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Entry into a Material Definitive Agreement.

On November 8, 2019, Humanigen, Inc. (the "Company") reported that it has entered into a purchase agreement (the "Purchase Agreement") and a registration rights agreement (the "Registration Rights Agreement") with Lincoln Park Capital Fund, LLC ("LPC"), pursuant to which the Company has the right to sell to LPC up to $20,000,000 in shares of the Company’s common stock, $0.001 par value per share (the "Common Stock"), subject to certain limitations and conditions set forth in the Purchase Agreement (Filing, 8-K, Humanigen, NOV 8, 2019, View Source [SID1234551036]).

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Under the Purchase Agreement, the Company has the right, from time to time at its sole discretion and subject to certain conditions, to direct LPC to purchase up to 100,000 shares of Common Stock, with such amounts increasing based on certain threshold prices but not to exceed $750,000 in total proceeds on any purchase date. The purchase price of shares of Common Stock pursuant to the Purchase Agreement will be based on the market prices of the Common Stock at the time of such purchases as set forth in the Purchase Agreement. Such sales of Common Stock by the Company, if any, may occur from time to time, at the Company’s option, over the 36-month period commencing on the date that a registration statement, which the Company agreed to file with the Securities and Exchange Commission (the "SEC") pursuant to the Registration Rights Agreement, is declared effective by the SEC and a final prospectus in connection therewith is filed and the other terms and conditions of the Purchase Agreement are satisfied.

In addition to regular purchases, as described above, the Company may also direct LPC to purchase additional amounts as accelerated purchases if the closing sale price of the Common Stock is not below certain threshold prices, as set forth in the Purchase Agreement. In all instances, the Company may not sell shares of its Common Stock to LPC under the Purchase Agreement if it would result in LPC beneficially owning more than 4.99% of the Common Stock then outstanding.

LPC represented to the Company, among other things, that it was an "accredited investor" (as such term is defined in Rule 501(a) of Regulation D under the Securities Act of 1933, as amended (the "Securities Act")), and the Company sold the securities to LPC pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of, and Regulation D under, the Securities Act.

The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, agreements and conditions to completing future sale transactions, indemnification rights and obligations of the parties. The Company has the right to terminate the Purchase Agreement at any time, at no cost or penalty. During any "event of default" under the Purchase Agreement, all of which are outside of LPC’s control, LPC does not have the right to terminate the Purchase Agreement; however, the Company may not initiate any regular or other sale of shares to LPC until such event of default is cured.

Actual sales of shares of Common Stock to LPC under the Purchase Agreement will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the Common Stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations. In consideration for entering in the Purchase Agreement, the Company has agreed to pay to LPC a commitment fee in shares of Common Stock. The Company will not receive any cash proceeds from the issuance of these shares.

The net proceeds under the Purchase Agreement to the Company will depend on the frequency and prices at which the Company sells shares of its stock to LPC. The Company expects that any proceeds received by the Company from such sales to LPC will be used for working capital and general corporate purposes.

This current report on Form 8-K shall not constitute an offer to sell or a solicitation of an offer to buy any shares of Common Stock, nor shall there be any sale of shares of Common Stock in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

Entry into a Material Definitive Agreement

On November 8, 2019, Corvus Pharmaceuticals, Inc. (the "Company") reported that it entered into an exchange agreement (the "Exchange Agreement") with entities affiliated with Biotechnology Value Fund, L.P. (the "Exchanging Stockholders"), pursuant to which the Company exchanged an aggregate of 10044135 shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), owned by the Exchanging Stockholders for warrants (the "Exchange Warrants") to purchase an aggregate of 1,458,000 shares of common stock (subject to adjustment in the event of stock splits, recapitalizations and other similar events affecting common stock), with an exercise price of $0.0001 per share (Filing, 8-K, Corvus Pharmaceuticals, NOV 8, 2019, View Source [SID1234550945]). The Exchange Warrants will expire ten years from the date of issuance. The Exchange Warrants are exercisable at any time prior to expiration except that the Exchange Warrants cannot be exercised by the Exchanging Stockholders if, after giving effect thereto, the Exchanging Stockholders would beneficially own more than 9.99% of Common Stock, subject to certain exceptions. The holders of the Exchange Warrants will not have the right to vote on any matter except to the extent required by Delaware law. The Exchange Warrants were issued without registration under the Securities Act of 1933, as amended (the "Securities Act"), in reliance on the exemption from registration contained in Section 3(a)(9) of the Securities Act.

The description of the Exchange Agreement and the Exchange Warrant are not complete and are qualified in their entirety by reference to the Exchange Agreement and the form of Exchange Warrant, which are filed as Exhibit 10.1 and Exhibit 4.1, respectively, to this Current Report on Form 8-K and incorporated herein by reference. The representations, warranties and covenants made by the Company in the Exchange Agreement and the Exchange Warrant were made solely for the benefit of the parties to the Exchange Agreement and the Exchange Warrant, as applicable, including, in some cases, for the purpose of allocating risk among the parties thereto, and should not be deemed to be a representation, warranty or covenant to investors. Moreover, such representations, warranties or covenants were made as of an earlier date. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state of our affairs.

Precision Biosciences, Inc. Presentation as of November 8, 2019

On November 8, 2019 Precision BioSciences presented the corporate presentation (Presentation, Precision Biosciences, NOV 8, 2019, View Source [SID1234550929]).

