Market Newsdesk

WESTLAKE VILLAGE, Calif. and NEW PROVIDENCE, N.J., Dec. 17, 2020 (GLOBE NEWSWIRE) — MannKind Corporation (Nasdaq: MNKD)andVertice Pharma today announced that they have entered into a co-promotion agreement for Thyquidity™ (levothyroxine sodium) oral solution through MannKind’s specialty sales force. THYQUIDITY is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. THYQUIDITY is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients or hypothyroidism during the recovery phase of subacute thyroiditis.

Under the terms of the agreement, MannKind’s sales force will promote Thyquidity to adult endocrinologists, pediatric endocrinologists and other US healthcare providers who treat hypothyroidism. Vertice will make a specified quarterly payment to MannKind to defray the costs of the additional promotional activity and will pay MannKind royalties on gross profit resulting from all sales of Thyquidity.

“We are excited to co-promote Thyquidity with Vertice Pharma,” said Michael Castagna, Chief Executive Officer of MannKind. “This arrangement allows us to strengthen our relationships with our current customers, expand into pediatric endocrinology and leverage the talent and capabilities of our sales force and reimbursement support systems.”

“The team at Vertice Pharma is thrilled to be joining forces with MannKind to help launch our product to patients and healthcare providers,” said Scott Meyers, Chief Executive Officer of Vertice Pharma. “I look forward to working with MannKind’s commercial team to get ready for the launch of Thyquidity in 1Q 2021.”

Hypothyroidism, also called underactive thyroid disease, is a common disorder in which the thyroid gland does not produce enough thyroid hormone. The prevalence of hypothyroidism is 4.6% in the US population.¹ Symptoms include fatigue, lethargy, cold intolerance, weight gain, constipation, change in voice, and dry skin.² Most patients require lifelong therapy to treat their hypothyroidism.³

INDICATION

Hypothyroidism

THYQUIDITY (levothyroxine sodium) oral solution is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.

Pituitary Thyrotropin (Thyroid Stimulating Hormone, TSH) Suppression

THYQUIDITY is indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

Limitations of Use

THYQUIDITY is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients, as there are no clinical benefits and over-treatment with THYQUIDITY may induce hyperthyroidism.

THYQUIDITY is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

Important Safety Information

WARNING: NOT FOR TREATMENT OF OBESITY OR WEIGHT LOSS

Thyroid hormones, including THYQUIDITY, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.

• THYQUIDITY is contraindicated in patients with uncorrected adrenal insufficiency.
• In the elderly and in patients with cardiovascular disease, THYQUIDITY should be initiated at lower doses than those recommended in younger individuals or in patients without cardiac disease. If cardiac symptoms develop or worsen, the THYQUIDITY dose should be reduced or withheld for one week and restarted at a lower dose.
• Patients with coronary artery disease who are receiving THYQUIDITY should be monitored closely during surgical procedures for cardiac arrhythmias. Monitor patients during concomitant administration of THYQUIDITY and sympathomimetic agents for signs and symptoms of coronary insufficiency.
• Use of oral thyroid hormone is not recommended in myxedema coma. Products formulated for IV administration should be used to treat myxedema coma.
• Patients with adrenal insufficiency should be treated with replacement glucocorticoids prior to initiating treatment with THYQUIDITY. Failure to do so may precipitate an acute adrenal crisis when thyroid hormone therapy is initiated.
• THYQUIDITY has a narrow therapeutic index. Regardless of the indication for use, careful dosage titration is necessary to avoid the consequences of over- or under-treatment.
• Addition of levothyroxine therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control after starting, changing, or discontinuing THYQUIDITY.
• Increased bone resorption and decreased bone mineral density may occur as a result of levothyroxine over-replacement, particularly in postmenopausal women. To mitigate this risk, patients receiving THYQUIDITY should be given the minimum dose necessary that achieves the desired response.
• Adverse reactions associated with THYQUIDITY therapy are primarily those of hyperthyroidism due to therapeutic overdosage.
• Many drugs and some foods affect thyroid hormone pharmacokinetics and metabolism and may alter the therapeutic response to THYQUIDITY. In addition, thyroid hormones and thyroid status have varied effects on the pharmacokinetics and actions of other drugs. Administer at least 4 hours before or after drugs that are known to interfere with absorption. Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect absorption. Prescribers should consult appropriate reference sources for additional information on drug or food interactions with THYQUIDITY.
• Closely monitor patients from birth to 3 months of age receiving THYQUIDITY due to the potential for glycerol- induced gastrointestinal irritation resulting in vomiting and/or osmotic diarrhea.
• THYQUIDITY should not be discontinued during pregnancy, and hypothyroidism diagnosed during pregnancy should be promptly treated. TSH levels may increase during pregnancy, so TSH should be monitored and THYQUIDITY dose adjusted as needed.

