Aptinyx Reports Third Quarter 2020 Financial Results and Recent Highlights

Aptinyx Reports Third Quarter 2020 Financial Results and Recent Highlights

Significant development progress across clinical-stage pipeline programs, with multiple clinical and regulatory milestones expected over the next 18 months

Recommenced patient recruitment in Phase 2b clinical study of NYX-2925 in patients with fibromyalgia

Near-term recommencements planned for Phase 2b clinical study in painful DPN and exploratory Phase 2 study in cognitive impairment

Reported positive results from exploratory Phase 2 clinical study of NYX-783 in patients with PTSD

Strengthened cash position through common stock offering, expected to provide operational runway into 2023 through multiple clinical data readouts

Management to host conference call today at 5:00 p.m. ET

EVANSTON, Ill.–(BUSINESS WIRE)–
Aptinyx Inc. (Nasdaq: APTX), a clinical-stage biopharmaceutical company developing transformative therapies for the treatment of brain and nervous system disorders, today reported financial results for the third quarter of 2020 and highlighted recent progress across the company’s clinical-stage pipeline of novel NMDA receptor modulators.

“I am very pleased with the remarkable progress we have made over the past several months despite the negative impact of COVID-19, including our decisive response to the emergence of the pandemic, the positive progress and results across our clinical studies, and the completion of a financing that funds all of our pipeline programs,” said Norbert Riedel, Ph.D., president and chief executive officer of Aptinyx. “While it has been a trying year with unexpected hurdles, I am very proud of the persistence shown by our team to work through such challenges and stay focused on advancing these important novel therapies in development. We resumed our fibromyalgia study and are poised to restart our studies in painful DPN and cognitive impairment in the coming months. In addition, we recently reported positive results from our Phase 2 clinical study of NYX-783 in patients with post-traumatic stress disorder. The PTSD study represents the third Phase 2 study demonstrating the therapeutic potential of compounds from our platform and further validates our mechanism of NMDA receptor modulation in the treatment of disorders of the central nervous system. We continue to be well served by our strong cash balance, which was bolstered by our recent financing and which we expect will provide operational runway into 2023, enabling the achievement of multiple clinical and regulatory milestones across our pipeline.”

Third Quarter 2020 and Recent Highlights

  • Recommenced patient recruitment in Phase 2b study of NYX-2925 in patients with fibromyalgia – In September, Aptinyx announced the re-activation of study sites and recommencement of patient recruitment in its Phase 2b clinical study of NYX-2925 in patients with fibromyalgia. Enrollment in the study had been suspended in March 2020 due to the escalation of the COVID-19 pandemic in the United States.
  • Reported positive results from Phase 2 exploratory study of NYX-783 in patients with post-traumatic stress disorder (PTSD) – In October, Aptinyx announced positive results from the initial exploratory Phase 2 clinical study of its novel NMDA receptor modulator, NYX-783, in 153 patients with PTSD. In the Phase 2 clinical study, NYX-783 demonstrated clinically meaningful and stasticically significant effects across multiple endpoints with a favorable adverse event and tolerability profile. Based on these results, the company expects to initiate a registration-supportive study in the second half of 2021.

    Summary of study results:

    • Clinically meaningful improvement from baseline on CAPS-5 Total score observed in 50 mg dose arm
    • Statistically significant separation of 50 mg from placebo achieved on multiple measures of responder rate on CAPS-5 Total score
    • Clinically meaningful and statistically significant improvement on CAPS-5 Arousal and Reactivity symptom cluster score observed with NYX-783
    • Clear dose response observed with 50 mg dose group performing better overall compared to 10 mg dose group
    • Favorable tolerability and adverse event profile observed in the study
  • Strengthened the company’s financial position through the completion of a $48.3 million common stock offering. In October, Aptinyx announced the closing of a public offering of common stock with gross proceeds totaling $48.3 million, inclusive of the full exercise of the underwriters’ option to purchase additional shares and before deducting underwriting discounts and commissions and offering expenses. The company’s current cash balance, inclusive of the net proceeds from the offering, is expected to provide financial support into 2023 and enable completion of multiple ongoing Phase 2 clinical studies.

Expected Upcoming Milestones

  • Recommencement of Phase 2b clinical study of NYX-2925 in patients with painful diabetic peripheral neuropathy – 4Q 2020
  • Recommencement of Phase 2 exploratory clinical study of NYX-458 in patients with cognitive impairment associated with Parkinson’s disease – 1Q 2021
  • Meeting with FDA to discuss future development and registration pathway for NYX-783 in PTSD – 1H 2021
  • Initiation of registration-supportive clinical study of NYX-783 in patients with PTSD – 2H 2021
  • Reporting of data from Phase 2b clinical study of NYX-2925 in patients with fibromyalgia – 1H 2022
  • Reporting of data from Phase 2b clinical study of NYX-2925 in patients with painful DPN – 1H 2022

Third Quarter 2020 Financial Results

Cash Position: Cash and cash equivalents were $103.8 million at September 30, 2020, compared to $98.8 million at December 31, 2019. Together with the net proceeds from the common stock offering in October 2020, pro forma cash and cash equivalents amount to approximately $148 million. Aptinyx expects its current cash balance to support anticipated operations into 2023 and fund completion of multiple clinical studies.

Collaboration Revenue: Revenue was $0.3 million for the third quarter of 2020, compared to $0.9 million for same period in 2019. Aptinyx’s revenue was derived from its research collaboration agreement (RCA) with Allergan, now a wholly owned subsidiary of AbbVie. In accordance with the terms of the RCA, jointly funded research activities—and the associated payments by Allergan/AbbVie to Aptinyx—came to their contractual conclusion at the end of August 2020. The company does not rely on these revenues to fund its continuing and expected future operations.

Research and Development (R&D) Expenses: Research and development expenses were $6.6 million for the three months ended September 30, 2020, compared to $11.8 million for the three months ended September 30, 2019. The decrease in R&D expenses was primarily due to a decrease in personnel costs as well as a decrease in clinical operations expenditures.

General and Administrative (G&A) Expenses: General and administrative expenses were $5.0 million for the three months ended September 30, 2020, compared to $4.5 million for the same period in 2019. The $0.5 million increase in G&A expenses was due to non-cash stock-based compensation expense.

Net Loss: Net loss was $11.3 million for the third quarter of 2020, compared to a net loss of $14.8 million for the third quarter of 2019.

Conference Call

The Aptinyx management team will host a conference call and webcast today at 5:00 p.m. ET to review its financial results and highlights for the third quarter of 2020 and subsequent period. To access the call, please dial (833) 772-0394 (domestic) or (236) 738-2205 (international) and refer to conference ID 9186375. A live webcast of the call will be available on the Investors & Media section of Aptinyx’s website at https://ir.aptinyx.com. The archived webcast will be available approximately two hours after the conference call and for 30 days thereafter.

About Aptinyx

Aptinyx Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of proprietary synthetic small molecules for the treatment of brain and nervous system disorders. Aptinyx has a platform for discovery of novel compounds that work through a unique mechanism to modulate—rather than block or over-activate—NMDA receptors and enhance synaptic plasticity, the foundation of neural cell communication. The company has three product candidates in clinical development in central nervous system indications, including chronic pain, post-traumatic stress disorder, and cognitive impairment associated with Parkinson’s disease. Aptinyx is also advancing additional compounds from its proprietary discovery platform, which continues to generate a rich and diverse pipeline of small-molecule NMDA receptor modulators with the potential to treat an array of neurologic disorders. For more information, visit www.aptinyx.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the company’s business plans and objectives, including future plans or expectations for NYX-2925, NYX-783, and NYX-458, including the timing and pivotal nature of a study of NYX-783, therapeutic effects of the company’s product candidates and discovery platform, expectations regarding the design, implementation, timing, and success of its current and planned clinical studies, including the timing of recommencement of clinical studies, effects of the COVID-19 pandemic on patient enrollment and the expected timing of study completion, and data reporting, the timing for the company’s receipt and announcement of data from its clinical studies, expectations regarding its preclinical development activities, expectations regarding its uses and sufficiency of capital, including the operational runway of its current cash balance, and the effect of the COVID-19 pandemic on the foregoing. Risks that contribute to the uncertain nature of the forward-looking statements include: the effect of the COVID-19 pandemic on our business and financial results, including with respect to disruptions to our clinical studies, business operations, and ability to raise additional capital; the success, cost, and timing of the company’s product candidate development activities and planned clinical studies; the company’s ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; the company’s estimates regarding expenses, future revenue, and capital requirements; the company’s ability to fund operations into 2023; as well as those risks and uncertainties set forth in the company’s most recent annual report on Form 10-K and subsequent filings with the Securities and Exchange Commission, including our upcoming Quarterly Report on Form 10-Q for the period ended September 30, 2020. All forward-looking statements contained in this press release speak only as of the date on which they were made. Aptinyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

 

APTINYX INC.

CONDENSED BALANCE SHEETS

(in thousands)

(unaudited)

 

Assets

 

September 30, 2020

 

December 31, 2019

Current Assets:

 

 

 

 

Cash and cash equivalents

 

$

103,810

 

$

98,849

Restricted cash

 

 

179

 

 

179

Accounts receivable

 

 

257

 

 

444

Prepaid expenses and other current assets

 

 

8,836

 

 

5,637

Total current assets

 

 

113,082

 

 

105,109

Property and equipment, net and other long-term assets

 

 

1,125

 

 

1,370

Total assets

 

$

114,207

 

$

106,479

 

 

 

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

Current Liabilities:

 

 

Accounts payable

$

986

$

1,555

Accrued expenses and other current liabilities

 

 

3,281

 

 

3,341

Total current liabilities

 

 

4,267

 

 

4,896

Other long-term liabilities

 

 

154

 

 

272

Total liabilities

 

 

4,421

 

 

5,168

Stockholders’ equity

 

 

109,786

 

 

101,311

Total liabilities and stockholders’ equity

 

$

114,207

 

$

106,479

APTINYX INC.

CONDENSED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

(Unaudited)

 

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

 

 

2020

 

 

 

2019

 

 

 

2020

 

 

 

2019

 

 

 

 

 

 

 

 

 

 

Revenues

 

 

 

 

 

 

 

 

Collaboration revenue

 

$

257

 

 

$

936

 

 

$

1,564

 

 

$

2,751

 

 

 

 

 

 

 

 

 

 

Operating expenses

 

 

 

 

 

 

 

 

Research and development

 

 

6,630

 

 

 

11,761

 

 

 

26,049

 

 

 

33,732

 

General and administrative

 

 

5,050

 

 

 

4,523

 

 

 

14,719

 

 

 

14,419

 

Total operating expenses

 

 

11,680

 

 

 

16,284

 

 

 

40,768

 

 

 

48,151

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

 

(11,423

)

 

 

(15,348

)

 

 

(39,204

)

 

 

(45,400

)

Other income

 

 

85

 

 

 

558

 

 

 

639

 

 

 

1,768

 

Net loss and comprehensive loss

 

$

(11,338

)

 

$

(14,790

)

 

$

(38,565

)

 

$

(43,632

)

Net loss per share – basic and diluted

 

$

(0.24

)

 

$

(0.44

)

 

$

(0.85

)

 

$

(1.30

)

Weighted average shares outstanding – basic and diluted

 

 

46,978

 

 

 

33,646

 

 

 

45,503

 

 

 

33,510

 

Source: Aptinyx Inc.

