Skip to main content

RENOVARO INC

For the period ended Sep 30, 2024. Filed Nov 14, 2024.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2024 · Filed Nov 14, 2024

LNAI$0.16-30.2%Stored close · as of Oct 29, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2024-03-31; filed 2024-05-15.

0001731122-24-000807

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2024-09-30; filed 2024-11-14.

0001731122-24-001811

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 105 previous paragraphs and 110 current paragraphs.

31 unchanged; 35 reworded; 43 added; 39 removed; 0 previous and 1 current paragraphs rearranged.

Tables are not compared: 10 previous and 40 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (43)

Current report

Renovaro Inc. operates through two subsidiaries, Renovaro Biosciences and Renovaro Cube. Renovaro Cube refers to Renovaro Cube Intl. Ltd. (formerly known as GediCube Intl. Ltd.) and its wholly owned subsidiaries GediCube, B.V. and Grace Systems B.V., which were acquired on February 13, 2024.

Current report

Renovaro Biosciences may also seek to explore various approaches for gene therapy design elements to potentially eliminate virus-infected or cancer cells by the modulation of the patient’s immune system. Upon injecting into the patients, these genetically engineered allogeneic cells have little to no risk of passing those modifications to the patient since they are terminally differentiated with locked functionality to activate the host immune system. Gene modified allogeneic cells are expected to be rejected naturally once they activate the patient’s immune system therefore will have a very short survival time.

Current report

Allogeneic Cell Therapy Platform – Completed pre-IND, IND-enabling phase.

Current report

RENB-DC20: Genetically modified Allogeneic Dendritic Cell Therapeutic Vaccine as Potential Treatment Product for Long-term Remission of Triple Negative Breast Cancer

Current report

Triple Negative Breast Cancer (TNBC) is a subtype of breast cancer that is negative for estrogens receptor (ER) negative, progesterone receptor (PR) negative and human epidermal growth factor receptor 2 (HER2). TNBC is characterized by its unique molecular profile, aggressive nature, and distinct metastatic patterns that lack targeted therapies. TNBC is well known for its aggressive behavior and is characterized by onset at a younger age, high mean tumor size, and higher-grade tumors.

Current report

RENB-HV12: Genetically Modified Allogeneic Dendritic Cell Therapeutic Vaccine as Potential Treatment Product for Long-term Remission of HIV; A Chronic Infectious Disease

Current report

The oncology therapeutic vaccine technology could potentially be adapted to target infectious disease antigens and be a viable therapeutic approach in difficult to treat chronic infectious diseases. As described above, the engineered allogenic dendritic cell drug substance is thought to be able to be loaded with various cancer antigens for specific solid tumors but could or may be loaded with infectious disease antigens to elicit a more robust immune response to viruses and other difficult to treat infections.

Current report

Renovaro Cube was initially incorporated as Grace Systems B.V. (“Grace Systems”) in 2013 under the laws of the Netherlands to develop unique data mining algorithms to enable banking, finance and government entities to extract business insights from data. Grace Systems began applying its algorithms to biological data in 2018 to uncover cancer-associated patterns. Beginning in 2018, Grace Systems pivoted its platform to focus only on healthcare. Renovaro Cube has focused on developing its AI technology for early cancer detection.

Current report

Renovaro Cube has now focused on commercialization of its AI technology. Renovaro Cube believes that it has developed a unique approach to the early detection and diagnosis of cancer and its recurrence and, in time, other rare diseases through the systematic analysis of data using AI technologies, data mining procedures and algorithms for health technology.

Current report

Renovaro Cube’s technology has been trained on complex heterogeneous cancer data and appears to find patterns associated with cancer in public and private data resources. With the help of Renovaro Cube’s algorithms, discovered patterns may be translated into biomarkers that can be used in a clinical setting to target various aspects of cancer diagnosis and treatment.

Current report

In response to these four core areas, the key components of Renovaro Cube’s product development are to build a software and hardware platform that:

Current report

One additional key focus of Renovaro Cube is its multi-modal, data analysis. Multi-modal data encompasses the whole aspect of data from a patient perspective, whether genomics, imaging, phenotypic or even wearable data, which can be cross analyzed to produce data that could not be previously produced. Renovaro Cube intends to use multi-modal data to bring new insights to the clinical and research teams trying to understand what to do next with the patient.

Current report

For this purpose, Renovaro Cube has developed an AI platform that aims to leverage expertise in both biological and computational sciences and to go beyond traditional tumor signals by detecting the body’s early warning signs of cancer. Renovaro Cube’s goal is to provide accurate and reliable tests that can aid in the early diagnosis and treatment of cancer. Renovaro Cube’s AI technology is created to detect a wide range of biological signs to enhance the accuracy and sensitivity of early cancer detection and, thereby, enable earlier intervention and potentially improved patient outcomes.

Current report

Moreover, the versatility of Renovaro Cube’s AI technology extends to encompass the realm of rare cancers, including cases such as cancer of unknown primary.

Current report

Leveraging DNA methylation data, Renovaro Cube has identified and validated biomarker panels tailored for the detection of a wide range of cancers, including bladder, breast, colon, prostate, thyroid, head and neck, liver, kidney and lung cancer.

Current report

For example, the capabilities of Renovaro Cube’s AI technology have unearthed biomarkers capable of pinpointing a specific subgroup of thyroid cancer patients characterized by a distinct genomic alteration, the neurotrophic tyrosine receptor kinase (“NTRK”) gene fusion. Identification of these NTRK-positive patients provides an actionable therapeutic target.

