Portada›Jueves 13 de noviembre de 2025

Biomédicas del NASDAQ ante la SEC, jueves 13 de noviembre de 2025

Los 158 documentos que 100 empresas del sector presentaron ante la SEC ese día, agrupados por tipo y con el enlace al original en EDGAR.

← miércoles 12 de noviembre de 2025 · viernes 14 de noviembre de 2025 →

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

ABOSAcumen Pharmaceuticals, Inc.424B5Nueva emisión de acciones con precioEDGAR
ANNXAnnexon, Inc.424B5Nueva emisión de acciones con precioEDGAR
CMNDClearmind Medicine Inc.424B5Nueva emisión de acciones con precioEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…covering the October 31, 2024 consolidated financial statements contains an explanatory paragraph that states that the Company’s recurring losses from operations and lack of sufficient resources raise substantial doubt about the entity’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of that uncertainty. Such financial statements are incorporated in this prospectus supplement by…
ELDNEledon Pharmaceuticals, Inc.424B5Nueva emisión de acciones con precioEDGAR
FENCFENNEC PHARMACEUTICALS INC.424B5Nueva emisión de acciones con precioEDGAR
GOVXGeoVax Labs, Inc.424B3Prospecto suplementario o de reventaEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…contracts, arrangements with strategic partners, or from other sources. There can be no assurance that additional funding will be available on favorable terms or at all. These factors collectively raise substantial doubt about the Company’s ability to continue as a going concern. Management believes that we will be successful in securing the additional capital required to continue the Company’s planned operations, but that our plans do not fully alleviate the substantial doubt…
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…placement agent commissions and other offering expenses were approximately $4.1 million. The pre-funded warrants were fully exercised during the second quarter of 2025. ATM Program. On September 25, 2024, we entered into a Sales Agreement and established an “At-the-Market” continuous offering program (the “ATM Program”), pursuant to which the Company may offer and sell, from time to time through its sales agent, shares of its common stock. During the three-month and nine-month periods ended…
GOVXGeoVax Labs, Inc.424B3Prospecto suplementario o de reventaEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…contracts, arrangements with strategic partners, or from other sources. There can be no assurance that additional funding will be available on favorable terms or at all. These factors collectively raise substantial doubt about the Company’s ability to continue as a going concern. Management believes that we will be successful in securing the additional capital required to continue the Company’s planned operations, but that our plans do not fully alleviate the substantial doubt…
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…placement agent commissions and other offering expenses were approximately $4.1 million. The pre-funded warrants were fully exercised during the second quarter of 2025. ATM Program. On September 25, 2024, we entered into a Sales Agreement and established an “At-the-Market” continuous offering program (the “ATM Program”), pursuant to which the Company may offer and sell, from time to time through its sales agent, shares of its common stock. During the three-month and nine-month periods ended…
GOVXGeoVax Labs, Inc.424B3Prospecto suplementario o de reventaEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…contracts, arrangements with strategic partners, or from other sources. There can be no assurance that additional funding will be available on favorable terms or at all. These factors collectively raise substantial doubt about the Company’s ability to continue as a going concern. Management believes that we will be successful in securing the additional capital required to continue the Company’s planned operations, but that our plans do not fully alleviate the substantial doubt…
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…placement agent commissions and other offering expenses were approximately $4.1 million. The pre-funded warrants were fully exercised during the second quarter of 2025. ATM Program. On September 25, 2024, we entered into a Sales Agreement and established an “At-the-Market” continuous offering program (the “ATM Program”), pursuant to which the Company may offer and sell, from time to time through its sales agent, shares of its common stock. During the three-month and nine-month periods ended…
GOVXGeoVax Labs, Inc.424B3Prospecto suplementario o de reventaEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…contracts, arrangements with strategic partners, or from other sources. There can be no assurance that additional funding will be available on favorable terms or at all. These factors collectively raise substantial doubt about the Company’s ability to continue as a going concern. Management believes that we will be successful in securing the additional capital required to continue the Company’s planned operations, but that our plans do not fully alleviate the substantial doubt…
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…placement agent commissions and other offering expenses were approximately $4.1 million. The pre-funded warrants were fully exercised during the second quarter of 2025. ATM Program. On September 25, 2024, we entered into a Sales Agreement and established an “At-the-Market” continuous offering program (the “ATM Program”), pursuant to which the Company may offer and sell, from time to time through its sales agent, shares of its common stock. During the three-month and nine-month periods ended…
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…
NTHINEONC TECHNOLOGIES HOLDINGS, INC.424B4Nueva emisión de acciones con precioEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…The report of our independent registered public accounting firm on our financial statements as of and for the year ended December 31, 2024 included an explanatory paragraph indicating that there was substantial doubt about our ability to continue as a going concern. See Note 1 to our l financial statements for additional information on our assessment. Components of Results of Operations Revenue We occasionally receive a fee from a patient for a “right to try” humanitarian…
RKTORocket One Inc.424B5Nueva emisión de acciones con precioEDGAR
TVRDTvardi Therapeutics, Inc.424B3Prospecto suplementario o de reventaEDGAR
El prospecto suplementario cubre la reventa de 2.084.117 acciones ordinarias por parte de ciertos accionistas vendedores.
Original en inglés · traducción automática
2,084,117 Shares of Common Stock This prospectus supplement supplements the prospectus dated November 8, 2025 (the “Prospectus”), which forms a part of our registration statement on Form S-1 (No. 333-287675).
Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
La compañía indicó que existen dudas sustanciales sobre su capacidad para continuar como negocio en marcha, sin productos aprobados para su venta.
Original en inglés · traducción revisada
raise substantial doubt about the Company’s ability to continue as a going concern. To date, the Company has no products approved for marketing and sale and it has not yet recorded any revenue from product sales.
Traducción automática (claude-sonnet-5), con la cita comprobada contra el documento y revisada por una persona.
Cara efectuó una división inversa de acciones de 1 por 3 el 15 de abril de 2025, inmediatamente antes del cierre de la fusión.
Original en inglés · traducción automática
on April 15, 2025, immediately prior to the closing of the Merger, Cara (i) effected a 1-for-3 reverse stock split of its common stock and (ii) increased its authorized shares of common stock to 150,000,000.
Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
Legacy Tvardi identificó una debilidad material en la revisión de sus estados financieros y una tercera relacionada con gastos de investigación y desarrollo prepagados y devengados.
Original en inglés · traducción revisada
Legacy Tvardi identified a material weakness in its financial reporting related to inadequate review of financial statements and disclosures. The third material weakness pertains to the prepaid and accrued research and development expenses related to the CRO.
Traducción automática (claude-sonnet-5), con la cita comprobada contra el documento y revisada por una persona.
