8-K
NextCure, Inc. (NXTC)
8-K
2024-12-05
For: 2024-12-05
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April 06, 2026
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 5, 2024
NextCure, Inc.
(Exact name of registrant as specified in its charter)
| Delaware (State or other jurisdiction of incorporation) | 001-38905 (Commission File Number) | 47-5231247 (IRS Employer Identification No.) |
|---|---|---|
| <br><br> | ||
| --- | --- | |
| 9000 Virginia Manor Road , Suite 200<br><br>Beltsville , Maryland | 20705 | |
| (Address of principal | (Zip Code) | |
| executive offices) |
Registrant's telephone number, including area code: (240) 399-4900
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, $0.001 par value per share | NXTC | Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 Regulation FD Disclosure
On December 5, 2024, NextCure, Inc. (the “Company”) updated its corporate presentation to reflect that it has filed an Investigational New Drug Application for its product candidate LNCB74. Beginning on December 5, 2024, the Company will be engaging with members of the investment community, which may reference these presentation materials. The Company is furnishing a copy of such presentation materials, which is attached hereto as Exhibit 99.1.
The information furnished in this Item 7.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of the Exchange Act, or otherwise subject to the liabilities of that section, and is not incorporated by reference into any filing under the Securities Act, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
.
Item 9.01Financial Statements and Exhibits
(d) Exhibits.
| <br><br><br><br> | | |
|---|---|---|
| Exhibit<br><br>No. | | Description |
| 99.1 | | NextCure, Inc. Presentation dated December 5, 2024 |
| 104 | | Cover Page Interactive Data File (embedded within the inline XBRL document) |
| <br><br><br><br><br><br> | | |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| November | ||
|---|---|---|
| Dated: December 5, 2024 | NEXTCURE, INC.<br><br> | |
| By: | /s/ Steven P. Cobourn | |
| Name: | Steven P. Cobourn | |
| Title: | Chief Financial Officer |
Exhibit 99.1
| Corporate Presentation<br>NASDAQ: NXTC<br>DECEMBER 2024 |
|---|
| Forward-Looking Statement<br>2<br>To the extent that statements contained in this presentation are not descriptions of historical facts, they may be deemed to be forward-looking statements under the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations, forecasts,<br>assumptions and other information available to NextCure as of the date hereof. Forward-looking statements include statements regarding<br>NextCure’s expectations, beliefs, intentions or strategies regarding the future and can be identified by forward-looking words such as “may,”<br>“will,” “potential,” “expects,” “believes,” “intends,” “hope,” “towards,” “forward,” “later” and similar expressions. Examples of forward-looking<br>statements in this presentation include, among others, statements about the development plans for our products, statements about the<br>progress and evaluation and expected timing of results of NextCure’s ongoing or planned clinical trials, expectations regarding the potential<br>benefits, activity, effectiveness and safety of our research stage, preclinical stage, and clinical stage therapeutic candidates, NextCure’s<br>financial guidance, expected upcoming milestones, and NextCure’s plans, objectives and intentions with respect to the discovery and<br>development of therapeutic products. Forward-looking statements involve substantial risks and uncertainties that could cause actual results<br>to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: the impacts<br>of the COVID-19 pandemic on NextCure’s