On May 13, 2022 UroGen Pharma Ltd. (Nasdaq: URGN) reported that highlighted four presentations of interest featuring data on JELMYTO (mitomycin) for pyelocalyceal solution for patients with low-grade upper tract urothelial cancer (LG-UTUC) and investigational agent UGN-102 (mitomycin) for intravesical solution in Phase 3 clinical development as primary non-surgical therapy for low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) at the upcoming 2022 American Urological Association (AUA) Annual Meeting, May 13-16 in New Orleans, Louisiana (Press release, UroGen Pharma, MAY 13, 2022, View Source [SID1234614523]). The presentations will be published in the June 2022 issue of The Journal of Urology and will be accessible via the AUA website.

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Details on AUA Presentations:

Podium Presentation
Abstract #: PD26-08
Session: Low-grade urothelial carcinoma recurs at a tempo that naturally accelerates from Adagio to Allegro
Presenter: Alex Sankin, M.D., Associate Professor Department of Urology, Albert Einstein College of Medicine
Date and Time: Saturday, May 14, 2022 at 2:10-2:20 PM CT
Location: Room 252

ICU Theater
Session: Chemoablation as primary treatment: Transforming the paradigm for low grade UTUC with JELMYTO
Presenter: Jennifer Linehan, M.D. Associate Professor of Urology and Urologic Oncology at the Saint John’s Cancer Institute
Date and Time: Sunday, May 15, 2022 at 12:00-1:00 PM CT
Location: S&T Hall: Booth 1043

Moderated Poster
Abstract #: MP54-06
Session: Longitudinal Health-Related Quality of Life Outcomes in Adults with Non-Muscle-Invasive Bladder Cancer Receiving a Chemoablative Gel as a Primary Treatment (Optima II: Phase 2b, single arm, open-label trial)
Presenter: Angela Smith, M.D., M.S. Associate Professor at the University of North Carolina (UNC) Department of Urology in Chapel Hill, North Carolina
Date and Time: Monday, May 16, 2022 at 8:45-10:00 AM CT
Location: Room 228

Podium Presentation
Abstract #: PD58-06
Session: Antegrade Administration of Reverse Thermal Mitomycin Gel for Primary Chemoablation of Upper Tract Urothelial Carcinoma via Percutaneous Nephrostomy Tube: a Multi-Institutional Real-World Experience
Presenter: Kyle Rose, M.D., Urologic Oncology Fellow at Moffitt Cancer Center in Tampa, Fla.
Date and Time: Monday, May 16, 2022 at 1:50-2:00 PM CT
Location: Room 252

UroGen will be hosting Booth #837 at the Ernest N. Morial Convention Center during AUA 2022.

About JELMYTO

JELMYTO (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for primary chemoablative treatment of LG UTUC in adults. It is recommended for primary treatment of biopsy-proven LG UTUC in patients deemed appropriate candidates for renal-sparing therapy. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.

APPROVED USE FOR JELMYTO

JELMYTO is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).

IMPORTANT SAFETY INFORMATION

You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.

Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:

are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose.

Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.

are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.
Tell your healthcare provider if you take water pills (diuretic).
How will I receive JELMYTO?

Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.
You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses.
JELMYTO is given to your kidney through a tube called a catheter.
During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving JELMYTO:

JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.
To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.
Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
JELMYTO may cause serious side effects, including:

Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.
Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.
The most common side effects of JELMYTO include: urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain.

You are encouraged to report negative side effects of prescription drugs to the U.S. Food and Drug Administration. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

On May 13, 2022 Glycostem Therapeutics B.V., a leading clinical-stage company focused on the development of therapeutic allogeneic off-the-shelf Natural Killer (NK) cells, reported that an abstract on further findings of patients treated in its phase I/IIa WiNK trial have been accepted and will be presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Congress, which will take place 9th – 12th June 2022 in Vienna, Austria (Press release, Glycostem Therapeutics, MAY 13, 2022, View Source [SID1234614540]). oNKord is the company’s first-generation off-the-shelf allogeneic NK cell therapy under clinical development. Glycostem is furthermore developing a range of CAR-NK, combination therapy and TCR-NK products in-house.