VSTMVerastem, Inc.424B5Nueva emisión de acciones con precioEDGAR
ALTAltimmune, Inc.S-3/ACapacidad de emisión registrada (enmienda)EDGAR
BDTXBlack Diamond Therapeutics, Inc.S-3Capacidad de emisión registradaEDGAR
CHRSCoherus Oncology, Inc.S-3Capacidad de emisión registradaEDGAR
ELTXElicio Therapeutics, Inc.S-3Capacidad de emisión registradaEDGAR
EQEquillium, Inc.S-3Capacidad de emisión registradaEDGAR
FLNAFILANA THERAPEUTICS, INC.S-3Capacidad de emisión registradaEDGAR
TRVITrevi Therapeutics, Inc.S-3ASRCapacidad de emisión registradaEDGAR

Participaciones y control

INDVIndivior Pharmaceuticals, Inc.SC 13D/ACambio en participación significativaEDGAR
NCELNewcelX Ltd.SC 13DCambio en participación significativaEDGAR
WVEWave Life Sciences, Inc.SC 13D/ACambio en participación significativaEDGAR

Informes y hechos relevantes

ALDXAldeyra Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸
…approved by the FDA; mild and transient instillation site irritation is the most commonly reported adverse event in clinical trials. FDA=U.S. Food & Drug Administration. The Phase 3 Dry Eye Chamber Trial Achieved the Primary Endpoint of Ocular Discomfort †Regulatory review and discussion timelines are flexible and subject to change based on the regulator's workload, governmental shutdown, and other potential review issues. P value…
En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸
…approved by the FDA; mild and transient instillation site irritation is the most commonly reported adverse event in clinical trials. FDA=U.S. Food & Drug Administration, PDUFA=Prescription Drug User Fee Act. PDUFA Target Action Date December 16, 2025† Mean Ocular Discomfort Score (0-100) Change from Baseline Second Dose Primary Endpoint Assessment Period Minutes in Dry Eye Chamber First Dose Before Chamber Entry Reproxalap Vehicle Prespecified Analysis…
CINGCingulate Inc.8-KResultadosEDGAR
En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸
…Presented at Annual AACAP Conference The positive Phase 3 results from Cingulate’s pivotal trial of CTx-1301 were recently presented by Ann Childress, M.D., at the AACAP Annual Meeting in Chicago. CTx-1301 met its primary endpoint, demonstrating dose-dependent improvements on the ADHD ratings scale 5 (ADHD-RS-5), and Clinical Global Impression-Severity (CGI-S) scales, and demonstrated the ability to deliver symptom relief with…
En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸
…next-generation products, today announced financial results for the quarter ended September 30, 2025, and provided recent corporate highlights. Recent Highlights (Post-Q3) FDA Accepts NDA for CTx-1301; PDUFA Date Set for May 31, 2026 In October of 2025, the U.S. Food and Drug Administration (FDA) accepted Cingulate’s New Drug Application (NDA) for CTx-1301 (dexmethylphenidate HCl), a once-daily, extended-release therapy designed to…
DCOYDecoy Therapeutics Inc.8-KVenta de acciones no registrada (colocación privada)EDGAR
GRCEGrace Therapeutics, Inc.8-KResultadosEDGAR
En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸
…2026 as its PDUFA target date. The application is supported by a comprehensive data package, including positive data obtained from the Company’s Phase 3 STRIVE-ON safety trial of GTx-104, whereby it met its primary endpoint and provided evidence of clinical benefit when compared to orally administered nimodipine. These data were presented at the Neurocritical Care annual meeting, held in Montreal, Quebec, Canada in September…
En el documentoDesignación de medicamento huérfanotexto original ▸
…which provide patent protection to 2037. The new patent on the IV dosing regimen for GTx-104 strengthens the Company’s intellectual property position and extends protection to 2043. Grace has also been granted Orphan Drug Designation from the FDA, which provides GTx-104 with seven years of marketing exclusivity in United States upon FDA approval of the Company’s NDA. • On October 23, 2025, the Company announced that it has secured…
En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸
…STRIVE-ON trial results point to a very promising role for GTx-104 in the treatment of these patients. We look forward to continuing to engage with the FDA during their review as they work toward the PDUFA target date of April 23, 2026.” Second Quarter 2026 Corporate Highlights • On August 22, 2025, the FDA accepted the Company’s NDA for GTx-104 for formal review, establishing April 23, 2026 as its PDUFA target date. The application…
KODKodiak Sciences Inc.8-KResultadosEDGAR
En el documentoEl ensayo alcanzó su objetivo principaltexto original ▸
…can achieve strong efficacy both in treating existing disease (primary endpoint) and preventing vision threatening complications and disease progression (key secondary endpoint). In GLOW1, tarcocimab met its primary endpoint of the proportion of patients with at least a 2-step improvement on the Diabetic Retinopathy Severity Scale (“DRSS”) score with 41.1% of tarcocimab-treated patients demonstrating at least a 2-step improvement…
AARDAardvark Therapeutics, Inc.8-KResultadosEDGAR
AARDAardvark Therapeutics, Inc.10-QInforme trimestralEDGAR
ABUSArbutus Biopharma Corp8-KResultadosEDGAR
ABUSArbutus Biopharma Corp10-QInforme trimestralEDGAR
ACOGAlpha Cognition Inc.10-QInforme trimestralEDGAR
En el documentoContrasplit de accionestexto original ▸
…FDA. Any additional capital is expected to further support our planned costs to begin commercial activities including launching U.S. sales of ZUNVEYL in AD. Reverse Stock Split On November 5, 2024, we completed a reverse stock split of our Common Shares with a stock split ratio of 1-for-25 (“Reverse Stock Split”). Except as otherwise indicated, all references to our Common Shares, share data, per share data and related information…
En el documentoDebilidad material en el control internotexto original ▸
…quarterly report on Form 10-Q are fairly stated in all material respects in accordance with GAAP for each of the periods presented therein. Changes in Internal Control over Financial Reporting Management has identified a material weakness in internal control over financial reporting in connection with the review of our unaudited condensed consolidated financial statements for the three and nine months ended September 30, 2025. A material…
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…Ending December 31, 2025 $ 5,387 2026 21,546 2027 21,546 2028 21,546 2029 21,546 Thereafter 305,238 Total $ 396,809 NOTE 7 – STOCKHOLDERS’ EQUITY At the Market Offering On August 22, 2025, the Company entered into an At the Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”) as sales agent. Under the terms of the ATM Agreement, the Company will be entitled to sell, at its sole discretion and from…
ACRVAcrivon Therapeutics, Inc.8-KResultadosEDGAR
ACRVAcrivon Therapeutics, Inc.10-QInforme trimestralEDGAR
ACTUACTUATE THERAPEUTICS, INC.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…or even cease operations, which could have a material adverse effect on the Company’s business, results of operations or financial condition. Based on the above matters, we have concluded that there is substantial doubt regarding the Company’s ability to continue as a going concern. 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES The Company’s significant accounting policies are disclosed in the audited financial statements and the notes thereto for the year ended December 31, 2024…
ADILADIAL PHARMACEUTICALS, INC.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…approximately $5.9 million from the exercise of warrants and equity issuances. However, the Company will require additional capital to continue operations and development of AD04. These factors raise substantial doubt about the Company’s ability to continue as a going concern. Other Uncertainties Generally, the industry in which the Company operates subjects the Company to a number of other risks and uncertainties that can affect its operating results and financial condition…
AKTXAkari Therapeutics Plc10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…$2.5 million as of September 30, 2025 is not sufficient to fund its operations for the one-year period after the date these condensed consolidated financial statements are issued. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the…
ALMSALUMIS INC.8-KResultadosEDGAR
ALMSALUMIS INC.10-QInforme trimestralEDGAR
AURAAura Biosciences, Inc.8-KResultadosEDGAR
