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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, will participate in a fireside chat during the 3rd Annual Evercore ISI HealthCONx Conference (Press release, TG Therapeutics, NOV 30, 2020, https://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-participate-3rd-annual-evercore-isi-healthconx [SID1234571946]). The fireside chat is scheduled to take place on Tuesday, December 1, 2020 at 10:05 AM ET.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source

On November 30, 2020 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, reported that it has commenced an underwritten public offering of $150 million of shares of its common stock (Press release, Intellia Therapeutics, NOV 30, 2020, View Source [SID1234571979]). Intellia also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of common stock offered in the public offering. All of the shares in the proposed offering are to be sold by Intellia.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Goldman Sachs & Co. LLC, Jefferies and SVB Leerink are acting as joint book-running managers for the proposed offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The shares of common stock are being offered by Intellia pursuant to a shelf registration statement that was previously filed with, and subsequently declared effective by, the U.S. Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and may be obtained, when available, from: Goldman Sachs & Co. LLC, by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected]; Jefferies LLC, by mail at 520 Madison Avenue, 2nd Floor, New York, NY 10022, Attention: Equity Syndicate Prospectus Department, by telephone at (877) 547-6340, or by email at [email protected]; SVB Leerink LLC, by mail at One Federal Street, 37th Floor, Boston, MA 02110, Attention: Syndicate Department, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; or by accessing the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On November 30, 2020 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported the completion of its previously-announced sale of a portfolio of select products to Celltrion Inc. ("Celltrion") for a total value of $278 million USD inclusive of milestone payments (Press release, Takeda, NOV 30, 2020, View Source [SID1234571998]). The portfolio includes 18 pharmaceutical products and over-the-counter (OTC) products sold in Asia Pacific, which is part of Takeda’s Growth & Emerging Markets Business Unit. This divestment agreement was first announced in June 2020.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The divested portfolio includes pharmaceutical products and OTC products in the Cardiovascular, Diabetes and General Medicine therapeutic areas, sold in Australia, Hong Kong, Macau, Malaysia, Philippines, Singapore, South Korea, Taiwan and Thailand. The products, while addressing key patient needs in these countries and territories, are outside of the business areas Takeda has chosen as core to its global long-term growth. As part of the deal, Takeda will continue to manufacture the portfolio of divested products and supply them to Celltrion under a manufacturing and supply agreement.

Takeda intends to use the proceeds from the sale to reduce its debt and accelerate deleveraging towards its target of 2x net debt/adjusted EBITDA within Fiscal Years 2021–2023.

Takeda has exceeded its $10 billion non-core asset divestiture target and has announced 10 deals since January 2019 to date for a total aggregate value of up to ~$11.3 billion, including agreements to divest:

Takeda Consumer Healthcare Company Limited to Oscar A-Co KK, a company controlled by funds managed by The Blackstone Group Inc. and its affiliates for a total value of approximately JPY 242.0 billion ($2.3 billion USD).
Other non-core portfolio assets within the Growth & Emerging Markets Business Unit, totaling ~$1.7 billion* with three separate buyers.
Select OTC and non-core assets in Europe to Orifarm for approximately $670 million.
Non-core assets in Europe and Canada to Cheplapharm for approximately $562 million.
The TachoSil Fibrin Sealant Patch to Corza Health, Inc. for approximately €350 million.
Transactions still pending are expected to close by March 31, 2021, subject to customary legal and regulatory closing conditions.

* Including an agreement for $825 million with Hypera S.A. for select non-core products in Latin America which remains subject to close.

On November 30, 2020 MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that it has partnered with EVERSANA, a pioneer of next-generation commercial services to the global life sciences industry, to commercialize margetuximab in the United States, if approved (Press release, MacroGenics, NOV 30, 2020, View Source [SID1234572016]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Margetuximab is an investigational, monoclonal antibody derived from MacroGenics’ proprietary Fc-Optimization technology platform. A Biologics License Application (BLA) for margetuximab for the treatment of patients with pre-treated metastatic HER2-positive breast cancer in combination with chemotherapy is under review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) goal date of December 18, 2020.

"We believe that margetuximab, if approved, could become a valuable treatment option for patients living with this devastating disease," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We are excited to partner with EVERSANA and leverage their integrated commercial services to efficiently launch margetuximab. We have been working closely with EVERSANA to fully align our commercialization strategies to educate healthcare providers and ensure patient access to margetuximab, while maintaining MacroGenics’ cash runway to fund our broader portfolio."

Jim Lang, CEO of EVERSANA, added, "We’ve built a suite of comprehensive commercial services for biopharmaceutical innovators like MacroGenics and look forward to entering this risk-sharing arrangement with MacroGenics to support the commercialization of margetuximab, if approved. Our partnership with MacroGenics puts the patient first by supporting broad market access and comprehensive patient support services. We will work closely with MacroGenics on each stage of the product launch and roll-out."

Under the terms of the agreement, MacroGenics maintains ownership of margetuximab, including all manufacturing, regulatory and development responsibilities for the product. This includes MacroGenics’ continued development of margetuximab in combination with immune checkpoint inhibitors in gastroesophageal cancer in the Phase 2/3 MAHOGANY study, as well as other ongoing studies. EVERSANA receives a co-exclusive right to conduct approved commercialization activities. EVERSANA will utilize its internal capabilities to support sales and marketing, market access, channel management services, data and analytics, medical affairs, and other patient access related services. MacroGenics will book sales for margetuximab. Upon the potential approval of margetuximab, EVERSANA and MacroGenics will equally share in funding EVERSANA’s commercialization expenses. In exchange for co-funding these expenses, EVERSANA will earn future revenue share payments which shall be capped at 125% of EVERSANA’s cumulative service fees. The term of the agreement is five years following the date of FDA approval, subject to predefined termination provisions.

About HER2-Positive Breast Cancer
Human epidermal growth factor receptor 2 (HER2) is a protein found on the surface of some cancer cells that promotes growth and is associated with aggressive disease and poor prognosis. Approximately 15-20% of breast cancer cases are HER2-positive. Antibody-based therapies targeting HER2 have greatly improved outcomes of patients with HER2-positive breast cancer and are now standard of care in both early-and late-stage disease. However, metastatic breast cancer remains an area of unmet need and ongoing HER2 blockade is recommended for the treatment of patients with relapsed or refractory disease.

About Margetuximab
Margetuximab is an Fc-engineered, monoclonal antibody that targets the HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors. Margetuximab was designed to provide HER2 blockade and has similar HER2 binding and antiproliferative effects as trastuzumab. In addition, margetuximab has been engineered to enhance the engagement of the immune system through MacroGenics’ Fc Optimization technology. Margetuximab is also being evaluated in combination with checkpoint blockade in the Phase 2/3 MAHOGANY trial for the treatment of patients with HER2-positive gastroesophageal cancer (NCT04082364), and in combination with tebotelimab (PD-1 × LAG-3 bispecific DART molecule) in various HER2+ indications (NCT03219268). For more information, please visit www.clinicaltrials.gov.