business, including NextCure’s clinical trials, third parties on which NextCure relies and NextCure’s<br>operations; positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure’s limited operating history and<br>no products approved for commercial sale; NextCure’s history of significant losses; NextCure’s need to obtain additional financing; risks<br>related to clinical development, marketing approval and commercialization; the unproven approach to the discovery and development of<br>product candidates based on NextCure’s discovery platform; and dependence on key personnel. More detailed information on these and<br>additional factors that could affect NextCure’s actual results are described in NextCure’s filings with the Securities and Exchange Commission<br>(the “SEC”), including in Item 1A of NextCure’s most recent Form 10-K, subsequent Form 10-Q and elsewhere in the Company’s filings with<br>the SEC. You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of<br>this press release, and NextCure assumes no obligation to update any forward-looking statements, except as required by law, even if<br>expectations change. |
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| 3<br>Value-Driven ADC Opportunity<br>• IND submitted Q4 2024<br>• Breast, endometrial and ovarian cancers<br>• FIH expected in Q1 2025<br>2024-2025<br>DELIVERABLES<br>SIGNIFICANT<br>OPPORTUNITY<br>• Antibody-drug conjugate targeting B7-H4<br>• Differentiated linker for improved safety and increased efficacy<br>• Completed GLP tox study and GMP manufacturing for Ph 1 trial<br>• Balance sheet, ~$75 M, end of Q3<br>• Runway 2H 2026<br>RUNWAY |
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| 4<br>LNCB74<br>LEVERAGING OUR DEEP EXPERTISE IN B7-H4 AND COLLABORATION<br>WITH LCB TO DEVELOP A DIFFERENTIATED THERAPEUTIC<br>Breast<br>CANCER<br>Ovarian<br>CANCER<br>Endometrial<br>CANCER |
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| Focused on a Clinically Validated Target with High Unmet Need<br>5<br>PROGRAMS TARGET CELLS DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3<br>ANTICIPATED<br>MILESTONES<br>LNCB74<br>(ADC)<br>B7-H4 Tumor<br>Cells<br>FIH<br>Q1 2025 Co-development with<br>Breast, Ovarian,<br>Endometrial |
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| 6<br>THERAPEUTIC POSITIONING<br>Improved safety and efficacy<br>PATIENT SELECTION STRATEGY<br>CLIA validated IHC<br>biomarker assays<br>NOVEL APPROACH<br>Unique antibody linker strategy<br>Co-development partnership<br>with LCB<br>DEEP EXPERTISE<br>Significant B7-H4 experience<br>LCB’s substantial ADC know-how<br>Differentiated ADC<br>LNCB74<br>B7-H4 ADC |
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| B7-H4 is the Next Target of Interest in Women’s Cancer<br>7<br>In 2nd big deal of the day, GSK inks $1.4B<br>pacy for Hansoh gynecology cancer asset<br>NextCure, LegoChem* join big-league rivals in<br>antibody-drug conjugate race<br>*Currently known as LigaChemBio |
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| Deep Expertise in B7-H4<br>8<br>• Extensive publications<br>• Expertise in expression<br>• Repertoire of models<br>• Top-tier KOL collaborative network<br>• Validated patient selection assay<br>• Co-development & cost-sharing<br>• Significant success advancing ADCs<br>• Differentiated linker technology |
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| LNCB74<br>Initiation of Phase 1<br>9<br>✓ Potent pre-clinical activity in vitro and in vivo<br>✓ DRF & GLP tox studies – favorable safety and<br>tolerability profile<br>✓ Favorable pre-IND feedback from FDA<br>✓ GMP manufacturing<br>✓ IND filing<br>• Planning for Ph1 initiation<br>COMPLETED<br>ONGOING |
