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Martes 13 oct 2026SEC · NASDAQ biomédico

Portada›Miércoles 12 de noviembre de 2025

Biomédicas del NASDAQ ante la SEC, miércoles 12 de noviembre de 2025

Los 190 documentos que 113 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

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El día, bloque a bloque

Va en color lo que cambia el capital o avisa de un riesgo: las emisiones con precio (424B1, 424B2, 424B4 y 424B5), los 8-K con item 1.02, 1.03, 2.04, 3.01, 3.02 y 4.02, y cualquier documento en el que haya aparecido una frase vigilada, que va citada debajo. Lo demás va en tinta normal. Una cita marcada «por primera vez» es una frase que no estaba en el informe previo del mismo tipo de esa empresa. La etiqueta del formulario lleva a su explicación.

Emisiones y dilución

  1. ANNXAnnexon, Inc.424B5Nueva emisión de acciones con precioEDGAR
  2. COGTCogent Biosciences, Inc.424B5Nueva emisión de acciones con precioEDGAR
  3. COGTCogent Biosciences, Inc.424B5Nueva emisión de acciones con precioEDGAR
  4. COGTCogent Biosciences, Inc.424B5Nueva emisión de acciones con precioEDGAR
  5. COGTCogent Biosciences, Inc.424B5Nueva emisión de acciones con precioEDGAR
  6. CYPHCYPHERPUNK TECHNOLOGIES INC.424B5Nueva emisión de acciones con precioEDGAR
  7. DCOYDecoy Therapeutics Inc.424B4Nueva emisión de acciones con precioEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…reserves. •The pendency of the Merger could have an adverse effect on the trading price of Salarius’ common stock and its business, financial condition and prospects. •Decoy’s financial condition raises substantial doubt regarding its ability to continue as a going concern. 19 •Decoy has never generated revenue from product sales and all of Decoy’s product candidates are currently in the preclinical stage, and Decoy may continue to incur significant losses for the foreseeable…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…Decoy and their respective directors and executive officers may sell shares into the market, which could adversely affect the market price of shares of Salarius’ common stock. Salarius has previously entered into an At the Market Offering Agreement dated as of February 5, 2021, with the representative, pursuant to which, from time to time, Salarius may offer and sell shares of its common stock under an “at-the-market” offering program…
  8. DTILPRECISION BIOSCIENCES INC424B5Nueva emisión de acciones con precioEDGAR
  9. ELDNEledon Pharmaceuticals, Inc.424B5Nueva emisión de acciones con precioEDGAR
  10. ENGNenGene Therapeutics Inc.424B5Nueva emisión de acciones con precioEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…activities for the year ended October 31, 2023, has an accumulated deficit at October 31, 2023, and will require additional financing in order to fund its future expected negative cash flows, that raise substantial doubt about its ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. The financial statements of Forbion European Acquisition Corp. for the year…
  11. INOINOVIO PHARMACEUTICALS, INC.424B5Nueva emisión de acciones con precioEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…medicines and proprietary device technology, which may prove difficult or costly to obtain. • We do not currently have sufficient working capital to fund our planned operations for the next twelve months and substantial doubt exists as to our ability to continue as a going concern. • If we are unable to obtain FDA approval of our proprietary devices and DNA medicine candidates, we will not be able to commercialize them in the United States. In particular, because our product candidates…
  12. INOINOVIO PHARMACEUTICALS, INC.424B5Nueva emisión de acciones con precioEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…medicines and proprietary device technology, which may prove difficult or costly to obtain. • We do not currently have sufficient working capital to fund our planned operations for the next twelve months and substantial doubt exists as to our ability to continue as a going concern. • If we are unable to obtain FDA approval of our proprietary devices and DNA medicine candidates, we will not be able to commercialize them in the United States. In particular, because our product candidates…
  13. IVAInventiva S.A.424B5Nueva emisión de acciones con precioEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…terms, or at all, and failure to obtain this necessary capital when needed may force us to curtail, delay or discontinue our product candidate development efforts or other operations. These factors raise substantial doubt regarding our ability to continue as a going concern. From inception, we have financed our growth through successive capital increases, debt including royalty certificates, collaboration and license agreements and payment of French Research tax credit…
  14. NKTRNEKTAR THERAPEUTICS424B5Nueva emisión de acciones con precioEDGAR
  15. PDSBPDS Biotechnology Corp424B5Nueva emisión de acciones con precioEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…losses from operations incurred since inception, the expectation of continued operating losses and the need to raise additional capital to finance our future operations, we have determined that there is substantial doubt about our ability to continue as a going concern within 12 months from the date of this Quarterly Report. We will continue to seek to raise additional capital, but without additional financing we may not be able to continue as a going concern. Our future…
  16. PTNPALATIN TECHNOLOGIES INC424B4Nueva emisión de acciones con precioEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…statements include, but are not limited to, statements about: ● our significant operating losses since our inception and our need to obtain additional financing has caused management to determine there is substantial doubt regarding our ability to continue as a going concern; ● our ability to obtain additional financing on terms acceptable to us, or at all, including unavailability of funds or delays in receiving funds as a result of economic disruptions; ● our expectation…
    En el documentoContrasplit de accionestexto original ▸…Restated Certificate of Incorporation with the Secretary of State of Delaware to effect a 1-for-50 reverse stock split of the outstanding shares of our common stock. The Company’s stockholders previously approved the Reverse Stock Split at our annual meeting of stockholders held on July 25, 2025. The Reverse Stock Split became effective after market on August 11, 2025 with the Company’s Common Stock trading on the OTCQB on a split-adjusted…
  17. VORVor Biopharma Inc.424B5Nueva emisión de acciones con precioEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2024, as set forth in their report (which contains an explanatory paragraph describing conditions that raise substantial doubt about the Company’s ability to continue as a going concern as described in Note 1 to the consolidated financial statements), which is incorporated by reference in this prospectus supplement. Our financial statements are incorporated by reference in reliance on…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…preliminary unaudited cash and cash equivalents was approximately $160.5 million. Subsequent to September 30, 2025, we issued and sold 1,370,111 shares pursuant to our “at-the-market” facility that we entered into in December 2022 (the “ATM Facility”) with Stifel, Nicolaus & Company, Incorporated, as sales agent, for net proceeds of $49.8 million. This preliminary financial information reflects our preliminary estimate, based on currently available…
  18. AUTLAutolus Therapeutics plc424B3Prospecto suplementario o de reventaEDGAR
  19. IMAImageneBio, Inc.424B3Prospecto suplementario o de reventaEDGAR
  20. NKTRNEKTAR THERAPEUTICSS-3ASRCapacidad de emisión registradaEDGAR
  21. PBMPSYENCE BIOMEDICAL LTD.424B3Prospecto suplementario o de reventaEDGAR
  22. SABSSAB Biotherapeutics, Inc.424B3Prospecto suplementario o de reventaEDGAR

Participaciones y control

  1. DSGNDesign Therapeutics, Inc.SC 13D/ACambio en participación significativaEDGAR
  2. GLUEMonte Rosa Therapeutics, Inc.SC 13D/ACambio en participación significativaEDGAR
  3. IVVDInvivyd, Inc.SC 13D/ACambio en participación significativaEDGAR
  4. LNAILunai Bioworks Inc.SC 13D/ACambio en participación significativaEDGAR
  5. NVAXNOVAVAX INCSC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

