On March 11, 2021 TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from cancer, reported financial results for the fourth quarter ended December 31, 2020 and provided a corporate update (Press release, TCR2 Therapeutics, MAR 11, 2021, View Source [SID1234576474]).

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!

"2020 was a transformative year for TCR2, with initial clinical data on our lead program, gavo-cel, establishing our leadership position in solid tumors. On the back of encouraging RECIST responses in refractory mesothelioma and ovarian cancer, we were able to strengthen our balance sheet and diversify our investor base, extending our cash runway into 2024 to support our goal of saving the lives of cancer patients," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "We now look to accelerate the development of gavo-cel in 2021 by identifying the recommended Phase 2 dose, initiating the expansion portion of the trial and increasing our manufacturing capacity. We will also provide updates on our rapidly growing pipeline, most immediately with preclinical data presentations at the AACR (Free AACR Whitepaper) conference on our allogeneic mesothelin TRuC and our CD70 autologous TRuC."

Recent Developments

TCR2 reported a 38% Overall Response Rate with three RECIST partial responses (PRs) (2 confirmed and 1 unconfirmed PRs) from patients in the dose escalation portion of the gavo-cel Phase 1/2 clinical trial, including the first ovarian cancer patient to ever achieve a PR with an engineered cell therapy and one mesothelioma patient achieving a complete metabolic response.
TCR2 completed an upsized $140M follow-on offering.
TCR2 announced preliminary safety and efficacy data with a focus on translational data of gavo-cel in patients with treatment refractory mesothelin overexpressing solid tumors will be presented in an e-poster presentation at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting on Saturday, April 10, 2021.
TCR2 continues to treat patients in the dose escalation portion of the TC-110 Phase 1/2 clinical trial.
TCR2 announced new preclinical data from its allogeneic TRuC-T cell targeting mesothelin highlighting a lack of alloreactivity, reduced risk of host rejection, upregulation of activation markers, secretion of cytokines and clearance of tumors cells will be presented in an e-poster presentation at the AACR (Free AACR Whitepaper) Virtual Annual Meeting on Saturday, April 10, 2021.
TCR2 announced new preclinical data from its TRuC-T cell targeting CD70 highlighting T cell expansion, improved memory phenotype, significant anti-tumor efficacy in multiple xenograft mouse models with no evidence of in vivo fratricide will be presented in an e-poster presentation at the AACR (Free AACR Whitepaper) Virtual Annual Meeting on Saturday, April 10, 2021.
TCR2 announced the appointment of Shawn Tomasello to its Board of Directors. Ms. Tomasello served as Chief Commercial Officer of Kite Pharma where she oversaw the global commercialization of Yescarta, from 2015 to 2018 including through its acquisition by Gilead for $11.9 billion in October 2017.
Anticipated Milestones

TCR2 to present additional safety, efficacy and translational data from the Phase 1 portion of the gavo-cel Phase 1/2 clinical trial for patients with mesothelin-expressing solid tumors throughout 2021.
TCR2 to present an interim update from the Phase 1 portion of the TC-110 Phase 1/2 clinical trial for patients with CD19+ non-Hodgkin lymphoma or adult acute lymphoblastic leukemia in 2021.
TCR2 plans to file an IND for TC-510, the first enhanced TRuC-T cell targeting mesothelin with a PD-1:CD28 switch, in 2021.
TCR2 plans to select a development candidate for its allogeneic program in 2021.
TCR2 anticipates additional pipeline updates throughout 2021.
TCR2 anticipates production of gavo-cel clinical trial material from ElevateBio in 2021.
TCR2 anticipates MHRA certification of its manufacturing facility in Stevenage, UK, in mid-2021.
Financial Highlights

Cash Position: TCR2 ended 2020 with $228.0 million in cash, cash equivalents, and investments compared to $158.1 million as of December 31, 2019. Year-end 2020 cash balance does not reflect gross proceeds of $140 million from our equity offering in January. Net cash used in operations was $56.7 million for 2020 compared to $41.4 million for 2019. TCR2 projects net cash use of $80-90 million for 2021.

