On May 13, 2022 Kiromic BioPharma, Inc. (NASDAQ: KRBP) ("Kiromic" or the "Company"), a clinical-stage fully integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence (AI) and data mining platform to discover and develop cell and gene therapies with a therapeutic focus on immuno-oncology, reported financial results for the first quarter ended March 31, 2022 (Press release, Kiromic, MAY 13, 2022, View Source [SID1234614525]).
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"This past quarter has seen tremendous progress inside the Company, particularly within the research, development, and manufacturing functions. As an organization, we have achieved important goals, from optimizing and validating our ALEXIS Gamma Delta T (GDT) cell platform, enhancing our GDT cell banking technology, to expanding and redesigning our cGMP manufacturing facility and deploying a master cell bank strategy. These are all critical activities for achieving our milestone of beginning the activation of the clinical trial for our first oncology cell therapy candidate Procel by the end of the fourth quarter later this year," stated Pietro Bersani, Kiromic BioPharma’s Chief Executive Officer. "We have been intensely preparing for this milestone, and we believe that we now have the right team, the right capabilities, and the right processes in place to achieve this objective. We have a tremendous opportunity ahead of us, with incredible science that we are looking forward to ultimately making available to patients."
Quarter 1 Fiscal Year 2022 Financial Highlights:
Cash Position: Cash and cash equivalents were $15,123,100 as of March 31, 2022, compared to $25,353,900 as of December 31, 2021. The difference is attributable to cash outflows of $7,520,200, $2,541,800, and $168,800 for operating, investing, and financing activities, respectively.
R&D Expenses: Our research and development expenses increased by $1,040,200, or 55.17%, to $2,925,800 for the three months ended March 31, 2022, from $1,885,600 for the three months ended March 31, 2021. The increase was attributable to increased headcount, manufacturing, and experimentation costs for the development of our ALEXIS clinical platform.
G&A Expenses: Our general and administrative expenses increased by $2,368,200, or 114.35%, to $4,439,200 for the three months ended March 31, 2022, from $2,071,000 for the three months ended March 31, 2021. This increase was primarily due to increases in professional services fees, personnel, and recruiting costs.
Net Loss: Our net loss increased to $7,019,400 during the three months ended March 31, 2022, compared to $3,854,500 during the three months ended March 31, 2021.
Recent Business Highlights:
New Company Leadership:
As previously announced, we appointed our Chief Executive Officer, a new Chair of our Board, and two new independent Board members.
ALEXIS (Gamma Delta CAR-T cell Platform) Research & Development:
Continued to improve and enhance the manufacturing efficiencies of the ALEXIS platform, optimizing both cellular function and cost containment
Progressed a Master Cell Bank strategy for retro-viral vector (RVV) production
Performed additional studies on supplementary target tumor cell lines, thereby providing additional pre-clinical validation of the potency and specificity of the ALEXIS platform of products.
Further optimized Kiromic’s Diamond AImediated pooled donor Gamma Delta T cell banking technology. The method of manufacturing GDT cells from pooled allogenic donors has been validated and confirmed with post-freezing, thawing, recovery, stability, and potency. As a next step, the pooled donor GDT cell banks will be tested in vivo for tolerability and efficacy.
Confirmed a quantitative methodology to determine the residual helper plasmid DNA in RVV preparations, which is an important RVV release test used in manufacturing Procel and Isocel.
cGMP Manufacturing:
We have expanded and redesigned our in-house current Good Manufacturing Practices (cGMP) facility.
DIAMONDAI 2.0 Platform for Drug Discovery and Development: NOEMI (NeurO Evolutive) Machine Learning Enabled Antibody Design)
Kiromic’s DIAMONDAI 2.0 identifies and validates cancer-specific proteins on the surface of cancer cells that can be targeted by engineered T-cells. Typically, a year of laboratory work in animal models and significant expense is then required to develop a chimeric antigen receptor (CAR) for our GDT cells so they will attack that cancer target.
Consistent with Kiromic’s mission to apply cutting edge techniques to improve immunotherapy, we believe we have created a groundbreaking system, NOEMI, to dramatically accelerate CAR development.
NOEMI is a machine learning and genetic algorithm trained to provide the sequence of a chimeric antigen receptor (CAR) receptor that will bind a Diamond AI target. This software can do in hours what would normally take a year.