Market Newsdesk

May 3, 2021 7:33 am

Intra-Cellular Therapies Announces FDA Acceptance of CAPLYTA® (lumateperone) sNDAs for the Treatment of Bipolar Depression

NEW YORK, May 03, 2021 (GLOBE NEWSWIRE) — Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Applications (sNDAs) for lumateperone, an investigational agent for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 17, 2021 for the applications. If approved, CAPLYTA has the potential to be an important medicine for a broad group of patients suffering from these highly prevalent, chronic complex conditions.

Two positive Phase 3 global placebo-controlled bipolar depression studies, Study 402 and Study 404, form the basis of the CAPLYTA sNDAs for the treatment of bipolar depression. In these clinical trials, lumateperone 42 mg demonstrated a favorable tolerability and safety profile consistent with findings in all of our previous studies in schizophrenia. The most commonly reported adverse events (defined as a rate greater than or equal to 5% and at least twice the rate of placebo) were somnolence, dizziness and nausea. Importantly, the rates of akathisia, restlessness and extrapyramidal symptoms were low and similar to placebo.

“We are pleased that the FDA has accepted our sNDAs for review and we look forward to working with the FDA during the review process,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. “We believe CAPLYTA has the potential to be an important option for patients in the treatment of bipolar depression.”

About Bipolar Depression

Bipolar I and Bipolar II disorder are serious, highly prevalent psychiatric conditions affecting approximately 11 million adults in the U.S.

These disorders are characterized by recurrent episodes of mania or hypomania interspersed with episodes of major depression known as Bipolar depression. Bipolar I and Bipolar II each represent about half of the overall population of patients with bipolar disorder.

Bipolar depression is the most common clinical presentation of bipolar disorder. These episodes tend to last longer, recur more often, and are associated with a worse prognosis than the manic/hypomanic episodes. Bipolar depression remains a significantly underserved medical need, with only a few FDA-approved treatment options available. These treatments are commonly associated with tolerability issues.

CAPLYTA® (lumateperone) is under investigation for the treatment of bipolar disorder. The safety and efficacy for this use has not been established.

CAPLYTA is indicated for the treatment of schizophrenia in adults. CAPLYTA is available in 42 mg capsules.

Important Safety Information

Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.

Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), and urticaria.

Warnings & Precautions: Antipsychotic drugs have been reported to cause:

Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room.
Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.
Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.
Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.
Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
Sleepiness and Trouble Concentrating. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.

Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers, moderate or strong CYP3A4 inhibitors and UGT inhibitors.

Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended. Use of CAPLYTA should be avoided in patients with moderate or severe liver problems.

Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).

Please click here to see full Prescribing Information including

Boxed Warning

.

About CAPLYTA (lumateperone)

CAPLYTA 42mg/day is an oral, once daily atypical antipsychotic approved for the treatment of schizophrenia of adults. While the mechanism of action of CAPLYTA in the treatment of schizophrenia is unknown, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

Lumateperone is being investigated for the treatment of bipolar depression, depression and other neuropsychiatric and neurological disorders. Lumateperone is not FDA approved for these disorders.

About Intra-Cellular Therapies

Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

Forward-Looking Statements

This news release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, expectations regarding the sNDAs, including the adequacy of the data contained in the sNDAs to serve as the basis for approval of lumateperone for the treatment of depressive episodes associated with bipolar I or II disorder both as monotherapy and as adjunctive therapy in adults; potential approval by the FDA of the sNDAs for lumateperone for the treatment of bipolar depression; the potential timing of review and action by the FDA with respect to the sNDAs; our belief that lumateperone has the potential to be an important medicine for a broad group of patients suffering from these highly prevalent, chronic complex conditions; our belief that lumateperone has the potential to represent an important option for patients in the treatment of bipolar depression; our beliefs about the potential utility of our product candidates; and development efforts and plans under the caption “About Intra-Cellular Therapies.” All such forward-looking statements are based on management’s present expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, the following: whether the preclinical and clinical results of the lumateperone studies will meet the regulatory requirements for approval by the FDA for the proposed indications; whether the sNDAs will be approved by the FDA and whether the FDA will complete its review within its target timelines, including its target action date; whether the FDA will require additional information, whether we will be able to provide in a timely manner any additional information that the FDA requests, and whether such additional information will be satisfactory to the FDA; there are no guarantees that CAPLYTA will be commercially successful; we may encounter issues, delays or other challenges in commercializing CAPLYTA; the COVID-19 pandemic may negatively impact our commercial plans and sales for CAPLYTA; the COVID-19 pandemic may negatively impact the conduct of, and the timing of enrollment, completion and reporting with respect to, our clinical trials; whether CAPLYTA receives adequate reimbursement from third-party payors; the degree to which CAPLYTA receives acceptance from patients and physicians for its approved indication; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; results achieved in CAPLYTA in the treatment of schizophrenia following commercial launch of the product may be different than observed in clinical trials, and may vary among patients; any other impacts on our business as a result of or related to the COVID-19 pandemic; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with CAPLYTA following commercial launch for the treatment of schizophrenia or in ongoing or future trials and other development activities; our other product candidates may not be successful or may take longer and be more costly than anticipated; product candidates that appeared promising in earlier research and clinical trials may not demonstrate safety and/or efficacy in larger-scale or later clinical trials or in clinical trials for other indications; our proposals with respect to the regulatory path for our product candidates may not be acceptable to the FDA; our reliance on collaborative partners and other third parties for development of our product candidates; and the other risk factors detailed in our public filings with the Securities and Exchange Commission. All statements contained in this press release are made only as of the date of this press release, and we do not intend to update this information unless required by law.

Contact:

Intra-Cellular Therapies, Inc.

Juan Sanchez, M.D.
Vice President, Corporate Communications and Investor Relations
646-440-9333

Burns McClellan, Inc.
Lisa Burns
[email protected]
212-213-0006

MEDIA INQUIRIES:

Ana Fullmer
Corporate Media Relations W2Owcg
[email protected]
202-507-0130

May 3, 2021 7:33 am

Cresco Labs Announces Expiration of HSR Act Waiting Period for the Proposed Acquisition of Cultivate

Cresco Labs Announces Expiration of HSR Act Waiting Period for the Proposed Acquisition of Cultivate

CHICAGO–(BUSINESS WIRE)–Cresco Labs (CSE:CL) (OTCQX:CRLBF) (“Cresco Labs” or “the Company”), a vertically integrated multistate operator and the number one U.S. wholesaler of branded cannabis products, today announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the “HSR Act”), as amended, in respect to Cresco Labs’ pending acquisition of Cultivate Licensing LLC and BL Real Estate LLC (collectively “Cultivate”)(the “Transaction”). The waiting period expired without the issuance of a so-called “second request” by the United States Department of Justice Antitrust Division (the “DOJ”). The Transaction remains subject to certain closing conditions, including approval from the Commonwealth of Massachusetts which is anticipated to be received in the fourth quarter of 2021.

“We look forward to completing the remaining steps required to close the Transaction and are excited to begin our work with the Cultivate team later this year,” said Charles Bachtell, CEO of Cresco Labs. “Upon closing, Cresco Labs will immediately vault to a top 3 share position in Massachusetts, the third $1B+ market where we’ve achieved this status. Once again, we will execute our playbook and demonstrate the growth and leverage that can be achieved by going deeper in strategic states.”

For additional highlights and details on the Transaction, please see the announcement press release and presentation provided on our Investor Relations website.

About Cresco Labs Inc.

Cresco Labs is one of the largest vertically integrated multistate cannabis operators in the United States, with a mission to normalize and professionalize the cannabis industry. Employing a consumer-packaged goods (“CPG”) approach, Cresco Labs is the largest wholesaler of branded cannabis products in the U.S. Its brands are designed to meet the needs of all consumer segments and comprised of some of the most recognized and trusted national brands including Cresco, High Supply, Mindy’s Edibles, Good News, Remedi, Wonder Wellness Co. and FloraCal Farms. Sunnyside, Cresco Labs’ national dispensary brand, is a wellness-focused retailer created to build trust, education and convenience for both existing and new cannabis consumers. Recognizing that the cannabis industry is poised to become one of the leading job creators in the country, Cresco Labs operates the industry’s largest Social Equity and Educational Development initiative, SEED, which was established to ensure that all members of society have the skills, knowledge and opportunity to work and own businesses in the cannabis industry. Learn more about Cresco Labs at www.crescolabs.com.