  1. BTAIBioXcel Therapeutics, Inc.8-KResultadosEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…ability to comply with covenant obligations and potential payment obligations related to such indebtedness and other contractual obligations; the Company has identified conditions and events that raise substantial doubt about its ability to continue as a going concern; its limited experience in drug discovery and drug development; risks related to the TRANQUILITY program; its dependence on the success and commercialization of IGALMI®, BXCL501, BXCL502, BXCL701 and…
    En el documentoDesignación de terapia innovadora (breakthrough)texto original ▸…agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia…
  2. DERMJourney Medical Corp8-KResultadosEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…protection for our technology and products; our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or our third parties’ cybersecurity; the substantial doubt about our ability to continue as a going concern; the effects of major public health issues, epidemics or pandemics on our product revenues and any future clinical trials; our potential need to raise additional capital; Fortress controls a voting majority…
  3. ELUTELUTIA INC.8-KAviso de incumplimiento de cotizaciónEDGAR
  4. HALOHALOZYME THERAPEUTICS, INC.8-KVenta de acciones no registrada (colocación privada)EDGAR
  5. KALAKALA BIO, Inc.8-KAviso de incumplimiento de cotizaciónEDGAR
    En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸…13(a) of the Exchange Act. ☐ ​ ​ ​ Item 3.01. Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing. On November 10, 2025, KALA BIO, Inc. (the “Company”) received a deficiency letter from the Listing Qualifications Department (the “Staff”) of the Nasdaq Stock Market (“Nasdaq”) notifying the Company that the listing of its common stock was not in compliance with Nasdaq Listing Rule…
  6. NXTSNexentis Technologies Inc.8-K/AOtros hechos relevantesEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…in accordance with the relevant ethical requirements relating to our audits. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion. Substantial Doubt About the Company’s Ability to Continue as a Going Concern The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1b to the financial statements, the Company has suffered recurring…
  7. ZBIOZenas BioPharma, Inc.8-KResultadosEDGAR
    En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸…in patients living with IgG4-RD to date. · Relapsing Multiple Sclerosis (RMS) Results for Obexelimab:Announced highly positive results from the Phase 2 MoonStone trial of obexelimab in RMS. Obexelimab met the primary endpoint, demonstrating a highly statistically significant 95% relative reduction in the cumulative number of new gadolinium (Gd)-enhancing (GdE) T1 hyperintense lesions over week 8 and week 12 compared with placebo…
  8. ABCLAbCellera Biologics Inc.8-KCambio en el consejo o la direcciónEDGAR
  9. ABEOABEONA THERAPEUTICS INC.8-KResultadosEDGAR
  10. ABEOABEONA THERAPEUTICS INC.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…the basic and diluted earnings per share calculation for the three and nine months ended September 30, 2025 given their nominal exercise price. Open Market Sale Agreement On August 17, 2018, the Company entered into an open market sale agreement (as amended, the “ATM Agreement”) with Jefferies LLC (“Jefferies”) pursuant to which, the Company may sell from time to time, through Jefferies, shares of its common stock for an aggregate sales price of up to $75.0 million. Any sales…
  11. ABOSAcumen Pharmaceuticals, Inc.8-KResultadosEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…soluble AβOs, sabirnetug aims to address the hypothesis that soluble AβOs are an early and persistent underlying cause of the neurodegenerative process in Alzheimer’s disease (AD). Sabirnetug has been granted Fast Track designation for the treatment of early AD by the U.S. Food and Drug Administration and is currently being evaluated in a Phase 2 study in patients with early AD. About ALTITUDE-AD (Phase 2) Initiated in 2024, ALTITUDE…
  12. ABOSAcumen Pharmaceuticals, Inc.10-QInforme trimestralEDGAR
  13. ABSIAbsci Corp8-KResultadosEDGAR
  14. ABSIAbsci Corp10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…and us. If such holders, by exercising their registration rights, sell a large number of shares, they could adversely affect the market price for our common stock. 74 Additionally, in August 2025, we entered into the Sales Agreement with TD Securities (USA) LLC (the Sales Agent) with respect to an “at the market offering” program under which we may offer and sell, from time to time, shares of our common stock having an aggregate offering price of up to $100.0 million through the Sales Agent. We will pay the Sales Agent…
  15. ACONAclarion, Inc.10-QInforme trimestralEDGAR

    El 24 de septiembre de 2024, Aclarion firmó un acuerdo de venta de acciones At-The-Market con Ascendiant Capital Markets, LLC como agente de ventas.

    Original en inglés · traducción revisadaOn September 24, 2024, the Company entered into an At-The-Market Issuance Sales Agreement (the “Sales Agreement”) with Ascendiant Capital Markets, LLC, (“Ascendiant”) as sales agent, to sell shares of its common stock, par value $0.00001 per share, having an aggregate offering price of up to $10 million from time to time, through an “at the market offering” as defined in Rule 415 under the Securities Act of 1933, as amended.

    Traducción automática (claude-sonnet-5), con la cita comprobada contra el documento y revisada por una persona.