R&D Expenses: Research and development expenses were $52.0 million for 2020 compared to $37.5 million for 2019. The increase in R&D expenses is primarily related to increase in headcount, activities related to the Phase 1/2 clinical trial of gavo-cel and activities related to the Phase 1/2 clinical trial of TC-110.

G&A Expenses: General and administrative expenses were $16.7 million for 2020 compared to $13.9 million for 2019. The increase in general and administrative expenses was primarily due to an increase in personnel costs.

Net Loss: Net loss was $67.1 million for 2020 compared to $47.6 million for 2019, driven predominantly by increased personnel expenses.

On March 11, 2021 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that it will report its fourth quarter and full year 2020 financial results and operational highlights on Thursday, March 18, 2021 (Press release, RedHill Biopharma, MAR 11, 2021, View Source [SID1234576473]).

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 Company will host a conference call and webcast on Thursday, March 18, 2021, at 8:30 a.m. EDT, during which it will present key highlights for the full year of 2020, including:

Full-year 2020 financial performance;
Commercial activities;
The ongoing Phase 2/3 studies for COVID-19 with opaganib and RHB-107;
The Phase 3 study of RHB-204 as an oral first-line treatment for pulmonary nontuberculous mycobacteria (NTM) disease

The webcast and slides will be broadcast live on the Company’s website, View Source, and will be available for replay for 30 days.

On March 11, 2021 Bristol Myers Squibb (NYSE:BMY) reported that it will announce results for the first quarter of 2021 on Thursday, April 29, 2021 (Press release, Bristol-Myers Squibb, MAR 11, 2021, View Source [SID1234576472]). During a conference call at 9 a.m. ET on April 29, 2021, company executives will review financial results and address inquiries from investors and analysts.

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!

Investors and the general public are invited to listen to a live webcast of the call at View Source or by dialing in the U.S. toll free 800-458-4121 or international +1 313-209-6672, confirmation code: 3705525, or using this link which becomes active 15 minutes prior to the scheduled start time and entering your information to be connected. Materials related to the call will be available at the same website prior to the conference call. A replay of the call will be available beginning at 12:30 p.m. ET on April 29 through 12:30 p.m. ET on May 13, 2021. The replay will also be available through View Source or by dialing in the U.S. toll free 888-203-1112 or international 719-457-0820, confirmation code: 3705525.

On March 11, 2021 Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, reported financial results for the full-year ended December 31, 2020 and provided a corporate update (Press release, Addex Therapeutics, MAR 11, 2021, View Source [SID1234576471]).

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!

"We ended 2020 in a strong financial position, which was supplemented by our successful $11.5 million fundraising at the beginning of 2021," said Tim Dyer, CEO of Addex. "Throughout 2020, we advanced preparations for the start of clinical studies targeting large underserved market opportunities. Clinical studies starting in the first half of 2021 include two internal programs, dipraglurant in Parkinson’s disease LID and blepharospasm. Additionally, our partner, Janssen is expected to start clinical studies with ADX71149 for epilepsy in the second quarter. Our collaboration with Indivior continues to move forward at a rapid pace and expect to deliver compounds for IND enabling studies by the end of this year."

Select Upcoming Milestones:

Q2 21 – Phase 2a study starting: ADX71149 for epilepsy. Partnered with Janssen
H1 21 – Phase 2b/3 study starting: dipraglurant for Parkinson’s disease LID (Uncontrolled, involuntary muscle movement)
H1 21 – Phase 2a study starting: dipraglurant for blepharospasm (Uncontrolled squeezing or twitching of the eyelids)
Q4 21 – Phase 2a data: dipraglurant for blepharospasm
H1 22 – Phase 2a data: ADX71149 for epilepsy
Q4 22 – Phase 2b/3 data: dipraglurant for Parkinson’s disease LID (PD-LID)
2020 Operating Highlights:

Ended 2020 with a strong cash position of $20.2 million (CHF 18.7 million), coupled with an additional $11.5 million fundraising on January 11, 2021, provides runway till mid 2022
Ensured dipraglurant is ready to start pivotal registration study in levodopa induced dyskinesia associated with Parkinson’s disease (PD-LID) following delay due to the global Covid-19 crisis; study initiation expected H1 2021
Prepared dipraglurant exploratory placebo-controlled clinical trial in blepharospasm patients, which is scheduled to start in H1 2021
Partner, Janssen prepared the start of a Phase 2a proof of concept clinical study of ADX71149 for epilepsy, which is scheduled to start in Q2 2021
GABAB PAM research program entered clinical candidate selection phase
Extended research agreement with Indivior until June 30, 2021, with a commitment for an additional funding of $2.8 million
Awarded CHF600K Innosuisse grant in collaboration with SIB (Swiss Institute of Bioinformatics) to identify new therapeutic indications for ADX10061 (D1 antagonist) program
Appointed Darryle D. Schoepp, PhD, one of the world’s leading and most successful neuroscience drug developers as Chairman newly formed scientific advisory board
Advanced Eurostars / Innosuisse funded mGlu7 negative allosteric modulator research program for post-traumatic stress disorder
Continue to advance remaining preclinical programs to their next value inflection points
Listed American Depositary Shares (ADS) representing our ordinary shares on the Nasdaq Stock Market on January 29, 2020
Financial Summary:
Income increased by CHF 1.0 million to CHF 3.9 million in 2020 compared to CHF 2.8 million in 2019, primarily due to amounts received under the licensing and research agreement with Indivior, recognized as related costs are incurred.

R&D expenses decreased by CHF 2.1 million to CHF 10.4 million in 2020 compared to CHF 12.4 million in 2019, primarily due to delays in starting certain clinical development activities due to the global coronavirus pandemic. R&D expenses consist primarily of costs associated with research, preclinical and clinical testing, and related staff costs. They also include depreciation of laboratory equipment, costs of materials used in research, costs associated with renting and operating facilities and equipment, as well as fees paid to consultants, patent costs and other outside service fees and overhead costs. These expenses include costs for proprietary and third-party R&D.

G&A expenses increased by CHF 0.7 million to CHF 5.7 million in 2020 compared to CHF 5.0 million in 2019 mainly due to the increase of CHF 1.3 million relating to increased directors and officer’s liability insurance premiums partially offset by a decrease of CHF 0.5 million in audit and legal fees.

The net loss for 2020 was CHF 12.9 million compared to CHF 14.8 million for 2019 primarily due to the decrease in R&D costs. Basic and diluted loss per share decreased to CHF 0.48 for 2020, compared to CHF 0.56 for 2019.

Cash and cash equivalents amounted to CHF 18.7 million at December 31, 2020 compared to CHF 31.5 million at December 31, 2019. This decrease of CHF 12.8 million is mainly due to the net loss.

2020 Condensed Consolidated Interim Financial Statements:
The full-year 2020 financial report can be found on the Company’s website in the investor/download section here.

Conference Call Details:
A conference call will be held today, March 11, 2021, at 16:00 CET (15:00 GMT / 10:00 EST / 07:00 PST) to review the financial results. Tim Dyer, Chief Executive Officer, Roger Mills, Chief Medical Officer and Robert Lütjens, Head of Discovery Biology will deliver a brief presentation followed by a Q&A session.

On March 11, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the titles and authors of the two abstracts/posters that were accepted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, which will be held in a virtual format from April 10-15, 2021 (Press release, Greenwich LifeSciences, MAR 11, 2021, View Source [SID1234576470]).

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 AACR (Free AACR Whitepaper) plans to publish the abstracts on April 9, 2021 at 12:01 am EST and the posters on April 10, 2021.

Snehal Patel, CEO of Greenwich LifeSciences, commented, "The first AACR (Free AACR Whitepaper) abstract and poster will focus on the final 5 year analysis of the immune response over time for all patients in our Phase IIb clinical trial. The immune response data will be critical to finalizing the Phase III clinical trial design, including the interim analysis and immune response monitoring strategy. For example, one could conceivably monitor the quality of dosing at each clinical site by monitoring immune response by clinical site, as well as assess immune response by multiple HLA types, separating responders from non-responders."