Current report

Illustrated below is the three-phase workflow behind Renovaro Cube’s AI platform for biomarker discovery using DNA methylation data. This workflow commences with the identification of pertinent single- and multi-omic data best suited to address the specific inquiries of Renovaro Cube’s clients, and the subsequent stages involve the meticulous pre-processing and loading of this data into the platform. This process culminates in the availability of a dashboard offering the client insights into the data’s characteristics, such as data quality, the technology employed, and associated metadata.

Current report

Renovaro Cube undertakes post-processing of data generated from sequence and arrays to ensure accurate and meaningful results. These post-processing steps for omic data include:

Current report

Other post-processing steps may include genotype calling, population stratification and association analysis. Specific post-processing steps may vary depending on the type of array used, the study design, and the analytical goals.

Current report

To enhance multi-omic and multi-modal capacity, and to work to validate those capabilities with human samples including liquid-biopsy-based tests/test kits, Renovaro Cube is actively pursuing relationships with leading academic cancer centers, pathology and imagery centers in Europe, the USA and the Middle East. In certain cases, scopes of work are in process. This is a very attractive model for partners to be involved with Renovaro Cube to perform multi-omics genetic analysis using liquid biopsies.

Current report

Renovaro Cube intends to hire additional staff to increase the speed and velocity of its organization, including the development of the AI platform and the opportunities to deploy the AI platform for research perspective and ultimately for clinical practice and into clinical trials.

Current report

In addition, Renovaro Cube intends to build out its infrastructure by leasing space for storage, networking and hosting facilities.

Current report

Renovaro Cube’s intended customers will be hospitals, clinics, insurance companies, pharmaceutical companies, biotech companies, research centers, physicians and individual patients.

Current report

Renovaro Cube aims to utilize its AI technology to commercialize products and test kits for healthcare providers, hospitals, clinics and doctors that will expedite diagnosis and the selection of appropriate treatment for various types of cancer. Renovaro Cube intends to differentiate its products based on the following factors:

Current report

The multi-omic design of Renovaro Cube’s AI platform enables the use of different molecular layers, such as epigenomics, transcriptomics, and metabolomics, together with genomics and clinical data.

Current report

Panel mining is designed to combine biomarkers into panels in such a way that the final panel meets:

Current report

In traditional machine learning approaches, such as deep neural networks, the internal workings of the model can be complex and difficult to interpret. This lack of interpretability poses challenges in critical domains where decisions have significant implications, such as healthcare.

Showing the first 40 of 43 passages. Open the source sections for the rest.

Removed paragraphs (39)

Previous report

Renovaro Inc. operates in two subsidiaries, Renovaro Biosciences and RenovaroCube. RenovaroCube was created upon our acquisition of GediCube Itnl. Ltd. and its wholly-owned subsidiary GediCube, BV, which closed on February 13, 2024.

Previous report

Our Product Development strategy related to our allogeneic cell and gene therapies is anchored in the use of “non-self” or allogeneic cells that enhance the immune response that we seek to elicit.

Previous report

Over the past several years, Renovaro Biosciences has evolved from a company with a single product candidate as a potential cure for HIV (RENB-HV12 and RENB-HV21), a pipeline for Hepatitis B Virus (HBV) (RENB-HB01), and with a significant expansion into cancer immune therapies to address high unmet needs from difficult-to-treat solid tumors (RENB-DC11.)

Previous report

The oncology platform is now at the forefront of our development activities, beginning with pancreatic cancer and other solid tumors with poor life expectancy, such as triple negative breast, second-line liver, head, neck, and oral among other possible targets.

Previous report

Many operational aspects of our platforms can be quickly adapted to multiple disease states from a single therapeutic approach, potentially streamlining and accelerating development, and regulatory process, as well as manufacturing operations. Moreover, because our product candidates do not require specialized delivery devices and surgical procedures, our potentially groundbreaking interventions could have worldwide applicability.

Previous report

Renovaro Biosciences responds quickly to new data and perceived development opportunities and risk assessments. Based on the maturation of our pipelines, the Company makes business decisions to prioritize the programs that could move more rapidly through development and commercial processes.

Previous report

In addition, because we focus on cells from donors, the strategy could potentially enhance the ability of the therapeutic candidates to induce a more robust response once injected into patients. The human immune system is designed to recognize and distinguish “self” from “non-self” and destroy “otherness” such as bacteria, viruses, and damaged or diseased cells such as cancer cells. Alloreactivity (reacting against another person’s cells) is the most powerful response the immune system generates. Several of our technologies take advantage of the alloreactivity to hyper stimulate a person’s immune response to better attack a chronic infection (e.g., HIV) or solid tumor.

Previous report

We believe that the combination of off-the-shelf allogeneic cells, combined with genetic modifications designed to enhance immune signaling, could potentially generate therapeutic candidates that have unique attributes that will increase the likelihood of clinical success.

Previous report

Renovaro Biosciences is exploring various approaches for gene therapy design elements to potentially eliminate virus-infected cells with an innovative molecular mechanism that co-opts the virus’ machinery to induce the death of infected cells rather than reproducing and causing more infection to exacerbate disease.