  16. ACXPAcurx Pharmaceuticals, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…if ever. Management plans to seek additional equity financing and grant funding, but cannot assure that such financing and funding will be available at acceptable terms, or at all. These matters raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying condensed interim financial statements do not include any adjustments that might result from the outcome of this uncertainty. There can be no assurance that the Company’s research and…
    En el documentoContrasplit de accionestexto original ▸…statements are read in conjunction with the audited financial statements and notes thereto as of December 31, 2024 filed in the Annual Report on Form 10-K. Reverse Stock Split On August 4, 2025, the Company effected a 1-for-20 reverse stock split of its issued and outstanding shares of common stock. The Company accounted for the reverse stock split on a retrospective basis pursuant to ASC 260, Earnings Per Share. All issued and outstanding common…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…C Warrants to purchase 66,667 shares of common stock and Series D Warrants to purchase 66,667 shares of common stock for gross proceeds of approximately $4.0 million. On November 15, 2023, the Company entered into a Sales Agreement and established an “At-the-Market” offering (the “ATM Program”), pursuant to which the Company may offer and sell, from time to time through A.G.P/Alliance Global Partners, as sales agent, shares of its common stock having an aggregate offering…
  17. ALKSAlkermes plc.8-KOtros hechos relevantesEDGAR
  18. ANTXAN2 Therapeutics, Inc.8-KResultadosEDGAR
  19. ANTXAN2 Therapeutics, Inc.10-QInforme trimestralEDGAR
  20. APREAprea Therapeutics, Inc.8-KResultadosEDGAR
  21. APREAprea Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…operating expenses and capital expenditure requirements through at least twelve months from the date of issuance of these condensed consolidated financial statements. Therefore, the Company has concluded that substantial doubt exists about its ability to continue as a going concern. The Company is in the process of seeking additional funding. In the event that additional funds are not available, management would expect to significantly reduce expenditures to conserve cash, which…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…subsequently filed a prospectus supplement to the 2024 Shelf Registration Statement for the sale of up to $2.0 million of shares of common stock pursuant to the ATM Agreement. On January 26, 2024, the Company entered into an At the Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“HCW”). Pursuant to the ATM Agreement and the prospectus supplement filed in connection therewith, the Company was able, from time to time…
  22. ARCTArcturus Therapeutics Holdings Inc.10-QInforme trimestralEDGAR
    En el documentoDebilidad material en el control internotexto original ▸…reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim consolidated financial statements will not be prevented or detected on a timely basis. Management concluded that the following material weakness disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 continues to exist as of September 30, 2025: • A material weakness related to information technology general…
  23. ARTLARTELO BIOSCIENCES, INC.10-QInforme trimestralEDGAR
  24. ARTVArtiva Biotherapeutics, Inc.8-KResultadosEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…RA.” Recent Business Highlights AlloNK® (also known as AB-101) Updates: • Lead indication and Fast Track Designation: In October 2025, Artiva announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to AlloNK for the treatment of refractory rheumatoid arthritis (RA) in combination with rituximab. This represents the first known therapy within the emerging deep B-cell depletion category to receive…
  25. ARTVArtiva Biotherapeutics, Inc.10-QInforme trimestralEDGAR
  26. ARTVArtiva Biotherapeutics, Inc.8-KOtros hechos relevantesEDGAR
  27. ATOSATOSSA THERAPEUTICS, INC.8-KResultadosEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸…resources on near-term, NDA-enabling activities for investigational (Z)-endoxifen. • Named Janet R. Rea, MSPH, as Senior Vice President, R&D to accelerate (Z)-endoxifen toward key regulatory milestones. Appointed Mark Daniel, CPA, as Chief Financial Officer to lead finance, systems, and capital strategy for commercial readiness - In October 2025, Atossa appointed Janet R. Rea, MSPH to its newly created position Senior Vice President, R&D. Ms. Rea brings…
  28. ATOSATOSSA THERAPEUTICS, INC.10-QInforme trimestralEDGAR
  29. ATRAAtara Biotherapeutics, Inc.8-KResultadosEDGAR
    En el documentoRevisión prioritaria de la FDAtexto original ▸…Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. There are no FDA approved therapies in this treatment setting. The BLA has been granted Priority Review with a Class 2 Resubmission Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026. Atara expects to receive an additional $40 million milestone payment from Pierre Fabre Laboratories…
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸EX-99.1 2 d66575dex991.htm EX-99.1 Exhibit 99.1 Atara Biotherapeutics Announces Third Quarter Financial Results and Operational Progress Tab-cel Prescription Drug User Fee Act (PDUFA) Target Action Date of January 10, 2026 Atara has completed the transfer of substantially all tab-cel activities, including BLA sponsorship, and associated costs to Pierre Fabre Laboratories Approval of BLA would unlock a $40 Million milestone…
  30. ATRAAtara Biotherapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…well as the completion of specific regulatory activities by us, our partner and actions taken by third parties, and are, therefore, uncertain at this time. In order to alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, we plan to secure additional capital, potentially through a combination of public or private security offerings; use of our ATM facility as described in Note 10; issuance of debt; and/or execution of…
    En el documentoContrasplit de accionestexto original ▸…June 10, 2024, our stockholders approved a proposal to authorize our Board of Directors (Board) to amend our Amended and Restated Certificate of Incorporation to effect a reverse stock split. The Board approved the reverse stock split on June 10, 2024 and, on June 20, 2024, we effected a 1-for-25 reverse stock split of our common stock. The par value and the authorized shares of the common stock were not adjusted as a result of the…
  31. AUTLAutolus Therapeutics plc8-KResultadosEDGAR
    En el documentoDesignación de terapia avanzada (RMAT)texto original ▸…data cut-off. Additional data will be presented in a poster presentation at the ASH Annual Meeting on December 7, 2025, from 6:00 – 8:00pm ET. In October 2025, the U.S. Food and Drug Administration (FDA) granted regenerative medicine advanced therapy (RMAT) designation to obe-cel for the treatment of pediatric patients with r/r B-ALL. The RMAT designation is a program created under the 21st Century Cures Act to accelerate development and regulatory…
  32. AUTLAutolus Therapeutics plc10-QInforme trimestralEDGAR
  33. AVIRAtea Pharmaceuticals, Inc.8-KResultadosEDGAR
  34. AVIRAtea Pharmaceuticals, Inc.10-QInforme trimestralEDGAR
  35. BBOTBridgeBio Oncology Therapeutics, Inc.8-KResultadosEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸…enable targeted KRAS combinations • Advanced three ongoing Phase 1 clinical trials, with clinical data readouts from each program expected in 2026 • Cash runway expected to fund BBOT operations into 2028 • Appointed industry veteran Uneek Mehra as Chief Financial Officer SOUTH SAN FRANCISCO, Calif., Nov. 12, 2025 — BridgeBio Oncology Therapeutics, Inc. (“BBOT”) (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, today reported…
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…durability in multiple preclinical models. Early data from Phase 1 dose escalation showed a 60% confirmed overall response rate in KRAS G12C NSCLC patients. • The U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to BBO-8520 for the treatment of adult patients with previously treated, KRAS G12C-mutated metastatic NSCLC. • The ongoing Phase 1 ONKORAS-101 trial (NCT06343402) is evaluating BBO-8520 for patients with…
  36. BBOTBridgeBio Oncology Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoDebilidad material en el control internotexto original ▸…these rules, BBOT is required to maintain effective disclosure and financial controls and to make a formal assessment of the effectiveness of BBOT’s internal control over financial reporting. BBOT has identified a material weakness in its internal controls over financial reporting. If BBOT is unable to maintain effective internal controls over financial reporting and disclosure controls and procedures, the accuracy and timeliness…