Investor & Media Contact:

Nick Smith

Aptinyx Inc.

[email protected] or [email protected]

847-871-0377

KEYWORDS: United States North America Illinois

INDUSTRY KEYWORDS: Biotechnology Health Science Pharmaceutical Research

MEDIA:

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CyrusOne Inc. to Present at Investor Conferences in November 2020

CyrusOne Inc. to Present at Investor Conferences in November 2020

DALLAS–(BUSINESS WIRE)–
CyrusOne Inc. (NASDAQ: CONE), a premier global data center REIT, today announced that it will be presenting at the following virtual investor conferences in November:

NAREIT’s REITworld: 2020 Annual Conference, being held November 17-19, 2020. Bruce W. Duncan, President and Chief Executive Officer, will be presenting at 1:45 pm Eastern Time on Wednesday, November 18.

BofA Securities Global Data Center Conference being held November 24-25, 2020. Bruce W. Duncan, President and Chief Executive Officer, will be presenting at 11:00 am Eastern Time on Wednesday, November 25.

Live webcasts of the events will be available in the “Investors / Events & Presentations” section of the Company’s website at http://investor.cyrusone.com/events.cfm. Replays will be available for 14 days following the presentations.

About CyrusOne

CyrusOne (NASDAQ: CONE) is a premier global REIT specializing in design, construction and operation of more than 50 high-performance data centers worldwide. The Company provides mission-critical facilities that ensure the continued operation of IT infrastructure for approximately 1,000 customers, including approximately 200 Fortune 1000 companies.

A leader in hybrid-cloud and multi-cloud deployments, CyrusOne offers colocation, hyperscale, and build-to-suit environments that help customers enhance the strategic connection of their essential data infrastructure and support achievement of sustainability goals. CyrusOne data centers offer world-class flexibility, enabling clients to modernize, simplify, and rapidly respond to changing demand. Combining exceptional financial strength with a broad global footprint, CyrusOne provides customers with long-term stability and strategic advantage at scale.

Investor Relations

Michael Schafer

Vice President, Capital Markets & Investor Relations

972-350-0060

[email protected]

KEYWORDS: Texas United States North America

INDUSTRY KEYWORDS: REIT Networks Data Management Technology Construction & Property

MEDIA:

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Griffon Corporation Declares Quarterly Dividend

Griffon Corporation Declares Quarterly Dividend

NEW YORK–(BUSINESS WIRE)–
The Board of Directors of Griffon Corporation (NYSE: GFF) (the “Company” or “Griffon”) declared a regular quarterly cash dividend of $0.08 per share. The dividend is payable on December 17, 2020 to shareholders of record as of the close of business on November 25, 2020.

About Griffon Corporation

Griffon is a diversified management and holding company that conducts business through wholly-owned subsidiaries. Griffon oversees the operations of its subsidiaries, allocates resources among them and manages their capital structures. Griffon provides direction and assistance to its subsidiaries in connection with acquisition and growth opportunities as well as in connection with divestitures. In order to further diversify, Griffon also seeks out, evaluates and, when appropriate, will acquire additional businesses that offer potentially attractive returns on capital.

Griffon currently conducts its operations through three reportable segments:

  • Consumer and Professional Products (“CPP”) conducts its operations through The AMES Companies, Inc. (“AMES”). Founded in 1774, AMES is the leading North American manufacturer and a global provider of branded consumer and professional tools and products for home storage and organization, landscaping, and enhancing outdoor lifestyles. CPP sells products globally through a portfolio of leading brands including True Temper, AMES, and ClosetMaid.
  • Home and Building Products conducts its operations through Clopay Corporation (“Clopay”). Founded in 1964, Clopay is the largest manufacturer and marketer of garage doors and rolling steel doors in North America. Residential and commercial sectional garage doors are sold through professional dealers and leading home center retail chains throughout North America under the brands Clopay, Ideal, and Holmes. Rolling steel door and grille products designed for commercial, industrial, institutional, and retail use are sold under the CornellCookson brand.
  • Defense Electronics conducts its operations through Telephonics Corporation, founded in 1933, a globally recognized leading provider of highly sophisticated intelligence, surveillance and communications solutions for defense, aerospace and commercial customers.

For more information on Griffon and its operating subsidiaries, please see the Company’s website at www.griffon.com.

Company Contact:

Brian G. Harris

SVP & Chief Financial Officer

Griffon Corporation

(212) 957-5000

Investor Relations Contact:

Michael Callahan

Managing Director

ICR Inc.

(203) 682-8311

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Consulting Other Professional Services Professional Services Finance

MEDIA:

TOMI Environmental Solutions, Inc. Reports Third Quarter 2020 Financial Results

FREDERICK, Md., Nov. 12, 2020 (GLOBE NEWSWIRE) — TOMI Environmental Solutions, Inc.® (“TOMI”) (NASDAQ:TOMZ), is a global company specializing in disinfection and decontamination utilizing its premier Binary Ionization Technology (BIT) platform through its SteraMist brand of products – a hydrogen peroxide-based mist and fog comprised of ionized Hydrogen Peroxide (iHP), announced its results for the third quarter of 2020.

TOMI Chief Executive Officer, Dr. Halden Shane stated, “We are a company that strives for SteraMist to become the gold standard in its industry, and I report another major milestone with revenues exceeding $21 million for our current calendar year. The third quarter also continued the trend of year over year revenue growth as SteraMist continues to see widespread adoption.   We have been pleasantly surprised to see that new clients in a number of the new verticals targeted by our commercial division are proving to be faster in integrating SteraMist into their protocol compared to blue-chip clients that adhere to stringent protocol and procedures. On the other hand, the TOMI Service Network and Healthcare Divisions faced persistent headwinds in the quarter as a number of potential clients elected to continue to utilize harsh chemical disinfectants and low-cost delivery systems. We anticipate these industries will increasingly see negative affects of these disinfectants and increasingly seek SteraMist to be their permanent solution, a trend that we have already seen as we begin the fourth quarter, as many of these companies are our either returning to or starting to use SteraMist. We also continued to make strides on the product development and intellectual property front with the SteraBot and SteraPack which will provide more differentiation in our product line and a competitive advantage in the marketplace. Management is adding executive sales division leaders and executing a plan for all divisions to grow consistently, both domestically and internationally, as we strive to innovate for a safer world.”

Financial Results for the Three Months Ended
September
3
0
, 20
20
compared to
September
30,
201
9

  • Total net revenue was $4,292,000 compared to $1,600,000, representing an increase of $2,692,000, or 168%.
    • SteraMist® equipment-based revenues was $2,945,000 and $669,000, respectively, representing an increase of $2,276,000 or 340%
    • SteraMist® BIT Solution-based revenues was $732,000 and $259,000, respectively, representing an increase of $473,000 or 183%
    • Service-based revenue was $615,000 and $672,000, respectively, representing a decrease of $57,000 or 8%.
    • Domestic revenue was $3,446,000 and $1,288,000, respectively, representing an increase of $2,158,000, or 168%.
    • International revenue was approximately $846,000 and $312,000, respectively, representing an increase of $534,000 or 171%.
  • Gross margins were 66.1% compared to 71.3%. The lower gross profit is attributable to the product mix in sales.
  • Income from operations was $1,096,000, compared to a Loss from operations of ($188,000), representing an increase of $1,284,000.
  • Net Income was $1,019,000, or $0.06 on a per share basis compared to a Net loss of ($237,000), or ($0.02) on a per share basis, representing an increase of $1,256,000.
  • EBIDTA was $1,274,000 compared to an adjusted net loss of ($5,000). A table reconciling EBITDA to the appropriate GAAP measure is included with the Company’s financial information below.
  • Cash provided from operations for the nine months ended September 30, 2020 and 2019 of $4,945,000, compared to cash used in operations of ($573,000), respectively.

     Balance sheet highlights as of September 30, 2020 and December 31, 2019

  • Cash and cash equivalents of approximately $5,885,000 and $897,000, representing an increase of $4,988,000.  
  • Working capital of $11,692,000 and ($1,266,000), representing an increase of $12,958,000.
  • Shareholders’ equity of $13,251,000 and $890,000, representing an increase of $12,361,000.

Current Business Highlights To Date


Revenues

  • Milestone reached in the third quarter of 2020 with total revenues exceeding $21 million in a calendar year.
  • Year over year growth in overall revenue through September 30th of $16,882,000 or 376%.
  • Year over year growth SteraMist® equipment revenue through September 30th of $13,165,000 or 456%.
  • Year over year growth SteraMist® BIT Solution revenue through September 30th of $2,931,000 or 509%.
  • Year over year growth in service revenue through September 30th of $786,000 or 76%.


Business Highlights

  • Increased demand on solution re-orders as disinfecting and decontamination procedures have increased exponentially across the world.
  • Saw an increase in Hospital-Healthcare customers purchasing multiple SteraMist units in order to deploy throughout multiple locations and/or areas within a facility.
  • Broke ground on installation of permanent fogging system into our Frederick MD Facility.
  • Continued development and testing of the “SteraBot” and launch of pilot program at Lithuanian University Hospital.
  • Continued development of SteraPack with a tentative launch set for first quarter 2021.
  • Launch of Commercial Division in response to increased demand in Federal Government facilities and agencies, the aircraft (both airplane and helicopter), manufacturing companies, automobile, naval, education, retail, housing and recreation, and of course emergency preparedness for counties and cities.
  • SteraMist was featured in a United States Department of Agriculture paper “Cold plasma-activated hydrogen peroxide aerosol on populations of Salmonella Typhimurium and Listeria innocua and quality changes of apple, tomato and cantaloupe during storage – A pilot scale study” is authored by Dr. Xuetong Fan, who has previously contributed to two prior studies regarding direct produce application.
  • Issuance of a first Australian patent protecting use of its iHP technology, and pursuing patent rights in diverse regions of the world, encompassing the European Union, Brazil, Mexico, Korea, China, India, and many other countries.
  • SteraMist was chosen to be a disinfection solution for the 2019-2020 PGA Champions Tour.
  • Increased demand of product and services has led to the hiring and onboarding of additional employees to assist in a wide variety of company operations, including but not limited to accounting, procurement, customer satisfaction, and quality control.

