On March 24, 2020 Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, reported the completion of a $65 million equity financing (Press release, Apexigen, MAR 24, 2020, View Source [SID1234555801]). The financing was led by Decheng Capital and new investor Oceanpine Capital and included participation from other new and existing investors. This financing is an extension of the Company’s Series C financing of $58 million, which was previously announced in August 2018, bringing the total amount raised in the Series C to $123 million. The completion of the Series C financing brings the total equity raised to date by the company to $158 million.

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Apexigen intends to use these proceeds to support the ongoing clinical development of its lead immunotherapeutic, APX005M, a monoclonal antibody targeting CD40. Currently, APX005M is in multiple Phase 2 clinical trials to treat different types of solid tumors. The proceeds will also be used to develop Apexigen’s pipeline of therapies, including the advancement of at least one new proprietary immunotherapeutic product candidate into Phase 1 clinical development.

"Over the past year and a half we have made exceptional progress and generated compelling data from our ongoing clinical trials with APX005M, which to date have enrolled and treated over 400 cancer patients. In addition, the regulatory approval and commercial launch of a licensed product, the first for a product that emerged from our APXiMAB discovery platform, provided further validation for the platform," said Xiaodong Yang, M.D., Ph.D., President and Chief Executive Officer of Apexigen. "We welcome the support of both new and existing investors in our efforts to advance a new generation of immunotherapeutic agents to treat a diverse range of malignancies."

About APX005M
APX005M is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response. APX005M targets CD40, a co-stimulatory receptor that is essential for activating both innate and adaptive immune systems. Binding of APX005M to CD40 on antigen presenting cells (i.e., dendritic cells, monocytes and B-cells) initiates a multi-faceted immune response bringing multiple components of the immune system (e.g., T cells, macrophages) to work in concert against cancer. APX005M is currently in Phase 2 clinical development for the treatment of cancers such as pancreatic cancer, esophageal and gastroesophageal junction cancers, melanoma, non-small cell lung cancer and sarcoma in various combinations with immunotherapy, chemotherapy or radiation therapy.

On March 24, 2020 ThermoGenesis Holdings, Inc. (Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field, reported financial and operating results for the year ended December 31, 2019 and provided a corporate strategic update (Press release, Thermogenesis, MAR 24, 2020, View Source [SID1234555800]).

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Key 2019 Achievements:

Net revenues for 2019 increased to $13.0 million, up 35% compared to 2018.
Gross profit for 2019 was $5.7 million, an increase of 156% compared to 2018.
Operating expenses were $10.4 million, a decrease of 77% as compared to 2018.
Completed the commercial launch of the AXP II System, an automated, fully closed cell separation system upgraded from the market-leading AXP System, for the advanced isolation, collection and storage of hematopoietic stem cell concentrates from cord blood and peripheral blood.
Announced that long-time customer, CBR, America’s largest cord blood bank, transitioned to the AXP II System.
Announced that Cordlife, a leading cord blood bank in Asia, signed a strategic agreement to start transitioning to the AXP II System
Received Health Canada approval of the Company’s PXP system for automated processing of bone marrow cells at the point-of-care. Entered into strategic supply agreement with Orthohealing Center Management to provide PXP System to Orthohealing Method’s network physician members.
Completed the commercial launch of the X-Series cell processing products and reagents, key components of the Company’s CAR-TXpress large scale cell manufacturing platform.
Completed the validations of system performance for the X-Series products from two prestigious academic medical centers at Duke University School of Medicine and University of North Carolina.
Entered an exclusive global supply agreement with Corning Incorporated under a five-year, renewable supply agreement for the X-Series product line and received $2 million upfront exclusivity fee.
Formed a new joint venture with HealthBanks Biotech (USA) named ImmuneCyte Life Sciences, Inc. ("ImmuneCyte"), to develop a proprietary immune cell banking service, leveraging ThermoGenesis’ CAR-TXpress cell processing platform. The joint venture, of which the Company owns 20% of the equity, received a $3 million equity investment.
Completed name change from Cesca Therapeutics Inc. to ThermoGenesis Holdings, Inc., reflecting the Company’s new strategic focus on being an automated cell processing tools and services provider in the cell and gene therapy field.
"Throughout 2019, not only did we achieve an increase in net revenues of 35% and an increase in gross profit of 156%, but we also took a number of strategic steps to position the Company to become a leading cell processing and manufacturing solution provider within the rapidly expanding cell and gene therapy field," said Chris Xu, PhD, Chief Executive Officer of ThermoGenesis. "The successful signing of the global supply agreement with Corning for our X-Series product line is expected to vastly increase visibility and awareness of our newly launched CAR-TXpress cell manufacturing platform going forward. The establishment of the ImmuneCyte joint venture, which will further leverage our CAR-TXpress platform to provide GMP quality immune cell banking services to healthy customers for future potential use in immunotherapies, is yet another step forward. Lastly, the divestiture of our clinical development assets, undertaken in conjunction with the formation of ImmuneCyte was a necessary step to allow us to stay focused solely on our scientific tools and services business in the cell and gene therapy field."

