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Zoned Properties Reports Third Quarter 2020 Financial Results

Zoned Properties Reports Third Quarter 2020 Financial Results

Large-Scale Development Expansion Proceeds as Arizona Voters Pass Prop 207

SCOTTSDALE, Ariz.–(BUSINESS WIRE)–
Zoned Properties®, Inc. (OTCQB: ZDPY), a strategic real estate development firm whose primary mission is to provide real estate and sustainability services for the regulated cannabis industry, positioning the company for property acquisitions and revenue growth, today announced its financial results for the nine and three-month periods ended September 30, 2020.

Nine Months and Third Quarter 2020 Company Highlights

  • Zoned Properties successfully leveraged its Arizona property portfolio to receive a commitment of at least $8 Million from our Significant Tenant, to be applied toward infrastructure expansion.
  • To date, nearly $5 Million of the $8 Million committed has been invested in the expansion projects located in Arizona. Construction and development work has made significant progress toward completion of the current phase of expansion, with anticipated operational readiness in 2021.
  • Zoned Properties completed a $100,000 strategic investment into a start-up cannabis franchise organization that is now in the final stages of its anticipated launch. Zoned Properties expects to play a significant role with the cannabis franchise related to the intricacies of strategic capital investment and commercial real estate development in the regulated cannabis industry.
  • In Arizona, and across the nation, the passage of regulated cannabis ballot measures reflect the overwhelming support from the majority of American voters for the regulated cannabis industry.

Nine Months and Third Quarter 2020 Financial Results

  • Revenue decreased 10.5% to $302,772 for the third quarter of 2020, compared to $338,339 for the third quarter of 2019. This decrease in revenues was primarily attributable to a decrease in advisory revenues of $42,191, or 70.2%, offset by an increase in rent revenues of $6,624, or 2.4%.
  • Operating expenses decreased 18.1% to $249,021 for the third quarter of 2020, compared to $304,052 for the third quarter of 2019.
  • Income from operations increased 56.8% to $53,751 for the third quarter of 2020, compared to income from operations of $34,287 for the third quarter of 2019, an increase of $19,464.
  • Net income was $25,089, or $0.00 per basic and diluted share, for the third quarter of 2020, compared to net income of $3,987, or $0.00 per basic and diluted share, for the third quarter of 2019.
  • Net cash provided by operating activities was $48,470 for the nine months ended September 30, 2020, compared to $219,433 for the nine months ended September 30, 2019.
  • As of September 30, 2020, Zoned Properties had cash of $577,763, compared to $639,781 as of December 31, 2019.

“It has been an exciting year for Zoned Properties as we continue expanding our operational footprint in Arizona, developing our national advisory services with new client projects and advisory professionals, and prepare for the launch of a new cannabis franchise concept,” commented Bryan McLaren, Chief Executive Officer of Zoned Properties. “We are empowered by Arizona voters and voters across the nation, who spoke up on election day to pass regulated cannabis measures on the ballot. Our expansion projects in Arizona could not have come at a better time, as we prepare for an exciting new adult-use marketplace and the completion of new operational square footage at our facilities in Arizona will lead to a material increase in leasing revenue for Zoned Properties.”

About Zoned Properties, Inc. (OTCQB: ZDPY):

Zoned Properties is a strategic real estate development firm whose primary mission is to provide real estate and sustainability services for clients in the regulated cannabis industry, positioning the company for real estate acquisitions and revenue growth. We intend to pioneer sustainable development for emerging industries, including the regulated cannabis industry. We are an accredited member of the Better Business Bureau, the U.S. Green Building Council, and the Forbes Real Estate Council. We focus on investing capital to acquire and develop commercial properties to be leased on a triple-net basis, and engaging clients that face zoning, permitting, development, and operational challenges. We provide development strategies and advisory services that could potentially have a major impact on cash flow and property value. We do not grow, harvest, sell or distribute cannabis or any substances regulated under United States law such as the Controlled Substance Act of 1970, as amended (the “CSA”).

Website: www.ZonedProperties.com

Twitter: @ZonedProperties

LinkedIN: @ZonedProperties

Safe Harbor Statement

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. All statements other than statements of historical facts included in this press release are forward-looking statements. In some cases, forward-looking statements can be identified by words such as “believe,” “expect,” “anticipate,” “plan,” “potential,” “continue” or similar expressions. Such forward-looking statements include risks and uncertainties, and there are important factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These factors, risks and uncertainties are discussed in the Company’s filings with the Securities and Exchange Commission. Investors should not place any undue reliance on forward-looking statements since they involve known and unknown, uncertainties and other factors which are, in some cases, beyond the Company’s control which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company’s current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to operations, results of operations, growth strategy and liquidity. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

