Mission Bio Partners With Top Researchers From University of Miami to Accelerate Early Relapse Detection & Treatment Selection of Multiple Myeloma Patients

On December 2, 2024 Mission Bio, a leader in single-cell multiomics solutions for precision medicine, reported a collaboration with Dr. C. Ola Landgren, MD, PhD, head of one of the world’s leading myeloma computational and translational research laboratories (Press release, Mission Bio, DEC 2, 2024, View Source [SID1234648738]). Dr. Landgren’s team, including Dr. David Coffey and Dr. Benjamin Diamond, at the University of Miami’s Sylvester Comprehensive Cancer Center, will work together to generate clinical data sets using Mission Bio’s Tapestri Single-cell DNA Multiple Myeloma Panel to examine Multiple Myeloma (MM) at an unprecedented level of clonal detail, promising to reveal new insights that may potentially improve outcomes for MM patients.

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MM is a challenging and incurable blood cancer that afflicts around 230,000 people worldwide. Relapse is a particular problem for many of these patients — as many as 50% experience relapse within the first year of frontline treatments, and only 20% of relapse victims survive for five years with current standard therapies.

The key to controlling relapse in MM patients lies in better understanding of resistant clones: cells that have developed mutations or alterations that help them evade treatment. However, current tools inadequately profile the disease from the initial emergence of clones to full-blown myeloma. Using clinical samples from University of Miami, the goal of the collaboration is to help predict which patients are at higher risk of relapse, and, in the event of relapse, whether it can inform and guide subsequent treatment decisions. In addition, the project will determine if blood can be used as an alternative sample for patient testing instead of bone marrow samples. The utilization of blood would vastly improve sample accessibility and alleviate the invasive patient experience.

"We recognize that Multiple Myeloma is a genetically complex disease that hasn’t been easy to comprehend fully using existing methods, particularly when it comes to the crucial questions of when patients might experience relapse and what clinicians should do next when relapse occurs," said Dr. Landgren. "Our aim is to utilize Tapestri to better understand Multiple Myeloma disease heterogeneity, which in turn will allow us to detect and treat relapse faster. Ultimately, we hope to demonstrate the clinical feasibility of the Multiple Myeloma assay and to facilitate the establishment of Tapestri to advance outcomes for patients."

"Our partners and customers continue to push the boundaries of single-cell DNA and multiomic analysis in new and inspiring ways," said Brian Kim, CEO of Mission Bio. "The work being done by Dr. Landgren and his team promises to unearth critical insights that will not only be able to help predict relapse in Multiple Myeloma patients, but also inform more effective, personalized treatment strategies in the future."

Caris Life Sciences to Showcase Research Highlighting the Clinical Value of Comprehensive Molecular Profiling at the 2024 San Antonio Breast Cancer Symposium

On December 3, 2024 Caris Life Sciences (Caris), a leading next-generation AI TechBio company and precision medicine pioneer, reported that the company and collaborators from leading cancer centers, including those within the Caris Precision Oncology Alliance (Caris POA), will collectively present seven studies across a range of breast cancer types, including male breast cancer, at the San Antonio Breast Cancer Symposium (SABCS) from December 10-13, 2024 (Booth #1217) (Press release, Caris Life Sciences, DEC 2, 2024, View Source [SID1234648773]). The research highlights the capability of Caris’ extensive multimodal database to uncover new cancer insights, which may significantly influence a patient’s diagnosis, prognosis, treatment plan and therapeutic response.

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"The research being presented at this year’s San Antonio Breast Cancer Symposium is a testament to Caris’ continued commitment to data-driven molecular innovation and the power of our ever-expanding network of collaborators to answer some of today’s pressing questions in precision oncology," said Caris EVP and Chief Medical Officer George W. Sledge, Jr., MD. "More than half of the studies presented focus on male breast cancer, an often-overlooked form of breast cancer. The findings underscore the critical role of comprehensive profiling in cancer care and the power of large clinico-genomic datasets to enable the identification of new biomarkers with clinical implications across diverse tumor types, including rare cancers."

The research highlights the capability of Caris’ extensive multimodal database to uncover new cancer insights

"Our comprehensive molecular profiling coupled with rich clinical data is enabling Caris to help clinicians make the best treatment choices, researchers to discover novel cancer biology, and the biopharmaceutical industry to develop the next breakthrough medicines," said Caris President David Spetzler, MS, PhD, MBA. "Our vast real-world evidence from over 748,000 cases, including over 550,000 with matched molecular data and outcomes, enables our team and research collaborators to better understand the biological hallmarks of cancers and how they impact clinical outcomes, paving the way for personalized therapies and improved patient outcomes."

