On March 17, 2020 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, reported a business update for the fourth quarter and full year 2019 (Press release, Cue Biopharma, MAR 17, 2020, View Source [SID1234555641]).
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"We continue to execute on our stated goals and objectives in a highly focused manner. The fourth quarter of 2019, as well as the beginning of 2020, has been marked by the successful opening of all 13 participating clinical centers and the associated enhancement of patient enrollment for our ongoing CUE-101 monotherapy Phase 1 trial," said Daniel Passeri, chief executive officer of Cue Biopharma. Mr. Passeri added, "Furthermore, we successfully accessed the capital markets in a highly effective and prudent manner through an At-the-Market ("ATM") instrument with Stifel Nicolaus & Company, Inc. ("Stifel") raising $49M, net of commissions paid, in the second half of the year through strategically placed blocks of shares with targeted fundamental institutional investors. As a result of our successful execution of clearly defined corporate initiatives, we are now well positioned to focus upon the next stages of our strategic corporate development plan."
According to Anish Suri, Ph.D., president and chief scientific officer of Cue Biopharma, "We continue to make significant progress across the R&D organization on many fronts including expanding our oncology pipeline assets, evolving our platform and generating key datasets to support application of our platform in autoimmune diseases. To the last point, we are very pleased to have Merck, our collaborator in autoimmune disease, recently present advances in the Immuno-STAT platform for selective modulation of pathologic T cells involved in autoimmune type 1 diabetes."
Fourth-Quarter 2019 Financial Results
The Company reported collaboration revenue of approximately $1.0 million and $0.3 million for the three months ended December 31, 2019 and 2018, respectively.
Research and development expenses were $6.9 million and $7.3 million for the three months ended December 31, 2019 and 2018, respectively. The decrease in research and development expenses of $0.4 million was primarily due to a decrease in manufacturing cost as our full clinical supply was manufactured during 2018. The decrease in these costs were offset by clinical trial expenses related to the CUE-101 monotherapy trial that was initiated in the latter part of the third quarter of 2019.
General and administrative expenses were $3.1 million and $5.3 million for the three months ended December 31, 2019 and 2018, respectively. The decrease in general and administrative expense of $2.2 million was primarily due to a decrease in stock-based compensation expense and legal and accounting fees incurred in the fourth quarter of 2019 as compared to the same period in 2018.
Full Year 2019 Financial Results
The Company reported collaboration revenue of approximately $3.5 million and $1.1 million for the years ended December 31, 2019 and 2018, respectively.
Research and development expenses were $27.5 million and $28.5 million for the years ended December 31, 2019 and 2018, respectively. The decrease in research and development expenses of $1.0 million was primarily due to a reduction in headcount and operational efficiencies realized during 2019.
General and administrative expenses were $12.7 million and $11.3 million for the years ended December 31, 2019 and 2018, respectively. The increase in general and administrative expense of $1.4 million was primarily due to an increase in headcount and legal fees related to our patent filings in 2019.
As of December 31, 2019, the Company had approximately $59.4 million in cash and cash equivalents compared with $39.2 million as of December 31, 2018.
Recent News & Business Updates
Extended cash runway through an ATM equity offering sales agreements for aggregate proceeds of $49 million, net of commissions paid, with Stifel, who acted as sales agent. As of December 31, 2019, the Company had sold 5,314,055 shares of common stock under the sales agreements.
Immuno-STAT (Selective Targeting and Alteration of T cells) platform was featured in a Merck presentation at the Antigen-Specific Immune Tolerance Drug Development Summit in February 2020. The presentation highlights an Immuno-STAT that was made to selectively deliver a PD-L1 inhibitory signal to CD4 T cells reactive to the proinsulin protein, which is associated with type 1 diabetes. This Immuno-STAT selectively inhibited the expansion of proinsulin reactive T cells isolated from the blood of type 1 diabetes patients, and also selectively inhibited the functional response of proinsulin-specific CD4 T cells when the Immuno-STAT was administered to transgenic mice.
Published research demonstrating the ability of the Company’s lead biologic candidate CUE-101 to activate tumor antigen specific antitumor immunity in the peer-reviewed medical journal Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The manuscript by Steven Quayle et al. is titled "CUE-101, a Novel HPV16 E7 pHLA-IL-2-Fc Fusion Protein, Enhances Tumor Antigen Specific T Cell Activation for the Treatment of HPV16-Driven Malignancies."
The research highlights the ability of our proprietary Immuno-STAT (Selective Targeting and Alternation of T cells) platform to selectively engage and modulate targeted T cells within the body. CUE-101 is the company’s lead drug candidate from the IL-2 based CUE-100 series designed to directly engage and activate T cells to target HPV16-driven recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).