Please see: [https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214047s000lbl.pdf] for full US Prescribing Information including Boxed Warning.

About MannKind Corporation

MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza^® (insulin human) Inhalation Powder, its first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

About Vertice Pharma

Vertice Pharma is a specialty pharmaceutical company focused on improving patients’ health. Vertice Pharma develops, manufactures, markets, and distributes high-quality and affordable pharmaceutical products through its operating companies. Vertice Pharma has global headquarters in the United Kingdom and United States headquarters in New Jersey. For more information visit www.verticepharma.com.

Forward-Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind’s filings with the SEC. For a discussion of these and other factors, please refer to MannKind’s annual report on Form 10-K for the year ended December 31, 2019 as well as MannKind’s other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

References

1. Hollowell JG, Staehling NW, Flanders WD, Hannon WH, Gunter EW, Spencer CA, Braverman LE. Serum TSH, T(4), and thyroid antibodies in the United States population (1988 to 1994): National Health and Nutrition Examination Survey (NHANES III). J Clin Endocrinol Metab. 2002 Feb;87(2):489-99. doi: 10.1210/jcem.87.2.8182. PMID: 11836274.
2. Chaker L, Bianco AC, Jonklaas J, Peeters RP. Hypothyroidism. Lancet. 2017;390(10101):1550-1562. https://pubmed.ncbi.nlm.nih.gov/28336049/
3. Jonklaas J, Bianco AC, Bauer AJ, et al. Guidelines for the treatment of hypothyroidism: prepared by the american thyroid association task force on thyroid hormone replacement. Thyroid. 2014;24(12):1670-1751. https://www.ncbi.nlm.nih.gov/pubmed/25266247.

Company Contact:

MannKind Corporation
818-661-5000
[email protected]

Vertice Pharma
Kimberly Branch
[email protected]
727-530-1633 x276

Washington, DC, Dec. 17, 2020 (GLOBE NEWSWIRE) —

FiscalNote, a global technology and media company, today announces the addition of former District of Columbia mayor and technology advisor Adrian Fenty to its Board of Advisors. 

“Adrian’s rare experience both as mayor of one of the most influential and complex city governments in the United States and advisor to numerous high growth technology companies in Silicon Valley provide him with an incredibly valuable perspective on the opportunities and challenges we face,” FiscalNote CEO Tim Hwang noted. “We work at the intersection of technology and government, and few people understand that intersection nearly as well as he does.”

Well known within the beltway for his widespread reforms in D.C. education, economic development, and public safety, Fenty has since made a name for himself by bringing government and technology firms closer together. Fenty has worked as special advisor to Silicon Valley venture capital firm, Andreessen Horowitz, in business development for law firm Perkins Coie and as General Partner at MaC Venture Capital. 

“Having met Tim six years ago after he moved a fledgling FiscalNote into downtown D.C., I was immediately excited about the long-term prospects of the company,” Fenty said. “Government activity — from local to international jurisdictions — has immense impact on organizations, and it has become painfully obvious to me that in this globalized world, FiscalNote’s products and services are critical to solving some of the larger information problems organizations encounter.”

A D.C. native and Howard University law school graduate, Fenty also serves on the board of a number of nonprofits and was recently named co-chair of the ReOpen DC Advisory Group appointed by the city’s current mayor, Muriel Bowser.

