On March 5, 2020 Cryoport, Inc. (NASDAQ: CYRX) (NASDAQ: CYRXW) ("Cryoport"), a global leader in life sciences solutions, reported financial results for the three and twelve-month periods ended December 31, 2019 (Press release, Cryoport, MAR 5, 2020, View Source [SID1234555244]).

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"We reported revenue of $33.9 million for fiscal year 2019, an increase of 73% from fiscal year 2018," said Jerrell Shelton, Chief Executive Officer of Cryoport. "This record revenue was driven partly by our commercial agreements supporting Gilead’s YESCARTA and Novartis’ KYMRIAH, which contributed $8.3 million in the twelve-month period, an increase of 295% or $6.2 million, compared with the prior year. Revenue from our commercial agreements is expected to continue to grow throughout 2020 as the rollouts of these lifesaving therapies accelerate. We also expect to start generating revenue from the commercial launch of bluebird bio’s ZYNTEGLO, commencing in the first quarter of 2020.

"Global Bioservices contributed $3.0 million in revenue for fiscal year 2019 as a result of the Cryogene acquisition in May 2019. We have made meaningful progress in leveraging cross-selling opportunities and onboarded several Cryoport clients to the Cryogene platform during the second half of 2019. We expect revenue from existing clients and cross-selling opportunities to continue to drive revenue growth throughout 2020.

Mr. Shelton continued, "As we deepen and broaden our Compliance Unified Ecosystem of global strategic alliances to better serve our life sciences markets we are also investing in infrastructure, adding new talent to our teams, and developing new, innovative solutions. This includes the build out of a larger Global Supply Chain Center in Morris Plains, New Jersey and a new Global Supply Chain Center in Houston, Texas to provide global logistics and bioservices solutions to meet the growing demands for our services and to ensure we have the scale to serve an expanded client base. Both centers are expected to be completed during the fourth quarter of 2020."

"In 2019 the global regenerative medicine market experienced significant growth, resulting in an expanding pipeline of therapies. According to the Alliance for Regenerative Medicine, there are currently a total of 1,066 clinical trials in the Regenerative Medicine market, globally, with 381 trials in Phase I, 591 in Phase II, and 94 in Phase III. A record total of five Cryoport supported Marketing Authorization Applications (MAA’s) or Biologics Licensing Applications (BLA’s) were filed during the fourth quarter of 2019. We expect this momentum to accelerate, with approximately 10 additional Cryoport-supported MAA’s and BLA’s filed in 2020, based on internal information and forecasts from the Alliance for Regenerative Medicine. These filings are anticipated to be primary revenue drivers for Cryoport in the future as each of them requires comprehensive temperature-controlled solutions support at scale.

"During the Fourth Quarter, we added a net total of 11 clinical trials, bringing the grand total of regenerative therapy clinical trials supported by Cryoport to a record 436, of which 56 are currently in Phase III. We anticipate the continued expansion of the Regenerative Medicine market, together with growth in Cryoport’s market share, to drive an ongoing and significant increase in the number of clinical trials we support," continued Mr. Shelton.

"The Reproductive Medicine market is solid and growing, with 2019 revenue growing 34% year over year driven by increased adoption of our specialized solutions in domestic and international markets. The Prelude Network, which is the largest network of fertility centers in the U.S., will accelerate our growth in the Reproductive Medicine market as it rolls out our platform of temperature-controlled solutions to its entire clinical network and its strong pipeline of prospects.

"Revenue from the Animal Health market increased 2% year over year and is expected to accelerate in 2020 due to expansion of services to our existing base and the development of new clients in this area. We are confident in our strategies to grow our presence in both the Reproductive Medicine and Animal Health markets in 2020."

"In Fiscal 2019 we secured several new client agreements and top-tier partnerships and invested in new infrastructure build. As a result, we have entered 2020 with a strong foundation, supported by approximately $94 million in cash and short-term investments, to further drive infrastructure build out, organic growth and acquisitions. We will continue to advance our strategy to build out our Compliance Unified Ecosystem ("CUE") within the life sciences industry by expanding both our global network and platform solutions. We believe the Regenerative Medicine market will continue to accelerate as new life changing therapies enter clinical trials and reach commercial approval. This is a pivotal time in Cryoport’s evolution, and we are laser-focused on seizing this unique opportunity to build value for our shareholders and bring life changing therapies to market," Mr. Shelton concluded.

