On August 4, 2022 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate tumor-specific T cells directly within the patient’s body, reported second quarter 2022 financial results (Press release, Cue Biopharma, AUG 4, 2022, View Source [SID1234617706]). The Company will host a business update call and webcast on Tuesday, August 23, 2022 at 4:30 p.m. EDT. Live and archived versions of the event can be accessed via the Company’s website.
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Recent Business Updates
Investigational New Drug (IND) application accepted by the U.S. Food and Drug Administration (FDA) for CUE-102 in Wilms’ Tumor 1 (WT1) expressing cancers. Based on the premise that CUE-102 possesses the same molecular framework as CUE-101 except for the nine amino acid sequence difference between HPV-E7 and WT1, the IND was supported by clinical and safety data from the ongoing CUE-101 monotherapy trial and did not require additional IND-enabling toxicology studies.
Initiated a dose escalation monotherapy Phase 1 trial with CUE-102 at a starting dose of 1mg/kg. The trial will focus on patients with WT1-positive recurrent/metastatic gastric, pancreatic, ovarian and colorectal cancers.
Presented interim CUE-101 clinical data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) on June 6th. Eight of the nine evaluable patients treated with CUE-101 and KEYTRUDA in the dose escalation portion of our combination study had at least one post dose scan at the time of the data cut-off of April 22. Of the eight patients, two patients, one patient at the 2mg/kg dose and one patient at the 4mg/kg dose, had confirmed ongoing partial responses and two additional patients had durable stable disease, defined as stable disease on at least two consecutive post-treatment scans lasting at least 12 weeks.
Extended cash runway with an aggregate of $23.6 million, net of commissions paid, from the sale of 3,593,407 shares of our common stock pursuant to our ATM equity offering sales agreement with Jefferies LLC during the first six months of 2022.
"As we continue to progress the IL-2-based CUE-100 series for oncology, our confidence is bolstered by the growing body of evidence that our Immuno-STAT platform and therapeutic approach appear to represent a potential breakthrough in oncology," said Daniel Passeri, chief executive officer of Cue Biopharma. "We are encouraged with the continued progress of the CUE-101 monotherapy and combination trials and look forward to providing a business update during our upcoming call. We are also pleased with the recent acceptance of the IND for the CUE-102 Phase 1 dose escalation trial, which importantly will begin at 1mg/kg dose, as compared to 0.16mg/kg in the Phase 1 dose escalation of CUE-101 saving us valuable time and resources in determining the tolerability and recommended Phase 2 dose of CUE-102. In summary, we are very pleased with our clinical trial progress and associated data to date as we continue to further the clinical development of our CUE-100 series pipeline throughout fiscal year 2022."
Kerri-Ann Millar, chief financial officer of Cue Biopharma added, "During the second quarter of 2022, management took proactive steps to decrease the Company’s office and lab footprint and restructure in support of newly prioritized corporate objectives and strategies. These important steps, resulting in a significant cost savings that has been allocated to key clinical programs, coupled with successfully accessing our at-the-market (ATM) common stock facility will allow us to assess the data readouts from our CUE-101 Phase 1 monotherapy and combination clinical trials."
Second-Quarter 2022 Financial Results
The Company reported collaboration revenue of approximately $26 thousand and $2.7 million for the three months ended June 30, 2022 and 2021, respectively.
Research and development expenses were $9.6 million and $8.8 million for the three months ended June 30, 2022 and 2021, respectively. The increase in research and development expenses of $0.8 million was primarily due to an increase in laboratory and drug substance manufacturing costs, employee compensation, other professional fees, licensing fees, and rent.
General and administrative expenses were $3.8 million and $4.3 million for the three months ended June 30, 2022 and 2021, respectively. The decrease in general and administrative expense of $0.5 million was primarily due to a decrease in stock-based compensation expense related to executive management, professional and consulting fees, and employee and board compensation incurred in the second quarter of 2022 as compared to the same period in 2021.