En el documentoDesignación de medicamento huérfanotexto original ▸
…care remains radiotherapy, which frequently results in irreversible vision loss. Bel-sar has the potential to become the first frontline vision-preserving therapy in this setting. The Company previously received Orphan Drug Designation from the FDA and the European Medicines Agency and Fast Track designation from the FDA for the treatment of early choroidal melanoma. The CoMpass trial is under a Special Protocol Assessment agreement…
En el documentoDesignación de vía rápida (Fast Track)texto original ▸
…care remains radiotherapy, which frequently results in irreversible vision loss. Bel-sar has the potential to become the first frontline vision-preserving therapy in this setting. The Company previously received Orphan Drug Designation from the FDA and the European Medicines Agency and Fast Track designation from the FDA for the treatment of early choroidal melanoma. The CoMpass trial is under a Special Protocol Assessment agreement with the FDA. Bladder Cancer Additional Phase 1 Biological Activity Data…
AURAAura Biosciences, Inc.10-QInforme trimestralEDGAR
AYTUAYTU BIOPHARMA, INC8-KResultadosEDGAR
AYTUAYTU BIOPHARMA, INC10-QInforme trimestralEDGAR
BCABBioAtla, Inc.8-KResultadosEDGAR
En el documentoRecorte de plantilla o reestructuracióntexto original ▸
…for the same quarter in 2024. The $6.9 million decrease was primarily driven by lower program development costs due to prioritization of clinical programs, lower headcount-related expenses following the workforce reduction announced in March 2025, and lower non-cash stock-based compensation. We continue to expect R&D expenses to decline through the remainder of 2025 as we concentrate resources on our prioritized programs…
En el documentoDesignación de vía rápida (Fast Track)texto original ▸
…asset is targeting multiple solid tumor indications, including the treatment of patients with HPV+ OPSCC who have previously experienced progression on PD-1/L1 therapies and platinum chemotherapy. The FDA granted Fast Track Designation to ozuriftamab vedotin for the treatment of patients with recurrent or metastatic SCCHN. About Mecbotamab Vedotin (Mec-V) Mecbotamab vedotin (Mec-V), CAB-Platform-AXL-ADC, is a conditionally and reversibly…
BCABBioAtla, Inc.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…Step 1). If management concludes that substantial doubt is raised, management is also required to consider whether its plans alleviate that doubt (Step 2). Management’s assessment concluded that there is substantial doubt about the Company’s ability to continue as a going concern for a period of at least one year from the issuance date of these financial statements. The Company has prepared its financial statements on a going concern basis, which assumes that the Company will…
En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸
…The Nasdaq Capital Market has established certain quantitative criteria and qualitative standards that companies must meet to remain listed for trading on this market. On February 6, 2025, the Company received written notice (the “Minimum Bid Price Deficiency Notice”) from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) stating that the Company is not in compliance with Nasdaq Listing Rule 5550(a)(2) (the “Minimum…
BFRIBiofrontera Inc.8-KResultadosEDGAR
BIVIBIOVIE INC.8-KCambio en el consejo o la direcciónEDGAR
CADLCandel Therapeutics, Inc.8-KResultadosEDGAR
En el documentoDesignación de terapia avanzada (RMAT)texto original ▸
…in the CAN-2409 plus valacyclovir and placebo arms with both hypofractionated (1.6% vs. 1.9%) and standard EBRT (1.8% vs. 1.1%), respectively. • The U.S. Food and Drug Administration (FDA) previously granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to CAN-2409 for the treatment of prostate cancer; the phase 3 clinical trial of CAN-2409 in localized prostate cancer was conducted under a Special Protocol Assessment agreed to with the FDA…
En el documentoDesignación de vía rápida (Fast Track)texto original ▸
…in the CAN-2409 plus valacyclovir and placebo arms with both hypofractionated (1.6% vs. 1.9%) and standard EBRT (1.8% vs. 1.1%), respectively. • The U.S. Food and Drug Administration (FDA) previously granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to CAN-2409 for the treatment of prostate cancer; the phase 3 clinical trial of CAN-2409 in localized prostate cancer was conducted under a Special…
CADLCandel Therapeutics, Inc.10-QInforme trimestralEDGAR
CDTCDT Equity Inc.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…activities of $10.9 million and $5.9 million, respectively. Management has determined that it does not have sufficient cash and other sources of liquidity to fund its current business plan. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern for at least the next 12 months from the financial statement filing date. The Company’s expectation is to generate operating losses and negative operating cash flows in the future and will need additional…
CHRSCoherus Oncology, Inc.8-KOtros hechos relevantesEDGAR
En el documentoRecorte de plantilla o reestructuracióntexto original ▸
…primarily due to: ● a net decrease of $13.7 million in personnel costs including stock-based compensation expense, primarily due to a decrease in headcount and restructuring charges of $3.6 million from our reduction in force in the first quarter of 2023; ● a decrease of $7.4 million in co-development costs for toripalimab and CHS-006 resulting from reducing the scope of the development plan for toripalimab in the United States…
En el documentoAcuerdo de licencia o colaboracióntexto original ▸
…Agreement with Apotex, pursuant to which, the Company granted to Apotex an exclusive license under the Company’s rights to toripalimab to commercialize toripalimab within Canada. Pursuant to the Canada License Agreement, Apotex paid the Company an upfront payment of $6.3 million United States Dollars which has been classified as net revenue in the consolidated statements of operations for the year ended December 31, 2024. In addition, Apotex agreed to…
En el documentoDesignación de medicamento huérfanotexto original ▸
…there is a rationale for inhibiting IL-27 to treat cancer, as this approach will influence the activity of multiple types of immune cells that are necessary to recognize and attack a tumor. Casdozokitug received orphan drug designation from the FDA for the treatment of HCC in October 2020 and fast track designation from the FDA for the treatment of HCC in November 2020. Casdozokitug is currently in three on-going clinical studies, including…
En el documentoDesignación de vía rápida (Fast Track)texto original ▸
…there is a rationale for inhibiting IL-27 to treat cancer, as this approach will influence the activity of multiple types of immune cells that are necessary to recognize and attack a tumor. Casdozokitug received orphan drug designation from the FDA for the treatment of HCC in October 2020 and fast track designation from the FDA for the treatment of HCC in November 2020. Casdozokitug is currently in three on-going clinical studies, including a Phase 1/2 study in advanced solid tumors (clinicaltrials.gov identifier…
CINGCingulate Inc.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…The Company can give no assurance that its plans will be effectively implemented in such a way that they will sufficiently alleviate or mitigate the conditions and events noted above, which results in substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization…
En el documentoContrasplit de accionestexto original ▸
…available for distribution, if any. Holders of shares of common stock are entitled to dividends when, as and if declared by the Board of Directors. Reverse Stock Splits On November 30, 2023, the Company completed a one-for-twenty reverse stock split (2023 Reverse Stock Split), which reduced the number of shares of the Company’s common stock that were issued and outstanding immediately prior to the effectiveness of the 2023 Reverse Stock Split. The…
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…amounts have been retrospectively restated in these financial statements to reflect the 2023 Reverse Stock Split and the 2024 Reverse Stock Split. (9) Securities Issuances At the Market Offering The Company entered into the At-the-Market Agreement (ATM Agreement) with H.C. Wainwright & Co., LLC (HCW) in January 2023, as amended in May 2023, pursuant to which the Company can issue and sell, from time to time, shares of the Company’s common stock…