Forward Looking Statements

This press release contains “forward-looking information” within the meaning of applicable Canadian securities legislation and may also contain statements that may constitute “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such forward-looking information and forward-looking statements are not representative of historical facts or information or current condition, but instead represent only the Company’s beliefs regarding future events, plans or objectives, many of which, by their nature, are inherently uncertain and outside of the Company’s control. Generally, such forward-looking information or forward-looking statements can be identified by the use of forward-looking terminology such as, ‘may,’ ‘will,’ ‘should,’ ‘could,’ ‘would,’ ‘expects,’ ‘plans,’ ‘anticipates,’ ‘believes,’ ‘estimates,’ ‘projects,’ ‘predicts,’ ‘potential’ or ‘continue’ or the negative of those forms or other comparable terms. The Company’s forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including but not limited to those risks discussed under “Risk Factors” in the Company’s Annual Information Form for the year ended December 31, 2020 filed on March 26, 2021, and other documents filed by the Company with Canadian securities regulatory authorities; and other factors, many of which are beyond the control of the Company. Readers are cautioned that the foregoing list of factors is not exhaustive. Because of these uncertainties, you should not place undue reliance on the Company’s forward-looking statements. No assurances are given as to the future trading price or trading volumes of Cresco Labs’ shares, nor as to the Company’s financial performance in future financial periods. The Company does not intend to update any of these factors or to publicly announce the result of any revisions to any of the Company’s forward-looking statements contained herein, whether as a result of new information, any future event or otherwise. Except as otherwise indicated, this press release speaks as of the date hereof. The distribution of this press release does not imply that there has been no change in the affairs of the Company after the date hereof or create any duty or commitment to update or supplement any information provided in this press release or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210503005337/en/

Media:

Jason Erkes, Cresco Labs

Chief Communications Officer

[email protected]

Investors:

Jake Graves, Cresco Labs

Manager, Investor Relations

[email protected]

For general Cresco Labs inquiries:

312-929-0993

[email protected]

KEYWORDS: United States North America Illinois

INDUSTRY KEYWORDS: Alternative Medicine Other Retail Health Tobacco Packaging Specialty Manufacturing Retail

MEDIA:

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May 3, 2021 7:33 am

GlycoMimetics Reports Highlights and Financial Results for First Quarter 2021

GlycoMimetics Reports Highlights and Financial Results for First Quarter 2021

GlycoMimetics continues to target year-end 2021 for completing enrollment of the Company-sponsored pivotal trial evaluating uproleselan in patients with relapsed/refractory acute myeloid leukemia (AML)
Enrollment in the Phase 2 portion of the NCI-sponsored Phase 2/3 registration trial evaluating uproleselan in newly diagnosed AML patients fit for chemotherapy is expected to complete by year-end 2021 and to support a subsequent interim analysis based on event-free survival
The Chinese heath agency granted a Breakthrough Therapy Designation for uproleselan as a treatment for relapsed or refractory AML; Apollomics, GlycoMimetics’ exclusive collaborator for uproleselan in Greater China, announced dosing of the first patient in its registration program
Company pipeline continued to advance with presentations of preclinical data at the 2021 annual meeting of the American Association for Cancer Research (AACR) as well progress in IND-enabling studies of GMI-1687
Hosting a conference call and webcast today at 8:30 a.m. ET

ROCKVILLE, Md.–(BUSINESS WIRE)–
GlycoMimetics, Inc. (Nasdaq: GLYC) today reported its financial results for the quarter ended March 31, 2021 and highlighted recent company events. Cash and cash equivalents at March 31, 2021 were $132.5 million.

“Our recent achievements, both in our collaboration with Apollomics and in data presentations at AACR, underscore the productivity of our pipeline. Working closely with investigators, regulators and collaborators, we are seeing great enthusiasm for our lead program, uproleselan, globally. The Chinese health agency’s granting of a Breakthrough Therapy Designation as well as Apollomics’ announcement of dosing of the first patient in Greater China support our outlook for this drug candidate. Complementing that achievement is our work with uproleselan in the U.S., namely, continued progress on our own Phase 3 AML trial and that of the National Cancer Institute, or NCI. Finally, with a focus on the early results from our GMI-1359 proof-of-concept trial and our preclinical work in the galectin-3 space, the AACR meeting added visibility for our pipeline opportunities that have the potential to address key unmet needs in hematology and beyond,” commented Rachel King, Chief Executive Officer.

Operational Highlights

Uproleselan

Enrollment of GlycoMimetics’ pivotal Phase 3 trial in relapsed/refractory AML continued in the U.S., Australia and Europe at a steady pace throughout the first quarter of 2021. The Company continues to be confident that enrollment will be completed by year-end 2021.
The pace of enrollment in the NCI-sponsored Phase 2/3 registration trial, designed to evaluate uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy, continues to support our expectation that the Phase 2 portion will complete in 2021, and allow for a subsequent interim Event-Free Survival analysis of 262 patients.
Apollomics, our exclusive collaborator for development and commercialization of uproleselan in Greater China, received Breakthrough Therapy Designation from the Center for Drug Evaluation of the China National Medical Products Administration in early January. In March, Apollomics reported the dosing of its first patient in a Phase 1 clinical trial that will bridge to a Phase 3 study in China.

GMI-1359

In April 2021 at the AACR meeting, Duke University clinicians reported biologic activity, cell mobilization and immune activation in the first two patients treated in a proof-of-concept Phase 1b study to evaluate GMI-1359 in patients with advanced breast cancer with bone metastases. The ongoing study’s data support the dual functionality of the compound.

GMI-1687

The Company announced it would focus on advancing GMI-1687, designed for subcutaneous dosing, towards an Investigational New Drug Application and further development in sickle cell disease. Published preclinical data support the compound’s profile as a fast-acting, subcutaneously-dosed, E-selectin inhibitor that could potentially be self-administered at the onset of a vaso-occlusive crisis to obviate the need for opioids, acute care visits and inpatient hospitalization.

Executive Management Team

The Company announced the promotion of Eric Feldman, M.D., to Senior Vice President and Chief Medical Officer. Dr. Feldman, who joined the Company two years ago as Vice President, Global Clinical Development, is internationally recognized for his work in the development of new therapies for the treatment of leukemias and related bone marrow disorders.

First Quarter 2021 Financial Results

Cash position: As of March 31, 2021, GlycoMimetics had cash and cash equivalents of $132.5 million as compared to $137.0 million as of December 31, 2020.

R&D Expenses: The Company’s research and development expenses decreased to $11.2 million for the quarter ended March 31, 2021 as compared to $12.7 million for the same period in 2020 primarily due to lower clinical assay development and manufacturing expenses related to uproleselan.

G&A Expenses: The Company’s general and administrative expenses decreased to $4.2 million for the quarter ended March 31, 2021 as compared to $4.4 million for the same period in 2020, primarily due to lower stock-based compensation expense.

Shares Outstanding: Shares of common stock outstanding as of March 31, 2021 were 51,539,010.

The Company will host a conference call and webcast today at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 for domestic participants or (216) 562-0466 for international participants, with participant code 9891637. Participants are encouraged to connect 15 minutes in advance of the call to ensure that all callers are able to connect. A webcast replay will be available via the “Investors” tab on the GlycoMimetics website for 30 days following the call. A dial-in phone replay will be available for 24 hours after the close of the call by dialing (855) 859-2056 for domestic participants and (404) 537-3406 for international participants, participant code 9891637.

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy Designation from the U.S. FDA and from the Chinese National Medical Products Administration for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed or refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better-than-expected remission rates and overall survival compared to historical controls, which have been derived from results from third-party clinical trials evaluating standard chemotherapy, as well as lower-than-expected induction-related mortality rates. Treatment in these patient populations was generally well-tolerated, with fewer than expected adverse effects.

