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 30, 2022 BiomX Inc. (NYSE American: PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, reported financial results, and provided a business update for the fourth quarter and full year ended December 31, 2021 (Press release, BiomX, MAR 30, 2022, View Source [SID1234611200]).

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"BiomX is now entering the most exciting period in its history, with proof-of-concept clinical data readouts expected in the cystic fibrosis and atopic dermatitis programs within the next 12 months," said Jonathan Solomon, Chief Executive Officer of BiomX. "We are also approaching this data-rich period in good financial condition, as our existing cash runway is expected to take us until at least the end of 2023, and additional tranches that might become available to us under our venture debt facility may further extend our cash runway to the first half of 2024. We are also pleased that both the atopic dermatitis (AD) and cystic fibrosis (CF) programs have attracted equity investments in BiomX common stock from Maruho Co. Ltd. and the Cystic Fibrosis Foundation, respectively."

"Looking ahead, investors can expect our first data readout from the Phase 1b/2a cystic fibrosis program in the third quarter of 2022, which should provide valuable insights into the safety, tolerability and potential treatment effects of BX004. We also anticipate initial clinical data in the fourth quarter of this year for our Phase 1/2 atopic dermatitis product candidate, BX005. Recall that our core mission at BiomX is to develop innovative treatments with the potential to advance the current standard of care. Both our CF and AD programs reflect this potential, and we look forward to providing updates from the BX004 and BX005 programs later this year."

RECENT CORPORATE HIGHLIGHTS

In January 2022, BiomX announced that the Company received a Therapeutics Development Award of up to $5 million from the Cystic Fibrosis Foundation. The first tranche of this award closed on December 21, 2021 with the foundation investing $3 million in our shares of common stock. Upon completion of patient dosing in Part 1 of the Company’s Phase 1b/2a study of BX004, BiomX would have the right to receive the second tranche of $2 million, also as an equity investment.
In October 2021, BiomX entered into an agreement with Maruho Co. Ltd., Japan’s largest dermatology-focused pharmaceutical company, for a right of first offer to license BiomX’s atopic dermatitis product candidate, BX005, in Japan. The right of first offer will commence following the availability of results from the Phase 1/2 study of BX005. Maruho also entered into a binding agreement for an equity investment in BiomX of $3 million at a premium to the market share price, intended primarily to support the Phase 1/2 study of BX005.
Clinical Program Updates

Cystic Fibrosis ("CF") (BX004)

BX004 is being developed for the treatment of chronic respiratory infections caused by Pseudomonas aeruginosa, a main contributor to morbidity and mortality in patients with CF.
The Phase 1b/2a trial is composed of two parts and is planned to start imminently. Part 1 of the trial will evaluate the safety, pharmacokinetics and microbiologic/clinical activity of BX004 in eight CF patients in a single ascending dose and multiple dose design, with results expected in the third quarter of 2022. Part 2 of the trial will evaluate the safety and efficacy of BX004 in 24 CF patients randomized to a treatment or placebo cohort in a 2:1 ratio. Results from Part 2 are expected by the first quarter of 2023.
Atopic Dermatitis ("AD") (BX005)

BX005 is designed to shift the skin microbiome composition of AD patients to its "pre-flare" state by reducing Staphylococcus aureus burden, potentially resulting in clinical improvement.
BX005 is currently in the final stages of GMP production. The Company expects the first data readout from its Phase 1/2 proof-of-concept trial evaluating the safety and efficacy of BX005 in the fourth quarter of 2022.
Inflammatory Bowel Disease ("IBD") and Colorectal Cancer Programs

BiomX’s IBD product candidate, BX003, is planned to enter its clinical trial in 2023, and the Company’s colorectal cancer product candidate will ramp up pre-clinical efforts in 2023.
Fourth Quarter and Full Year 2021 Financial Results

Cash balance, short-term deposits and restricted cash as of December 31, 2021, were $63.1 million, compared to $57.1 million as of December 31, 2020. The increase was primarily due to net cash provided by financing activities, partially offset by net cash used in operating activities. Based upon the Company’s strategic focus on the CF and AD programs, the existing cash and cash equivalents are expected to be sufficient to fund the current operating plan through the end of 2023. Additional tranches that would become available to the Company under its venture debt facility upon satisfaction of certain specified milestones can further extend the Company’s cash runway to the first half of 2024.
Research and development ("R&D") expenses, net were $6.6 million for the three months ended December 31, 2021, compared to $6.1 million for the same period in 2020. R&D expenses, net were $22.7 million for the year ended December 31, 2021, compared to $19.4 million for the prior year. The increase was primarily due to increased expenses related to conducting pre-clinical and clinical trials of our product candidates and an increase in salaries and related expenses, mainly due to the growth in the number of employees in R&D and clinical activities, offset by a decrease resulting from receiving higher levels of grants from the Israel Innovation Authority (IIA).
General and administrative expenses were $2.8 million for the three months ended December 31, 2021, compared to $2.6 million for the same period in 2020. General and administrative expenses were $11.3 million for the year ended December 31, 2021, compared to $9.3 million for the prior year. The increase was primarily due to an increase in expenses associated with operating as a public company, such as directors’ and officers’ insurance, listing fees and investor relations activity, and also due to an increase in stock-based compensation and salaries and related expenses, mainly due to the growth in the number of employees and due to an increase in rent and related operational expenses resulting from moving into a new facility.
Net loss for the fourth quarter of 2021 was $10.5 million, compared to $9.1 million for the same period in 2020. Net loss was $36.2 million for the year ended December 31, 2021, compared to $30.1 million for the prior year.
Net cash used in operating activities for the twelve months ended December 31, 2021 was $27.6 million, compared to $24.4 million for the same period in 2020.
Conference Call and Webcast Information

BiomX management will host a conference call and webcast today at 8:00 am ET to report financial results and business updates for the fourth quarter and full year ended December 31, 2021. To participate in the conference, please dial 1-877-407-0724 (U.S.), 1-809-406-247 (Israel), or 1-201-389-0898 (International). A live and archived webcast of the call will be available on the Investors section of the Company’s website at www.biomx.com.