Medical Marijuana, Inc. Investment Company AXIM® Biotechnologies Completes Acquisition of Oncology Research and Development Company Sapphire Biotech, Inc.

On March 24, 2020 Medical Marijuana, Inc. (OTC: MJNA) (the "Company"), the first-ever publicly traded cannabis company in the United States that launched the world’s first-ever cannabis-derived nutraceutical products, brands and supply chain, reported that its investment company AXIM Biotechnologies, Inc. (OTCQB: AXIM) ("AXIM Biotech" or "AXIM") has completed the acquisition of leading oncology research and development company Sapphire Biotech, Inc. ("Sapphire") (Press release, Medical Marijuana Sciences, MAR 24, 2020, https://www.prnewswire.com/news-releases/medical-marijuana-inc-investment-company-axim-biotechnologies-completes-acquisition-of-oncology-research-and-development-company-sapphire-biotech-inc-301028615.html [SID1234555797]).

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In January of this year, AXIM announced that the Company signed a binding term sheet to acquire Sapphire. As part of the acquisition, AXIM has acquired 100 percent of the capital stock of Sapphire and will operate Sapphire as a wholly-owned subsidiary. Sapphire will continue to be led by Catalina Valencia as Chief Executive Officer. Ms. Valencia has stewarded Sapphire in the development of its unique patent-pending pipeline.

"Sapphire Biotech has already proven itself to have great potential in just the one year since its founding. We look forward to bringing them into our family of companies and helping them further their efforts in the field of oncology," said Medical Marijuana, Inc. CEO Dr. Stuart Titus. "It is very exciting to announce that Sapphire Biotech has both a diagnostic application as well as a promising oncology treatment in their arsenal. This acquisition marks a transformation of AXIM while aligning with the therapeutic cannabinoid analog space."

Sapphire has licensed a leading compound called SBI-183, which inhibits and suppresses invasion in vitro and metastasis in vivo. The company recently announced that it now holds exclusive license rights to SBI-183 and intends to study the compound’s ability to treat cancer. In February, Sapphire signed a Sponsored Research Agreement with a leading cancer research organization to conduct preclinical studies to develop a metastatic cancer inhibitor using the licensed SBI-183 compound.

"Sapphire Biotech’s research team is making impressive progress in the field of oncology, which is one of the main reasons we were attracted to the company," said John W. Huemoeller II, Chief Executive Officer of AXIM Biotech. "At the end of the day, we want to help as many people as we can. Through this acquisition, we expect to be able to bring treatments to market for the millions of people battling cancer even more quickly."

In addition to its upcoming research on cancer-treating compounds, Sapphire is also developing a novel line of diagnostics for early cancer detection, response to treatment and recurrence monitoring. One of Sapphire’s diagnostic tools is currently being evaluated in a clinical trial for its potential to diagnose pancreatic cancer.

AXIM chose to acquire Sapphire because of its focus on cancer therapeutics for inhibiting cancer growth and metastasis, its diagnostics line, and a world-renowned research team. Through this acquisition, AXIM not only gains Sapphire’s already existing patent-pending portfolio of technologies but also now has the ability to develop new in-house proprietary molecules and potential treatments for numerous diseases.

Black Diamond Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Corporate Update

On March 24, 2020 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of small molecule, tumor-agnostic therapies, reported financial results for the fourth quarter and full year ended December 31, 2019, while providing a corporate update (Press release, Black Diamond Therapeutics, MAR 24, 2020, View Source [SID1234555782]).
"Black Diamond has achieved important scientific, clinical, and operational milestones over the past year," said David M. Epstein, Ph.D., President and CEO. "Our IND for our lead product candidate, BDTX-189, was allowed in December and we have initiated our Phase 1/2 clinical trial. We believe the $316 million raised since November, including via our initial public offering, will enable us not only to execute on the clinical development of BDTX-189, but also to continue to invest in our proprietary MAP platform, and to progress our early stage pipeline of small molecule, tumor-agnostic precision medicine programs."