Market Highlights:

Global Logistics Solutions

Biopharma

Biopharma revenue increased by 64% in the twelve months ended December 31, 2019 compared to the same period in 2018; for the quarter ended December 31, 2019, biopharma revenue increased 42% compared to the same period in 2018.
Commercial revenue increased $6.2 million or 295% to $8.3 million for year ended December 31, 2019, as compared to $2.1 million for the same period in 2018; for the quarter ended December 31, 2019, commercial revenue increased $1.6 million or 200% to $2.4 million, as compared to $0.8 million for the same period in 2018.
Cryoport is now supporting a net total of 436 clinical trials as of December 31, 2019 compared with 357 as of December 31, 2018. The number of trials in Phase III grew to 56, compared with 47 as of December 31, 2018. Of the 436 total trials Cryoport supports, 361 are in the Americas, 61 in EMEA (Europe, the Middle East and Africa) and 14 in APAC (Asia Pacific). This compares to 317 in the Americas and 40 in EMEA as of December 31, 2018.
During 2019, Cryoport expanded its Compliance Unified Ecosystem of global strategic alliances through previously announced relationships with Lonza, Vineti, and EVERSANA to further expand its leadership position in the markets.
Animal Health

Animal Health revenue increased by 2% in the twelve months ended December 31, 2019 compared to the same period in 2018; for the quarter ended December 31, 2019, Animal Health revenue increased 28% compared to the same period in 2018.
Cryoport is growing its revenue in the Animal Health market through new dedicated resources. It has a strong pipeline of potential clients, which is anticipated to drive revenue growth in 2020.
Reproductive Medicine

Reproductive Medicine revenue increased by 34% for the twelve months ended December 31, 2019 compared to the same period in 2018; for the quarter ended December 31, 2019 Reproductive Medicine revenue increased by 23%, growing both domestically as well as internationally. This growth can be attributed to increasing awareness of our CryostorkTM platform as well as maturing commercial relationships with large clinical networks.
Global Bioservices

Bioservices revenue was $1.3 million and $3.0 million for the three and twelve-month periods ended December 31, 2019 resulting from the acquisition of Cryogene consummated in May 2019.
Financial Highlights:

Revenue increased 73% to $33.9 million and 62% to $9.2 million for the twelve and three-month periods ended December 31, 2019, compared with the same periods in the prior year.
Excluding revenue from the Cryogene acquisition, consummated in May of 2019, for the three and twelve-month periods ended December 31, 2019, revenue grew 40% and 58%, compared with the same periods in the prior year.
Gross margin for the three and twelve-months ended December 31, 2019 was 53% and 51%, respectively, compared to 50% and 52% for the respective periods in the prior year.
The 2019 financial results include a one-time charge of $9.6 million in accelerated stock-based compensation expense (non-cash) of which $0.4 million and $9.2 million are included in cost of revenues and operating costs and expenses, respectively. The charge recorded in the third quarter of 2019 incorrectly included stock option grants to nonemployee directors which was reversed in the fourth quarter resulting in a reduction of $0.8 million of stock-based compensation expense in the fourth quarter of 2019.
Operating costs and expenses increased by $0.8 million, and $16.1 million, for the three and twelve-month periods ended December 31, 2019, respectively, compared to the same periods in the prior year, as a result of $9.6 million in one-time accelerated stock-based compensation expenses (non-cash) as well as continued investments in the build out of infrastructure to support the accelerating market demands.
Adjusted EBITDA for the three-month period ended December 31, 2019 was $0.8 million, compared with ($0.4 million) in the same three-month period in the prior year. Adjusted EBITDA for the twelve-month period ended December 31, 2019, was $2.0 million, compared with ($2.2 million) in the same twelve-month period in the prior year.
Net loss for the three-month period ended December 31, 2019 was $0.9 million, or $0.03 per share (Adjusted net loss was $1.7 million, or $0.05 per share, excluding the reversal of accelerated stock-based compensation expense for nonemployee directors described above), compared to a net loss of $2.3 million, or $0.08 per share in the same three-month period in 2018.
Net loss for the twelve-month period ended December 31, 2019 was $18.3 million, or $0.55 per share (Adjusted net loss was $8.8 million, or $0.26 per share, excluding the accelerated vesting stock-based compensation expense described above), compared with $9.6 million, or $0.34 per share, in the same twelve-month period in 2018.
Cryoport reported $94.3 million in cash, cash equivalents and short-term investments as of December 31, 2019, compared with $47.3 million as of December 31, 2018. This increase includes net proceeds of $68.8 million received from a public offering completed in June 2019.
Further information on Cryoport’s financial results is included on the attached condensed consolidated balance sheets and statements of operations, and additional explanations of Cryoport’s financial performance are provided in Cryoport’s annual report on Form 10-K for the twelve months ended December 31, 2019, which will be filed with the Securities and Exchange Commission ("SEC") on March 10, 2020. The full report will be available on the SEC Filings section of the Investor Relations section of Cryoport’s website at www.cryoport.com.

