On March 31, 2022 Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ: ENSC, OTC: ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety and performance with a current focus on reducing abuse and overdose, reported financial results for the fourth quarter and full year 2021 (Press release, Ensysce Biosciences, MAR 31, 2022, View Source [SID1234611281]).

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Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "Following the successful completion of our convertible note financing of $15 million, providing the necessary funds to advance our clinical trials, the year concluded with an exceptional Company milestone as the first patients were enrolled in the Phase 1 study of PF614-MPAR, the first product utilizing our MPAR platform designed to reduce drug overdose.

"Subsequently, we initiated and recently concluded, the final dosing in the Bioequivalence (BE) trial of our TAAP opioid, PF614. We believe that the BE study data, expected to be available in the second quarter, will position PF614 as our first commercial candidate, fueling our ability to bring a unique pipeline of products to the market aligned with our mission of helping millions suffering with severe pain."

Dr. Kirkpatrick concluded, "Regarding our financial results, it’s important to note that our net loss for the full year consisted of significant non-cash expenses, including $17.9 million related to fair value accounting for warrants and convertible notes. Cash used in operating activities during 2021 totaled $8.2 million."

TAAP (Opioid Abuse Deterrent Program) Updates

On March 21, 2022, the Company concluded the clinical treatment of the Bioequivalence (BE) portion of the PF614-102 trial, which is studying the novel TAAP opioid, PF614. This followed the successful completion of the multi-ascending twice daily dosing part of the study in December 2021.
BE data from the PF614-102 study is expected to be available by the end of the second quarter 2022. The Company believes that the data will support the 505(b)(2) regulatory path for clinical development of PF614, an abbreviated pathway to FDA approval.
Human abuse liability (HAL) studies to determine labeling claims for PF614 are scheduled to initiate in the second quarter of 2022.
PF614 is designed using the abuse protective platform TAAP, a chemical modification which inactivates the active ingredient in Ensysce’s opioid products, including PF614, until swallowed and exposed to the enzyme trypsin in the digestive system. Our TAAP platform, which we believe provides abuse protection and resistance to manipulation and other forms of recreational drug abuse, should also control the rate of release of the active opioid. The 102 study builds on the safety and pharmacokinetic results of the initial Phase 1 study and is designed to improve the understanding of how PF614 compares to currently available commercial products.
MPAR (Opioid Abuse Deterrent and Overdose Protection Program) Updates

PF614-MPAR-101 Phase 1 study initiated dosing of PF614 in combination with trypsin inhibitor nafamostat and the first subjects successfully completed administration of PF614 followed by PF614 with nafamostat.
The study is continuing with additional subjects enrolling to receive PF614 and nafamostat in various combinations through the third quarter of 2022. Safety and pharmacokinetic results are expected by the end of the third quarter 2022.
Financial Results

Cash – Cash and cash equivalents were $12.3 million as of December 31, 2021, as compared to $0.2 million for the same period in 2020. In the fourth quarter of 2021, Ensysce received funding of $10 million under the convertible note financing, bringing the total cash provided by financing activities in fiscal year 2021 to $20.3 million. Cash used in operating activities in 2021 totaled $8.2 million.

Federal Grants – Funding under federal grants was $1.6 million for the fourth quarter of 2021 compared to $0.4 million in the comparable year ago quarter. For the full year 2021, funding under federal grants was $3.5 million compared to $3.9 million for the same period in 2020. The Company successfully increased clinical development activity with our PF614-MPAR overdose protection product, contributing to an increase in federal grant funding in the fourth quarter of 2021.

Research & Development Expenses – R&D expenses were $2.2 million for the fourth quarter of 2021 compared to $1.3 million in the fourth quarter of 2020 and $4.7 million for the year ended December 31, 2021, compared to $4.4 million for the same period in 2020. The increases for both the quarter and full year were primarily the result of increased external research and development costs related to the clinical programs for PF614 and PF614-MPAR.

General & Administrative Expenses – G&A expenses were $1.5 million for the fourth quarter of 2021 and $0.3 million for the fourth quarter 2020 and $18.7 million for the year ended December 31, 2021, compared to $1.2 million for December 31, 2020. The quarterly increase reflects increased costs from operating as a public company in the 2021 period. The full year increase was primarily driven by $11.6 million of non-cash expense for warrants issued in July 2021 related to a $60.0 million share subscription facility. Also contributing to the increase was $1.3 million of non-cash expense for consultants and $1.1 million expense for commitment fees for the share subscription facility.