Previous report

Renovaro Biosciences has initiated a collaboration with Dr. Anahid Jewett from UCLA to study further thein vitro andin vivo effectiveness of the approach in pancreatic cancer. Dr. Jewett created an innovative pancreatic cancer mouse model that comprises the human immune system repertoire in combination with human cancer cells implanted in the corresponding anatomical location found in human cancer. Multiple experiments in different humanized mouse models are consistently showing with only one regimen cycle of therapy (2 injections in mice, likely 5-6 in human) - what Dr. Jewett calls “the Holy Grail of cancer research” with now seven independent animal studies:

Previous report

The confirming reproducibility and robustness of the therapeutic response in an aggressive form of human pancreatic cancer in several models is promising. We received FDA input from pre-IND interactions which helped solidify our IND-enabling plan as well as our investigational plan. We are now fully committed to process development/improvements and IND-enabling activities. We believe that we can complete IND-enabling activities in the second half of 2024 which if successful, would enable the start of clinical trials in humans during the first half of 2025. The investigational plan discussed with the FDA includes phase 1 safety testing broadly in all solid tumor types, followed by a phase 2a focusing on a few solid tumor types that are difficult to treat and have poor life expectancy, for example triple negative breast, second-line liver, and head and neck cancers. Phase 2b would expand cohorts in cancers with the strongest response in phase 2a.

Previous report

RENB-DC-12--XX: Genetically modified Allogeneic Dendritic Cell Therapeutic Vaccine as Potential Product for Long-term Remission of Additional Indications

Previous report

The technology is a platform that could potentially be adapted to other solid tumors first line and/or salvage therapy, by itself or, potentially, in combination with other cancer treatments. Additional cancer vaccine designs are being evaluated strategically to balance risk and opportunity to advance therapeutic development quickly in cancer indications with few treatment options.

Previous report

RENB-HV12: HIV Therapeutic Vaccines for Potential Long-term Remission/Cure

Previous report

Allogeneic Cell Therapy Platform - Advanced Pre-Clinical Stage; Non-Human Primate Studies Ongoing.

Previous report

In persons living with HIV who are controlling the spread of virus with anti-retroviral (ARV) treatment, boosting the immune system in a different way than the virus already has through infection, could allow for control of HIV after stopping ARVs.

Previous report

Renovaro Biosciences is developing RENB-HV12 that utilizes a novel cellular and immunotherapy approach that could potentially provide therapeutic vaccines for HIV. A non-human study of the therapeutic vaccine in primates at the Fred Hutchinson Cancer Research Center is ongoing. Animals began receiving the first injections of the potential therapeutic vaccine in August, 2023. Preliminary results assessment may potentially be available in the second half of 2024. A Pre-IND request could be submitted in the first half of 2025, with IND submission and the beginning of Phase I clinical trials by mid- to end-2025.

Previous report

Allogeneic Cell Therapy Platform - Pre-IND conducted - Advanced Pre-Clinical with Human Data through a Collaboration

Previous report

We are also exploring RENB-HV21, an innovative treatment for HIV with allogeneic Natural Killer (NK) and Gamma Delta T-Cells (GDT). It is believed that the GDT cells, a small subset of immune cells that can be infected with HIV, could both be infected by, and be a key factor in controlling the virus. The initial scientific findings were presented during the American Society of Gene & Cell Therapy (ASCGT) Annual Meeting in 2021. We have an exclusive license to use the underlying patent to develop RENB-HV21 for potential treatment or cure of HIV. A successful investigator-initiated Pre-IND was completed in October 2021. However, due to a shift in priorities to the Oncology pipeline, Renovaro Biosciences does not plan to pursue the IND and potential clinical trial in the medium- to long-term.

Previous report

RENB-HB01 is in an early pre-clinical phase as we explore various approaches for gene therapy design elements. If those explorations are successful, it is possible we could begin the regulatory process at the earliest in the second half of 2024. However, our highest priority is currently the oncology platform, beginning with pancreatic cancer and other solid tumors with poor life expectancy.

Previous report

Our operating expenses for the three months ended March 31, 2024 and 2023, were$17,190,840 and $4,063,436 respectively, representing an increase of $13,127,404 or approximately 323%. The increase in operating expenses primarily relates to the increase in general and administrative expenses of $3,856,322, the increase in research and development expenses of $848,019 and an indefinite life intangible assets impairment charge of $8,421,000.

Previous report

General and administrative expenses for the nine months ended March 31, 2024, and 2023, were $19,558,981 and $12,365,960, respectively, representing an increase of $7,193,021 or approximately 58%. The variance is related to an increase in non-cash consulting fees of $4,570,000, non-cash stock-based compensation of $922,492, accrued expenses related to the GEDi Cube acquisition of $797,203, legal expenses of $693,473, investor relations expenses of $505,395, consulting expenses of $447,407, marketing expenses of $270,010, rent expenses of $156,626, and insurance expenses of $127,628, partially offset by a decrease in accounting fees of $403,538.

Previous report

Research and development expenses for the three months ended March 31, 2024, and 2023, were $1,087,156 and $239,137, respectively, representing an increase of $848,019 or approximately 355%. The variance is primarily driven by an increase of $584,912 in collaborating partner expenses with CDMO and CROs, $115,616 in consumables related to pre-clinical testing and $150,811 in consulting expenses related to regulatory and outsourced consultants.

Previous report

Intangible assets impairment expense for the three and nine months ended March 31, 2024, was $8,421,000. This was dueto the termination of the HV-01 license agreement in which the Company abandoned the development of a technology included in its IPR&D and recorded an impairment of $8,421,000 in the period ended March 31, 2024.