Spotlight Poster Presentations include:

A Caris study titled "Molecular and Immune Landscape of Metaplastic Triple Negative Breast Cancer Compared with Invasive Ductal Triple Negative Breast Cancer" (Presentation #PS17-02) will be featured in Concurrent Poster Spotlight Session 17, named "Early Triple Negative Breast Cancer," on Thursday, December 12, from 5:30 – 6:30 p.m. CST in the Stars at Night Ballroom 1-2. The study was performed in collaboration with Caris Precision Oncology Alliance (Caris POA) members Dana-Farber Cancer Institute, Norris Comprehensive Cancer Center, Legorreta Cancer Center at Brown University and Yale School of Medicine, as well as the Mayo Clinic.
In the featured study, the molecular and immunological landscapes of metaplastic triple-negative breast cancer (M-TNBC) were investigated using Caris’ Next-Generation Sequencing (NGS) technology. The results indicate that M-TNBC is associated with an aggressive disease biology, with differential molecular and immune features compared to invasive ductal TNBC. A better understanding of these differences may help inform disease outcomes, provide a rationale for tailored therapeutic approaches and guide the design of future treatments for M-TNBC, a rare and aggressive form of breast cancer.

A Caris study titled "Mechanisms of Resistance to Trastuzumab Deruxtecan in Breast Cancer Elucidated by Multi-omic Molecular Profiling" (Presentation #PS13-09) will be featured during Concurrent Poster Spotlight Session 13, named "Molecular Determinants of Therapeutic Response and Resistance – Spotlight on CDK 4/6i and ADCs" on Friday, December 13 from 7:00 – 8:30 a.m. CST in the Stars at Night Ballroom 1-2. Caris EVP and Chief Medical Officer George W. Sledge Jr., MD will present results of the study conducted by Caris scientists.
In this study, whole transcriptome sequencing (WTS), immunohistochemistry and real-world clinical data were analyzed for more than 2,000 Trastuzumab Deruxtecan (T-DXd)-treated breast cancer samples. This multi-omic approach revealed a clinically relevant mechanism of resistance to T-DXd, a drug widely used in the treatment of metastatic HER-2 low and HER2-positive breast cancer. In T-DXd-treated patients, clinical outcome was a function of trastuzumab target expression and expression of ABCC1, the gene encoding the multidrug resistance protein-1 (MRP1). These results increase our understanding of how T-DXd resistance develops and may help oncologists tailor treatment plans for breast cancer patients accordingly.

Additional Presentations Reveal Potential Impact of Comprehensive Molecular Profiling
Poster and abstract summaries highlighting the Caris research presented at SABCS 2024 will be available onsite at Caris’ Booth #1217. The full abstracts will be available on the Caris website at the event’s conclusion.

Molecular landscape of HR+/HER2- male breast cancer (MaBC) compared with female breast cancer (FeBC) (Presentation Number: P1-01-16)
This study aimed to identify the molecular and immune differences between HR+/HER2- male and female breast cancer. NGS-based analysis of more than 8,200 breast cancer samples indicated that HR+/HER2- male breast cancer has a distinct mutational and immunological profile compared to its female counterpart. These findings suggest important differences in tumor biology between men and women with HR+/HER2- breast cancer. A better understanding of these differences may help in the design of future clinical trials and the development of treatments for men with HR+/HER2- breast cancer.

Spliceosome Mutations (Smut) in Metastatic Breast Cancer (MBC): An Analysis of a De-centralized Clinical Trial and Large Clinical-Genomic Dataset (Presentation Number: P1-01-20)
In this study, spliceosome mutations were analyzed in metastatic breast cancer (MBC) using data from the PRISMM (Patient Response to Immunotherapy using Spliceosome Mutational Markers) trial and Caris’ large clinical-genomic dataset. This analysis found that patients with spliceosome mutations do not have significant responses to immunotherapy. HR+/HER2- MBC had the highest frequency of spliceosome mutations and was associated with genomic aberrations of endocrine resistance, an immune-cold phenotype, and worse overall survival. These findings underscore the importance of molecular profiling in patients with MBC.