About GMI-1687

Discovered and developed by GlycoMimetics, GMI-1687 is a highly-targeted, highly-potent E-selectin antagonist. It has been shown in preclinical studies to be bioavailable via subcutaneous administration. During 2020, data from oral presentations at major scientific conferences pointed to the potential for a self-administered drug to treat VOC of sickle cell disease. Previously, GlycoMimetics demonstrated in preclinical models that GMI-1687 could be a potentially self-administered drug to be used in treatment of AML. The investigational drug also represents a potential life cycle extension opportunity for uproleselan.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4, which are adhesion molecules involved in tumor trafficking and metastatic spread. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow, such as AML and multiple myeloma, or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer, as well as in osteosarcoma, a rare pediatric tumor affecting about 900 adolescents a year in the United States. GMI-1359 completed a Phase 1 clinical trial in healthy volunteers, and a Phase 1b clinical study designed to enable investigators to study dose ranging and to generate initial biomarker data around the drug’s activity in breast cancer patients is in progress. In the first two patients evaluated, the study showed evidence of on-target effects, immune-activation and cell mobilization. GMI-1359 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for the treatment of osteosarcoma.

About GlycoMimetics, Inc.

GlycoMimetics is a biotechnology company with a focus in hematology-oncology and a pipeline of novel glycomimetic drugs, all designed to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role. GlycoMimetics’ drug candidate, uproleselan, an E-selectin antagonist, was evaluated in a Phase 1/2 clinical trial as a potential treatment for AML and is being evaluated across a range of patient populations including in a Company-sponsored Phase 3 trial in relapsed/refractory AML. GlycoMimetics has an ongoing Phase 1b clinical trial evaluating its wholly-owned drug candidate GMI-1359, a combined CXCR4 and E-selectin antagonist. GlycoMimetics is located in Rockville, MD in the BioHealth Capital Region. Learn more at www.glycomimetics.com.

Forward-Looking Statements

This press release contains forward-looking statements. These forward-looking statements include those relating to the planned or potential clinical development of the Company’s product candidates, as well as the presentation of data from preclinical studies and clinical trials, and the potential benefits and impact of the Company’s drug candidates. Actual results may differ materially from those described in these forward-looking statements. For a further description of the risks associated with these statements, as well as other risks facing GlycoMimetics, please see the risk factors described in the Company’s annual report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 2, 2021, and other filings GlycoMimetics makes with the SEC from time to time. Forward-looking statements speak only as of the date of this release, and GlycoMimetics undertakes no obligation to update or revise these statements, except as may be required by law.

GlycoMimetics, Inc.

Condensed Statements of Operations

(In thousands, except share and per share data)


	Three months ended March 31,
	2021		2020
	(Unaudited)

Revenue	$	1,055	$	9,000

Costs and expenses:
Research and development expense		11,147		12,668
General and administrative expense		4,188		4,440
Total costs and expenses		15,335		17,108

Loss from operations		(14,280)		(8,108)

Interest income		6		445

Net loss and comprehensive loss	$	(14,274)	$	(7,663)


Net loss per common share – basic and diluted	$	(0.28)	$	(0.18)
Weighted-average common shares – basic and diluted		50,697,183		43,575,590

GlycoMimetics, Inc.

Balance Sheet Data

(In thousands)


	March 31,		December 31,
	2021		2020
	(unaudited)

Cash and cash equivalents	$	132,471	$	137,035

Working capital		122,867		125,845

Total assets		138,020		142,832

Total liabilities		12,896		14,613

Total stockholders’ equity		125,124		128,219

View source version on businesswire.com: https://www.businesswire.com/news/home/20210503005339/en/

Investor Contact:

Shari Annes

Phone: 650-888-0902

Email: [email protected]

Media Contact:

Jamie Lacey-Moreira

Phone: 410-299-3310

Email: [email protected]

KEYWORDS: United States North America Maryland

INDUSTRY KEYWORDS: Oncology FDA Health Clinical Trials Pharmaceutical Biotechnology

MEDIA:

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May 3, 2021 7:33 am

Wells Fargo Asset Management Announces Change to the Wells Fargo Global Dividend Opportunity Fund Portfolio Management Team

SAN FRANCISCO–(BUSINESS WIRE)–
Wells Fargo Asset Management (WFAM) announced today that Harindra de Silva, Ph.D., CFA, and Dennis Bein, CFA, will be added as portfolio managers to the Wells Fargo Global Dividend Opportunity Fund (NYSE: EOD) effective immediately. They will join Megan Miller, CFA, in managing the fund’s options strategy. Michael Schueller, CFA, Justin Carr, CFA, Vince Fioramonti, CFA, and Chris Lee, CFA, remain as portfolio managers of the fund’s fixed-income and equity sleeves. There are no changes to the investment philosophy or process as a result of this change.

Portfolio Manager Bios

Harindra de Silva, Ph.D., CFA

Harindra (“Harin”) de Silva is a portfolio manager with the Analytic Investors team at Wells Fargo Asset Management (WFAM). Before joining the team, Harin was a principal at Analysis Group, Inc., where he was responsible for providing economic research services to institutional investors, including investment managers, large pension funds, and endowments. He focuses on the ongoing research effort for equity and factor-based asset allocation strategies. Harin has authored several articles and studies on finance-related topics, including stock market anomalies, market volatility, and asset valuation. He was recognized with the prestigious Graham and Dodd Award of Excellence for research published in the Financial Analysts Journal in 2002 and 2005. Harin earned a bachelor’s degree in mechanical engineering from the University of Manchester Institute of Science and Technology, a master’s degree in business administration with an emphasis in finance, a master’s degree in econometrics from the University of Rochester, and a Ph.D. in finance from the University of California, Irvine. He has earned the right to use the Chartered Financial Analyst® (CFA®) designation.

Dennis Bein, CFA

Dennis Bein is a portfolio manager for the Analytic Investors team at Wells Fargo Asset Management (WFAM). He focuses on day-to-day portfolio management and research related to equity-based investment strategies. Prior to joining the Analytic Investors team, Dennis was a senior consultant for Analysis Group, Inc., where he provided investment consulting services for institutional investors and plan sponsors. He began his investment industry career in 1990. Dennis earned a bachelor’s degree in business administration and a master’s degree in business administration with an emphasis in finance from the University of California, Riverside. He has earned the right to use the Chartered Financial Analyst® (CFA®) designation.

Disclosures

The Wells Fargo Global Dividend Opportunity Fund is a closed-end equity and high-yield bond fund. The fund’s investment objective is to seek a high level of current income. The fund’s secondary objective is long-term growth of capital.

For more information on Wells Fargo’s closed-end funds, please visit our website.

This closed-end fund is no longer engaged in initial public offerings, and shares are available only through broker-dealers on the secondary market. Unlike an open-end mutual fund, a closed-end fund offers a fixed number of shares for sale. After the initial public offering, shares are bought and sold through broker-dealers in the secondary marketplace, and the market price of the shares is determined by supply and demand, not by NAV, and is often lower than the NAV. A closed-end fund is not required to buy its shares back from investors upon request.

High-yield, lower-rated bonds may contain more risk due to the increased possibility of default. Foreign investments may contain more risk due to the inherent risks associated with changing political climates, foreign market instability, and foreign currency fluctuations. Risks of international investing are magnified in emerging or developing markets. Funds that concentrate their investments in a single industry or sector may face increased risk of price fluctuation over more diversified funds due to adverse developments within that industry or sector. Small- and mid-cap securities may be subject to special risks associated with narrower product lines and limited financial resources compared with their large-cap counterparts. When interest rates rise, the value of debt securities tends to fall. When interest rates decline, interest that a fund is able to earn on its investments in debt securities also may decline, but the value of those securities may increase. Changes in market conditions and government policies may lead to periods of heightened volatility in the debt securities market and reduced liquidity for certain fund investments. Interest rate changes and their impact on the funds and their NAVs can be sudden and unpredictable.

The use of leverage results in certain risks, including, among others, the likelihood of greater volatility of the NAV and the market price of common shares. Derivatives involve additional risks, including interest rate risk, credit risk, the risk of improper valuation, and the risk of noncorrelation to the relevant instruments they are designed to hedge or to closely track. There are numerous risks associated with transactions in options on securities. Illiquid securities may be subject to wide fluctuations in market value and may be difficult to sell.

