On April 15, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS genome editing platform, reported that Alan List, M.D. has been appointed as the Company’s Chief Medical Officer and a member of the senior leadership team at Precision BioSciences (Press release, Precision Biosciences, APR 15, 2021, View Source [SID1234578081]). Dr. List is a world-renowned hematologist with extensive academic and clinical experience in the research and development of hematology and oncology products. He has led clinical development programs for multiple FDA-approved drugs to treat hematologic malignancies, including myelodysplastic syndromes, acute leukemia, multiple myeloma, and lymphoma.

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"We are very pleased to welcome Alan to the senior leadership team of Precision BioSciences," said Matt Kane, Chief Executive Officer and Co-Founder of Precision BioSciences. "With three hematology products in the clinic and a fourth entering clinical trials soon, Alan’s deep clinical expertise in hematology and oncology, including pioneering work to develop novel products from the laboratory to the clinic, will be a strong addition to the Precision team. Over the past 12 months, Alan has been intimately involved in our clinical strategy to develop our lead allogeneic CAR T therapy, PBCAR0191, as well as the design of our clinical program for PBCAR19B, our next generation, stealth cell program. We believe that Alan’s leadership will be critical to the successful execution of our clinical development strategy."

Since April 2020, Dr. List has been a strategic clinical advisor to Precision BioSciences, providing advice to the company and its Board of Directors on its clinical stage and pre-clinical allogeneic CAR T programs. Prior to joining Precision BioSciences, Dr. List served in various roles at the Moffitt Cancer Center, including as President and Chief Executive Officer from 2012 to 2019; Executive VP, Physician in Chief from 2008 to 2012 and Chief of the Malignant Hematology Division from 2003 to 2008. Dr. List is internationally recognized for his many contributions in the development of effective treatment strategies for myelodysplastic syndrome (MDS) and acute myeloid leukemia. His pioneering work led to the development of Revlimid (lenalidomide) a transformational treatment for patients with MDS and multiple myeloma.

Dr. List is the author of more than 425 peer-reviewed articles and books. He previously served as the President for the Society of Hematologic Oncology and a member of the MDS Foundation Board of Directors. Dr. List is an active member of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the American Society of Hematology (ASH) (Free ASH Whitepaper) and the American Association for Cancer Research (AACR) (Free AACR Whitepaper). He is a Charter Fellow in the National Academy of Inventors, an inductee in the Florida Inventors Hall of Fame, and holds 18 U.S. patents and >45 applications filed. Dr. List was 2016 recipient of the Celgene Career Achievement Award for Clinical Research in Hematology, and other recognitions including the General Motors Cancer Research Foundation Merit Award, the J.P. McCarthy Foundation International Prize, the Emil J. Freireich Award, the Joshua Lederberg Society, and the Aplastic Anemia & MDS International Foundation Leadership in Science Award.

Dr. List received B.S. and M.S. degrees from Bucknell University and earned his M.D. from the University of Pennsylvania. He is board certified in internal medicine, hematology, and medical oncology. He completed his residency in internal medicine at Good Samaritan Medical Center in Phoenix, Arizona and fellowships in hematology and medical oncology at Vanderbilt University Medical Center. Prior to joining the Moffitt Cancer Center in 2003, Dr. List held academic and clinical appointments at the University of Arizona.

"After advising Precision BioSciences on its clinical trial programs for nearly a year, I’m very excited to join as the Chief Medical Officer as we approach the launch of the first of our stealth CAR T programs. I look forward to working with the management team and the clinical team to advance the development of our potentially breakthrough allogeneic CAR T cell programs, including PBCAR0191 and PBCAR19B. I’m particularly optimistic about the potential opportunity to bring novel cell therapies to patients who suffer from hematologic malignancies, such as non-Hodgkin lymphoma, B-cell acute lymphoblastic leukemia, and multiple myeloma," said Dr. List. "I’m also looking forward to interacting with the clinical investigators who are conducting our clinical trials at leading academic centers across the country."

Dr. List will succeed Chris Heery, M.D., who is leaving Precision BioSciences to pursue other opportunities. Dr. Heery will continue to serve as a consultant to the company to ensure a smooth transition in the conduct of clinical trials underway at Precision.

"During Chris’ time with the company, Precision successfully transitioned PBCAR20A and PBCAR269A into Phase 1 clinical trials and designed the Phase 1 clinical trial for PBCAR19B. We thank Chris for his contributions to Precision BioSciences and wish him success in his future endeavors," added Mr. Kane.