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"Achieving measurable residual disease (MRD) negativity is associated with longer-term survival in patients with AML. Our initial clinical data shows that all patients in the first dose cohort reached some level of MRD negativity with an excellent safety profile thus far," said Dr. Kai Pinkernell, CMO of Glycostem. "We are looking forward to the results on the following, increased dose levels, which we expect to further support the safety and activity of oNKord as shown in the early follow up."

The EHA (Free EHA Whitepaper) abstract is now available at View Source as EHA (Free EHA Whitepaper)-3555 with the title:

EARLY SAFETY AND CLINICAL COURSE OF PATIENTS WITH ACUTE MYELOID LEUKEMIA AND MEASURABLERESIDUAL DISEASE RECEIVING GTA002, AN OFF-THE-SHELF, EX VIVO-CULTURED ALLOGENEIC NK CELL PREPARATION

Glycostem will present the poster on Friday, 10th June 2022 at 16:30 – 17:45 CEST.

On May 13, 2022 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, reported financial results for the quarter ended March 31, 2022 and provided a corporate update (Press release, Tempest Therapeutics, MAY 13, 2022, View Source [SID1234614524]).

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"The team continued to execute well throughout the first quarter of this year, enabling us to present the first clinical data from a Tempest program at the ASCO (Free ASCO Whitepaper) Annual Meeting in June," said Stephen R. Brady, chief executive officer of Tempest. "We look forward to the upcoming oral presentation, which will highlight the clinical profile and responses observed in the monotherapy and combination Phase 1 study of TPST-1120, our novel PPARa antagonist."

________________________
1 If approved by the FDA

Recent Highlights

TPST-1120 (clinical PPARα antagonist): (i) completed enrollment in the Phase 1 monotherapy and combination dose escalation arms; (ii) announced that the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) accepted for an oral presentation at its 2022 Annual Meeting an abstract containing the TPST-1120 Phase 1 monotherapy and combination data; and (iii) continued enrollment in first-line, randomized global Phase 1b/2 study in patients with hepatocellular carcinoma (HCC), under a collaboration with F. Hoffmann La Roche.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) continued enrollment in a Phase 1 study evaluating both monotherapy and combination (with anti-PD-1 checkpoint inhibitor, pembrolizumab) dose and schedule optimization arms, towards establishing an RP2D; (ii) presented preclinical data further differentiating TPST-1495 from other approaches targeting the prostaglandin E2 (PGE2) pathway at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting; and (ii) announced that ASCO (Free ASCO Whitepaper) accepted for a poster presentation a "trials in progress" for the ongoing TPST-1495 Phase 1 clinical monotherapy and combination therapy clinical trial.
TREX1 Inhibitor (preclinical tumor-selective STING pathway activator): presented the first data with proprietary targeted molecules demonstrating therapeutic benefit in tumor-bearing mice at the AACR (Free AACR Whitepaper) 2022 Annual Meeting.
Planned Near-Term Milestones

TPST-1120 (clinical PPARα antagonist): (i) first presentation of clinical data from a Tempest program at the oral presentation of the Phase 1 monotherapy and combination data at the ASCO (Free ASCO Whitepaper) 2022 Annual Meeting; and (ii) objective response data from the first 40 HCC patients in the first-line randomized study expected by year end or early 2023.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) selection of monotherapy RP2D expected in the first half of 2022; (ii) presentation of "trial in progress" poster at ASCO (Free ASCO Whitepaper) 2022 Annual Meeting; and (iii) data from Phase 1 monotherapy and combination dose and schedule optimization arms expected by year end or early 2023.
TREX1 Inhibitor (preclinical tumor-selective STING pathway activator): planned selection of development candidate in the second half of 2022.
PIPE Financing

On April 27, we announced a $15 million private investment in public equity (PIPE) financing to EcoR1 Capital, LLC and Versant Venture Capital.
Financial Results