Wells Fargo Asset Management (WFAM) is the trade name for certain investment advisory/management firms owned by Wells Fargo & Company. These firms include but are not limited to Wells Capital Management Incorporated and Wells Fargo Funds Management, LLC. Certain products managed by WFAM entities are distributed by Wells Fargo Funds Distributor, LLC (a broker-dealer and Member FINRA).

This material is for general informational and educational purposes only and is NOT intended to provide investment advice or a recommendation of any kind—including a recommendation for any specific investment, strategy, or plan.

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May 3, 2021 7:33 am

Green Plains Reports First Quarter 2021 Financial Results

Results for the First Quarter of 2021:

Net loss attributable to the company of $6.5 million, or $(0.17) per diluted share inclusive of a $36.9 million gain related to the sale of certain assets and a $22.1 million charge related to the extinguishment of convertible notes
Adjusted EBITDA of $15.4 million, exclusive of a $36.9 million gain related to the sale of certain assets
Consolidated crush margin of $0.11 per gallon, significantly better than the prior year’s first quarter
Strong liquidity position, with cash, cash equivalents and restricted cash of $654.4 million and $330.4 million available under committed credit facilities
Fully funded its Total Transformation Plan during the quarter by completing over $600.0 million in transactions while retiring over $170.0 million of debt

OMAHA, Neb., May 03, 2021 (GLOBE NEWSWIRE) — Green Plains Inc. (NASDAQ:GPRE) today announced financial results for the first quarter of 2021. Net loss attributable to the company was $6.5 million, or $(0.17) per diluted share inclusive of a gain on the sale of certain assets of $36.9 million and a $22.1 million charge related to extinguishment of convertible notes compared with a net loss of $16.4 million, or $(0.47) per diluted share, for the same period in 2020. Revenues were $553.6 million for the first quarter of 2021 compared with $632.9 million for the same period last year.

First Quarter Highlights

Announced the acquisition of a majority stake in Fluid Quip Technologies, along with Ospraie Management
Produced 58% sustainable Ultra-High Protein at its Shenandoah, Iowa biorefinery through development efforts between Green Plains, Fluid Quip Technologies and other innovation partners
Announced construction plans for MSC Ultra-High Protein at its Obion, Tenn. and Mount Vernon, Ind. facilities
Completed the USP upgrade at its York, Neb. location
Announced a clean sugar project at its York, Neb. Innovation Center to produce dextrose to target applications in food production, renewable chemicals and synthetic biology
Funds and accounts managed by BlackRock invested in Fluid Quip Technologies and completed a $125.0 million, 5-year junior mezzanine note facility
Announced a partnership with Summit Carbon Solutions which is developing one of the largest carbon capture and sequestration projects in the world, capable of capturing and sequestering more than 10 million tons of carbon dioxide annually upon completion
Completed concurrent offerings of 8,751,500 shares of common stock at $23 per share and $230.0 million aggregate principal of convertible senior notes due 2027, of which $156.5 million was used to repurchase a portion of the 4.125% convertible senior notes due 2022
Completed the sale of its plant located in Ord, Neb. to GreenAmerica Biofuels Ord LLC for $64.0 million plus working capital

“Our first quarter was transformative to both our balance sheet and our technology platform. Additionally, our 1.0 platform performed well, as our risk management and hedging programs were beneficial to the quarter,” said Todd Becker, president and chief executive officer. “Fully funding our Total Transformation Plan to deploy Fluid Quip’s protein technology was a critical step in building the biorefinery platform of the future. The milestones achieved during the quarter have moved us along the path to achieving our 2024 financial goals, including partnering with BlackRock and Ospraie Management in the acquisition of Fluid Quip Technologies to transform Green Plains into a global leading ag tech company focused on value added, low carbon novel agricultural ingredients.”

“We achieved a number of impressive milestones in the first quarter across every phase of our transformation, including protein, sugar, corn oil, and carbon, culminating with successful capital raises to provide the liquidity necessary to achieve our vision for Green Plains 2.0,” added Becker. “Moving forward, we are focused on announcing the construction sequence of MSC Ultra-High Protein deployment, finalizing our selection of a general contractor to build our Ultra-High Protein technology across our biorefinery platform, finalizing Project 24, beginning production of Ultra-High Protein at our Wood River, Nebraska biorefinery and startup of clean sugar production at our York Innovation Center. Even more exciting are the advancements we are seeing in Ultra-High Protein purities, renewable corn oil yields and innovations in yeasts, oils and sugars. Across our platform we believe we are on track to achieve our 2024 financial goals.”

“Today, we are stronger financially than ever before, with more than $650 million in cash at the end of the quarter as a result of executing on a number of key transactions, demonstrating our dedication to transforming our business to Green Plains 2.0,” added Becker. “Our capital raise combined with further portfolio optimization from the sale of Ord were important steps in fully funding our Ultra-High Protein buildout while maintaining strong liquidity.”

“Our partnership with Summit Carbon Solutions is in the early stages and we recently expanded our participation with the addition of our Shenandoah, Iowa and all of our Nebraska biorefineries,” added Becker. “The potential to provide low or even zero carbon biofuels, renewable corn oil and high value protein feed ingredients aligns perfectly with the growing global demand for reduced or net zero carbon products. Through the transformation of our platform, we can participate in the decarbonization of food, feed and fuel. We believe being both a shipper and an owner of the carbon pipeline itself will be an attractive opportunity for Green Plains shareholders in the years to come and we will evaluate our future options to maximize both environmental benefits and our financial returns.”

Results of Operations

Green Plains sold 178.0 million gallons of ethanol during the first quarter of 2021, compared with 240.5 million gallons for the same period in 2020. The consolidated ethanol crush margin was $18.9 million, or $0.11 per gallon, for the first quarter of 2021, compared with $(2.3) million, or $(0.01) per gallon, for the same period in 2020. The consolidated ethanol crush margin is the ethanol production segment’s operating income before depreciation and amortization, which includes corn oil and Ultra-High Protein, plus intercompany storage, transportation, nonrecurring decommissioning costs and other fees, net of related expenses.

Consolidated revenues decreased $79.2 million for the three months ended March 31, 2021, compared with the same period in 2020, due primarily to lower production volumes of ethanol, distillers grains and corn oil and decreased trading revenues within our agribusiness and energy services segment.

Operating income increased $85.7 million for the three months ended March 31, 2021, compared with the same period last year primarily due to a gain on the sale of certain assets of $36.9 million in the current year quarter, $24.1 million noncash goodwill impairment in the prior year quarter and improved margins on ethanol production. Interest expense increased $22.0 million for the three months ended March 31, 2021 compared with the same period in 2020 due to the loss upon extinguishment of convertible notes of $22.1 million recorded during the quarter. Income tax expense was $1.9 million for the three months ended March 31, 2021, compared with income tax benefit of $44.3 million for the same period in 2020, primarily due to benefits recorded related to the CARES Act during the three months ended March 31, 2020.

Segment Information

The company reports the financial and operating performance for the following four operating segments: (1) ethanol production, which includes the production of ethanol, including industrial-grade alcohol, distillers grains, Ultra-High Protein and corn oil, (2) agribusiness and energy services, which includes grain handling and storage, commodity marketing and merchant trading for company-produced and third-party ethanol, distillers grains, corn oil, natural gas and other commodities, (3) food and ingredients, which includes food-grade corn oil and (4) partnership, which includes fuel storage and transportation services. Intercompany fees charged to the ethanol production segment for storage and logistics services, grain procurement and product sales are included in the partnership and agribusiness and energy services segments and eliminated upon consolidation. Third-party costs of grain consumed and revenues from product sales are reported directly in the ethanol production segment.