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| LNCB74 Is an Anti-B7-H4 MMAE ADC<br>Fc Modification<br>Protects immune cells<br>Tumor Selectivity<br>Glucuronidase cleavable linker<br>provides greater selectivity<br>and specificity<br>10<br>MMAE DAR 4<br>Improves safety and control<br>over how the payload<br>is dispersed<br>Antibody Linker Payload<br>STRUCTURAL DIFFERENTIATION |
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| LNCB74 Uses Differentiating Glucuronidase Linker for<br>Potentially Improved Safety & Efficacy<br>11<br>Bloodstream Tissues Cancer Cell Bystander Effect<br>Linker Glucuronidase<br>cleavable<br>Payload Tubulin inhibitor<br>Conjugation Site Specific<br>DAR 4<br>•Efficient release of toxin<br>•Higher concentration<br>Stable No Toxicity<br>Potent<br>Glucuronidase Linker<br>+<br>+<br>Transfer to albumin<br>Released by platelets & neutrophils<br>Unstable Toxicity<br>•Inefficient release of toxin<br>•Lower concentration<br>Less potent<br>Other Linkers Linker Protease or<br>esterase cleavable<br>Payload Tubulin or Topo-1<br>inhibitors<br>Conjugation Site Specific or<br>cysteine<br>DAR ~4, 6, 8 |
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| Key Differentiating Features of Glucuronidase Linkers<br>12<br>Time (Hours)<br>Relative Toxin Concentration<br>per Cancer Cell 100%<br>Val-cit Linker<br>Glucuronidase Linker<br>Control ADC<br>Glucuronidase Linker Val-Cit Linker<br> Site specific attachment to mAb □ Non-specific attachment to mAb<br> Highly stable linkage □ Unstable linkage<br>‒ Prone to transferring to albumin<br>‒ Increases toxicity<br> Specifically cleaved in cancer<br>cells<br>□ Susceptible to cleavage by<br>platelets and neutrophils,<br>increasing toxicity<br> Efficient release of payload □ Less efficient release of payload<br> Higher concentration of toxin<br>per cancer cell<br>□ Lower concentration of toxin per<br>cancer cell<br>• Improved therapeutic index • Higher efficacy • Lower toxicity • Less frequent dosing |
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| 13<br>LNCB74 Shows Potent Anti-Tumor Activity in CDX and PDX Models<br>OVARIAN (OVCAR-3-B7-H4-OE)<br>Days from Treatment Initiation<br>Mean Volume<br>(mm3) +/- SEM<br>TNBC (CTG-0012)<br>Mean Volume<br>(mm3) +/- SEM<br>Days from Treatment Initiation<br>BREAST (ZR-75-1)<br>Days from Treatment Initiation<br>Mean Tumor Volume<br>(mm3) +/- SEM<br>CDX PDX<br>Dosing Q7D x 3 1.5 mg/kg: Q7D x 3<br>4.5 mg/kg: single dose Single dose |
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| LNCB74 is More Effective than Comparator B7-H4-MMAE<br>14<br>0 10 20 30 40<br>0<br>500<br>1000<br>1500<br>2000 No Treatment LNCB74 3 mg/kg Comp 3 mg/kg<br>0 10 20 30 40<br>0<br>500<br>1000<br>1500<br>2000 No Treatment Comp 4.5 mg/kg<br>LNCB74 4.5 mg/kg<br>0 10 20 30 40<br>0<br>500<br>1000<br>1500<br>2000 No Treatment LNCB74 6 mg/kg Comp 6mg/kg<br>30 40 50 60<br>0<br>500<br>1000<br>1500<br>2000 No Treatment LNCB74 3 mg/kg Comp 3 mg/kg<br>30 40 50 60<br>0<br>500<br>1000<br>1500<br>2000 No Treatment LNCB74 4.5 mg/kg Comp 4.5 mg/kg<br>30 40 50 60<br>0<br>500<br>1000<br>1500<br>2000 No Treatment LNCB74 6 mg/kg Comp 6mg/kg<br>HCC1569 HER2+ BC OVCAR3 OC<br>Comparator<br>val-cit MMAE<br>(B7-H4 ADC)<br>WT hG1 Fc<br> ↑<br>immune cell engagement<br>MMAE<br>payload<br>(DAR4)<br>Stochastic, reduced cystine conjugation<br>[CTSB-cleavable, inter-chain linker]<br>LNCB74<br>(B7-H4 ADC)<br>LCB site-specific conjugation<br>[GUSB-cleavable, light-chain linker]<br>hG1-LALA Fc<br> ↓↓↓<br>Limited immune cell engagement<br>MMAE<br>payload<br>(DAR4) |
