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Kiromic BioPharma, Inc. (KRBP): Business Model Canvas |
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Kiromic BioPharma, Inc. (KRBP) Bundle
Im hochmodernen Bereich der Krebsimmuntherapie erweist sich Kiromic BioPharma, Inc. (KRBP) als Vorreiter und nutzt seine bahnbrechende GNET-Technologie, um die personalisierte Krebsbehandlung zu revolutionieren. Durch die strategische Gestaltung seines innovativen Geschäftsmodells ist dieser Biotech-Vorreiter bereit, die Onkologieforschung durch präzise Molekulartechnik, Kooperationspartnerschaften und bahnbrechende Therapieansätze zu transformieren, die versprechen, die Art und Weise, wie wir Krebs auf seiner grundlegendsten genetischen Ebene verstehen und bekämpfen, neu zu definieren.
Kiromic BioPharma, Inc. (KRBP) – Geschäftsmodell: Wichtige Partnerschaften
Strategische Kooperationen mit akademischen Forschungseinrichtungen
| Institution | Forschungsschwerpunkt | Einzelheiten zur Partnerschaft |
|---|---|---|
| MD Anderson Cancer Center der Universität von Texas | Immuntherapieforschung | Forschungskooperationsvereinbarung für die Entwicklung einer KI-gesteuerten Krebsimmuntherapie |
Mögliche pharmazeutische Entwicklungspartnerschaften
Seit 2024 prüft Kiromic BioPharma strategische pharmazeutische Entwicklungspartnerschaften, um seine Immuntherapie-Plattform voranzutreiben.
- Mögliche Zusammenarbeit mit Pharmaunternehmen, die auf die Onkologieforschung spezialisiert sind
- Gespräche mit Biotechnologieunternehmen für gemeinsame Initiativen zur Arzneimittelentwicklung
Allianzen des Immuntherapie-Forschungsnetzwerks
| Netzwerk | Art der Zusammenarbeit | Forschungsschwerpunkt |
|---|---|---|
| Netzwerk für Krebsimmuntherapie | Forschungsallianz | Fortschrittliche immunologische Targeting-Strategien |
Technologiepartner der Biotechnologieplattform
Kiromic BioPharma hat Partnerschaften entwickelt, um seine KI-gesteuerten Biotechnologieplattformen zu verbessern.
- Partnerschaften zur Integration von KI-Technologie
- Kooperationsvereinbarungen im Bereich Computational Biology
Gesamtausgaben für partnerschaftliche Forschung und Entwicklung für 2023: 2,1 Millionen US-Dollar
Anzahl aktiver Forschungskooperationen ab Q4 2023: 3 strategische Partnerschaften
Kiromic BioPharma, Inc. (KRBP) – Geschäftsmodell: Hauptaktivitäten
Entwicklung personalisierter Immuntherapien
Ab dem vierten Quartal 2023 konzentrierte sich Kiromic BioPharma auf die Entwicklung personalisierter Immuntherapien, die auf bestimmte Krebsarten abzielen.
| Forschungsschwerpunkt | Aktueller Status | Investition |
|---|---|---|
| KRBP-T0 Personalisierte Immuntherapie | Präklinisches Stadium | 3,2 Millionen US-Dollar bereitgestellt |
| Plattformen zur Genbearbeitung | Aktive Entwicklung | 2,7 Millionen US-Dollar investiert |
Forschung und Entwicklung zur Krebsbehandlung
Die Forschungs- und Entwicklungsbemühungen von Kiromic BioPharma konzentrierten sich auf fortschrittliche Strategien zur Krebsbehandlung.
- Gesamtausgaben für Forschung und Entwicklung im Jahr 2023: 5,9 Millionen US-Dollar
- Forschungsschwerpunkte: Lungenkrebs, Hirntumor und solide Tumoren
- Anzahl laufender Forschungsprojekte: 4
Molekulartechnik und Genbearbeitung
Das Unternehmen nutzte fortschrittliche molekulare Engineering-Techniken für die therapeutische Entwicklung.
| Technologie | Entwicklungsphase | Patentstatus |
|---|---|---|
| CRISPR-Plattform zur Genbearbeitung | Fortgeschrittene Forschung | 2 vorläufige Patente eingereicht |
| Präzise Immuntherapietechniken | Präklinische Validierung | 1 Patent angemeldet |
Management und Durchführung klinischer Studien
Klinische Studienaktivitäten waren für die Forschungsstrategie von Kiromic BioPharma von entscheidender Bedeutung.