  37. BCDABioCardia, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…cash equivalents of approximately $5.3 million as of September 30, 2025 are not sufficient to fund our planned expenditures and meet our obligations beyond the second quarter of 2026. These factors raise substantial doubt about our ability to continue as a going concern beyond one year from the date these financial statements are issued. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. 5 Our ability to continue…
    En el documentoContrasplit de accionestexto original ▸…Exercise Price Balance as of December 31, 2024 2,467,104 $ 3.10 Warrants for common stock sold 5,481,514 1.33 Balance as of September 30, 2025 7,948,618 $ 1.88 Reverse Stock Split - On May 30, 2024, we effected a 1-for-15 reverse stock split of our common stock and reduced the authorized common shares from 100,000,000 to 50,000,000. The par value was not adjusted as a result of the reverse stock split. All issued and outstanding common stock…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…representing gross proceeds of $918,000. The gross proceeds of the September 2025 Offering were $6.0 million, with associated issuance costs of $824,000. At-the-Market (ATM) Offerings – On December 6, 2023, we entered into an “At The Market” offering agreement (the Sales Agreement) with H.C. Wainwright & Co., LLC (HCW). Under the Sales Agreement, we may offer and sell our common stock, from time to time having an aggregate offering amount of up to…
  38. BCDABioCardia, Inc.8-KResultadosEDGAR
  39. BFRIBiofrontera Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…million in July 2025 and $2.5 million in October 2025). As of September 30, 2025, we had cash and cash equivalents of $3.4 million, compared to $5.9 million as of December 31, 2024. These factors raise substantial doubt about the Company’s ability to continue as a going concern for a period of at least twelve months from the issuance date of this report. The Company plans to address the conditions that raise substantial doubt regarding its ability to continue as a going concern…
  40. BOLTBolt Biotherapeutics, Inc.8-KResultadosEDGAR
  41. BOLTBolt Biotherapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…sufficient to fund the Company's operations into 2027. However, due to the significant uncertainty in its plans, including the achievement of its collaboration income, the Company has concluded that there is substantial doubt about its ability to continue as a going concern within one year after the issuance of the condensed consolidated financial statements. As a result, the Company will be required to raise additional capital by partnering, selling equity, or other means…
    En el documentoContrasplit de accionestexto original ▸…additional capital through equity or partnering will depend on the general economic environment in which it operates and its ability to achieve key milestones. Reverse Stock Split On June 6, 2025, the Company effected a 1-for-20 reverse stock split (the “Reverse Stock Split”) of its common stock. The par value per share and the number of authorized shares were not adjusted as a result of the Reverse Stock Split. The shares of common stock underlying…
  42. BTAIBioXcel Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…of operations and financial condition. We may not have sufficient cash flow from operations to satisfy our obligations under the Credit Agreement. ● We have identified conditions and events that raise substantial doubt about our ability to continue as a going concern. ● Our strategic reprioritization and other workforce reductions in force may not achieve our intended outcome. ● We have limited experience in drug discovery and drug development. ● Developments relating…
    En el documentoContrasplit de accionestexto original ▸…hinder or prevent our product candidates’ commercial success.” in Part II, Item 1A, “Risk Factors” elsewhere in this Quarterly Report on Form 10-Q. Reverse Stock Split On February 10, 2025, the Company effected a 1-for-16 reverse stock split of its issued and outstanding common stock (the “Reverse Stock Split”). As a result of the Reverse Stock Split, each 16 shares of common stock issued and outstanding immediately prior to February 10,…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…common stock, having an aggregate offering price of up to $100,000, from time to time, through an “at the market offering” program under which Jefferies will act as sale agent. On November 1, 2023, we entered into an amendment to the Sale Agreement with Jefferies to increase the size of the “at the market offering” program; pursuant to the Sale Agreement, as amended, we can offer and sell shares of our common stock having an aggregate offering price of up to $150,000 (excluding any shares of common stock already…
  43. BYSIBeyondSpring Inc.8-KResultadosEDGAR
  44. BYSIBeyondSpring Inc.10-QInforme trimestralEDGAR
  45. CALCCalciMedica, Inc.8-KResultadosEDGAR
  46. CALCCalciMedica, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…its cash, cash equivalents and short-term investments may not be sufficient to fund its operations for a period of one year following the issuance of these financial statements. As a result, there is substantial doubt about the Company’s ability to continue as a going concern. The unaudited condensed consolidated financial statements have been prepared on a basis which assumes we are a going concern and does not include any adjustments to reflect the possible future effects…
  47. CDIOCardio Diagnostics Holdings, Inc.10-QInforme trimestralEDGAR
    En el documentoContrasplit de accionestexto original ▸…with the Securities and Exchange Commission (“SEC”) on March 20, 2025. Reverse Stock Split The Company held its 2024 annual meeting of stockholders on November 15, 2024, where the Company’s stockholders approved a reverse stock split at a ratio within a range of 1-for-5 and 1-for-40 and granted the Company’s Board of Directors the discretion to determine the timing and ratio of the split within such range. On April 10, 2025, the Company…
    En el documentoDebilidad material en el control internotexto original ▸…there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Management’s Report on Internal Controls Over Financial Reporting Management identified the following material weakness in our internal control over financial reporting: inadequate segregation of duties within the financial reporting process due to our limited staff resources, which increases the risk of errors or unauthorized…
  48. CELZCREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.8-KCambio en el consejo o la direcciónEDGAR
  49. CNTBConnect Biopharma Holdings Ltd8-KResultadosEDGAR
    En el documentoAcuerdo de licencia o colaboracióntexto original ▸…Greater China, Simcere Pharmaceutical Co., Ltd. (Simcere), submitted to and received acceptance of its NDA for rademikibart by the NMPA for the treatment of AD in adults and adolescents. ◦As part of the license agreement with Simcere, Connect is eligible to receive remaining milestone payments up to an aggregate amount of approximately $110 million upon the achievement of certain development, regulatory and commercial milestones. Connect is also eligible to receive royalties at tiered…
  50. CNTBConnect Biopharma Holdings Ltd10-QInforme trimestralEDGAR
  51. COYACoya Therapeutics, Inc.8-KResultadosEDGAR
  52. COYACoya Therapeutics, Inc.10-QInforme trimestralEDGAR
  53. CRBPCorbus Pharmaceuticals Holdings, Inc.8-KResultadosEDGAR
  54. CRBPCorbus Pharmaceuticals Holdings, Inc.10-QInforme trimestralEDGAR
  55. CRBUCaribou Biosciences, Inc.8-KResultadosEDGAR
    En el documentoDesignación de terapia avanzada (RMAT)texto original ▸…cel is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to enhance CAR-T cell activity by limiting premature CAR-T cell exhaustion. The FDA granted vispa-cel Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, and Fast Track designations for B-NHL. About the ANTLER phase 1 clinical trial The ANTLER clinical trial is a multicenter, open-label phase 1 trial evaluating vispa-cel in adult patients…
  56. CRBUCaribou Biosciences, Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…offering program described below). As of September 30, 2025, we had the full amount available for sale under the 2025 Shelf Registration Statement. At-the-Market Equity Offering Program On August 9, 2022, we entered into an at-the-market Open Market Sale AgreementSM (“ATM Sales Agreement”) with Jefferies LLC (“Jefferies”), pursuant to which, through Jefferies as sales agent, from time to time, we could have sold and issued shares of our common stock having an aggregate offering price…