Previous report

The Company recorded other expense of $383,534 for the nine months ended March 31, 2024, compared to other expense of $863,886 for the nine months ended March 31, 2023, representing a decrease in other expense of $480,352 or 56%. The variance is primarily due to the loss on extinguishment of contingent consideration liability of $419,182 in the prior period, and an increase of $486,500 in change in fair value of contingent consideration in the current period, partially offset by an increase of $447,291 in interest expense in the current period.

Previous report

Net loss for the nine months ended March 31, 2024, and 2023, was $30,728,563 and $16,485,804, respectively, representing an increase in net loss of $14,242,759 or approximately 86%. The increase in net loss was primarily due to the indefinite life intangible assets impairment charge of $8,421,000 and an increase in general and administrative expenses of $7,193,021.

Previous report

Cash used in operating activities for the nine months ended March 31, 2024, and 2023 was ($8,557,649) and ($9,512,937), respectively. Cash used in operating activities during the current period primarily related to the net loss including $2,274,321 in research and development expenses for CDMO and CRO costs, along with approximately $10,477,101 in general and administrative expenses, net of non-cash items, partially offset by an increase in accounts payable of $2,693,808 and accrued expenses of $3,031,803 due to the timing of cash payments and a $216,293 increase in prepaid expenses.
Reworded paragraphs (35)

Previous wording

Renovaro Biosciences is a biotechnology company committed to developing advanced allogeneic cell and gene therapies to promote stronger immune system responses potentially for long-term or life-long cancer remission in some of the deadliest cancers, and potentially to treat or cure serious infectious diseases such as Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV) infections. As a result of our acquisition of GEDi Cube on February 13, 2024, we have also expanded our technology pipeline to include diagnostic related services with an early emphasis on the detection of cancer.

Current wording

Renovaro Biosciences is a biotechnology company intending, if the necessary funding is obtained, to develop advanced allogeneic cell and gene therapies to promote stronger immune system responses potentially for long-term or life-long cancer remission in some of the deadliest cancers, and potentially to treat or cure serious infectious diseases such as Human Immunodeficiency Virus (HIV) infections. As a result of our acquisition of GEDi Cube Intl Ltd. on February 13, 2024, we have shifted the Company’s primary focus and resources to the development of the Renovaro Cube technologies.

Previous wording

Renovaro Bioscience’s general approach with gene- and/or cell-therapy is to train the immune system to allow a person to better fight diseases. Our vision is for a world free from toxic chemotherapy and healthy longevity for those with cancer and other diseases. Renovaro Biosciences is leveraging general principles and advances in the knowledge of the immune response to engineer cells with enhanced attributes to promote the recognition and elimination of diseased cells.

Current wording

Renovaro Biosciences aims to train the immune system to allow a person to better fight diseases through allogeneic cell and/or gene therapy. Our vision is for a world with healthy longevity, and free from toxic chemotherapy, for those with cancer and other serious diseases. Renovaro Biosciences will seek to leverage general principles and advances in the knowledge of the immune response to engineer cells with enhanced attributes to promote the recognition and elimination of disease cells.

Previous wording

The strategic benefit of cell therapy platforms is to potentially allow for manufacture of large, “off-the-shelf” banks of therapeutic cells that could be accessed on demand by health care professionals to potentially decrease the time between diagnosis and treatment.

Current wording

The strategic benefit of the allogeneic cell therapy technologies is to potentially allow for the manufacture of large, “off-the-shelf” banks of therapeutic cells that are readily available on demand by healthcare professionals, to potentially decrease the time between diagnosis and treatment.

Previous wording

In certain treatments (e.g., HIV and cancer), cells taken from healthy donors are sometimes genetically modified to introduce signaling molecules that are designed to enhance the ability of specific immune cells to recognize diseased cells, and to help recruit other cells that will destroy cancer or virus infected cells.

Current wording

In certain treatments (e.g., HIV and cancer), cells taken from healthy donors are engineered to introduce signaling molecules that are designed to enhance the ability of specific immune cells to recognize diseased cells, and to help recruit other cells that will destroy cancer or virus infected cells.

Previous wording

RENB-DC11: Genetically modified Allogeneic Dendritic Cell Therapeutic Vaccine as Potential Product for Long-term Remission of Solid Tumors – Starting with Pancreatic Cancer

Current wording

RENB-DC11: Genetically modified Allogeneic Dendritic Cell Therapeutic Vaccine as Potential Product for Long-term Remission of Solid Tumors; specifically Pancreatic tumors

Previous wording

Based on learnings from literature reviews of ongoing clinical development for solid tumors, and recent advances in immune modulation, we have designed an innovative therapeutic vaccination platform that could potentially be used to induce life-long remission from some of the deadliest solid tumors. The survival rate in pancreatic cancer is currently only 5 to 10 percent at 5 years.

Current wording

Based on learnings from our internal research, literature reviews of ongoing clinical development for solid tumors, and recent advances in immune modulation, we have designed an innovative therapeutic vaccination platform that could potentially be used to induce life-long remission from some of the deadliest solid tumors such as pancreatic, liver, triple negative breast and head & neck cancers.