GREEN PLAINS INC.
SEGMENT OPERATIONS
(unaudited, in thousands)

	Three Months Ended March 31,
	2021			2020			% Var.
Revenues:
Ethanol production	$	423,722		$	475,725		(10.9	)	%
Agribusiness and energy services		133,944			163,189		(17.9	)
Partnership		20,406			20,271		0.7
Intersegment eliminations		(24,432	)		(26,316	)	(7.2	)
	$	553,640		$	632,869		(12.5	)	%
Gross margin:
Ethanol production	$	8,197		$	(13,425	)	161.1		%
Agribusiness and energy services		17,870			6,687		167.2
Partnership		20,406			20,271		0.7
Intersegment eliminations		(2,066	)		2,108		*
	$	44,407		$	15,641		183.9		%
Depreciation and amortization:
Ethanol production	$	18,528		$	15,898		16.5		%
Agribusiness and energy services		607			553		9.8
Partnership		887			961		(7.7	)
Corporate activities		659			668		(1.3	)
	$	20,681		$	18,080		14.4		%
Operating income (loss):
Ethanol production ⁽¹⁾	$	(20,320	)	$	(60,781	)	(66.6	)	%
Agribusiness and energy services		13,346			2,560		*
Partnership		12,871			12,430		3.5
Intersegment eliminations		(2,066	)		2,133		*
Corporate activities		27,516			(10,670	)	*
	$	31,347		$	(54,328	)	157.7		%
Adjusted EBITDA:
Ethanol production	$	(1,789	)	$	(44,125	)	95.9		%
Agribusiness and energy services		13,951			3,128		*
Partnership		13,933			13,548		2.8
Intersegment eliminations		(2,066	)		2,133		*
Corporate activities ⁽²⁾		28,214			948		*
EBITDA		52,243			(24,368	)	*
Gain on sale of assets, net		(36,893	)		–		*
Proportional share of EBITDA adjustments to equity method investees		44			2,937		*
Noncash goodwill impairment		–			24,091		*
Adjusted EBITDA	$	15,394		$	2,660		*		%

(1) Includes the goodwill impairment charge of $24.1 million for the three months ended March 31, 2020.
(2) Includes corporate expenses, offset by the gain on sale of assets of $36.9 million for the three months ended March 31, 2021 and earnings from equity method investments of $7.8 million for the three months ended March 31, 2020.


GREEN PLAINS INC.
SELECTED OPERATING DATA
(unaudited, in thousands)

	Three Months Ended March 31,
	2021	2020	% Var.
Ethanol production
Ethanol sold (gallons)	178,000	240,466	(26.0	)	%
Distillers grains sold (equivalent dried tons)	465	642	(27.6	)
Corn oil sold (pounds)	46,563	62,552	(25.6	)
Corn consumed (bushels)	62,505	83,883	(25.5	)

Agribusiness and energy services
Domestic ethanol sold (gallons)	178,820	209,583	(14.7	)
Export ethanol sold (gallons)	67,735	99,720	(32.1	)
	246,555	309,303	(20.3	)
Partnership
Storage and throughput (gallons)	178,976	241,638	(25.9	)


GREEN PLAINS INC.
CONSOLIDATED CRUSH MARGIN
(unaudited, in thousands except per gallon amounts)

	Three Months Ended March 31,						Three Months Ended March 31,
	2021			2020			2021			2020
							($ per gallon produced)

Ethanol production operating loss	$	(20,320	)	$	(60,781	)	$	(0.11	)	$	(0.25	)
Depreciation and amortization		18,528			15,898			0.10			0.07
Noncash goodwill impairment		–			24,091			–			0.10
Total adjusted ethanol production		(1,792	)		(20,792	)		(0.01	)		(0.08	)

Intercompany fees, net:
Storage and logistics (partnership)		13,246			12,700			0.07			0.05
Marketing and agribusiness fees ⁽¹⁾ (agribusiness and energy services)		7,423			5,782			0.05			0.02
Consolidated ethanol crush margin	$	18,877		$	(2,310	)	$	0.11		$	(0.01	)

(1) Includes $3.5 million for certain nonrecurring decommissioning and nonethanol operations costs for the three months ended March 31, 2021.

Liquidity and Capital Resources

On March 31, 2021, Green Plains had $654.4 million in total cash, cash equivalents and restricted cash, and $330.4 million available under committed credit facilities, which are subject to restrictions and other lending conditions. Total debt outstanding at March 31, 2021, was $773.4 million, including $174.1 million outstanding debt under working capital revolvers and other short-term borrowing arrangements and $61.1 million of debt related to Green Plains Partners, net of debt issuance costs.

Conference Call Information

On May 3, 2021, Green Plains Inc. and Green Plains Partners LP will host a joint conference call at 11 a.m. Eastern time (10 a.m. Central time) to discuss first quarter 2021 operating results for each company. Domestic and international participants can access the conference call by dialing 877.711.2374 and 281.542.4862, respectively, and referencing conference ID 9070109. The company advises participants to call at least 10 minutes prior to the start time. Alternatively, the conference call, transcript and presentation will be accessible on Green Plains’ website at https://investor.gpreinc.com/events-presentations.

Non-GAAP Financial Measures

Management uses adjusted EBITDA, segment EBITDA and consolidated ethanol crush margins to measure the company’s financial performance and to internally manage its businesses. EBITDA is defined as earnings before interest expense, income tax expense, depreciation and amortization excluding the change in right-of-use assets. Adjusted EBITDA includes adjustments related to our proportional share of EBITDA adjustments of our equity method investees, gains and losses related to the sale of assets, and noncash goodwill impairment. Management believes these measures provide useful information to investors for comparison with peer and other companies. These measures should not be considered alternatives to net income or segment operating income, which are determined in accordance with U.S. Generally Accepted Accounting Principles (GAAP). These non-GAAP calculations may vary from company to company. Accordingly, the company’s computation of adjusted EBITDA, segment EBITDA and consolidated ethanol crush margins may not be comparable with similarly titled measures of another company.

About Green Plains Inc.

Green Plains Inc. (NASDAQ:GPRE) is a leading biorefining company focused on the development and utilization of fermentation, agricultural and biological technologies in the processing of annually renewable crops into sustainable value-added ingredients. This includes the production of cleaner low carbon biofuels, renewable feedstocks for advanced biofuels and high purity alcohols for use in cleaners and disinfectants. Green Plains is an innovative producer of Ultra-High Protein and novel ingredients for animal and aquaculture diets to help satisfy a growing global appetite for sustainable protein. The Company also owns a 48.9% limited partner interest and a 2.0% general partner interest in Green Plains Partners LP. For more information, visit www.gpreinc.com.

About Green Plains Partners LP

Green Plains Partners LP (NASDAQ:GPP) is a fee-based Delaware limited partnership formed by Green Plains Inc. to provide fuel storage and transportation services by owning, operating, developing and acquiring ethanol and fuel storage terminals, transportation assets and other related assets and businesses. For more information about Green Plains Partners, visit www.greenplainspartners.com.

Forward-Looking Statements

This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements reflect management’s current views, which are subject to risks and uncertainties including, but not limited to, anticipated financial and operating results, plans and objectives that are not historical in nature. These statements may be identified by words such as “believe,” “expect,” “may,” “should,” “will” and similar expressions. Factors that could cause actual results to differ materially from those expressed or implied include: disruption caused by health epidemics, such as the coronavirus outbreak, competition in the industries in which Green Plains operates; commodity market risks, financial market risks; counterparty risks; risks associated with changes to federal policy or regulation, including changes to tax laws; risks related to closing and achieving anticipated results from acquisitions and disposals. Other factors can include risks associated with Green Plains’ ability to realize higher margins anticipated from the company’s high protein feed initiative or to achieve anticipated savings from Project 24 and other risks discussed in Green Plains’ reports filed with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this news release. Green Plains assumes no obligation to update any such forward-looking statements, except as required by law.