Earnings Conference Call Information

IMPORTANT INFORMATION: A document titled "Cryoport 2019 Year in Review", which will provide a review of Cryoport’s recent financial and operational performance and a general business update, will be issued by management at 4:05 pm ET on Thursday, March 5. The document is designed to be read by investors before the questions and answers conference call and can be accessed at http://ir.cryoport.com/events-and-presentations .

Cryoport management will host a conference call at 5:00 pm ET on March 5, 2020. The conference call will be in the format of a questions and answers session and will address any queries investors have regarding Cryoport’s reported results.

Conference Call Information

Date:

March 5, 2020

Time:

5:00 p.m. ET

Dial-in numbers:

+1 (855) 327-6837 (U.S.) or +1 (631) 891-4304 (International)

Confirmation code:

Request the "Cryoport Call"

Live webcast:

‘Investor Relations’ section at www.cryoport.com or at this link. Please allow 10 minutes prior to the call to visit this site to download and install any necessary audio software.

An archive of the question and answer webcast will be available approximately three hours after completion of the live event and will be accessible on the Investor Relations section of the Company’s website at www.cryoport.com for a limited time. To access the replay of the webcast, please follow this link. A dial-in replay of the call will also be available to those interested until March 12, 2020. To access the replay, dial +1 (844) 512-2921 (United States) or +1 (412) 317-6671 (International) and enter replay pin number: 10008682.

On March 5, 2020 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, reported financial results for the three and 12 months ended December 31, 2019, after the close of the U.S. financial markets on Thursday, March 12, 2020 (Press release, CNS Pharmaceuticals, MAR 5, 2020, View Source [SID1234555243]).

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CNS’ senior management will provide a business update in a conference call and live audio webcast at 4:30 p.m. Eastern time on Thursday, March 12, 2020. The conference call dial-in and webcast information is as follows:

DOMESTIC DIAL-IN:

(844) 535-4071

INTERNATIONAL DIAL-IN:

(706) 679-2458

PASSCODE:

1254059

WEBCAST:

CNS Business Update Conference Call

For those unable to participate in the live conference call or webcast, a replay will be available beginning approximately two hours after the close of the conference call. To access the replay, dial 855-859-2056 or 404-537-3406. The replay passcode is 1254059. The replay can be accessed for a period of time on CNS website at CNS Business Update Conference Call.

On March 5, 2020 CytoSorbents Corporation (NASDAQ: CTSO) reported a critical care immunotherapy leader commercializing its CytoSorb blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, achieves record total revenue, CytoSorb sales, and product gross margins in 2019 (Press release, Cytosorbents, MAR 5, 2020, View Source [SID1234555242]).

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2019 Financial Highlights:

Q4 2019 total revenue was approximately $7.4 million compared to $6.1 million a year ago
Growth accelerated in Q4 2019, with quarterly product sales of approximately $6.6 million, a 21% increase when compared to $5.5 million of product sales a year ago, bolstered by a 30% increase in direct sales. On a constant currency/exchange rate basis, Q4 2019 product sales increased 24%
2019 total revenue was approximately $24.9 million compared to $22.5 million in 2018
2019 total product sales were approximately $22.8 million compared to $20.3 million in 2018
On a constant currency/exchange rate basis, 2019 total revenue and product sales were $26.1 million and $24.0 million, representing 16% and 18% growth, respectively when compared to the prior year
Achieved Q4 2019 blended product gross margins of 80%, mixing higher margin direct sales and lower margin distributor and partner sales
2019 and Recent Operational Highlights:

Exceeded 80,000 cumulative CytoSorb treatments delivered, up from 56,000 in 2018
Modified partnership with Fresenius Medical Care to now include Mexico, Korea, France, the Czech Republic, and Finland
Added 5 new direct sales countries including Poland, the Netherlands, Denmark, Norway and Sweden
Strengthened our commercial capabilities and more than doubled the number of customer-facing sales reps and specialists in Germany, with a 50% expansion of our workforce
Expanded CytoSorb distribution in Latin and South America, including Brazil, Colombia, and Costa Rica
Renewed CytoSorb CE Mark through May 2024 and annual ISO 13485:2016 certification through September 2022
Approximately 25 published papers, and additional studies highlighting the clinical benefit and utility of CytoSorb therapy in a number of observational studies
Significant reduction in bleeding complications in cardiac surgery patients on ticagrelor, resulting in projected cost savings of $5,000 per patient
Improvements in hemodynamic stability during cardiac surgery
Reversal of septic shock when CytoSorb is started early
Improvements in microcirculation in septic shock
Decreased observed versus expected 28-day mortality in septic shock patients on continuous renal replacement therapy
Doubling of actual survival versus predicted survival in refractory cardiac arrest patients when CytoSorb was used with extracorporeal cardiopulmonary resuscitation (eCPR)
Third interim report of the International CytoSorb Registry confirming a marked reduction in IL-6 in critically-ill patients with treatment
CytoSorb was included in the treatment guidelines on salvage treatment of relapsed and refractory hemophagocytic lymphohistiocytosis (HLH), where infection often triggers a massive cytokine storm, similar to cytokine release syndrome (CRS) in CAR T-cell immunotherapy
Commencement of the first trial using CytoSorb to treat cytokine release syndrome (CRS) in CAR T-cell patients
Award of a $3 million, 2-year contract from the U.S. Air Force Rapid Innovation Fund (RIF) to advance development of the K+ontrol system to treat severe hyperkalemia
Initiated the company-sponsored TISORB trial in the United Kingdom to further support use of CytoSorb to remove ticagrelor during cardiac surgery
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, "As discussed in our January 14, 2020 stockholder letter, 2019 was a year of progress, though not without its fair share of growing pains. That said, we believe the significant investments and efforts made last year to strengthen our commercialization infrastructure have solidly positioned the company for future potential successes. I recommend that you read this letter if you have interest."

Dr. Chan continued, "That said, 2020 has started with a burst of important achievements and new opportunity, but also a very deep sense of responsibility to investigate the use of CytoSorb as a possible adjunctive treatment in critically-ill patients infected with either COVID-19 coronavirus or influenza. In the U.S. alone, the Centers for Disease Control and Prevention (CDC) has estimated that influenza has infected 30 million people this season, killing 18,000. There have been more than 90,000 documented cases of COVID-19 coronavirus infection worldwide, with more than 3,000 deaths. In the U.S., there have been 162 cases across 18 states, and 11 deaths. We predict that as the coronavirus test becomes more available, and more people are tested, the number of documented cases in the U.S. will increase dramatically. We want to be in a position to help as many people here in the U.S. and worldwide as possible."

"As we have discussed in the past couple of weeks, our partnership with China Medical System Holding Ltd, a publicly-traded $800+ million in revenue specialty pharma company in China, has led to the rapid introduction of donated CytoSorb devices into key hospitals in the Wuhan, China region, the epicenter of the COVID-19 pandemic, announced last Friday," stated Dr. Chan.

"We have now learned that multiple COVID-19 infected patients at multiple hospitals have been undergoing CytoSorb treatment. Although too soon to report on clinical outcomes, we expect information to begin to be available in the near future. Physicians from hospitals in Beijing (Peking), Shanghai, and other cities throughout China, have generously come to Wuhan to assist in treating those infected with COVID-19. In particular, physicians working in Wuhan from Peking Union Medical College Hospital, one of the most prestigious medical institutions in China, have registered a clinical study entitled, ‘Cytosorb adsorption therapy combined with standard therapy for new coronavirus pneumonia in adult severe patients’ in order to have a mechanism to collect ongoing safety and efficacy data from patients they are treating, and to publish these data."

Dr. Chan continued, "We are also pleased that on March 3, 2020, the National Health Commission in China issued the official, updated "Diagnosis and Treatment of New Coronavirus Pneumonia (7th Version)" guidelines, which now includes the following translated statement as a treatment recommendation, "For severe and critically ill patients with cytokine storms, in order to remove inflammatory factors, block "cytokine storms" and increase "blood purification treatment".