COVID-19 Statement

In March 2020, the World Health Organization declared COVID-19 a global pandemic and recommended containment and mitigation measures worldwide. We are monitoring this closely, and although operations have not been materially affected by the COVID-19 outbreak to date, the ultimate duration and severity of the outbreak and its impact on the economic environment and our business is uncertain. Currently, all of the properties in our portfolio are open to our Significant Tenants and their customers and will remain open pursuant to state and local government requirements. At this time, we do not foresee any material changes to our operations from COVID-19. Our tenants are continuing to generate revenue at these properties and they have continued to make rental payments in full and on time and we believe the tenants’ liquidity position is sufficient to cover its expected rental obligations. Accordingly, while we do not anticipate an impact on our operations, we cannot estimate the duration of the pandemic and potential impact on our business if the properties must close or if the tenants are otherwise unable or unwilling to make rental payments. In addition, a severe or prolonged economic downturn could result in a variety of risks to our business, including weakened demand for our properties and a decreased ability to raise additional capital when needed on acceptable terms, if at all. At this time, the Company is unable to estimate the impact of this event on its operations.

Investor Relations

Zoned Properties, Inc.

Bryan McLaren

Tel (877) 360-8839

[email protected]

www.zonedproperties.com

KEYWORDS: United States North America Arizona

INDUSTRY KEYWORDS: Professional Services Retail Tobacco Commercial Building & Real Estate Construction & Property Urban Planning Consulting

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The LGL Group Reports Third Quarter 2020 Results

The LGL Group Reports Third Quarter 2020 Results

ORLANDO, Fla.–(BUSINESS WIRE)–
The LGL Group, Inc. (NYSE American: LGL) (the “Company” or “LGL”), announced its financial results for the three and nine months ended September 30, 2020.

  • Revenues of $8.1 million declined (6.0%) compared to Q3 2019 revenues of $8.6 million
  • Operating income was $0.7 million in Q3 2020 versus $1.1 million for the prior year period
  • Diluted net income of $0.12 per share compared to $0.91 per share ($0.24 per share excluding a $3.3 million tax benefit) for the prior year quarter
  • Order backlog was $21.5 million compared to $23.3 million at September 30, 2019
  • Adjusted EBITDA for Q3 2020 was $0.9 million compared to $1.3 million for Q3 2019
  • Warrant dividend declared October 29, 2020 providing shareholders’ efficient participation in future value.

The Company’s President and Chief Executive Officer, Ivan Arteaga, said, “I commend the team for pulling together as we worked through the spring COVID-19 shock, and ensuing summer impacts. While demand from the avionics industry has contracted significantly, the trajectory of the military/aerospace business is strong and growing. Recent orders offer promise that we are getting back to normal.”

Commenting on the Company’s Q3 2020 results, Bill Drafts, President and Chief Executive Officer of LGL’s main operating unit, MtronPTI, stated, “Our results improved sequentially quarter-to-quarter as the overall business environment began to stabilize and we could focus on the strategic actions previously planned. I would like to thank the team for their dedication and thank our customers for their continued business.”

THIRD QUARTER RESULTS – In 2020, LGL’s third quarter revenues decreased $0.5 million, or 6.0%, to $8.1 million compared to $8.6 million for the corresponding quarter in 2019. Operating income declined to $0.7 million reflecting lower sales than prior year, although sales showed improvement over second quarter 2020 levels. Product mix changes and costs related to the avionics production work slowdown also contributed to the operating profit decline. Adjusted EBITDA was $0.9 million in the third quarter of 2020 versus $1.3 million in the third quarter of 2019.

EARNINGS PER SHARE – Diluted earnings per share from ongoing operations, during the third quarter were $0.12 per share in 2020 as compared to $0.91 per share in the third quarter of 2019. The decrease was largely attributable to the $3.3 million tax benefit in 2019 primarily due to release of the valuation allowance related to the Company’s U.S. deferred tax assets and also from the operating income impacts noted above. Weighted average shares outstanding at September 30, 2020 were 5.3 million versus 5.0 million at September 30, 2019.

BALANCE SHEET – LGL’s balance sheet continued to improve in 2020. The balance sheet reflects a net cash position including marketable securities of $22.9 million at September 30, 2020 compared to $18.1 million at December 31, 2019. The Company continues to explore growth organically and through diversified merger and acquisitions and believes the relationship with the SPAC has enhanced its strategic profile in this context.

OPERATING STATISTICS – As of September 30, 2020, the Company’s backlog decreased 7.9% to $21.5 million as compared to $23.3 million at September 30, 2019.