First Quarter

Tempest ended the first quarter of 2022 with $45.8 million in cash and cash equivalents, compared to $51.8 million at December 31, 2021. The decrease was primarily due to cash used in operations of $7.1 million offset by proceeds from sales under our ATM program of $1.4 million. Cash balance does not reflect $15 million raised in April from PIPE financing.
Net cash used in operations for the quarter ended March 31, 2022 was $7.1 million compared to $6.3 million for the same period in 2021.
Net loss and net loss per share for the quarter ended March 31, 2022 were $8.5 million and $1.18, respectively, compared to $5.4 million and $10.55, respectively, for the first quarter of 2021.
Research and development expenses for the first quarter of 2022 were $5.1 million compared to $3.6 million for the same period in 2021. The $1.5 million increase was primarily attributable to expanded research and development efforts and increased fees for consulting services and compensation expenses.
For the three months ended March 31, 2022, general and administrative expenses were $3.0 million compared to $1.5 million for the same period in 2021. The increase of $1.5 million was primarily due to higher professional and consulting fees, insurance, and compensation expenses.

On May 13, 2022 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported its financial and operational results and provided an update for the first quarter ended March 31, 2022 (Press release, IMV, MAY 13, 2022, View Source [SID1234614484]).

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"A top priority for 2022 is to accelerate MVP-S towards registration trials. The positive clinical data we presented on MVP-S in combination with pembrolizumab in bladder cancer patients at the recent AACR (Free AACR Whitepaper) annual meeting support IMV’s prior results in solid and hematologic cancer," said Andrew Hall, Chief Executive Officer of IMV. "These results further underscore our conviction in the value of our DPX platform. In parallel, we are actively looking for opportunities to leverage our DPX delivery platform and expand our pipeline through business development. We continue to enrich our understanding of the DPX mechanism through foundational science and translational research."

Clinical Programs with Maveropepimut-S (MVP-S)

VITALIZE Phase 2B Study in Relapsed/Refractory DLBCL ("r/r DLBCL")

In January 2022, the Company announced that the first patient was dosed in VITALIZE Phase 2B clinical trial, advancing IMV’s lead compound, MVP-S on the path to a registration trial. This trial is designed to further evaluate the clinical benefit of MVP-S in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with r/r DLBCL. Fifteen clinical sites are now activated in the U.S., Canada, Australia and New Zealand. The Company is activating more sites in North America, Europe, Asia and Australia to accelerate enrollment. Early data from the initial patient group is expected in the third quarter of 2022.

AVALON Phase 2B Study in Platinum-Resistant Ovarian Cancer

The Company is preparing to initiate AVALON, a Phase 2B, single arm trial evaluating MVP-S and intermittent low-dose CPA in subjects with platinum-resistant ovarian cancer. The goal of this trial is to further validate the encouraging data observed in our Phase 2 DeCidE trial, which was completed in 2021. The design of the study has been approved by the FDA and Health Canada earlier this year. Site selection and activation are ongoing, and the first patient is expected to be dosed in H2 2022.

Positive Clinical Results in Bladder Cancer Presented at AACR (Free AACR Whitepaper) Annual Meeting

Safety and preliminary efficacy data on a combination of MVP-S with pembrolizumab from the Phase 2 basket study of patients with advanced, metastatic bladder cancer were presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting. Seventeen subjects with advanced, metastatic bladder cancer, who on average had received two prior lines of therapy, were enrolled in this arm of the Phase 2 basket study. The combination showed encouraging clinical activity, particularly in patients who had received prior immune checkpoint inhibitor therapy.

Key findings in this cohort included:

Treatment with MVP-S/CPA and pembrolizumab was well-tolerated with mostly grade 1-2 injection site reactions, and no severe adverse events attributed to MVP-S;

Of the 17 treated patients, 5 showed response: 2 confirmed CRs and 3 PRs per RECIST v1.1;

Complete and partial responses were observed in patients previously treated with checkpoint inhibitors;

Clinical response was most evident in patients with survivin-specific T cells; and

One patient is still on treatment after 18 months and remains a complete responder

KOL discussions are ongoing to map out the clinical opportunities for MVP-S in bladder cancer.

Clinical Program with IMV’s Second DPX-based Product Candidate, DPX-SurMAGE

IMV initiated a Phase 1 clinical trial evaluating both MVP-S and DPX-SurMAGE, in patients with non-muscle invasive bladder cancer (NMIBC) in early 2022. The first patient was dosed early April 2022. Preliminary data are expected by the end of 2022.