  57. CRMDCorMedix Inc.8-KResultadosEDGAR
  58. CRMDCorMedix Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…On May 9, 2024, the Company filed a shelf registration statement (the “2024 Shelf Registration Statement”) for the issuance of up to $150 million of Company securities. Also on May 9, 2024, the Company entered into an At-The-Market Issuance Sales Agreement with Leerink Partners LLC, as sales agent, pursuant to which the Company may sell, from time to time, an aggregate of up to $50 million of its common stock through the sales agents under the 2024 Shelf…
  59. CUECue Biopharma, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…matters as to which forward-looking statements are made in this report could be materially different from those anticipated in such forward-looking statements. • Our recurring losses from operations raise substantial doubt regarding our ability to continue as a going concern. • We are a clinical-stage biopharmaceutical company, have no history of generating commercial revenue, have a history of operating losses, and may never achieve or maintain profitability. • We currently…
    En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸…None. ITEM 4. MINE SAFETY DISCLOSURES Not applicable. ITEM 5. OTHER INFORMATION (a) Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing On May 12, 2025, we received a deficiency letter, or the Notice, from the Listing Qualifications Department, or the Staff, of Nasdaq indicating that we failed to comply with the Nasdaq continued listing requirement to maintain a minimum closing bid…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…September 30, 2025 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2025, or any future periods. Public Offerings In October 2021, the Company entered into an open market sale agreement (the “ATM Sales Agreement”) with Jefferies LLC ("Jefferies"), as agent, to sell shares of the Company’s common stock for aggregate gross proceeds of up to $80 million, from time to time, through an at-the-market equity offering…
  60. CUECue Biopharma, Inc.8-KResultadosEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸…strategic transition in leadership to further enable next stage of growth with disruptive autoimmune therapeutic candidates most notably, CUE-401, the Company’s lead autoimmune asset — Usman Azam, M.D., appointed President and Chief Executive Officer, effective as of September 29 — CUE-401 is uniquely engineered and designed as a tolerogenic bifunctional molecule harnessing the power of TGF-beta and IL-2 to re-establish immune tolerance and balance…
    En el documentoAcuerdo de licencia o colaboracióntexto original ▸EX-99.1 2 cue-ex99_1.htm EX-99.1 Cue Biopharma Reports Third Quarter 2025 Financial Results and Recent Business Highlights • Announced strategic collaboration and license agreement with ImmunoScape to develop breakthrough cell therapy approach for solid tumors – Company is entitled to receive upfront payments totaling $15M • Announced strategic transition in leadership to further enable next stage of growth with disruptive autoimmune therapeutic candidates most notably, CUE-401, the Company’s lead…
  61. CYPHCYPHERPUNK TECHNOLOGIES INC.8-KNuevo acuerdo materialEDGAR
  62. CYPHCYPHERPUNK TECHNOLOGIES INC.10-QInforme trimestralEDGAR
  63. CYPHCYPHERPUNK TECHNOLOGIES INC.8-KNuevo acuerdo materialEDGAR
  64. DERMJourney Medical Corp10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. However, as a result of recurring and historical losses, substantial doubt exists about the Company’s ability to continue as a going concern for a period of at least twelve months from the date of issuance of these financial statements. The financial statements do not include any adjustments relating to the recoverability and classification…
  65. DMACDiaMedica Therapeutics Inc.8-KResultadosEDGAR
  66. DMACDiaMedica Therapeutics Inc.10-QInforme trimestralEDGAR
  67. DTILPRECISION BIOSCIENCES INC8-KOtros hechos relevantesEDGAR
  68. DYAIDYADIC INTERNATIONAL INC10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued. The Company expects to incur losses and have negative net cash flows from operating activities as it continues developing its DapibusTM…
  69. DYAIDYADIC INTERNATIONAL INC8-KResultadosEDGAR
  70. ELUTELUTIA INC.10-QInforme trimestralEDGAR
  71. ELVNEnliven Therapeutics, Inc.8-KResultadosEDGAR
  72. ELVNEnliven Therapeutics, Inc.10-QInforme trimestralEDGAR
  73. ENGNenGene Therapeutics Inc.8-KOtros hechos relevantesEDGAR
  74. ERASErasca, Inc.8-KResultadosEDGAR
  75. ERASErasca, Inc.10-QInforme trimestralEDGAR
  76. ESLAEstrella Immunopharma, Inc.10-QInforme trimestralEDGAR
  77. FLNAFILANA THERAPEUTICS, INC.8-KResultadosEDGAR
  78. FLNAFILANA THERAPEUTICS, INC.10-QInforme trimestralEDGAR
  79. GANXGain Therapeutics, Inc.8-KResultadosEDGAR
  80. GANXGain Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…expenditures for a period of at least 12 months from the date these financial statements are issued. Because of the current liquidity situation and lack of expected revenues in the foreseeable future, substantial doubt exists about its ability to continue as a going concern. The Company will need to obtain additional capital and/or other funding in order to continue operations beyond the first quarter of 2026. Management plans to raise additional capital primarily through…
  81. HUMAHumacyte, Inc.8-KResultadosEDGAR
    En el documentoDesignación de terapia avanzada (RMAT)texto original ▸…Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. 4 For uses other than the FDA…
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment…
  82. HUMAHumacyte, Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…RDO Warrants”) in a registered direct offering (the “October 2025 Registered Direct Offering”). See Note 14 — Subsequent Events for additional information. ATM Facility On September 1, 2022, the Company entered into the ATM Facility for the sale from time to time of up to $80.0 million of shares of Common Stock. During the three months ended September 30, 2025, the Company sold an aggregate of 2,492,410 shares of Common Stock under…
  83. IBIOiBio, Inc.8-KResultadosEDGAR
  84. IBIOiBio, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…September 30, 2024. ​ The history of significant losses, the negative cash flow from operations, and the dependence by the Company on its ability to obtain additional financing to fund its operations raised substantial doubt about the Company's ability to continue as a going concern. In August 2025, the Company closed on an underwritten public offering raising gross proceeds of approximately $50 million. (See Note 15 – Stockholders’ Equity for additional information.) Based on the…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…Agreement); provided that sixty (60) days after the Effective Date entering into an at-the-market facility shall not be deemed a Variable Rate Transaction. ​ ATM Agreement ​ On July 3, 2024, the Company entered into the ATM Agreement with its Sales Agents providing for the issuance and sale by the Company of its Common Stock, from time to time, through the Sales Agents, with certain limitations on the amount of Common Stock that may…
  85. IMAImageneBio, Inc.8-KResultadosEDGAR
  86. IMAImageneBio, Inc.10-QInforme trimestralEDGAR
    En el documentoContrasplit de accionestexto original ▸…the “Merger”). In addition, on July 25, 2025, Ikena changed its name from “Ikena Oncology, Inc.” to “ImageneBio, Inc.” Prior to the effective time of the First Merger (the “First Effective Time”), Ikena effected a 1-for-12 reverse stock split (the “Reverse Stock Split”) of its issued common stock (“Ikena Common Stock”). At the First Effective Time, (i) each ordinary share and preferred share of Legacy Inmagene (each such share, a “Legacy Inmagene…
  87. IMRXImmuneering Corp8-KResultadosEDGAR
  88. IMRXImmuneering Corp10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…offering costs for the 2022 ATM Program were written off in August 2025, after the 2022 Shelf Registration Statement and the 2022 ATM Program expired, the 2022 Sales Agreement was terminated, and the Company entered into the 2025 Sales Agreement related to the 2025 ATM Program. The Company had approximately $0.5 million of deferred offering costs as of December 31, 2024 associated with the 2022 Sales Agreement. 2025 Shelf Registration Statement On August 13, 2025, the Company…
  89. INDPIndaptus Therapeutics, Inc.8-KResultadosEDGAR