Our summary operating statistics are as follows:

 

Three months ended

 

 

 

 

 

 

 

 

 

 

September 30,

 

 

Change

 

(Amounts in millions, except book:bill)

2020

 

 

2019

 

 

$

 

 

%

 

Bookings (Sales)

$

7,031

 

 

$

7,391

 

 

$

(360

)

 

 

(4.9

%)

Shipments (Revenues)

$

8,071

 

 

$

8,588

 

 

$

(517

)

 

 

(6.0

%)

Book:Bill

 

0.871

 

 

 

0.861

 

 

 

0.011

 

 

 

1.2

%

Backlog

$

21,456

 

 

$

23,285

 

 

$

(1,829

)

 

 

(7.9

%)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nine months ended

 

 

 

 

 

 

 

 

 

 

September 30,

 

 

Change

 

(Amounts in millions, except book:bill)

2020

 

 

2019

 

 

$

 

 

%

 

Bookings (Sales)

$

23,347

 

 

$

28,837

 

 

$

(5,490

)

 

 

(19.0

%)

Shipments (Revenues)

$

23,748

 

 

$

23,058

 

 

$

690

 

 

 

3.0

%

Book:Bill

 

0.983

 

 

 

1.251

 

 

 

(0.268

)

 

 

(21.4

%)

About The LGL Group, Inc.

The LGL Group, Inc., through its two principal subsidiaries MtronPTI and PTF, designs, manufactures and markets highly-engineered electronic components used to control the frequency or timing of signals in electronic circuits, and designs high performance frequency and time reference standards that form the basis for timing and synchronization in various applications.

Headquartered in Orlando, Florida, the Company has additional design and manufacturing facilities in Yankton, South Dakota, Wakefield, Massachusetts and Noida, India, with local sales offices in Hong Kong and Austin, Texas.

For more information on the Company and its products and services, contact James Tivy at The LGL Group, Inc., 2525 Shader Rd., Orlando, Florida 32804, (407) 298-2000, or visit www.lglgroup.com and www.mtronpti.com.

Caution Concerning Forward Looking Statements

This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21 E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include all statements that do not relate solely to historical or current facts, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. These forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to us and our current plans or expectations and are subject to a number of uncertainties and risks that could significantly affect current plans, anticipated actions and our future financial condition and results. Certain of these risks and uncertainties are described in greater detail in our filings with the Securities and Exchange Commission. We are under no obligation to (and expressly disclaim any such obligation to) update or alter our forward-looking statements, whether as a result of new information, future events or otherwise.

 

THE LGL GROUP, INC.

Condensed Consolidated Statements of Operations

(Unaudited)

(Dollars in Thousands, Except Share and Per Share Amounts)

 

 

 

For the Three Months Ended

September 30,

 

 

 

2020

 

 

2019

 

REVENUES

 

$

8,071

 

 

$

8,588

 

Costs and expenses:

 

 

 

 

 

 

 

 

Manufacturing cost of sales

 

 

5,203

 

 

 

5,049

 

Engineering, selling and administrative

 

 

2,159

 

 

 

2,417

 

OPERATING INCOME

 

 

709

 

 

 

1,122

 

Total other income (expense), net

 

 

91

 

 

 

82

 

INCOME BEFORE INCOME TAXES

 

 

800

 

 

 

1,204

 

Income tax expense (benefit)

 

 

171

 

 

 

(3,326

)

NET INCOME

 

$

629

 

 

$

4,530

 

 

 

 

 

 

 

 

 

 

Weighted average number of shares used in basic EPS calculation

 

 

5,212,652

 

 

 

4,901,698

 

BASIC NET INCOME PER COMMON SHARE

 

$

0.12

 

 

$

0.92

 

Weighted average number of shares used in diluted EPS calculation

 

 

5,251,078

 

 

 

4,965,808

 

DILUTED NET INCOME PER COMMON SHARE

 

$

0.12

 

 

$

0.91

 

 

 

For the Nine Months Ended

September 30,

 

 

 

2020

 

 

2019

 

REVENUES

 

$

23,748

 

 

$

23,058

 

Costs and expenses:

 

 

 

 

 

 

 

 

Manufacturing cost of sales

 

 

15,681

 

 

 

13,970

 

Engineering, selling and administrative

 

 

6,514

 

 

 

6,676

 

OPERATING INCOME

 

 

1,553

 

 

 

2,412

 

Total other income (expense), net

 

 

(204

)

 

 

353

 

INCOME BEFORE INCOME TAXES

 

 

1,349

 

 

 

2,765

 

Income tax expense (benefit)

 

 

282

 

 

 

(3,286

)

NET INCOME

 

$

1,067

 

 

$

6,051

 

 

 

 

 

 

 

 

 

 

Weighted average number of shares used in basic EPS calculation

 

 

5,159,452

 

 

 

4,872,461

 

BASIC NET INCOME PER COMMON SHARE

 

$

0.21

 

 

$

1.24

 

Weighted average number of shares used in diluted EPS calculation

 

 

5,195,754

 

 

 

4,965,989

 

DILUTED NET INCOME PER COMMON SHARE

 

$

0.21

 

 

$

1.22

 

 

THE LGL GROUP, INC.

