Entry into a Material Definitive Contract

On November 20, 2019, CASI Pharmaceuticals (WUXI) Co., Ltd. ("CASI-Wuxi"), a joint venture between CASI Pharmaceuticals, Inc. (the "Company") and Wuxi Jintou Huicun Investment Enterprise (Limited Partnership) in which the Company owns 80% of the equity interests, completed the Contract for Assignment of the Right to the Use of the State-owned Construction Land (the "Land Use Contract") with the Wuxi Natural Resources and Planning Bureau (Filing, 8-K, CASI Pharmaceuticals, NOV 20, 2019, View Source [SID1234551698]). Pursuant to the Land Use Contract, CASI-Wuxi will acquire the right to use the 74,028 square meters of industrial land in Wuxi for a period of 50 years.

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As consideration for the land use right, CASI-Wuxi has committed to a land use fee in the total amount of approximately RMB 44,420,000 (USD$ 6,316,524), of which RMB 8,880,000 (USD$ 1,262,736) was paid as an advance deposit. A lump sum payment of the remaining land use fee (less the deposit) is expected to be paid by CASI-Wuxi on or about November 29, 2019.

As previously reported, CASI-Wuxi intends to construct a cGMP manufacturing facility on the land parcel. Under the Land Use Contract, CASI-Wuxi has agreed to make specified fixed asset investments on the land with initial construction to begin before August 26, 2020 and be completed before August 26, 2022, unless extended. CASI-Wuxi may transfer portions of the granted land to a third party once it has invested 25 percent of the total fixed asset investments amount and completed 25 percent of the project.

The foregoing description of the Land Use Contract does not purport to be a complete description of the rights and obligations of the parties thereunder and is qualified in its entirety by reference to the full text of the Land Use Contract that will be filed as an exhibit to the Company’s Annual Report on Form 10-K. for the year ended.

Entry into a Material Definitive Agreement.

On November 20, 2019 Genprex, Inc. (the "Company") reported that it has entered into a securities purchase agreement (the "Securities Purchase Agreement") with certain accredited investors identified on the signature pages thereto (the "Purchasers") pursuant to which the Company agreed to issue and sell an aggregate of 3,167,986 shares (the "Shares") of its common stock, par value $0.001 per share (the "Common Stock"), in a registered direct offering (the "Registered Direct Offering") (Filing, 8-K, Genprex, NOV 20, 2019, View Source [SID1234551612]). The Shares were offered by the Company pursuant to its shelf registration statement on Form S-3 (File No. 333-233774) filed with the Securities and Exchange Commission (the "Commission") on September 16, 2019, as amended on October 4, 2019 (as amended, the "Registration Statement").

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In a concurrent private placement, the Company also agreed, pursuant to the Securities Purchase Agreement, to issue and sell to each of the Purchasers a warrant to purchase one share of Common Stock (the "Warrants") for each share of Common Stock purchased by a Purchaser in the Registered Direct Offering (the "Private Placement" and, together with the Registered Direct Offering, the "Offerings"). The exercise price of the Warrants is $0.46 per share, subject to adjustment as provided therein, and will be exercisable beginning on May 22, 2020 through May 22, 2025. Each holder of a Warrant will not have the right to exercise any portion of its Warrant if the holder, together with its affiliates, would beneficially own in excess of 4.99% (or at the election of a holder prior to the date of issuance, 9.99%) of the number of shares of Common Stock outstanding immediately after giving effect to such exercise (the "Beneficial Ownership Limitation"); provided, however, that upon 61 days’ prior notice to the Company, the holder may increase the Beneficial Ownership Limitation, but not to above 9.99%. The exercise price and number of shares of Common Stock issuable upon the exercise of the Warrants will be subject to adjustment in the event of any stock dividend, stock split, reverse stock split, certain subsequent rights offerings, recapitalization, reorganization or similar transaction, as described in the Warrants. After May 22, 2020, if a registration statement covering the issuance or resale of the shares of Common Stock issuable upon exercise of the Warrants (the "Warrant Shares") is not available for the issuance, the holders may exercise the Warrants by means of a "cashless exercise."

The Warrants are not and will not be listed for trading on any national securities exchange. The Warrants and the Warrant Shares are not being registered under the Securities Act of 1933, as amended (the "Securities Act"), pursuant to the Registration Statement.

The purchase price for one Share in the Registered Direct Offering was $0.40. No additional consideration was paid for the Warrants. The closing of the Offerings occurred on November 22, 2019 (the "Closing Date"). The Company expects the aggregate net proceeds from the Offerings, after deducting the placement agent’s fees and other estimated offering expenses, to be approximately $1.1 million. The Company intends to use the aggregate net proceeds for working capital and other general corporate purposes.