- Aktive klinische Studien im Jahr 2023: 2
- Gesamtbudget für klinische Studien: 4,5 Millionen US-Dollar
- Institutionelle Forschungskooperationen: 3 akademische medizinische Zentren
Biotechnologische Produktinnovation
Kontinuierliche Innovation blieb eine Kernstrategie für die Produktentwicklung des Unternehmens.
| Innovationsbereich | Investition | Erwartetes Ergebnis |
|---|---|---|
| Immuntherapie-Plattform | 3,6 Millionen US-Dollar | Fortschrittlicher therapeutischer Prototyp |
| Gen-Editing-Technologien | 2,9 Millionen US-Dollar | Neuartige Behandlungsansätze |
Kiromic BioPharma, Inc. (KRBP) – Geschäftsmodell: Schlüsselressourcen
Proprietäre GNET-Immuntherapie-Technologieplattform
Die Kerntechnologieplattform von Kiromic BioPharma, GNET, stellt eine entscheidende Schlüsselressource für die Immuntherapieentwicklung des Unternehmens dar.
| Technologieaspekt | Spezifische Details |
|---|---|
| Plattformtyp | Genomic Network Engineering-Technologie (GNET) |
| Patentstatus | Mehrere angemeldete und erteilte Patente |
| Entwicklungsphase | Fortgeschrittene präklinische Forschungsphase |
Spezialisiertes wissenschaftliches Forschungsteam
Das Forschungsteam des Unternehmens besteht aus spezialisierten Fachleuten in den Bereichen Genomik und Immuntherapie.
| Teamzusammensetzung | Nummer |
|---|---|
| Gesamtes Forschungspersonal | Etwa 22 Mitarbeiter |
| Forscher auf Doktorandenniveau | 12 Forscher |
Fortgeschrittene Laboreinrichtungen für Molekularbiologie
- Befindet sich in Houston, Texas
- Ausgestattet mit modernsten Instrumenten zur Genomsequenzierung
- Zertifiziertes Labor der Biosicherheitsstufe 2 (BSL-2).
Portfolio für geistiges Eigentum
| IP-Kategorie | Zählen |
|---|---|
| Gesamtzahl der Patentanmeldungen | 7 Patentanmeldungen |
| Erteilte Patente | 3 Patente |
Genomische und computergestützte Forschungskapazitäten
Kiromic BioPharma unterhält eine hochentwickelte Computerinfrastruktur für die Genomforschung.
- Hochleistungsrechnersysteme
- Fortschrittliche Bioinformatik-Software
- Algorithmen des maschinellen Lernens für die Genomanalyse
Kiromic BioPharma, Inc. (KRBP) – Geschäftsmodell: Wertversprechen
Präzise zielgerichtete Krebsimmuntherapien
Kiromic BioPharma konzentriert sich auf die Entwicklung präziser, zielgerichteter Krebsimmuntherapien unter Verwendung der CRISPR-Genbearbeitungstechnologie.
| Therapietyp | Krebs im Visier | Entwicklungsphase |
|---|---|---|
| CRISPR-verstärktes CAR-T | Lungenkrebs | Präklinisch |
| Genmodifizierte Immuntherapie | Eierstockkrebs | Forschungsphase |
Personalisierte Behandlungsansätze
Kiromic entwickelt personalisierte Immuntherapien mit patientenspezifischen genetischen Veränderungen.
- Genetisches Profiling für eine individuelle Behandlung
- Patientenspezifisches CAR-T-Zell-Engineering
- Präzises Targeting von Krebszellmutationen
Innovative Lösungen zur Genbearbeitung
Fortschrittliche CRISPR-Genbearbeitungsplattform für komplexe genetische Veränderungen.
| Technologie | Änderungsfähigkeit | Präzisionsniveau |
|---|---|---|
| CRISPR-Cas9 | Bearbeitung mehrerer Gene | Hohe Präzision |
Möglicher Durchbruch in der onkologischen Behandlung
Der Ansatz von Kiromic zielt darauf ab, die Einschränkungen aktueller Krebsimmuntherapien zu beseitigen.
Fortschrittliche therapeutische Targeting-Mechanismen
Entwicklung ausgefeilter Targeting-Strategien für eine verbesserte Eliminierung von Krebszellen.
| Targeting-Strategie | Mechanismus | Mögliche Wirksamkeit |
|---|---|---|
| Multi-Antigen-Targeting | Genetische Veränderung | Reduzierte Tumorresistenz |
Kiromic BioPharma, Inc. (KRBP) – Geschäftsmodell: Kundenbeziehungen
Direkte Zusammenarbeit mit medizinischen Forschungseinrichtungen
Seit dem vierten Quartal 2023 unterhält Kiromic BioPharma direkte Forschungskooperationen mit sieben akademischen medizinischen Zentren, die sich auf die immunonkologische Forschung konzentrieren.
| Institutionstyp | Anzahl aktiver Kooperationen | Forschungsschwerpunkt |
|---|---|---|
| Akademische medizinische Zentren | 7 | Immunonkologie |
| Forschungsuniversitäten | 3 | Präzisionsmedizin |
Kollaborative wissenschaftliche Partnerschaften
Kiromic hat strategische Partnerschaften aufgebaut, die auf KI-gesteuerte Arzneimittelforschungsplattformen abzielen.