  90. INDPIndaptus Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…it may need to delay, reduce, or eliminate its research and development programs, which could adversely affect its business prospects, or cease operations. As a result of these uncertainties, there is substantial doubt about the Company’s ability to continue as a going concern. The unaudited condensed consolidated financial statements do not include any adjustments to the carrying amounts and classifications of assets and liabilities that would result if the Company was unable…
    En el documentoContrasplit de accionestexto original ▸…adjustments to the carrying amounts and classifications of assets and liabilities that would result if the Company was unable to continue as a going concern. Reverse Split On June 26, 2025, the Company effected a 1-for-28 reverse stock split of its common stock with the Company’s shares and began trading on a post-split basis on the Nasdaq Capital Market on June 27, 2025, which resulted in the Company regaining compliance with the Nasdaq…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…of common stock under the SEPA for aggregate net proceeds of approximately $1.74 million, after deducting offering expenses in the amount of approximately $0.1million. d. On June 1, 2022, the Company entered into an ATM Agreement which was amended on September 1, 2022 with a sales agent, pursuant to which the Company may offer and sell, from time to time through the sales agent, shares of the Company’s common stock. The issuance…
  91. INOINOVIO PHARMACEUTICALS, INC.8-KNuevo acuerdo materialEDGAR
  92. IRDOpus Genetics, Inc.8-KResultadosEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…visual disturbances under mesopic, low-contrast conditions, with topline results expected in the first half of 2026. • The program is being conducted under a Special Protocol Assessment (SPA) and has received Fast Track Designation from the FDA. Medical Publications and Presentations • Peer-reviewed publication of LCA5 Phase 1/2 trial data in Molecular Therapy: “Recovery of Cone-Mediated Vision in a Severe Ciliopathy after Gene…
  93. IRDOpus Genetics, Inc.10-QInforme trimestralEDGAR
  94. KLRSKalaris Therapeutics, Inc.8-KResultadosEDGAR
  95. KLRSKalaris Therapeutics, Inc.10-QInforme trimestralEDGAR
  96. KRROKorro Bio, Inc.8-KNuevo acuerdo materialEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸…Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. On November 7, 2025, Olukemi A. Olugemo, M.D., FAAN resigned from her position of Chief Medical Officer of Korro to pursue another opportunity, effective November 12, 2025. In order to ensure the smooth transition of her functions, Dr. Olugemo has agreed to be available to serve as an advisor for three…
    En el documentoRecorte de plantilla o reestructuracióntexto original ▸…collaboration and license agreement with Novo Nordisk A/S (Novo Nordisk). This amendment establishes a 12-month pause to reassess the rationale for the current target under the first research program. Workforce Reduction • Approximately 34% reduction in workforce impacting all levels of the organization. • Extending cash runway into second half of 2027 to provide sufficient capital to deliver clinical data from KRRO-121…
  97. KRROKorro Bio, Inc.10-QInforme trimestralEDGAR
  98. KRSAKorsana Biosciences, Inc.10-K/AInforme anual (enmienda)EDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has suffered recurring losses from operations, has limited financial resources, and has stated that substantial doubt exists about the Company’s ability to continue as a going concern. Management's evaluation of the events and conditions and management’s plans regarding these matters are also described in Note 1. The consolidated financial statements do not include any adjustments…
  99. KRSAKorsana Biosciences, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…necessary to develop this technology, establish and successfully complete clinical studies, obtain necessary regulatory governmental approvals and successfully commercialize this product candidate; • there is substantial doubt regarding our ability to continue as a going concern and we will need to raise capital in the near term in order to maintain our operations; • we may be unable to access capital, capabilities, and transactions necessary to advance the development of the…
  100. KYTXKyverna Therapeutics, Inc.8-KResultadosEDGAR
  101. KYTXKyverna Therapeutics, Inc.10-QInforme trimestralEDGAR
  102. LBRXLB PHARMACEUTICALS INC8-KOtros hechos relevantesEDGAR
  103. LGVNLongeveron Inc.8-KCambio en el consejo o la direcciónEDGAR
  104. LNTHLantheus Holdings, Inc.8-KCambio en el consejo o la direcciónEDGAR
  105. LTRNLantern Pharma Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…incur, losses and generate negative operating cash flows and as such will require substantial additional funding in the near future to continue its research and development activities. These factors raise substantial doubt about the Company’s ability to continue as a going concern in the absence of obtaining substantial additional funding. While the Company plans to pursue periodic capital raises, including additional potential sales under the ATM, no assurance can be given that…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…approximately $9,421,000. The Company plans to pursue periodic capital raises and also plans to apply for grant funding in the future to assist in supporting its capital needs. In July 2025, the Company entered into an ATM Sales Agreement (“ATM”), with ThinkEquity LLC (“ThinkEquity”), as sales agent, pursuant to which the Company may offer and sell up to $15,530,000 of its common stock from time to time, in “at-the-market” offerings to…
  106. LYELLyell Immunopharma, Inc.8-KResultadosEDGAR
    En el documentoDesignación de terapia avanzada (RMAT)texto original ▸…an 83% disease control rate and a manageable safety profile at the highest dose level studied to date in patients with refractory metastatic colorectal cancer in an ongoing U.S. Phase1 clinical trial •Received RMAT designation from the U.S. FDA for ronde-cel for the treatment of patients with relapsed or refractory LBCL receiving treatment in the second-line (2L) setting •Announced that two abstracts highlighting…
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…therapy enhanced with CD19 CAR expression and controlled cytokine release to increase cell expansion, immune cell infiltration and cancer cell killing in the hostile tumor microenvironment. LYL273 was granted Fast Track designation for the treatment of mCRC by the FDA. •Dose-dependent clinical activity was observed in patients with refractory mCRC in a U.S. Phase 1 clinical trial. •Across both dose levels, the overall response rate…
  107. LYELLyell Immunopharma, Inc.10-QInforme trimestralEDGAR
    En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸…within the 180-day period following the date of the letter. We completed a reverse stock split of our common stock by a ratio of 1-for-20, effective May 30, 2025 (Reverse Stock Split). On June 16, 2025, we received a letter from Nasdaq advising us that we had regained compliance with the minimum bid price required for continued listing by Nasdaq because the closing price of our common stock closed at $1.00 or more for over 10 consecutive trading days. Although we regained compliance with the $1.00 minimum…
    En el documentoContrasplit de accionestexto original ▸…conjunction with the Company’s audited financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. Reverse Stock Split On May 30, 2025, the Company effected a 1-for-20 reverse stock split (“Reverse Split”) of its issued and outstanding shares of common stock, and the common stock began trading on a split-adjusted basis on June 2, 2025. The Reverse Split did not reduce the total number…
  108. MGNXMACROGENICS INC10-QInforme trimestralEDGAR
  109. MGNXMACROGENICS INC8-KResultadosEDGAR
  110. MGXMetagenomi Therapeutics, Inc.8-KResultadosEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸…Organizational restructuring reduced workforce by 25%; Capital allocation strategy anticipated to extend cash runway into the 4Q 2027 Jian Irish, Ph.D., M.B.A., currently President and Chief Operating Officer, appointed as Chief Executive Officer; Brian Thomas, Ph.D., former Chief Executive Officer, continuing on Board of Directors and Dr. Willard Dere serving as new Board Chair Conference call today at 4:30 p.m. ET EMERYVILLE, Calif., November…
