On February 18, 2022 4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical Company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, reported that the Company has determined that the warrants and units assumed by the Company in connection with its March 2021 merger with Longevity Acquisition Corporation should not be recorded as equity instruments, and in accordance with IFRS and US GAAP, should be recorded as derivative liabilities (Press release, 4d Pharma, FEB 18, 2022, View Source [SID1234608319]). While the issues identified are non-cash, and do not impact the cash and cash equivalents, the Company has restated the unaudited interim consolidated financial statements for the six months period ending June 30, 2021.

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 issues disclosed in this release are an accounting technicality and were identified during the Company’s ongoing preparation of its audited financial statements for the year ended December 31, 2021. The restatements do not impact the Company’s cash and cash equivalents, revenues, operating expenses, operating loss, assets, or liquidity for the affected period.

This restatement will apply to the Company’s International Financial Reporting Standards "IFRS" and US Generally Accepted Accounting Principles "GAAP" financial statements for the six months period ending June 30, 2021.The Company’s audited financial statements for the year ended December 31, 2020 are not affected.

IFRS Statements

As previously reported under IFRS, the Company had concluded that the warrants and units were determined to be equity instruments and accounted for under IFRS 2. During the re-assessment and in line with the IFRIC discussion paper dated February 1, 2022 (‘Special purpose acquisition companies (SPAC); accounting for warrants at acquisition’), the Company has reviewed its warrant accounting policies and determined that the rules outlined in IAS 32 may provide a more appropriate treatment than that of IFRS 2. IAS 32 states that equity linked financial instruments must meet a "fixed for fixed" criteria to be accounted for as equity based. As a result of the variation in the strike price currency (USD$) and the Company’s functional currency (GBP£) together with the cashless exercise features, the warrants and units are to be determined as liabilities. Therefore, the Company has decided to reassess its accounting policy, changing the reporting of the warrants and units to liabilities in its restated financials. The restated IFRS financial statements are set out below. The effect on IFRS reporting are as follows:

●Income Statement: Restated comprehensive loss of (£49.2) million compared to (£56.1) million as previously reported. This is a reduction in comprehensive loss of £6.9 million due to the change in fair value of the warrants as of June 30, 2021
●Balance Sheet: Reduction in equity and net assets of £11.5 million, offset by an increase in liabilities of £11.5 million

GAAP Statements

As previously reported under GAAP, the Company had concluded that the warrants and units were indexed to its own stock and were equity based. According to Accounting Standards Codification "ASC" 815-40-15-71, equity linked financial instruments issued with a strike price denominated in a currency (USD$) different than the Company’s functional currency (GBP£) incurs an exposure to changes in currency exchange rates and thus cannot be indexed to the Company’s stock. Therefore, the Company has corrected this issue and will report the warrants and units as derivative liabilities in the Form 6-K to be furnished with the US Securities and Exchange Commission. The effect on GAAP reporting are as follows:

●Income Statement: Restated comprehensive loss of ($24.2) million compared to ($18.5) million as previously reported. This is an increase in comprehensive loss of $5.8 million, due to $11.0 million loss on issuance of securities, partially offset by $5.2 million in the change in fair value of the warrants as of June 30, 2021
●Balance Sheet: Reduction of $5.8 million in stockholder’s equity, offset by an increase in liabilities of $5.8 million

On February 18, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult to treat cancers, reported that the Company will report fourth quarter and full year 2021 financial results on Thursday, February 24, 2022, after market close (Press release, Cytori Therapeutics, FEB 18, 2022, View Source [SID1234608318]). Plus Therapeutics’ management team will then host a conference call and webcast at 5:00 p.m. ET to discuss the financial results and provide a corporate update.

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 will be available at ir.plustherapeutics.com/events

Please refer to the information below for conference call dial-in information. Callers should dial in approximately 10 minutes prior to the start of the call.

Conference Call Name: Plus Therapeutics Fourth Quarter and Full Year 2021 Results Conference Call
Following the live call, a replay will be available on the Company’s website under the ‘Investor Relations’ section. The webcast will be available on the Company’s website for 90 days following the live call.

On February 18, 2022 TransThera Sciences (Nanjing), Inc. ("TransThera") reported that the U.S. Food and Drug Administration ("FDA") approved the Investigational New Drug ("IND") application of TT-01488, a non-covalent reversible Bruton’s Tyrosine Kinase ("BTK") inhibitor, for the treatment of B-cell lymphomas on January 24, 2022, and TransThera will initiate the Phase I clinical trials in the U.S. soon (Press release, TransThera Biosciences, FEB 18, 2022, View Source [SID1234608317]). TransThera also announced that China National Medical Products Administration ("NMPA") officially accepted the IND application of TT-01488 for the treatment of B-cell lymphomas on February 14, 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!

According to Frost & Sullivan, the global and China BTK inhibitor market reached USD7.2 billion and RMB1.3 billion in 2020 respectively. The market is expected to continue to expand in the next 5 years, with the CAGR of 22.7% globally and 58.6% in China from 2020 to 2025. As of 2021, there were 5 BTK inhibitors approved in different markets, all being covalent irreversible BTK inhibitors. The mechanism of action for covalent irreversible BTK inhibitors is to form covalent bond with the C481 site of BTK. However, when C481S mutation occurs, they will not be able to maintain the covalent bond, which eventually leads to drug resistance. Long-term follow-up results for the use of irreversible BTK inhibitors, according to Frost & Sullivan, demonstrate cumulative discontinuation rates as high as 40%, which show the large unmet medical needs.