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2019 Corporate Highlights
•Advanced BDTX-189, Black Diamond’s mutation spectrum-selective, oral, irreversible small molecule inhibitor product candidate which targets cancer-causing driver mutations in human epidermal growth factor receptor 2 (HER2) and epidermal growth factor receptor (EGFR) that have not yet been drugged, to investigational new drug (IND) application submission in November 2019 and IND allowance by the U.S. Food and Drug Administration in December 2019.
•Initiated a Phase 1/2 clinical trial of BDTX-189, which is actively enrolling and dosing patients in the Phase 1 portion.
◦The Phase 1 portion of the trial will evaluate escalating doses of BDTX-189 and is designed to determine the recommended Phase 2 dose and to assess preliminary indications of anti-tumor activity. The Phase 2 portion will determine the objective response rate and duration of response in patients with solid tumors that have an allosteric HER2 mutation or EGFR or HER2 exon 20 insertion mutation determined using next-generation sequencing.
•Continued to advance its program in glioblastoma (GBM) toward nominating a development candidate that targets a range of driver mutations in GBM and progress the Company’s other earlier stage programs derived from Black Diamond’s Mutation-Allostery-Pharmacology (MAP) platform.
◦Black Diamond’s MAP platform is built on three central pillars – discover, reveal, and target. The Company uses population-level cancer genetic data obtained from all tumor types to identify potential families of mutations that occur within individual oncogenes and rank the mutations for potential oncogenicity. Black Diamond then uses its MAP platform to understand the mechanism for oncogenic activation and the Company’s team of experienced medicinal chemists then develops mutation spectrum-selective drugs for the identified targets.
•Raised $85.0 million in an oversubscribed Series C financing round in November 2019 led by Boxer Capital of the Tavistock Group. Additional new investors Wellington Management Company, BVF Partners L.P., Deerfield Management, funds managed by Janus Henderson Investors, Casdin Capital, and Logos Capital joined existing investors Versant Ventures, New Enterprise Associates, RA Capital Management, Nextech Invest, Invus, Perceptive Advisors, City Hill Ventures, and Roche Venture Fund in the round.
•Strengthened Black Diamond’s management team and Board of Directors in 2019 by adding Brent Hatzis-Schoch as Chief Operating Officer and General Counsel, Thomas (Tommy) Leggett as Chief Financial Officer, and Christopher D. Roberts, Ph.D., as Chief Scientific Officer, along with Samarth (Sam) Kulkarni, Ph.D., CEO of CRISPR Therapeutics AG, to its Board of Directors.
Recent Developments
•In February 2020, Black Diamond completed an initial public offering pursuant to which it issued and sold 12,174,263 shares of common stock, including full exercise of the underwriters’ over-allotment option, resulting in gross proceeds of $231.3 million before deducting underwriting discounts and commissions and other offering expenses.

Financial Highlights
•Black Diamond ended 2019 with $154.7 million in cash and cash equivalents compared to $51.7 million as of December 31, 2018. Net cash from financing activities for the year ended December 31, 2019 was $127.8 million compared to $52.3 million for the year ended December 31, 2018. Net cash used in operations was $24.7 million for the year ended December 31, 2019 compared to $8.5 million for the year ended December 31, 2018.
•Net loss for the year ended December 31, 2019 was $35.3 million compared to $8.9 million for the year ended December 31, 2018.
•Research and development (R&D) expenses were $21.8 million for the year ended December 31, 2019 compared to $7.0 million for the year ended December 31, 2018. The increase in R&D expenses was primarily related to increase in headcount, preclinical development, and IND filing of BDTX-189.
•General and administrative (G&A) expenses were $7.6 million for the year ended December 31, 2019, compared to $2.0 million for the year ended December 31, 2018. The increase in G&A expenses was primarily due to an increase in personnel and other corporate-related costs.

Neogen reports third quarter results

On March 24, 2020 Neogen Corporation (NASDAQ: NEOG) reported that its revenues for the third quarter of its 2020 fiscal year, which ended Feb. 29, were $99,869,000, up 2% from the previous year’s third quarter revenues of $97,700,000 (Press release, Neogen, MAR 24, 2020, View Source [SID1234555798]). The third quarter was the 112th of the past 117 quarters that Neogen reported revenue increases as compared with the previous year — including all consecutive quarters in the past 14 years. Current year-to-date revenues were $309,096,000, also up 2% compared to $304,424,000 for the same period a year ago.

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Third quarter net income was $12,200,000, compared to the prior year’s $13,073,000. Earnings per share in the current quarter were $0.23, compared to $0.25 a year ago. Current year-to-date net income was $43,128,000, or $0.82 per share, compared to $44,361,000, or $0.85 per share, for the same period a year ago.

"Given the dramatic world events of the last few months, I am extremely proud of our Neogen employees who are working tirelessly to supply the worldwide demand for our products. Our mission matters more today than ever; we are strategically important to the world’s ability to contain and recover from the global threat posed by COVID-19, and ensuring the safety, quality and quantity of the global food supply," said John Adent, Neogen’s president and chief executive officer. "While operating results overall were disappointing for the quarter, we were encouraged by continued strong performance in our genomics services and growth in a number of our food safety product lines. Additionally, in the third quarter we made four strategic acquisitions to enhance our global footprint.