About FiscalNote
FiscalNote is a global technology company focused on delivering timely and relevant political and regulatory intelligence in a complex and evolving world. More than 4,000 clients worldwide rely on FiscalNote for legislative and regulatory data, policy news & analysis, stakeholder management, collaboration and advocacy tools. 

To learn more about FiscalNote and its family of brands, visit www.fiscalnote.com. 

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• Adrian.Fenty

Mike Stubbs
FiscalNote
[email protected]

HAUPPAUGE, N.Y., Dec. 17, 2020 (GLOBE NEWSWIRE) — Forward Industries, Inc. (NASDAQ:FORD), a single source solution provider for the full spectrum of hardware and software product design and engineering services as well as a designer and distributer of carry and protective solutions, today announced financial results for the year ended September 30, 2020.

Full Fiscal Year
2020 Financial Highlights

• Revenues were $34.5 million compared to $37.4 million for 2019, a decrease of 7.8%.
• Loss from operations was $2.0 million compared to $3.1 million in 2019.
• Gross margin improved to 19.3% compared to 17.6% in 2019.
• Net loss was $1.8 million compared to $3.6 million in 2019.
• Net loss per share was $0.19 compared to $0.38 for 2019.
• Cash and cash equivalents totaled $2.9 million at September 30, 2020.

Terry Wise, Chief Executive Officer of Forward Industries, stated, “In spite of the very challenging trading circumstances, I am pleased that the fiscal year-end financial performance has improved relative to the previous year.

“Importantly, as trading conditions improve, particularly within the retail sector, we will continue to build momentum in terms of achieving profitability. Additionally, our underlying business within the design division remains robust, and with the addition of Kablooe Design, I am confident that will continue to strengthen. Thus, whilst there has continued to be the predictable decline in our historical core business, I am strongly encouraged by Forward’s progress this fiscal year. 

“During this fiscal year, we will seek to build upon the considerable momentum we have been able to achieve despite the exceptional trading environment. It is for this very reason that I look forward to the future with cautious optimism.”

The tables below are derived from the Company’s consolidated financial statements included in its Form 10-K filed on December 17, 2020 with the Securities and Exchange Commission. Please refer to the Form 10-K for complete financial statements and further information regarding the Company’s results of operations and financial condition relating to the fiscal years ended September 30, 2020 and 2019. Please also refer to the Form 10-K for a discussion of risk factors applicable to the Company and its business. 

Note Regarding Forward-Looking Statements

This press release contains certain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 including statements regarding momentum and growth in our business. Forward has tried to identify these forward-looking statements by using words such as “may”, “should,” “expect,” “hope,” “anticipate,” “believe,” “intend,” “plan,” “estimate” and similar expressions. These forward-looking statements are based on information currently available to the Company and are subject to a number of risks, uncertainties and other factors that could cause its actual results, performance, prospects or opportunities to differ materially from those expressed in, or implied by, these forward-looking statements. These risks include the inability to expand our customer base, pricing pressures, lack of success of our salespeople, failure to develop products at a profit, failure to commercialize products that we develop and unanticipated issues with our affiliated sourcing agent, failure to take advantage of synergies between Kablooe. No assurance can be given that the actual results will be consistent with the forward-looking statements. Investors should read carefully the factors described in the “Risk Factors” section of the Company’s filings with the SEC, including the Company’s Form 10-K for the year ended September 30, 2020 for information regarding risk factors that could affect the Company’s results. Except as otherwise required by Federal securities laws, Forward undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances or any other reason.

A
bout Forward Industries

Forward is a fully integrated design, development and manufacturing solution provider to top tier medical and technology customers worldwide. Through its acquisition of Intelligent Product Solutions, Inc. and Kablooe Design, Inc., the Company has expanded its ability to design and develop solutions for our existing multinational client base and expand beyond the diabetic product line into a variety of industries with a full spectrum of hardware and software product design and engineering services. In addition to our existing design and distribution of carry and protective solutions, primarily for hand-held electronic devices, we are now a one-stop shop for design development and manufacturing solutions serving a wide range of clients in the industrial, commercial, medical and consumer industries.