TOMI™ Environmental Solutions, Inc.: Innovating for a safer world®

TOMI™ Environmental Solutions, Inc. (NASDAQ:TOMZ) is a global decontamination and infection prevention company, providing environmental solutions for indoor surface disinfection through the manufacturing, sales and licensing of its premier Binary Ionization Technology® (BIT™) platform. Invented under a defense grant in association with the Defense Advanced Research Projects Agency (DARPA) of the U.S. Department of Defense, BIT™ solution utilizes a low percentage Hydrogen Peroxide as its only active ingredient to produce a fog of  ionized Hydrogen Peroxide (iHP™). Represented by the SteraMist® brand of products, iHP™ produces a germ-killing aerosol that works like a visual non-caustic gas.
TOMI products are designed to service a broad spectrum of commercial structures, including, but not limited to, hospitals and medical facilities, cruise ships, office buildings, hotel and motel rooms, schools, restaurants, meat and produce processing facilities, military barracks, police and fire departments, and athletic facilities. TOMI products and services have also been used in single-family homes and multi-unit residences.

TOMI develops training programs and application protocols for its clients and is a member in good standing with The American Biological Safety Association, The American Association of Tissue Banks, Association for Professionals in Infection Control and Epidemiology, Society for Healthcare Epidemiology of America, America Seed Trade Association, and The Restoration Industry Association.

For additional information, please visit http://www.tomimist.com/ or contact us at [email protected].

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995

Certain written and oral statements made by us may constitute “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 (the “Reform Act”). Forward-looking statements are identified by such words and phrases as “we expect,” “expected to,” “estimates,” “estimated,” “current outlook,” “we look forward to,” “would equate to,” “projects,” “projections,” “projected to be,” “anticipates,” “anticipated,” “we believe,” “could be,” and other similar phrases. All statements addressing operating performance, events, or developments that we expect or anticipate will occur in the future, including statements relating to revenue growth, earnings, earnings-per-share growth, or similar projections, are forward-looking statements within the meaning of the Reform Act. They are forward-looking, and they should be evaluated in light of important risk factors that could cause our actual results to differ materially from our anticipated results. The information provided in this document is based upon the facts and circumstances known at this time. We undertake no obligation to update these forward-looking statements after the date of this release.

Use of Non-GAAP Financial Measures

TOMI uses a non-GAAP financial measures in this release. Earnings before interest, taxes, depreciation and amortization (EBITDA) is a non-GAAP financial measure and is intended to serve as a supplement to TOMI’s results provided in accordance with GAAP. TOMI believes that such information may provide its investors a better understanding of TOMI’s underlying operational performance, business and performance trends. 

Although TOMI believes that the use of non-GAAP financial measures enhance its investors’ understanding of its business and performance, TOMI’s use of non-GAAP financial measures should not be considered an alternative to GAAP basis financial measures and should be read in conjunction with the relevant GAAP financial measures. Other companies in similar industries may define or calculate non-GAAP financial measures differently than TOMI, limiting their usefulness as a comparative measure.  Because of these limitations, the non-GAAP financial measure used in this release should not be considered in isolation or as a substitute for performance measures calculated in accordance with GAAP. A reconciliation of the non-GAAP financial measures to the most directly comparable GAAP measure is available in this news release.

           
           
           
ASSETS          
  September 30, 2020
(Unaudited)
  December 31, 2019
Cash and Cash Equivalents $ 5,885,383   $ 897,223
Accounts Receivable – net 3,504,284   1,494,658
Other Receivables 157,487  
Inventories 4,374,500   2,315,214
Vendor Deposits 333,212   141,052
Prepaid Expenses 376,758   187,664
Total Current Assets 14,631,624   5,035,811
       
Property and Equipment – net 1,111,342   1,367,864
       
Other Assets:      
Intangible Assets – net 658,969   939,010
Operating Lease – Right of Use Asset 642,738   674,471
Capitalized Software Development Costs – net 62,852   94,278
Other Assets 469,024   114,033
Total Other Assets 1,833,583   1,821,792
Total Assets $ 17,576,549   $ 8,225,467
       
                    LIABILITIES AND SHAREHOLDERS’ EQUITY 
 
Current Liabilities:    
Accounts Payable $ 2,149,988   $ 713,222
Accrued Expenses and Other Current Liabilities 671,381   450,112
Accrued Officers Compensation 40,050  
Accrued Interest   66,667
Current Portion of Long-Term Operating Lease 78,723   71,510
Convertible Notes Payable, net of discount of $0  
at December 31, 2020   5,000,000
Total Current Liabilities 2,940,142   6,301,511
       
Long-Term Liabilities:    
Loan Payable 410,700    
Long-Term Operating Lease, Net of Current Portion 974,311   1,034,413
Total Long-Term Liabilities 1,385,011   1,034,413
Total Liabilities 4,325,153   7,335,924
       
Commitments and Contingencies  
       
Shareholders’ Equity:    
Cumulative Convertible Series A Preferred Stock;
par value $0.01 per share, 1,000,000 shares authorized; 63,750 shares issued    
and outstanding at September 30, 2020 and December 31, 2019 638   638
Cumulative Convertible Series B Preferred Stock; $1,000 stated value;    
7.5% Cumulative dividend; 4,000 shares authorized; none issued    
and outstanding at September 30, 2020 and December 31, 2019  
Common stock; par value $0.01 per share, 250,000,000 shares authorized;    
16,748,513 and 15,587,552 shares issued and outstanding    
at September 30, 2020 and December 31, 2019, respectively. 167,485   155,875
Additional Paid-In Capital 49,287,039   44,232,274
Accumulated Deficit (36,203,766)   (43,499,244)
Total Shareholders’ Equity 13,251,396   889,543
Total Liabilities and Shareholders’ Equity $ 17,576,549   $ 8,225,467
       
(1) Share amounts have been retroactively restated to reflect the Company’s reverse stock split, which was
effected September 10, 2020. Refer to Note 11—Equity for further information.    
       

TOMI ENVIRONMENTAL SOLUTIONS, INC.
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
(UNAUDITED)
                   
    For The Three Months Ended   For The Nine Months Ended  
    September 30,    September 30,   
    2020   2019   2020   2019  
                   
Sales, net $ 4,291,589   $ 1,600,387   $ 21,373,504   $ 4,491,719  
Cost of Sales 1,455,568   460,008   8,484,580   1,616,680  
Gross Profit 2,836,021   1,140,379   12,888,924   2,875,039  
                   
Operating Expenses:                
Professional Fees 227,560   82,945   418,516   297,349  
Depreciation and Amortization 177,279   182,689   521,486   539,070  
Selling Expenses 212,624   314,110   980,096   1,274,326  
Research and Development 44,862   88,137   245,443   249,373  
Equity Compensation Expense 10,621     307,686   87,033  
Consulting Fees 75,204   31,799   226,454   87,066  
General and Administrative 991,543   628,285   2,776,846   1,931,770  
Total Operating Expenses 1,739,693   1,327,965   5,476,527   4,465,987  
Income (loss) from Operations 1,096,328   (187,586)   7,412,397   (1,590,948)  
                   
Other Income (Expense):                
Amortization of Debt Discounts       (17,534)  
Interest Income 762   773   2,347   2,432  
Interest Expense (790)   (50,000)   (42,266)   (150,000)  
Total Other Income (Expense) (28)   (49,227)   (39,919)   (165,102)  
                   
Income (loss) before income taxes 1,096,300   (236,813)   7,372,478   (1,756,050)  
Provision for Income Taxes 77,000     77,000    
Net Income (loss) $ 1,019,300   ($236,813)   $ 7,295,478   ($1,756,050)  
                   
Net income (loss) Per Common Share                
Basic $ 0.06   ($0.02)   $ 0.44   ($0.11)  
Diluted $ 0.05   ($0.02)   $ 0.40   ($0.11)  
                   
Basic Weighted Average Common Shares Outstanding 16,741,622   15,588,680   16,429,360   15,585,822  
Diluted Weighted Average Common Shares Outstanding 18,593,255   15,588,680   18,280,993   15,585,822  
                   
(1) Share and per share amounts have been retroactively restated to reflect the Company’s reverse stock split, which was effected
September 10, 2020. Refer to Note 11—Equity for further information.              

 

 
Reconciliation of Net Income to EBITDA
           
                   
      For The Three Months Ended   For The Nine Months Ended
      September 30,   September 30,
        2020       2019       2020       2019  
      (Unaudited)   (Unaudited)   (Unaudited)   (Unaudited)
Net income (loss)   $ 1,019,300     $ (236,813)     $ 7,295,478     $ (1,756,050)  
                   
  Interest Income   (762)       (773)       (2,347)       (2,432)  
  Interest Expense   790       50,000       42,266       150,000  
  Depreciation and Amortization   177,279       182,689       521,486       539,070  
  Provision for Income Taxes (Note 17)   77,000           77,000      
  Other                       17,534  
  EBITDA (Adjusted Loss)   $ 1,273,607     $ (4,897)     $ 7,933,883     $ (1,051,878)  
                   
  EBITDA Margin     30 %     0 %     37 %     -23 %


INVESTOR RELATIONS CONTACT

Harold Paul
[email protected]

Nkarta Reports Third Quarter 2020 Financial Results

  • First pa
    tient
    dos
    ed in clinical trial of
    NKX101
    , investigational NK cell therapy engineered with NKG2D-targeted CAR
    ,
    in
    acute myeloid leukemia and
    myelodysplastic syndromes
  • IND
    application
    for NKX019 expected to be filed in 1Q 2021
  • Ended third quarter 2020 with
    $
    3
    30.
    2
    million of
    cash and cash equivalents,
    believed to be sufficient to fund operations
    into at least the second half of
    2023

SOUTH SAN FRANCISCO, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) — Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today reported financial results for the third quarter ended September 30, 2020, and highlighted recent corporate accomplishments.

“We’re excited by the continued progress made at Nkarta this quarter and the ability of our teams to advance Nkarta’s allogeneic, off-the-shelf cell therapy programs,” said Paul J. Hastings, President and Chief Executive Officer of Nkarta. “We have dosed the first patient in our first clinical trial of NKX101, continue to prepare our in-house clinical GMP capabilities for the production of NKX019, and remain on track to file Nkarta’s second IND in the first quarter of 2021 for NKX019. With patients always foremost in mind, we remain focused on advancing Nkarta’s NK cell platform as the next foundation in anti-cancer cell therapy.”

