Presentation dated November 20, 2019

On November 20, 2019, Bicycle Therapeutics plc (the "Company") presented the corporate presentation (Filing, 8-K, Bicycle Therapeutics, NOV 20, 2019, View Source [SID1234553767]).

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PharmAbcine’s Olinvacimb, able to manage the first recruitment of patients for phase II clinical trial

On November 20, 2019 PharmAbcine, a biotech company specialized for developing novel human antibody therapeutics, reported that the company successfully recruited the first patient for Phase II clinical trials of olinvacimab (TTAC-0001) in US/Australia as of November 13, 2019 (Press release, PharmAbcine, NOV 20, 2019, View Source;mode=VIEW&num=6&category=&findType=&findWord=&sort1=&sort2=&it_id=&shop_flag=&mobile_flag=&page=1 [SID1234553401]).

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In the phase II, 36 patients with rGBM (recurrent glioblastoma multiforme), whose tumour is reported to be progressed post the bevacizumab treatment, will be treated with a gradual successive increased dosage of olinvacimab from 16mg/kg, 20mg/kg to 24mg/kg. In this study, safety is the primary endpoint, followed by the assessment of efficacy. The study will also substantiate its effectiveness on patients with respect to Quality of Life through the assessment of tumour and of their reliance on steroid usage.

Gliobloastoma multiforme (GBM) is a type of brain tumour and it represents 15% of brain tumours. Even though there appears to be rigorous attempts to remove the tumour through surgery, chemotherapy and radiotherapy as a means of primary treatments, there is a high proclivity that GBM will likely relapse within a year. Regardless of prudent attentive post-treatment that has been performed for the patients, it is reported that 5 year survival rates are found to be less than 3%

Recently, Roche’s Avastin (bevacizumab) has been able to gain its top-notch clinical value through the manifestation of remarkable effectiveness in mitigating cerebral edema and consequently it has been approved for medical use in rGBM as a standard treatment. Nevertheless, an issue that starts to arise is that there are non-responding patients to bevacizumab and patients who start to develop non-responsiveness as a consequence of repeated use of bevacizumab. For these individuals, unmet medical needs for the rGBM indication are quite high owing to the deficient availability of alternative treatments for them.

One of representatives from PharmAbcine said, "There is no current suitable treatment for rGBM patients who are progressed after the bevacizumab treatment and it is unfortunate that it will cause cerebral edema in patients and cause severe damage," and continued, "We are looking to subjugate other rare diseases that are currently medically unmet and expecting to substantiate prominent asset of olinvacimab. From there we will extend our hands to a bigger spectrum of different indications of cancers."

Even though they both can mitigate angiogenesis in the TME (tumour microenvironment), onlinvacimb is significantly thought to be a more powerful strategic treatment to impede the process of metastasis and growth of tumour. Notably, while bevacizumab particularly binds to VEGF-A and inhibits the signaling caused by the binding of VEGF-A to VEGFR2, olinvacimab specifically targets VEGFR2 and consequently interferes with the activation of VEGFR2 caused by VEGF-A, C and D.

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].