Contact:

Forward Industries, Inc.
Anthony Camarda, CFO
(631) 547-3041

FORWARD INDUSTRIES, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
	September 30,
		2020				2019
Assets
Current assets:
Cash	$	2,924,627			$	3,092,813
Accounts receivable, net		7,602,316				6,695,120
Inventories		1,275,694				1,608,827
Prepaid expenses and other current assets		419,472				441,502
Total current assets		12,222,109				11,838,262
Property and equipment, net		215,323				243,002
Intangible assets, net		1,531,415				1,248,712
Goodwill		1,758,682				2,182,427
Investment		–				326,941
Operating lease right of use assets, net		3,512,042				–
Other assets		116,697				255,008
Total assets	$	19,356,268			$	16,094,352
Liabilities and shareholders’ equity
Current liabilities:
Line of credit	$	1,000,000			$	1,300,000
Note payable to Forward China		1,600,000				1,600,000
Accounts payable		197,022				315,444
Due to Forward China		3,622,401				3,236,693
Deferred income		485,078				219,831
Current portion of notes payable		983,395				54,799
Current portion of capital leases payable		18,411				39,941
Current portion of deferred consideration		45,000				834,000
Current portion of operating lease liability		259,658				–
Accrued expenses and other current liabilities		615,401				694,972
Total current liabilities		8,826,366				8,295,680
Other liabilities:
Notes payable, less current portion		529,973				–
Operating lease liability, less current portion		3,359,088				–
Capital lease liability, less current portion		12,769				26,438
Deferred rent		–				60,935
Deferred consideration, less current portion		45,000				–
Total other liabilities		3,946,830				87,373
Total liabilities		12,773,196				8,383,053
Commitments and contingencies
Shareholders’ equity:
Common stock, par value $0.01 per share; 40,000,000 shares authorized;
9,883,851 and 9,533,851 shares issued and outstanding at September 30, 2020
and 2019, respectively		98,838				95,338
Additional paid-in capital		19,579,684				18,936,130
Accumulated deficit		(13,095,450	)			(11,320,169	)
Total shareholders’ equity		6,583,072				7,711,299
Total liabilities and shareholders’ equity	$	19,356,268			$	16,094,352

FORWARD INDUSTRIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
	For the Fiscal Years Ended September 30,
		2020				2019
Revenues, net	$	34,478,358			$	37,409,030
Cost of sales		27,839,851				30,828,148
Gross profit		6,638,507				6,580,882
Sales and marketing		1,950,704				1,965,230
General and administrative		5,655,186				7,713,035
Goodwill impairment		1,015,000				–
Loss from operations		(1,982,383	)			(3,097,383	)
Fair value adjustment of earn-out consideration		(350,000	)			260,000
Fair value adjustment of deferred cash consideration		16,000				36,000
Interest income		(60,932	)			–
Interest expense		174,962				201,004
Other expense, net		3,701				13,805
Loss before income taxes		(1,766,114	)			(3,608,192	)
Provision for (benefit from) income taxes		9,167				(4,162	)
Net loss	$	(1,775,281	)		$	(3,604,030	)
Net loss per share:
Basic	$	(0.19	)		$	(0.38	)
Diluted	$	(0.19	)		$	(0.38	)
Weighted average common shares outstanding:
Basic		9,583,441				9,532,034
Diluted		9,583,441				9,532,034

 

Vancouver, BC, Dec. 17, 2020 (GLOBE NEWSWIRE) — GCT Canada is pleased to announce the completion of the final two tracks of the GCT Deltaport Intermodal Rail Yard Expansion Project, which sets GCT Deltaport apart as the most efficient and capable ship-to-rail discharge facility in the world. 