"Non-covalent BTK inhibitors are not affected by the C481S mutation and are expected to overcome acquired resistance developed from marketed covalent BTK inhibitors. In a head-to-head kinase panel screening, TT-01488 demonstrated higher potency and better kinase selectivity on EGFR and TEC than peer non-covalent reversible BTK inhibitor under clinical investigation, indicating a potentially better safety profile. Moreover, in the DLBCL CDX model, TT-01488 showed a superior antitumor effect compared to peer non-covalent reversible BTK inhibitor." Said Dr. Peng Peng, vice president of project management and head of oncology portfolio at TransThera, "The approval by FDA and the acceptance from NMPA for its IND applications are two important milestones in the development of TT-01488. We will actively cooperate with the regulatory authorities to initiate the clinical trials of TT-01488 globally as soon as possible. "

About TT-01488：

TT-01488 is a non-covalent, reversible BTK inhibitor for overcoming acquired resistance mutation developed from marketed covalent BTK inhibitors in various types of B-Cell lymphomas. In preclinical trials, TT-01488 showed potential advantages such as overcoming drug resistance, improved target selectivity, antitumor efficacy and favorable safety.

On February 18, 2022 Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, and Calyxt, Inc. ("Calyxt"), a majority-owned (61.8% as of December 31, 2021) subsidiary of Cellectis S.A., reported the placement to an institutional investor in an underwritten offering of (i) 3,880,000 shares of Calyxt common stock, (ii) pre-funded warrants to purchase up to 3,880,000 shares of its common stock, and (iii) common warrants to purchase up to 7,760,000 shares of its common stock (the "Offering") (Press release, Cellectis, FEB 18, 2022, View Source [SID1234608315]).

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 shares of common stock and the pre-funded warrants were each sold in combination with corresponding common warrants, with one common warrant to purchase one share of common stock for each share of common stock or each pre-funded warrant sold. The pre-funded warrants will have an exercise price of $0.0001 per share of Calyxt common stock and the common warrants will have an exercise price of $1.41 per share of Calyxt common stock. The pre-funded warrants will be immediately exercisable and remain exercisable until exercised, while the common warrants will be exercisable six months after the date of issuance and will have a term of five years from the date of exercisability. The aggregate public offering price for each share of common stock or each pre-funded warrant and, in each case, an accompanying common warrant was $1.41. All securities sold in the Offering were sold by Calyxt.

In connection with the Offering, Calyxt disclosed certain preliminary estimated financial information as of December 31, 2021: Calyxt’s cash and cash equivalents was $13.7 million, restricted cash was $0.6 million, total current liabilities were $4.1 million, and financing lease obligations, including current portion, were $17.9 million.

This preliminary financial information, which has not been audited, is based on information currently available to Calyxt and is subject to the completion of Calyxt’s year-end financial closing procedures. It is possible that Calyxt’s independent registered public accounting firm may identify items that require Calyxt to make adjustments to the preliminary estimates set forth above and those changes could be material.

In connection with the Offering, Calyxt also provided an updated description of certain aspects of its business (the "Updated Calyxt Business Disclosure") and updated the risk factor disclosure (the "Updated Calyxt Risk Factor Disclosure") from Calyxt’s prior filings with the U.S. Securities and Exchange Commission.

On February 18, 2022 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, developing transformative therapies for patients with cancer and autoimmune diseases, reported Memorial Sloan Kettering Cancer Center’s (MSK) notification to the U.S. Food and Drug Administration (FDA) of a fatal serious adverse event (SAE) associated with a patient treated in the ongoing Phase 1, MSK-conducted dose-escalation clinical study of autologous mesothelin CAR T, ATA2271 (Press release, Atara Biotherapeutics, FEB 18, 2022, View Source [SID1234608314]). MSK has voluntarily paused enrollment of new patients in the study on a temporary basis while additional information regarding the case is gathered and reviewed. The FDA has notified MSK of its agreement with this approach.

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!

ATA2271 is a next-generation, autologous chimeric antigen receptor (CAR) T-cell therapy targeting mesothelin currently under clinical investigation in patients with malignant pleural mesothelioma. The single case involved a patient with a history of multiple malignancies and other comorbidities undergoing treatment for advanced recurrent mesothelioma. MSK is in the process of further evaluating the occurrence, including the extent of the relationship of the event to ATA2271.

"The safety of every patient participating in studies we are funding or conducting is of the utmost priority for Atara," said Jakob Dupont, MD, Head of Global Research & Development at Atara. "Clinical evaluation of the case remains ongoing, and we are working closely with investigators at MSK, who are conducting the ATA2271 study under their IND, to establish the underlying causes of the event. We anticipate providing a further update in the coming weeks following further discussion and consultation with MSK."

The median survival of treated patients with malignant pleural mesothelioma is 9-17 months even with successful completion of a combination of chemotherapy, aggressive surgical resection, and radiation therapy. The first six patients enrolled in the two lowest dose cohorts received either 1×106 cells/kg (patients 1-3) or 3×106 cells/kg (patient 4-6) intrapleural ATA2271. Within these two cohorts, no dose limiting toxicities have been reported to date. The patient event being reported relates to the first patient in a third, higher-dose cohort (6×106 cells/kg).

The temporary pause in ATA2271 study enrollment does not impact the IND-enabling work currently underway to advance ATA3271, a separate, off-the-shelf, allogeneic CAR-T therapy targeting mesothelin using next-generation PD1DNR and 1XX CAR technologies for patients with advanced mesothelioma. ATA3271, ATA3219, tab-cel, and ATA188 all utilize Atara’s allogeneic EBV T-cell platform, the safety and tolerability of which has been validated by clinical studies and experience in approximately 400 patients in various disease areas with no observed cytokine release syndrome (CRS) to date.

MSK Disclosure: MSK has intellectual property rights and associated interests by virtue of licensing agreements between MSK and Atara.