Previous wording

Initial preclinicalin vitro and proof of conceptin vivo studies have been compelling. The platform is designed to enable broad immune enhancements that are combined with cancer specific antigens that could be applicable to a wide range of solid tumors. We initially plan to target pancreatic cancer. Other potential targets for later development could include triple-negative breast cancer, liver or mesothelioma amongst many. Similar to our approach with HIV, RENB-DC11 would potentially allow for outpatient therapy without wiping out or significantly impairing the patient’s immune system often associated with standard of care chemotherapies.

Current wording

The platform may one day enable broad immune enhancements that are combined with cancer specific antigens that could be applicable to a wide range of solid tumors. This approach allows us to quickly adapt our approach to any patient solid tumor using the same banked allogenic drug substance.

Previous wording

Renovaro Cube (“RenCube”) is an artificial intelligence driven healthcare technology company focused on developing diagnostic tests and test kits that would analyze samples derived from non-invasive liquid biopsy procedures for the early detection of cancer, disease recurrence, treatment selection and monitoring of treatment in cancer. RenCube is developing a proprietary platform that will analyze genetic information using “Explainable AI” (as defined below) to provide earlier and more accurate cancer diagnosis. This platform applies a multi-omics approach to search for individual biomarkers that are present even in asymptomatic patients. RenCube’s process also generates biomarker panels, which are used for training models per cancer type and per clinical application, and are integrated into a machine learning library referred to as a “Cube” to facilitate accurate diagnosis. The “Cube” will become more effective and accurate over time due to retraining of its models on the enriched database of molecular data.

Current wording

Renovaro Cube is an AI-driven healthcare technology company focusing on the earliest possible detection of cancer and its recurrence. Renovaro Cube has developed a proprietary AI platform that analyzes genetics using Explainable AI (as defined below) to provide earlier and more accurate cancer diagnosis. This platform uses a multi-omics approach to search for individual biomarkers that are present even in asymptomatic patients. This approach is combined with differential molecular capabilities that are designed to identify, differentiate and pinpoint the exact source. Renovaro Cube’s process also involves the mining of biomarker panels, which are integrated into a machine learning library referred to as “RenovaroCube” to further enhance diagnosis.

Previous wording

RenCube also aims to utilize and commercialize its proprietary platform RenCube for use in developing products and services by third parties aimed at (i) early cancer characterization, (ii) personalized treatment selection, (iii) tracking response to therapies, (iv) recurrence detection, and (v) ultimately, drug discovery.

Current wording

Renovaro Cube also aims to utilize its proprietary AI platform in the development of commercial products to support clinical, research and pharmaceutical organizations that are trying to improve patient care through precision diagnosis, prediction of success of therapy, new drug discovery, treatment protocols or clinical trials. Specifically, Renovaro Cube is focused on developing products and services aimed at (i) early cancer characterization, (ii) personalized treatment selection, (iii) prediction and tracking response to therapies, (iv) recurrence detection and efficacy monitoring, and (v) ultimately, drug discovery.

Previous wording

RenCube’s product development focuses on four core areas:

Current wording

Renovaro Cube’s product development focuses on four core areas:

Previous wording

As part of RenCube’s dedication to the development of early cancer detection blood tests it expects to develop partnerships with third-party laboratories across the United Kingdom, the Netherlands, Europe and the United States. In particular, RenCube is focused on developing diagnostic tests and test kits that make use of non-invasive liquid biopsy samples.

Current wording

Renovaro Cube is dedicated to the development of early cancer detection blood tests and expects to develop partnerships with third-party laboratories across the United Kingdom, the Netherlands and the rest of Europe and will also expand to the United States. Renovaro Cube is focused on developing diagnostic tests and test kits that would analyze samples derived from non-invasive liquid biopsy samples and intends to perform these tests from Renovaro’s dedicated fully certified service laboratory and engage third-party laboratories to perform these tests for end-users.

Previous wording

RenCube’s AI technology aims to address three critical facets of medical needs within the domain of cancer diagnosis:

Current wording

Renovaro Cube’s AI technology aims to address three critical facets of medical needs within the domain of cancer diagnosis (as illustrated below):

Previous wording

The foundational architecture of RenCube’s AI technology will be engineered to facilitate comprehensive pan-cancer analysis through its extensive record of informative biomarkers discovered across a diverse array of cancer types. This comprehensive repository empowers RenCube’s technology to swiftly cross-reference biomarkers and explore molecular commonalities and distinctions that span multiple tumor categories.

Current wording

The foundational architecture of Renovaro Cube’s AI technology is engineered to facilitate comprehensive pan-cancer analysis through its extensive record of informative biomarkers discovered across a diverse array of cancer types. This comprehensive repository empowers Renovaro Cube’s AI technology to swiftly cross-reference biomarkers and explore molecular commonalities and distinctions that span multiple tumor categories.

Previous wording

RenCube’s AI platform will be an enterprise software platform that is distinguished from its competitors’ technology by its core attributes encompassing AI-guided analysis and meticulous record-keeping of data handling procedures within audit trails, logs, and data discoveries. RenCube is designing this technology to support and validate every phase of the process, from the initial handling of raw data to the creation of essential biomarker panels. RenCube’s AI platform may also facilitate the integration of data originating from diverse sources, including public databases and collaborative partnership data.

Current wording

Renovaro Cube’s AI platform is an enterprise software platform that is distinguished from its competitors’ technology by its core attributes encompassing AI-guided analysis and meticulous record-keeping of data handling procedures within audit trails, logs, and data discoveries. Renovaro Cube designed this technology to support and validate every phase of the process, from the initial handling of raw data to the creation of essential biomarker panels. Renovaro Cube’s AI platform also facilitates the integration of data originating from diverse sources, including public databases and collaborative partnership data.