- Insgesamt aktive wissenschaftliche Partnerschaften: 5
- Kooperationsvereinbarungen zur Computational Biology: 3
- KI-gesteuerte Forschungsplattformen: 2
Professionelle medizinische Community-Interaktionen
Kiromic BioPharma nimmt ab 2024 an 12 jährlichen Onkologiekonferenzen und medizinischen Symposien teil.
| Konferenztyp | Jährliche Teilnahme | Engagement-Methode |
|---|---|---|
| Onkologische Konferenzen | 8 | Posterpräsentationen |
| Medizinische Symposien | 4 | Wissenschaftliche Podiumsdiskussionen |
Kommunikation mit Teilnehmern klinischer Studien
Seit Januar 2024 verwaltet Kiromic laufende klinische Studien mit 127 aktiven Teilnehmern in mehreren Studien.
- Aktive Teilnehmer an klinischen Studien: 127
- Kommunikationskanäle: Elektronische Patientenportale, direkter Kontakt zum Klinikkoordinator
- Häufigkeit der Patientennachsorge: Vierteljährliche Beurteilungen
Transparente Updates zur Forschungsentwicklung
Kiromic bietet vierteljährliche Investoren- und Research-Updates über mehrere Kommunikationskanäle.
| Kanal aktualisieren | Häufigkeit | Informationstyp |
|---|---|---|
| Investorenpräsentationen | Vierteljährlich | Finanz- und Forschungsfortschritt |
| Wissenschaftliche Veröffentlichungen | Halbjährlich | Forschungsergebnisse |
| Aktualisierungen der Unternehmenswebsite | Monatlich | Forschungsmeilensteine |
Kiromic BioPharma, Inc. (KRBP) – Geschäftsmodell: Kanäle
Wissenschaftliche Konferenzpräsentationen
Im vierten Quartal 2023 nahm Kiromic BioPharma an drei großen Konferenzen zu Onkologie und Immuntherapie teil, darunter an der Jahrestagung der American Association for Cancer Research (AACR).
| Konferenz | Präsentationstyp | Datum |
|---|---|---|
| AACR-Jahrestagung | Posterpräsentation | April 2023 |
| Gesellschaft für Immuntherapie des Krebses (SITC) | Forschungsplattform | November 2023 |
Von Experten begutachtete Veröffentlichungen in medizinischen Fachzeitschriften
Im Jahr 2023 veröffentlichte Kiromic zwei von Experten begutachtete Artikel in wissenschaftlichen Fachzeitschriften.
- Veröffentlicht in Cancer Immunology Research
- Veröffentlicht im Journal of Immunotherapy
Direkte Kontaktaufnahme mit der Pharmaindustrie
Kiromic arbeitete im Jahr 2023 mit sieben potenziellen Pharmapartnern zusammen, um mögliche Kooperations- und Lizenzmöglichkeiten zu finden.
| Pharmaunternehmen | Interaktionstyp | Möglicher Fokus |
|---|---|---|
| Großes Pharmaunternehmen A | Erstes Gespräch | KI-gesteuerte Immuntherapie |
| Onkologische Spezialfirma B | Lizenzerkundung | Proprietäre KRBP-Plattform |
Digitale wissenschaftliche Kommunikationsplattformen
Kiromic unterhält eine aktive digitale Präsenz auf drei wichtigen wissenschaftlichen Kommunikationsplattformen.
- LinkedIn Wissenschaftliches Netzwerk
- Professionelles Netzwerk von ResearchGate
- Wissenschaftlicher Bereich der Unternehmenswebsite
Kommunikation mit Investoren und Stakeholdern
Im Jahr 2023 führte Kiromic vier Investor-Relations-Veranstaltungen und Telefonkonferenzen durch.
| Ereignistyp | Häufigkeit | Anzahl der Teilnehmer |
|---|---|---|
| Vierteljährlicher Gewinnaufruf | 4 Mal | Ungefähr 50-75 Teilnehmer |
| Investorenpräsentation | 2 Mal | 100-150 Teilnehmer |
Kiromic BioPharma, Inc. (KRBP) – Geschäftsmodell: Kundensegmente
Onkologische Forschungseinrichtungen
Ab dem vierten Quartal 2023 zielt Kiromic BioPharma auf 127 spezialisierte onkologische Forschungseinrichtungen in Nordamerika ab.
| Institutionstyp | Anzahl potenzieller Kunden | Jährliches Forschungsbudget |
|---|---|---|
| Vom NCI ausgewiesene Krebszentren | 71 | 3,2 Milliarden US-Dollar |
| Akademische medizinische Zentren | 56 | 2,7 Milliarden US-Dollar |
Pharmaunternehmen
Kiromic zielt mit immunonkologischen Forschungsprogrammen auf 42 Pharmaunternehmen ab.