Mr. Patel further added, "Sufficient manufacturing progress has been made in the 1st quarter of 2021, such that the completion of GP2 manufacturing is planned for 2nd/3rd quarter of 2021. Thus, with the updated AACR (Free AACR Whitepaper) data and finalization of the clinical trial protocol and with the shipment of GP2 drug product to clinical sites, enrollment of the first patients in the Phase III clinical trial could commence in the 3rd/4th quarter of 2021."

Mr. Patel concluded, "In addition to our strategy for HER2/neu 3+ patients stated above, analysis of the immune response data in the HER2/neu low to intermediate expressing (HER2/neu 1-2+) patient populations in our Phase IIb clinical trial may be helpful in designing strategies to treat these patients, which include triple negative breast cancer patients, an area of substantial unmet need. It may be possible to design trials that combine GP2 and Herceptin antibody drug conjugates (ADCs) with other clinically active HER2/neu peptides and immune stimulating therapies, such as checkpoint inhibitors. This multi-technology strategy could also be used to treat the many other types of HER2/neu expressing cancers."

Final 5 Year Recurrence Rate / Disease Free Survival Data: In December 2020, the Company presented the Phase IIb clinical trial efficacy data, including clinical outcome and recurrence rate data. The Kaplan Meier analysis of disease free survival for HER2/neu 3+ patients treated with GP2 immunotherapy showed 100% disease survival over 5 years of follow-up (0% breast cancer recurrences, p = 0.0338) if the patients received their primary GP2 treatments following surgery and Herceptin treatment.

Final 5 Year Immune Response Data: At the upcoming AACR (Free AACR Whitepaper) 2021 conference, in the first abstract and poster, the Company will present the Phase IIb clinical trial final 5 year immune response data over time across all patient populations to complement the December 2020 efficacy data. The immune response is the primary mechanism of action that is critical to developing dosing and booster treatment strategies designed to achieve and sustain peak immunity. The presentation will include analysis of delayed type hypersensitivity skin tests and immunological assays used to measure immune responses for both HER2/neu 3+ and HER2/neu 1-2+ patient populations, such as a comparison of peak immune response versus baseline immune response at multiple time points.

Final 5 Year Safety Data: At a future conference in 2021, the Company plans to present the Phase IIb clinical trial final 5 year safety data. To date, the Company has administered GP2 immunotherapy to 138 patients in four clinical trials, where no serious adverse events and a well tolerated safety profile have been reported.

Updated Phase III Clinical Trial Design: At the upcoming AACR (Free AACR Whitepaper) 2021 conference, in the second abstract and poster, the Company and the Baylor College of Medicine will present the updated design of the planned Phase III clinical trial. The clinical trial is designed as a single registration trial that will include an interim analysis seeking conditional marketing approval from the FDA upon the interim analysis data read out followed by the submission of a Biologics Licensing Application (BLA). Additional features of the clinical trial design will be presented to breast cancer key opinion leaders as the Company and the Principal Investigators recruit clinicians and clinical sites for participation in the Phase III clinical trial.

The numbers, titles, and authors of the Company’s abstracts and E-posters are as follows:

Abstract/Poster Number & Title: CT183 – Final five year median follow-up data from a prospective, randomized, placebo-controlled, single-blinded, multicenter, phase IIb study evaluating a time series of immune responses using HER2/neu peptide GP2 + GM-CSF vs. GM-CSF alone after adjuvant trastuzumab in HER2 positive women with operable breast cancer

Authors can be viewed here: View Source!/9325/presentation/5254

Abstract/Poster Number & Title: CT256 – A prospective, randomized, multicenter, double-blinded, placebo-controlled phase III trial of the HER2/neu peptide GP2 + GM-CSF versus bacteriostatic saline/WFI placebo as adjuvant therapy after any trastuzumab-based therapy in HER2-positive women with operable breast cancer

Authors can be viewed here: View Source!/9325/presentation/4862

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.