On March 31, 2022 Carina Biotech reported that we have submitted a pre-IND (Investigational New Drug) application to the US FDA (Food & Drug Administration) for our CAR-T therapy that targets a cancer stem cell antigen known as LGR5 (Press release, Carina Biotech, MAR 31, 2022, View Source [SID1234611333]).

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This represents a major step towards taking our CAR-T cell (CNA3103) into a Phase I/IIa clinical trial in patients with advanced colorectal (bowel) cancer later this year.

HIGHLIGHTS

A pre-IND package submission comes before a pre-IND meeting with the FDA, which will occur on 26 April
The next step will be the full IND application anticipated at the end of September 2022
Carina’s LGR5 CAR-T cells are targeted at LGR5, a cancer stem cell marker that is highly expressed on colorectal cancer (and other cancers)
Colorectal cancer is the deadliest cancer for Australians aged 25-34 and Australia’s second deadliest cancer overall
More than $US1 billion was earned by CAR-T therapy products in 2020*; and revenue of $US20.3 billion is forecast for 2028**
Carina Biotech CEO, Dr Deborah Rathjen said:

"Submitting our pre-IND package to the FDA is a milestone achievement for Carina as we transition from a discovery-stage pre-clinical company to a clinical-stage company, addressing unmet clinical needs in the treatment of solid cancers using our proprietary CAR-T technology to generate effective therapies that harness the power of the immune system."

Colorectal cancer is the third most commonly diagnosed cancer in Australia and in the United States, and the second leading cause of cancer deaths in Australia.

Metastatic colorectal cancer represents a significant unmet clinical need and has a large market potential. The therapeutics market is estimated at US$10.4 billion pa, growing at 4.6% pa.***

New CAR-T product approvals are anticipated to expand to an addressable patient population of 2 million within the next 10 years****, with solid tumours anticipated to account for more than 50% of CAR-T revenues by 2030*****.

About Carina’s LGR5 CAR-T cell
LGR5 is a cancer stem cell marker that is highly expressed on advanced colorectal cancer and some other cancers. In colorectal cancer patients, LGR5+ expression has been correlated with a particularly poor prognosis.

Cancer stem cells are a small sub-population of cells within a tumour with the ability to self-renew, differentiate into the many cell types of a tumour, initiate new tumours, and resist chemotherapy and radiotherapy (leading to relapses).

By targeting cancer stem cells, it is hoped that this therapy will reduce the tumour’s ability to generate new cancer cells, resulting in durable tumour suppression and preventing the relapses that are very common in patients with colorectal cancer.

Carina’s pre-clinical studies of the LGR5-targeted CAR-T cell have shown highly promising results with complete tumour regression and no tumour recurrence. They have also demonstrated impressive tumour access and prolonged CAR-T cell survival.

REFERENCES
*Yescarta and Kymriah market size estimates calculated from various publicly available sources. Estimates vary and different analyses may give different results. Estimated cost of goods US$58,200 (range $40,000-$106,000, 2018) with pricing outcomes/value based.
** Grandview Research, ‘T-cell therapy market size, share and trends analysis’, Feb 2021.
*** Calculated as the average of estimates published by Reportlinker, BCC Research and Nature Reviews Drug Discovery. Estimates vary and other analyses may give different results. Prevalence data is for US cases only.
**** Grandview Research, ‘T-cell therapy market size, share and trends analysis’, Feb 2021.
***** Polaris Market Research, ‘CAR-T cell therapy market share, size trends, industry analysis report’, June 2021.

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 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a biopharmaceutical company developing and commercializing specialty products for allergy, opioid overdose, respiratory and inflammatory disease, reported financial results for the year ended December 31, 2021 (Press release, Adamis Pharmaceuticals, MAR 31, 2022, View Source [SID1234611297]).

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"We managed to achieve all of our internal objectives for 2021," stated Dennis J. Carlo, Ph.D., President and Chief Executive Officer of Adamis Pharmaceuticals. "Included among them, we began enrolling patients in a Phase 2/3 clinical trial evaluating Tempol as a treatment of COVID-19, resubmitted our NDA for ZIMHI and subsequently received FDA approval."

Product and Pipeline Updates and Other Corporate Developments

ZIMHI

•In October 2021, the U.S. FDA approved ZIMHI TM (naloxone HCL Injection, USP) 5 mg/0.5 mL for the treatment of opioid overdose.

•Drug overdoses are now the leading cause of death for Americans under age 50. Powerful synthetic opioids, like fentanyl and its analogues, are responsible for approximately 85% of all opioid overdose related deaths in the U.S.

•According to the Centers for Disease Control and Prevention (CDC), drug overdoses resulted in over 100,000 deaths in the U.S. during the 12-month period ending April 2021, which was a 29% increase over the prior year.

•Earlier today, Adamis and our U.S. commercial partner, US WorldMeds, jointly announced the nationwide commercial launch of ZIMHI.