Prognostic implications of oncogenetic pathway alterations in advanced male breast cancer(Presentation Number: P1-05-21)
Male breast cancer has a distinct molecular and immune landscape compared to female breast cancer, but the prognostic implications of these differences have previously been unclear. In this study, 17,759 breast tumors were tested using WES and WTS to assess the effect of gene alterations on male breast cancer-related survival. Results showed that select genomic alterations have different prognostic significance in male and female breast cancer, suggesting that breast cancer in men may have a unique trajectory that differs from female breast cancer. Further investigation of sex-defined differences in breast cancer may help tailor future therapeutic strategies.

Comprehensive characterization of androgen receptor in male breast cancer (Presentation Number: P1-03-22)
While the estrogen receptor (ER) is well-studied in breast cancer, the role of the androgen receptor (AR) is less understood, particularly in male patients. This study aimed to characterize the molecular and immunological features associated with AR gene expression in male breast cancer. Comprehensive molecular profiling revealed that specific genomic alterations and immune markers are associated with AR expression. Further investigations of these features may assist in clinical trial design for men with breast cancer.

Molecular and immunological characterization of HER2-low, HER2 ultra-low, and HER2-null male breast cancer (Presentation Number: P3-01-25)
This final study aimed to determine whether there are differences in molecular and immunological features between HER2-low, HER2-ultra-low and HER2-null/negative breast cancer in males. Generally, these three HER2 subtypes in men shared genomic features, suggesting that their disease biology may be similar across the spectrum of what historically has been considered HER2-negative disease. Differences were noted, however, between these HER2 subtypes in their tumor immune microenvironments and warrant further investigation. These findings expand our current understanding of the HER2 spectrum in male breast cancer.
The Caris POA includes 96 cancer centers, academic institutions, research consortia and healthcare systems, including 47 NCI-designated cancer centers, who collaborate to advance precision oncology and biomarker-driven research. Caris and POA members work together to establish and optimize standards of care for molecular testing through innovative research focused on predictive and prognostic markers that improve the clinical outcomes for cancer patients.

Purple Biotech Reports Positive Final Results from Randomized Phase 2 Study of CM24 in Second Line Pancreatic Cancer

On December 2, 2024 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that overcome tumor immune evasion and drug resistance, reported positive final results from the randomized Phase 2 study of its lead oncology drug, CM24, a humanized monoclonal antibody that blocks CEACAM1, in patients with pancreatic ductal adenocarcinoma (PDAC) (Press release, Purple Biotech, DEC 2, 2024, View Source [SID1234648722]).

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"We are very excited about the final data, demonstrating CM24’s clear and consistent improvement across all efficacy endpoints evaluated in our randomized Phase 2 study," stated Purple Biotech CEO Gil Efron. "The enhanced results in patients with CEACAM1 and other serum markers gives us further optimism that a biomarker enriched patient population selection could further strengthen CM24’s magnitude of efficacy, potentially positioning CM24 as a treatment for multiple CEACAM1-expressing malignancies in line with its mechanism of action."

Michael Cecchini, MD Associate Professor of Medicine at the Yale Cancer Center, a principal investigator in this study, commented, "The promising results in PDAC, along with the identification of a potential patient subgroup that may benefit from targeting CEACAM1 and NET serum levels, potentially position CM24 as an encouraging treatment option. As a clinician, it is inspiring to see data that suggest the potential for improved outcomes in patients with late-stage metastatic PDAC, who desperately need new and effective therapies. These findings support further investigation of CM24 in combination with a checkpoint inhibitor and standard-of-care chemotherapy to improve outcomes not only in PDAC but also in other challenging cancer types."

Summary of Data and Findings:

The Phase 2 study evaluated CM24, a novel first-in-class multi-functional anti-CEACAM1 antibody, in combination with Bristol Myers Squibb’s immune checkpoint inhibitor nivolumab plus stand-of-care (SoC) chemotherapy in second-line metastatic PDAC patients versus SoC chemotherapy alone. CM24 is a humanized monoclonal antibody that blocks CEACAM1, a multi-faceted membrane glycoprotein that is one of the main proteins present on NETs, also acting as a pro-angiogenic and anti-apoptotic agent collectively promoting tumor invasiveness, metastasis and immune evasion.