Recent Developments

  • First patient dosed in the Phase 1 clinical trial of NKX101, a first-in-class investigational NK cell cancer immunotherapy engineered to express a chimeric antigen receptor (CAR) targeting NKG2D ligand, for the treatment of relapsed/refractory acute myeloid leukemia (AML) and higher risk myelodysplastic syndromes (MDS).
  • Nadir Mahmood, Ph.D. appointed to the expanded role of Chief Financial and Business Officer, having previously served as Nkarta’s Chief Business Officer. He succeeded Matthew Plunkett, Ph.D., who stepped down as Chief Financial Officer in October 2020.
  • Alicia J. Hager, J.D., Ph.D. joined Nkarta as its Chief Legal Officer.

Anticipated
Near-term Clinical
Milestone
s

  • In 1Q 2021, Nkarta expects to file an Investigational New Drug (IND) Application for NKX019, an investigational NK cell therapy engineered to target tumors expressing CD19 antigen for the treatment of B-cell malignancies.

Third
Quarter 2020
Financial Highlights

  • Cash and
    C
    ash E
    quivalents
    : As of September 30, 2020, Nkarta had cash, cash equivalents, restricted cash and short-term investments of $330.2 million, which includes proceeds from the Company’s July 2020 IPO of $265.1 million, net of underwriting discounts and commissions and other offering costs.

  • R
    &D Expenses: Research & development expenses were $9.8 million for the third quarter of 2020, which includes $0.7 million of non-cash stock-based compensation expense.

  • G&A Expenses: General and administrative expenses were $3.9 million for the third quarter of 2020, which includes $0.9 million of non-cash stock-based compensation expense.

  • Net Loss. Net loss was $13.7 million, or $0.44 per basic and diluted share, for the quarter ended September 30, 2020.

Financial Guidance

  • Nkarta expects its current cash and cash equivalents will be sufficient to fund its current operating plan into at least the second half of 2023. The company expects cash and cash equivalents at December 31, 2020 to be in the range of $300 million to $310 million.

About NKX101

NKX101 is an investigational, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy donors and engineered with membrane-bound IL15 and a chimeric antigen receptor (CAR) targeting NKG2D ligands on tumor cells. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely expressed on cancer cells. By engineering NKX101 with the proprietary NKG2D-based CAR, the ability of NK cells to recognize and kill tumor cells in pre-clinical models is increased significantly compared to non-engineered NK cells. The addition of membrane-bound IL15, a proprietary version of a cytokine for activating NK cell growth, has been shown in pre-clinical models to enhance the proliferation, persistence and sustained activity of NK cells. A multi-center Phase 1 clinical trial of NKX101 in patients with relapsed/refractory acute myeloid leukemia (AML) or higher risk myelodysplastic syndromes (MDS) is currently enrolling. Additional information about the clinical trial is available on ClinicalTrials.gov, identifier NCT04623944.

About NKX019

NKX019 is an investigational, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy donors and engineered with a chimeric antigen receptor (CAR) targeting the CD19 antigen and membrane-bound IL15. CD19 antigen is a B-cell marker and validated target for B cell cancer therapies. NKX019 uses the CAR to target and bind to CD19, leading to an immune response that eliminates CD19-expressing cells in preclinical studies. The addition of membrane-bound IL15, a proprietary version of a cytokine for activating NK cell growth, has been shown in preclinical models to enhance the proliferation, persistence and activity of NK cells. Nkarta plans to file an IND application with the FDA in the first quarter of 2021. A Phase 1 clinical trial of NKX019 in patients with advanced relapsed/refractory B cell malignancies is planned to initiate in 2021.

About
Nkarta’s
NK
C
ell T
echnologies

Nkarta has pioneered a novel discovery and development platform for the engineering and efficient production of allogeneic, off-the-shelf natural killer (NK) cell therapy candidates. The approach harnesses the innate ability of NK cells to recognize and kill tumor cells, and builds upon the important advances in cellular immunotherapy and chimeric antigen receptor (CAR) biology. To enhance the intrinsic activity of NK cells, Nkarta genetically engineers the cells with a CAR that consists of a targeting receptor designed to recognize and bind to specific proteins on the surface of cancerous cells. This receptor is fused to co-stimulatory and signaling domains to amplify cell signaling and NK cell cytotoxicity. Upon binding the target, NK cells become activated and release cytokines that enhance the immune response and cytotoxic granules that lead to killing of the target cell. All of Nkarta’s NK cell therapy candidates are engineered with a membrane-bound IL15, a proprietary version of a cytokine known for activating NK cell growth, to enhance the persistence and activity of the NK cells.

Nkarta’s manufacturing process generates an abundant supply of NK cells that, at commercial scale, is expected to be significantly lower in cost than other current allogeneic and autologous cell therapies. Key to this efficiency is the rapid expansion of donor-derived NK cells using a proprietary NKSTIM cell line, leading to the production of hundreds of individual doses from a single manufacturing run. The platform also features the ability to freeze and store CAR NK cells for an extended period of time and is designed to enable immediate, off-the-shelf administration to patients at the point of care.

About Nkarta

Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off the shelf natural killer (NK) cell therapies for cancer. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies, Nkarta is building a pipeline of cell therapy candidates generated by efficient manufacturing processes, which are engineered to enhance tumor targeting and improve persistence for sustained activity in the body. For more information, please visit the company’s website at www.nkartatx.com.

Cautionary Note on Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “anticipates,” “believes,” “expects,” “intends,” “plans,” “potential,” “projects,” “would” and “future” or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Nkarta’s expectations regarding its growth, strategy, progress and timing of its preclinical studies and clinical trials for NKX101 and NKX019, including its regulatory plans and the timing of the NKX019 IND and trial initiation; the mechanism of action and activity of Nkarta’s product candidates; the efficiency and cost of Nkarta’s manufacturing processes; the number of doses generated from a manufacturing run; Nkarta’s progress towards in-house clinical GMP capability; the proprietary nature of Nkarta’s technology; and Nkarta’s expected cash burn for 2020 and cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Nkarta’s limited operating history and historical losses; Nkarta’s ability to raise additional funding to complete the development and any commercialization of its product candidates; Nkarta’s dependence on the success of its co-lead product candidates, NKX101 and NKX019; that Nkarta may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Nkarta’s ability to obtain, maintain and protect its intellectual property; Nkarta’s dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.

These and other risks are described more fully in Nkarta’s filings with the Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of Nkarta’s final prospectus for its initial public offering, filed with the SEC on July 13, 2020, Nkarta’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2020, filed with the SEC on August 20, 2020, Nkarta’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, filed with the SEC on November 12, 2020, and our other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Nkarta undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Nkarta, Inc.

Condensed Statements of Operations

(in thousands, except share and per share data)

(Unaudited)

    Three Months Ended September 30,   Nine Months Ended September 30,  
      2020       2019       2020       2019    
Collaboration revenue   $     $     $     $ 115    
Operating expenses                  
Research and development     9,828       4,620       24,950       10,535    
General and administrative     3,918       1,289       8,560       3,281    
Total operating expenses     13,746       5,909       33,510       13,816    
Loss from operations     (13,746 )     (5,909 )     (33,510 )     (13,701 )  
Other income (expense), net:                  
Change in fair value of preferred stock purchase right liability           3,383       (40,163 )     3,383    
Other income (expense), net     53       (142 )     209       (271 )  
Total other income (expense), net     53       3,241       (39,954 )     3,112    
Net loss   $ (13,693 )   $ (2,668 )   $ (73,464 )   $ (10,589 )  
                   
Net loss per share, basic and diluted   $ (0.44 )   $ (1.75 )   $ (6.39 )   $ (7.45 )  
Weighted average shares used to compute net loss per share, basic and diluted     30,981,441       1,528,510       11,499,327       1,421,882    
                   

Nkarta, Inc.

Condensed Balance Sheets

(in thousands)

(Unaudited)

    September 30, 2020   December 31, 2019  
Assets          
Cash, cash equivalents, restricted cash and short-term investments   $ 330,172   $ 37,259    
Property and equipment, net     9,180     3,080    
Operating lease right-of-use assets     8,763     7,144    
Other assets     4,180     929    
Total assets   $ 352,295   $ 48,412    
Liabilities and stockholders’ equity (deficit)          
Preferred stock purchase right liability   $   $ 1,478    
Operating lease liabilities     9,135     7,296    
Other liabilities     8,179     5,305    
Total liabilities     17,314     14,079    
Convertible preferred stock         59,815    
Stockholders’ equity (deficit)     334,981     (25,482 )  
Total liabilities and stockholders’ equity (deficit)   $ 352,295   $ 48,412    
           

Nkarta Media/Investor Contact:
Greg Mann
Nkarta, Inc.
[email protected]

StoneMor Inc. Reports Third Quarter Financial Results

TREVOSE, Pa., Nov. 12, 2020 (GLOBE NEWSWIRE) — StoneMor Inc. (NYSE: STON) (“StoneMor” or the “Company”), a leading owner and operator of cemeteries and funeral homes, today reported operating and financial results for the third quarter and nine-month period ended September 30, 2020. Investors are encouraged to read the Company’s quarterly report on Form 10-Q when it is filed with the Securities and Exchange Commission (the “SEC”), which will contain additional details, and will be posted at www.stonemor.com.

THIRD
QUARTER
FINANCIAL PERFORMANCE

  • Revenues for the third quarter were $76.9 million compared to $73.2 million in the third quarter in the prior year. Nine-month revenues were $218.8 million compared to $223.1 million in the prior year period. When adjusted to exclude revenues from properties divested since January 1, 2019, revenues for the quarter and nine months ended September 30, 2020 were $76.8 million and $217.3 million, respectively, compared to revenues of $69.2 million and $211.0 million, respectively, for the prior year periods.
  • Cemetery segment operating income for the third quarter was $11.7 million compared to $4.2 million in the third quarter in the prior year, representing an increase of $7.5 million. Nine-month cemetery segment operating profit was $24.3 million compared to $11.8 million in the prior year period, representing an increase of $12.6 million.
  • Funeral home segment operating income for the third quarter was $1.5 million compared to $1.1 million in the third quarter in the prior year, representing an increase of $0.4 million. Nine-month funeral home segment operating profit was $4.9 million compared to $4.4 million in the prior year period, representing an increase of $0.5 million.
  • Corporate overhead expense decreased to $9.8 million in the third quarter compared to $11.6 million in the third quarter in the prior year.
  • Third quarter net loss was $7.9 million compared to $42.7 million in the third quarter in the prior year. Third quarter net loss in the prior year included a loss on impairment of goodwill of $24.9 million.
  • Third quarter operating income was $3.2 million, compared to an operating loss of $6.6 million in the third quarter in the prior year which included other losses of $0.1 million.