Jeff Cauble, Chief Financial Officer of ThermoGenesis, added, "The significant increase in sales of AXP and CAR-TXpress were important catalysts for our revenue growth. The AXP System provided an additional $3.1 million in revenue over 2018, while CAR-TXpress added $658,000. Gross profit improved, jumping to $5.7 million in 2019 compared to $2.2 million last year, a 156% improvement. Continued revenue growth and increased margins led to the Company having positive adjusted EBITDA for two quarters in 2019. Furthermore, Boyalife’s recent conversion of $3.0 million in principal and interest, as part of its Revolving Credit Agreement, not only illustrates their unwavering support of ThermoGenesis, but it will also reduce our interest obligation over the next year."

Recent Update on Coronavirus Pandemic

The current global pandemic of the coronavirus (COVID-19) has now affected more than 180 countries and regions, including over 40,000 cases in the United States alone. The disease has spread rapidly, leading to a tremendous impact on the U.S. healthcare system and causing societal disruption. The public health threat posed by COVID-19 is extremely high, both globally and in the U.S.

To effectively respond to the COVID-19 pandemic, ThermoGenesis and ImmuneCyte are working together mobilizing their expertise, global resources and relationships in the medical technology field to develop, register, import and seek U.S. Food and Drug Administration (FDA) approval for advanced point-of-care tests that will allow rapid diagnosis of the COVID-19 virus, including asymptomatic cases. The tests would be able to be done both at point-of-care settings, or potentially at home, without further burdening the already stressed healthcare system. A quick do-it-yourself (DIY) testing kit, as simple as a routine pregnancy test or diabetic glucose test, if approved, would allow millions of people currently quarantined at home to conduct a self-test.

Management noted that the first of such a rapid point-of-care test could be available as early as April through ThermoGenesis and ImmuneCyte. "We expect to file for an expedited review process with the FDA for the assay," noted Dr. Xu.

Financial Results for the Fiscal Year Ended December 31, 2019

Net revenues. Net revenues for the year ended December 31, 2019 was $13.0 million compared to $9.7 million for fiscal 2018, an increase of $3.3 million or 35%. The increase was driven by AXP revenues which increased by $3.1 million in 2019 with approximately 1,300 more cases sold in 2019 as compared to 2018. Additionally, AXP device sales increased by approximately $0.7 million in 2019, driven by customers upgrading to AXP II devices in the current year and CAR-TXpress sales increased by approximately $0.6 million. BioArchive and clinical development segment sales decreased slightly year over year.

Gross profit. Gross profit was $5.7 million or 44% of net revenues for the year ended December 31, 2019 compared to $2.2 million or 23% for the year ended December 31, 2018, an increase of $3.5 million or 156%. The increase was primarily due to AXP sales, generating approximately $2.2 million more in gross profit from disposables and devices. The remainder of the increase is due to increased gross profit from service revenue of approximately $0.2 million and additional sales of CAR-TXpress which resulted in approximately $0.3 million more gross profit.