Previous wording

The process of biomarker discovery facilitated by RenCube’s AI technology has yielded a set of biomarkers that enables scrutiny of the genomic distinctions and commonalities inherent in diverse cancer types. This biomarker set may support the diagnosis of cancers when their type or origin remains unidentified.

Current wording

The process of biomarker discovery facilitated by Renovaro Cube’s AI technology has yielded a set of data that enables scrutiny of the genomic distinctions and commonalities inherent in diverse cancer types. This data set can support the diagnosis of cancers when their type or origin remains unidentified.

Previous wording

In addition to this role in biomarker discovery and the development of diagnostic tests, RenCube’s AI technology will integrate AI-guided molecular profiling of patient samples to generate diagnostic patient reports. These diagnostic reports reflect the outcomes of molecular profiling, coupled with interpretations provided by RenCube’s team, to facilitate the process of cancer diagnostics by a qualified healthcare provider, who can consider these reports in the context of a patient’s medical history, clinical signs, and symptoms, among other factors.

Current wording

In addition to this role in biomarker discovery and the development of diagnostic tests, Renovaro Cube’s AI technology also integrates AI-guided molecular profiling of patient samples and furnishes diagnostic patient reports. These diagnostic reports reflect the outcomes of molecular profiling, coupled with interpretations provided by Renovaro Cube’s team, to facilitate the process of cancer diagnostics by a qualified healthcare provider, who can consider these reports in the context of a patient’s medical history, clinical signs, and symptoms, among other factors.

Previous wording

The unique panel mining technique in RenCube’s technology repeatedly investigates genes to identify relevant biomarkers. The proprietary technique in RenCube’s technology not only searches for individual biomarkers, but also integrates validated panels for different cancer types into the “Cube” machine learning library. This process enables precision diagnosis, by including one cancer and excluding others on the basis of statistically, scientifically and clinically validated machine-learning panels.

Current wording

The unique panel mining technique in Renovaro Cube’s technology repeatedly investigates genes to identify relevant biomarkers. The proprietary technique in Renovaro Cube’s technology not only searches for individual biomarkers, but also integrates validated panels for different cancer types into the “RenovaroCube” machine learning library. This process enables precision diagnosis, by including one cancer and excluding others based on statistically, scientifically and clinically validated machine-learning panels.

Previous wording

The term “Explainable AI” refers to the ability of an artificial intelligence system or model to provide human-understandable explanations for its decision-making process or predictions. This feature aims to bridge the gap between the “black box” nature of many AI algorithms and the need for transparency, interpretability, and accountability in AI applications.

Current wording

The term “Explainable AI” refers to the ability of an AI system or model to provide human-understandable explanations for its decision-making process or predictions. This feature aims to bridge the gap between the “black box” nature of many AI algorithms and the need for transparency, interpretability, and accountability in AI applications.

Previous wording

RenCube believes that Explainable AI is crucial for ensuring transparency, fairness, and accountability in AI systems. RenCube’s AI platform includes Explainable AI by design. All data points, calculations and results are traceable, and all calculations are verifiable and reproducible with the same result.

Current wording

Renovaro Cube believes that Explainable AI is crucial for ensuring transparency, fairness, and accountability in AI systems. Renovaro Cube’s AI platform includes Explainable AI by design. All data points, calculations and results are traceable, and all calculations are verifiable and reproducible with the same result.

Previous wording

The financial statements included elsewhere herein for the period ended March 31, 2024, were prepared under the assumption that we would continue our operations as a going concern, which contemplates the realization of assets and the satisfaction of liabilities during the normal course of business. As of March 31, 2024, we had cash and cash equivalents of $312,697, an accumulated deficit of $274,757,816 and a working capital deficit of $19,654,098 and total liabilities of $43,683,784. We have incurred significant losses from continuing operations, have used cash in our continuing operations, and are dependent on additional financing to fund operations. These conditions raise substantial doubt about our ability to continue as a going concern for one year after the date the financial statements are issued. The financial statements included elsewhere herein do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty.

Current wording

The Company’s consolidated financial statements are prepared using the generally accepted accounting principles applicable to a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. However, the Company has incurred substantial recurring losses from continuing operations, has used cash in the Company’s continuing operations, and is dependent on additional financing to fund operations. The Company incurred a net loss of $44,212,036 and $9,175,028 for the quarters ended September 30, 2024 and 2023, respectively. As of September 30, 2024, the Company had cash and cash equivalents of $220,571 and an accumulated deficit of $368,891,461 and a working capital deficit of $21,087,220. These conditions raise substantial doubt about the Company’s ability to continue as a going concern for one year after the date the financial statements are issued. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue in existence.

Previous wording

Management has reduced overhead and administrative costs by streamlining the organization to focus around two of its therapies (oncology and a HIV therapeutic vaccine) and investment in the development and validation of our AI driven cancer diagnostics platform. The Company has tailored its workforce to focus on these therapies. In addition, the Company intends to attempt to secure additional required funding through equity or debt financing. However, there can be no assurance that the Company will be able to obtain any sources of funding. Such additional funding may not be available or may not be available on reasonable terms, and, in the case of equity financing transactions, could result in significant additional dilution to our stockholders. If we do not obtain required additional equity or debt funding, our cash resources will be depleted and we could be required to materially reduce or suspend operations, which would likely have a material adverse effect on our business, stock price and our relationships with third parties with whom we have business relationships, at least until additional funding is obtained. If we do not have sufficient funds to continue operations, we could be required to seek bankruptcy protection or other alternatives that could result in our stockholders losing some or all of their investment in us.