Consolidated Financial Results


GREEN PLAINS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)

	March 31, 2021		December 31, 2020
	(unaudited)
ASSETS
Current assets
Cash and cash equivalents	$	446,833	$	233,860
Restricted cash		207,593		40,950
Accounts receivable, net		62,519		55,568
Income tax receivable		483		661
Inventories		258,759		269,491
Other current assets		34,353		41,823
Total current assets		1,010,540		642,353
Property and equipment, net		799,546		801,690
Operating lease right-of-use assets		64,597		61,883
Other assets		69,943		72,991
Total assets	$	1,944,626	$	1,578,917

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable	$	92,972	$	140,058
Accrued and other liabilities		36,236		38,471
Derivative financial instruments		41,098		20,265
Current operating lease liabilities		15,627		14,902
Short-term notes payable and other borrowings		174,104		140,808
Current maturities of long-term debt		61,442		98,052
Total current liabilities		421,479		452,556
Long-term debt		537,880		287,299
Long-term operating lease liabilities		51,682		49,549
Other liabilities		13,056		12,849
Total liabilities		1,024,097		802,253

Stockholders’ equity
Total Green Plains stockholders’ equity		787,568		646,852
Noncontrolling interests		132,961		129,812
Total liabilities and stockholders’ equity	$	1,944,626	$	1,578,917


GREEN PLAINS INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands except per share amounts)

	Three Months Ended March 31,
	2021			2020			% Var.
Revenues
Product	$	551,980		$	631,581		(12.6	)	%
Services		1,660			1,288		28.9
Total revenues		553,640			632,869		(12.5	)
Costs and expenses
Cost of goods sold (excluding depreciation and amortization expenses reflected below)		509,233			617,228		(17.5	)
Operations and maintenance		5,754			6,160		(6.6	)
Selling, general and administrative		23,518			21,638		8.7
Gain on sale of assets, net		(36,893	)		–		*
Goodwill impairment		–			24,091		*
Depreciation and amortization		20,681			18,080		14.4
Total costs and expenses		522,293			687,197		(24.0	)
Operating income (loss)		31,347			(54,328	)	157.7
Other income (expense)
Interest income		30			593		(94.9	)
Interest expense		(31,679	)		(9,697	)	*
Other, net		10			836		(98.8	)
Total other expense		(31,639	)		(8,268	)	*
Loss before income taxes and income from equity method investees		(292	)		(62,596	)	(99.5	)
Income tax benefit (expense)		(1,862	)		44,283		*
Income from equity method investees, net of income taxes		175			7,966		*
Net loss		(1,979	)		(10,347	)	(80.9	)
Net income attributable to noncontrolling interests		4,566			6,098		(25.1	)
Net loss attributable to Green Plains	$	(6,545	)	$	(16,445	)	(60.2	)	%

Earnings per share:
Net loss attributable to Green Plains – basic and diluted	$	(0.17	)	$	(0.47	)

Weighted average shares outstanding:
Basic and diluted		37,695			34,665


GREEN PLAINS INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited, in thousands)

	Three Months Ended March 31,
	2021			2020
Cash flows from operating activities:
Net loss	$	(1,979	)	$	(10,347	)
Noncash operating adjustments:
Depreciation and amortization		20,681			18,080
Gain on sale of assets, net		(36,303	)		–
Loss on extinguishment of convertible notes		22,100			–
Goodwill impairment		–			24,091
Deferred income taxes		1,960			(23,895	)
Other		4,536			1,710
Net change in working capital		(46,737	)		8,138
Net cash provided by (used in) operating activities		(35,742	)		17,777

Cash flows from investing activities:
Purchases of property and equipment, net		(31,524	)		(38,792	)
Proceeds from the sale of assets, net		73,846			–
Other investing activities		3,330			(1,098	)
Net cash provided by (used in) investing activities		45,652			(39,890	)

Cash flows from financing activities:
Net proceeds – long-term debt		219,165			(21	)
Net payments – short-term borrowings		(4,680	)		(24,052	)
Proceeds from issuance of common stock		191,134			–
Payment for repurchase of common stock		–			(11,479	)
Other		(35,913	)		(6,707	)
Net cash provided by (used in) financing activities		369,706			(42,259	)

Net change in cash, cash equivalents and restricted cash		379,616			(64,372	)
Cash, cash equivalents and restricted cash, beginning of period		274,810			269,896
Cash, cash equivalents and restricted cash, end of period	$	654,426		$	205,524


Reconciliation of total cash, cash equivalents and restricted cash:
Cash and cash equivalents	$	446,833		$	194,333
Restricted cash		207,593			11,191
Total cash, cash equivalents and restricted cash	$	654,426		$	205,524


GREEN PLAINS INC.
RECONCILIATIONS TO NON-GAAP FINANCIAL MEASURES
(unaudited, in thousands)

	Three Months Ended March 31,
	2021			2020
Net loss	$	(1,979	)	$	(10,347	)
Interest expense ⁽¹⁾		31,679			9,697
Income tax expense (benefit), net of equity method income tax expense		1,862			(41,798	)
Depreciation and amortization⁽²⁾		20,681			18,080
EBITDA		52,243			(24,368	)
Gain on sale of assets, net		(36,893	)		–
Proportional share of EBITDA adjustments to equity method investees		44			2,937
Noncash goodwill impairment		–			24,091
Adjusted EBITDA	$	15,394		$	2,660

(1) Interest expense for the three months ended March 31, 2021 includes a loss upon extinguishment of convertible notes of $22.1 million.
(2) Excludes amortization of operating lease right-of-use assets and amortization of debt issuance costs.

Green Plains Inc. Contacts

Investors: Phil Boggs | Senior Vice President, Investor Relations | 402.884.8700 | [email protected]

Media: Leighton Eusebio | Manager, Public Relations | 402.952.4971 | [email protected]

May 3, 2021 7:33 am

Oragenics Announce Changes in Management and Board of Directors

Oragenics Announce Changes in Management and Board of Directors

TAMPA, Fla.–(BUSINESS WIRE)–Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) announced that on May 2, 2021, Dr. Alan Joslyn resigned as Chief Executive Officer, President and director of Oragenics, Inc. to pursue other opportunities.

During the interim period before a new CEO is hired, the Board of Directors will provide direction to the Company, with Dr. Frederick Telling transitioning from Chairman of the Board to the newly established position of Executive Chairman, effective immediately. Mr. Sullivan, the Company’s current Chief Financial Officer, will serve as the Company’s interim principal executive officer to address the vacancy created by Dr. Joslyn’s resignation.

Speaking for the Board of Directors, Dr. Telling stated, “The Company has in place a team of qualified and experienced vaccine development consultants engaged and working on our Terra CoV-2 vaccine product candidate and we are in the process of seeking a seasoned vaccine development executive to lead our vaccine program.” Dr. Telling continued, “Through Dr. Joslyn’s efforts the Company began the transition to vaccine development and closed several substantial financings to advance the development of our Terra CoV-2 vaccine and continue to fund the Company’s operations, which has positioned the Company for future growth. I want to thank Dr. Joslyn for his efforts on behalf of the Company, and am confident he will be successful in his future endeavors.”

About Oragenics, Inc.

Oragenics, Inc. is focused on the creation of the Terra CoV-2 vaccine candidate to combat the novel coronavirus pandemic and the further development of effective treatments for novel antibiotics against infectious diseases. The Company is dedicated to the development and commercialization of a vaccine candidate providing specific immunity from novel coronavirus. The Terra CoV-2 immunization leverages coronavirus spike protein research conducted by the National Institutes of Health. In addition, Oragenics has an exclusive worldwide channel collaboration with Eleszto Genetika, Inc. relating to the development of novel lantibiotics.

For more information about Oragenics, please visit www.oragenics.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210503005308/en/

Oragenics, Inc.

Michael Sullivan, Chief Financial Officer

813-286-7900

[email protected]

or

LHA Investor Relations

Kim Golodetz

212-838-3777

[email protected]

KEYWORDS: United States North America Florida

INDUSTRY KEYWORDS: Health Pharmaceutical

MEDIA:

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May 3, 2021 7:33 am

Turning Point Brands’ Zig-ZagPartners with One Tree Planted to Launch Burn One / Plant One Program

Turning Point Brands’ Zig-ZagPartners with One Tree Planted to Launch Burn One / Plant One Program

Initiative Aims to Offset Paper Products’ Carbon Footprint Resulting from TPB’s Continued Commitment to Environmental Sustainability

LOUISVILLE, Ky.–(BUSINESS WIRE)–Turning Point Brands, Inc. (“TPB” or the “Company”) (NYSE: TPB), a manufacturer, marketer and distributor of branded consumer products, including alternative smoking accessories and consumables with active ingredients, today announced that its iconic brand Zig-Zag has partnered with One Tree Planted, a non-profit 501(c)(3) environmental tree planting charity, to launch the new Burn One / Plant One program. Focused on fostering a healthy climate, protecting biodiversity and helping global reforestation efforts, the program’s mission is to help restore forests in the U.S. to offset carbon emissions that are produced from paper products.