Sales and marketing expenses. Sales and marketing expenses were $1.7 million for the year ended December 31, 2019, as compared to $1.4 million for the year ended December 31, 2018, an increase of $0.3 million or 22%. The increase was driven by stock compensation expense and increased salaries and benefits.

Research and development expenses. Research and development (R&D) expenses were $2.4 million for the year ended December 31, 2019, compared to $3.0 million for the year ended December 31, 2018, a decrease of $0.6 million or 20%. The decrease is primarily due to a decline in personnel costs related to corporate reorganization in June 2018.

General and administrative expenses. General and administrative expenses for the year ended December 31, 2019 were $6.4 million, compared to $8.3 million for the year ended December 31, 2018, a decrease of $1.9 million or 23%. The decrease was driven by a decline in personnel costs of approximately $1.2 million and a loss on the disposal of fixed assets of approximately $1.3 million incurred in 2018. India general and administrative expenses were also approximately $0.3 million less in 2019. These decreases were offset by a $1.4 million expense as the result of the verdict against the Company in the Mavericks lawsuit.

Impairment Charges: The Company incurred no impairment charges during the year ended December 31, 2019 as compared to impairment charges of $33.1 million during the year ended December 31, 2018. In 2018, the Company recorded impairment charges of $13.2 million to goodwill and $19.9 million to the Company’s intangible assets in the Clinical Development Segment.

Interest Expense. Interest expense increased to $4.5 million for the year ended December 31, 2019 as compared to $2.7 million for the year ended December 31, 2018, a difference of $1.8 million. The increase is driven by interest recorded and the amortization of the debt discount, interest expense and the loss on the extinguishment of debt related convertible notes issued by the Company during 2019. Additionally, 2019 had more in interest and amortization of the debt discount on the beneficial conversion feature related to the Revolving Credit Agreement with Boyalife.

Loss on Extinguishment of Debt: The Company recorded a loss of extinguishment of debt of $0.8 million for the year ended December 31, 2019 as compared to $0 for the year ended December 31, 2018. The increase is due to the loss on the extinguishment of the convertible note issued in January 2019, which was deemed to be extinguished as a result of its amendment in July 2019.

Benefit for Income Taxes: For the year ended December 31, 2019, the Company has no income tax benefit compared to $4.7 million for the year ended December 31, 2018. The benefit for income tax in 2018 was due to the impairment of the indefinite lived intangible assets for the clinical protocols and goodwill.

Net loss. For the year ended December 31, 2019, the Company reported a comprehensive loss attributable to common stockholders of $9.5 million, or ($3.36) per share, based on approximately 2.8 million weighted average basic and diluted common shares outstanding. This compares to a comprehensive net loss of $39.7 million, or ($21.57) per share, based on approximately 1.8 million weighted average basic and diluted common shares outstanding for the year ended December 31, 2018.

Adjusted EBITDA. In addition to the results reported under US GAAP, the Company also uses a non-GAAP measure to evaluate operating performance and to facilitate the comparison of our historical results and trends. The Company uses the metric to determine operational cash flow. Adjusted EBITDA loss for the year ended December 31, 2019 was $3.3 million, as compared to a loss of $9.1 million for the year ended December 31, 2018, an increase of $5.8 million or 64%. The increase was due to $3.4 million in additional gross profit as the result of higher sales, decreased overhead expenses and lower costs. Additionally, the Company decreased personnel costs by approximately $1.5 million in 2019 as compared to 2018. These decreases were offset by a $1.4 million expense related to the Mavericks lawsuit. A reconciliation of adjusted EBITDA loss to net loss is set forth below.

At December 31, 2019, the Company had cash and cash equivalents totaling $3.2 million, compared with $2.4 million at December 31, 2018. Working capital improved to $3.2 million at December 31, 2019 as compared to $2.3 million at December 31, 2018.