"Meanwhile, CytoSorb is already being sold in many countries around the world where COVID-19 cases have surged, including Italy, Iran, Germany, France, Spain, Hong Kong, and others. Meanwhile, here in the U.S., we have submitted our documentation to the multi-agency coronavirus task force, led by the Biomedical Advanced Research and Development Authority (BARDA), had a preliminary conversation with the agency, and await further feedback. There are many cases in the published literature where the use of CytoSorb, in conjunction with standard of care, has been successful in helping to treat the severe complications of influenza and coronavirus infection. These include the "cytokine storm" that triggers an overwhelming systemic inflammatory response syndrome that can then lead to acute respiratory distress syndrome (ARDS), shock, multiple organ failure, and sepsis from secondary bacterial pneumonia. If we observe the similar ability to treat these complications in patients afflicted with COVID-19, it would represent a major advance in the treatment of this deadly illness."

"For further updates on our existing business, we invite you to join us on our earnings conference call, details below."

Conference Call Details:

Date: Thursday, March 5, 2020
Time: 4:45 PM Eastern Time
Participant Dial-In: 1-201-389-0879
Conference ID: 13699145
Live Presentation Webcast View Source

It is recommended that participants dial in approximately 10 minutes prior to the start of the call. There will also be a simultaneous live webcast of the conference call that can be accessed through the following audio feed link: View Source

An archived recording and written transcript of the conference call will be available under the Investor Relations section of the Company’s website at View Source

Fiscal Year 2019 Financial Results:

Revenues:

For the year ended December 31, 2019, we generated total revenue, which includes product revenue and grant income, of approximately $24,949,000 as compared to revenues of approximately $22,504,000 for the year ended December 31, 2018, an increase of approximately $2,445,000, or 11%. Revenue from product sales was approximately $22,766,000 for the year ended December 31, 2019, as compared to approximately $20,252,000 in the year ended December 31, 2018, an increase of approximately $2,514,000 or 12%. This increase was primarily driven by an increase in direct sales of approximately $3,194,000 resulting from both new customers and repeat orders from existing customers. This increase was offset by a decrease in distributor sales of approximately $680,000. In addition, sales were negatively impacted by approximately $1,201,000 as a result of the decrease in the average exchange rate of the Euro to the U.S. dollar. For the year ended December 31, 2019, the average exchange rate of the Euro to the U.S. dollar was $1.12 as compared to an average exchange rate of $1.18 for the year ended December 31, 2018.

Cost of Revenue:

For the years ended December 31, 2019 and 2018, cost of revenue was approximately $7,364,000 and $7,489,000, respectively, a decrease of approximately $125,000. Product cost of revenues decreased approximately $63,000 during the year ended December 31, 2019 as compared to the year ended December 31, 2018 as a result of achieved production efficiencies. Product gross margins were approximately 77% for the year ended December 31, 2019 and approximately 74% for the year ended December 31, 2018.

Gross Profit:

Gross profit was approximately $17,586,000 for the year ended December 31, 2019, an increase of approximately $2,571,000 or 17%, over gross profit of $15,015,000 in 2018. This increase is attributed to an increase in CytoSorb product sales during 2019 as well as achieved production efficiencies.

Research and Development Expenses:

Our research and development costs were approximately $12,092,000 and $7,723,000 for the years ended December 31, 2019 and 2018, respectively, an increase of approximately $4,369,000, or 57%. This increase was due to an increase in clinical trial and related costs of approximately $3,890,000, which include expenditures related to our REFRESH 2-AKI study and our TISORB study, an increase in non-clinical research and development salary related costs of approximately $223,000, decreases in direct labor and other costs being deployed toward grant-funded activities of approximately $62,000, which had the effect of increasing the amount of our non-reimbursable research and development costs and an increase in our non-grant related research and development costs of approximately $194,000.

Legal, Financial and Other Consulting Expenses:

Our legal, financial and other consulting costs were approximately $2,462,000 and $2,002,000 for the years ended December 31, 2019 and 2018, respectively, an increase of approximately $460,000, or 23%. This increase was due to an increase in legal fees of approximately $334,000 related to patent matters and certain corporate initiatives, an increase in employment agency fees of approximately $88,000 related to the hiring of senior level personnel, an increase in accounting and auditing fees of approximately $24,000 and an increase in consulting fees of approximately $14,000.