CLNNClene Inc.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…Notes”), we are required to maintain unrestricted cash and cash equivalents of at least $2.0 million to avoid acceleration of the full balance of the 2024 SSCP Notes (see Note 8). These conditions raise substantial doubt about the Company’s ability to continue as a going concern. To mitigate our funding needs, we plan to raise additional funding, including exploring equity financing and offerings, debt financing, licensing or collaboration arrangements with third parties, as…
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…Warrants recorded as an expense and the amounts allocated to the Common Stock and 2024 Pre-Funded Warrants as a reduction to their initial carrying values. Common Stock Sales Agreement In April 2022, we entered into an equity distribution agreement (the “2022 ATM Agreement”), which we amended in December 2022. In April 2025, we entered into an equity distribution agreement (the “2025 ATM Agreement,” and collectively with the 2022 ATM Agreement, the “ATM Agreements”). Canaccord…
CLNNClene Inc.8-KResultadosEDGAR
CLRBCellectar Biosciences, Inc.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…Company or its assets, a merger or other strategic business combination, discontinuance of certain operations, a wind-down of operations and/or filing for bankruptcy protection. These uncertainties raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying financial statements have been prepared on the basis that the Company will continue to operate as a going concern, which contemplates it will be able to realize assets and settle liabilities…
CLRBCellectar Biosciences, Inc.8-KResultadosEDGAR
COGTCogent Biosciences, Inc.8-KNuevo acuerdo materialEDGAR
DAREDare Bioscience, Inc.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…the next several years, and may never generate sufficient revenues to finance its operations or achieve profitability. Based on the Company’s current analysis of the conditions described above, there is substantial doubt about the Company's ability to continue as a going concern within the 12 month period from the issuance date of the accompanying condensed consolidated financial statements. The accompanying condensed consolidated financial statements were prepared on a going…
DAREDare Bioscience, Inc.8-KResultadosEDGAR
ELDNEledon Pharmaceuticals, Inc.8-KNuevo acuerdo materialEDGAR
ELTXElicio Therapeutics, Inc.8-KResultadosEDGAR
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…free survival (“DFS”); event-driven primary DFS analysis now anticipated in 1H 2026.  Since the beginning of Q3 2025, the Company has raised gross proceeds of approximately $11.1 million through its established at-the-market program, extending Elicio’s cash runway through Q2 2026.  Current cash position is expected to support operations beyond the anticipated Phase 2 AMPLIFY-7P event-driven primary DFS endpoint analysis anticipated…
ELTXElicio Therapeutics, Inc.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…cash flows and accumulated deficit, as well as the additional capital needed to fund operations for at least twelve months following the issuance of the condensed consolidated financial statements, raise substantial doubt about the Company’s ability to continue as a going concern. The Company expects to incur substantial expenditures in the foreseeable future for the development of its product candidates and will require additional financing to continue this development. The Company…
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…preferred stock, debt securities, and warrants to purchase common stock, preferred stock and/or debt securities, not to exceed an aggregate initial offering price of $100 million. Simultaneously, the Company entered into an At-the-Market Equity Offering Sales Agreement with Stifel, Nicolaus & Company, Incorporated and Virtu Americas LLC, as sales agents, that provided for the issuance and sale of up to $21 million of shares of common stock from time…
ELVNEnliven Therapeutics, Inc.8-K/AResultadosEDGAR
EQEquillium, Inc.8-KResultadosEDGAR
EQEquillium, Inc.10-QInforme trimestralEDGAR
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…stock issuable upon the exercise of the pre-funded warrants that were issued at the Initial Closing, and it was declared effective on September 18, 2025. 2023 ATM Facility In October 2023, the Company entered into an at-the-market facility with Jefferies LLC (Jefferies) under which the Company may offer and sell shares of its common stock having an aggregate offering price of up to $21.95 million from time to time through Jefferies acting…
EXOZEXOZYMES INC.10-QInforme trimestralEDGAR
En el documentoDebilidad material en el control internotexto original ▸
…Report on Form 10-Q fairly state, in all material respects, the financial position, results of operations and cash flows for the periods presented in conformity with GAAP. Ongoing Remediation of Previously Identified Material Weakness The Company is implementing measures designed to ensure that control deficiencies contributing to the previously disclosed material weakness are remediated, such that these controls are designed, implemented…
EXOZEXOZYMES INC.8-KOtros hechos relevantesEDGAR
FATEFATE THERAPEUTICS INC8-KResultadosEDGAR
En el documentoCambio en la dirección de la empresatexto original ▸
…studies and is currently evaluating opportunities for clinical investigation of FT839 in hematological malignancies and autoimmune disease in 2026. Other Corporate Updates • Kamal Adawi, M.S., M.B.A., appointed to the role of Chief Financial Officer. Mr. Adawi brings to the Company more than 20 years of financial leadership experience in the life sciences industry, including over 10 years serving as CFO across innovative life science companies, with…
FATEFATE THERAPEUTICS INC10-QInforme trimestralEDGAR
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…registration statement would be established at the time of such offering. We were initially eligible to issue an aggregate of $300.0 million in securities under the shelf registration statement. Additionally, we entered into a sales agreement with Jefferies Group LLC (Jefferies) with respect to an at-the-market offering program, under which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $100.0 million (which is included in the $300…
FENCFENNEC PHARMACEUTICALS INC.10-QInforme trimestralEDGAR
FTLFFITLIFE BRANDS, INC.10-QInforme trimestralEDGAR
FTLFFITLIFE BRANDS, INC.8-KResultadosEDGAR
GOVXGeoVax Labs, Inc.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…contracts, arrangements with strategic partners, or from other sources. There can be no assurance that additional funding will be available on favorable terms or at all. These factors collectively raise substantial doubt about the Company’s ability to continue as a going concern. Management believes that we will be successful in securing the additional capital required to continue the Company’s planned operations, but that our plans do not fully alleviate the substantial doubt…
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…placement agent commissions and other offering expenses were approximately $4.1 million. The pre-funded warrants were fully exercised during the second quarter of 2025. ATM Program. On September 25, 2024, we entered into a Sales Agreement and established an “At-the-Market” continuous offering program (the “ATM Program”), pursuant to which the Company may offer and sell, from time to time through its sales agent, shares of its common stock. During the three-month and nine-month periods ended…
GOVXGeoVax Labs, Inc.8-KResultadosEDGAR
GRCEGrace Therapeutics, Inc.10-QInforme trimestralEDGAR
GRMLGreenland Mines Ltd10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…obtaining additional working capital funding from the sale of equity and/or debt securities in order to continue to execute its development plans and continue operations. Without additional funding, there is substantial doubt about the Company’s ability to continue as a going concern for twelve months from the date of these financial statements. Basis of Presentation and Principles of Consolidation The Company prepares its consolidated financial statements in accordance with accounting…
