On April 1, 2021 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a patient-first biotechnology company developing novel cannabinoid (CBD)_medicines to improve quality of life for cancer patients, reported its financial results for the year ended December 31, 2020 and provided shareholders with an update on its accomplishments in 2021 thus far (Press release, Enveric Biosciences, APR 1, 2021, View Source [SID1234577523]).

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David Johnson, Chairman and Chief Executive Officer, said, "Since the closing of our going public transaction in late December 2020, our team has achieved several critical milestones that have positioned our Company to accelerate the execution of our vision to extend and enhance the quality of life for cancer patients in need through researching and developing novel supportive care therapies."

Mr. Johnson continued, "Our ability to strengthen our balance sheet through the closing of approximately $22.8 million in gross proceeds during the first quarter of 2021 has allowed us the opportunity to not only accelerate the research and development of our cannabinoid-based therapies, but also the optionality to evaluate a robust pipeline of strategic asset acquisitions and partnerships. During the first quarter of 2021, we launched a development collaboration and supply agreement with PureForm and shortly thereafter acquired the exclusive license to five molecules focused on pain and dermatology indications. Our team remains focused on advancing several pivotal studies throughout the remainder of 2021 in the large, unmet, supportive care market for cancer."

Corporate Updates:

Strengthened balance sheet with the closing of two registered direct offering totaling $22.8 million in gross proceeds from the closing of $10 million on January 14, 2021 and $12.8 million on February 11, 2021.

Acquired an exclusive, perpetual license from Diverse Biotech for five molecules, four of which are dermatology-focused and one that is pain-focused. As part of the agreement, Enveric will gain access to scientists and formulators to help with the research and development of these assets through pre-clinical and clinical studies to alleviate certain side effects resulting from cancer treatment.

Launched development collaboration and exclusive supply agreement with PureForm Global to support cannabinoid clinical programs aimed to treat pain and inflammation resulting from cancer treatments initially targeting supportive care indications that include radiodermatitis, chemotherapy-induced neuropathy, and glioblastoma.

Assembled a talented, world-class Executive Leadership Team, Board of Directors and Scientific Advisory Board with experience having held positions at Bristol Myers Squibb, Pfizer, Merck, Abbott, Baxter and other global healthcare and biotechnology companies. Collectively, the team has successfully led multiple therapies throughout the entire regulatory process, with substantial expertise in product development, dermatology, wound healing, oncology, intellectual property, and capital markets.
Milestones for the Remainder of 2021:

Glioblastoma Multiforme (GBM)

Q3 ’21 –We intend to seek approval from Israeli Ministry of Health (MOH), Center for Cannabis, to move forward with a Phase I/II trial
Q4 ’21 – We intend to begin enrollment of Phase I/II trial, an open label evaluation of temozolomide with clomiphene and CBD in GBM
Radiation Dermatitis

Q3 ’21 – We intend to an investigational new drug application
Q4 ’21 – We intend to initiate a Phase I/II Trial
Financial Results for the Year Ended December 31, 2020:

Net cash used in operating activities was $3,888,785 during the year ended December 31, 2020, which consisted primarily of a net loss of $6,864,676, offset by amortization of note discount of $288,631, stock-based compensation of $1,977,155, induced conversion of warrants of $802,109, amortization of intangible assets of $120,872, increases in prepaid expenses and other current assets for $636,497, and increases in accounts payable and accrued liabilities of $267,002.

Enveric’s operating expenses increased to $5,617,317, for the year ended December 31, 2020 from $2,296,534 for the year ended December 31, 2019, for an increase of $3,320,783, or 145%. This change was primarily driven by an increase in general and administrative fees of $3,146,700 and an increase in research and development costs of $174,083.

Net cash provided by financing activities was $5,531,270 during the year ended December 31, 2020. Cash as of December 31, 2020 totaled $1,578,460 and the Company currently has no debt.

Subsequent to December 31, 2020, the Company completed two registered direct offerings for gross proceeds of $22.8 million. On March 10, 2021, the Company also received $3,267,245 from the exercise of warrants to purchase 851,099 shares of common stock.