The primary endpoint of the study is OS and the secondary endpoints include PFS, ORR and disease control rate (DCR). A Bayesian methodology was used to estimate the magnitude of effect of the experimental arm versus the SoC arm in each chemotherapy cohort; the study was not powered for hypothesis testing. A total of 63 patients were enrolled, across 18 centers in the U.S., Spain, and Israel in 2 parallel and independent randomized study cohorts (total of 2 arms per cohort). The experimental arms administered patients with CM24 plus nivolumab and a choice of one of two SoC chemotherapies for second-line PDAC, dependent on prior first line therapy regimen; either gemcitabine/nab-paclitaxel or liposomal irinotecan (Nal-IRI)/5-fluorouracil (5-FU) and leucovorin (LV) (Nal-IRI/5FU/LV), while the control arms administered either respective chemotherapy alone. CA19-9 as well as additional exploratory biomarkers were also evaluated. Of the 63 patients enrolled, 32 were in the gemcitabine/nab-paclitaxel study (experimental and control) and 31 were in the Nal-IRI/5FU/LV study (experimental and control). The gemcitabine/nab-paclitaxel-based part of the study was impacted by informative censoring of the control arm that led to an imbalance between the control and experimental arms, rendering this part of the study unsuitable for analysis; this part of the study has no impact on the CM24+nivolumab+Nal-IRI/5FU/LV portion of the study.

The study’s final efficacy results in the Nal-IRI/5FU/LV intent to treat (ITT) cohort population are summarized in the following table:

Metric CM24 + Nivolumab +
Nal/IRI/5FU/LV Arm
(n = 16) Nal/IRI/5FU/LV Arm
(n = 15)
Hazard ratio for OS 0.81 (95% CI: 0.38-1.71)
Median OS 7.92 months 5.55 months
6 months OS rate 53 % 47 %

Hazard Ratio for PFS 0.75 (95% CI: 0.35-1.61)
Median PFS 3.9 months 2.0 months
3 months PFS rate 67 % 47 %
6 months PFS rate 17 % 13 %
ORR 25 % 7 %
DCR 63 % 47 %

A consistent and continuous decrease of CA19-9, a clinically validated PDAC biomarker, was observed in the experimental arm reaching a median percentage reduction from baseline of approximately 80% vs. an increase of 40% in the control arm.

Subgroup analysis of patients with a range of pretreatment serum CEACAM1 between 6,000 pg/mL and 15,000 pg/mL, resulted in statistically significant results as follows:

Metric CM24 + Nivolumab +
Nal/IRI/5FU/LV Arm
(n = 4)
Nal/IRI/5FU/LV Arm
(n = 7)

Hazard ratio for OS 0.21 (95% CI: 0.04-1.06)
Median OS 9 months 3.9 months
Hazard ratio for PFS <0.1 (95% CI: 0-inf)
Median PFS 4.7 months 1.8 months
ORR 50 % 0 %
DCR 100 % 43 %

An additional subgroup analysis of patients, which comprised 80% of the patients in the study cohort, with a range of pretreatment serum CEACAM1 between 6,000 pg/mL and 15,000 pg/mL together with patients with pretreatment serum Myeloperoxidase (MPO) levels of 200 ng/mL and 600 ng/mL, resulted in statistically significant results as follows:

Metric CM24 + Nivolumab +
Nal/IRI/5FU/LV Arm
(n = 13) Nal/IRI/5FU/LV Arm
(n = 11)
Hazard ratio for OS 0.39 (95% CI: 0.16-0.98)
Median OS 7.90 months 5.50 months
Hazard ratio for PFS 0.28 (95% CI: 0.11-0.73)
Median PFS 4.1 months 1.9 months
ORR 31 % 0 %
DCR 69 % 36 %

Additional biomarkers analysis based on the patient pretreatment biopsies, demonstrated significant OS and PFS benefit (HR 0.1, P=0.013 and HR 0.19, P=0.033, respectively) in patients with both high tumor CEACAM1 (≥100) and low Combined Positive Score (CPS) (≤1) (a measure of PD-L1 positive tumor cells) supporting the CM24/nivolumab combined treatment and its mechanistic rationale, and may open a new opportunity for patients who are not eligible for anti-PD1 therapy in various indications

The CM24+nivolumab+Nal/IRI/5FU/LV regimen was well tolerated, with the most frequent treatment emergent Grade 3 or higher adverse events being diarrhea (4 patients in the experimental arm vs. 1 patient in the control arm), fatigue (2 patients in the experimental arm vs. no patients in the control) and neutropenia (2 patients in the experimental arm vs. no patients in the control). Accordingly, no meaningful difference in safety and tolerability were observed between the experimental arm and SoC arm.