Foundational Science

AACR 2022 Annual Meeting Presentation: NK Cells are involved in Promoting Anti-tumor Responses to DPX-based Immunotherapy

It has been previously shown in clinical trials that MVP-S consistently incites a robust and persistent, survivin-specific immune response and promotes T and B cell infiltration into tumor tissues. At AACR (Free AACR Whitepaper), new data were presented providing the first evidence from preclinical and clinical studies that Natural Killer (NK) cells are also involved in the anti-cancer efficacy of DPX-based therapy.

Corporate Update

Michael P. Bailey appointed as Chairman of the Board, effective May 1, 2022.

Mr. Bailey has more than 30 years of pharmaceutical industry experience, having been instrumental in the commercial planning and launch of several new medicines across multiple oncology indications. He is currently President and Chief Executive Officer of AVEO Oncology, where he played a critical role in the approval of AVEO’s lead compound, FOTIVDA (tivozanib), a treatment targeting renal cell carcinoma. Mr. Bailey has served on IMV’s Board of Directors since mid 2020.

Selected Upcoming Milestones

Maveropepimut-S (MVP-S):

Q3 2022: Early data look for the open label VITALIZE Phase 2 DLBCL trial

Q3 2022: Initiate enrollment in AVALON Phase 2b trial in platinum-resistant ovarian cancer

Q4 2022: Early data look for the investigator-initiated breast cancer trial

H1 2023: Early data look from the AVALON trial in platinum resistant ovarian cancer

DPX-SurMAGE:

Q4 2022: Early data look from Phase 1 Non-muscle invasive bladder cancer study in Canada

OVERVIEW OF FIRST QUARTER 2022 FINANCIAL RESULTS

All dollar amounts noted herein are denominated in United States dollars (unless otherwise noted herein).

As of March 31, 2022, the Company had cash and cash equivalents of $28.7 million and working capital of $27.1 million, compared with $38.6 million and $37.1 million, respectively at December 31, 2021. Based on its current operating plan, which includes the additional $10 million available under the Horizon Venture Debt Facility and excludes the $47.5 million remaining under our current At-The-Market facility, IMV expects its current cash position will be sufficient to fund operations into Q2 2023.

Research and development expenses were $6.6 million for the three months ended March 31, 2022, compared with $4.7 million for the three months ended March 31, 2021. This increase was mainly due to a rise in expenses related to the manufacturing and development costs for MVP-S, start-up costs for the VITALIZE DLBCL phase 2B trial, and personnel costs due to an increase in headcount. This increase was partly offset by a decrease in basket trial costs following completion of enrollment in 2021.

General and administrative expenses were $4.0 million for the three months ended March 31, 2022, compared with $3.2 million for the three months ended March 31, 2021. This increase of $0.8 million was largely attributable to salaries and non-cash stock-based compensation related to planned hiring and executive leadership changes as well as loan interest associated with the Horizon Venture Debt Facility.

The net loss and comprehensive loss of $10.5 million ($0.13 per share) for the three months ended March 31, 2022, was $3.5 million higher than the net loss and comprehensive loss of $7 million ($0.10 per share) for the three months ended March 31, 2021.

As of May 12, 2022, the number of issued and outstanding common shares was 82,269,462 and a total of 16,799,130 shares are reserved for the issuance of outstanding stock options, warrants and deferred share units.

The Company’s unaudited interim condensed consolidated results of operations, financial condition and cash flows for the quarter ended March 31, 2022, and the related management’s discussion and analysis (MD&A) are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov as well as the Company’s website at www.imv-inc.com

Conference Call and Webcast Information

Management will host a conference call and webcast today May 13, 2022, at 8:00 a.m. ET. Financial analysts are invited to join the conference call by dialing 1-844-461-9932 (U.S. and Canada) or 1-636-812-6632 (international) and using the conference ID: 5396906.

Other interested parties will be able to access the live audio webcast at this link: View Source The webcast will be recorded and will then be available on the Company’s website for 30 days following the call.

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.