Other Income (Expense) – Total other income (expense), net was expense of $8.0 million in the fourth quarter of 2021 and income of $1.1 million in the fourth quarter of 2020. For the full year periods, total other income (expense), net was expense of $9.3 million in 2021 and income of $1.5 million in 2020. The increase in net expenses in the 2021 periods results primarily from non-cash fair value adjustments for the convertible notes and related warrants issued in late 2021, which totaled $6.7 million in the fourth quarter of 2021 and $6.3 million for fiscal year 2021.

Net Income (Loss) – Net loss for the fourth quarter was $10.0 million compared to net income of $18,340 for the comparable year ago period. Net loss was $29.1 million for the year ended December 31, 2021, compared to net loss of $0.2 million for the same period in 2020. As noted above, significant components of the net loss are non-cash expenses. For the fourth quarter, $6.7 million of the $10.0 million net loss was for non-cash fair value adjustments related to the convertible notes issued in September and November 2021. For fiscal year 2021, $17.9 million of the $29.1 million net loss resulted from non-cash expenses for fair value of warrants and convertible notes. As we are a clinical stage biotech company, our research and development of, and regulatory approvals for, our product candidates continues, resulting in expected losses for the foreseeable future.
Additional Company Highlights

Announced the appointment of Dr. Linda Pestano as Chief Development Officer on October 15, 2021, to lead the non-clinical drug development activities.
The Company further strengthened its Board of Directors with the appointment of Ms. Lee Rauch on February 28, 2022.
Completed a $15 million convertible note financing, receiving the second tranche of $10 million on November 5, 2021, after receiving the first tranche of $5 million on September 24, 2021.
Corporate Update Conference Call

Management will host a corporate update conference call on Wednesday, April 6, 2022, at 11:00 a.m. Eastern time. The call will conclude with Q&A from participants.

A playback of the call will be available through May 6, 2022 on Ensysce’s Investor Relations website at ir.ensysce.com.

On March 31, 2022 Allist Pharmaceuticals Co., Ltd., reported that the European Lung Cancer Congress (ELCC) published an abstract detailing results from the FURLONG study, a Phase 3 pivotal trial of Ivesa (Furmonertinib) in a first-line setting of patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, ArriVent Biopharma, MAR 31, 2022, https://arrivent.com/ivesa-demonstrates-progression-free-survival-of-over-20-months-in-first-line-setting-for-egfr-mutated-advanced-nsclc/ [SID1234611280]). The FURLONG study demonstrated that first-line treatment with Ivesa resulted in a median progression-free survival (PFS) of 20.8 months and reduced the risk of disease progression or death by 56% compared to Gefitinib.

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The FURLONG study was sponsored by Shanghai Allist Pharmaceuticals Co., Ltd. (hereinafter referred to as "Allist", Stock Code: 688578), and led by Professor Yuankai Shi from Cancer Hospital Chinese Academy of Medical Sciences.

Key Results

FURLONG is a national multi-center, randomized, double-blind, placebo-controlled, Phase 3 study designed to assess the efficacy and safety of Ivesa (Furmonertinib) versus Iressa (Gefitinib) in treatment-naïve patients with locally advanced or metastatic EGFRm NSCLC.

The final results show that the median PFS is significantly prolonged with Ivesa compared to Gefitinib group by 9.7 months (PFS, 20.8 months vs 11.1 months, hazard ratio [HR] 0.44 [95% confidence interval 0.34-0.58], p<0.0001), and the risk of disease progression or death was reduced by 56%. Despite the longer exposure, the incidence of grade ≥ 3 adverse reactions of Ivesa group is still lower than that of the Gefitinib group (11% vs 18%).

The release of breakthrough results of FURLONG study further concluded that first-line Ivesa provided a significant improvement versus the comparator first-generation EGFR-TKI in patients with EGFR-mutated advanced NSCLC. Ivesa is the only third-generation EGFR TKI that showed the primary endpoint PFS value beyond 20 months and the risk of disease progression or death reduced by 56% in a pivotal stage study versus a first-generation EGFR-TKI.

The detail of FURLONG study results will be released in the form of Proffered Paper session at ELCC on March 31, 2022.