HYPDHYPERION DEFI, INC.8-KResultadosEDGAR
ICCCIMMUCELL CORP /DE/10-QInforme trimestralEDGAR
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…on Form S-3 relating to the offer, issuance and sale by the Company of up to $20,000,000 of securities was declared effective by the Securities and Exchange Commission (SEC). Also on April 9, 2024, we entered into an At-The-Market (ATM) Agreement with Craig-Hallum Capital Group LLC, pursuant to which we may offer and sell up to $11,000,000 of shares of our common stock. Net proceeds through December 31, 2024 from 1,228,227 shares sold pursuant…
ICCCIMMUCELL CORP /DE/8-KResultadosEDGAR
IDXXIDEXX LABORATORIES INC /DE8-KNuevo acuerdo materialEDGAR
IMNNImunon, Inc.8-KResultadosEDGAR
IMNNImunon, Inc.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…fund operations for the next twelve months. Such conditions raise substantial doubts about the Company’s ability to continue as a going concern. Based on the above, management has determined there is substantial doubt regarding our ability to continue as a going concern. The report of our independent registered public accounting firm for the year ended December 31, 2024, includes an explanatory paragraph which expresses substantial doubt about our ability to continue…
En el documentoContrasplit de accionestexto original ▸
…public float increased above $75.0 million, and the Company is no longer subject to the limitations contained in General Instruction I.B.6 of Form S-3. Reverse Stock Split On July 25, 2025, the Company effected a 15-for-1 reverse stock split of its common stock which was made effective for trading purposes as of 12:01 a.m. ET on July 25, 2025. As of that date, each 15 shares of issued and outstanding common stock and equivalents were consolidated…
IMUXIMMUNIC, INC.8-KResultadosEDGAR
IMUXIMMUNIC, INC.10-QInforme trimestralEDGAR
IPSCCentury Therapeutics, Inc.10-QInforme trimestralEDGAR
IPSCCentury Therapeutics, Inc.8-KResultadosEDGAR
KODKodiak Sciences Inc.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…significant net losses in each period since our inception and anticipate that we will continue to incur significant and increasing net losses for the foreseeable future. • Our financial condition raises substantial doubt about our ability to continue as a going concern. • If we fail to obtain additional financing, we may be unable to complete the development and, if approved, commercialization of our product candidates. • Drug development is a highly uncertain undertaking…
KTTAPasithea Therapeutics Corp.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…obtaining additional working capital funding from the sale of equity and/or debt securities in order to continue to execute its development plans and continue operations. Without additional funding, there is substantial doubt about the Company’s ability to continue as a going concern through twelve months from the date of these financial statements. NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Principles of Consolidation The Company evaluates the need to consolidate affiliates…
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…exercised. In addition, the September 2024 PIPE Warrants have not been exercised as of September 30, 2025. At The Market Offering Agreement with H.C. Wainwright & Co., LLC On November 26, 2024, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), as sales agent, pursuant to which the Company may issue and sell, from time to time, through Wainwright, shares of its Common…
KURAKura Oncology, Inc.8-KOtros hechos relevantesEDGAR
LBRXLB PHARMACEUTICALS INC8-KNuevo acuerdo materialEDGAR
LTRNLantern Pharma Inc.8-KResultadosEDGAR
En el documentoDesignación de medicamento huérfanotexto original ▸
…clinical protocol with confidence in the regulatory pathway. Regulatory Designations and Market Opportunity: ● LP-184, which is being developed as STAR-001 by Starlight Therapeutics in CNS cancers, has received both Rare Pediatric Disease Designation and Orphan Drug Designation from the FDA for ATRT, along with additional Rare Pediatric Disease Designations for hepatoblastoma, rhabdomyosarcoma, and malignant rhabdoid tumors. These designations underscore the urgent unmet need…
MBRXMoleculin Biotech, Inc.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…7 million as of September 30, 2025 is not sufficient to fund its planned operations for a period of at least one year from when these consolidated financial statements are issued. These factors raise substantial doubt regarding the Company's ability to continue as a going concern. These unaudited condensed consolidated financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might…
En el documentoContrasplit de accionestexto original ▸
…regain compliance with the Bid Price Rule. 2. Basis of presentation, principles of consolidation, and significant accounting policies and liquidity Reverse Stock Split - On March 22, 2024, the Company completed a reverse stock split of all the issued and outstanding shares of the Company’s common stock at a ratio of 1 to 15. The accompanying consolidated financial statements and notes to the consolidated financial statements give…
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…services provided. The Company issued 19,889 shares of common stock upon the vesting of RSUs in July 2025 pertaining to the prior quarter. At Market Issuance Sales Agreement (ATM) In July 2025, the Company entered into a certain At Market Issuance Offering Agreement (2025 ATM Agreement) with Roth Capital Partners, LLC. (Roth). Pursuant to the terms of the 2025 ATM Agreement, the Company may offer and sell shares of our common stock having an aggregate offering price of up to $6.5 million…
MGTXMeiraGTx Holdings plc8-KResultadosEDGAR
En el documentoDesignación de terapia avanzada (RMAT)texto original ▸
…in total milestone payments. MeiraGTx is also eligible to receive tiered royalties on licensed products. AAV2-hAQP1 for the Treatment of Radiation-Induced Xerostomia: · In December 2024, MeiraGTx was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA for AAV2-hAQP1 for the treatment of Grade 2/3 RIX. · Following FDA interactions through the RMAT meeting process, the Company has aligned with the agency on both the CMC…
MGTXMeiraGTx Holdings plc10-QInforme trimestralEDGAR
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…reported in cash flows from operations or cash flows from financing activities for the nine-month periods ended September 30, 2025 and 2024. 6. Ordinary Shares At-the-Market In December 2023, the Company entered into an “at-the-market” sales agreement with BofA Securities, Inc., or BofA, pursuant to which the Company may sell from time to time, ordinary shares having an aggregate offering price of up to $100.0 million through BofA, acting as the Company…
MIRAMIRA PHARMACEUTICALS, INC.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…generate losses and have insufficient cash and cash equivalents on hand to support its operations for at least the 12 months following the date the financial statements are issued. These factors raise substantial doubt about the Company’s ability to continue as a going concern for a period of twelve months from the issuance date of this report. Management cannot provide assurance that the Company will ultimately achieve profitable operations or become cash flow positive or…
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…Board of Directors when a series of Preferred Stock is designated. On August 12, 2024, the Company filed a shelf registration statement with the SEC to facilitate the issuance of our common stock and entered into an At-the-Market Offering Agreement (the “ATM Agreement”) with Rodman & Renshaw LLC, under which the Company may offer and sell shares of its Common Stock, with an aggregate offering amount sold of up to $19,268,571. On September…
MNPRMonopar Therapeutics10-QInforme trimestralEDGAR
En el documentoContrasplit de accionestexto original ▸
…a reverse stock split of the outstanding shares, providing the Board of Directors with the authority to effect a reverse split within a specified range of ratios. Subsequently, the Board of Directors approved a reverse stock split of 1 for 5 shares of the Company’s common stock in order to regain compliance with Nasdaq’s continued listing requirements. The reverse stock split became effective at 5:00 pm on Monday August 12, 2024…