Joe Redling, StoneMor’s President and Chief Executive Officer said, “The third quarter continued the trend of growth established in the first half of 2020, particularly as it relates to our cemetery sales production1 and expense management initiatives. We delivered record levels of cemetery sales production during the third quarter of 2020, including a 27% year-over-year increase. The upward trajectory was largely driven by 32% growth in same-store pre-need sales production and included increases in both contract volume and average pricing. This sales production growth was generated while reducing our expenses across the board and driving increased Field EBITDA2 levels.”

LIQUIDITY UPDATE

As of September 30, 2020, the Company had $64.6 million of cash, including $20.6 million of restricted cash, and $328.3 million of total debt.

“StoneMor produced a third quarter that generated adjusted EBITDA of $5.5 million and operating cash flow of $2.6 million, which includes a $6.6 million cash interest payment,” said Jeff DiGiovanni, StoneMor’s Senior Vice President and Chief Financial Officer. “In addition, through the management of its Trust assets, between investment return and cash collections, net of distributions, StoneMor has increased the value of its Trust assets by $15.4 million, resulting in a further deleveraging of our balance sheet. As we look forward, we continue to focus on generating operating cash flow through effective management of our operations and related treasury functions and our corporate cost reduction initiatives.”

CONFERENCE CALL INFORMATION

StoneMor will conduct a conference call to discuss this news release today, November 12, 2020 at 4:30 p.m. Eastern Time. The conference call can be accessed by calling (800) 954-0623. No reservation number is necessary; however, due to the on-going pandemic, it is advised that interested parties access the call-in number 5 to 10 minutes prior to the scheduled start time to avoid delays. StoneMor will also host a live webcast of this conference call. Investors may access the live webcast via the Investors page of the StoneMor website www.stonemor.com under Events & Presentations.


About StoneMor Inc.

StoneMor Inc., headquartered in Trevose, Pennsylvania, is an owner and operator of cemeteries and funeral homes in the United States, with 318 cemeteries and 86 funeral homes in 27 states and Puerto Rico. StoneMor’s cemetery products and services, which are sold on both a pre-need (before death) and at-need (at death) basis, include: burial lots, lawn and mausoleum crypts, burial vaults, caskets, memorials, and all services which provide for the installation of this merchandise. For additional information about StoneMor Inc. please visit StoneMor’s website, and the investors section, at http://www.stonemor.com.

CONTACT

Investor Relations
StoneMor Inc.
(215) 826-4438


Cautionary Note Regarding Forward-Looking Statements

Certain statements contained in this press release, including, but not limited to, information regarding continued implementation of the Company’s performance and cost structure improvement efforts and the anticipated financial impact thereof, are forward-looking statements. Generally, the words “believe,” “
may
,” “will,” “estimate,” “continue,” “anticipate
,” “intend,” “project,” “expect,” “predict” and similar expressions identify these forward-looking statements. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Forward-looking statements are based on management’s current expectations and estimates. These statements are neither promises nor guarantees and are made subject to certain risks and uncertainties that could cause actual results to differ materially from the results stated or implied in this press release.
StoneMor’s
major risks are related to uncertainties associated with
current business and economic disruptions resulting from the recent coronavirus pandemic, including the effect of government regulations issued in connection therewith, its ability to identify, and negotiate acceptable agreements with, purchasers of additional properties, uncertainties associated with the cash flow from pre-need and at-need sales, trusts and financings, which may impact
StoneMor’s
ability to meet its financial projections and service its debt, as well as with
StoneMor’s
ability to maintain an effective system of internal control over financial reporting and disclosure controls and procedures.

When considering forward-looking statements, you should keep in mind the risk factors and other cautionary statements set forth in
StoneMor’s
Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the other reports that StoneMor files with the Securities and Exchange Commission, from time to time. Except as required under applicable law, StoneMor assumes no obligation to update or revise any forward-looking statements made herein or any other forward-looking statements made by it, whether as a result of new information, future events or otherwise.

Non-GAAP Financial Measures

This release includes certain non-GAAP financial measures, including comparable location revenues, adjusted operating income and adjusted comparable location operating income, EBITDA, adjusted EBITDA and field EBITDA, and unlevered cash provided by operating activities, which are intended as supplemental measures of the Company’s performance that are not required by or presented in accordance with GAAP. All business results presented in this release are not prepared in accordance with Article 11 of Regulation S-X.

Management uses these non-GAAP measures internally to evaluate and manage the Company’s operations and to better understand its business because they facilitate a comparative assessment of the Company’s operating performance relative to its performance based on results calculated under GAAP. These non-GAAP measures also isolate the effects of some items that vary from period to period without any correlation to core operating performance and eliminate certain charges that management believes do not reflect the Company’s operations and underlying operational performance. The compensation committee of the Company’s board of directors also uses certain of these measures to evaluate management’s performance and set its compensation. The Company believes that these non-GAAP measures also provide useful information to investors regarding certain financial and business trends relating to the Company’s financial condition and operating results facilitates an evaluation of the financial performance of the Company and its operations on a consistent basis. Providing this information therefore allows investors to make independent assessments of the Company’s financial performance, results of operation and trends while viewing the information through the eyes of management.

These non-GAAP measures are subject to limitations. The non-GAAP measures presented in this release may not be comparable to similarly titled measures used by other companies because other companies may not calculate one or more in the same manner. Additionally, the non-GAAP performance measures exclude significant expenses and income that are required by GAAP to be recorded in the Company’s financial statements; do not reflect changes in, or cash requirements for, working capital needs; and do not reflect interest expense, or the requirements necessary to service interest or principal payments on debt. Further, our historical adjusted results are not intended to project our adjusted results of operations or financial position for any future period. To compensate for these limitations, management presents and considers these non-GAAP measures in conjunction with the Company’s GAAP results; no non-GAAP measure should be considered in isolation from or as alternatives to net income, earnings per share or any other measure determined in accordance with GAAP. Readers should review the reconciliations included below, and should not rely on any single financial measure to evaluate the Company’s business.

A reconciliation of each non-GAAP measure to the most directly comparable GAAP measure is set forth below (in thousands):

COMPARABLE LOCATION
REVENUES

    Three Months Ended September
 
30,
    Nine Months Ended September
 
30,
 
    2020     2019     2020     2019  
Total revenues   $ 76,856     $ 73,151     $ 218,808     $ 223,115  
Less: Revenue associated with divested properties     77       3,922       1,538       12,116  
Comparable location revenues   $ 76,779     $ 69,229     $ 217,270     $ 210,999  

ADJUSTED OPERATING
INCOME (
LOSS
)
AND ADJUSTED COMPARABLE LOCATION OPERATING INCOME (LOSS)

    Three Months Ended September
 
30,
    Nine Months Ended September
 
30,
 
    2020     2019     2020     2019  
Operating income (loss)   $ 3,211     $ (6,570 )   $ 30,475     $ (26,121 )
Less: Gain on sale of businesses                 31,120        
Less: Other losses, net           (129 )     (2,169 )     (3,558 )
Adjusted operating income (loss)     3,211       (6,441 )     1,524       (22,563 )
Less: Operating income (loss) associated with
divested properties
    60       1,331       (255 )     3,418  
Adjusted comparable location operating
income (loss)
  $ 3,151     $ (7,772 )   $ 1,779     $ (25,981 )

EBITDA
,
ADJUSTED EBITDA
AND FIELD EBITDA

    Three Months Ended September
 
30,
    Nine Months Ended September
 
30,
 
    2020     2019     2020     2019  
Net loss   $ (7,857 )   $ (42,652 )   $ (2,768 )   $ (99,584 )
Income tax benefit (expense)     (1,129 )     (1,545 )     (3,333 )     4,841  
Interest expense     12,197       12,765       36,576       35,282  
Depreciation and amortization     2,285       2,647       7,078       8,120  
EBITDA     5,496       (28,785 )     37,553       (51,341 )
Less: Gain on sale of businesses                 31,120        
Less: Other losses, net           (129 )     (2,169 )     (3,558 )
Less: Loss on debt extinguishment                       (8,478 )
Less: Loss on impairment of goodwill           (24,862 )           (24,862 )
Adjusted EBITDA     5,496       (3,794 )     8,602       (14,443 )
Less: Investment and other income     9,905       10,063       30,830       29,474  
Plus: Corporate overhead     9,762       11,595       27,019       38,145  
Field EBITDA   $ 5,353     $ (2,262 )   $ 4,791     $ (5,772 )

UNLEVERED CASH PROVIDED BY (USED IN) OPERATING ACTIVITIES

    Three Months Ended September
 
30,
    Nine Months Ended September
 
30,
 
    2020     2019     2020     2019  
Net cash provided by (used in) operating activities   $ 2,584     $ 4,817     $ 3,785     $ (26,755 )
Cash interest payments     6,686       7,463       20,361       24,444  
Unlevered cash provided by (used in) operating activities   $ 9,270     $ 12,280     $ 24,146     $ (2,311 )

STONEMOR
INC
.

CONDENSED CONSOLIDATED B
ALANCE SHEETS (UNAUDITED)

(
in
thousands, except share and per share data)

    September
 
30,
    December 31,  
    2020     2019  
Assets                
Current assets:                
Cash and cash equivalents, excluding restricted cash   $ 44,003     $ 34,867  
Restricted cash     20,601       21,900  
Accounts receivable, net of allowance     57,995       55,794  
Prepaid expenses     4,808       4,778  
Assets held for sale     32,109       23,858  
Other current assets     14,756       17,142  
Total current assets     174,272       158,339  
                 
Long-term accounts receivable, net of allowance     75,104       75,549  
Cemetery property     302,918       320,605  
Property and equipment, net of accumulated depreciation     90,234       103,400  
Merchandise trusts, restricted, at fair value     484,520       517,192  
Perpetual care trusts, restricted, at fair value     300,738       343,619  
Deferred selling and obtaining costs     117,367       114,944  
Deferred tax assets     20       81  
Intangible assets     55,377       56,246  
Other assets     25,862       29,393  
Total assets   $ 1,626,412     $ 1,719,368  
                 
Liabilities and Owners’ Equity                
Current liabilities:                
Accounts payable and accrued liabilities   $ 52,524     $ 55,134  
Liabilities held for sale     24,815       20,668  
Accrued interest     113       125  
Current portion, long-term debt     1,143       374  
Total current liabilities     78,595       76,301  
                 
Long-term debt, net of deferred financing costs     327,173       367,963  
Deferred revenues     929,120       949,375  
Deferred tax liabilities     31,062       34,613  
Perpetual care trust corpus     300,738       343,619  
Other long-term liabilities     46,938       49,987  
Total liabilities     1,713,626       1,821,858  
Commitments and contingencies                
                 
Owners’ equity:                
Common stock, par value $0.01 per share, 200,000,000 shares authorized, 117,824,266
and 94,447,356 shares issued and outstanding, respectively
    1,178       944  
Paid-in capital in excess of par value     (85,624 )     (103,434 )
Retained deficit     (2,768 )      
Total owners’ equity     (87,214 )     (102,490 )
Total liabilities and owners’ equity   $ 1,626,412     $ 1,719,368  

STONEMOR INC.