"The recent acquisitions of our distributors in Argentina and Uruguay demonstrate our strong belief that the Southern Cone of South America, with its large beef and dairy populations, holds significant growth potential for us," continued Adent. "These acquisitions, along with the other recent purchases of our food safety distributors in Australia and Italy, position us to promote, market and sell Neogen’s comprehensive suite of food safety, animal safety and genomics products around the globe."

"The strength of our balance sheet, with no debt, substantial cash reserves and solid cash generation, leaves us well prepared to weather the current adverse economic conditions that threaten the global economy in 2020 as a result of COVID-19," said Steve Quinlan, Neogen’s chief financial officer. "We are proactively addressing issues associated with the current environment, including strengthening our global supply chain to secure availability of the raw materials we need for production. We are also focused on maintaining adequate staffing for our worldwide manufacturing operations to ensure we are able to continue to serve our global customer base."

Revenues for the company’s Food Safety segment decreased 1% during the third quarter compared to the prior year quarter. Sales of the company’s general sanitation products, including its AccuPoint Advanced product line, increased 5% in the third quarter of the 2020 fiscal year, compared to the prior year. Moving forward, Neogen’s AccuPoint Advanced product line is seen as an important tool in the fight against the spread of disease, as it provides an almost instant indication of the cleanliness of a surface — and the effectiveness of a sanitation program. Sales of Neogen’s rapid diagnostic tests to detect natural toxins increased 4% in the quarter; our food allergen product line also grew 4%. These increases only partially offset a significant decrease in sales of drug residue test kits as Neogen ended its exclusive relationship with its distributor of dairy antibiotic tests in Europe during the quarter, and the loss of forensic kit sales in Brazil, due to a large customer switching to an alternative technology platform.

Neogen’s European operations revenues rose 5%, aided by growth in disinfectants to fight the spread of COVID-19 and African swine fever, higher sales of food allergen tests, and equipment sales. Neogen Latinoamerica’s revenues increased 15%, on strength across their diagnostics product portfolio and a large rodenticide order in Mexico. China’s revenues for the current quarter increased 38%, largely the result of increased sales of Neogen’s disinfectant products to combat the spread of COVID-19 in the country. Revenues from the company’s Brazilian operations decreased 16%, as revenues continue to be adversely impacted by the loss of sales of forensic test kits formerly used to test the nation’s truck drivers; as discussed previously, this business was lost in the first quarter of the current fiscal year.

Neogen’s Animal Safety segment reported a 6% revenue increase for the third quarter, largely on the strength of the domestic genomics business, with additional incremental volume of rodenticides, insecticides, and certain cleaners and disinfectants.

Neogen’s worldwide animal genomics business recorded an increase of 8% in the third quarter of fiscal 2020 compared to the prior year. This broad-based increase included strength in the domestic companion animal market, and genomic testing of beef and dairy cattle, swine and poultry around the world. In January, Neogen launched Igenity + Envigor — the first and only genetic test in the beef industry that measures heterosis in crossbred cattle. In cattle, heterosis is the tendency of a crossbred calf to show traits superior to those of its parents.

Neogen’s gross margin was 45.4% of sales in the third quarter of the current year, compared to 45.7% in the same quarter of the prior fiscal year. The gross margin percentage decrease was primarily the result of a greater proportion of total sales derived from the Animal Safety segment, which has lower gross margins than the overall corporate average. Expressed as a percentage of sales, operating income was 13.1% for the current quarter, compared to 15.0% in the third quarter of the 2019 fiscal year, with the decline attributed to the lower gross margin percentage and operating expense growth which exceeded that of revenue. The effective income tax rate for the third quarter was 14.4%, compared to 21.4% in the prior year quarter; this year’s lower rate primarily resulted from the benefit of stock option exercises.

Neogen Corporation develops and markets products dedicated to food and animal safety. The company’s Food Safety Division markets dehydrated culture media and diagnostic test kits to detect foodborne bacteria, natural toxins, food allergens, drug residues, plant diseases and sanitation concerns. Neogen’s Animal Safety Division is a leader in worldwide biosecurity products, animal genomics testing, and the manufacturing and distribution of a variety of animal healthcare products, including diagnostics, pharmaceuticals and veterinary instruments.