MNPRMonopar Therapeutics8-KResultadosEDGAR
MRKRMarker Therapeutics, Inc.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…expenses and capital expenditure requirements through the third quarter of 2026, assuming no additional grant funds are received, either from new grants or from existing awarded grants. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern. Management is considering raising additional capital through the issuance of securities and intends to apply for additional grant funds, which could enable the Company to fund its operating expenses…
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…qualified personnel; and develop strategic alliances and collaborations. From inception, the Company has been funded by a combination of equity and debt financings and grants. In November 2024, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co. LLC, relating to the sale of shares of its common stock , from time to time, through H.C. Wainwright & Co. LLC pursuant to the Company’s shelf…
MXCTMAXCYTE, INC.10-QInforme trimestralEDGAR
NGNENeurogene Inc.10-QInforme trimestralEDGAR
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…as an equity-for-equity transaction. The Company derecognized the common shares and recognized an equivalent value in pre-funded warrants, with no gain or loss recognized. In August 2025, the Company entered into an at-the-market (“ATM”) sales agreement (the “Sales Agreement”) with Leerink Partners, LLC (“Leerink”), as sales agents, pursuant to which the Company may offer and sell, from time to time, shares of the Company’s common stock with an aggregate…
NGNENeurogene Inc.8-KResultadosEDGAR
En el documentoDesignación de medicamento huérfanotexto original ▸
…without causing overexpression-related toxic effects associated with conventional gene therapy. NGN-401 was selected by the U.S. Food and Drug Administration (FDA) for its START Pilot Program and has also received Regenerative Medicine Advance Therapy (RMAT) designation, orphan drug designation, Fast Track designation and rare pediatric designation from the FDA. Neurogene was previously granted an INTERACT meeting with the FDA regarding the EXACT technology. NGN-401 also received Priority Medicines…
En el documentoDesignación de terapia avanzada (RMAT)texto original ▸
…without causing overexpression-related toxic effects associated with conventional gene therapy. NGN-401 was selected by the U.S. Food and Drug Administration (FDA) for its START Pilot Program and has also received Regenerative Medicine Advance Therapy (RMAT) designation, orphan drug designation, Fast Track designation and rare pediatric designation from the FDA. Neurogene was previously granted an INTERACT meeting with the FDA regarding the EXACT technology…
En el documentoDesignación de vía rápida (Fast Track)texto original ▸
…without causing overexpression-related toxic effects associated with conventional gene therapy. NGN-401 was selected by the U.S. Food and Drug Administration (FDA) for its START Pilot Program and has also received Regenerative Medicine Advance Therapy (RMAT) designation, orphan drug designation, Fast Track designation and rare pediatric designation from the FDA. Neurogene was previously granted an INTERACT meeting with the FDA regarding the EXACT technology. NGN-401 also received Priority Medicines (PRIME) designation…
NXTSNexentis Technologies Inc.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…balances as of September 30, 2025, management currently is of the opinion that its existing cash will be sufficient to fund operations until the end of the third quarter of 2026. As a result, there is substantial doubt regarding the Company’s ability to continue as a going concern. Management plans to continue securing sufficient financing through the sale of additional equity securities or capital inflows from strategic partnerships. Additional funds may not be available when…
En el documentoContrasplit de accionestexto original ▸
…under the symbol “NITO”. 10 N2OFF, INC. NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS (unaudited) NOTE 1 – GENERAL (continued) B. Reverse stock split On September 22, 2025, the Company effected a 1-for-35 reverse stock split of the Company’s outstanding Common Stock (the “Reverse Stock Split”) in order to regain compliance with the Nasdaq minimum bid price requirement, following the notice received from Nasdaq on March 28…
OMEROMEROS CORP8-KResultadosEDGAR
En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸
…Drug User Fee Act (“PDUFA”), the class 2 resubmission was assigned September 25, 2025 as the target action date. Following a comprehensive response to an FDA information request, the Agency extended the PDUFA date to December 26, 2025. We expect that FDA will meet this PDUFA date. All analyses requested by FDA as part of its review have been consistent with and have provided statistically significant support of narsoplimab’s benefit…
OMEROMEROS CORP10-QInforme trimestralEDGAR
ONCOOnconetix, Inc.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…to support its strategic growth initiatives, which includes the commercialization of Proclarix, and the development and commercialization of the Company’s future product candidates. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date of the issuance of these condensed consolidated financial statements. Management’s plans for funding the Company’s operations include generating product revenue from sales…
En el documentoContrasplit de accionestexto original ▸
…to “Onconetix, Inc.” In connection with each of the name changes, the Company also amended the Company’s bylaws to reflect the new corporate name. Reverse Stock Split On September 24, 2024, the Company effected a reverse stock split of all shares of its issued and outstanding Common Stock at a ratio of one-for-forty (1:40). The Company accounted for the reverse stock split on a retrospective basis pursuant to Accounting Standards…
ORICOric Pharmaceuticals, Inc.8-KResultadosEDGAR
ORICOric Pharmaceuticals, Inc.10-QInforme trimestralEDGAR
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…filed a Form S-3 registering the shares sold in the private placement. The Form S-3 was declared effective by the SEC on February 2, 2024. At-The-Market Sales Agreement and Offering The Company previously entered into an “at the market” (ATM) sales agreement with Jefferies LLC as the Company’s sales agent, to sell shares of the Company’s common stock. On March 11, 2024, pursuant to the terms of the ATM sales agreement, the Company filed a Form S-3ASR and…
ORMPORAMED PHARMACEUTICALS INC.10-QInforme trimestralEDGAR
En el documentoContrasplit de accionestexto original ▸
…of the shares as of September 30, 2025 was $4,200. The Company has classified the PTHS ordinary shares as short-term marketable securities. NOTE 4 - INVESTMENTS, AT FAIR VALUE On April 14, 2025, Scilex effected a 1-for-35 reverse stock split of its issued and outstanding common stock (“Reverse Split”). As a result, every 35 shares of Scilex common stock were automatically reclassified into 1 share of common stock, with fractional shares rounded…
OTLKOutlook Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
En el documentoFecha de decisión de la FDA (PDUFA)texto original ▸
…ONS-5010 (bevacizumab-vikg). The FDA determined that the BLA is a Class 1 review, which results in a two-month review period from the date of resubmission. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of December 31, 2025. SIGNATURES 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. Outlook…
PDSBPDS Biotechnology Corp8-KResultadosEDGAR
PDSBPDS Biotechnology Corp10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…operations and prospects. Failure to obtain adequate financing may also adversely affect the Company’s ability to operate as a going concern. As a result of these uncertainties, the Company has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for a period of at least 12 months from the date of the issuance of these unaudited Condensed Consolidated Financial Statements on Form 10-Q. The unaudited Condensed Consolidated Financial Statements…
PGENPRECIGEN, INC.8-KResultadosEDGAR
PAPZIMEOS (zopapogene imadenovec-drba) recibió la aprobación completa de la FDA en agosto y se lanzó en Estados Unidos como el primer y único tratamiento aprobado por la FDA para adultos con RRP.