- Top 20 globale Pharmaunternehmen mit Schwerpunkt Onkologie
- Auf Immuntherapie spezialisierte Biotechnologieunternehmen
- Mittelgroße pharmazeutische Forschungsorganisationen
Krebsbehandlungszentren
| Zentrumsklassifizierung | Gesamtzentren | Potenzielle Marktdurchdringung |
|---|---|---|
| Umfassende Krebszentren | 51 | 38% |
| Gemeindekrebszentren | 1,500 | 12% |
Akademische Forschungslabore
Die Marktabdeckung umfasst 238 akademische Forschungslabore mit Schwerpunkt auf Immunogenomik.
- Forschungsuniversitäten mit speziellen Onkologieprogrammen
- Genomforschungszentren
- Labore für translatorische Medizin
Biotechnologie-Investoren
| Anlegerkategorie | Anzahl potenzieller Investoren | Geschätzte Investitionskapazität |
|---|---|---|
| Risikokapitalfirmen | 87 | 1,6 Milliarden US-Dollar |
| Private-Equity-Investoren | 53 | 2,3 Milliarden US-Dollar |
Kiromic BioPharma, Inc. (KRBP) – Geschäftsmodell: Kostenstruktur
Forschungs- und Entwicklungskosten
Für das am 31. Dezember 2022 endende Geschäftsjahr meldete Kiromic BioPharma Forschungs- und Entwicklungskosten in Höhe von 8,7 Millionen US-Dollar.
| Geschäftsjahr | F&E-Ausgaben |
|---|---|
| 2022 | 8,7 Millionen US-Dollar |
| 2021 | 7,3 Millionen US-Dollar |
Investitionen in klinische Studien
Die Investitionen des Unternehmens in klinische Studien beliefen sich im Jahr 2022 auf insgesamt etwa 5,2 Millionen US-Dollar und konzentrierten sich auf immunonkologische Programme.
Personal- und wissenschaftliche Talentakquise
| Personalkategorie | Jährliche Kosten |
|---|---|
| Wissenschaftliches Personal | 3,5 Millionen Dollar |
| Verwaltungspersonal | 1,8 Millionen US-Dollar |
Wartung von Laborgeräten und -technik
Die gesamten Wartungskosten für Ausrüstung und Technologie beliefen sich im Jahr 2022 auf 2,1 Millionen US-Dollar.
- Spezialisierte Biotech-Ausrüstung: 1,3 Millionen US-Dollar
- Technologieinfrastruktur: 0,8 Millionen US-Dollar
Kosten für den Schutz geistigen Eigentums
Die jährlichen Ausgaben für den Schutz geistigen Eigentums beliefen sich im Jahr 2022 auf 650.000 US-Dollar.
| IP-Schutzkategorie | Jährliche Kosten |
|---|---|
| Patentanmeldung | $450,000 |
| Rechtsberatung | $200,000 |
Gesamtbetriebskostenstruktur für 2022: 20,25 Millionen US-Dollar
Kiromic BioPharma, Inc. (KRBP) – Geschäftsmodell: Einnahmequellen
Mögliche Lizenzierung von Immuntherapie-Technologien
Bis zum vierten Quartal 2023 hat Kiromic BioPharma keine aktiven Lizenzeinnahmen aus seinen Immuntherapie-Technologien gemeldet.
Finanzierung von Forschungsstipendien
| Jahr | Grant-Quelle | Betrag |
|---|---|---|
| 2022 | NIH Small Business Innovation Research (SBIR) | $299,980 |
| 2023 | Gesamtfinanzierung der Forschungsstipendien | $336,000 |
Zukünftige Kommerzialisierung therapeutischer Produkte
Ab 2024 wurden keine kommerziellen Einnahmen gemeldet. Pipeline-Produkte befinden sich noch in der präklinischen und klinischen Entwicklungsphase.
Strategische Partnerschaftsvereinbarungen
- Ab 2024 gibt es keine aktiven strategischen Partnerschaftsvereinbarungen, die Einnahmen generieren
- Laufende Forschungskooperationen ohne unmittelbare finanzielle Rendite
Mögliche Meilensteinzahlungen aus pharmazeutischen Kooperationen
| Kooperationsstatus | Möglicher Meilensteinzahlungsbereich |
|---|---|
| Mögliche zukünftige Kooperationen | 0 bis 500.000 US-Dollar geschätzt |
Gesamtumsatz des Unternehmens für 2023: $336,000
Kiromic BioPharma, Inc. (KRBP) - Canvas Business Model: Value Propositions
You're looking at the core value Kiromic BioPharma, Inc. is trying to deliver with its platform, especially when you compare it to the established, but cumbersome, autologous (patient-specific) cell therapies. The main draw here is speed and accessibility for serious conditions.
The primary offering is Deltacel™, which is an allogeneic, off-the-shelf Gamma Delta T-cell (GDT) therapy. This means it's ready to go from the donor, not custom-made for each patient, which directly addresses the 'faster patient access' proposition.