As of March 29, 2021, the Company had 19,450,507 shares of common stock outstanding.

On April 1, 2021 Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for futibatinib (TAS-120), a covalently-binding FGFR inhibitor, for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements, including gene fusions (Press release, Taiho, APR 1, 2021, View Source [SID1234577522]). Futibatinib is an investigational therapy and has not been approved by any regulatory authority for use in patients.

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"Patients living with locally advanced and metastatic cholangiocarcinoma, or bile duct cancer, currently have a poor prognosis,1,2 particularly since there is no standard treatment after the failure of first-line chemotherapy3," said Martin J. Birkhofer, MD, Senior Vice President and Chief Medical Officer, Taiho Oncology, Inc. "We are pleased that the FDA has recognized the potential benefit of futibatinib in previously treated CCA patients. We look forward to continued dialogue with FDA and other Health Authorities as we work toward global availability of futibatinib for cholangiocarcinoma patients."

The decision by FDA to grant this designation is based on efficacy and safety results from the Phase 2 FOENIX-CCA2 study, which will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, taking place April 9-14, 2021.

"We are very pleased with the designation of futibatinib as a breakthrough therapy by the FDA," said Teruhiro Utsugi, Ph.D., Senior Managing Director at Taiho. "We will continue to advance our research and development efforts to deliver futibatinib, discovered in our research center, as one of the agents which may benefit cholangiocarcinoma patients around the world awaiting for new treatment options."

The FDA states that Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for BTD require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.

In May 2018, the FDA Office of Orphan Drug Development granted futibatinib orphan drug status for the treatment of cholangiocarcinoma.

About Cholangiocarcinoma
Cholangiocarcinoma (CCA), also known as bile duct cancer, is not common. About 8,000 people in the U.S. are diagnosed with CCA each year.4 This includes both intrahepatic (inside the liver) and extrahepatic (outside the liver) cancers. CCA can occur at younger ages, but it is seen mainly in older people. The average age of people in the U.S. diagnosed with cancer of the intrahepatic bile ducts is 70, and for cancer of the extrahepatic bile ducts it is 72.4 The five-year survival rate of intrahepatic CCA (all SEER stages combined) is 9%.1

The main treatment for CCA is surgery. Radiation therapy and chemotherapy may be used if the cancer cannot be entirely removed with surgery and in cases where the edges of the tissues removed at the operation show cancer cells (also called a positive margin). Both stage III and stage IV cancers cannot be completely removed surgically. Currently, standard treatment options are limited to radiation, palliative therapy, liver transplantation, surgery, chemotherapy and interventional radiology.2

About Futibatinib (TAS-120)
Futibatinib (TAS-120) is an investigational, oral, potent, selective, and irreversible small-molecule inhibitor of FGFR1, 2, 3 and 4 being studied as a potential treatment for patients with advanced solid tumors with FGFR1-4 genetic aberrations, including cholangiocarcinoma, who were previously treated with chemotherapy or other therapies. Futibatinib selectively and irreversibly binds to the ATP binding pocket of FGFR1-4 resulting in the inhibition of FGFR-mediated signal transduction pathways, reduced tumor cell proliferation and increased tumor cell death in tumors with FGFR1-4 genetic aberrations.

On April 1, 2021 Secura Bio, Inc. (Secura Bio) – (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of COPIKTRA as monotherapy for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) after at least two prior therapies and follicular lymphoma (FL) that is refractory to at least two prior systemic therapies (Press release, Secura Bio, APR 1, 2021, View Source [SID1234577521]).

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CLL and FL are slowly progressing, incurable blood cancers that can lead to life-threatening complications such as anemia, serious infections and bone marrow failure. COPIKTRA is an oral dual inhibitor of the PI3K-delta and gamma pathways, which are involved in the proliferation, growth, and migration of malignant cells and are thought to play a role in the formation and maintenance of a supportive tumor microenvironment.