"The significant results in the subgroup based on certain range of serum CEACAM1 and MPO levels, that covered 80% of the patients in the Nal-IRI cohort, is encouraging. We believe that tumors with low CEACAM1 or NETs are less reliant on these targets whereas extremely high levels may suggest potential resistance to the treatment. Based on the emerging role of neutrophil extracellular traps (NETs) in cancer and the positive findings of our study in this selected population overlapping with CEACAM1 expression, we are planning a 3-arm Phase 2b study comparing either CM24 plus a PD1 inhibitor or CM24 monotherapy to SoC in multiple tumor types selected based on their NET and CEACAM1 expressions. This design will also investigate the contribution of parts in regard to the need for PD1 blockade on top of CM24. We plan to target patients with higher serum levels of CEACAM1 and MPO, as they are potentially more likely to benefit from CM24 treatment," stated Dr Michael Schickler, Head of Clinical and Regulatory Affairs.

Omeros Corporation Announces Upcoming Presentations at ASH Annual Meeting

On December 2, 2024 Omeros Corporation (Nasdaq: OMER) reported that two abstracts directed to zaltenibart (OMS906), Omeros’ investigational inhibitor of MASP-3, the key activator of the alternative pathway of complement, will be presented at the 66th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), to be held December 7-10, 2024 in San Diego (Press release, Omeros, DEC 2, 2024, View Source [SID1234648739]). The zaltenibart abstracts are directed to the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare, life-threatening hematological disorder. Enrollment for the zaltenibart Phase 3 clinical trials in PNH is expected to open in early 2025.

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Both abstracts are available on the ASH (Free ASH Whitepaper) website at www.hematology.org. Details of the congress presentations and direct links to the abstracts are found below.

Monotherapy Treatment with Zaltenibart (OMS906), an Alternative Pathway Masp-3 Inhibitor, Improved Key Hematologic Parameters in Patients with PNH with a Suboptimal Response to Ravulizumab: Interim Results from a Phase 2 Proof-of-Concept Study
Abstract Number / Link: 4072
Session: 508. Bone Marrow Failure: Acquired: Poster III
Presentation Time: Monday, December 9, 2024, 6:00 PM-8:00 PM
Location: San Diego Convention Center, Halls G-H
Presenting Author: Morag Griffin, MBChB, MRCP

Population Pharmacokinetics/Pharmacodynamics and Clinical Pharmacology of Zaltenibart (OMS906) in Healthy Subjects and Patients with PNH
Abstract Number / Link: 4081
Session: 508. Bone Marrow Failure: Acquired: Poster III
Presentation Time: Monday, December 9, 2024, 6:00 PM-8:00 PM
Location: San Diego Convention Center, Halls G-H
Presenting Author: William Pullman, BMedSc, MBBS, PhD, FRACP

The presentation materials associated with each abstract will be made available on Omeros’ website at www.omeros.com following the congress presentations.

About OMS906

OMS906 is an investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 (MASP-3), the key and most proximal activator of the complement system’s alternative pathway. The complement system is a critical part of innate immunity and plays a central role in host homeostasis and defense against pathogens. Responsible for the conversion of pro-complement factor D to complement factor D, MASP-3 is believed to be the premier target in the alternative pathway – it has the lowest native circulating level and low relative clearance compared to the other alternative pathway proteins and, unlike C5 and C3 blockers, MASP-3 inhibition leaves intact the lytic arm of the classical pathway, important for fighting infection. Also, unlike other components of the alternative pathway, MASP-3 is believed not to be an acute phase reactant, which could provide a significant advantage to MASP-3 inhibitors, like OMS906, over other alternative pathway inhibitors. MASP-3 inhibitors are thought to have preventive or therapeutic effects across a broad range of diseases including paroxysmal nocturnal hemoglobinuria (PNH), hemolytic uremic syndrome (HUS), atypical HUS, traumatic brain injury, arthritis, geographic atrophy or "dry" macular degeneration, ischemia-reperfusion injury, transplant-related complications and other immune-related disorders.

Rakovina Therapeutics Announces 2024 Q3 Financial Results and Provides Corporate Update

On December 2, 2024 Rakovina Therapeutics Inc. (TSX-V: RKV, the "Company"), a biopharmaceutical company committed to advancing new cancer therapies based on novel DNA-damage response technologies, reported the financial results for the third quarter ending September 30, 2024, and provides an update to corporate activities (Press release, Rakovina Therapeutics, DEC 2, 2024, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-announces-2024-q3-financial-results-and-provides-corporate-update [SID1234648723]).

