On February 10, 2022 TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") (NASDAQ: TCBP) (NASDAQ: TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and viral indications, reported the pricing of its initial public offering of 4,117,648 American Depositary Shares (the "ADSs") and warrants (the "Warrants") to purchase up to 8,235,296 ADSs, for aggregate gross proceeds of approximately $17.5 million, prior to deducting underwriting discounts, commissions, and other offering expenses (Press release, TC Biopharm, FEB 10, 2022, View Source [SID1234607998]). Each ADS represents one ordinary share, and each Warrant represents the right to purchase one ADS. The ADSs and Warrants will be separately issued, and the ADSs and Warrants will be sold to purchasers only in a combination of one ADS and two Warrants, for a combined aggregate offering price of $4.25. Each Warrant will be immediately exercisable for one ordinary share, that will then be deposited with the custodian for the issuance of a corresponding ADS at an exercise price of $4.25 per ADS, and expire six years after the issuance date.

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!

In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 617,647 ADSs and/or warrants to purchase up to 1,235,294 ADSs, in any combination thereof, at the public offering price per security, less the underwriting discounts and commissions to cover over-allotments, if any.

The Company intends to use the net proceeds from the offering to finance the cost of treating patients under our proposed clinical trials OmnImmune (TCB 008-001), a phase 2b-into-pivotal (phase 3) trial for the treatment of acute myeloid leukemia, and ImmuniStim (TCB 008-002) (for the treatment of viral infections such as COVID-19) and to continue the research and development of our proposed GD-T CAR therapies to treat sold cancers, as well as financing our operating overhead costs, capital expenditure and limited repayment of convertible loan notes.

The offering is expected to close on or about February 15, 2022, subject to satisfaction of customary closing conditions.

The Company has received approval to list its ADSs and Warrants on the Nasdaq Global Market, with its ADSs trading under the symbol "TCBP" and the Warrants trading under the symbol "TCBPW", with trading expected to begin on February 11, 2022.

EF Hutton, division of Benchmark Investments, LLC, is acting as sole book-running manager for the offering.

A registration statement on Form F-1, as amended (File No. 333-260492), was filed with the Securities and Exchange Commission ("SEC") and was declared effective on February 10, 2022. A final prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at View Source Electronic copies of the final prospectus relating to this offering, when available, may be obtained from EF Hutton, division of Benchmark Investments, LLC, 590 Madison Avenue, 39th Floor, New York, NY 10022, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 404-7002.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 February 10, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that it will release its fourth quarter and full-year 2021 financial results on Thursday, February 24, 2022 (Press release, Personalis, FEB 10, 2022, View Source [SID1234607997]). In conjunction with the release, the company will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.

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!

Interested parties may access the live call via telephone by dialing (866) 220-8061 for domestic callers or (470) 495-9168 for international callers, using conference ID: 6877026. The live webinar of the call may be accessed by visiting the Events section of the company’s website at investors.personalis.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

On February 10, 2022 MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for the quarter ended December 31, 2021, and highlighted recent corporate progress (Press release, MEI Pharma, FEB 10, 2022, View Source [SID1234607996]).

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 next few quarters have the makings for a potentially transformational period for MEI Pharma, headlined by complete Phase 2 TIDAL data in follicular lymphoma later in the year, which we believe will provide the foundation to support our plan to submit our first New Drug Application pursuant to the FDA’s Accelerated Approval Program," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "The expanding set of clinical data from the zandelisib program continues to support our plans to leverage zandelisib’s differentiated profile, expand the clinical program into additional indications and promising combination therapy studies, and build its potential as a cornerstone therapy across the B-cell malignancy landscape. With about $186 million in cash at the end of the quarter expected to fund operations through calendar year 2023, we are well positioned to reach key inflection points in our zandelisib clinical programs and build out our commercial infrastructure in the United States, in cooperation with our partner Kyowa Kirin."

"We also remain committed to furthering the clinical development of our other oncology pipeline candidates, voruciclib and ME-344, to evaluate novel combination regimens and the potential to provide improved benefit to patients in need."

Second Quarter Fiscal Year 2022 Financial and Drug Candidate Pipeline Highlights

MEI received a $10 million milestone payment from Kyowa Kirin Co. pursuant to the 2020 global license, development and commercialization agreement between the companies in October 2021. The payment was triggered by the dosing of the first patient in Japan in the Phase 3 COASTAL study and follows the receipt of a $10 million milestone payment from Kyowa Kirin Co. triggered by the dosing of the first patient in the Phase 3 COASTAL study earlier in fiscal year 2022.

MEI Pharma and Kyowa Kirin reported data from the ongoing global Phase 2 TIDAL study evaluating zandelisib as a single agent in patients with relapsed or refractory follicular lymphoma. The data demonstrates:

Overall response rate of 70.3% in the primary efficacy population; the complete response rate was 35.2%.
9.9% of patients discontinued therapy due to a drug related adverse event.
As of the data cutoff date, the data were not sufficiently mature to accurately estimate the final duration of response in the FL primary efficacy population. At that time, the median follow-up time for response was 8.4 months.
The Company announced that the U.S. Food and Drug Administration granted orphan-drug designation to zandelisib for the treatment of follicular lymphoma.