The Company also agreed, pursuant to the Securities Purchase Agreement, to file a registration statement on Form S-3 (or other appropriate form if the Company is not then S-3 eligible) by January 6, 2020 to provide for the resale of the Warrant Shares, and will be obligated to use commercially reasonable efforts to cause such registration to become effective within 181 days following the Closing Date and to keep such registration statement effective until the date upon which no Purchaser owns any Warrants or Warrant Shares.

The Securities Purchase Agreement contains customary representations, warranties and agreements by the Company and customary conditions to closing.

Joseph Gunnar & Co., LLC (the "Placement Agent") acted as the placement agent for the Offerings.

In addition, in connection with the Offerings, the Company reduced the exercise price of an aggregate of 2,283,740 outstanding warrants held by the Purchasers in the Registered Direct Offering to $0.46. In connection with such adjustment, the warrants shall not be exercisable for six months and one day from the Closing Date and the expiration date of the warrants will be extended by six months and one day.

The foregoing descriptions of the material terms of the Securities Purchase Agreement and the Warrants do not purport to be complete and are qualified in their entirety by reference to the full text of the Securities Purchase Agreement and Warrant, copies of which are filed herewith as Exhibits 10.1 and 10.2, respectively, and are incorporated herein by reference.

The representations, warranties and covenants contained in the Securities Purchase Agreement and the Warrants were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to the Securities Purchase Agreement and the Warrants and may be subject to limitations agreed upon by the contracting parties. Accordingly, the Securities Purchase Agreement and the Warrants are incorporated herein by reference only to provide investors with information regarding the terms of the Securities Purchase Agreement and the Warrants and not to provide investors with any other factual information regarding the Company or its business, and should be read in conjunction with the disclosures in the Company’s periodic reports and other filings with the Commission.

The legal opinion, including the related consent, of Sheppard Mullin Richter & Hampton, LLP relating to the issuance and sale of the Shares is filed as Exhibit 5.1 hereto.

This Current Report on Form 8-K does not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

CRISPR Therapeutics Announces Pricing of Public Offering of Common Shares

On November 20, 2019 CRISPR Therapeutics (Nasdaq:CRSP), a biopharmaceutical company focused on developing transformative gene-based medicines for serious diseases, reported the pricing of an underwritten public offering of 4,250,000 common shares at a public offering price of $64.50 per share (Press release, CRISPR Therapeutics, NOV 20, 2019, View Source [SID1234551580]). In addition, the underwriters have a 30-day option to purchase up to an additional 637,500 common shares at the public offering price less the underwriting discount. CRISPR Therapeutics anticipates its gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, to be approximately $274.1 million, excluding any exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on or about November 25, 2019, subject to customary closing conditions.

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Goldman Sachs & Co. LLC, Piper Jaffray & Co. and Jefferies LLC are acting as joint book-running managers for the offering. Chardan, Oppenheimer & Co. Inc., BTIG, LLC and Roth Capital Partners are acting as co-managers for the offering.

The common shares will be offered and sold pursuant to the Company’s previously filed automatically effective shelf registration statement on Form S-3 (File No. 333-227427) filed with the U.S. Securities and Exchange Commission (the "SEC") on September 19, 2018. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities 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 jurisdiction.

A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC on November 19, 2019. The final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. A copy of the final prospectus supplement may be obtained, when available, from Goldman Sachs & Co. LLC by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected]; from Piper Jaffray & Co., Attn: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at [email protected]; or from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 547-6340, or by email at [email protected].

Immunomic Therapeutics’ Collaborator, University of Florida Presents New Clinical Data from ATTAC-II Study in GBM at the 2019 Society for Neurology (SNO) Annual Meeting

On November 20, 2019 Immunomic Therapeutics, Inc., a privately held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, reported that Duane Mitchell, MD, Ph.D., a University of Florida professor of neurosurgery and co-director of the Preston A. Wells Jr. Center for Brain Tumor Therapy, and his team will present new clinical data at the 2019 Society for Neurology (SNO) Annual Meeting being held in Phoenix, Arizona Nov. 20-24, 2019 (Press release, Immunomic Therapeutics, NOV 20, 2019, View Source [SID1234551572]).

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The data being presented at the SNO meeting are from a Phase 2 clinical trial (ATTAC-II) evaluating the efficacy of autologous CMV pp65-LAMP RNA pulsed dendritic cell vaccines mixed with GM-CSF and administered during cycles of adjuvant dose-intensified temozolomide (NCT02465268). The results demonstrate that a CMV pp65-LAMP RNA-pulsed DC vaccination was associated with positive immunologic and clinical response in a patient with MGMT unmethylated midline glioblastoma (GBM).