SYMJEPI

•Despite the challenges posed by the pandemic and related lockdowns, Symphony Health data indicates SYMJEPI retail scripts increased approximately 115% and total unit sales increased approximately 124% in 2021, compared to the same period of 2020.

•On March 21, 2022, Adamis announced a voluntary recall of certain lots of SYMJEPI. The recall is being conducted with the knowledge of the FDA.

•Manufacturing of SYMJEPI is on hold pending the results of an investigation currently underway to determine the root cause. The Company anticipates a resolution and resumption of manufacturing after the investigation is completed and any issues are satisfactorily addressed.

TEMPOL

•In September 2021, the first patient was enrolled into the Company’s ongoing Phase 2/3 clinical trial of Tempol as a treatment for COVID-19. As of today, 140 patients have been enrolled in the clinical trial.

•On March 11, 2022, the Data Safety Monitoring Board (DSMB) overseeing the Tempol trial met to evaluate the clinical and safety data from the first planned interim analysis. Following their evaluation, the DSMB recommended that the study continue without modification.

•In addition to the work in COVID, the Company is exploring additional indications for the use of Tempol including, but not limited to the treatment of asthma, long COVID and methamphetamine use disorder.

US COMPOUNDING

•During July 2021, the Company sold assets relating to its US Compounding human compounding pharmacy business. Adamis expects to receive monthly payments over a 12-month period in an amount equal to one to two times the amount collected for sales of products to certain identified customers included in the sale.

•The Company is continuing a process of selling or otherwise disposing of the remaining assets of US Compounding.

Financial Results

Despite the significant increase in retail scripts for, and unit sales of, SYMJEPI in 2021 compared to 2020, reported net revenues from continuing operations for the year ending December 31, 2021 were $2.2 million compared to $2.8 million in 2020, reflecting the effect and impact of a $2.0 million reserve reflected in the Company’s financial statements related to the SYMJEPI recall.

As a result of the SYMJEPI voluntary recall in March, we have reserved approximately $2.0 million as a reduction of revenue for the year ended 2021. The company may recover some or all of the cost of the recall from certain third parties under the terms our manufacturing agreements, but the amount of the cost and recovery cannot be determined at this time.

Selling, general and administrative expenses for the years ending December 31, 2021 and 2020 were $16.1 million and $20.1 million, respectively. The decrease was primarily attributable to the reduction in expenses related to legal, compensation related to employee terminations, including forfeitures of stock compensation, and depreciation and amortization.

Research and development expenses were approximately $11.3 million and $8.0 million for the years ending December 31, 2021 and 2020, respectively. The increase in R&D expense was primarily due to development costs related to ZIMHI and Tempol.

Net loss from discontinued operations for the twelve months ended December 31, 2021, and 2020 was $11.2 million and $13.5 million, respectively. The decrease in loss was primarily due to the offset by the gain from the sale of assets.

Cash and equivalents as of December 31, 2021, totaled approximately $23.2 million. In 2022, the Company expects to receive additional proceeds resulting from amounts payable to Adamis pursuant to the sale of certain of the USC assets to Fagron and from the disposition of the remaining USC assets which includes the land, the building, the machinery and the equipment.

Conference Call

Adamis will host a conference call and live webcast today, March 31, 2022, at 2 p.m. PT (5 p.m. ET) to discuss its financial and operating results for the year ended December 31, 2021, as well as provide an update on business developments and activities.

A live audio webcast of the conference call will also be available via this link – View Source;tp_key=857fdc0361. If you are unable to participate in the live call, a replay will be available shortly after the live event. To listen to the replay please visit the events page of the Adamis investor relations section of the company website at View Source

On March 31, 2022 Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, reported that testing of 150 patients has been completed in the ongoing clinical trial for Chinese National Medical Products Administration (NMPA) approval (Press release, Guided Therapeutics, MAR 31, 2022, View Source [SID1234611315]). The trial is underway at four sites in China. The trial is expected to be completed in the second quarter of this year and submitted for approval shortly thereafter.

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In addition, the Company’s Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation (SMI), made a scheduled milestone payment to the Company of $177,740. A portion of these funds will be used to supply SMI with LuViva devices and parts. According to SMI, both the interim safety and accuracy results of LuViva justify the completion of the clinical study and submission of the data to the NMPA as soon as practicable.

"We are pleased to hear that LuViva has performed well and as expected in the first clinical trials in China," said Gene Cartwright, CEO of Guided Therapeutics. "We look forward to a speedy conclusion and filing of study results with the Chinese regulatory authorities."

On March 31, 2022 Fresenius Kabi reported that it has agreed to acquire a stake of 55% of mAbxience Holding S.L. ("mAbxience") (Press release, Fresenius, MAR 31, 2022, View Source [SID1234611221]). The purchase price will be a combination of €495 million upfront payment and milestone payments, strictly tied to the achievement of commercial and development targets. The contractual provisions also include a put / call option scheme regarding the current owners’ remaining shares in mAbxience (45%).