  111. MGXMetagenomi Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoContrasplit de accionestexto original ▸…and obligations. The Reorganization was a non-taxable transaction to Metagenomi, Inc. for United States (“U.S.”) income tax purposes. On January 26, 2024, following the Reorganization, Metagenomi, Inc. effected a reverse stock split of the shares of common stock at a ratio of 1-for-1.74692 (the “Reverse Stock Split”). The number of authorized shares and par value per share were not adjusted as a result of the Reverse Stock Split…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…of shares of our common stock, preferred stock, debt securities, warrants and/or units, in one or more offerings and in any combination. In connection with the Shelf Registration Statement, the Company entered into an Open Market Sale AgreementSM (the “ATM Sales Agreement”) with Jefferies LLC (“Jefferies”) on March 17, 2025, pursuant to which the Company may issue and sell, from time to time and at its sole discretion, shares of its common stock, through Jefferies as the…
  112. MISTMilestone Pharmaceuticals Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…underwriters of their option to purchase the additional 3,000,000 common shares in full, was $31.9 million after deducting underwriting commissions and offering expenses payable by us. ​ On July 29, 2020, we entered into an Open Market Sale AgreementSM, or the “Original Sale Agreement,” with respect to an at-the-market offering program, or the “ATM Program,” under which the Company could issue and sell its common shares having an aggregate offering price of up to $50.0 million through Jefferies LLC, or “Jefferies,” as its sales…
  113. MISTMilestone Pharmaceuticals Inc.8-KResultadosEDGAR
    En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸EX-99.1 2 tm2530945d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Milestone Pharmaceuticals Reports Third Quarter 2025 Financial Results and Provides Regulatory and Corporate Update PDUFA Target Date of December 13, 2025 for CARDAMYST™ (etripamil) Nasal Spray in Paroxysmal Supraventricular Tachycardia (PSVT) Promotional Launch Plans Set with Quick-Start Capability Upon Potential FDA Approval $82.6 million in Cash at September…
  114. MNOVMEDICINOVA INC10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…option valuation model, was $1.34 and $0.99 per option, respectively. 15 6. Stockholders’ Equity At-The-Market Issuance Sales Agreements and Private Placement Transactions On August 23, 2019, the Company entered into an at the market issuance sales agreement, which was amended on August 26, 2022 (as amended, the ATM Agreement) with B. Riley FBR, Inc. (B. Riley FBR) pursuant to which the Company may sell common stock through B. Riley FBR from time to time…
  115. MTEXMANNATECH INC10-QInforme trimestralEDGAR
  116. MTEXMANNATECH INC8-KResultadosEDGAR
  117. MXCTMAXCYTE, INC.8-KResultadosEDGAR
  118. NAIINATURAL ALTERNATIVES INTERNATIONAL INC10-QInforme trimestralEDGAR
  119. NMADNOMAD POWER SOLUTIONS, INC.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…revenues and has experienced negative operating cash flows since inception. The Company has financed its working capital requirements through the recurring sale of its equity securities. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements are issued. In addition the Company’s independent registered public accounting firm, in their report on the Company’s audited consolidated…
  120. ORKAOruka Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoContrasplit de accionestexto original ▸…Agreement”). Following the transactions contemplated by the Merger Agreement, on August 29, 2024, the Company changed its name from “ARCA biopharma, Inc.” to “Oruka Therapeutics, Inc.” and the Company effected a 1-for-12 reverse stock split (the “Reverse Stock Split”) of its common stock, par value $0.001 per share (“Company Common Stock”), which became effective on September 3, 2024. All references to common stock, options to purchase common…
  121. OVIDOvid Therapeutics Inc.8-KResultadosEDGAR
    En el documentoCambio en la dirección de la empresatexto original ▸EX-99.1 2 ovidexhibit9912025-q3.htm EX-99.1 Exhibit 99.1 Ovid Therapeutics Announces Planned Leadership Succession and Reports Business Updates and Third Quarter 2025 Financial Results •Meg Alexander appointed Chief Executive Officer effective January 1, 2026; Dr. Jeremy M. Levin to transition to Executive Chair of the Board of Directors •Next-generation GABA-aminotransferase (GABA-AT) inhibitor, OV329, demonstrated strong inhibitory…
  122. OVIDOvid Therapeutics Inc.10-QInforme trimestralEDGAR
    En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸…the Company was granted an additional 180-day grace 8 Table of Contents period, or until February 9, 2026, to regain compliance with the minimum bid price requirement. On September 11, 2025, the Company received formal notification from Nasdaq that it had regained compliance with the minimum bid price requirement. NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (A) Unaudited Interim Condensed Consolidated Financial Statements The interim condensed consolidated balance sheet at September 30, 2025…
  123. PDSBPDS Biotechnology Corp8-KNuevo acuerdo materialEDGAR
  124. PEPGPepGen Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…6 million after deducting underwriters' fees of $6.9 million and estimated offering expenses of $0.5 million. The Company had previously disclosed in the financial statements as of June 30, 2025 that substantial doubt existed regarding the Company’s ability to continue as a going concern. Based on the improvement in its cash position due to the 2025 Offering, the Company believes that its cash, cash equivalents, and marketable securities as of September 30, 2025, will be sufficient to…
  125. PEPGPepGen Inc.8-KResultadosEDGAR
  126. PLURPluri Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…sufficient resources to meet its operating obligations for at least twelve months from the issuance date of these interim unaudited condensed consolidated financial statements. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The interim unaudited condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of assets or liabilities that might be necessary should…
  127. PMNProMIS Neurosciences Inc.8-KResultadosEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…Corporate Highlights ​ Alzheimer’s Disease Program (PMN310) ​ ProMIS’ lead candidate, PMN310, is a humanized IgG1 antibody directed toward toxic AβO that are believed to be a major driver of AD. PMN310 was granted Fast Track Designation by the U.S. Food and Drug Administration . ​ ● As of November 12, 2025, ProMIS has fully enrolled Cohorts 1 and 2 and is well into Cohort 3, with complete enrollment expected before the end of the year…
  128. PMNProMIS Neurosciences Inc.10-QInforme trimestralEDGAR
    En el documentoDebilidad material en el control internotexto original ▸…defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of September 30, 2025. Based on this evaluation, our principal executive officer and principal financial and accounting officer have concluded that our disclosure controls and procedures were not effective due to a material weakness previously identified in our internal control over financial reporting. This material weakness in the Company’s internal control over financial reporting and the Company’s ongoing remediation efforts…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…nine months ended September 30, 2025. ​ At-the-Market Offering In September 2023, the Company filed a shelf registration statement with the SEC. In conjunction with the shelf registration, the Company entered into an At The Market Offering (“ATM”) Agreement with BTIG, LLC (the “2023 ATM Agreement”) on January 5, 2024 to offer up to $25.0 million of its Common Shares. The Company terminated the 2023 ATM Agreement on July 21, 2025. The Company…
  129. PMVPPMV Pharmaceuticals, Inc.8-KResultadosEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…class, small molecule, p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein, restoring the wild-type tumor-suppressor function. The U.S. Food and Drug Administration granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation. About the PYNNACLE Clinical Trial The ongoing Phase 1/2 PYNNACLE clinical trial…
  130. PMVPPMV Pharmaceuticals, Inc.10-QInforme trimestralEDGAR
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…board of directors subject to the rights of any preferred stockholders. As of September 30, 2025, no dividends on common stock had been declared by the Company. ATM Program On October 4, 2021, the Company entered into an at-the-market offering program (the “ATM Program”) pursuant to which, the Company may offer and sell shares of its common stock having aggregate gross sales proceeds of up to $150.0 million from time to time. During the three…
  131. PRLDPrelude Therapeutics Inc8-KResultadosEDGAR
