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NextCure Provides Business Update and Reports First Quarter 2024 Financial Results

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NextCure, a clinical-stage biopharmaceutical company, reported its first-quarter 2024 financial results and provided a business update. They highlighted presenting Phase 1b data for NC410 combo with pembro at the ASCO Annual Meeting, showcasing preclinical data from LNCB74 at the AACR Annual Meeting, and having cash of approximately $96.0 million to fund operations into the second half of 2026. The company is focused on developing novel cancer therapies.

Positive
  • Presenting Phase 1b data for NC410 combo with pembro at ASCO Annual Meeting demonstrates the progress in developing innovative cancer therapies.

  • Having cash of approximately $96.0 million to fund operations into the second half of 2026 provides financial stability for future endeavors.

  • Advancing LNCB74 program to a planned IND submission by year-end indicates promising developments in the pipeline of novel therapies.

Negative
  • A decrease in cash, cash equivalents, and marketable securities from $108.3 million as of December 31, 2023, to $96.0 million as of March 31, 2024, raises concerns about the company's financial management and sustainability.

  • Net loss of $17.1 million for the three months ended March 31, 2024, compared to a net loss of $16.1 million for the same period in 2023, reflects financial challenges impacting the company's profitability.

  • Restructuring and asset impairment costs associated with a reduction in workforce and manufacturing pause may signal internal operational struggles affecting business efficiency.

Insights

Assessing the financial health of NextCure, the decrease in cash from $108.3 million to $96.0 million aligns with expectations for a pre-revenue biopharmaceutical firm, which typically endures significant burn rates to fund research and development. While the net loss widened slightly from the previous year, this is not unusual given the phase of development. The cash runway extending into the second half of 2026 provides a reasonable buffer for continuing their research without immediate dilutive financing, which is reassuring for investors.

The upcoming presentation at the ASCO Annual Meeting could be significant if the Phase 1b data for the NC410 and pembrolizumab combination shows positive results. This combo targets colorectal and ovarian cancer, areas with substantial unmet medical needs. The preclinical data on LNCB74, especially if it demonstrates a favorable safety profile and effective pharmacokinetics, could signal potential for advancement into clinical stages. The IND submission planned by year-end marks a critical regulatory step forward, indicating progression in the drug development pipeline.
  • Phase 1b data for NC410 combo with pembro to be presented at ASCO annual meeting on June 1
  • Presented preclinical data from LNCB74 (B7-H4 ADC) at recent AACR annual meeting
  • Cash of approximately $96.0 million expected to fund operations into second half of 2026

BELTSVILLE, Md., May 02, 2024 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, today provided a business update and reported its first-quarter 2024 financial results.

“We look forward to providing an update on the NC410 combo trial at the ASCO Annual Meeting, which will include data from the additional colorectal patients enrolled earlier this year," said Michael Richman, NextCure’s president and chief executive officer. “LNCB74, our B7-H4 ADC program, is advancing to a planned IND submission by year-end. GLP toxicology studies have been initiated and clinical material is being produced.”

Business Highlights and Near-Term Milestones

NC410 (LAIR-2 fusion)

  • Scheduled to present a poster at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 1st, highlighting clinical data from the Phase 1b study of NC410 in combination with pembrolizumab (pembro) in colorectal cancer (CRC) and ovarian cancer patients.
  • Included in the ASCO poster presentation will be the additional 20 CRC patients in the 100 mg cohort enrolled in January 2024.
  • Commenced enrolling additional ovarian cancer patients in March 2024 and plan to present data in the second half of 2024.

LNCB74 (B7-H4 ADC)

  • Presented a poster highlighting strong safety and pharmacokinetic profiles for LNCB74 at the 2024 American Association for Cancer Research (AACR) Annual Meeting.
  • Manufactured the monoclonal antibody intermediate and commenced clinical material production with our collaborator, LigaChem Biosciences (LCB), formerly LegoChem Biosciences.
  • Planned submission of an investigational new drug application by year-end.