Mr. Sujay Kango, an experienced executive with more than 25 years of experience in the pharmaceutical and biotechnologies industries, joined the Board of Directors.

At the 63rd Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, MEI Pharma presented three posters highlighting data and information from the clinical development programs of oncology drug candidates zandelisib, voruciclib and ME-344.

The Company completed a public offering of common stock resulting in net proceeds to the Company of approximately $48.7 million.

Expected Drug Candidate Pipeline Developments

Zandelisib – Oral PI3K delta inhibitor for the treatment of various B-cell malignancies

Provide a more complete report of the Phase 2 TIDAL data reported on November 30, 2021 intended for an upcoming scientific congress in 2022.
Initiate CORAL, a Phase 2 study evaluating zandelisib plus venetoclax and rituximab in patients with chronic lymphocytic leukemia in the first half of calendar year 2022.
Provide an update from the arm of a Phase 1b study evaluating zandelisib plus zanubrutinib, including in expansion cohorts enrolling patients with relapsed or refractory mantle cell and follicular lymphomas intended for an upcoming scientific congress in 2022.
Report updated data from the Phase 2 TIDAL study arm in follicular lymphoma intended for an upcoming scientific congress in the fourth calendar year quarter of 2022.
Voruciclib – Oral CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia

Initiate Phase 1b study evaluating voruciclib in combination with Venclexta (venetoclax) in patients with acute myeloid leukemia by mid calendar year 2022.
ME-344 – Tumor selective mitochondrial inhibitor

Initiate a Phase 1b study of ME-344 in relapsed colorectal cancer in mid calendar year 2022.
Second Quarter Fiscal Year 2022 Financial Results

As of December 31, 2021, MEI had $185.8 million in cash, cash equivalents, and short-term investments with no outstanding debt.
For the quarter ended December 31, 2021, cash used in operations was $8.6 million, compared to $4.1 million provided by operations for the quarter ended December 31, 2020. The increase in cash used in operations reflects increased development activity in 2021 and changes in working capital balances.
Research and development expenses were $21.5 million for the quarter ended December 31, 2021, compared to $22.2 million for the quarter ended December 31, 2020. The decrease was primarily related to start-up costs for the COASTAL study during the quarter ended December 31, 2020, offset by increased expenses during the quarter ended December 31, 2021 related to voruciclib and ME-344.
General and administrative expenses were $7.9 million for the quarter ended December 31, 2021, compared to $5.7 million for the quarter ended December 31, 2020. The increase primarily relates to personnel costs and professional services and general corporate expenses incurred during the quarter ended December 31, 2021 to support our planned commercial launch of zandelisib.
MEI recognized revenues of $18.2 million for the quarter ended December 31, 2021, compared to $9.2 million for the quarter ended December 31, 2020. The increase in recognized revenue relates to the partial satisfaction of the research and development obligations under the license agreement with Kyowa Kirin.
Net loss was $5.8 million, or $0.05 per share, for the quarter ended December 31, 2021, compared to net loss of $11.5 million, or $0.10 per share for the quarter ended December 31, 2020. The Company had 132,904,545 shares of common stock outstanding as of December 31, 2021, compared with 112,527,860 shares as of December 31, 2020.
The adjusted net loss for the quarter ended December 31, 2021, excluding non-cash expenses related to changes in the fair value of the warrants (a non-GAAP measure), was $11.2 million, compared to an adjusted net loss of $18.5 million for the quarter ended December 31, 2020.

On February 10, 2022 Elpiscience Biopharmaceuticals, Inc. ("Elpiscience"), a global clinical-stage biopharmaceutical company dedicated to discovering and developing next-generation cancer immunotherapies, reported that its co-founder and chief executive officer, Dr. Darren Ji, will participate in a panel discussion about R&D and innovation leading cross-pacific collaboration (Press release, Elpiscience, FEB 10, 2022, View Source [SID1234607995]). The conference takes place at the Marriott Marquis in New York City from February 14 to 15 and virtually through February 17, 2022.

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 panel, titled "What is New in Cross-Pacific Deal Making and Investment?", will take place from 9:00 a.m. to 9:45 a.m. EST Wednesday, February 16, 2022, and will be accessible live to conference registrants.

A recorded Elpiscience presentation will also be available to registered attendees through the event platform beginning February 11.

For additional information, visit BIO CEO & Investor Conference.

On February 10, 2022 TriSalus Life Sciences, an immunotherapy company on a mission to improve the lives of patients living with liver and pancreatic tumors, reported the addition of three new members to its Scientific Advisory Boards and two new members of its clinical leadership team, Drs. Alexander Kim and John Hardaway, as director of interventional oncology clinical strategies and strategic immunotherapy advisor, respectively (Press release, TriSalus Life Sciences, FEB 10, 2022, View Source [SID1234607994]).

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!

