NextCure Provides Business Update and Reports Second Quarter 2024 Financial Results

Rhea-AI Summary

NextCure (Nasdaq: NXTC) provided a business update and reported Q2 2024 financial results. Key highlights include:

1. Completed enrollment of 16 additional ovarian cancer patients in the NC410 + pembrolizumab Phase 1b study.

2. Finished GLP toxicology studies for LNCB74 (B7-H4 ADC), targeting IND submission by year-end.

3. Cash position of $86.4 million, expected to fund operations into H2 2026.

4. Q2 2024 financials: R&D expenses $12.4M, G&A expenses $4.1M, net loss $15.4M.

5. On track to present expanded ovarian cancer cohort data and CRC update in Q4 2024.

6. Advancing NC181 (APOE4) and NC605 (Siglec-15) programs, seeking partnerships for IND filings.

Positive

• Completed enrollment of additional ovarian cancer patients in NC410 + pembrolizumab Phase 1b study
• Finished GLP toxicology studies for LNCB74, targeting IND submission by year-end
• Cash position of $86.4 million expected to fund operations into second half of 2026
• Reduced net loss to $15.4 million in Q2 2024 compared to $17.9 million in Q2 2023
• Decreased G&A expenses by $1.6 million year-over-year

Negative

• Cash and equivalents decreased by $21.9 million from December 31, 2023 to June 30, 2024
• Continued net loss of $15.4 million in Q2 2024

Biotechnology Analyst

NextCure's Q2 2024 update reveals significant progress in their oncology pipeline, particularly with NC410 and LNCB74. The completion of enrollment for the NC410-pembrolizumab combination in ovarian cancer is a important milestone, with data expected later this year. This could potentially position NextCure as a key player in immuno-oncology combinations.

The completion of GLP toxicology studies for LNCB74, their B7-H4 antibody-drug conjugate, is a critical step towards IND submission. B7-H4 is an emerging target in oncology and if LNCB74 demonstrates a favorable safety profile, it could differentiate NextCure in the competitive ADC landscape.

However, the company's financial position requires careful consideration. While the $86.4 million cash runway into 2026 provides some stability, the $15.4 million net loss in Q2 indicates a significant burn rate. The reduction in R&D and G&A expenses is positive, but investors should monitor how this impacts pipeline progression.

The diversification into Alzheimer's (NC181) and rare diseases (NC605) could provide additional value, but the search for partners or funding for these programs suggests resource constraints. This strategy of seeking external support for non-core assets is prudent but highlights the challenges of a small biotech managing multiple programs.

Financial Analyst

NextCure's Q2 2024 financials present a mixed picture. The cash position of $86.4 million, while down from $108.3 million at the end of 2023, still provides a runway into the second half of 2026. This is a important buffer for a clinical-stage biotech, especially given the current challenging market conditions for raising capital.

The reduction in net loss to $15.4 million from $17.9 million year-over-year is encouraging, driven by decreased R&D and G&A expenses. R&D expenses fell by $1 million, while G&A expenses decreased by $1.6 million, indicating improved operational efficiency. However, investors should note that some of these reductions come from lower personnel-related costs, which could impact the company's ability to execute on its pipeline.

The company's focus on its lead assets (NC410 and LNCB74) while seeking partnerships for secondary programs (NC181 and NC605) demonstrates a strategic approach to resource allocation. This could potentially reduce future cash burn and extend the runway. However, it also highlights the challenges of funding multiple programs simultaneously.

Overall, while NextCure's financial position appears stable in the near term, the company will need to demonstrate clinical success, particularly with NC410 and LNCB74, to support its valuation and potentially access additional capital markets in the future.

• LNCB74 (B7-H4 ADC) GLP tox studies completed and targeting an IND application by year-end
• NC410 combo with pembrolizumab ovarian cohort enrollment completed
• Cash of approximately $86.4 million expected to fund operations into second half of 2026
  

BELTSVILLE, Md., Aug. 01, 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 second-quarter 2024 financial results.

“Following the release of Phase 1b data for the combination of NC410 and pembrolizumab at ASCO, we have completed enrollment of additional ovarian cancer patients, and we look forward to sharing results from the expanded ovarian cohort later this year,” said Michael Richman, president and CEO of NextCure. “We also continue to make important progress with our promising B7-H4 antibody-drug conjugate program, LNCB74, including the completion of GLP toxicology studies in July. We remain on track to submit an IND filing by year-end and rapidly advance into clinical development. NextCure is well capitalized to continue executing on our strategic priorities, with cash reserves expected to fund operations into the second half of 2026.”