Original en inglés · traducción automática
PAPZIMEOS (zopapogene imadenovec-drba) received full approval by the FDA in August · PAPZIMEOS launched with a broad label in the US as the first and only FDA-approved treatment for adults with RRP · PAPZIMEOS is now available and shipping to prescribers in the US for the treatment of adults with RRP · To date, over 100 patients have been registered in the PAPZIMEOS Patient Hub · The Company has made significant progress with private health insurance coverage, with more than 100 million lives covered to date;
Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
PGENPRECIGEN, INC.10-QInforme trimestralEDGAR
PHIOPhio Pharmaceuticals Corp.8-KResultadosEDGAR
PHIOPhio Pharmaceuticals Corp.10-QInforme trimestralEDGAR
En el documentoContrasplit de accionestexto original ▸
…accounts have been eliminated in consolidation. Segments The Company operates as one operating segment and all assets are located in the United States. Reverse Stock Split Effective July 5, 2024, the Company completed a 1-for-9 reverse stock split of the Company’s outstanding common stock, including reclassifying an amount equal to the reduction in par value to additional paid-in capital. The reverse stock split did not reduce the number of authorized…
QTTBQ32 Bio Inc.8-KResultadosEDGAR
QTTBQ32 Bio Inc.10-QInforme trimestralEDGAR
En el documentoContrasplit de accionestexto original ▸
…pursuant to the Pre-Closing Financing were converted into the right to receive 1,682,045 shares of Homology common stock after taking into account the Reverse Stock Split. On March 25, 2024, Homology effected a one-for-eighteen reverse stock split of its then outstanding common stock (the “Reverse Stock Split”) where all issued and outstanding shares of Legacy Q32’s common stock (including common stock issued upon the conversion of all Legacy Q32…
RLMDRELMADA THERAPEUTICS, INC.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…agreements. Any such expenditures related to any subsequent clinical trials will not be incurred until such additional financing is raised. As a result, the Company concluded that management’s plans alleviated substantial doubt about the Company’s ability to continue as a going concern as of September 30, 2025 and the Company has sufficient funds to maintain operations for at least 12 months from the issuance of these unaudited condensed consolidated financial statements. NOTE 3 - SUMMARY…
RLMDRELMADA THERAPEUTICS, INC.8-KResultadosEDGAR
RNACCartesian Therapeutics, Inc.8-KOtros hechos relevantesEDGAR
En el documentoDesignación de medicamento huérfanotexto original ▸
…require preconditioning chemotherapy, can be administered in the outpatient setting, and does not carry the risk of genomic integration associated with cancerous transformation. Descartes-08 has been granted Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation by the U.S. Food and Drug Administration for the treatment of MG, and Rare Pediatric Disease Designation for the treatment of juvenile dermatomyositis…
En el documentoDesignación de terapia avanzada (RMAT)texto original ▸
…require preconditioning chemotherapy, can be administered in the outpatient setting, and does not carry the risk of genomic integration associated with cancerous transformation. Descartes-08 has been granted Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation by the U.S. Food and Drug Administration for the treatment of MG, and Rare Pediatric Disease Designation for the treatment of juvenile dermatomyositis. About Descartes-15 Descartes-15 is a…
RNXTRenovoRx, Inc.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…equivalents as of the date of this Report will be sufficient to fund our operating, investing and financing needs for at least the next twelve months from the date of this Report. This raises a current substantial doubt about our ability to continue as a going concern. We have incurred significant losses and negative cash flows from operations since our inception. At September 30, 2025, we had an accumulated deficit of approximately $58.4 million. For the three and…
En el documentoDebilidad material en el control internotexto original ▸
…including the performance of user access reviews, access to edit data in applications was not properly restricted, and formal approval of application access was not documented and retained. The previously identified material weakness has not been remediated but we are in the process of implementing a number of measures to address the material weaknesses that has been identified including: (i) engaging additional accounting and financial…
RNXTRenovoRx, Inc.8-KResultadosEDGAR
En el documentoDesignación de medicamento huérfanotexto original ▸
…infusion. The combination product candidate (IAG), which is enabled by the RenovoCath device, is currently under investigation and has not been approved for commercial sale. RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides seven years of market exclusivity upon new drug application approval by the FDA. RenovoRx is also actively commercializing its TAMP technology…
SBFMSunshine Biopharma Inc.10-QInforme trimestralEDGAR
SCNXScienture Holdings, Inc.8-KOtros hechos relevantesEDGAR
SGMTSagimet Biosciences Inc.10-QInforme trimestralEDGAR
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…Offering (as defined below), the Company terminated the 2024 ATM Offering. No shares of Series A common stock were sold under the 2024 ATM Offering prior to such termination. In August 2025, the Company entered into a Sales Agreement with Leerink Partners LLC to establish an at-the-market offering (2025 ATM Offering) through which the Company may sell, from time to time at its sole discretion, up to $75.0 million shares of its Series A common stock. There were no sales under the 2025 ATM Offering…
SGMTSagimet Biosciences Inc.8-KResultadosEDGAR
SHPHShuttle Pharmaceuticals Holdings, Inc.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…successfully raise additional equity or debt financing to allow it to fund ongoing operations, conduct clinical trials and bring a drug candidate to commercialization to generate revenues. These conditions raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the unaudited condensed consolidated financial statements are issued. The accompanying unaudited condensed consolidated financial statements do not include any adjustments…
SILOSilo Pharma, Inc.10-QInforme trimestralEDGAR
SNTISenti Biosciences Holdings, Inc.8-KResultadosEDGAR
SNTISenti Biosciences Holdings, Inc.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…and when, needed, we may have to significantly delay, scale back, or discontinue the development and commercialization of our product candidates or delay our efforts to expand our product pipeline. As substantial doubt exists about our ability to continue as a going concern, we may also be required to sell or license to other parties’ rights to develop or commercialize our product candidates that we would prefer to retain. From inception to September 30, 2025, we raised…
En el documentoContrasplit de accionestexto original ▸
…upon liquidation, winding up, and dissolution of the Company. Through September 30, 2025, no cash dividends have been declared or paid. On July 10, 2024, the Company’s Board of Directors (the “Board”) approved a reverse stock split of the common stock, $0.0001 par value, at a ratio of 1-for-10. Effective as of 5:00 p.m. Eastern Time on July 17, 2024, the Company filed the Reverse Stock Split Amendment and effected a 1-for-10 reverse…
En el documentoDebilidad material en el control internotexto original ▸
…reported, in connection with our preparation and the audit of our consolidated financial statements as of and for the year ended December 31, 2024, we and our independent registered public accounting firm identified a material weakness, as defined under the Exchange Act and by the Public Company Accounting Oversight Board (United States), in our internal control over financial reporting. The material weakness related to a lack of sufficient…
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…existing trading symbol “SNTI.” 2025 ATM Agreement 15 Table of Contents SENTI BIOSCIENCES, INC. Notes to Condensed Consolidated Financial Statements— (Continued) (Unaudited) On March 20, 2025, the Company entered into a Sales Agreement (the “2025 ATM Agreement”) with Leerink Partners LLC (“Leerink Partners”) with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, up to a maximum…
SNYRSynergy CHC Corp.8-KResultadosEDGAR
SNYRSynergy CHC Corp.10-QInforme trimestralEDGAR
SPROSpero Therapeutics, Inc.10-QInforme trimestralEDGAR
En el documentoAviso de incumplimiento de las reglas de cotizacióntexto original ▸
…the “Bid Price Requirement”). The closing bid price for our common stock must remain at or above $1.00 per share to comply with the Bid Price Requirement for continued listing. On February 25, 2025, we received a deficiency letter (the “Notice”) from the Listing Qualifications Department of the Nasdaq Stock Market, LLC (“Nasdaq”) notifying us that, for the preceding 30 consecutive trading days, the closing bid price of our common…
SPROSpero Therapeutics, Inc.8-KResultadosEDGAR
SXTP60 DEGREES PHARMACEUTICALS, INC.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…operations and obtain financing. The audited consolidated financial statements for the year ended December 31, 2024 included an explanatory note referring to our recurring operating losses and expressing substantial doubt in our ability to continue as a going concern. Our future results are subject to substantial risks and uncertainties. Since our inception, we have not demonstrated the ability to generate enough revenues to date to cover operating expenses and we…