Conference Call and Webcast Information

ThermoGenesis will host a conference call today at 1:30 p.m. PDT/4:30 p.m. EDT. To participate in the conference call, please dial 1-844-889-4331 (domestic), 1-412-380-7406 (international) or 1-866-605-3852 (Canada). To access a live webcast of the call, please visit: View Source

A replay of the call can be accessed by dialing 1-877-344-7529 (domestic), 1-412-317-0088 (international) or 855-669-9658 (Canada), and referencing access code 10139041. The replay will be available until April 9, 2020.

On March 24, 2020 The National Comprehensive Cancer Network (NCCN) reported that it is now an alliance of 30 leading cancer centers, with the addition of two new Member Institutions: UCLA Jonsson Comprehensive Cancer Center and UT Southwestern Simmons Comprehensive Cancer Center (SCCC) (Press release, NCCN, MAR 24, 2020, View Source [SID1234555799]). These top-tier academic cancer centers are located in two of the most-populous cities in the United States, Los Angeles and Dallas, respectively, and serve large, diverse groups of patients. Both centers have a strong commitment for advancing innovative research that improves cancer care and reduces disparities. Experts from both centers will now be involved in the creation of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines)—the recognized standard for clinical direction in cancer care and the most thorough and frequently-updated clinical practice guidelines available in any area of medicine.

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"We are very excited to incorporate the significant medical and scientific expertise from both UCLA Jonsson Comprehensive Cancer Center and UT Southwestern Simmons Comprehensive Cancer Center into our network of top academic cancer centers," said Robert W. Carlson, MD, Chief Executive Officer, NCCN. "Both have proven track records when it comes to improving outcomes and quality-of-life for people with cancer. Their facilities include top-notch programs throughout the spectrum of cancer management, including pediatric oncology, genetics, immunotherapy, telemedicine, and other increasingly-important areas of interest for NCCN and the greater cancer care community. They serve diverse, growing populations with strong immigrant representation at a time when the global need for NCCN Guidelines is higher than ever. The multi-disciplinary experts at UCLA and Simmons are among the best in the world, and both centers are ranked very highly by U.S. News & World Report. We are happy to have them work with us to improve and facilitate quality, effective, efficient, and accessible cancer care so patients can live better lives."

"We are honored and thrilled to become a member of the National Comprehensive Cancer Network," said Michael Teitell, MD, PhD, Director, UCLA Jonsson Comprehensive Cancer Center. "We look forward to joining our peer institutions and bringing our focus on cutting-edge research and top-quality cancer care to this association of the nation’s top cancer centers."

"We are excited to be able to join forces with the other leading cancer centers who are part of NCCN," said John Sweetenham, MD, Associate Director of Clinical Affairs, UT Southwestern Simmons Comprehensive Cancer Center. "Working with the other Member Institutions, we will ensure that the best possible evidence-based cancer care is available to patients throughout the nation and beyond. Our membership will bring the combined expertise of 30 elite cancer centers to the people of North Texas." Carlos L. Arteaga, MD, Director of the Simmons Cancer Center, echoed Dr. Sweetenham by adding "membership of the NCCN will greatly enhance our ability to apply the most recent cancer discoveries to our patient care mission."

In 2019 alone, more than 1,500 experts from NCCN Member Institutions contributed a combined 35,000+ hours to create and update NCCN Guidelines. Those guidelines provide the latest evidence- and expert consensus-based recommendations applying to 97 percent of cancers affecting patients in the United States, and also include prevention, screening, and supportive care topics. The development of the NCCN Guidelines is solely supported by membership dues from the NCCN Member Institutions.

The announcement of the addition of the UCLA Jonsson Comprehensive Cancer Center and UT Southwestern Simmons Comprehensive Cancer Center comes as NCCN celebrates its 25th anniversary year. The non-profit organization consisted of 13 centers when it was first founded in 1995.

In addition to joining the panels behind the NCCN Guidelines and their derivatives, experts from UCLA and SCCC will work with NCCN to provide continuing education; policy and advocacy outreach; best practices information; organization of clinical trials and research; global adaptations and translations; and up-to-date patient information. Visit NCCN.org to learn more about the various programs and their role in improving cancer care worldwide.

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.

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.