Business Highlights and Near-Term Milestones

NC410 (LAIR-2 fusion)

• Completed enrollment in June 2024 of an additional 16 ovarian cancer patients among the 100 mg and 200 mg cohorts of the Phase 1b portion of a Phase 1b/2 study evaluating NC410 in combination with pembrolizumab (pembro) in colorectal cancer (CRC) and ovarian cancer patients.
• Clinical data from the Phase 1b portion of the trial was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2024.
• On track to present data from ongoing ovarian cancer cohort expansion along with an update on the CRC data in the fourth quarter of 2024.
  

LNCB74 (B7-H4 ADC)

• Recently completed GLP toxicology studies.
• Presented a poster highlighting strong safety and pharmacokinetic profiles for LNCB74 at the 2024 American Association for Cancer Research (AACR) Annual Meeting.
• Planned submission of an Investigational New Drug (IND) application by year-end.
  

NC181 (APOE4)

• Presented “NC181: First-in-class Approach to Treat Alzheimer’s Disease” at the H.C. Wainwright 5^th Annual Neuro Perspectives Virtual Conference.
• Initiated manufacturing of material for toxicology studies.
• Seeking partnering or other funding sources with the potential to file an IND mid-2025.
  

NC605 (Siglec-15)

• Conducted FDA pre-IND meeting related to treating osteogenesis imperfecta.
• Toxicology studies are ongoing; seeking partnering or other funding sources with the potential to file an IND in the second half of 2025.

Financial Results for Quarter Ended June 30, 2024

• Cash, cash equivalents, and marketable securities as of June 30, 2024 were $86.4 million as compared to $108.3 million as of December 31, 2023. The decrease of $21.9 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 $12.4 million for the three months ended June 30, 2024, as compared to $13.4 million for the three months ended June 30, 2023. Net costs on the LNCB74 program were more than offset by lower costs on other programs and preclinical development and lower personnel-related costs.
• General and administrative expenses were $4.1 million for the three months ended June 30, 2024, as compared to $5.7 million for the three months ended June 30, 2023. The decrease of $1.6 million was primarily related to payroll, lower stock compensation expense, lower professional fees and lower insurance costs.
• Net loss was $15.4 million for the three months ended June 30, 2024, as compared to a net loss of $17.9 million for the three months ended June 30, 2023.

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								Six Months Ended
		June 30,								June 30,
(in thousands, except share and per share amounts)		2024				2023				2024				2023
Operating expenses:
Research and development		$	12,418			$	13,447			$	23,816			$	25,094
General and administrative			4,076				5,711				8,440				11,135
Restructuring and asset impairment			—				—				2,542				—
Loss from operations			(16,494	)			(19,158	)			(34,798	)			(36,229	)
Other income, net			1,090				1,299				2,287				2,274
Net loss		$	(15,404	)		$	(17,859	)		$	(32,511	)		$	(33,955	)
Net loss per common share - basic and diluted		$	(0.55	)		$	(0.64	)		$	(1.16	)		$	(1.22	)
Weighted-average shares outstanding - basic and diluted			27,972,744				27,828,741				27,937,892				27,801,788

Selected Balance Sheet Items:
		June 30,				December 31,
(in thousands)		2024				2023
Cash, cash equivalents, and marketable securities		$	86,436			$	108,299
Total assets		$	102,589			$	128,038
Accounts payable and accrued liabilities		$	10,833			$	6,883
Total stockholders' equity		$	85,441			$	114,421

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

FAQ

What is NextCure's (NXTC) cash position as of Q2 2024?

NextCure's cash, cash equivalents, and marketable securities as of June 30, 2024, were $86.4 million.

When does NextCure (NXTC) expect to submit an IND for LNCB74?

NextCure is targeting an IND submission for LNCB74 by the end of 2024.

What was NextCure's (NXTC) net loss for Q2 2024?

NextCure reported a net loss of $15.4 million for the three months ended June 30, 2024.

When will NextCure (NXTC) present data from the expanded ovarian cancer cohort?

NextCure is on track to present data from the ongoing ovarian cancer cohort expansion in the fourth quarter of 2024.

How long is NextCure's (NXTC) current cash expected to fund operations?

NextCure expects its current financial resources to fund operating expenses and capital expenditures into the second half of 2026.