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mAbxience is a leading international biopharmaceutical company, focused on the rapidly developing biosimilars market. The company was founded in 2010 by Dr. Hugo Sigman and Dr. Silvia Gold as the biotechnology division of Insud Pharma S.L. mAbxience has established itself as a leader in the development and manufacturing of biological drugs, with two commercialized biosimilar products (Rituximab and Bevacizumab) and a mid-single-digit number of molecules across immunology and oncology expected to be launched globally in the years 2024 to 2029. This is supported by internal R&D laboratories and state-of-the-art manufacturing facilities in Spain and Argentina. In addition to highly competitive production costs for the internal programs, the manufacturing platform allows mAbxience to offer third party biological CDMO services, including a recent contract with AstraZeneca to produce the drug substance for its COVID-19 vaccine in Latin America. The company currently employs approximately 600 staff and generated sales of approx. €255 million in 2021.

The acquisition of a majority stake in mAbxience follows Fresenius Kabi’s recently unveiled Vision 2026 strategy, delivering on one of the core growth vectors – to "Broaden Biopharma" – by expanding along the value chain and further enhancing the existing Fresenius Kabi biosimilars pipeline.

Fresenius Kabi expects, through its in-house biosimilars programs and through its investment in mAbxience, to capture an overproportionate share of the underlying rapid growth in the biopharmaceutical market. Fresenius Kabi’s footprint in biopharmaceuticals will be significantly strengthened by broadening its biosimilars portfolio and by gaining access to the distinctive manufacturing capabilities of mAbxience. It will also allow Fresenius Kabi to provide end-to-end integrated biopharmaceutical solutions for customers from its state-of-the-art facilities.

mAbxience operates three state-of-the-art facilities for the production of biologic drug substance. This addresses a critical gap in Fresenius Kabi’s value chain, adding flexible, single-use biologic drug substance capacity that can be leveraged to provide competitive cost of production for the enlarged biosimilars portfolio. This manufacturing capability also offers end-to-end integrated biopharmaceutical solutions for customers and thus establishes a strategic foothold for Fresenius Kabi in the fast-growing biologic CDMO sector, complementing the existing small molecule API and fill & finish operations.

Once completed, the transaction is expected to deliver material operating and cost synergies for Fresenius Kabi, primarily driven by leveraging mAbxience’s manufacturing capabilities for Fresenius Kabi’s existing biosimilars business.

The transaction remains subject to regulatory approvals and other customary closing conditions and is expected to close by mid-2022.

Ivenix strengthens Fresenius Kabi’s MedTech business and accelerates growth

Delivers on core growth vector "Expand MedTech" of Vision 2026
Provides next-generation infusion therapy platform for U.S. market
Complements Fresenius Kabi’s global infusion therapy offering
Provides Fresenius Kabi with key capabilities in hospital connectivity and creates new options for growth of MedTech business
Significant scale and growth synergies expected
Fresenius Kabi announced today that it has agreed to acquire Ivenix, Inc. („Ivenix"), a specialized infusion therapy company. The purchase price will be a combination of US$240 million upfront payment and milestone payments, strictly linked to the achievement of commercial and operating targets.

Ivenix is a privately held company based in North Andover, Massachusetts, USA. The company has developed the technologically most advanced infusion system including a large volume pump ("LVP") with administration sets, infusion management software tools, applications and analytics to inform care and advance efficiency. The Ivenix Infusion System’s innovative design and architecture sets a new standard in infusion safety, simplicity and interoperability. The system is centred around the patient and clinician and is designed to reduce infusion-related errors and drive down the total cost of ownership. After having received the U.S. Food and Drug Administration’s (FDA) approval, the Ivenix Infusion System was successfully launched in late 2021.

Ivenix’ Infusion System provides access to attractive growth potential for Fresenius Kabi in the large and growing infusion therapy market. The combination of Ivenix’ leading hardware and software products with Fresenius Kabi’s offerings in intravenous fluids and infusion devices will create a comprehensive and leading portfolio of premium products, forming a strong basis to enable sustainable growth in the high-value MedTech space.

The transaction is subject to regulatory approvals and other customary closing conditions and is expected to close by mid-2022.

Financing and implications on Group financials

mAbxience is expected to be accretive to Group cash earnings per share (earnings before amortization and integration costs) right after closing. Ivenix is expected to be neutral to Group cash earnings per share in 2025 and accretive from 2026 onwards.

Combined, these acquisitions are expected to be broadly neutral to Group cash earnings per share in 2022 and accretive as of 2023.

The transactions are currently expected to be financed by cash flow and available liquidity.

Conference Call

A telephone conference on the acquisition of a majority stake in mAbxience Holding S.L. and the acquisition of Ivenix, Inc. will be held on March 31, 2022 at 1:30 p.m. CEST (7:30 a.m. EDT). All investors are cordially invited to follow the conference call in a live broadcast over the Internet at www.fresenius.com/investors. Following the call, a replay will be available on our website.