On November 30, 2020 Kiromic BioPharma ("the Company") (NASDAQ: KRBP), a pre-clinical stage biotechnology company using its proprietary DIAMOND artificial intelligence ("A.I.") platform to improve drug discovery and development with a therapeutic focus on immune-oncology, reported its financial results for the third quarter ended September 30, 2020, and provided an update on its corporate developments (Press release, Kiromic, NOV 30, 2020, View Source [SID1234571997]).
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"Kiromic BioPharma achieved important scientific and operational milestones during the quarter that have us well positioned for growth as we focus on being the leader in A.I.-enabled immune-oncology drug development," said Dr. Maurizio Chiriva-Internati, CEO and President of Kiromic BioPharma. "We are thankful to our employees and collaborators who have maintained this high level of execution in the middle of the hard challenges posed by the COVID-19 pandemic. Through their efforts, as of today nothing has come to our attention causing us to believe that we are not poised to file our two INDs for Epithelial Ovarian Cancer during 4Q-2020. The first IND will be our chimeric PD1 for ovarian cancer, and the second IND will be our isoform mesothelin in ovarian cancer."
Subsequent to the quarter end, on October 20, 2020, we completed a successful IPO, raising gross proceeds of $15,000,000, significantly strengthening the Company’s balance sheet to support the continued development of our promising pipeline of targeted cancer therapies. Our approach and goal is to defeat cancer by developing immunotherapies that rely on improving target discovery and validation. With better targets, we believe our therapies will be more effective than the current crop of immunotherapies using older targets.
Corporate and Scientific Highlights
Intellectual Property Application Filing – Kiromic BioPharma ("The Company") filed a United States provisional patent application on July 6, 2020, entitled "Mesothelin Isoform Binding Molecules and Uses Thereof," that discloses engineered gamma-delta T cells containing mesothelin isoform-directed molecules. This provisional application is expected to expire on July 7, 2021, and the Company plans to file at least an international PCT patent application claiming priority to the provisional application before it expires. The Company plans to build at least one patent family directed to engineered allogeneic effector cells, in support of its development of off-the-shelf allogeneic immunotherapy treatments to patients with indications of Isoform Mesothelin Epithelial Ovarian Cancer, and Isoform Mesothelin Malignant Pleural Mesothelioma.
External Validation of Targets – The Company completed external validation of Isoform Mesothelin targets including mesothelioma, ovarian cancer, and pancreatic cancer during the 3 months ended September 30, 2020.
Clean Rooms and Vivarium Facility Construction Completion – The Company completed construction of an $820,000 leasehold improvement located at the Houston, TX based offices. The asset contains a current Good Lab Practices ("cGLP") Vivarium Facility, and current Good Manufacturing Practices ("cGMP") Clean Rooms for clinical manufacturing. The cGLP Vivarium is currently being used to perform key in vivo non-clinical research to support the Company’s clinical initiatives through an Initial New Drug ("IND") filing with the FDA. The cGMP suite consists of 5 clean rooms which will be used to manufacture the Company’s off-the-shelf allogeneic therapies during clinical trials. Management plans to commence clinical trials only if IND applications are approved by the FDA.
Q3 2020 Financial Highlights
Cash Position: Cash and cash equivalents were $469,300 as of September 30, 2020, compared to $1,929,100 as of December 31, 2019. The decrease was primarily due to cash outflows of $3,557,200 and $1,013,100 attributable to operating activities and investing activities, respectively. The offsetting cash inflows of $3,110,500 was attributed to financing activities related to the Company’s Series B Preferred Stock issuance along with proceeds net of repayments from the Paycheck Protection Program loan.
R&D Expenses: Research and development expenses were $1,225,700 for the quarter ended September 30, 2020, compared to $272,100 for the quarter ended September 30, 2019. The increase was primarily attributable to augmented headcount, increased square footage to our Houston, TX leased facilities, and in-vitro experimentation costs.
G&A Expenses: General and administrative expenses were $1,190,000 for the quarter ended September 30, 2020, compared to $607,400 for the quarter ended September 30, 2019. This increase was primarily due to personnel expenses.
Net Loss: Net loss was $2,415,700 for the quarter ended September 30, 2020, compared to a net loss of $886,900 for the quarter ended September 30, 2019.
Dr. Chiriva-Internati continued, "Developing live-cell therapies by leveraging artificial intelligence is central to transforming the cost and efficiency of the immune-oncology field and improving the potential for off-the-shelf therapies for cancer patients. We believe our approach will help us design more efficient pre-clinical validation studies and more targeted clinical trials, thereby accelerating our drug candidates’ time to approval and eventually to market. DIAMOND is central to our process in achieving this outcome rapidly and with reduced costs," concluded Dr. Chiriva-Internati.