Comments from Professor Yuankai Shi, Principal Investigator of FURLONG study, from National Cancer Center/Cancer Hospital Chinese Academy of Medical Sciences:

"Lung cancer is one of the malignant tumors with highest incidence rate and mortality rate in China. The EGFR mutation is the most common driven gene mutation in lung cancer. There is still an unmet clinical demand for the first-line treatment of NSCLC patients harboring EGFR sensitive mutations. The results of the FURLONG study are so exciting that Furmonertinib showed median PFS of 20.8 months as the first line treatment with favorable safety profile, providing an additional and better option for the first-line treatment for patients with locally advanced or metastatic NSCLC harboring EGFR sensitive mutations."

On March 31, 2022 CTI BioPharma Corp. (Nasdaq: CTIC) reported its financial results for the fourth quarter and full year ended December 31, 2021 (Press release, CTI BioPharma, MAR 31, 2022, View Source [SID1234611279]).

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"VONJO’s recent FDA approval establishes a new standard of care for myelofibrosis patients suffering from cytopenic myelofibrosis. With a fully funded commercial launch following the debt and royalty transaction with DRI, we are pleased to provide these patients with a new, efficacious, and safe treatment option," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma. "We believe the launch of VONJO positions CTI for sustained growth as we work towards our mission to make a meaningful impact on the lives of patients with blood-related cancers."

Fourth Quarter Financial Results
Operating loss was $35.4 million and $95.3 million for the three months and year ended December 31, 2021, respectively, compared to operating loss of $14.8 million and $47.8 million for the corresponding periods in 2020. The increase in operating loss for the three months and year ended December 31, 2021 as compared to the comparable periods in 2020 resulted primarily from increases in selling, general and administrative activities related to the growth in our commercial infrastructure and commercial-launch readiness activities in support of commercialization of VONJO, as well as research and development activities related to the continued development of pacritinib.

Net loss for the three months ended December 31, 2021 was $36.8 million, or $0.38 for basic and diluted loss per share, compared to net loss of $15.0 million, or $0.20 for basic and diluted loss per share, for the same period in 2020. Net loss for the year ended December 31, 2021 was $97.9 million, or $1.09 for basic and diluted loss per share, compared to net loss of $52.5 million, or $0.74 for basic and diluted loss per share, for the same period in 2020.

As of December 31, 2021, cash and cash equivalents totaled $65.4 million. As of December 31, 2020, cash, cash equivalents and short-term investments totaled $52.5 million. We expect our current cash and cash equivalents, together with $60.0 million received from DRI Healthcare Trust following FDA approval of VONJO, will enable us to fund our operations into the fourth quarter of 2022.

About Myelofibrosis
Myelofibrosis is bone marrow cancer that results in formation of fibrous scar tissue and can lead to thrombocytopenia and anemia, weakness, fatigue and an enlarged spleen and liver. Within the United States, there are approximately 21,000 patients with myelofibrosis, 7,000 of which have severe thrombocytopenia (defined as blood platelet counts of less than 50 x109/L). Severe thrombocytopenia is associated with poor survival and high symptom burden and can occur as a result of disease progression or from drug toxicity with other JAK2 inhibitors, such as JAKAFI and INREBIC.

On March 31, 2022 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of chronic viral infections, cancer, and other serious diseases, reported financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Silverback Therapeutics, MAR 31, 2022, View Source [SID1234611278]).

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"Upon comprehensive review of our clinical and preclinical data for our TLR8 oncology programs, we have made the decision to discontinue the development of SBT6050 and SBT6290, and focus our resources on SBT8230 for chronic HBV as well as our ImmunoTAC discovery programs," said Laura Shawver, Ph.D., chief executive officer of Silverback. "We would like to thank the investigators and the staff at each of our sites, and most importantly, the patients who participated in our trial and their families."

Business Update and Strategy

SBT6050 and SBT6290 (HER2-TLR8 and Nectin4-TLR8 ImmunoTAC conjugates for oncology)

Silverback has discontinued the SBT6050 development program. In the Phase 1/1b trial, a total of 58 patients were enrolled and received SBT6050 as monotherapy and in combination with a checkpoint inhibitor at dose levels ranging from 0.15 mg/kg through 1.2 mg/kg with the length of patient experience ranging from 2 weeks through 41 weeks. A dose response was observed in serum and intratumoral exposure, and in pharmacodynamic markers, inclusive of data that demonstrates immune activation in biopsies collected from patients after treatment. Further development was discontinued based on limited monotherapy anti-tumor activity and cytokine-related adverse events that limited the dose in combination with pembrolizumab.