The clinical focus is squarely on solid tumors, an area where CAR-T has historically struggled. Specifically, the initial target is metastatic non-small cell lung cancer (NSCLC), which makes up about 80% to 85% of all lung cancer cases.
This approach gained significant regulatory validation. Kiromic BioPharma secured FDA Fast Track Designation in August 2024 for Deltacel™ when used with low-dose radiation therapy for metastatic NSCLC patients who have already progressed on 2 or more prior lines of standard-of-care treatment.
Here's a quick look at the early clinical data supporting this value, keeping in mind the trial is ongoing with an estimated completion date of January 2027:
- Average Progression-Free Survival (PFS) of 4.8 months (range, 2-8) among 5 evaluable patients from Part 1 data reported on August 9, 2024.
- One patient showed a 32% Decrease in Tumor Volume eight months post-treatment (reported December 12, 2024).
- Another patient reached 10-Month Progression-Free Survival (reported February 18, 2025).
- The trial reported No dose-limiting toxicities for patients completing the full course of therapy.
The engine driving the discovery of these targets is the proprietary DIAMOND® AI 2.0 target discovery engine. While general industry data suggests AI can reduce drug discovery costs by up to 40% and slash timelines to 12-18 months, Kiromic BioPharma is using this to create high-precision immuno-oncology candidates.
The cost and logistics proposition is where the allogeneic nature really shines against the competition. You can see the contrast clearly when you map the known issues of autologous treatments against the intended benefits of Kiromic BioPharma's platform:
| Value Proposition Aspect | Autologous Therapy Challenge | Kiromic BioPharma Deltacel (Allogeneic) Value |
| Manufacturing Cost | Exorbitant production costs, limiting accessibility. | Aims to mitigate high costs through scalable, donor-derived production. |
| Manufacturing Timeline | Long time needed to process patient cells, delaying treatment. | Off-the-shelf availability for faster patient access. |
| Solid Tumor Targeting | Limited efficacy in solid tumors remains a significant challenge. | Designed to exploit natural potency of GDT cells to target solid cancers. |
To give you some context on the investment required to support this development, the clinical trials expenses for Deltacel-01 rose to $8.1 million for the year ended December 31, 2024, contributing to a reported net loss of $26.9 million for that same fiscal year. The company raised $18.4 million through financing activities to support operations, though it noted insufficient cash resources beyond March 2025.
Kiromic BioPharma, Inc. (KRBP) - Canvas Business Model: Customer Relationships
You're looking at the relationships Kiromic BioPharma, Inc. maintained with its key external stakeholders, which, for a clinical-stage biotech, are primarily investigators, regulators, and capital providers. These relationships were critical, especially given the company's financial position leading into 2025.
High-touch, direct collaboration with clinical investigators and sites
The core of the customer relationship, in the clinical sense, involved the investigators and sites running the Deltacel-01 Phase 1 study. This required close, direct interaction to ensure protocol adherence and data integrity. The company was actively working to expand this network, having expected to activate a fifth clinical trial site on August 30, 2024.
The relationship with the medical community was built on the preliminary data generated from the Deltacel therapy in combination with low-dose radiation for metastatic non-small cell lung cancer (NSCLC).
Here's a look at the clinical milestones that underpinned these collaborations:
| Metric | Value/Status | Date Context |
| Product Candidate | Deltacel (KB-GDT-01) | Ongoing Phase 1 |
| Tumor Volume Decrease (Patient 4) | 32% | Eight Months Post-Treatment (Reported Dec 2024) |
| Progression-Free Survival (Patient 4) | 10-Month | Reported Dec 2024 |
| Preliminary Tumor Reduction (First Patient) | 6.6% | Reported March 2024 |
| Total Product Candidates | 3 (Deltacel, Isocel, Procel) | Pre-Bankruptcy |
Dedicated investor relations for capital raising and market communication
For a company operating with substantial doubt about its ability to continue as a going concern, investor relations was a survival function. The focus was squarely on capital raising to fund operations, which were heavily weighted toward clinical expenses. For the year ended December 31, 2024, Kiromic BioPharma, Inc. reported net losses of $26.9 million.
The company actively engaged investors, for instance, by participating in the OTC Markets' Life Science Investor Forum on March 7, 2024. The financial activities show the reliance on external funding sources.
Key financial interactions defining this relationship included:
- Cash provided by financing activities for the nine months ended September 30, 2024: $16,000,000.
- Gross proceeds from a private placement in August 2024: $2,000,000 via a note bearing 25% interest.
- Total financing raised to support operations (as of Feb 2025 filing): $18.4 million.
- Cash and cash equivalents as of September 30, 2024: $3,056,000.
- The company acknowledged that cash resources were insufficient to meet obligations beyond March 2025.
The IR contact listed for the company was Alliance Advisors IR, with Tirth T. Patel as the contact.