En el documentoContrasplit de accionestexto original ▸
…Significant estimates include the reserve for inventory, the fair value of derivative liabilities, and stock-based compensation. 7 Reverse Stock Splits Following stockholder approval in July 2024, the Company effected a reverse stock split at a ratio of 1:12, which was effective as of August 12, 2024 (the “1:12 Reverse Stock Split”).On November 6, 2024, a majority of the Company’s stockholders approved an additional reverse stock split…
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 that evaluation, the Company’s Chief Executive Officer and the Company’s Chief Financial Officer have concluded that as of September 30, 2025, due to the existence of the material weakness in the Company’s internal control over financial reporting described below, the Company’s disclosure controls and procedures were not effective. Management is responsible for establishing and maintaining…
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…resulting in net proceeds to the Company of approximately $4,281,300, after deducting placement agent fees and other offering expenses paid by the Company. 2025 ATM Agreement On September 5, 2025, the Company entered into an At-The-Market Sales Agreement (the “2025 ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”) pursuant to which the Company may, from time to time, offer and sell shares of its common stock, having aggregate gross sales…
TILInstil Bio, Inc.8-KResultadosEDGAR
TILInstil Bio, Inc.10-QInforme trimestralEDGAR
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…2024. Pursuant to our shelf registration statement we may, from time to time, sell up to an aggregate of $200 million of our common stock, preferred stock, debt securities or warrants. In March 2025, we entered into an Open Market Sale AgreementSM, or the ATM Sales Agreement, with Jefferies LLC, or Jefferies, as sales agent, under which we may offer and sell, from time to time, shares of our common stock through Jefferies, with an aggregate offering price of up to $100.0…
TRAWTraws Pharma, Inc.8-KResultadosEDGAR
TRAWTraws Pharma, Inc.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…that it does not have sufficient cash and cash equivalents to support its operations for more than one year following the date that these financial statements are issued. As a result of these conditions, substantial doubt exists about the Company’s ability to continue as a going concern. The Company will require substantial additional financing to fund its ongoing clinical trials and operations, and to continue to execute its strategy. Management plans to explore various dilutive and…
En el documentoContrasplit de accionestexto original ▸
…ratutrelvir, and its strategic objective for narazaciclib and rigosertib is to establish additional partnerships for further development of the compounds. Reverse Stock Split In September 2024, the Company effected a one-for-25 reverse stock split of its issued and outstanding shares of common stock (the “Reverse Stock Split”). All share and per share amounts for the Company’s common stock, as well as the number of shares of common stock issuable…
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…issued and outstanding immediately after giving effect to such conversion (the “Beneficial Ownership Limitation”). 19 Table of Contents At the Market Offering Agreement On March 10, 2025, the Company entered into an At the Market Offering Agreement (the “ATM Agreement”) with Citizens JMP Securities, LLC (“Citizens”), pursuant to which the Company may offer and sell shares of its common stock, having an aggregate sales price of up to $50…
TRVITrevi Therapeutics, Inc.8-KResultadosEDGAR
TRVITrevi Therapeutics, Inc.10-QInforme trimestralEDGAR
En el documentoPrograma de venta continua de acciones (ATM)texto original ▸
…Plan 1,116,075 1,131,973 Shares of common stock reserved for future issuance under the 2012 Stock Incentive Plan 278,418 288,944 29,661,288 41,891,573 At-the-Market Offering 13 In June 2020, the Company entered into a sales agreement (the "2020 ATM Sales Agreement") with SVB Securities LLC ("SVB Securities") under which the Company was able to issue and sell shares of its common stock, from time to time, having an aggregate offering price of up to $12.0 million…
TTRXTurn Therapeutics Inc.8-KResultadosEDGAR
TTRXTurn Therapeutics Inc.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…operations through at least the next 12 months from the date that these unaudited condensed consolidated financial statements as of September 30, 2025 are issued based on our expected cash needs, which raises substantial doubt about our ability to continue as a going concern. 5 Turn Therapeutics Inc. Notes to Condensed Consolidated Financial Statements As we continue to pursue our business plan, we expect to finance our operations through potential public or private equity…
En el documentoDebilidad material en el control internotexto original ▸
…Rule 13a-15(e) of the Exchange Act) as of the end of the period covered by this Quarterly Report. During the preparation of our financial statements for the year ended December 31, 2024, our management identified a material weakness in our internal control over financial reporting due to a lack of segregation of duties. A material weakness is defined as a deficiency, or a combination of deficiencies, in internal control over financial…
TVRDTvardi Therapeutics, Inc.10-QInforme trimestralEDGAR
La compañía concluyó que existen condiciones que generan duda sustancial sobre su capacidad de continuar como negocio en marcha y que aún no ha registrado ingresos por venta de productos.
Original en inglés · traducción revisada
raise substantial doubt about the Company’s ability to continue as a going concern. To date, the Company has no products approved for marketing and sale and it has not yet recorded any revenue from product sales.
Traducción automática (claude-sonnet-5), con la cita comprobada contra el documento y revisada por una persona.
El 15 de abril de 2025, justo antes del cierre de la fusión, Cara realizó un split inverso de sus acciones de 1 por 3 y aumentó sus acciones autorizadas a 150.000.000.
Original en inglés · traducción automática
on April 15, 2025, immediately prior to the closing of the Merger, Cara (i) effected a 1-for-3 reverse stock split of its common stock and (ii) increased its authorized shares of common stock to 150,000,000.
Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
Tvardi identificó una debilidad material relacionada con la revisión inadecuada de sus estados financieros y divulgaciones.
Original en inglés · traducción automática
Legacy Tvardi identified a material weakness in its financial reporting related to inadequate review of financial statements and disclosures.
Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
TVRDTvardi Therapeutics, Inc.8-KResultadosEDGAR
Tvardi Therapeutics anunció sus resultados financieros y operativos del tercer trimestre finalizado el 30 de septiembre de 2025.
Original en inglés · traducción automática
today announced its ﬁnancial and operating results for the third quarter ended September 30, 2025, and provided a business update.
Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
TXMDTherapeuticsMD, Inc.8-KResultadosEDGAR
VBIOValion Bio, Inc.8-KOtros hechos relevantesEDGAR
VORVor Biopharma Inc.10-QInforme trimestralEDGAR
En el documentoContrasplit de accionestexto original ▸
…Company’s stockholders approved a proposal to authorize the Company’s board of directors to amend the Company’s Amended and Restated Certificate of Incorporation to effect a reverse stock split. The Board approved the reverse stock split on August 27, 2025 and, on September 18, 2025, the Company effected a 1-for-20 reverse stock split of its common stock. The par value and the authorized shares of the common stock were not adjusted as…
VTGNVistagen Therapeutics, Inc.8-KResultadosEDGAR
VTGNVistagen Therapeutics, Inc.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…within one year after the date that the consolidated 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 consolidated financial statements are issued. In performing its analysis, management excluded certain elements of its operating plan that cannot be considered probable…
XBIOXenetic Biosciences, Inc.8-KResultadosEDGAR
XLOXilio Therapeutics, Inc.8-KResultadosEDGAR
XLOXilio Therapeutics, Inc.10-QInforme trimestralEDGAR
En el documentoDuda sustancial sobre la continuidad de la empresatexto original ▸
…stock warrants issued in connection with our June 2025 follow-on public offering are exercised; • our ability to secure sufficient additional capital or implement other strategies needed to alleviate the substantial doubt about our ability to continue as a going concern; • the potential advantages and benefits of our current and future product candidates, including our beliefs regarding the potential benefits of our current and future product candidates in combination…
ZURAZura Bio Ltd8-KResultadosEDGAR
ZURAZura Bio Ltd10-QInforme trimestralEDGAR

Juntas de accionistas

CELZCREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.DEF 14AConvocatoria de junta de accionistasEDGAR

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