  132. PRLDPrelude Therapeutics Inc10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…securities may not be sufficient to fund its operating expenses and capital expenditure requirements for at least the next twelve months from the filing date of this Quarterly Report on Form 10-Q. As a result, substantial doubt exists about the Company's ability to continue as a going concern. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The…
    En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸…maintain a minimum bid price of $1.00 per share for continued listing on Nasdaq, as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). On September 18, 2025, the Company received a letter from Nasdaq notifying the Company that it had regained compliance with the Minimum Bid Price Requirement and that the matter is now closed. Components of Results of Operations Since inception, we have devoted substantially all of our resources to developing product and technology rights, conducting…
  133. PTNPALATIN TECHNOLOGIES INC8-KOtros hechos relevantesEDGAR
  134. PVLAPALVELLA THERAPEUTICS, INC.10-QInforme trimestralEDGAR
  135. QNCXQuince Therapeutics, Inc.8-KResultadosEDGAR
    En el documentoDesignación de vía rápida (Fast Track)texto original ▸…agreement with the U.S. Food and Drug Administration (FDA). • Assuming positive study results, the company plans to submit a New Drug Application (NDA) to the FDA in the second half of 2026. • Quince was granted FDA Fast Track designation for the company’s eDSP System for the treatment of patients with A-T based on the potential to address a high unmet medical need. • NEAT is an international, multicenter, randomized, double-blind, placebo…
  136. QNCXQuince Therapeutics, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…its business prospects. Because of the uncertainty in securing additional funding and the insufficient amount of cash and cash equivalent resources as of September 30, 2025, management concluded that substantial doubt exists with respect to the Company's ability to continue as a going concern within one year after the date that these unaudited condensed consolidated financial statements are issued. The accompanying unaudited condensed consolidated financial statements have been prepared on…
  137. QNRXQuoin Pharmaceuticals Ltd.8-KOtros hechos relevantesEDGAR
  138. RKTORocket One Inc.10-QInforme trimestralEDGAR
    En el documentoDebilidad material en el control internotexto original ▸…ii) accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosures. Identified Material Weakness In connection with the audit of our financial statements as of December 31, 2024, for the years ended December 31, 2024 and 2023, we identified a material weakness in our internal control over financial…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…stock. These common shares were valued at $850,500, or $1.89 per share, on the measurement date based on quoted closing price of the Company’s common stock (see Note 4). On November 8, 2024, the Company entered into the ATM Agreement with Wainwright under which the Company could offer and sell shares of its common stock having an aggregate sales price of up to $2,700,000 through Wainwright as the sales agent pursuant to the Company…
  139. RMTIROCKWELL MEDICAL, INC.8-KResultadosEDGAR
  140. RMTIROCKWELL MEDICAL, INC.10-QInforme trimestralEDGAR
  141. SCNXScienture Holdings, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…predict. These factors include, but are not limited to: ● Our limited amount of cash; ● The negative effect on our business and our ability to raise capital that is created by the fact that there is a substantial doubt about our ability to continue as a going concern; ● Our limited revenue generating operations, and risks of our operations not being profitable; ● Claims relating to alleged violations of intellectual property rights of others; ● Cybersecurity risks…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…originally filed by the Company with the Securities and Exchange Commission (the “Commission”) on August 1, 2025, and declared effective on August 8, 2025. ATM Program On September 19, 2025, the Company entered into an Equity Distribution Agreement (the “ATM Agreement”) with Maxim Group LLC (“Maxim”). Pursuant to the ATM Agreement, Maxim will act as the Company’s sole sales agent with respect to the offer and sale from time-to-time of shares of the Company’s common…
  142. SLSSELLAS Life Sciences Group, Inc.10-QInforme trimestralEDGAR
  143. SLSSELLAS Life Sciences Group, Inc.8-KResultadosEDGAR
  144. SLXNSilexion Therapeutics Corp10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…there is no assurance that the Company will be successful in obtaining such funding. Under these circumstances, in accordance with the requirements of ASC 205-40, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern for at least 12 months from the date these financial statements are issued. The unaudited condensed consolidated financial statements do not include any adjustments that might result from the outcome…
    En el documentoPrograma de venta continua de acciones (ATM)texto original ▸…Company in the September Offering, in accordance with the Company’s conversion right under the Related Party Promissory Note. NOTE 6 - At the Market Offering Agreement On September 26, 2025 the Company entered into an At The Market Offering Agreement (the “Sales Agreement”) with a sales agent. In accordance with the terms of the Sales Agreement, the Company may offer and sell up to $13,170 of its newly issued ordinary shares from time to…
  145. SLXNSilexion Therapeutics Corp8-KResultadosEDGAR
  146. SVRASavara Inc10-QInforme trimestralEDGAR
  147. TBPHTheravance Biopharma, Inc.10-QInforme trimestralEDGAR
  148. TCRXTScan Therapeutics, Inc.8-KResultadosEDGAR
  149. TCRXTScan Therapeutics, Inc.10-QInforme trimestralEDGAR
  150. TELOTelomir Pharmaceuticals, Inc.8-KOtros hechos relevantesEDGAR
  151. TENXTENAX THERAPEUTICS, INC.10-QInforme trimestralEDGAR
  152. TENXTENAX THERAPEUTICS, INC.8-KResultadosEDGAR
  153. TLPHTALPHERA, INC.8-KResultadosEDGAR
  154. TLPHTALPHERA, INC.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…recurring operating losses and negative cash flows from operating activities since inception and expects to continue to incur operating losses and negative cash flows in the future. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Considering the Company’s current cash resources and its current and expected levels of operating expenses for the next twelve months, management expects to need additional capital to fund its planned…
    En el documentoDebilidad material en el control internotexto original ▸…markets and recession risks have in the past and may continue to adversely affect our business, future results of operations, and financial condition, the effects of which remain uncertain. ● We previously identified a material weakness in our internal control over financial reporting. In the future, we may identify additional material weaknesses or otherwise fail to maintain an effective system of internal control over financial reporting…
  155. TXMDTherapeuticsMD, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…anticipate, our existing cash reserves may be insufficient to satisfy our liquidity requirements. The potential impact of these factors in conjunction with the uncertainty of the capital markets raises substantial doubt about our ability to continue as a going concern for the next twelve months from the issuance of these financial statements. The accompanying condensed consolidated financial statements do not include any adjustments that might be necessary if we are…
  156. UNCYUnicycive Therapeutics, Inc.10-QInforme trimestralEDGAR
  157. UNCYUnicycive Therapeutics, Inc.8-KResultadosEDGAR
    En el documentoDesignación de medicamento huérfanotexto original ▸…in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information about…
  158. VORVor Biopharma Inc.8-KOtros hechos relevantesEDGAR
  159. XBIOXenetic Biosciences, Inc.10-QInforme trimestralEDGAR
  160. XBITXBiotech Inc.10-QInforme trimestralEDGAR
  161. ZBIOZenas BioPharma, Inc.10-QInforme trimestralEDGAR
    En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸…fund our operations and capital expenditure requirements for at least twelve months from the date our condensed consolidated financial statements are issued and accordingly have concluded that there is substantial doubt with respect to our ability to continue as a going concern. Our financial statements do not include any adjustments or changes in classification of assets or liabilities that may result from our possible inability to continue as a going concern. However, we expect…

Juntas de accionistas

  1. BTAIBioXcel Therapeutics, Inc.DEF 14AConvocatoria de junta de accionistasEDGAR
  2. YARWYarrow Bioscience, Inc.DEF 14AConvocatoria de junta de accionistasEDGAR

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