The GCT Deltaport Intermodal Rail Yard Expansion Project is the second, $300 million privately-funded stage of the multi-phased expansion Deltaport Terminal Road and Rail Improvement Project (DTRRIP), a collaboration with the Port Authority and the Province of British Columbia. The densification approach to this project demonstrates GCT’s commitment to increasing capacity within our existing footprint and minimizing operational and environmental impacts on the surrounding community. 

This project also ensures B.C. remains competitive to meet projected carrier rail demand for the Canadian and US markets, without any impact to local road traffic. Further, the GCT Deltaport Intermodal Rail Yard Expansion Project:

• Improves safety;
• Increases rail capacity enabling sustainable intermodal cargo growth;
• Improves operational performance and provide surge and recovery capacity;
• Decreases noise and greenhouse gas emissions with the introduction of modernized electric CRMGs; and
• Reduces light pollution as a result of the new energy-efficient LED lights.

As the premier ship-to-rail terminal on the continent, rail handling capacity at GCT Deltaport has increased by more than 50% due to the project. The total terminal capacity is now 2.4 million TEUs annually. This state-of-the-art, fully operational rail yard provides necessary surge capacity and added certainty on transit and dwell times for our customers.

“Integrity and reliability of the supply chain is more important than ever as affirmed by the events of this year. The completion of this project will provide our customers and Canadians with the peace of mind to know that GCT has the capacity and capability to get them what they need when they need it.  GCT Deltaport Rail Yard is fully operational and ready for Canadian winters”, says Doron Grosman, President and Chief Executive Officer of Global Container Terminals Inc.” 

As a Canada Port Authority, we’re mandated to protect the environment and consider communities that neighbour the port, while ensuring port infrastructure is in place to handle our country’s expected growth in trade. GCT’s completion of its intermodal rail yard expansion is a welcome achievement towards that effort, demonstrating the port’s readiness to grow with trade demand,” says Peter Xotta, Vice President, Planning and Operations, Vancouver Fraser Port Authority.

Media photo assets are available for download:

 
https://www.dropbox.com/sh/axqblw6mljgeiuu/AAD504oj8fkZ_avOMqK7775_a?dl=0

About GCT Global Container Terminals Inc.

Headquartered in Vancouver, BC, GCT Global Container Terminals Inc. operates Green Marine certified terminals in two principal North American ports. For over a century, GCT has sustainably grown with innovative technology and our industry-leading Global Commitment to the environment and community. On the West Coast, GCT Canada operates two gateway terminals: GCT Vanterm and GCT Deltaport in Vancouver and Delta, BC. These two West Coast terminals provide customers and ocean carriers with reliable and convenient access to all the major Asia-Pacific trade lanes.

– 30 –

Background:

• GCT Deltaport rail yard is fully operational and ready for a Canadian winter
• The final two tracks were installed in late summer 2020, bringing the total number of tracks to seven
• GCT Canada is more equipped than ever to handle cargo surges  with a more efficient track configuration, modern semi-automated cranes, and remote operating centers
• North America’s largest, most modern, technologically advanced facility of its kind
• completion of the $300M project brings online 1.9M TEU in annual rail capacity
• Record-breaking productivity since going fully operational (in late August) (builds 45,000 to 55,000 footage of train)
• Investment maximizes Safety, Environmental & Community Benefits
• Enhances safety by removing worker and machinery interaction and in 2019, the project won an IHCA International and TT Innovation in Safety Award – recognizing safety innovation in the global freight supply chain
• Another successful densification project increases the capacity of the terminal by 50% without increasing the footprint
• Fully electrified operation; decreased noise and GHG emissions
• New energy-efficient LEF lights, reducing light pollution
• Improved operational procedures reduce equipment travel time and emissions
• GCT wants to continue to make private sector investments to ensure that Vancouver is the port of choice and remains competitive vis a vis other jurisdictions for transpacific trade.

Learn more about this project at:


https://youtu.be/nYjwa-kLduQ 

For more information on GCT’s ongoing investments to improve the gateway, visit our projects page:


https://globalterminalscanada.com/projectupdates/

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Jennifer Perih
GCT Global Container Terminals Inc.
+1 604 267 5102
[email protected]