Current wording

Management has reduced overhead and administrative costs by streamlining the organization to focus around the development and validation of its AI-driven cancer diagnostics platform. The Company has tailored its workforce to focus on these activities. In addition, the Company intends to secure additional required funding through equity or debt financing. However, there can be no assurance that the Company will be able to obtain any sources of funding. Such additional funding may not be available or may not be available on reasonable terms, and, in the case of equity financing transactions, could result in significant additional dilution to our stockholders. If we do not obtain required additional equity or debt funding, our cash resources will be depleted and we could be required to materially reduce or suspend operations, which would likely have a material adverse effect on our business, stock price and our relationships with third parties with whom we have business relationships, at least until additional funding is obtained. If we do not have sufficient funds to continue operations, we could be required to seek bankruptcy protection or other alternatives that could result in our stockholders losing some or all of their investment in us.

Previous wording

Funding that we may receive during the fiscal year 2024 is expected to be used to satisfy existing and future obligations and liabilities and working capital needs, to support commercialization of our products and conduct the clinical and regulatory work to develop our product candidates, and to begin building working capital reserves.

Current wording

Funding that we may receive during the fiscal year 2025 is expected to be used to satisfy existing and future obligations and liabilities and working capital needs, to support commercialization of our products, to conduct the clinical and regulatory work to develop our product candidates, and to begin building working capital reserves.

Previous wording

Results of Operations for the three and nine months ended March 31, 2024, compared to the three and nine months ended March 31, 2023

Current wording

Results of Operations for the three months ended September 30, 2024 and 2023

Previous wording

The following table sets forth our revenues, expenses and net loss for the three and nine months ended March 31, 2024 and 2023. The financial information below is derived from our unaudited condensed consolidated financial statements.

Current wording

The following table sets forth our revenues, expenses and net loss for the three months ended September 30, 2024 and 2023. The financial information below is derived from our unaudited condensed consolidated financial statements.

Previous wording

Our operating expenses for the nine months ended March 31, 2024 and 2023, were$30,345,029 and $15,621,918 respectively, representing an increase of $14,723,111, or approximately 94%. The increase in operating expenses primarily relates to the increase in general and administrative expenses of $7,193,021, and the indefinite life intangible assets impairment charge of $8,421,000, partially offset by the decrease in research and development expenses of $896,150.

Current wording

Our operating expenses for the three months ended September 30, 2024 and 2023, were $53,338,554 and $8,884,114, respectively, representing an increase of $44,454,440, or approximately 500%. The increase in operating expenses primarily relates to goodwill impairment of $47,614,729 offset by the decrease in general and administrative expenses of $2,988,959 and the decrease in research and development expenses of $176,455.

Previous wording

General and administrative expenses for the three months ended March 31 2024, and 2023, were $7,652,379 and $3,796,057, respectively, representing an increase of $3,856,322 or approximately 102%. The variance is related to an increase in legal expenses of $1,552,970, non-cash stock-based compensation of $785,396, non-cash consulting fees of $544,657, accrued expenses related to the GEDi Cube acquisition of $797,203, investor relations expenses of $264,344, marketing expenses of $148,827, and compensation and related expenses of $97,528, partially offset by a decrease in accounting fees of $466,145.

Current wording

General and administrative expenses for the three months ended September 30, 2024, and 2023, were $5,301,251 and $8,290,210, respectively, representing a decrease of $2,988,959 or approximately 36%. The variance is related to a decrease in non-cash consulting fees of $3,070,000 partially offset by an increase in compensation and related expenses of $377,142 and legal expenses of $261,903.

Previous wording

Research and development expenses for the nine months ended March 31, 2024, and 2023, were $2,274,321 and $3,170,471, respectively, representing a decrease of $896,150 or approximately 28%. The variance is primarily driven by a decrease of $1,603,896 in collaborating partner expenses with CDMO and CROs related to discontinued product candidates, partially offset by an increase in consumables of $355,235 and consulting expenses of $351,466.

Current wording

Research and development expenses for the three months ended September 30, 2024, and 2023, were $390,189 and $566,644, respectively, representing a decrease of $176,455 or approximately 31%. The variance is primarily driven by a decrease of $262,065 in collaborating partner expenses with CDMO and CROs related to discontinued product candidates.

Previous wording

The Company recorded other income of $166,426 for the three months ended March 31, 2024, compared to other expense of $264,860 for the three months ended March 31, 2023, representing a decrease in other expense of $431,286 or 163%. The variance is primarily due to an increase of $486,500 in change in fair value of contingent consideration following the acquisition of GEDi Cube.

Current wording

The Company recorded other income of $9,126,518 for the three months ended September 30, 2024, compared to other expense of $290,914 for the three months ended September 30, 2023, representing a change in other income (expense) of $9,417,432 or 3,237%. The variance is primarily due to the change in fair value of contingent consideration of $9,250,000 in the current period.