Regulatory engagement with the U.S. FDA (e.g., Fast Track process)
Regulatory engagement was a high-stakes relationship, especially following past disclosure issues. A major positive milestone was the U.S. Food and Drug Administration (FDA) granting Fast Track designation to Deltacel in August 2024. This designation is designed to expedite development and review for serious conditions filling an unmet need, allowing for more frequent communication with the FDA.
This positive engagement contrasts with prior regulatory friction. The company settled an SEC investigation in December 2024 related to the non-disclosure of clinical holds placed on IND applications in June 2021. The SEC did not impose a civil penalty due to the company's self-reporting, prompt remediation, and cooperation.
The Fast Track status for Deltacel was specifically for its use in combination with low-dose radiation therapy for metastatic NSCLC patients who progressed on at least two lines of standard of care therapy.
Scientific and medical community outreach via publications and conferences
Outreach to the scientific community centered on presenting clinical data and highlighting the underlying technology platform. The company's proprietary DIAMOND® artificial intelligence (AI) 2.0 target discovery engine was a key asset discussed in these forums.
The scale of the data underpinning this platform was cited as a relationship-building asset with the scientific community.
Key metrics related to scientific outreach and platform development included:
- Data collected into the DIAMOND® platform: Over two billion data points (as of March 2024).
- Clinical Trial Expenses for 2024: $8.1 million.
- Research and development expenses for 2024: $6.9 million.
- The platform supports 3 product candidates: Deltacel, Isocel, and Procel.
The company's management, including the CEO, participated in investor forums to communicate these scientific developments directly to the market.
Kiromic BioPharma, Inc. (KRBP) - Canvas Business Model: Channels
You're looking at the Channels for Kiromic BioPharma, Inc. (KRBP) as of late 2025. Honestly, the reality of the situation dictates the current channel strategy, which is far from a typical commercialization roadmap. The most significant financial and operational event defining this period is the filing of a voluntary petition for relief under Chapter 7 of Title 11 of the United States Code on March 21, 2025, in the United States Bankruptcy Court for the District of Delaware.
Clinical trial sites (e.g., Texas Oncology, Virginia Oncology Associates)
The activation of clinical trial sites, which was an active channel focus in 2023 for the Deltacel (KB-GDT-01) Phase 1 trial in non-small cell lung cancer (NSCLC), is effectively suspended or in the process of being terminated due to the Chapter 7 filing on March 21, 2025. Any remaining site relationships would now be managed through the bankruptcy proceedings for asset disposition or contract wind-down, not patient enrollment.
- Last known trial focus: Phase 1 for Deltacel in NSCLC.
- Operational status: Governed by Chapter 7 proceedings as of March 21, 2025.
Scientific publications and presentations at oncology conferences
For a company in Chapter 7 liquidation, presenting new data is not a near-term channel. However, the scientific community where Kiromic BioPharma, Inc. would have aimed to present its data on Gamma Delta T-cell therapy remains active. For instance, the Society of Hematologic Oncology (SOHO) Annual Meeting in September 2025 was expected to draw more than 3,800 participants. Other relevant forums included the IASLC World Conference on Lung Cancer in September 2025 and the Summit for Novel Therapeutics in Oncology & Precision Medicine in Cancer (STOP Cancer) in late September 2025.
The primary channel for scientific communication shifts from presenting new trial data to managing the scientific record related to their proprietary DIAMOND® AI platform and cell therapy candidates.
Investor relations portal and SEC filings for public communication
The official channel for public and investor communication is now dominated by bankruptcy-related disclosures. The company's CIK identifier is 0000071691. The critical filing was the Form 8-K reporting the Bankruptcy or Receivership on March 21, 2025. Prior to this, the company was filing quarterly reports, such as the 10-Q for the quarter ending March 31, 2025, filed on May 7, 2025. The July 2021 follow-on public offering, which raised $40 million to fund prospective clinical trials, is now a historical financial data point relevant to the company's wind-down.
| Communication Channel Element | Key Identifier/Date/Amount |
| CIK Number | 0000071691 |
| Chapter 7 Filing Date | March 21, 2025 |
| Bankruptcy Court Location | District of Delaware |
| Last Reported Offering Amount (Historical Context) | $40 million (July 2021) |
Direct sales force (future, post-commercialization)
The deployment of a direct sales force for commercialization is not a current or future channel for Kiromic BioPharma, Inc. given the Chapter 7 status as of March 21, 2025. In the biopharma industry generally, successful commercialization requires deploying sales forces supported by Pharma CRM software to manage relationships with healthcare professionals (HCPs). For context, industry benchmarks suggest that successful commercialization must maximize returns during the approximately 7 to 10 years of patent protection remaining after launch, a phase Kiromic BioPharma, Inc. will not reach for its current pipeline assets.
- Post-commercialization sales force: Not applicable due to bankruptcy.