“In 2020, devastating wildfires swept across the country, destroying more than 4 million acres in California alone,” said Ryan Parker, Brand Manager, Zig-Zag. “As Zig-Zag is a leading paper goods producer in the cannabis space, it is our responsibility, with our customers’ help, to do our part in preserving forests and offsetting our carbon footprint through paper production. We look forward to launching this new initiative with One Tree Planted in an effort to preserve our planet’s beauty and health. Additionally, as part of our continued commitment to environmental sustainability, we recognize that processing wood and paper is a fundamental part of our brand. As such, our goal is to be carbon-neutral by 2031.”

Through the Burn One / Plant One program, a tree will be planted in a California forest for every online customer purchase above $15 that’s made through the Zig-Zag website. This partnership will enable thousands of trees to be planted to help restore these forests, which suffered more damage from wildfires in 2020 than in any other year.

Turning Point Brands’ Zig-Zag rolling paper products use trees that are responsibly selected and harvested, with environmental impact being a top priority for the wood fiber papers. Zig-Zag chooses wood from carefully controlled logging operations that meet strict criteria, such as those set forth by Forest Stewardship Council (FSC) certification and from areas that best preserve biological diversity.

About Turning Point Brands

Turning Point Brands (NYSE: TPB) is a manufacturer, marketer and distributor of branded consumer products, including alternative smoking accessories and consumables with active ingredients, through its iconic core brands Zig-Zag® and Stoker’s® and its emerging brands within the NewGen segment. TPB’s products are available in more than 210,000 retail outlets in North America, in addition to sites such as www.zigzag.com, www.nu-x.com and www.solacevapor.com. For the latest news and information about TPB and its brands, please visit www.turningpointbrands.com.

About One Tree Planted

One Tree Planted is a 501(c)(3) nonprofit on a mission to make it simple for anyone to help the environment by planting trees. Their projects span the globe and are done in partnership with local communities and knowledgeable experts to create an impact for nature, people, and wildlife. Reforestation helps to rebuild forests after fires and floods, provide jobs for social impact, and restore biodiversity. Many projects have overlapping objectives, creating a combination of benefits that contribute to the UN’s Sustainable Development Goals. Learn more at www.onetreeplanted.org.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws. Forward-looking statements may generally be identified by the use of words such as “anticipate,” “believe,” “expect,” “intend,” “plan” and “will” or, in each case, their negative, or other variations or comparable terminology. These forward-looking statements include all matters that are not historical facts. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. As a result, these statements are not guarantees of future performance and actual events may differ materially from those expressed in or suggested by the forward-looking statements. Any forward-looking statement made by TPB in this press release, its reports filed with the Securities and Exchange Commission (the “SEC”) and other public statements made from time-to-time speak only as of the date made. New risks and uncertainties come up from time to time, and it is impossible for TPB to predict or identify all such events or how they may affect it. TPB has no obligation, and does not intend, to update any forward-looking statements after the date hereof, except as required by federal securities laws. Factors that could cause these differences include, but are not limited to those included it the company’s Annual reports on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed by the Company with the SEC. These statements constitute the Company’s cautionary statements under the Private Securities Litigation Reform Act of 1995.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210503005040/en/

Caitlin Kasunich / Raquel Cona

KCSA Strategic Communications

212.896.1241 / 516.779.2630

[email protected] / [email protected]

KEYWORDS: California Kentucky United States North America

INDUSTRY KEYWORDS: Environment Other Retail Tobacco Philanthropy Forest Products Other Philanthropy Retail Foundation Natural Resources

MEDIA:

Posted on May 3, 2021 7:32 am
Aramark Announces $500 Million Debt Repayment

Aramark Announces $500 Million Debt Repayment

Enhances capital structure; Reduces interest expense

PHILADELPHIA–(BUSINESS WIRE)–
Aramark (NYSE:ARMK), a global leader in food, facilities management and uniforms, announced today that the Company is issuing notice to optionally redeem in full the $500 million outstanding principal amount of its 4.75% Senior Notes due 2026 effective on June 2, 2021. The Company plans to fund the repayment, together with related premium and accrued interest, with available cash on hand. The debt repayment will result in annual interest expense savings of nearly $25 million.

“We remain extremely encouraged by our strong cash flow and liquidity position that provides a platform to execute our capital allocation priorities, including this debt repayment as well as our refinancing in early April and acquisition announced just last week,” stated Tom Ondrof, Aramark’s Chief Financial Officer. “These actions collectively reduce interest expense and further enhance our flexibility to drive our ongoing pursuit of growth opportunities.”

As previously announced, Aramark is scheduled to host its fiscal second quarter earnings call on May 11, 2021 at 8:30 a.m. ET.

About Aramark

Aramark (NYSE: ARMK) proudly serves the world’s leading educational institutions, Fortune 500 companies, world champion sports teams, prominent healthcare providers, iconic destinations and cultural attractions, and numerous municipalities in 19 countries around the world with food, facilities, and uniform services. Because our culture is rooted in service, our employees strive to do great things for each other, our partners, our communities, and our planet. Aramark has been named to DiversityInc’s “Top 50 Companies for Diversity” list, the Forbes list of “America’s Best Employers for Diversity,” the Human Rights Campaign Foundation’s “Best Place to Work for LGBTQ Equality” and scored 100% on the Disability Equality Index. Learn more at www.aramark.com and connect with us on Facebook, Twitter, and LinkedIn.

Forward-Looking Statements

Certain statements made in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws. Forward-looking statements are based on management’s expectations, estimates, projections, and assumptions. These statements are not guarantees of future performance and involve certain risks and uncertainties, which are difficult to predict. Therefore, actual future results and trends may differ materially from what is forecast in forward-looking statements due to a variety of factors. Additional information regarding these factors is contained in the “Risk Factors,” “Legal Proceedings” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections and other sections of Aramark’s Annual Report on Form 10-K, filed with the SEC on November 24, 2020, as such factors may be updated from time to time in its other periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and which may be obtained by contacting Aramark’s investor relations department via its website at www.aramark.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210503005259/en/

Felise Glantz Kissell (215) 409-7287

[email protected]

Scott Sullivan (215) 238-3953

[email protected]

KEYWORDS: United States North America Pennsylvania

INDUSTRY KEYWORDS: Food/Beverage Other Retail Retail Professional Services Other Professional Services

MEDIA:

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Posted on May 3, 2021 7:31 am
Ebix Announces Appointment of Priyanka Kaul to Its Board of Directors

JOHNS CREEK, Ga., May 03, 2021 (GLOBE NEWSWIRE) — Ebix, Inc. (NASDAQ: EBIX), a leading international supplier of On-Demand software and E-commerce services to the insurance, financial, e-governance and healthcare industries, today announced the appointment of Ms. Priyanka Kaul as a new independent director to the Ebix Board.

In a career spanning 22 years, Priyanka has held various leadership positions including being the CEO of Forbes India and Division President of Network 18 Group (CNBC TV 19 and CNN TV18). She has also been the Chief Marketing and Revenue Officer at one of India’s leading media groups – NDTV.

An environmentalist to the core, she has pioneered and conceptualized India’s best known and award-winning environment campaigns for brands like: Toyota (Greenathon), Aircel (Save Our Tigers), Coca-Cola (Support my School), Reckitt Benckiser (Banega Swachh India), and the Gates Foundation amongst others. She has been widely recognized for her work in India and at various international platforms. Priyanka has won several awards including prestigious international awards like the CBA (Common Wealth Broadcasting Association), One World Media Award for the best Brand Campaign with a Social Message for Toyota.

Her campaign with Gates Foundation, on maternal and child health won Gold at the New York Film Festival. Priyanka also represented India at the First BRICS Media Summit in Beijing in 2015. She was invited to speak at the World Economic Forum at Davos for her campaign on Water.

“Priyanka’s leadership experience across respected names like Forbes India, CNN TV18, CNBC TV18 and NDTV provides her a deep grasp of the Indian corporate sector and the overall Indian economy. India is emerging as a big market for Ebix and thus this is a valuable addition to our Board.” Neil Eckert, Chairman of Ebix’s nominating committee said. “She brings in increased balance and diversity to the Ebix Board. We value her passion for the environment, as also her understanding of branding, as all these attributes can help guide the Company not only in the impending India IPO, but also from the perspective of being a socially responsible company.”

