BERKELEY, Calif. and VANCOUVER, British Columbia, March 07, 2018 –BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSX-V:BCT) (OTCQB:BCTXF), an immuno-oncology focused biotechnology company with a proprietary targeted immunotherapy technology, announced today that it expects to enter into a securities purchase agreement of convertible notes with a leading group of Institutional and Family Office funds focused on investments in the biotech sector for an investment of US$800,000 (the “Note Offering”).
Under the terms of a securities purchase agreement expected to be entered into between the Company and the purchasers of Notes (as defined herein), the Note Offering will consist of a: (i) 5.0% unsecured convertible note of BriaCell in the principal amount of US$800,000 (each, a “Note”) which will be convertible at the option of the holder of the Note into common shares of BriaCell for so long as the Note is outstanding, at the holder’s sole option, at a fixed conversion price of C$0.10 per common share of BriaCell (each, a “Common Share”), subject to adjustment in certain events for a period of six months from the date of issuance, which may be extended by the applicable holder for up to six additional six month terms at the holder’s sole option; and (ii) one common share purchase warrant (each, a “Warrant”). The Warrants will be valid for 36 months following the date of closing of the Note Offering and each Warrant will be exercisable for one Common Share at an exercise price of C$0.14.
Concurrent with the Note Offering, the Company also announced today that it intends complete a non-brokered private
placement (the “Non-Brokered Unit Offering”) of units of the Company (the “Units”) at a price of $0.10 per Unit for aggregate gross proceeds of up to C$4,000,000. The Non-Brokered Unit Offering is in addition to BriaCell’s proposed strategic US$800,000 Note Offering and also includes an investment from a recognized Biotech Family office in the United States. Under the Non-Brokered Unit Offering, each Unit shall consist of one Common Share and one Warrant. The Warrants will be valid for 36 months following the date of closing of the Non-Brokered Unit Offering and each Warrant will be exercisable for one Common Share at an exercise price of C$0.14.
The Company intends to use the proceeds from the Note Offering and the Non-Brokered Unit Offering to: (i) finance the Company’s Phase-2a clinical trial; (ii) to finance the Company’s pursuit of other research opportunities; and (iii) for working capital and general corporate purposes.
The Note Offering and Non-Brokered Unit Offering are expected to close on or about March 14, 2018, and is subject to the approval of the TSX Venture Exchange and other customary closing conditions.
All securities issued under the Note Offering and Non-Brokered Unit Offering will have a four month and one day hold expiring on the date of issuance of such securities.
The Company also announced that it has granted incentive stock options of 3.4 million common shares exercisable on or before the expiry of March 1, 2021 from the date of grant at a price of $0.15 per common share. This event follows the recent expiration of 11.87 million warrants at an exercise price of $0.25 (such warrants expired on November 27, 2017), and 0.45 million warrants at an exercise price of $0.35 (such warrants expired on December 2, 2017, and February 5, 2018), and the expired Stock Options of 2.4 million (at exercise prices of $0.22, and $0.255) on January 31, 2018.
BriaCell is an immuno-oncology focused biotechnology company developing a targeted and safe approach to the management of cancer. Immunotherapy has come to the forefront in the fight against cancer, harnessing the body’s own immune system in recognizing and selectively destroying cancer cells while sparing normal ones. Immunotherapy, in addition to generally being more targeted and less toxic than commonly used types of chemotherapy, is also thought to be a potent approach with the potential to prevent cancer recurrence.
Bria-IMT™ (SV-BR-1-GM), the Company’s lead product candidate, is derived from a specific breast cancer cell line. It is genetically engineered to release granulocyte-macrophage colony-stimulating factor (GM-CSF), a substance that activates the immune system. We believe that Bria-IMT™ helps the body to recognize and kill tumor cells by activating T cells that attack the tumor and B cells that produce anti-tumor antibodies.
The results of two previous proof-of-concept clinical trials (one with the precursor cell line not genetically engineered to produce GM-CSF and one with Bria-IMT™) produced encouraging results in patients with advanced breast cancer. Most notably, one patient with metastatic breast cancer responded to Bria-IMT™ with substantial reduction in tumor burden including breast, lung, soft tissue and brain metastases. The company is currently conducting a Phase I/IIa clinical trial for Bria-IMT™ in patients with advanced breast cancer. This trial is listed in ClinicalTrials.gov as NCT03066947. The trial is being conducted along with the co-development of BriaDX™, the Company’s companion diagnostic test. The interim data for the first 6 patients was the subject of a press release in early 2018. Additionally, the FDA recently approved the roll-over combination study of Bria-IMT™ with pembrolizumab [Keytruda®; manufactured by Merck & Co., Inc.] or ipilimumab [Yervoy®; manufactured by
Bristol-Myers Squibb Company] for patients previously treated with Bria-IMT™ in the Company’s ongoing Phase I/IIa clinical trial in advanced breast cancer. The roll-over trial is listed in ClinicalTrials.gov as NCT03328026.
BriaCell is also developing Bria-OTS™, an off-the-shelf personalized Immunotherapy. Bria-OTS™ consists of 14 individually pre-manufactured genetic alleles. BriaCell’s BriaDX™ companion diagnostic reveals a patient’s specific HLA-types and the 2 best matching alleles are administered to the patient. BriaCell’s 14 alleles (8 Class I and 6 Class II) cover approximately 90% of the Breast Cancer population while eliminating the complex manufacturing logistics required for other personalized immunotherapies. Bria-OTS™ is a personalized therapy without the need for personalized manufacturing.
Yet another item in the BriaCell pipeline is a novel, selective protein kinase C delta (PKCδ) inhibitor. PKCδ inhibitors have shown activity in a number of pre-clinical models of RAS genes’ transformed cancers including breast, pancreatic, non-small cell lung cancer and neuroendocrine tumors (such as carcinoid tumors). For additional information on BriaCell, please visit our website: https://briacell.com.
Cautionary Note Regarding Forward-Looking Information
The TSX Venture Exchange Inc. has in no way passed upon the merits of the Company has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
The securities offered have not been, and will not be, registered under the U.S. Securities Act or any U.S. state securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the U.S. Securities Act and applicable U.S. state securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy securities in the United States, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.
Except for the statements of historical fact, this news release contains “forward-looking information” within the meaning of the applicable Canadian securities legislation which involves known and unknown risks relevant to the Company in particular and to the biotechnology and pharmaceutical industries in general, uncertainties and other factors that may cause actual events to differ materially from current expectation. These risks are more fully described in the Company’s public filings available at www.sedar.com.
Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For further information, please contact:
BriaCell Therapeutics Corp.
Manager, Corporate Development