Tocagen Highlights Toca 6 Phase 1b Data at Society for Immunotherapy of Cancer Annual Meeting

On November 8, 2019 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported that the Company presented data from the Toca 6 Phase 1b study of Toca 511 and Toca FC in patients with non-CNS tumors at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting in National Harbor, MD and will have two presentations related to brain cancer at the 24th Annual Meeting of the Society for Neuro-Oncology (SNO), to be held Nov. 20-24 in Phoenix (Press release, Tocagen, NOV 8, 2019, View Source [SID1234550838]).

The SITC (Free SITC Whitepaper) poster titled, "Immunomodulation in peripheral blood and tumor following Toca 511 & Toca FC treatment in patients with solid tumors," was a summary of the results in the Toca 6 Phase 1b, single arm study of Toca 511 and Toca FC in advanced non-CNS solid tumors. The objectives of the study were to assess changes in immune activity of peripheral blood mononuclear cells (PBMCs) relative to baseline following treatment and to evaluate immune cell modulation in the tumor microenvironment from tumor biopsies taken at baseline compared to biopsies collected following treatment.

Data Summary

The Toca 6 Phase 1b, single arm study of Toca 511 and Toca FC in advanced non-CNS solid tumors demonstrated vector deposition, immune activity, a potential signal of clinical activity and a favorable safety profile.

Treatment was generally well tolerated, with predominantly Grade 1 and 2 treatment-related gastrointestinal adverse events. Most patients enrolled (81%) had metastatic colorectal cancer; the median lines of prior chemotherapies was four (1, 12).
Clinical activity was supported by observations of partial response and stable disease. The median overall survival was 9.6 months (95% CI 6.3, 16.4) in this heavily pre-treated population.
Toca 511 and Toca FC was associated with a T-cell mediated immune response in peripheral blood and metastatic tumor in some patients, consistent with the mechanism of action observed in preclinical models.
Peripheral blood T-cells shift from naïve to effector phenotypes indicating that T-cells are encountering their target antigens, potentially including proteins released by tumor cell killing.
Expansion of CD4+ memory T-cells after treatment is consistent with engagement of the adaptive immune system.
Increased post-treatment quantities of B-cells further suggests immune activation during the course of Toca 511 and Toca FC therapy.
Toca 511 and Toca FC led to a decrease of CD11b+ myeloid cells in five of six patients with evaluable colorectal metastasis. This immune fluorescence analysis suggests a decrease in the immunosuppressive myeloid cells, as seen in preclinical models, and potentially makes the tumor and the tumor microenvironment more conducive to immunologic modulation.
"Data from our poster at SITC (Free SITC Whitepaper) are encouraging and support the planned exploration of our Toca regimen in non-muscle invasive bladder cancer," said Marty Duvall, chief executive officer of Tocagen. "In addition, we look forward to presenting Toca 5 analyses at the upcoming SNO conference Toca 5 analyses including subgroups and molecular data in addition to details of the planned NRG Oncology trial in patients with newly diagnosed glioblastoma."

Details of the SNO presentations are as follows. Copies of the presentations will be available on Tocagen’s website following the presentations.

Presentation Type: Plenary Presentation (Abstract: LTBK-08)
Title: Toca 511 & Toca FC Versus Standard of Care in Patients With Recurrent High Grade Glioma
Presenter: Timothy Cloughesy, M.D., director of the University of California, Los Angeles, Neuro-Oncology Program
Date and Time: Friday, Nov. 22, 11:50 a.m. – 12:00 p.m. MST

Presentation Type: Poster Presentation (Abstract: RBTT-11)
Title: NRG Oncology NRG-BN006: A phase II/III randomized, open-label study of Toca 511 and Toca FC with standard of care compared to standard of care in patients with newly diagnosed glioblastoma
Presenter: Manmeet Ahluwalia, M.D., head of operations, Burkhardt Brain Tumor and Neuro-Oncology Center, Cleveland Clinic.
Date and Time: Saturday, Nov. 23, 5:00 p.m. – 7:00 p.m. MST

About Toca 511 & Toca FC
Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprising an investigational biologic, Toca 511 (vocimagene amiretrorepvec), and an investigational small molecule, Toca FC (flucytosine, extended-release). Toca 511 is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells resulting in anti-cancer immune activation and subsequent tumor killing.

prismCDX Implements Ultivue’s UltiMapper™ Platform for Standardized, Comprehensive Cancer Tissue Phenotypic Characterization

On November 8, 2019 prismCDX, a highly specialized contract research organization reported the selection and adoption of the UltiMapper platform to broaden its offering of translational biomedical research services (Press release, PrismCDX, NOV 8, 2019, View Source [SID1234550829]). The addition of Ultivue’s highly standardized multiplex tissue marker assays enables the identification of critical cellular phenotypes and tissue marker signatures in support of translational and clinical research programs.

"The combination of Ultivue’s next generation tissue marker assays with our platforms for genomic and proteomic analysis provides novel biological insights into the characterization of individual tumor microenvironments," commented Dong-Jun Bae, CEO with prismCDX. "Such complete tumor profiling and characterization data support our mission at prismCDX to partner with biopharma organizations developing targeted, precision medicine therapies and associated companion diagnostic tests."

Prior to the launch of those expanded capabilities, prismCDX has received scientific personnel training and certification at both Ultivue’s lab in Cambridge, MA and at its company facilities in Seoul, South Korea.