On April 15, 2021 Brooklyn ImmunoTherapeutics, Inc. (NYSE American: BTX) ("Brooklyn"), a biopharmaceutical company focused on exploring the role that cytokine-based therapy can have in treating patients with cancer, reported it has paid $1 million towards the acquisition of a license for Factor Bioscience’s and Novellus’ mRNA Gene Editing and Cell Therapies technology and has extended through May 21, 2021 its option exercise period for entering into a related license agreement with Factor Bioscience and Novellus (Press release, Brooklyn ImmunoTherapeutics, APR 15, 2021, View Source [SID1234578098]).

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If a license agreement is completed, it would allow Brooklyn to utilize an extensively patented process to seek to develop gene edited compounds using mRNA, which preclinical data suggest to be more efficient, non-immunogenic and non-mutagenic, for treatment of several solid tumor and liquid indications, sickle cell anemia, as well as a number of additional inherited disorders. Gene editing is an investigational technique that is used to add, delete, or correct a patient’s genetic material in an effort to treat a disease. Research suggests that editing genes in patients could potentially result in cures for a number of genetic diseases. The licensed platform would include mRNA cell reprogramming, mRNA-based gene editing, a proprietary gene editing protein, and the proprietary ToRNAdo lipid delivery system that provides efficient delivery of mRNA ex vivo and in vivo to skin, brain, eye and lung tissue.

If Brooklyn does not enter into the license agreement by May 21, 2021, it will be entitled to be reimbursed for the $1 million payment.

On April 15, 2021 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the "Company") reported that members of the executive management team will participate in a fireside chat during the 2021 Bloom Burton & Co. Healthcare Investor Conference on Tuesday, April 20, 2021 at 2:30 p.m. ET (Press release, Aurinia Pharmaceuticals, APR 15, 2021, View Source [SID1234578063]).

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In order to participate in the audio webcast, interested parties can access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

On April 15, 2021 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a biopharmaceutical company developing and commercializing specialty products for respiratory disease, allergy and opioid overdose, reported financial results for the year ended December 31, 2020 and provided a business update (Press release, Adamis Pharmaceuticals, APR 15, 2021, View Source [SID1234578082]).

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"Adamis made significant advancements over the past year and that momentum has carried over into 2021," stated Dennis J. Carlo, Ph.D., President and Chief Executive Officer of Adamis Pharmaceuticals. "We completed the transition of SYMJEPI to our new commercial partner, US WorldMeds, and we look forward to its continued market penetration and sales growth in 2021. As we announced earlier this week, we recently met with the FDA to discuss the regulatory path forward for ZIMHI in the treatment of opioid overdose, and we intend to resubmit our NDA to the FDA. We also intend to commence our Phase 2/3 clinical trial for Tempol in the second quarter of this year, to evaluate the use of Tempol for the prevention of hospitalization of patients with COVID-19. Earlier this year, we completed an underwritten public offering that raised net proceeds of approximately $48.6 million, which provides the financial flexibility we need to move our programs forward. Adamis has an opportunity to reach several meaningful inflection points that could make 2021 a transformative year for the company."

Product and Pipeline Updates and Other Corporate Developments

SYMJEPI (epinephrine) Injection

In October 2020, the SYMJEPI product line, for use in the emergency treatment of acute allergic reactions, completed its transition to a new commercial partner, US WorldMeds.

In January 2021, the SYMJEPI products became available through the Walgreens Prescription Savings Club. The products are being offered at a discounted price of $99.99 per two-pack, which the company believes is the lowest price for an epinephrine device in the U.S.
ZIMHI (naloxone) Injection

Adamis submitted responses to the FDA to address the deficiencies identified in a complete response letter (CRL) received in November. Adamis recently met with the FDA to discuss the responses. After the meeting, and based on discussions with the agency, Adamis expects to resubmit the Naloxone NDA within the next 45 days.

Recently, the U.S. Patent and Trademark Office allowed one of Adamis’ patent applications relating to ZIMHI. The claims allowed describe a naloxone composition at a dose greater than or equal to five milligrams configured for administration as an injection.
Tempol

In June 2020, Adamis entered into an exclusive worldwide license for a novel patented compound, Tempol, for the treatment of all respiratory diseases including asthma, respiratory syncytial virus, influenza and COVID-19. Additionally, the license also includes the use of Tempol for reducing radiation dermatitis in patients undergoing treatment for cancer.

In February 2021, the company announced results from a study in collaboration with Stanford University demonstrated that Tempol inhibited the release of multiple cytokines from activated immune cells of COVID-19 patients, which may be a unique mechanism of action for the agent. In-vivo preclinical data from a hamster virus challenge model has shown an attenuation of the lung pathology and more rapid healing in animals treated with Tempol. This animal model has been used successfully to test vaccines and monoclonal antibodies against COVID-19. These results further support the clinical program of testing Tempol in early COVID.