SBT6290, comprised of the same linker payload conjugated to a Nectin4 antibody, was expected to show a similar clinical profile and, therefore, this development program was also discontinued.

SBT8230 (ASGR1-TLR8 ImmunoTAC conjugate for chronic HBV)

"Our understanding of TLR8 conjugates in preclinical species and in the clinic provides a lens for interpretation of the preclinical characteristics of SBT8230," said Valerie Odegard, Ph.D., president and chief scientific officer. "The comparative preclinical data between SBT6050 and SBT8230 suggest that the clinical safety, pharmacokinetic and pharmacodynamic profiles for SBT8230 will likely be different than those for SBT6050, given the significant differences in preclinical serum exposures and expected overall conjugate disposition for SBT8230 in patients due to its efficient liver targeting. We continue to advance SBT8230 and are on track to complete a Phase 1 regulatory submission in the fourth quarter of 2022."

SBT8230 is comprised of an ASGR1 monoclonal antibody conjugated to a TLR8 linker-payload and is designed to elicit an anti-viral immune response by targeting TLR8 activation to the liver. ASGR1 is highly expressed in liver and is restricted in its expression to this organ. An anti-viral immune response is achieved through activation of myeloid cells and subsequent indirect activation of B cells and T cells. In non-human-primate studies, SBT8230 demonstrated lower serum exposures compared to SBT6050 due to its efficient localization to liver. Liver-localized TLR8 agonism has the potential to lead to durable responses and possibly seroconversion, an important determinant of functional cure. At the AASLD Liver Meeting 2021, Silverback presented preclinical studies demonstrating that SBT8230 was efficiently delivered to the liver, resulting in myeloid cell activation in the liver but not in the blood. Silverback initiated Phase 1-enabling toxicology studies for SBT8230 in the first quarter of 2022.

ImmunoTAC Discovery Program

Silverback will continue advancement of early-stage discovery research that is focused on exploring different antigen targets, novel linker technologies, and small molecule payloads that expand the reach of the ImmunoTAC platform.

Key Strategic Priorities and Cash Runway Extension

Complete the Phase 1 regulatory submission for SBT8230 in the fourth quarter of 2022
Open enrollment for a Phase 1 single ascending dose study of SBT8230 in healthy volunteers in the first half of 2023
Provide an update on Silverback’s discovery pipeline in the fourth quarter of 2022
Restructure workforce to focus resources on SBT8230 program and discovery pipeline, reducing headcount by 27%
Estimated cash runway extended into the second half of 2026 following strategic prioritization
Dr. Shawver added, "Over the course of the next few days and weeks, we are restructuring our workforce and allocating resources around our new strategic priorities. It will be difficult to part with valued team members who have been so committed to the organization, and I’d like to thank each one of them for their valuable contributions towards our mission to develop the next generation of tissue targeted therapeutics."

Financial Results

For the fourth quarter ended December 31, 2021, Silverback reported a net loss of $23.5 million, compared to a net loss of $13.1 million for the comparable period in 2020. For the year ended December 31, 2021, Silverback reported a net loss of $89.5 million, compared to a net loss of $32.9 million for 2020. Net loss for the fourth quarter and full year of 2021 included non-cash stock-based compensation expense of $5.2 million and $19.2 million, respectively, compared to $2.3 million and $2.6 million for the same periods in 2020, respectively.

Research and development expenses for the fourth quarter ended December 31, 2021 were $15.9 million, compared to $8.8 million for the same period in 2020. For the year ended December 31, 2021, research and development expenses were $61.5 million, compared to $24.6 million for 2020. The increases in Silverback’s research and development expenses for the 2021 periods, as compared to the same periods in 2020, were primarily attributable to an increase in direct costs related to the development of SBT6050 and SBT6290 and direct costs related to SBT8230 and other preclinical research efforts. Silverback also incurred additional personnel-related expenses in 2021 as compared to 2020 as operations grew in support of program advances.

General and administrative expenses for the fourth quarter ended December 31, 2021 were $7.6 million, compared to $4.3 million for the same period in 2020. For the year ended December 31, 2021, general and administrative expenses were $28.1 million, compared to $8.3 million for 2020. The increases in general and administrative expenses for the 2021 periods, as compared to the same periods in 2020, were primarily attributable to an increase in personnel-related expenses due to increased headcount in 2021, including new executives that were new in 2020 being present for a full year in 2021, as well as increases in salaries, bonuses, and stock-based compensation. To a lesser extent, the increase in general and administrative expenses was due to an increase in professional fees primarily attributable to legal, insurance, and outside consultant costs.

