BOSTON, May 10, 2022 (GLOBE NEWSWIRE) — Cue Biopharma, Inc. (CUE), a clinical-stage biopharmaceutical company developing a new class of injectable biologics to selectively engage and modulate targeted T cells directly in the patient’s body, today announced its first quarter 2022 financial results. Company will not hold a business update call in conjunction with its financial results press release.

Recent Company Updates

  • Extension of the cash trail with a total of $23.6 million from the sale of 3,593,407 shares of common stock under our stock market (ATM) sale agreement with Jefferies LLC. As of March 31, 2022, the Company has sold 2,396,013 shares of common stock under the October 2021 ATM Agreement for proceeds of approximately $17.6 million net of commissions paid, excluding transaction costs, and in April 2022 sold an additional 1,197,394 shares of common stock for proceeds of approximately $6.0 million, net of commissions paid, excluding transaction costs.
  • Completed enrollment of 20 patients at the recommended Phase 2 dose of 4 mg/kg of the Phase 1b monotherapy trial of CUE-101 for the treatment of recurrent head and neck squamous cell carcinoma (R/M HNSCC) /metastatic induced by HPV16 in second line and beyond treatment refractory patients. To date, CUE-101 has demonstrated a favorable safety profile as well as encouraging clinical anti-tumor activity and what appears to be an emerging trend of improved overall survival (OS).
  • Completed dose escalation phase of CUE-101 in combination with Merck’s KEYTRUDA®, an anti-PD-1 biologic, as first-line therapy in patients with advanced HPV16+ HNSCC. Patient enrollment began in the expansion phase at the recommended Phase 2 dose of 4 mg/kg CUE-101.

“Through a focused and strategic deployment of resources during the first quarter of 2022, we have made significant progress in advancing the IL-2-based CUE-100 series for oncology, as well as strengthening our financial situation,” said Daniel Passeri, Chief Executive Officer. CEO of Cue Biopharma. “As noted, we have recently completed the patient expansion phase of the CUE-101 monotherapy Phase 1b clinical trial and the dose escalation phase of the CUE-101 Phase 1 combination trial. with KEYTRUDA®. We are very pleased with the progress of our clinical trials to date and have increased confidence in the emerging data supporting the potential of our CUE-100 series pipeline in immuno-oncology through targeted and selective stimulation of the patient’s immune system. against cancer.

Kerri-Ann Millar, CFO of Cue Biopharma, added, “We continue to be in a strong financial position as we remain disciplined in our deployment of resources and adroit in our response to the challenges of today’s biotech capital markets. Access to our ATM common stock facility in the first four months of 2022 has allowed us to extend the planned operational track to the third quarter of 2023, which we believe will allow us to assess readings of data from our phase 1 monotherapy and combination clinical trials of CUE-101. »

First quarter 2022 financial results
The company reported collaboration revenue of approximately $1.0 million and $1.6 million for the three months ended March 31, 2022 and 2021, respectively.

Research and development expenses were $10.1 million and $9.8 million for the three months ended March 31, 2022 and 2021, respectively. The increase in research and development expenses of $0.3 million was primarily due to an increase in laboratory and drug substance manufacturing costs, employee compensation, and scientific and clinical advisory boards, other fees professionals, license fees and rent.

General and administrative expenses were $5.2 million and $4.3 million for the three months ended March 31, 2022 and 2021, respectively. The increase in general and administrative expenses of $0.9 million was primarily due to an increase in stock-based compensation expense, professional and consulting fees, and employee and board compensation incurred in the first quarter of 2022 compared to the same period in 2021.

Cue Biopharma, Inc.
Certain consolidated income statement data
(In thousands, except shared data)
Three months completed
March, 31st,
2022 2021
Collaboration revenue $ 1,000 $ 1,553
Operating costs :
general and administrative 5,156 4,255
Research and development 10,082 9,816
Total operating expenses 15,238 14,071
Operating loss (14,238 ) (12,518 )
Other income:
Interest income (expense), net (17 ) 13
Net loss $ (14,255 ) $ (12,512 )
Net loss per common share – basic and diluted $ (0.44 ) $ (0.41 )
Weighted average number of common shares outstanding – basic and diluted 32,436,316 30,434,525
Cue Biopharma, Inc.
Selected consolidated balance sheet data
(In thousands)
March, 31st,
2022
The 31st of December,
2021
Cash and cash equivalents 67,927 64,371
Total current assets 75,947 68,469
Working capital 64,536 55,680
Total assets 90,704 83,402
Full shareholder equity 64,673 65,492


About Cue Biopharma

Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a new class of injectable biologics to selectively engage and modulate targeted T cells directly in the patient’s body to transform the treatment of cancer, infectious diseases and autoimmune diseases. -immune. The company’s proprietary Immuno-STAT™ system (Selective targeting and alteration of T cells) platform, is designed to harness the body’s intrinsic immune system without the need for ex vivo manipulation.

Based in Boston, Massachusetts, the company is led by an experienced management team and an independent Board of Directors with deep expertise in immunology and immuno-oncology as well as in the design and clinical development of biological proteins.

For more information, visit https://www.cuebiopharma.com and follow us on Twitter at https://twitter.com/CueBiopharma.

Forward-looking statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be within the scope of security created by these rubrics. These forward-looking statements include, but are not limited to, those regarding: the company’s estimate of the period over which it expects to have cash available to fund its operations; the company’s belief that the Immuno-STAT platform drives targeted immune modulation through the selective engagement of disease-relevant T cells; and the company’s business strategies, plans and outlook. Forward-looking statements, which are based on certain assumptions and describe the company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking words such as “believe”, “expect”, “may”. , “will”, “should”, “do”, “could”, “seek”, “intend”, “plan”, “goal”, “project”, “estimate”, “anticipate”, ” strategy”, “future”, “likely” or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical fact included in this press release regarding the strategies, prospects, financial condition, operations, costs, plans and objectives of the company are forward-looking statements. Important factors that could cause the actual results and financial condition of the company to differ materially from those indicated s in forward-looking statements include, among other things, the company’s limited operating history, limited liquidity and history of losses; the company’s ability to achieve profitability; potential setbacks in the company’s research and development efforts, including negative or inconclusive results from its preclinical studies, its ability to obtain required United States Food and Drug Administration (“FDA”) approvals, or other governmental approvals for its product candidates and the scope of any approved indications; adverse effects caused by public health pandemics, including COVID-19, including possible effects on the Company’s trials; negative or inconclusive results from the Company’s clinical trials or preclinical studies or serious and unexpected drug-related side effects or other safety issues experienced by clinical trial participants; delays and changes in regulatory requirements, policies and guidelines, including potential delays in submitting required regulatory submissions to FDA; the company’s dependence on licensors, collaborators, contract research organizations, suppliers and other business partners; the company’s ability to obtain adequate financing to fund its business operations in the future; operations and clinical the company’s ability to maintain and enforce necessary patents and other intellectual property protections; competitive factors; general economic and market conditions and other risks and uncertainties described in the Risk Factors and Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recent annual report on Form 10 -K and any subsequently filed quarterly report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based solely on information currently available to the company and speaks only as of the date on which it is made. The Company undertakes no obligation to update publicly any forward-looking statements, written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Contact Investor
Mary Campinell
Senior Director, Corporate Communications
Cue Biopharma, Inc.
[email protected]

Media Contact
Darren Opland, Ph.D.
LifeSci Communications
[email protected]

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