Previous wording

Net loss for the three months ended March 31, 2024, and 2023, was $17,024,414 and $4,328,296, respectively, representing an increase in net loss of $12,696,118 or approximately 293%. The increase in net loss was primarily due to the indefinite life intangible assets impairment charge of $8,421,000 and an increase in general and administrative expenses of $3,856,322.

Current wording

Net loss for the three months ended September 30, 2024, and 2023, was $44,212,036 and $9,175,028, respectively, representing an increase in net loss of $35,037,008 or approximately 382%. The increase in net loss was primarily due to an increase in goodwill impairment of $47,614,729, partially offset by the change in fair value of contingent consideration of $9,250,000.

Previous wording

As noted above under the heading “Going Concern and Management’s Plans,” through March 31, 2024, we have incurred substantial losses. We will need additional funds for (a) research and development, (b) increases in personnel, (c) the purchase of equipment, specifically to advance towards an Investigational New Drug Application (IND) following Pre-IND readouts from the FDA for RENB-DC11, RENB-HV12, RENB-HV21 and RENB-HB01 and (d) investment in the development and validation of our AI driven cancer diagnostics platform. The availability of any required additional funding cannot be assured. In addition, an adverse outcome in legal or regulatory proceedings in which we are currently involved or in the future may be involved could adversely affect our liquidity and financial position. We may raise such funds from time to time through public or private sales of our equity or debt securities. Such financing may not be available on acceptable terms, or at all, and our failure to raise capital when needed could materially adversely affect our growth plans and our financial condition and results of operations.

Current wording

As noted above under the heading “Going Concern and Management’s Plans,” through September 30, 2024, we have incurred substantial losses. We will need additional funds both in the next twelve months and beyond for (a) research and development, (b) increases in personnel, (c) the purchase of equipment, and investment in the development and validation of our technology. The availability of any required additional funding cannot be assured. In addition, an adverse outcome in legal or regulatory proceedings in which we are currently involved or in the future may be involved could adversely affect our liquidity and financial position. We may raise such funds from time to time through public or private sales of our equity or debt securities. Such financing may not be available on acceptable terms, or at all, and our failure to raise capital when needed could materially adversely affect our growth plans and our financial condition and results of operations.

Previous wording

As of March 31, 2024, the Company had $312,697 in cash and working capital of $(19,654,098) as compared to $1,874,480 in cash and working capital of $(8,457,693) as of June 30, 2023, a decrease of 83% and 132%, respectively.

Current wording

As of September 30, 2024, the Company had $220,571 in cash and working capital of $(21,087,220) as compared to $220,467 in cash and working capital of $(28,312,274) as of June 30, 2024, a decrease of zero and 26%, respectively.

Previous wording

Total assets at March 31, 2024, were $212,279,340 compared to $58,300,796 as of June 30, 2023. The increase in total assets was primarily due to the increase in goodwill of $152,546,852 from the acquisition of Renovaro Cube.

Current wording

Total assets at September 30, 2024, were $121,832,637 compared to $163,129,450 as of June 30, 2024. The decrease in assets is primarily due to goodwill impairment of $47,614,729 in the current period.

Previous wording

Total liabilities at March 31, 2024, were $43,683,784 compared to $11,798,685 as of June 30, 2023. The increase in total liabilities was primarily related to increases of $20,071,000 in contingent consideration liability, $3,031,803 in accrued expenses, $2,693,808 in accounts payable, $3,700,694 in convertible notes payable, net of discount and $2,774,856 in deferred tax liability offset by a decrease of $1,206,326 in notes payable, net of discount.

Current wording

Total liabilities at September 30, 2024, were $23,745,639 compared to $31,152,306 as of June 30, 2024. The decrease in total liabilities was primarily related to the decrease of $9,250,000 in contingent consideration liability, partially offset by an increase of $1,953,540 in accounts payable.

Previous wording

Cash used in investing activities for the nine months ended March 31, 2024, and 2023 was ($1,206,806) and ($23,633), respectively. Cash used in investing activities during the current period primarily related to the issuance of notes receivable prior to the acquisition of Renovaro Cube totaling $1,193,000 in principal and $32,779 of interest accrued as of February 13, 2024.

Current wording

Cash used in investing activities for the three months ended September 30, 2024, and 2023 was zero and ($1,057,875), respectively. Cash used in investing activities during the prior period primarily related to the issuance of notes receivable prior to the acquisition of Renovaro Cube totaling $1,057,875.

Previous wording

Cash provided by financing activities for the nine months ended March 31, 2024, was $8,050,737 as compared to cash provided by financing activities of $3,267,008 during the nine months ended March 31, 2023. During the nine months ended March 31, 2024, the Company received net proceeds of $5,355,000 from issuance of notes payable, $3,000,000 from private placements and $341,865 from Common Stock warrants exercised, that were partially offset by $646,128 in repayment of a finance agreement.

Current wording

Cash provided by financing activities for the three months ended September 30, 2024, was $2,029,183 as compared to cash provided by financing activities of $2,562,817 during the three months ended September 30, 2023. During the three months ended September 30, 2024, the Company received net proceeds of $156,947 from issuance of notes payable and $2,096,181 from private placements that were partially offset by $223,945 in repayment of a finance agreement.
Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

Based upon our internal research, literature reviews of ongoing clinical development for solid tumors, and recent advances in immune modulation, we believe we may have the ability to design an innovative therapeutic vaccination platform that could potentially be used to treat some of the deadliest and hard-to-treat solid tumors that include triple negative breast cancer.