Financial Results for Quarter Ended March 31, 2024

  • Cash, cash equivalents, and marketable securities as of March 31, 2024, were $96.0 million as compared to $108.3 million as of December 31, 2023. The decrease of $12.3 million was primarily due to cash used to fund operations. NextCure expects financial resources to fund operating expenses and capital expenditures into the second half of 2026.
  • Research and development expenses were $11.4 million for the three months ended March 31, 2024, as compared to $11.6 million for the three months ended March 31, 2023. Higher costs associated with increased patient enrollment in our phase 1b combination trial of NC410 were offset by reimbursements under our cost-sharing agreement with LigaChem and lower personnel-related costs.
  • General and administrative expenses were $4.4 million for the three months ended March 31, 2024, as compared to $5.4 million for the three months ended March 31, 2023. The decrease of $1.0 million was primarily related to lower personnel-related costs and lower insurance costs.
  • Restructuring and asset impairment costs associated with our reduction in workforce and the manufacturing pause announced in March 2024 totaled $2.5 million.
  • Net loss was $17.1 million for the three months ended March 31, 2024, as compared with a net loss of $16.1 million for the three months ended March 31, 2023. Lower general and administrative expenses and higher other income were offset by restructuring and impairment costs.

About NextCure, Inc.

NextCure is a clinical-stage biopharmaceutical company that is focused on advancing innovative medicines that treat cancer patients that do not respond, to or have disease progression on, current therapies, through the use of differentiated mechanisms of actions including antibody-drug conjugates, antibodies and proteins. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells, including in the tumor microenvironment, and the role each interaction plays in a biologic response. www.nextcure.com

Forward-Looking Statements

Some of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to funding for our operations, objectives and expectations for our business, operations and financial performance and condition, including the progress and results of clinical trials, development plans and upcoming milestones regarding our therapies. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “continue,” “could,” “should,” “due,” “estimate,” “expect,” “intend,” “hope,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “target,” “towards,” “forward,” “later,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language.

Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure’s limited operating history and not having any products approved for commercial sale; NextCure’s history of significant losses; NextCure’s need and ability to obtain additional financing on acceptable terms or at all; risks related to clinical development, marketing approval and commercialization; and NextCure’s dependence on key personnel. More detailed information on these and additional factors that could affect NextCure’s actual results are described under the heading “Risk Factors” in NextCure’s most recent Annual Report on Form 10-K and in NextCure’s other filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this press release, and NextCure assumes no obligation to update any forward-looking statements, even if expectations change.

Selected Financial Information
      
Selected Statement of Operations Items:Three Months Ended
 March 31,
(in thousands, except share and per share amounts)2024    2023
Operating expenses:     
Research and development$11,398  $11,647 
General and administrative 4,364   5,424 
Restructuring and asset impairment 2,542   - 
Loss from operations (18,304)  (17,071)
Other income, net 1,197   975 
Net loss$(17,107) $(16,096)
Net loss per common share - basic and diluted$(0.61) $(0.58)
Weighted-average shares outstanding - basic and diluted 27,903,040   27,774,536 
      
Selected Balance Sheet Items:     
 March 31,
 December 31,
(in thousands)2024
     2023
Cash, cash equivalents, and marketable securities$96,001  $108,299 
Total assets$115,159  $128,038 
Accounts payable and accrued liabilities$9,583  $6,883 
Total stockholders' equity$99,048  $114,421 
        

Investor Inquiries
Timothy Mayer, Ph.D.
NextCure, Inc.
Chief Operating Officer
(240) 762-6486
IR@nextcure.com


FAQ

What data will NextCure present at the ASCO Annual Meeting on June 1, 2024?

NextCure will present Phase 1b data for NC410 combo with pembro at the ASCO Annual Meeting on June 1, 2024.

How much cash does NextCure expect to fund operations into the second half of 2026?

NextCure expects to have approximately $96.0 million to fund operations into the second half of 2026.

What is the planned submission timeline for LNCB74 program?

NextCure plans to submit an investigational new drug application for LNCB74 program by year-end.

What were the general and administrative expenses for the three months ended March 31, 2024?

General and administrative expenses were $4.4 million for the three months ended March 31, 2024.

What was the net loss for the three months ended March 31, 2024?

The net loss was $17.1 million for the three months ended March 31, 2024.

NextCure, Inc.

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BELTSVILLE