As of December 31, 2021, Silverback reported cash, cash equivalents, restricted cash, and investments of $319.1 million, compared to cash and cash equivalents of $386.6 million at December 31, 2020, which is expected to fund operating expenses and capital expenditure requirements into the second half of 2026 following strategic prioritization. As of December 31, 2021, Silverback had 35,133,934 shares of common stock outstanding.

Conference Call and Webcast on Thursday, March 31, 2022 at 5:00 PM ET

Silverback’s management team will host a conference call on Thursday, March 31, 2022 at 5:00 PM ET to discuss the strategic prioritization and corporate update. A live webcast, including slides, can be accessed through the Events section of the Company’s website at View Source An archived replay will be available shortly after the conclusion of the event.

On March 31, 2022 Nykode Therapeutics AS (Euronext Growth (Oslo): NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies, reported that the Board of Directors has approved the Company’s financial statements for 2021 (Press release, Nykode Therapeutics, MAR 31, 2022, View Source [SID1234611277]).

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"2021 was another year of significant progress for Nykode," said Michael Engsig, Chief Executive Officer of Nykode Therapeutics. "We launched our new company name and brand identity, a first step in our journey to become a leading global immunotherapy company. We signed two transformative research licensing agreements with Adaptive Biotechnologies and Regeneron, which will accelerate the development of our technology platform across multiple areas of high unmet need. In addition, we made substantial progress in the development of our oncology and infectious disease pipelines, including dosing the first subjects in our Phase I/II clinical trial of Nykode’s next-generation SARSCoV-2 vaccine candidates. Furthermore, we expanded and evolved the organization to over 100 employees, adding new valuable skills and capabilities to our team. We believe Nykode is wellpositioned to continue to execute on our world-class collaborations and advance our technology platform and clinical programs, and we look forward to sharing updates this year."

Highlights for 2021
• March-Adopted IFRS (International Financial Reporting Standards) and announced initiative to explore a potential listing of its shares on the Nasdaq Global Market in the US
• March – Nykode’s first IND was opened in the VB10.NEO program
• June-Initiated a Phase I/II trial to evaluate two next-generation SARS-CoV-2 virus DNA vaccine candidates to address emerging variants of concern
• July-Entered into worldwide in-licensing agreement with Adaptive Biotechnologies for clinically validated SARS-CoV-2 T cell epitopes to combine in next-generation T cell vaccine candidate to specifically address emerging SARS-CoV-2 variants of concern
• November-First subject dosed in Phase I/II clinical trial with next-generation SARS-CoV-2 vaccine candidates
• November-Nykode announced a change of company name from Vaccibody to Nykode Therapeutics
• November-Entered into multi-target license and collaboration agreement with Regeneron
• December-Announced first subject dosed with its T cell-focused next-generation SARSCoV-2 vaccine candidate

Full year 2021 key figures
• Total operating income of USD 35.8 million in 2021, compared to USD 215.7 million in 2020
• Total operating expenses of USD 46.5 million in 2021, compared to USD 37.4 million in 2020
• Net loss of USD 9.4 million in 2021, compared to a net profit of USD 149.8 million in 2020
• Cash and cash equivalents of USD 216.2 million at year-end 2021, compared to USD 183.9 million at year-end 2020 • Other current financial assets of USD 12.2 million at year-end 2021, compared to USD 24.9 million at year-end 2020 • Total equity of USD 194.1 million at year-end 2021, compared to USD 178.9 million at yearend 2020
• Total assets of USD 265.6 million at year-end 2021, compared to USD 230.0 million at yearend 2020

—The Company’s annual accounts for the financial year 2021, including the financial statements and annual report, are together with the auditor’s report attached to this announcement. Investors and analysts are invited to join a webcast presentation of the 2021 financial results conducted by CEO Michael Engsig and other members of management April 1, 2022, at 11.30 a.m. CET / 5.30 a.m. ET.

An updated corporate presentation will be available in the Investors section of the Company’s website at 7:00 a.m. CET on April 1 at www.nykode.com/investors. The live and archived webcast of the presentation can be accessed in the Investors section of the Company’s website here.