Osteogenesis Imperfecta

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

March 18, 2025 -- Angitia Biopharmaceuticals, a global, clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases, today announced the presentation of data from its randomized, double-blind, placebo-controlled Phase 1/2 study evaluating AGA111 for use in spinal fusion procedures on March 12, 2025, at the 2025 American Academy of Orthopedic Surgeons (AAOS) Annual Meeting in San Diego, California. In the study, treatment with AGA111, a recombinant human bone morphogenetic protein 6 (rhBMP6), led to faster radiographic fusion and a higher fusion success rate, as well as greater improvements in functional outcomes as assessed by the Oswestry Disability Index (ODI) and pain visual analog scale (VAS), compared to placebo. “We are honored and excited to present the full dataset from our Phase 1/2 study of AGA111, representing a rare and valuable randomized, placebo-controlled study in the field of orthopedics and spinal fusion,” said Willard Dere, M.D., Chief Medical Officer of Angitia. “Based on these encouraging results, we are now executing a registrational Phase 3 study of AGA111, which we believe has the potential to significantly accelerate bony fusion and meaningfully improve patient outcomes following spinal fusion surgery.” The Phase 1/2 trial was a randomized, double-blind, placebo-controlled study enrolling 63 patients with degenerative disc disease (DDD) requiring single-level Transforaminal Lumbar Interbody Fusion (TLIF) surgery. Patients were randomized 1:1:1 to 1 of 3 groups: placebo, 0.25mg AGA111, or 0.5mg AGA111. AGA111 or placebo was mixed with autologous blood to create a coagulum, which was then administered into the interbody area during TLIF surgery. No bovine material was used in the treatment or placebo arms. Blinded adjudicators assessed fusion success using CT scan images and hyperflexion/hyperextension X-rays at Months 3, 6, and 12. At the same time, functional outcomes were assessed via the ODI and pain VAS. Study results indicated that AGA111 induced more rapid fusion, increased fusion success rate, and improved functional outcomes compared to placebo. The abstract outlining the study is entitled, “AGA111, a Recombinant Human Bone Morphogenetic Protein 6 (rhBMP6), Improved Lumbar Interbody Fusion Success Following Single-Level Transforaminal Lumbar Interbody Fusion (TLIF) Surgery in a Phase I/II, Double-Blind, Placebo-Controlled, Randomized Study." AGA111 is a recombinant human bone morphogenic protein 6 (rhBMP6) product candidate in clinical development to promote bone fusion and functional outcomes in patients undergoing spinal fusion procedures. AGA111 is mixed with autologous blood to create an autologous blood coagulum and administered during the surgery. Angitia is currently studying AGA111 in double-blind, placebo-controlled, randomized Phase 3 study. Spinal fusion is a widely used surgical treatment for spinal disorders, including degenerative disc disease (DDD). Each year, approximately 146,000 patients in China and over 300,000 patients in the US undergo spinal fusion procedures to treat DDD. The rate of spinal fusion following surgery has a significant impact on patient outcomes. Although lumbar spinal fusion is a commonly performed spinal procedure, it can result in significant morbidity, including nonunion or pseudarthrosis. Patients with nonunion following spinal fusion surgery are at risk for pain, decreased functional outcomes, and re-operation. Angitia Biopharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases. Angitia is currently studying 3 biologic product candidates in clinical studies for the treatment of osteoporosis, osteogenesis imperfecta (OI), and spinal fusion. Leveraging the team's extensive experience and scientific acumen in novel drug development, Angitia is committed to providing groundbreaking therapies to satisfy key unmet medical needs. The content above comes from the network. if any infringement, please contact us to modify.

Completed cohort 1 of the Phase 1 trial of LNCB74 (B7-H4 ADC) in multiple cancers in February 2025 and plan to initiate backfill cohorts in the second half of 2025 Cash of approximately $68.6 million expected to fund operations into the second half of 2026 BELTSVILLE, Md., March 06, 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 full year 2024 financial results. “In 2024 we reprioritized our resources to advance our antibody-drug conjugate (“ADC”) program and recently completed cohort 1 of the Phase 1 study evaluating LNCB74 as a potential therapeutic for treating multiple cancers. We look forward to additional progress in 2025, including initiating backfill cohorts in the second half of the year,” said Michael Richman, NextCure’s president and CEO. Business Highlights and Near-Term Milestones LNCB74 (B7-H4 ADC) Presented preclinical data from LNCB74 (B7-H4 ADC) at the Society of Immunotherapy of Cancer (SITC) annual meeting in November 2024 to highlight its potential as a therapeutic for treating multiple solid tumor indications. The U.S. Food and Drug Administration accepted an Investigational New Drug (IND) application in December 2024. Dosed our first patient in January 2025 in the Phase 1 trial, clearing cohort 1 in February 2025 and currently dosing cohort 2. We plan to initiate backfill cohorts in the second half of 2025. 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 IND filings within 12 to 18 months if financial support from partners or third parties is secured. Financial Results for Full Year Ended December 31, 2024 Cash, cash equivalents, and marketable securities as of December 31, 2024 were $68.6 million as compared to $108.3 million as of December 31, 2023. The decrease of $39.7 million was primarily due to cash used to fund operations. We expect current financial resources to fund operating expenses and capital expenditures into the second half of 2026. Research and development expenses were $41.5 million for the full year ended December 31, 2024, as compared to $47.9 million for the full year ended December 31, 2023. Higher 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 $15.7 million for the full year ended December 31, 2024, as compared to $19.7 million for the full year ended December 31, 2023. The decrease of $4.0 million was primarily related to lower payroll, lower stock compensation expense and lower insurance costs. Net loss was $55.7 million for the full year ended December 31, 2024, as compared to a net loss of $62.7 million for the full year ended December 31, 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. 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; 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