CONDENSED CONSOLIDATED STATEM
ENTS OF OPERATIONS (UNAUDITED)

(
in
thousands, except per share and per unit data)

    Three Months Ended September
 
30,
    Nine Months Ended September
 
30,
 
    2020     2019     2020     2019  
Revenues:                                
Cemetery:                                
Interments   $ 21,409     $ 15,605     $ 54,755     $ 52,544  
Merchandise     16,328       18,014       46,567       51,870  
Services     16,435       17,068       48,923       50,400  
Investment and other     9,905       10,063       30,830       29,474  
Funeral home:                                
Merchandise     6,590       5,572       18,767       17,920  
Services     6,189       6,829       18,966       20,907  
Total revenues     76,856       73,151       218,808       223,115  
Costs and Expenses:                                
Cost of goods sold     9,977       10,677       29,464       31,263  
Cemetery expense     16,703       18,362       52,458       57,245  
Selling expense     13,658       14,609       39,316       44,839  
General and administrative expense     10,491       11,033       30,602       33,430  
Corporate overhead     9,762       11,595       27,019       38,145  
Depreciation and amortization     2,285       2,647       7,078       8,120  
Funeral home expenses:                                
Merchandise     1,755       1,896       5,069       5,227  
Services     5,653       5,351       16,347       16,363  
Other     3,361       3,422       9,931       11,046  
Total costs and expenses     73,645       79,592       217,284       245,678  
                                 
Gain on sale of businesses                 31,120        
Other losses           (129 )     (2,169 )     (3,558 )
Operating income (loss)     3,211       (6,570 )     30,475       (26,121 )
Interest expense     (12,197 )     (12,765 )     (36,576 )     (35,282 )
Loss on debt extinguishment                       (8,478 )
Loss on impairment of goodwill           (24,862 )           (24,862 )
Loss from operations before income taxes     (8,986 )     (44,197 )     (6,101 )     (94,743 )
Income tax benefit (expense)     1,129       1,545       3,333       (4,841 )
Net loss   $ (7,857 )   $ (42,652 )   $ (2,768 )   $ (99,584 )
Net loss per common share (basic)(1)   $ (0.07 )   $ (1.10 )   $ (0.03 )   $ (2.59 )
Net loss per common share (diluted)(1)   $ (0.07 )   $ (1.10 )   $ (0.03 )   $ (2.59 )
Weighted average number of common shares
outstanding – basic(2)
    117,819       38,916       103,341       38,438  
Weighted average number of common shares
outstanding – diluted(2)
    117,819       38,916       103,341       38,438  

      (1)   For the three and nine months ended September 30, 2020, represents net loss divided by weighted average number of common shares outstanding and for the three and nine months ended September 30, 2019, represents net loss divided by weighted average number of common limited partner units outstanding.
      (2)   For the three and nine months ended September 30, 2020, represents weighted average number of common shares outstanding and for the three and nine months ended September 30, 2019, represents weighted average number of common limited partner units outstanding.

STONEMOR
INC.

CONDENSED CONSOLIDATED STATEM
ENTS OF CASH FLOWS (UNAUDITED)

(
in
thousands)

    Nine Months Ended September
 
30,
    2020     2019    
Cash Flows From Operating Activities:                  
Net loss   $ (2,768 )   $ (99,584 )  
Adjustments to reconcile net loss to net cash provided by (used in) operating
activities:
                 
Cost of lots sold     4,346       5,339    
Depreciation and amortization     7,078       8,120    
Provision for bad debt     4,529       5,380    
Non-cash compensation expense     1,080       2,814    
Loss on debt extinguishment           8,478    
Loss on impairment of goodwill           24,862    
Non-cash interest expense     16,159       12,435    
Gain on sale of businesses     (31,120 )        
Other losses, net     2,169       3,558    
Changes in assets and liabilities:                  
Accounts receivable, net of allowance     (16,180 )     (14,305 )  
Merchandise trust fund     (12,284 )     (11,137 )  
Other assets     3,799       (1,339 )  
Deferred selling and obtaining costs     (4,974 )     (1,850 )  
Deferred revenues     39,238       23,860    
Deferred taxes, net     (3,490 )     4,620    
Payables and other liabilities     (3,797 )     1,994    
Net cash provided by (used in) operating activities     3,785       (26,755 )  
Cash Flows From Investing Activities:                  
Cash paid for capital expenditures     (4,784 )     (5,743 )  
Proceeds from divestitures     48,336       1,250    
Net cash provided by (used in) investing activities     43,552       (4,493 )  
Cash Flows From Financing Activities:                  
Proceeds from issuance of Series A Preferred Stock     8,800          
Proceeds from issuance of Common Stock     8,200          
Proceeds from issuance of redeemable convertible preferred units, net           57,500    
Proceeds from borrowings     3,672       406,087    
Repayments of debt     (54,782 )     (366,644 )  
Principal payment on finance leases     (1,061 )     (1,098 )  
Cost of financing activities     (4,294 )     (17,972 )  
Shares repurchased related to share-based compensation     (35 )     (677 )  
Net cash (used in) provided by financing activities     (39,500 )     77,196    
Net increase in cash, cash equivalents and restricted cash     7,837       45,948    
Cash, cash equivalents and restricted cash

Beginning of period
    56,767       18,147    
Cash, cash equivalents and restricted cash

End of period
  $ 64,604     $ 64,095    
Supplemental disclosure of cash flow information:                  
Cash paid during the period for interest   $ 20,361     $ 24,444    
Cash paid during the period for income taxes     1,077       1,470    
Cash paid for amounts included in the measurement of lease liabilities:                  
Operating cash flows from operating leases   $ 2,372     $ 2,759    
Operating cash flows from finance leases     328       370    
Financing cash flows from finance leases     1,061       1,098    
Non-cash investing and financing activities:                  
Acquisition of assets by financing   $     $ 2,234    
Net transfers within assets held for sale     81,108          
Accrued paid-in-kind interest on Senior Secured Notes     10,572          


1 Cemetery sales production represents dollar volume associated with new contracts executed during the period.
2 Field EBITDA represents Adjusted Operating Income less Investment and Other Income plus Corporate Overhead and Depreciation and Amortization.

Navidea Biopharmaceuticals Reports Third Quarter and Year-to-Date 2020 Financial Results

Navidea Biopharmaceuticals Reports Third Quarter and Year-to-Date 2020 Financial Results

Conference Call to be held Thursday, November 12, 2020 at 5:00 pm EST

DUBLIN, Ohio–(BUSINESS WIRE)–
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced its financial results for the third quarter and year-to-date for the period ended September 30, 2020.

“Navidea continues to build on its clinical momentum and this quarter fully shows our ability to execute during a very trying time globally,” said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. “The due diligence continues with Jubilant and the Phase 2b is nearing its conclusion. We are very excited to move forward and present to the FDA in the near future.”

Third Quarter 2020 Highlights and Subsequent Events

  • Executed a binding memorandum of understanding (“MOU”) on August 9, 2020 with Jubilant Draximage Inc. dba Jubilant Radiopharma, Radiopharmaceuticals Division (“Jubilant”). The MOU outlines the terms and framework for an Exclusive License and Distribution Agreement for Navidea’s Rheumatoid Arthritis Diagnostic in the United States, Canada, Mexico, and Latin America. In connection with the MOU, Jubilant made a $1 million equity investment in exchange for a limited exclusivity period while final due diligence efforts are completed.
  • Entered into a Stock Purchase Agreement with investors, pursuant to which the investors agreed to purchase up to $25.0 million in shares of the Company’s Common Stock.
  • Entered into a Stock Purchase Agreement and Letter of Investment Intent with an existing investor, pursuant to which the Company agreed to issue to the investor 150,000 shares of newly-designated Series D Redeemable Convertible Preferred Stock (the “Series D Preferred Stock”) for an aggregate purchase price of $15.0 million. Pursuant to the Series D Preferred Stock Purchase Agreement, Keystone will purchase Series D Preferred Stock in amounts to be determined by Keystone in one or more closings during the nine-month period following the date on which the prospectus supplement to register the underlying Common Stock was filed with the SEC, provided that all of the Series D Preferred Stock must be purchased by such date. The Series D Preferred Stock will be convertible into a maximum of 5,147,000 shares of Common Stock.
  • Announced acceptance by the American College of Rheumatology (“ACR”) of the results from the Company’s second interim analysis of its ongoing NAV3-31 Phase 2b clinical study for presentation at the ACR Annual Meeting (“ACR Convergence 2020”) under the title, “Tc99m Tilmanocept Imaging Is an Early Predictor of Clinical Response in Rheumatoid Arthritis Patients Beginning New Anti-TNFα Therapy.”
  • Continued longitudinal imaging and clinical assessments of Arm 3 subjects, who are beginning new anti-TNFα therapy, in the NAV3-31 trial.
  • Continued enrollment in the Investigator Initiated Phase 2 trial being run at the Massachusetts General Hospital evaluating Tc99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals.
  • Converted a provisional patent on blocking off-target organ uptake of Tilmanocept to improve on-target localization.
  • Received a one-year extension on its NIH phase 1 Small Business Technology Transfer grant (1R41HL147640-01A1) entitled Gallium 68 Tilmanocept for PET Imaging of Atherosclerosis Plaques, due to COVID-19 related shutdown of the research facility at the University of Alabama Birmingham. The site has reopened and these preclinical studies are ongoing.
  • Won dismissal of Platinum-Montaur Life Sciences LLC’s lawsuit against the Company.

Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, “The clinical research team is working diligently to advance the technology in key disease areas, with an emphasis on our RA program. The currently running Phase 2b trial in RA is proceeding well, with Arm 3 subjects having their later imaging and clinical assessments. Preparation of the package to discuss with the FDA in planning for the upcoming Phase 3 is nearing completion. We are also preparing for the start of our second Phase 2b trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients.”