"Today’s positive opinion from the CHMP is an important step on the path toward authorization in Europe for COPIKTRA, which is expected to improve overall response rates in patients suffering from relapsed and/or refractory CLL and FL, who currently have limited treatment options. Assuming approval, COPIKTRA will provide patients and physicians across much of Europe with a treatment option that works differently from other available therapies for these incurable diseases," said Dr. David Cohan, Chief Medical Officer of Secura Bio.

The EMA summary of opinion stated "The benefits of COPIKTRA are that it prolongs the survival time without any progression of the disease as compared to ofatumumab in patients with CLL who have received 2 or more prior lines of treatment and induces tumour responses in patients with FL who have received 2 or more prior treatments. The most common side effects are respiratory tract infections, neutropenia, anaemia, thrombocytopenia, headache, dyspnoea, cough, decreased appetite diarrhoea/colitis, nausea, vomiting, abdominal pain, constipation, rash, musculoskeletal pain, arthralgia, pyrexia, fatigue and increased transaminases."

"With the expected approval of COPIKTRA in the European Union, Secura Bio will have two meaningful oncology drugs with novel modes of action. Our corporate goal is to expand our portfolio of indications worldwide, for the treatment of challenging hematologic and solid malignancies in patients with important unmet needs." said Joseph M. Limber, President and CEO of Secura Bio.

About Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Chronic lymphocytic leukemia (CLL) is a cancer that affects lymphocytes with most of the cancer cells located in the bloodstream and/or the bone marrow, although the lymph nodes and spleen are often involved. The symptoms of CLL include a tender, swollen abdomen and feeling full even after eating only a small amount. Other symptoms can include fatigue, shortness of breath, anemia, bruising easily, night sweats, weight loss, and frequent infections. However, many patients with CLL will live for years without symptoms. There are approximately 250,000 patients in the EU affected by CLL, with nearly 25,000 new diagnoses expected this year alone. While there are therapies currently available, real-world data reveals that a significant number of patients either relapse following treatment, become refractory to current agents, or are unable to tolerate treatment, generating significant unmet medical needs. The potential of effective new oral agents, particularly those that can be used as monotherapies in the community setting, offer hope in the treatment of patients with CLL.

About Follicular Lymphoma

Follicular lymphoma (FL) is typically a slow-growing or indolent form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes, making it a "B-cell lymphoma." FL accounts for 20 to 30 percent of all NHL cases affecting more than 180,000 people in the EU, with more than 16,500, newly diagnosed cases expected this year. Common symptoms of FL include enlargement of the lymph nodes in the neck, underarms, abdomen, or groin; as well as fatigue, shortness of breath, night sweats, and weight loss. Often, patients with FL have no obvious symptoms of the disease at the time of diagnosis. Follicular lymphoma is usually not considered to be curable, but more of a chronic disease, with patients often living for many years following diagnosis with this form of lymphoma. New oral agents that can be added to the community hematologist’s/oncologist’s s armamentarium, particularly monotherapies, may offer significant benefit in the treatment of patients with FL.

About COPIKTRA (duvelisib)

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first United States FDA approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant cells. PI3K signaling may lead to the proliferation of malignant cells and is thought to play a role in the formation and maintenance of a supportive tumor microenvironment. COPIKTRA is indicated in the United States for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies, and has accelerated approval for refractory follicular lymphoma (FL) after at least two prior systemic therapies. COPIKTRA is also being developed for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status in the United States, and is being investigated in combination with other agents through investigator-sponsored studies. For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

IMPORTANT SAFETY INFORMATION ABOUT COPIKTRA

WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS

See full prescribing information for complete boxed warning

Fatal and/or serious infections occurred in 31% (4% fatal) of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.
Fatal and/or serious diarrhea or colitis occurred in 18% (<1% fatal) of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.
Fatal and/or serious cutaneous reactions occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Withhold COPIKTRA.
Fatal and/or serious pneumonitis occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA.
INDICATIONS AND USAGE

COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with:

Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.
Relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Accelerated approval based on overall response rate; continued approval may be contingent upon confirmatory trials.
WARNINGS AND PRECAUTIONS

Hepatotoxicity: Monitor hepatic function.
Neutropenia: Monitor blood counts.
Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS

The most common adverse reactions (≥20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.