Selling, General and Administrative Expenses:

Our selling, general and administrative expenses were approximately $22,006,000 and $20,874,000 for the years ended December 31, 2019 and 2018, respectively, an increase of approximately $1,132,000, or 5%. This increase was due to an increase in salaries, commissions and related costs of approximately $2,323,000, additional sales and marketing costs, which include advertising and conference attendance of approximately $863,000, an increase in royalty expenses of approximately $198,000 due to the increase in product sales, and an increase in restricted stock expense of approximately $226,000 related to restricted stock units granted to the Company’s executive officers, an increase in public relations cost of approximately $78,000 and increase in other general and administrative costs of approximately $215,000. These increases were offset by a decrease in non-cash stock compensation expense of approximately $2,771,000.

Interest Expense, Net:

For the year ended December 31, 2019, interest expense, net was approximately $1,034,000, as compared to interest expense, net of approximately $1,461,000 for the year ended December 31, 2018. This decrease in net interest expense of approximately $427,000 is related to the settlement of the Success Fee with Bridge Bank in the amount of $637,000 that became due in May 2018 in accordance with the terms of the 2016 Success Fee Letter, offset by an increase in interest due to the draw down of the $5,000,000 Term B Loan with Bridge Bank on July 31, 2019.

Gain (Loss) on Foreign Currency Transactions:

For the year ended December 31, 2019, the loss on foreign currency transactions was approximately $350,000, as compared to a loss on foreign currency transactions of approximately $785,000 for the year ended December 31, 2018. The 2019 loss is directly related to the decrease in the exchange rate of the Euro at December 31, 2019, as compared to December 31, 2018. The exchange rate of the Euro to the U.S. dollar was $1.12 per Euro at December 31, 2019 as compared to $1.15 per Euro at December 31, 2018. The 2018 loss is directly related to the decrease in the exchange rate of the Euro at December 31, 2018, as compared to December 31, 2017. The exchange rate of the Euro to the U.S. dollar was $1.15 per Euro at December 31, 2018 as compared to $1.20 per Euro at December 31, 2017.

Benefit from Income Taxes:

Our benefit from income taxes was approximately $1,092,000 and $620,000 for the years ended December 31, 2019 and 2018, respectively. These benefits were realized by utilizing the New Jersey Technology Business Tax Certificate Transfer Program whereby the State of New Jersey allows us to sell a portion of our state net operating losses to a third party.

Liquidity and Capital Resources

Since inception, our operations have been primarily financed through the private and public placement of our debt and equity securities. At December 31, 2019, we had current assets of approximately $20,902,000 including cash on hand of approximately $12,232,000 and had current liabilities of approximately $9,936,000. During the period from January 1, 2020 through March 2, 2020, we raised approximately $13,322,000 by utilizing our ATM facility with co-agents Jefferies LLC and B. Riley FBR. Also, we expect to receive approximately $1,092,000 in cash from the approved sale of our net operating losses and research and development credits from the State of New Jersey in the first quarter of 2020. We believe that we have sufficient cash to fund our operations into 2021.

2020 First Quarter Revenue Guidance

CytoSorbents has not historically given specific financial guidance on quarterly results until the quarter has been completed. However, we expect our first quarter 2020 product sales will exceed product sales reported in the first quarter of 2019.

For additional information, please see the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 filed on March 5, 2020 on View Source

On March 5, 2020 Rafael Holdings, Inc., (NYSE: RFL), reported revenue of $1.2 million and a loss per diluted share of $0.08 for the fiscal quarter ended January 31, 2020 (Press release, Rafael Holdings, MAR 5, 2020, View Source [SID1234555241]).

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Recent Rafael Holdings Highlights

Subsequent to the quarter close, Rafael Holdings and other shareholders in Rafael Pharmaceuticals, a leader in cancer metabolism-based therapeutics, entered into an agreement to provide up to $50 million to finance Rafael Pharmaceuticals’ operations and clinical development program. Please see Rafael Holdings’ Form 8-K filed with the U.S. Securities and Exchange Commission on February 3, 2020 for additional information.
On November 21, 2019, Rafael Holdings up-listed its Class B common stock to the New York Stock Exchange from the NYSE American exchange. The Company retained its ticker symbol, ‘RFL’.
The Barer Institute successfully synthesized novel chemical entities that have shown efficacy at inhibiting cancer metabolism, with ongoing studies in syngeneic animal models.
Revenue of $1.2 million in Q2 FY2020, generated through Rafael Holdings’ real estate portfolio, increased from $1.0 million in the year-ago quarter. The loss per share of $0.08 was unchanged from Q2 FY2019.
Rafael Pharmaceuticals

Following the equity issued in connection with the financing arrangement referenced above, Rafael Holdings and its subsidiaries held 50.7% (38.7% exclusive of minority interests) of the capital stock of Rafael Pharmaceuticals.

