Collagen Diseases

Dosing cohort 3 of the Phase 1 trial of LNCB74 (B7-H4 ADC) in multiple cancers and plan to initiate backfill cohorts in the second half of 2025 Plan to provide a proof of concept data readout in the first half of 2026 Cash of approximately $55.9 million expected to fund operations into the second half of 2026 BELTSVILLE, Md., May 01, 2025 (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 first quarter 2025 financial results. “With our LNCB74 antibody-drug conjugate (“ADC”) program completing cohort 2 in April 2025, we are progressing as planned through the dose escalation portion of the Phase 1 study. We expect to be in a position to initiate backfill cohorts in the second half of the year with 10 active investigator sites, and an additional 3 sites projected to be onboard in May 2025. We plan to provide a proof of concept data readout in the first half of 2026,” said Michael Richman, NextCure’s president and CEO. Business Highlights and Near-Term Milestones LNCB74 (B7-H4 ADC) Dosed our first patient in January 2025 in the Phase 1 trial, cleared cohort 2 in April 2025 and currently dosing cohort 3. Expanded clinical footprint for the LNCB74 study with a total of 10 active trial sites. Plan to initiate backfill cohorts in the second half of 2025. Plan to provide a proof of concept data readout in the first half of 2026. Preclinical Non-Oncology Programs Seeking Partnering Preclinical data for NC181 (ApoE4), a humanized antibody for the treatment of Alzheimer’s disease, has demonstrated amyloid clearance, prevention of amyloid deposition, plaque clearance and reduced neuroinflammation. Preclinical data for NC605 (Siglec-15), a humanized antibody for the treatment of osteogenesis Imperfecta (OI), has demonstrated that NC605 treatment reduced bone loss and enhanced bone quality in mice with OI. Both programs could lead to investigational new drug (IND) filings within 12 to 18 months if financial support from partners or third parties is secured. Financial Results for Quarter Ended March 31, 2025 Cash, cash equivalents, and marketable securities as of March 31, 2025 were $55.9 million as compared to $68.6 million as of December 31, 2024. The decrease of $12.8 million was primarily due to cash used to fund operations. We expect current financial resources to be sufficient to fund operating expenses and capital expenditures into the second half of 2026. Research and development expenses were $7.9 million for the three months ended March 31, 2025, as compared to $11.4 million for the three months ended March 31, 2024. The decrease of $3.5 million was due to lower costs related to programs other than LNCB74, lower preclinical development costs and lower personnel-related costs resulting from the restructuring and reduction-in-force announced during the first quarter of 2024 (the “2024 Restructuring”). General and administrative expenses were $3.7 million for the three months ended March 31, 2025, as compared to $4.4 million for the three months ended March 31, 2024. The decrease of $0.6 million was primarily related to lower personnel costs and lower insurance costs resulting from the 2024 Restructuring. There were no restructuring and asset impairment costs for the three months ended March 31, 2025 as compared to $2.5 million for the three months ended March 31, 2024, which costs resulted from the 2024 Restructuring. Net loss was $11.0 million for the three months ended March 31, 2025, as compared to a net loss of $17.1 million for the three months ended March 31, 2024 due to lower costs as described above. 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 targeted therapies including antibody-drug conjugates. 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. Please visit www.nextcure.com for more information. 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; NextCure’s ability to maintain listing of its common stock on the Nasdaq Global Select Market; 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. Investor Inquiries Timothy Mayer, Ph.D. NextCure, Inc. Chief Operating Officer (240) 762-6486 IR@nextcure.com Source: NextCure

The US Food and Drug Administration (FDA) has approved Abeona Therapeutics’ Zevaskyn (prademagene zamikeracel) for use in recessive dystrophic epidermolysis bullosa (RDEB). The decision makes Zevaskyn the first autologous cell-based gene therapy approved in the US to treat wounds in adult and paediatric patients with the rare skin disorder. RDEB is an incurable connective tissue disease that causes the skin to become very fragile. It is characterised by extensive blistering and severe wounds that often cover more than 30% of a patient’s body surface. Zevaskyn consists of a patient’s own skin cells that are genetically modified to produce functional type VII collagen, which RDEB patients are unable to produce due to a defect in both copies of the COL7A1 gene. The therapy is surgically applied to a patient’s wounded areas in the form of a sheet and is expected to be available in the US from the third quarter of this year. Abeona’s chief executive officer, Vish Seshadri, said the approval represents a “pivotal moment in the treatment of RDEB”. “Through a single surgical application, Zevaskyn can now offer people with RDEB the opportunity for wound healing and pain reduction in even the most severe wounds,” Seshadri said. The FDA’s approval was supported by results from the phase 3 VIITAL study, which demonstrated significant wound healing and pain reduction after a single treatment with Zevaskyn. In the trial, 81% of the 43 large and chronic wounds treated with a single application of Abeona’s therapy showed 50% or more healing at six months, compared to 16% in 43 matched control wounds treated with standard of care. A phase 1/2a study in 38 chronic wounds across seven patients also showed that a single application of Zevaskyn was associated with long-term improvement at treated sites over a median follow-up of 6.9 years. Zevaskyn was well-tolerated in both studies, with no treatment-related serious adverse events observed to date. Madhav Vasanthavada, Abeona’s chief commercial officer, said: “Based on the strength of our data across clinical trials, we are confident in Zevaskyn’s ability to deliver long-term results after a single treatment application. “We are committed to working closely with both commercial and government payers on outcome-based agreements that stand behind the promise of Zevaskyn for patients, and expedite access.”

Novartis plans to acquire Regulus Therapeutics for $7.00 per share in cash, or $800 million, the microRNA specialist said Wednesday. The biotech’s share price $RGLS jumped more than 135% in premarket trading, surpassing the buyout price at more than $7.90 apiece. Regulus is based in San Diego, which has become a biotech hot spot. It will be the future home to one of Novartis’ new biomedical hubs, the company said earlier this month. The hub is part of a 10-site, $23 billion investment in American manufacturing and R&D over the coming five years. The deal marks the second acquisition of the year for Novartis. The Swiss drug giant brought one of its former experimental cardio medicines back into its fold, purchasing Anthos Therapeutics for $925 million upfront in February. Novartis was active on the M&A front in 2024 as well, with five small deals. For Regulus shareholders, the deal is split about evenly between upfront and down-the-road payments. The shareholders could get an additional $7.00 per share in cash through a contingent value right, which depends on the approval of Regulus’ lead candidate, farabursen. If this is exercised, the total value of the deal is around $1.7 billion. The deal is slated to close in the second half of this year. Ionis and Alnylam created Regulus as a joint venture in 2007. The biotech then went public via an IPO in October 2012 at $4.00 per share. Over the years, Regulus built up a rich pipeline of pharma partnerships with Sanofi, GSK and AstraZeneca, but the tie-ups eventually fumbled. Sanofi culled a mid-stage program in Alport syndrome after a Phase 2 failure; a clinical hold for a different drug in hepatitis C led to challenges in the GSK pact; and AstraZeneca reneged on rights to a drug for NASH , the fatty liver disease now known as MASH. Now, Regulus is headed toward a pivotal trial for farabursen. The oligonucleotide targets miR-17, and it’s being tested as a treatment for autosomal dominant polycystic kidney disease, the most common genetic cause of renal failure. Phase 1b data in March 2024 led the company’s stock price to skyrocket and an immediate $100 million boon to the company’s coffers via a private placement. In March of this year, Regulus said it had an agreement with the FDA on “key components” for a single Phase 3 trial for potential accelerated approval. Editor’s note: This story has been updated throughout to include additional details.