- Industry benchmark for patent life post-launch: 7 to 10 years.
Kiromic BioPharma, Inc. (KRBP) - Canvas Business Model: Customer Segments
You're looking at the core groups Kiromic BioPharma, Inc. (KRBP) needs to satisfy to move its cell therapy pipeline forward, especially as of late 2025.
The most immediate customer segment involves the patients themselves, specifically those with advanced disease who have exhausted other options.
- Patients with stage 4 metastatic or locally-advanced non-small cell lung cancer (NSCLC) failing standard therapies are the target for the Deltacel-01 Phase 1 clinical trial.
The clinical side represents the next layer of customer engagement, where the product is tested and administered.
- The Deltacel-01 trial has involved multiple clinical sites, including Beverly Hills Cancer Center (BHCC), Clinical Research Advisors Koreatown, and Virginia Oncology Associates.
- The University of Arizona Cancer Center was activated as the fifth clinical trial site in September 2024.
Funding this development is critical, making investors a key segment, even if the company has acknowledged substantial doubt about its ability to continue as a going concern beyond March 2025. The company was actively seeking additional financing.
Future pharmaceutical partners are the ultimate commercial customers for licensing or co-development deals, which are essential for market access and revenue generation.
Here's a quick look at the quantifiable data points related to these segments as reported in early 2025 filings and press releases:
| Customer Segment | Key Metric | Reported Value/Amount | Date Context |
|---|---|---|---|
| Patients (Deltacel-01 Trial) | Number of Patients Enrolled/Treated (Minimum) | 9 patients treated/enrolled as of January 21, 2025 | |
| Patients (Deltacel-01 Trial) | Tumor Volume Reduction (Patient 1) | 33.33% reduction at 12-month follow-up | |
| Patients (Deltacel-01 Trial) | Tumor Volume Reduction (Patient 7) | 9.5% reduction at two-month follow-up | |
| Clinical Sites/Investigators | Number of Activated Trial Sites (Minimum) | 5 sites activated as of September 2024 | |
| Institutional Investors | Financing Raised (Convertible Notes) | $18.4 million raised to support operations | |
| Institutional Investors | Reported Institutional Filers (13D/G or 13F) | 1 institutional owner reported | |
| Future Partners | Prior Equity Offering Amount | $40 million raised in a July 2021 offering |
The success of current and future license and collaboration agreements is a stated factor in the company's outlook.
Finance: draft 13-week cash view by Friday.
Kiromic BioPharma, Inc. (KRBP) - Canvas Business Model: Cost Structure
You're looking at the core expenses driving Kiromic BioPharma, Inc.'s operations as they push their cell therapy candidates through clinical stages. For a pre-commercial biotech, the cost structure is almost entirely weighted toward discovery, development, and compliance. The numbers from the fiscal year ended December 31, 2024, paint a clear picture of where the cash burn is concentrated.
The primary cost drivers are heavily skewed toward the science. For FY 2024, Research and Development (R&D) expenses totaled $6.9 million, a slight dip from $7.0 million the prior year, showing a tight focus on their Deltacel product candidate development. However, the real spike is in the clinical execution. Significant clinical trial expenses hit $8.1 million in FY 2024, a substantial increase from $2.7 million the year before, directly tied to activating the Deltacel-01 trial. That's where the money goes when you're testing a therapy in humans; you can't really skimp there.
General and administrative (G&A) costs, which cover the overhead of running the company-salaries, rent, professional fees-were $8.9 million for FY 2024. That's down from $10.3 million previously, suggesting some belt-tightening on the non-R&D side, likely through a reduction in professional and legal fees. Still, the total operating expenses for the year were $23.77 million, leading to a net loss of $26.9 million for the period. That's the cost of keeping the lights on and the trials running.
Here's a quick look at the main operating expense categories for the fiscal year ending December 31, 2024:
| Expense Category | FY 2024 Amount (in millions) |
|---|---|
| Research and Development (R&D) | $6.9 |
| Clinical Trial Expenses | $8.1 |
| General and Administrative (G&A) | $8.9 |
| Total Operating Expenses | $23.77 |
The physical infrastructure supporting this work is also a cost center. Kiromic BioPharma, Inc. maintains its Houston cGMP manufacturing facility. While specific annual maintenance costs aren't itemized in the same way as R&D, the balance sheet shows the investment in the physical plant. As of December 31, 2024, Property, Plant, and Equipment stood at $4.31 million. You have to factor in the depreciation, utilities, and specialized staffing required to keep a current Good Manufacturing Practice (cGMP) site ready for potential future commercial production or advanced clinical supply.
Beyond the direct R&D and G&A spend, there are essential, recurring costs to protect the core assets. These include:
- Patent prosecution expenses to secure new intellectual property.
- Intellectual property maintenance fees to keep existing patents active.
- Costs related to regulatory filings and compliance activities.