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| B7-H4 is a Validated ADC Target<br>Key<br>Features LNCB74 SGN-B7H4V XMT-1660 HS-20089 AZD8205 DB-1312 / BG-C9074<br>ADC Design<br>• B7-H4 mAb • B7-H4 mAb • B7-H4 mAb • B7-H4 mAb • B7-H4 mAb • B7-H4 mAb<br>• Glucuronidase cleavable linker • Val-Cit cleavable linker • Protease cleavable linker • Protease cleavable linker • Pegylated Val-Ala<br>cleavable linker • GGFG cleavable linker<br>• Monomethyl Auristatin E<br>(MMAE)<br>• Monomethyl Auristatin E<br>(MMAE)<br>• Auristatin F-HPA<br>(Dolasynthen) • TOPO1 inhibitor (Exatecan) • TOPO1 inhibitor (Proprietary) • Non-Pgp substrate payload<br>• DAR 4 • DAR ~4 • DAR 6 • DAR 6 • DAR 8 • DAR 6<br>DLT Safe and tolerable up to 10<br>mg/kg*<br>1.25 (N=1) or 1.5 mg/kg<br>(N=2) TBD 7.2 mg/kg (N=2) 3.2 mg/kg (N=2) TBD<br>Common<br>Aes<br>No major toxicity observed<br>in NHPs<br>Neutropenia, Peripheral<br>sensory neuropathy,<br>Nausea, Fatigue, Anemia,<br>Dyspnea, Hypotension, and<br>Pneumonia<br>TBD Leukopenia, Neutropenia,<br>Nausea, Anemia, Vomiting,<br>Fatigue, Thrombocytopenia,<br>Increased ALT and AST,<br>Anorexia, and Hyponatremia<br>Nausea, Neutropenia,<br>Thrombocytopenia, Anemia<br>and WBC decrease<br>TBD<br>RESPONSES<br>• IND Submitted Q4 2024 • TNBC: 1 CR / 8 PR (N=42)*<br>• HR+/HER2- Breast: 5 PR<br>(N=24)*<br>• Ovarian: 2 PR (N=15)<br>• Endometrial: 1 CR (N=16)<br>• Dose escalation progressed<br>to 115 mg/m² w/o MTD<br>• Anticipated Ph1 read out<br>(safety, efficacy and<br>biomarker analysis) – YE<br>• Expected initiation of TNBC<br>expansion cohort in post<br>topo-1 ADC patients – YE<br>• TNBC: 6 PR (N=16)<br>• Ovarian: 2 PR (N=3)<br>• Ovarian 3 PR (N=7)<br>• Breast 3 PR (N=17)<br>• Endometrial 3 PR (N=12)<br>TBD<br>Data Source 2024 2023 2023<br>*Cyno tox study<br>2024<br>*Pfizer Oncology Innovation Day<br>February 29, 2024<br>Partnership with<br>15 |
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| TOX STUDY GMP MANUFACTURING<br>16<br>GLP Tox and GMP Manufacturing Complete<br>Species Cynomolgus<br>Dose<br>Range<br>4, 7 & 10 mg/kg<br>Q3W, i.v.<br>Evaluation Toxicology profiling, pathology,<br>hematology, immunotoxicology<br>Findings Favorable safety and tolerability<br>profile<br>Master cell bank generated<br>Process development complete<br>Antibody manufactured<br>Clinical supply ready |
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| DOSE ESCALATION DOSE EXPANSION<br>17<br>LNCB74 Ph1 Monotherapy Study Plans<br>• 5 dose cohorts<br>• Regimen Q3W<br>• N=65 subjects<br>• 2 dose cohorts<br>• 2 tumor types<br>• N=80 subjects<br>• Pre-treatment & on study biopsies<br>Breast<br>CANCER<br>Ovarian<br>CANCER<br>Endometrial<br>CANCER<br>Readouts: Scans every 6 weeks<br>Endpoints: Safety and ORR<br>Readout: Scans every 6 weeks<br>Endpoint: Safety |
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| POTENTIAL FOR IMPROVED<br>SAFETY & EFFICACY<br>Opportunity<br>to Develop Differentiated B7-H4 ADC Therapeutic<br>18<br>B7-H4 ADC<br>UNMET NEED IN BREAST &<br>GYNECOLOGICAL CANCERS<br>PATIENT SELECTION<br>STRATEGY |
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| Programs Available for Partnering<br>19<br>PROGRAMS TARGET CELLS DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3<br>NC410<br>Combo LAIR-2<br>Extracellular<br>Matrix<br>NC525 LAIR-1 Leukemia<br>NC605 S15 Osteoclasts<br>NC181 APOE4 Microglia &<br>Neurons<br>Alzheimer’s<br>Disease<br>Osteogenesis<br>Imperfecta<br>Acute Myeloid Leukemia<br>Colorectal (CRC)<br>Ovarian |
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| 20<br>Anticipated Milestones<br>✓Completed GLP tox study and GMP manufacturing for Ph 1 trial<br>✓IND submitted Q4 2024<br>• FIH expected in Q1 2025<br>2024-2025<br>DELIVERABLES<br>SIGNIFICANT<br>OPPORTUNITY<br>• Antibody-drug conjugate targeting B7-H4<br>• Breast, endometrial and ovarian cancers<br>• Differentiated linker for improved safety and increased efficacy |
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