Priyanka is an alumni of one of India’s leading boarding schools, the Welham Girls’ School. She later graduated in Economics from the University of Mumbai, besides studying Advanced Management from the Harvard Business School, Boston.

About Ebix, Inc.

With 50+ offices across 6 continents, Ebix, Inc., (NASDAQ: EBIX) endeavors to provide On-Demand software and E-commerce services to the insurance, financial, healthcare and e-learning industries. In the Insurance sector, Ebix’s main focus is to develop and deploy a wide variety of insurance and reinsurance exchanges on an on-demand basis, while also, providing Software-as-a-Service (“SaaS”) enterprise solutions in the area of CRM, front-end & back-end systems, outsourced administration and risk compliance services, around the world.

With a “Phygital” strategy that combines over 320,000 physical distribution outlets in many Southeast Asian Nations (“ASEAN”) countries, to an Omni-channel online digital platform, the Company’s EbixCash Financial exchange portfolio encompasses leadership in areas of domestic & international money remittance, foreign exchange (Forex), travel, pre-paid & gift cards, utility payments, lending, wealth management etc. in India and other markets. EbixCash’s Forex operations have emerged as a leader in India’s airport Foreign Exchange business with operations in 20 international airports, including Delhi, Mumbai, Mumbai, Hyderabad, Chennai and Kolkata, combined conducting over $4.8 billion in gross transaction value per year (pre-COVID-19). EbixCash’s inward remittance business in India processes approximately $5 billion in gross annual remittance volume (pre-COVID-19) and is the clear market leader. EbixCash, through its travel portfolio of Via and Mercury, is also one of Southeast Asia’s leading travel exchanges with over 200,000 agents, 25 branches and over 9,800 corporate clients, combined processing an estimated $2.5 billion in gross merchandise value per year (pre-COVID-19).

Through its various SaaS-based software platforms, Ebix employs thousands of domain-specific technology professionals to provide products, support and consultancy to thousands of customers on six continents. For more information, visit the Company’s website at www.ebix.com

CONTACT:

Darren Joseph
678 -281-2027 or [email protected]

David Collins, Chris Eddy
Catalyst Global – 212-924-9800 or [email protected]

Posted on May 3, 2021 7:18 am
CI Financial Affiliated RIA Congress Wealth Management Acquires Pinnacle Advisory Group to Create $5.8-billion Firm

CI Financial Affiliated RIA Congress Wealth Management Acquires Pinnacle Advisory Group to Create $5.8-billion Firm

Transaction boosts CI’s U.S. assets to $58 billion

All financial amounts in U.S. dollars unless stated otherwise.

BOSTON & TORONTO–(BUSINESS WIRE)–Congress Wealth Management, LLC (“CWM”) and CI Financial Corp. (“CI”) (TSX: CIX; NYSE: CIXX) announced today that CWM has acquired Pinnacle Advisory Group, Inc. (“Pinnacle”) of Columbia, MD in a transaction that increases the size of CWM’s business by 70% and expands its presence to new markets on the East Coast and in South Florida.

The addition of Pinnacle’s $2.4 billion in assets and offices in Columbia and Miami will increase CWM’s business to $5.8 billion and seven offices nationwide.

The transaction, which closed on April 30, 2021, was financially supported by CI, which holds a significant strategic ownership stake in CWM as part of a U.S. wealth management business with direct investments in 13 registered investment advisor (“RIA”) firms with $56 billion in assets.

“Pinnacle is an ideal addition to our firm with an impressive group of investment professionals and financial planning advisors,” said Paul Lonergan, CWM President. “We are also fortunate to have CI Financial as a strategic partner. Given the size and complexity of the transaction, we could not have executed this without their ongoing support.”

The combination with Pinnacle deepens CWM’s financial planning, trust planning, and tax expertise through access to Pinnacle’s team of professionals, while Pinnacle clients will benefit from a wider range of investment products and strategies.

“We believe there are tremendous complementary advantages by combining our firm with Congress Wealth. From day one we felt a connection between the firm’s cultures,” said John Hill, Chief Executive Officer and Founding Partner of Pinnacle. “We were extremely impressed with Congress’s year-over-year growth rate, and their ability to execute a comprehensive expansion strategy.”

“Congress and Pinnacle exemplify the high quality of the firms within CI’s network and the benefits of partnership,” said Kurt MacAlpine, CI Chief Executive Officer. “Paul and his team have been an exceptional addition to our group and have more than doubled Congress Wealth’s assets since we made our investment last year. The addition of Pinnacle is the latest step in the firm’s continued growth and development.”

CI, a diversified global asset and wealth manager, entered the U.S. wealth management market in early 2020 and has become one of the fastest-growing RIA platforms through 17 acquisitions (including Pinnacle and other acquisitions by affiliated RIAs) and strong organic growth. The Pinnacle transaction and other recently completed acquisitions will increase CI’s U.S. assets to approximately $58 billion and its total combined assets under management and wealth management assets to approximately $225 billion (C$283 billion).

All asset amounts are as at March 31, 2021.

About Congress Wealth Management

Congress Wealth Management provides wealth management and family office services to high-net-worth individuals, families, foundations and endowments, with an emphasis on comprehensive and customized client plans. The firm was named to the Financial Times 300 Top Registered Investment Advisors list in 2019, the third time in four years it has made the list. CWM achieved $2 billion in assets through organic growth over a 10-year period through October 2019 and has grown rapidly since that time through a national initiative to identify M&A opportunities and strategic partnerships. In addition to its Boston head office, the firm has offices in Westport, CT, Scottsdale, AZ, and Orange County, CA. For more information, please visit www.congresswealth.com.

About CI Financial

CI Financial Corp. is an independent diversified global asset and wealth management company operating in Canada, the United States and Australia. CI managed and advised on approximately C$240.6 billion (US$191.5 billion) in client assets as at March 31, 2021. CI is listed on the Toronto Stock Exchange under CIX and on the New York Stock Exchange under CIXX. For more information, visit www.cifinancial.com.

The FT 300 assesses registered investment advisers based on desirable traits for investors and presents the FT 300 as an elite group, not a competitive ranking of one to 300. RIAs must complete an application to be considered. The formula the FT uses to grade advisers is based on six broad factors and calculates a numeric score for each adviser. Areas of consideration include AUM, asset growth, the company’s age, industry certifications of key employees, SEC compliance record and online accessibility.

This press release contains forward-looking statements concerning anticipated future events, results, circumstances, performance or expectations with respect to CI Financial Corp. (“CI”) and its products and services, including its business operations, strategy and financial performance and condition. Forward-looking statements are typically identified by words such as “believe”, “expect”, “foresee”, “forecast”, “anticipate”, “intend”, “estimate”, “goal”, “plan” and “project” and similar references to future periods, or conditional verbs such as “will”, “may”, “should”, “could” or “would”. These statements are not historical facts but instead represent management beliefs regarding future events, many of which by their nature are inherently uncertain and beyond management’s control. Although management believes that the expectations reflected in such forward-looking statements are based on reasonable assumptions, such statements involve risks and uncertainties. The material factors and assumptions applied in reaching the conclusions contained in these forward-looking statements include that the investment fund industry will remain stable and that interest rates will remain relatively stable. Factors that could cause actual results to differ materially from expectations include, among other things, general economic and market conditions, including interest and foreign exchange rates, global financial markets, changes in government regulations or in tax laws, industry competition, technological developments and other factors described or discussed in CI’s disclosure materials filed with applicable securities regulatory authorities from time to time. The foregoing list is not exhaustive and the reader is cautioned to consider these and other factors carefully and not to place undue reliance on forward-looking statements. Other than as specifically required by applicable law, CI undertakes no obligation to update or alter any forward-looking statement after the date on which it is made, whether to reflect new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210503005329/en/

Congress Wealth Management

Paul Lonergan

President

617-428-7601

CI Financial

Investor Relations

Jason Weyeneth, CFA

Vice-President, Investor Relations & Strategy

416-681-8779

[email protected]

Media Relations

United States

Trevor Davis, Gregory FCA for CI Financial

443-248-0359

[email protected]

Canada

Murray Oxby

Vice-President, Corporate Communications

416-681-3254

[email protected]

KEYWORDS: United States North America Canada Massachusetts

INDUSTRY KEYWORDS: Professional Services Finance

MEDIA:

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