Financial Results

  • Total revenues for the third quarter 2020 were $268,000, compared to $237,000 for the same period in 2019. Total revenues for the first nine months of 2020 were $696,000, compared to $539,000 for the same period in 2019. The increases were primarily due to increased grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept™ development.
  • Research and development (“R&D”) expenses for the third quarter of 2020 were $1.4 million, compared to $1.8 million in the same period in 2019. The third quarter decrease was primarily due to net decreases in drug project expenses, including decreased Manocept diagnostic and Tc99m tilmanocept development costs, coupled with decreased employee compensation. R&D expenses for the first nine months of 2020 were $3.7 million, compared to $3.6 million in the same period in 2019. The year-to-date increase was primarily due to net increases in drug project expenses, including increased Manocept diagnostic development costs offset by decreased Manocept therapeutic and Tc99m tilmanocept development costs, coupled with increased employee compensation.
  • Selling, general and administrative (“SG&A”) expenses for the third quarter of 2020 were $1.8 million, compared to $1.5 million in the same period in 2019. The third quarter increase was primarily due to increased legal and professional services and employee compensation, offset by decreased travel, insurance, and depreciation costs. SG&A expenses for the first nine months of 2020 were $4.9 million, compared to $5.1 million in the same period in 2019. The year-to-date decrease was primarily due to decreased travel, legal and professional services, insurance, depreciation, and investor relations costs, offset by increased employee compensation and franchise taxes.
  • Navidea’s net loss attributable to common stockholders for the third quarter of 2020 was $3.3 million, or $0.13 per share, compared to $3.1 million, or $0.17 per share, for the same period in 2019. Navidea’s net loss attributable to common stockholders for the first nine months of 2020 was $8.4 million, or $0.37 per share, compared to $8.2 million, or $0.62 per share, for the same period in 2019.
  • Navidea ended the third quarter of 2020 with $3.7 million in cash and cash equivalents. Since September 30, 2020, the Company has received $700,000 of cash related to the August 2020 funding transactions.

Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Participants who would like to ask questions during the question and answer session will be prompted by the moderator, who will provide instructions.

 

Event:

Q3 2020 Earnings and Business Update Conference Call

Date:

Thursday, November 12, 2020

Time:

5:00 p.m. (EST)

U.S. & Canada Dial-in:

800-754-1336

International Dial-in:

 

+1 415-226-5358

Conference ID:

21971993

Webcast Link:

 

https://webcasts.eqs.com/navidbioph20201112/en

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

About Navidea

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit www.navidea.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.

Investors are urged to consider statements that include the words “will,” “may,” “could,” “should,” “plan,” “continue,” “designed,” “goal,” “forecast,” “future,” “believe,” “intend,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.

You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.

 
NAVIDEA BIOPHARMACEUTICALS, INC.
 
CONDENSED CONSOLIDATED BALANCE SHEETS
September 30, December 31,

2020

2019

(unaudited)
Assets:
Cash and cash equivalents

$

3,722,852

$

1,047,159

 

Other current assets

 

1,070,099

 

1,868,624

 

Non-current assets

 

1,202,884

 

1,235,123

 

Total assets

$

5,995,835

$

4,150,906

 

 
Liabilities and stockholders’ equity (deficit):
Current liabilities

$

4,014,418

$

3,819,551

 

Deferred revenue, non-current

 

700,000

 

700,000

 

Other liabilities

 

380,236

 

512,344

 

Total liabilities

 

5,094,654

 

5,031,895

 

Navidea stockholders’ equity (deficit)

 

169,877

 

(1,612,292

)

Noncontrolling interest

 

731,304

 

731,303

 

Total stockholders’ equity (deficit)

 

901,181

 

(880,989

)

Total liabilities and stockholders’ equity (deficit)

$

5,995,835

$

4,150,906

 

 
 
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
 
Three Months Ended Nine Months Ended
September 30, September 30, September 30, September 30,

2020

2019

2020

2019

(unaudited) (unaudited) (unaudited) (unaudited)
Revenue:
Royalty revenue

$

2,047

 

$

4,895

 

$

26,188

 

$

13,985

 

License revenue

 

4,726

 

 

 

 

4,726

 

 

9,953

 

Grant and other revenue

 

261,616

 

 

231,916

 

 

664,848

 

 

514,589

 

Total revenue

 

268,389

 

 

236,811

 

 

695,762

 

 

538,527

 

Cost of revenue

 

82

 

 

195

 

 

1,048

 

 

6,559

 

Gross profit

 

268,307

 

 

236,616

 

 

694,714

 

 

531,968

 

Operating expenses:
Research and development

 

1,377,998

 

 

1,801,558

 

 

3,659,046

 

 

3,612,783

 

Selling, general and administrative

 

1,788,934

 

 

1,519,496

 

 

4,946,279

 

 

5,109,612

 

Total operating expenses

 

3,166,932

 

 

3,321,054

 

 

8,605,325

 

 

8,722,395

 

Loss from operations

 

(2,898,625

)

 

(3,084,438

)

 

(7,910,611

)

 

(8,190,427

)

Other income (expense):
Interest income (expense), net

 

(149

)

 

11,858

 

 

12,822

 

 

23,336

 

Other, net

 

(564

)

 

(1,524

)

 

(777

)

 

(5,880

)

Loss before income taxes

 

(2,899,338

)

 

(3,074,104

)

 

(7,898,566

)

 

(8,172,971

)

Provision for income taxes

 

 

 

 

 

 

 

(707

)

Loss from continuing operations

 

(2,899,338

)

 

(3,074,104

)

 

(7,898,566

)

 

(8,173,678

)

Loss from discontinued operations, net of tax effect

 

 

 

 

 

 

 

(2,665

)

Net loss

 

(2,899,338

)

 

(3,074,104

)

 

(7,898,566

)

 

(8,176,343

)

Loss (income) attributable to noncontrolling interest

 

 

 

2

 

 

(1

)

 

16

 

Deemed dividend on Series C and Series D
preferred stock beneficial conversion feature

 

(405,555

)

 

 

 

(483,333

)

 

 

Net loss attributable to common stockholders

$

(3,304,893

)

$

(3,074,102

)

$

(8,381,900

)

$

(8,176,327

)

Loss per common share (basic and diluted):
Continuing operations

$

(0.13

)

$

(0.17

)

$

(0.37

)

$

(0.62

)

Attributable to common stockholders

$

(0.13

)

$

(0.17

)

$

(0.37

)

$

(0.62

)

Weighted average shares outstanding (basic)

 

25,843,732

 

 

18,044,406

 

 

22,946,201

 

 

13,082,393

 

 

 

Navidea Biopharmaceuticals, Inc.

Jed Latkin, CEO

614-973-7490

[email protected]

Joel Kaufman, CBO

614-822-2372

[email protected]

KEYWORDS: United States North America Ohio

INDUSTRY KEYWORDS: Health Managed Care Clinical Trials Research Science Pharmaceutical Biotechnology

MEDIA:

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Splunk Appoints Four-Star U.S. Army General Dennis Via to its Board of Directors

Splunk Appoints Four-Star U.S. Army General Dennis Via to its Board of Directors

Seasoned Leader Brings 40+ Years of Military and Technology Leadership Expertise to Splunk

SAN FRANCISCO–(BUSINESS WIRE)–Splunk Inc. (NASDAQ: SPLK), provider of the Data-to-Everything Platform, today announced that retired Army General Dennis Via has joined Splunk’s Board of Directors, bringing more than 40 years of military, technology and public sector leadership experience to the role.

Currently, General Via serves as an Executive Vice President with Booz Allen Hamilton, a technology and management consulting firm headquartered in McLean, Virginia. As a senior leader in the Booz Allen Global Defense Group’s Joint Combatant Command business, General Via leads security cooperation with a focus on innovation, transformation and multi-year market growth strategies. He also serves as a Defense Fellow, helping defense, intelligence and homeland security clients manage today’s evolving threat and budgetary environments.

“All three branches of the U.S. government and all four branches of the U.S. military leverage Splunk’s Data-to-Everything Platform to solve their toughest IT, Security and Observability challenges. General Via is a technology luminary within the government, and knows this world inside and out,” said Doug Merritt, President and CEO of Splunk. “I am thrilled to welcome Dennis to Splunk’s Board of Directors and am confident his extensive experience will help accelerate Splunk’s impact on our public sector customers and broader customer base.”

During his 36-year military career, General Via held multiple command and senior leader positions across the Department of Defense (DoD) in the areas of information technology, network operations, cybersecurity and global supply chain. Via culminated his career as the Commanding General of the U.S. Army Materiel Command, the Army’s primary logistics and sustainment command, responsible for managing the global supply chain and synchronizing logistics and sustainment activities across the U.S. Army. He also held multiple commander, signal, and chief information officer roles, working on everything from communications infrastructure and cybersecurity to global logistics and engineering.

“I am honored to join the Splunk Board,” said General Via. “Splunk’s customer-first focus, along with the company’s exceptional reputation for delivering actions and outcomes that positively impact the world through data, is truly admirable. I look forward to the opportunity to support the company’s vision of creating lasting data outcomes for its customers.”

General Via holds a B.S. from Virginia State University and a Master of Education from Boston University. He serves on the boards of directors of Milliken & Company and the nonprofit Capital Partners for Education, and is a member of the Council on Foreign Relations, the Association of the United States Army, and the Armed Forces Communications Electronics Association (AFCEA).

About Splunk Inc.

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Splunk, Splunk>, Data-to-Everything, D2E and Turn Data Into Doing are trademarks and registered trademarks of Splunk Inc. in the United States and other countries. All other brand names, product names, or trademarks belong to their respective owners. © 2020 Splunk Inc. All rights reserved.

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Splunk Inc.

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KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Data Management Defense Security Technology Software Networks Other Defense

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SemiLEDs Reports Fourth Quarter and Fiscal Year End 2020 Financial Results

SemiLEDs Reports Fourth Quarter and Fiscal Year End 2020 Financial Results

HSINCHU, Taiwan–(BUSINESS WIRE)–
SemiLEDs Corporation (NASDAQ: LEDS), “SemiLEDs” or the “Company,” a developer and manufacturer of LED chips and LED components, today announced its financial results for the fourth quarter and full year of fiscal year 2020, ended August 31, 2020.

Revenues for the fourth quarter of fiscal year 2020 were $1.4 million, a 12% decrease compared to $1.6 million in the third quarter of fiscal year 2020. GAAP net loss attributable to SemiLEDs stockholders for the fourth quarter of fiscal year 2020 was $62 thousand, compared to a loss of $513 thousand in the third quarter of fiscal year 2020, or a net loss of $0.02 per diluted share, compared to a net loss of $0.14 per diluted share for the third quarter of fiscal year 2020.

GAAP gross margin for the fourth quarter of fiscal year 2020 was 8%, compared with gross margin for the third quarter of fiscal year 2020 of 27%. Operating margin for the fourth quarter of fiscal year 2020 was negative 28%, compared with negative 47% in the third quarter of fiscal year 2020. The Company’s cash and cash equivalents, excluding restricted cash, was $2.8 million as of August 31, 2020, compared to $2.5 million at the end of the third quarter of fiscal year 2020.

