cheongbo Industrial Co Ltd (CBI).

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Proceeds from this financing will advance Kineta’s lead anti VISTA antibody, KVA12.1 to an IND with the US FDA in 2022.

"We are excited to have the confidence of this leading investor syndicate in supporting KVA12.1 and our pipeline of novel immunotherapies. Closing this financing round further validates the innovative research and development at Kineta", said Shawn Iadonato, PhD, Chief Executive Officer at Kineta. "These new funds provide the resources to advance the preclinical development of our potential best-in-class anti-VISTA antibody to benefit patients with a broad range of solid tumor cancers.

"The innovative science, company strategy and management team at Kineta are well positioned to develop important new therapeutics for managing cancer", said Kyungwon Oh, President of CBI. "We are pleased to join Kineta as a major investor and lead this financing round of the company."

An investor representative from CBI, to be named later in 2021, will be appointed to the Kineta board of directors. Shawn Iadonato, Chief Executive Officer and Craig Philips, President at Kineta will be appointed to the CBI board of directors.

KVA12.1 is Kineta’s lead anti-VISTA antibody in development for the treatment of solid tumors. VISTA is a key driver of the immunosuppressive tumor microenvironment (TME) and is overexpressed on myeloid-derived suppressor cells (MDSC) and regulatory T cells (Tregs). It is a critical myeloid cell immune-checkpoint, and VISTA blockade can reprogram suppressive myeloid cells and reactivate antitumor immune function. Blocking VISTA activates an immune cell cascade that increases T cell effector functions to drive an efficient anti-tumor response. Preclinical studies have demonstrated single agent anti-VISTA activity but also demonstrate that targeting VISTA in combination with PD-1, PD-L1 or CTLA-4 can significantly improve the efficacy of those checkpoint inhibitors.