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"I couldn’t be more proud of the Rakovina Therapeutics team and the remarkable progress we’ve made together in 2024," said Executive Chairman Jeffrey Bacha. "Artificial intelligence is no longer just the future of drug development—it’s the reality we’re building today. We are privileged to have world-class experts driving the integration of cutting-edge AI with our laboratory infrastructure at the University of British Columbia. What we’ve accomplished so far is just the beginning—a glimpse of what’s possible as we advance our innovative cancer therapy platform.

The overwhelming support from our investors, exemplified by the upsized investment offering announced this week, is both humbling and deeply motivating. These additional funds will play a critical role in unlocking the transformative opportunities that await us in 2025 as we continue our mission to develop life-changing treatments for cancer patients," he added.

2024 Q3 Highlights and Recent Developments: Rakovina continues to hit 2024 milestones

On September 17, 2024, we broadened our capabilities in AI through a collaboration with Variational AI. This partnership grants Rakovina exclusive rights to compounds generated by Variational’s Enki platform, specifically tailored to selected target product profiles, along with an option to license validated drug candidates for further development. The Enki platform will provide novel inhibitors of specific DDR kinase targets identified by Rakovina Therapeutics. Our team will synthesize and assess the potential of these candidates as cancer therapies at our state-of-the-art laboratories at the University of British Columbia. By combining Variational AI’s expertise in kinase drug discovery with our focus on DDR pathways, we aim to enhance partnering opportunities, particularly as "big pharma" continues to prioritize innovative therapies targeting these critical pathways.
On October 23, 2024, we announced receipt of the initial results from the proprietary Deep Docking AI platform. The Deep Docking algorithm was able to evaluate billions of molecular structures to develop a short-list of drug candidates that have been optimized to a specific target-product profile. With the AI platform, results were achieved in less than five months—a feat not capable through traditional methods of discovery. The selected drug candidates will be synthesized for validation in Rakovina Therapeutics’ laboratories at the University of British Columbia during the coming months with the goal of advancing a best-in-class DDR drug candidate to human clinical trials in collaboration with pharmaceutical company partners.
In October and November 2024, we had the privilege of presenting our latest research from our PARP1/2 inhibitor KT-3000 program and our AI-driven drug discovery initiatives at two prestigious conferences. At the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium in Spain, we highlighted innovative findings from the KT-3000 series, a promising class of PARP1/2 inhibitors. And at the 29th Annual Meeting of the Society for Neuro-Oncology (SNO), we presented compelling data on a shortlist of targeted therapies identified through our Deep Docking AI platform. Notably, early studies suggest that these PARP inhibitor compounds have the potential to cross the blood-brain barrier—an achievement that positions them as significant candidates for advancing treatments in areas of critical unmet need, including neurological cancers.
On November 27, 2024, we announced a non-brokered private placement financing of units priced at $0.06 per unit, with each unit consisting of one common share and one common share purchase warrant with an exercise price of $0.10 per warrant and a term of two years, for gross proceeds to the Company of $1.25 Million (the "Offering").
On November 28, 2024, we announced that due to high investor demand, the Offering would be increased to $2.5 Million (subject to exchange approval).
Summary of Financial Results for the quarter ended September 30, 2024

For the three and nine months ended September 30, 2024, the Company reported a net loss of $1,015,667 and $2,588,630, respectively. Research and development expenses were $678,299 and $1,597,067 for the three and nine months ended September 30, 2024, respectively. General and administrative expenses were $268,909 and $796,183 for the three and nine months ended September 30, 2024, respectively. Total cash expenses related to research and development and general and administrative expenses for the three and nine months ended September 30, 2024, were $793,867 and $1,922,037, respectively.

Selected Financial Information

As at September 30, 2024
Cash & cash equivalents $255,049
Working capital $358,060
Intangible assets $4,112,602
Total Assets $5,308,181
Total liabilities $2,233,687
Deficit $(13,513,941)
Total equity $3,074,494
Statements of net loss and comprehensive loss data:

For the nine months ended September 30, 2024 For the nine months ended September 30, 2023
Research & Development $1,597,067 $1,252,165
General and Administrative $796,183 $568,496
Net loss and comprehensive loss $2,588,630 $1,890,162
Basic and diluted income (loss) per share $(0.03) $(0.03)
Operating cash burn $1,922,037 $1,328,271
Weighted average shares outstanding 76,660,137 69,829,500
Rakovina Therapeutics’ financial statements as filed with SEDAR+ can be accessed from the Company’s website at: View Source

Senior management of Rakovina Therapeutics will hold an information and update webinar on December 4, 2024, at 3 PM Pacific Time/6 PM Eastern Time. Interested parties may sign up at https://bit.ly/rakovina-q3.