Alexander Y. Kim, MD, FSIR, is a nationally recognized vascular and interventional radiologist. Throughout his career, Dr. Kim has led or participated in clinical trials related to the study of liver cancers, uterine fibroids and symptoms of benign prostate hypertrophy. Recognized for his expertise, Dr. Kim has served in leadership positions on professional associations including the Society of Interventional Radiology and the American Board of Radiology. Following his clinical training, which included a research fellowship at Memorial Sloan-Kettering Cancer Center, he served as Chief of the vascular and interventional radiology division at Georgetown University Hospital.

John Hardaway, MD, PhD, is a board-certified general surgeon and surgical oncologist focused on surgical management of gastrointestinal malignancies, including diseases of the liver and pancreas. In addition to his surgical practice, Dr. Hardaway is a trained cellular immunologist with research efforts focused on translational development of CAR-T therapies against solid tumors and regional delivery of immunotherapies to treat solid tumors. He currently serves as a cancer liaison physician on the American College of Surgeons’ Commission on Cancer.

In addition to these hires, Drs. Venu Pillarisetty, Divya Sridhar, and Jordan Tasse have joined TriSalus’ Scientific Advisory Boards. The three new appointments join 10 other preeminent experts—across medical, surgical and radiation oncology, interventional radiology and immunology—who guide and support the company as it aims to transform the way liver and pancreatic tumors are treated through its interventional immunotherapy platform.

"These additions come at a critical point in TriSalus’ growth as we advance work to enable more liver and pancreas tumor patients to benefit from checkpoint inhibitors and other immunotherapeutic agents," said Steven Katz, MD, FACS, chief medical officer at TriSalus and Scientific Advisory Board chairman. "Our advisors represent the integration of key leaders in the medical oncology, surgical oncology and interventional radiology fields who share our vision of overcoming current limitations in immunotherapy treatment success for liver and pancreatic cancers. This collective expertise enhances our focus on overcoming specific immunologic barriers in the liver or pancreas and physical limitations to drug delivery that result in treatment failure."

Venu G. Pillarisetty, MD, FACS, is a board-certified surgical oncologist, professor of surgery at the University of Washington Medical School and medical director for the Continuous Performance Improvement Department at Seattle Cancer Care Alliance. Dr. Pillarisetty specializes in treating pancreatic cancer and his expertise includes both open and minimally invasive surgical techniques. Throughout his career, Dr. Pillarisetty has authored and co-authored over 70 medical publications. His research focuses on the immune response to pancreatic cancer as well as other solid tumors. Dr. Pillarisetty received his medical degree from Columbia University and completed a surgical oncology fellowship at Memorial Sloan-Kettering Cancer Center. He is a fellow of the American College of Surgeons.

Divya Sridhar, MD, is an interventional radiologist and chief of vascular and interventional radiology at Harlem Hospital Center, a Level 1 Trauma Center affiliated with Columbia University Medical Center. Dr. Sridhar’s specialties include image-guided therapies for cancer and many other conditions. She received her medical degree from the University of Miami Medical School and is a board-certified in diagnostic radiology and interventional radiology by the American Board of Radiology.

Jordan C. Tasse, MD, is a vascular and interventional radiologist, an associate professor of radiology, and the director of interventional oncology at Rush University Medical Center. Dr. Tasse received his medical degree from the Chicago Medical School at Rosalind Franklin University of Medicine and Science.

TriSalus’ Scientific Advisory Boards reflect a unique blend of specialties, including clinical expertise on the barriers that prevent optimal delivery and performance of immunotherapeutics when treating liver and pancreatic tumors, as well as clinical research and evaluation of new therapeutics. Additional Scientific Advisory Board members include:

Oncology

Richard D. Carvajal, MD
Christopher Crane, MD
Marlana M. Orloff, MD
Sapna Patel, BA, MD
Vincent Picozzi, MD
Interventional Radiology

Terence Gade, MD, PhD​
Ripal Gandhi, MD​​
Sirish Kishore, MD ​
Rahul Sheth, MD​​
Particularly as the company continues its Pressure Enabled Regional Immuno-Oncology (PERIO)-01 clinical study evaluating the administration of SD-101, an investigational toll-like receptor 9 (TLR9) agonist, via the Pressure Enabled Drug DeliveryTM (PEDD) method, input from leading experts is instrumental. The ongoing study is the first program to evaluate TriSalus’ platform aimed at improving outcomes in liver and pancreatic cancer by delivering SD-101 to the site of disease via an intra-vascular approach through proprietary PEDD method of administration. TriSalus’ immunotherapy platform aims to solve two primary issues that limit the effectiveness of immunotherapy in the liver and pancreas: immunosuppressive pathways dominant in the liver or pancreas and physical barriers to delivery.​

PERIO-01 investigators include Sapna Patel, MD, associate professor of melanoma medical oncology at The University of Texas MD Anderson Cancer Center; Richard Carvajal, MD, director of the melanoma service at Columbia University Irving Medical Center; and Marlana Orloff, MD, associate professor at Thomas Jefferson University Hospital.

For more background, visit www.trisaluslifesci.com/scientific-boards.