The company’s IND relating to a protocol for a clinical trial of Tempol in COVID-19 patients received FDA clearance in January 2021. Adamis expects to begin the Phase 2/3 trial during the second quarter of 2021 to examine the effects of Tempol on preventing hospitalization in subjects with COVID-19 infection.
Drug Outsourcing Facility

In January, the company announced that it had entered into a non-binding letter of intent with a potential buyer for the sale of substantially all of the assets of its US Compounding, Inc. (USC) registered outsourcing facility subsidiary. Under the terms of the LOI, the buyer would acquire substantially all of the assets of USC, in exchange for a total gross consideration that could range from approximately $10-$20 million, before transaction fees and expenses and other potential post-closing adjustments. Any definitive agreement would be subject to approval by the respective parties, including approval by the board of directors of Adamis, and would likely include customary provisions, including representations and warranties of Adamis and USC, restrictive covenants and indemnification provisions.
2020 Financial Results

Total revenues for the year ended December 31, 2020 and 2019 were $16.5 million and $22.1 million, respectively. The total revenue decrease was primarily attributable to a decline in sales of products by USC due to restrictions and limitations on outpatient surgery and other medical procedures caused by the COVID-19 pandemic, and related impacts of the pandemic on sales and marketing efforts.

Selling, general and administrative expenses for the years ending December 31, 2020 and 2019 were approximately $30.6 million and $25.3 million, respectively. The increase was primarily due to the $7.9 million contingent liability related to the Nephron litigation, offset by the decreases in selling expenses at USC.

Research and development expenses were approximately $8.3 million and $10.4 million for the years ended December 31, 2020 and 2019, respectively. The decrease was primarily due to a decrease in development expense for the company’s pipeline candidates.

Cash and equivalents at the end of the year was approximately $6.9 million. In January and February 2021, the company received approximately $5.9 million and $48.6 million from the exercise of warrants and an equity financing transaction, respectively.

Targeted Potential Milestones

Resubmit the ZIMHI NDA to FDA within the next 45 days
Start of Phase 2/3 clinical trial of Tempol in COVID-19 patients in the second quarter of 2021
Progress from non-binding term sheet to executed purchase agreement for the sale of USC outsourcing division in the second half of 2021
On-going market penetration and increasing sales of SYMJEPI in the U.S. throughout 2021
Approval and commercial launch of ZIMHI
Conference Call

Adamis will host a conference call and live webcast today, April 15, 2021 at 2 p.m. PDT (5 p.m. EDT) to discuss its financial and operating results for the fourth quarter 2020 and year ended December 31, 2020, as well as provide an update on business developments and activities.

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 April 15, 2021 Prestige BioPharma and Pharmapark LLC reported that the two companies have entered into a binding agreement for the exclusive partnership and supply for the commercialization of Prestige BioPharma’s Bevacizumab biosimilar in the Russian Federation (Press release, Prestige BioPharma, APR 15, 2021, View Source [SID1234578099]).

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Prestige’s Bevacizumab (HD204) is a mAb biosimilar to Roche’s Avastin, an inhibitor of vascular endothelial growth factor (VEGF), which is used in combination with other therapies to treat patients with multiple forms of cancer including metastatic colorectal cancer, advanced non-small-cell lung cancer, advanced kidney cancer, certain types of epithelial cancers and cancers of the cervix. HD204 is currently in Phase III clinical development with active recruitment ongoing within the pivotal efficacy and safety trial SAMSON-II. Positive results were previously reported from the Phase I clinical trial (SAMSON-I) which evaluated the pharmacokinetics, safety and immunogenicity of HD204 to Avastin.

The partnership arrangement includes the exclusive rights for Pharmapark to commercialize the Bevacizumab biosimilar in the Russian Federation, leveraging the company’s strong sales and marketing capabilities and experience in successfully bringing new biosimilars to market. Whilst the terms of the deal are not being disclosed, Prestige BioPharma will assume responsibility for product commercial supply out of its manufacturing facilities in Osong, Korea, while Pharmapark will be responsible for local registration, sales and marketing in the Russian Federation with the option to manufacture the product in Russian Federation in line with the Russian import substitution strategy.

This agreement expands upon the existing collaboration between Prestige BioPharma and Pharmapark LLC with the companies signing a license agreement in July 2019 for Prestige BioPharma’s Herceptin biosimilar.