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.

On November 30, 2020 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the Company will host a conference call at 8:00am ET on Monday, December 7, 2020 to discuss updated findings from the first-in-human trial of IMGN632, an antibody-drug conjugate targeting CD123, in patients with relapsed/refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN) to be presented in an oral session at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on December 5, 2020 (Press release, ImmunoGen, NOV 30, 2020, View Source [SID1234571996]). During the call, Dr. Naveen Pemmaraju, Associate Professor in the Department of Leukemia at MD Anderson Cancer Center, will summarize the data presented during the oral session and management will provide an update on the pathway to FDA approval for IMGN632 in BPDCN as well as recent progress in the acute myeloid leukemia (AML) program.

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CONFERENCE CALL INFORMATION

To access the live call by phone, dial (877) 621-5803; the conference ID is 1795760. The call, along with associated slides, may also be accessed through the Investors and Media section of immunogen.com. Following the call, a replay will be available at the same location.

On November 30, 2020 Shanghai Stock Exchange listed company HitGen Inc. ("HitGen") reported that it has entered into a research collaboration agreement with Cedilla Therapeutics, Inc. ("Cedilla"), a private biotechnology company developing targeted small molecules for the treatment of cancer and other diseases caused by protein dysregulation (Press release, HitGen, NOV 30, 2020, View Source [SID1234571994]). The companies will conduct joint research to identify and develop drug candidates directed to a validated, high-value target in oncology that has remained beyond the reach of previous efforts.

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HitGen is a world leading biotech company in DNA encoded library-screening, a high throughput compound screening technology, where more than 100,000 times larger libraries can be used than in traditional drug discovery. The platform thus enables faster identification of innovative drug candidates with improved target specificity and enhanced drug-like characteristics.

Pursuant to the terms of the collaboration agreement, HitGen has successfully applied its DEL technology and discovered program compounds that met certain criteria, and Cedilla has received an exclusive license to these compounds as well as associated IP for further development and commercialization. HitGen will be eligible for milestone payments and sublicensing income from Cedilla as the project progresses, in addition to research payments and upfront license fee.

"HitGen is a perfect partner for us in this program, with their cutting-edge DEL platform for screening. Their technology is well established and is now widely used by leading global pharmaceutical and biotech companies," said Dr. Alexandra Glucksmann, President and CEO of Cedilla. "With HitGen’s support, we are able to accelerate our ongoing efforts to pursue a breadth of high-value oncology targets that have eluded conventional therapeutic modalities. We are very pleased with the program compounds discovered by HitGen to date, are excited to advance these programs forward as we pursue our mission of delivering profound benefit to patients in areas of high unmet need."

"We are delighted to enter this collaboration with Cedilla, and believe their unique approach to identifying functionally-relevant proteoforms represents a powerful advance in how we think about treating diseases caused by protein dysregulation," said Dr. Jin Li, Chairman of the Board and Chief Executive Officer of HitGen. "We believe the collaboration will reinforce the role and reputation of HitGen’s platform in the rapidly developing field of DEL and further demonstrates the power of our DEL platform to discover novel small molecules against a variety of targets. We are working closely with Cedilla scientists and have seen early success towards generating new small-molecule lead compounds for their research programs to help bring transformative medicines to patients."

On November 30, 2020 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTsTM), announced that, effective November 24, 2020, Steve Hoffman will remain in the role of Chairman of the board of directors and continue as the Company’s Chief Science Officer, after a successful tenure as Chief Executive Officer since 2015 (Press release, TYME, NOV 30, 2020, View Source [SID1234571993]). Richie Cunningham, former Icagen CEO and Boehringer Ingelheim executive, has been appointed as TYME’s next Chief Executive Officer.

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"We are fortunate to have been able to identify and bring on an individual with Mr. Cunningham’s significant experience in key facets sought by emerging biotech companies. His leadership and expertise in the biopharmaceutical industry, as well as his knowledge of efficient partnering strategies will be invaluable in helping TYME establish itself as a commercial organization with a pipeline of next-generation metabolic-based compounds," said Steve Hoffman, Chairman and Chief Science Officer of TYME.

Mr. Cunningham brings more than 20 years of successful leadership experience spanning from pre-IND drug discovery through the commercialization and launch of over a dozen therapies in oncology, rare disease, infectious disease, respiratory, neurology, cardiovascular and metabolic diseases. Richie brings to TYME an in-depth understanding of maximizing therapeutic lifecycles, enhancing efficiencies and outcomes in biotech business models, and most importantly a commitment to a values-driven culture.

Mr. Cunningham also brings significant experience in mergers & acquisitions, business development, strategy development, therapeutic launches, contracting, managed care, and sales & marketing. Most recently, Richie served as CEO at Icagen, leading the company through two transformational acquisitions, acquiring assets and talent out of Pfizer and Sanofi. While CEO at Icagen, he successfully negotiated and signed multiple licensing deals with Roche, Sanofi and the Cystic Fibrosis Foundation.

Prior to joining Icagen, Mr. Cunningham was an executive with one of the world’s largest pharmaceutical companies, Boehringer Ingelheim, where he held a variety of key strategic and operational roles, including the launch of Boehringer’s first entrance into the oncology market with Gilotrif (afatinib), an oral tyrosine kinase inhibitor, as a treatment for patients with non-small cell lung cancer.

In addition, Mr. Cunningham excelled in the National Football League holding All-Pro honors for the Dallas Cowboys. His career in the NFL spanned from 1994 until his retirement in 2002.

"TYME is positioned for success and I look forward to working with the leadership team and TYME employees to achieve its strategic short- and long-term objectives. I am excited about the prospects of making a positive impact in the lives of patients and enhancing the value for all stakeholders," said Richie Cunningham.

On November 30, 2020 Agilent Technologies Inc. (NYSE: A) reported the launch of the Biomarker Pathologist Training Program, a global initiative created to empower pathologists to score biomarkers accurately and confidently (Press release, Agilent, NOV 30, 2020, View Source [SID1234571992]). Developed by Agilent – a worldwide leader in developing and commercializing diagnostic products – this training program incorporates Agilent’s unique expertise in companion diagnostics and partnership with top pharmaceutical companies.

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"This program will allow pathologists to learn and practice scoring techniques, to gain the necessary confidence and competence to accurately score biomarker cases in their own laboratories. Combined with Agilent’s high-quality pathology staining solutions this training program will help ensure pathologists can score cases with high concordance."

Biomarker testing has profoundly influenced the practice of both pathology and oncology today. Targeted therapies have seen more than 30% increase from 2019, and more than 50% of targeted therapies currently in clinical trials are being co-developed with a predictive biomarker [1][2]. The Agilent Biomarker Pathologist Training Program will enable pathologists to gain confidence with scoring methodologies to enable the pursuit of the right treatment for patients.

"We are excited to successfully launch the Agilent Biomarker Pathologist Training Program to further support our efforts in the fight against cancer," said Simon Oestergaard, general manager and vice president of Pathology at Agilent. "This program will allow pathologists to learn and practice scoring techniques, to gain the necessary confidence and competence to accurately score biomarker cases in their own laboratories. Combined with Agilent’s high-quality pathology staining solutions this training program will help ensure pathologists can score cases with high concordance."

The program, which will initially be available in Europe and North America, followed by China and Asia, utilizes a digital platform, Pathcore Scholar, where attendees can navigate both standard and challenging cases. For Agilent products with approved indications, the training, supports Agilent biomarkers only and will provide strategies and best practices for delivering optimal scoring results, which will in turn improve patient outcomes. Training will be offered at different levels, from basic to advanced, and both in-person and remotely, to address individual training requirements.