DRUG INTERACTIONS

CYP3A inducers: Avoid co-administration with strong CYP3A inducers.
CYP3A inhibitors: Monitor for COPIKTRA toxicities when co-administered with strong or moderate CYP3A inhibitors. Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors.
CYP3A substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates.
USE IN SPECIFIC POPULATIONS

On April 1, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported it has completed the acquisition of Ipsen’s (Euronext: IPN; ADR; IPSEY) intellectual property and assets related to IPN-1087 (Press release, Fusion Pharmaceuticals, APR 1, 2021, View Source [SID1234577520]). IPN-1087 is a small molecule targeting neurotensin receptor 1 (NTSR1), a protein expressed on multiple solid tumor types. Fusion intends to use IPN-1087 to create an alpha-emitting radiopharmaceutical, FPI-2059, targeting solid tumors expressing NTSR1.

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Under the terms of the agreement, Fusion issued to Ipsen 600,000 shares of its common stock at the time of closing, including shares due upon the achievement of a patent-related milestone which occurred prior to closing. Such shares were issued pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended. Fusion will also be obligated to pay Ipsen up to an additional €67.5 million upon the achievement of certain development and regulatory milestones; low single-digit royalties on potential future net sales; and up to €350.0 million in net sales milestones, in each case, relating to products covered by the asset purchase agreement. Fusion will be responsible for paying to a third-party licensor up to €70.0 million in development milestone payments and mid-single to low-double-digit royalties on potential future net sales of products covered by the license agreement.

The closing of the acquisition was subject to the satisfaction of customary closing conditions, including the expiration of the waiting period under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976. Additional details regarding the financial terms can be found in Fusion’s Form 8-K filed with the Securities and Exchange Commission on March 2, 2021.

About FPI-2059
FPI-2059 will be a radioconjugate combining actinium-225 with IPN-1087, for development as a targeted alpha therapy for various solid tumors. The molecule targets NTSR1, a promising target for cancer treatment, that is overexpressed in multiple solid tumors. IPN-1087 was in Phase 1 clinical development as a lutetium-177-based radiopharmaceutical for pancreatic ductal adenocarcinoma, colorectal cancer and gastric cancers expressing NTSR1.

On April 1, 2021 Fresenius Kabi, a global health care company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition, reported it has signed an exclusive distribution agreement for the U.S. with Corvida Medical (Press release, Fresenius, APR 1, 2021, View Source [SID1234577519]).

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Under the terms of the agreement, Fresenius Kabi will be the exclusive U.S. distributor for the HALO Closed System Drug-Transfer Device (CSTD). The HALO system is an airtight and leak-proof CSTD that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and droplets. These are common challenges during the compounding and administration of hazardous drugs like chemotherapy.

"Fresenius Kabi is committed to offering solutions that provide the safe preparation and delivery of medications across the continuum of care," said John Ducker, president and CEO of Fresenius Kabi USA. "CSTDs play a critical role in protecting health care professionals from the risks of exposure to hazardous drugs during the preparation in the pharmacy and during patient administration by nurses. The combination of Fresenius Kabi freeflex/freeflex+ IV solution containers, oncology medicines and Corvida Medical’s HALO CSTD allows Fresenius Kabi to provide customers a broad range of products to assist with their oncology needs."

Mitch Moeller, CEO of Corvida Medical added, "We believe Fresenius Kabi is a great partner for the HALO Closed System Drug-Transfer Device. Their reputation for quality and patient focus along with their commercial infrastructure, distribution experience, customer relationships and extensive product portfolio will help our efforts to make HALO a leading CSTD option for U.S. customers. We are pleased that Fresenius Kabi recognized the design benefits, innovation and quality of the HALO product portfolio."

The distribution agreement may be expanded to other territories in the future. Financial terms of the agreement were not disclosed.