- Stock-based compensation, which was $0.60 million for the year.
These fixed costs are non-negotiable for a company whose value is tied to its pipeline exclusivity. Finance: draft 13-week cash view by Friday.
Kiromic BioPharma, Inc. (KRBP) - Canvas Business Model: Revenue Streams
You're looking at the revenue side for Kiromic BioPharma, Inc. as of late 2025. Since this is a clinical-stage company, the current revenue picture is almost entirely non-operational, meaning it comes from capital markets rather than selling a product.
Zero product revenue (pre-commercial stage)
As of the end of fiscal year 2024, Kiromic BioPharma, Inc. has consistently reported zero revenue. This is typical for a company focused on developing its pipeline candidates, like Deltacel™, through clinical trials. The financial data from the annual report filed in February 2025 confirms this pre-commercial status, showing zero revenue for the year ended December 31, 2024. This zero revenue, coupled with widening net losses-which reached $26.9 million for the year ended December 31, 2024-is the financial signature of a company funding its research and development entirely through external capital. The company has reported zero revenue and negative gross profit in each year from 2021 through 2024.
Proceeds from financing activities (e.g., convertible notes, equity offerings)
The primary source of cash inflow for Kiromic BioPharma, Inc. is financing. This capital is essential to fund operations, especially the clinical trials for Deltacel™. The company actively sought and secured funds through debt instruments, primarily convertible notes, to bridge operational gaps. For instance, the nine months ending September 30, 2024, showed Cash provided by financing activities was $16,000,000. Separately, the annual report covering the fiscal year ended December 31, 2024, indicated the company raised $18.4 million through financing activities, mainly from issuing convertible notes to support operations. One specific transaction noted was the completion of a private placement on August 1, 2024, issuing a senior secured convertible promissory note for gross proceeds of $2,000,000, which carried a 25% per annum interest rate and was set to mature on August 1, 2025.
Here's a look at the financing activity reported around the 2024 period:
| Financing Metric/Event | Amount (USD) | Reporting Period/Date |
|---|---|---|
| Cash Provided by Financing Activities | $16,000,000 | Nine months ended September 30, 2024 |
| Total Raised via Financing Activities (Convertible Notes) | $18.4 million | Fiscal Year Ended December 31, 2024 |
| Gross Proceeds from Senior Secured Convertible Note | $2,000,000 | Completed August 1, 2024 |
| Exchange of Senior Convertible Notes into Preferred Stock (Non-cash) | $16,838,000 | Reported in 2024 filings |
The reliance on these activities highlights the ongoing need for capital, as the company faced substantial doubt about its ability to continue as a going concern without additional financing as of late 2024.
Potential future upfront payments from licensing or collaboration deals
As of late 2025, Kiromic BioPharma, Inc. has not publicly announced any realized upfront payments from licensing or collaboration deals for its pipeline assets. The focus has been on advancing Deltacel™ through its Phase 1 clinical trial, which received Fast-Track Designation from the FDA in August 2024. The potential for future revenue streams is tied directly to the success of this clinical advancement. The company's strategy involves developing its allogeneic Gamma Delta T-cell therapy platform, which could attract strategic partners interested in licensing rights for specific indications or geographies once positive data emerges from the ongoing Deltacel-01 trial.
Potential future milestone payments from strategic alliances
Milestone payments are contingent revenues tied to achieving specific development, regulatory, or commercial goals outlined in a partnership agreement. Currently, there are no reported active agreements that specify dollar amounts for future milestone payments. The potential exists for such payments upon:
- Successful completion of the Deltacel-01 Phase 1 trial, especially moving into Phase 2 or Phase 3.
- Achieving specific endpoints, such as progression-free survival targets, which were recently reported for Patient 4 at 10 months as of January 2025.
- Regulatory milestones, such as receiving Investigational New Drug (IND) clearance for other pipeline candidates like Isocel or Procel.
Future product sales of Deltacel™ and other pipeline candidates
Future product sales represent the ultimate, long-term revenue stream for Kiromic BioPharma, Inc., but these are entirely prospective. The company is developing Deltacel™ for stage 4 metastatic non-small cell lung cancer (NSCLC), which represents about 80% to 85% of all lung cancer cases. The realization of sales revenue depends on successfully navigating the remaining clinical trial phases, securing regulatory approval, and establishing manufacturing and commercialization capabilities. No specific sales forecasts or pricing data for Deltacel™ are available as of late 2025, given its status in the Phase 1 trial.
The company's pipeline includes:
- Deltacel™ (KB-GDT-01): Lead candidate, currently in the Deltacel-01 Phase 1 trial.
- Isocel: Another product candidate on the GDT platform.
- Procel: Another product candidate on the GDT platform.
The near-term financial action for you is tracking cash burn against the next financing round needed, as current resources are insufficient to fund operations beyond December 2024, according to a late 2024 filing. Finance: draft 13-week cash view by Friday.
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