"The new clinical data to be presented demonstrates the potential impact of our UNITE technology platform and will help validate our therapeutic approach utilizing vaccines to treat difficult cancers like glioblastoma," said Dr. Teri Heiland, Chief Scientific Officer of Immunomic Therapeutics, Inc. "We are encouraged by the immunological response shown with this patient and we look forward to Dr. Mitchell’s presentation of these positive findings at the SNO meeting."

SNO posters – presentation details:

Title: "(ATIM-15) Sustained complete radiographic response and prolonged systemic immune activation in a patient with MGMT unmethylated midline glioblastoma receiving CMV pp65-LAMP RNA-pulsed dendritic cell vaccines"

Category: Adult Clinical Trials – Immunologic

Date and Time: Saturday, Nov 23rd, 5:00 PM – 7:00 PM

Location: Ballroom Lawn, JW Marriott Desert Ridge, Phoenix, Arizona

Title: "(ATIM-34) Single-cell RNA sequencing reveals dynamic immune response changes in glioblastoma patient with durable complete response to CMV pp65-LAMP RNA-pulsed dendritic vaccines
Category: Adult Clinical Trials – Immunologic

Date and Time: Friday, Nov 22nd, 7:30 PM – 9:30 PM

Location: Ballroom Lawn, JW Marriott Desert Ridge, Phoenix, Arizona

The abstracts for University of Florida’s posters at SNO can be found on the following meeting site: View Source and also have been published online in the journal "Neuro-Oncology" by Oxford Academic and can be found here: View Source

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein, an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

Harpoon Therapeutics and AbbVie Announce Licensing and Option Collaboration to Advance HPN217, Harpoon’s BCMA-Targeting TriTAC®, and Expand Existing Discovery Collaboration

On November 20, 2019 Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, and AbbVie Inc. (NYSE: ABBV), a global biopharmaceutical company, reported an exclusive worldwide option and license transaction for HPN217, Harpoon’s B cell maturation antigen (BCMA)-targeting Tri-specific T cell Activating Construct (TriTAC), and an expansion of their existing discovery collaboration for up to six additional targets (Press release, Harpoon Therapeutics, NOV 20, 2019, View Source [SID1234551561]). These agreements build upon the discovery collaboration established by the two companies in October 2017 and are expected to advance and broaden the use of Harpoon’s proprietary TriTAC platform. The TriTAC platform produces novel T cell engagers targeting both solid tumors and hematologic malignancies.

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"Harpoon has built a unique and proprietary biologics platform that utilizes the cancer patient’s own immune system to attack cancer. HPN217, targeting BCMA, is poised to advance to clinical development for the treatment of multiple myeloma", stated Gerald McMahon, Ph.D., President and Chief Executive Officer of Harpoon. "We believe AbbVie is the ideal partner for Harpoon to support the advancement of our BCMA program given the commercial focus of AbbVie in the treatment of this cancer. In addition, we look forward to expanding our discovery collaboration to include up to six additional molecular targets."

"Harpoon’s BCMA TriTAC holds promise for myeloma patients, and their novel drug development engine, combined with AbbVie’s development expertise, has the potential to generate innovative new medicines for patients with cancer," said Mohit Trikha, Ph.D., Vice President, Head, Oncology Early Development and AbbVie Bay Area Site Head. "Our collaboration with Harpoon has been productive and we look forward to further strengthening this collaboration."

Relating to the HPN217 license agreement, Natalie Sacks, M.D., Chief Medical Officer of Harpoon Therapeutics notes, "As our pipeline of initial TriTAC clinical candidates advance in prostate and ovarian

cancers, we are thrilled to partner with AbbVie in pursuit of therapies geared towards hematologic cancers. With our efforts and expertise combined, we look forward to the initiation of our planned Phase 1/2 clinical trial with HPN217 in patients with multiple myeloma."

Under the terms of the license and option agreement, Harpoon granted to AbbVie an option to license worldwide exclusive rights to HPN217. Harpoon will be responsible for development of HPN217 through Phase 1/2 clinical trials. Upon exercise of the option, AbbVie will conduct all future clinical development, manufacturing and commercialization activities. AbbVie may exercise its option to license HPN217 after completion of the Phase 1/2 clinical trial. The license and option agreement represents a potential transaction value of up to $510 million in upfront, option and milestone payments, plus royalties on global commercial sales.

Under the terms of the expanded discovery collaboration agreement, AbbVie will receive worldwide exclusive rights to develop and commercialize two new TriTAC molecules engineered for two selected targets. AbbVie has the option to select up to four additional targets for a total of up to six new targets. For each selected target under the Amended Discovery agreement, Harpoon is eligible to receive up to $310 million in upfront and potential development, regulatory and commercial milestone payments, plus royalties on global commercial sales. Consistent with the existing discovery collaboration agreement, Harpoon and AbbVie will conduct certain initial research and discovery activities for each designated target, after which AbbVie will be solely responsible for further development and commercialization efforts.