and a COH sponsored Phase 1 clinical trial for MB-105 is scheduled to commence during 2019. A Phase 1 clinical trial for MB-108 is scheduled to commence in the first half of 2019. We also plan to file INDs and initiate Mustang sponsored clinical trials for MB-103 for the treatment of patients with metastatic breast cancer to brain and for the combination of MB-101 and MB-108 for the treatment of patients with GBM. Finally, we plan to file an IND and initiate a Mustang sponsored clinical trial for MB-105 for the treatment of patients with prostate cancer.
Additionally, we hold complementary patent licenses relating to the use, delivery and possible enhancement of our proprietary CAR technologies. In particular, we licensed intellectual property from Harvard University pertaining to CRISPR/Cas9 gene editing of CAR T cells, and we hope to use this technology to enhance the activity of our CAR T cell therapies.
To date, we have not received approval for the sale of our product candidates in any market and, therefore, have not generated any product sales from our product candidates. In addition, we have incurred substantial operating losses since our inception, and expect to continue to incur significant operating losses for the foreseeable future and may never become profitable. As of December 31, 2018, we have an accumulated deficit of $79.1 million.
We are a majority-controlled subsidiary of Fortress Biotech, Inc. (“Fortress”).
Recent Developments
At the Market Stock Sales
We entered into an At Market Issuance Sales Agreement (the “Agreement”), dated July 27, 2018, with B. Riley FBR, Inc., Cantor Fitzgerald & Co., National Securities Corporation, and Oppenheimer & Co. Inc. (each individually an “Agent” and collectively, the “Agents”). For the period from January 1, 2019 through April 23, 2019, we issued 3,506,222 shares of our common stock in market sales through an Agent under the Agreement, at an average price of $6.42 per share for gross proceeds of $22.5 million and paid fees of approximately $0.4 million.
Additionally, pursuant to our Founders Agreement with Fortress, we issued 87,656 shares of common stock to Fortress as an equity fee, representing 2.5% of the shares we issued.
Publication of Data from Phase 1/2 Trial for Bubble Boy Disease
On August 2, 2018, we entered into an exclusive worldwide license agreement with St. Jude for the development of a first-in-class ex vivo lentiviral gene therapy for the treatment of XSCID. We paid an upfront fee of $1.0 million in August 2018 in consideration for the exclusive license. Additional payments are due to St. Jude upon the achievement of five development and commercialization milestones totaling $13.5 million. The acquisition of this license expands our pipeline into gene therapy, allowing us to leverage existing synergies for our Worcester, Massachusetts cell-processing facility.
On April 18, 2019, we announced that the New England Journal of Medicine had published data from St. Jude coming from a Phase 1/2 clinical trial of a lentiviral gene therapy combined with low-dose busulfan for the treatment of newly diagnosed infants under two years old with XSCID, also referred to as SCID-X1 and commonly known as bubble boy disease, which data highlighted the following:
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Bone marrow harvest, busulfan conditioning and cell infusion were well tolerated;
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In seven of the eight cases, normalization of CD3+, CD4+ and CD4+ naïve T-cell and natural killer (“NK”) cell numbers occurred within three to four months after treatment, accompanied by vector marking in T, B, NK and myeloid cells and marrow progenitors;
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The eighth infant had insufficient T cells initially, but normalization of T cells occurred following an unconditioned boost of gene-corrected cells, and the patient is progressing favorably;
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All patients cleared previous infections and are growing normally;
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Seven of the eight infants treated have developed normal IgM levels to date;