On March 3, 2020, Rafael Pharmaceuticals announced the appointment of Sanjay Sehgal, Ph.D., to Chief Regulatory Affairs and Quality Assurance Officer. Dr. Sehgal formerly served as the Senior Vice President of Regulatory Affairs and Conformance at Celularity, Inc. and was Chair of Regulatory Sciences for the American Association of Pharmaceutical Scientists (AAPS) from 2007-2008.
On January 21, 2020, Rafael Pharmaceuticals announced a collaboration with Michigan Medicine on a Phase 1b/2 clinical trial of CPI-613 (devimistat) in combination with gemcitabine and cisplatin for patients with biliary tract cancer.
On January 14, 2020, Rafael Pharmaceuticals announced that it had enrolled 250 patients – half of its enrollment goal – in its Phase 3 clinical trial (AVENGER 500) of CPI-613 for patients with metastatic pancreatic cancer. The study is being conducted at multiple sites in the United States, France, Israel and South Korea.
LipoMedix

Rafael Holdings owns 57.9% of the issued and outstanding ordinary shares of LipoMedix, a development-stage Israeli company focused on the development of an innovative, safe and effective cancer therapy based on liposome delivery.

On January 23, 2020, LipoMedix announced that a Phase 1 study of Promitil (PL-MLP) in 53 patients with advanced, treatment-refractory colorectal cancer treated with Promitil either as a single agent or in combination with capecitabine and/or bevacizumab was well tolerated and resulted in a substantial rate of disease stabilization. Prolonged survival of stable disease patients was also observed.
Remarks by Howard Jonas, Chairman and CEO of Rafael Holdings

"Rafael Holdings’ key pharmaceutical investments, Rafael Pharmaceuticals and LipoMedix, both achieved important milestones in their respective clinical development programs this quarter. We also entered into an agreement to finance Rafael Pharmaceuticals’ expanding clinical development program and put in place key Barer Institute research programs. Finally, we continue to work to monetize some of our real estate portfolio including our office building in Newark, New Jersey."

On March 5, 2020 McKesson Corporation (NYSE:MCK) reported the final exchange ratio of 11.4086-for-one in connection with its previously announced offer to its stockholders to exchange their shares of McKesson common stock for shares of PF2 SpinCo, Inc. ("SpinCo") common stock (Press release, McKesson, MAR 5, 2020, View Source [SID1234555239]). The exchange offer to split-off SpinCo, which holds McKesson’s interest in Change Healthcare LLC ("Change Healthcare"), is part of McKesson’s agreement with Change Healthcare Inc. (NASDAQ:CHNG) ("Change") to merge SpinCo with and into Change.

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McKesson also announced that the upper limit on the number of SpinCo shares that can be received for each share of McKesson Common Stock tendered has been reached.

For each share of McKesson common stock that is validly tendered and accepted for exchange McKesson will deliver approximately 11.4086 shares of SpinCo common stock, which will be immediately converted into an equal number of shares of Change common stock upon completion of the proposed merger (subject to receipt of cash in lieu of fractional shares). The exchange offer and merger are generally expected to be tax-free to participating McKesson stockholders for U.S. federal income tax purposes except to the extent of any cash received in lieu of fractional shares of Change common stock. The transaction is subject to customary closing conditions.

McKesson will accept 15,426,537 shares of its common stock for exchange if the exchange offer is fully subscribed, based on the final exchange ratio. The exchange offer will be subject to proration if it is oversubscribed, and the number of shares accepted in the exchange offer may be fewer than the number of shares tendered.

The exchange offer is scheduled to expire at 11:59 p.m., New York City time, on March 9, 2020, unless it is extended or terminated. Holders of McKesson common stock may withdraw their tendered shares at any time before the expiration date of the exchange offer.

In connection with the transactions, Goldman Sachs & Co. LLC is acting as financial advisor and Davis Polk & Wardwell LLP is acting as legal advisor to McKesson.

For more information about the exchange offer, please visit www.dfking.com/McKesson or contact the information agent, D.F. King & Co., at 1-866-304-5477 (toll-free in the United States) or 1-212-269-5550 (outside of the United States), or by email at [email protected].