We are unable to forecast revenue for the first quarter ending November 30, 2020 at this time given the uncertain impact of COVID-19 on the global economy and the Company.

Revenues for fiscal year 2020 were $6.1 million, a 3% increase compared to $5.9 million in fiscal year 2019. GAAP net loss attributable to SemiLEDs stockholders for fiscal year 2020 was $544 thousand, compared to a loss of $3.6 million in fiscal year 2019 or a net loss of $0.15 per diluted share, compared to a net loss of $1.00 per diluted share for fiscal year 2019.

GAAP gross margin for the fiscal year 2020 was 26%, compared with gross margin for the fiscal year 2019 of 8%. Operating margin for the fiscal year 2020 was negative 34%, compared with negative 62% in the fiscal year 2019. The Company’s cash and cash equivalents, excluding restricted cash, was $2.8 million as of August 31, 2020, compared to $1.4 million as of August 31, 2019.

About SemiLEDs

SemiLEDs develops and manufactures LED chips and LED components for general lighting applications, including street lights and commercial, industrial, system and residential lighting, along with specialty industrial applications such as ultraviolet (UV) curing, medical/cosmetic, counterfeit detection, horticulture, architectural lighting and entertainment lighting. SemiLEDs sells blue, white, green and UV LED chips.

Forward Looking Statements

This press release contains statements that may constitute “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact could be deemed forward-looking, including, but not limited to, any statements about historical results that may suggest trends for SemiLEDs’ business; and any statements of assumptions underlying any of the foregoing. These forward-looking statements are based on current expectations, estimates, forecasts and projections of future SemiLEDs’ or industry performance based on management’s judgment, beliefs, current trends and market conditions and involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. SemiLEDs’ Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) and other SemiLEDs filings with the SEC (which you may obtain for free at the SEC’s website at http://www.sec.gov) discuss some of the important risks and other factors that may affect SemiLEDs’ business, results of operations and financial condition. SemiLEDs undertakes no intent or obligation to publicly update or revise any of these forward looking statements, whether as a result of new information, future events or otherwise, except as required by law.

SEMILEDS CORPORATION AND SUBSIDIARIES

Unaudited Condensed Consolidated Balance Sheets

(In thousands of U.S. dollars)

 

 

 

August 31,

2020

 

August 31,

2019

ASSETS

 

 

 

 

CURRENT ASSETS:

 

 

 

 

Cash and cash equivalents

 

$

2,832

 

 

$

1,363

 

Restricted cash and cash equivalents

 

 

85

 

 

 

19

 

Accounts receivable (including related parties), net

 

 

1,331

 

 

 

703

 

Inventories

 

 

2,476

 

 

 

2,083

 

Prepaid expenses and other current assets

 

 

781

 

 

 

460

 

Total current assets

 

 

7,505

 

 

 

4,628

 

Property, plant and equipment, net

 

 

5,645

 

 

 

5,878

 

Operating lease right of use assets

 

 

203

 

 

 

 

Intangible assets, net

 

 

89

 

 

 

93

 

Investments in unconsolidated entities

 

 

952

 

 

 

894

 

Other assets

 

 

186

 

 

 

169

 

TOTAL ASSETS

 

$

14,580

 

 

$

11,662

 

LIABILITIES AND EQUITY

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

Current installments of long-term debt

 

$

4,750

 

 

$

398

 

Accounts payable

 

 

536

 

 

 

680

 

Advance receipt toward the convertible note

 

 

500

 

 

 

500

 

Accrued expenses and other current liabilities

 

 

2,654

 

 

 

2,342

 

Other payable to related parties

 

 

460

 

 

 

 

Operating lease liabilities, current portion

 

 

97

 

 

 

 

Total current liabilities

 

 

8,997

 

 

 

3,920

 

Long-term debt, excluding current installments

 

 

2,909

 

 

 

5,954

 

Operating lease liabilities, less current portion

 

 

106

 

 

 

 

Total liabilities

 

 

12,012

 

 

 

9,874

 

Commitments and contingencies

 

 

 

 

EQUITY:

 

 

 

 

SemiLEDs stockholders’ equity

 

 

 

 

Common stock

 

 

 

 

 

 

Additional paid-in capital

 

 

177,235

 

 

 

175,804

 

Accumulated other comprehensive income

 

 

3,647

 

 

 

3,753

 

Accumulated deficit

 

 

(178,360

)

 

 

(177,816

)

Total SemiLEDs stockholders’ equity

 

 

2,522

 

 

 

1,741

 

Noncontrolling interests

 

 

46

 

 

 

47

 

Total equity

 

 

2,568

 

 

 

1,788

 

TOTAL LIABILITIES AND EQUITY

 

$

14,580

 

 

$

11,662

 

SEMILEDS CORPORATION AND SUBSIDIARIES

Unaudited Condensed Consolidated Statements of Operations

(In thousands of U.S. dollars and shares, except per share data)

 

 

 

Three Months Ended

 

Year Ended August 31,

 

 

August 31, 2020

 

May 31, 2020

 

2020

 

2019

Revenues, net

 

$

1,399

 

 

$

1,569

 

 

$

6,068

 

 

$

5,902

 

Cost of revenues

 

 

1,291

 

 

 

1,153

 

 

 

4,478

 

 

 

5,450

 

Gross profit

 

 

108

 

 

 

416

 

 

 

1,590

 

 

 

452

 

Operating expenses:

 

 

 

 

 

 

 

 

Research and development

 

 

426

 

 

 

375

 

 

 

1,538

 

 

 

1,613

 

Selling, general and administrative

 

 

667

 

 

 

782

 

 

 

2,808

 

 

 

2,792

 

Gain on disposals of long-lived assets, net

 

 

(590

)

 

 

 

 

 

(669

)

 

 

(288

)

Total operating expenses

 

 

503

 

 

 

1,157

 

 

 

3,677

 

 

 

4,117

 

Loss from operations

 

 

(395

)

 

 

(741

)

 

 

(2,087

)

 

 

(3,665

)

Other income (expenses):

 

 

 

 

 

 

 

 

Gain on disposals of investment

 

 

 

 

 

 

 

 

634

 

 

 

 

Interest income (expenses), net

 

 

(85

)

 

 

(95

)

 

 

(358

)

 

 

(190

)

Other income (loss), net

 

 

318

 

 

 

270

 

 

 

912

 

 

 

250

 

Foreign currency transaction gain (loss), net

 

 

96

 

 

 

57

 

 

 

352

 

 

 

40

 

Total other expenses, net

 

 

329

 

 

 

232

 

 

 

1,540

 

 

 

100

 

Loss before income taxes

 

 

(66

)

 

 

(509

)

 

 

(547

)

 

 

(3,565

)

Income tax expense

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

(66

)

 

 

(509

)

 

 

(547

)

 

 

(3,565

)

Less: Net loss attributable to noncontrolling interests

 

 

(4

)

 

 

4

 

 

 

(3

)

 

 

 

Net loss attributable to SemiLEDs stockholders

 

$

(62

)

 

$

(513

)

 

$

(544

)

 

$

(3,565

)

Net loss per share attributable to SemiLEDs stockholders:

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.02

)

 

$

(0.14

)

 

$

(0.15

)

 

$

(1.00

)

Shares used in computing net loss per share attributable

to SemiLEDs stockholders:

 

 

 

 

 

 

 

 

Basic and diluted

 

 

4,008

 

 

 

3,738

 

 

 

3,921

 

 

 

3,580

 

Christopher Lee

Chief Financial Officer

SemiLEDs Corporation

+886-37-586788

[email protected]

KEYWORDS: Taiwan Asia Pacific

INDUSTRY KEYWORDS: Retail Technology Home Goods Other Technology Construction & Property Building Systems

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Steven Mickelsen, MD, Joins Acutus Medical as Chief Translational Science Officer

CARLSBAD, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) — Acutus Medical (Nasdaq: AFIB) today announced the appointment of Steven Mickelsen, MD, as Chief Translational Science Officer. Dr. Mickelsen will help guide the company’s vision to deliver the most advanced electrophysiology therapeutic solutions on the market for physicians and their patients. Mickelsen’s impact will further advance the company’s commitment to innovation across its access, diagnostic and therapy product portfolio, including researching, developing and advancing gold-tip catheter technology for Pulsed Field Ablation (PFA) and Radiofrequency (RF) ablation technologies.

“Acutus is committed to creating game-changing solutions and establishing new standards of care for cardiac arrhythmia management,” said Vince Burgess, President and CEO of Acutus Medical. “Dr. Mickelsen’s clinical and technical expertise and unique history pioneering the development of breakthrough therapeutic medical devices is indispensable as we progress from research to commercialization of important technologies such as Pulsed Field Ablation.”

Dr. Mickelsen joins Acutus Medical following an esteemed career practicing as a cardiac electrophysiologist at the University of Iowa Hospitals and Clinics in Iowa City. He focuses on complex ablation procedures and serves on faculty as Assistant Professor of Cardiovascular Medicine and Internal Medicine, and will continue his tenure going forward. In 2012, Dr. Mickelsen founded Farapulse, a company devoted to the discovery of more effective treatments for atrial fibrillation through the utilization of a pulsed electric field system that he invented. He served as the company’s initial President and CEO, and later as its Chief Science Officer, before stepping down in 2016 to focus on clinical research.

“The field of arrhythmia science is evolving at a breakneck speed. Physicians want to provide the best possible care, but we’re often confined by the limitations of technology. Acutus is changing that, and this is an opportunity to play a critical role delivering advanced EP solutions to treat the entire spectrum of cardiac arrhythmias,” said Dr. Mickelsen. “Pulsed field ablation represents an exciting potential future for EP; I’m thrilled to join a team that is dedicated to creating new solutions and enhancing the possibilities for physicians and their patients.”

Dr. Mickelsen is a board-certified electrophysiologist. He received his medical degree from the University of New Mexico School of Medicine, was a Howard Hughes Research Scholar at the National Institutes of Health in Bethesda, MD, and completed his internal medicine residency and clinical research at the Mayo Clinic. He also completed fellowships in Cardiology and Cardiac Electrophysiology at the University of Iowa Hospitals and Clinics.

About Acutus Medical

Acutus Medical is an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated. Acutus is committed to advancing the field of electrophysiology with a unique array of products and technologies which will enable more physicians to treat more patients more efficiently and effectively. Through internal product development, acquisitions and global partnerships, Acutus has established a global sales presence delivering a broad portfolio of highly differentiated electrophysiology products that provide its customers with a complete solution for catheter-based treatment of cardiac arrhythmias in each of its geographic markets. Founded in 2011, Acutus is based in Carlsbad, California.

Acutus PFA Technology is not for sale in the United States

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