Certain portions of this news release that do not relate to historical financial information constitute forward-looking statements. These forward-looking statements are subject to certain risks and uncertainties. Actual future results and trends may differ materially from historical results or those expected depending on a variety of factors listed in Management’s Discussion and Analysis of Financial Condition and Results of Operations in the Company’s most recently filed Form 10-K.

The Lancet Haematology Publishes Results from Oncopeptides’ Multicenter, International Phase 1/2 Study (O-12-M1)

On March 24, 2020 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported the publication of results from its O-12-M1 study, melflufen plus dexamethasone in relapsed/refractory multiple myeloma (RRMM), a multicenter, international, open-label, phase 1/2 study in The Lancet Haematology (Press release, Oncopeptides, MAR 24, 2020, View Source [SID1234555761]). Melflufen is a first-in-class anti-cancer peptide-drug conjugate currently in development by Oncopeptides with activity in a variety of cancers. Current clinical development is focused on the treatment of RRMM.

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In the O-12-M1 study, heavily pre-treated RRMM patients with a median of four prior lines of therapy (2-14), were dosed with 40 mg of melflufen administered intravenously once every 28 days in combination with weekly dexamethasone. Patients receiving melflufen plus dexamethasone experienced an overall response rate (ORR) of 31%, a median duration of response (DOR) of 8.4 months, and median overall survival (OS) of 20.7 months.

"We are excited to share with the scientific community these findings from our phase 1/2 study of our peptide-drug conjugate, melflufen. The results published today served as the foundation of our broad clinical development program," said Klaas Bakker, Chief Medical Officer of Oncopeptides. "We recognize the significant unmet needs of patients with RRMM who currently have few available treatment options and are in desperate need of well-tolerated treatments with the potential to overcome cancer resistance patterns. I would like to thank all patients and their care partners for participation in this study."

Additional findings from the study include:

The median progression-free survival was 5.7 months
The most common adverse events were thrombocytopenia (62%) and neutropenia (58%), while grade 3 or higher non-haematological toxicities were infrequent
Melflufen plus dexamethasone showed activity regardless of previous treatment failure, including in patients with disease refractory to alkylators
More information about the O-12-M1 study is available on www.oncopeptides.com.

For more information, please contact:

Rein Piir, Head of Investor Relations at Oncopeptides
E-mail: [email protected]
Cell phone: +46 70 853 72 92

This information was submitted for publication at 00.35 CET March 24, 2020.

About melflufen

Melflufen (INN melphalan flufenamide) is a first-in-class anti-cancer peptide-drug conjugate that rapidly delivers an alkylating payload into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately cleaved by peptidases to deliver an entrapped hydrophilic alkylator payload. Peptidases play a key role in protein homeostasis and feature in cellular processes such as cell-cycle progression and programmed cell death. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the increased intracellular alkylator concentration. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies.

Laikai Medical gets another global exclusive license for a clinical anti-tumor project

On March 24, 2020 Laekna Therapeutics Shanghai Co., Ltd. (Laekna) reported a new agreement with Novartis giving the China-based biotech company exclusive global rights to Novartis’ anti-PD-L1 Antibody (FAZ053).

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FAZ053 has been involved in a phase I clinical trial in patients with advanced cancer. The trial demonstrated positive proof-of-concept results for a tolerable safety profile and clinical efficacy of FAZ053 in diverse solid tumors. Laekna, a company dedicated to the research and development of small-molecule and antibody-targeted drugs, now has exclusive rights to develop and commercialize the PD-L1 oncology asset. With this move, the company aims to advance clinical research and introduce pioneering new drugs to patients, including the rapidly growing cancer patient population in China.

"A combination of PD-L1 Antibody with chemotherapy, or targeted therapy can greatly improve treatment response and prolong survival," said Dr. Yong Yue, CMO of Laekna. "We have mapped a number of combination strategies to treat a variety of cancers that do not respond or are resistant to checkpoint inhibitor treatments."

Laekna plans to start trials on combination therapies as soon as possible in order to address the unmet needs of people with cancer and bring innovative, effective treatments to more cancer patients across China.

This is the third in a recent series of agreements between Laekna and Novartis. "Novartis is a global leader in oncology drug innovation and we believe that the three oncology assets we have acquired from Novartis have great synergistic anti-cancer effects," said Dr. Chris Lu, founder and CEO of Laekna. "This synergy will allow us to apply various combinations to treat many cancer indications, including triple negative breast cancer and prostate cancer."

As part of this agreement, Novartis will receive an upfront payment, with additional payments at key development milestones as well as royalties on future sales.