Condensed Consolidated Balance Sheets

(Unaudited)

(Dollars in Thousands)

 
 

 

 

September 30,

2020

 

 

December 31,

2019

 

ASSETS

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

17,276

 

 

$

12,453

 

Marketable securities

 

 

5,646

 

 

 

5,631

 

Accounts receivable, net

 

 

4,644

 

 

 

4,445

 

Inventories, net

 

 

5,430

 

 

 

6,016

 

Prepaid expenses and other current assets

 

 

268

 

 

 

365

 

Total Current Assets

 

 

33,264

 

 

 

28,910

 

Property, plant, and equipment, net

 

 

2,824

 

 

 

2,831

 

Equity investment in unconsolidated subsidiary

 

 

3,134

 

 

 

3,334

 

Deferred income taxes, net

 

 

3,046

 

 

 

3,307

 

Intangible assets, net

 

 

366

 

 

 

402

 

Right-of-use lease asset

 

 

452

 

 

 

331

 

Other assets

 

 

–

 

 

 

102

 

Total Assets

 

$

43,086

 

 

$

39,217

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

Total Current Liabilities

 

 

3,700

 

 

 

4,324

 

Total Stockholders’ Equity

 

 

39,386

 

 

 

34,893

 

Total Liabilities and Stockholders’ Equity

 

$

43,086

 

 

$

39,217

 

Reconciliations of GAAP to Non-GAAP Measures

To supplement our consolidated financial statements presented on a GAAP (generally accepted accounting principles) basis, the Company uses certain non-GAAP measures, including Adjusted EBITDA, which we define as net income adjusted to exclude depreciation and amortization expense, interest income (expense), provision (benefit) for income taxes, stock-based compensation expense, investment income and other items we believe are discrete events which have a significant impact on comparable GAAP measures and could distort an evaluation of our normal operating performance. These adjustments to our GAAP results are made with the intent of providing both management and investors a more complete understanding of the underlying operational results and trends and our marketplace performance. The presentation of this additional information is not meant to be considered in isolation or as a substitute for net earnings or diluted earnings per share prepared in accordance with generally accepted accounting principles in the United States.

 

Reconciliation of GAAP Net Income Before Income Taxes to Non-GAAP Adjusted EBITDA:
 
 

 

 

For the Three Months Ended

September 30,

 

 

 

2020

 

 

2019

 

(000’s, except share and per share amounts)

 

 

 

 

 

 

 

 

Net income before income taxes

 

$

800

 

 

$

1,204

 

Interest expense (income)

 

 

3

 

 

 

—

 

Depreciation and amortization

 

 

131

 

 

 

125

 

Non-cash stock compensation

 

 

57

 

 

 

5

 

Investment income

 

 

(124

)

 

 

(76

)

Loss on equity investment in unconsolidated subsidiary

 

 

61

 

 

 

—

 

Adjusted EBITDA

 

$

928

 

 

$

1,258

 

 

 

 

 

 

 

 

 

 

Basic per share information:

 

 

 

 

 

 

 

 

Weighted average shares outstanding

 

 

5,212,652

 

 

 

4,901,698

 

Adjusted EBITDA per share

 

$

0.18

 

 

$

0.26

 

 

 

 

 

 

 

 

 

 

Diluted per share information:

 

 

 

 

 

 

 

 

Weighted average shares outstanding

 

 

5,251,078

 

 

 

4,965,808

 

Adjusted EBITDA per share

 

$

0.18

 

 

$

0.25

 

 

 

For the Nine Months Ended

September 30,

 

 

 

2020

 

 

2019

 

(000’s, except shares and per share amounts)

 

 

 

 

 

 

 

 

Net income before income taxes

 

$

1,349

 

 

$

2,765

 

Interest expense (income)

 

 

7

 

 

 

(1

)

Depreciation and amortization

 

 

392

 

 

 

365

 

Non-cash stock compensation

 

 

104

 

 

 

17

 

Investment income

 

 

(67

)

 

 

(346

)

Loss on equity investment in unconsolidated subsidiary

 

 

200

 

 

 

—

 

Adjusted EBITDA

 

$

1,985

 

 

$

2,800

 

 

 

 

 

 

 

 

 

 

Basic per share information:

 

 

 

 

 

 

 

 

Weighted average shares outstanding

 

 

5,159,452

 

 

 

4,872,461

 

Adjusted EBITDA per share

 

$

0.38

 

 

$

0.57

 

 

 

 

 

 

 

 

 

 

Diluted per share information:

 

 

 

 

 

 

 

 

Weighted average shares outstanding

 

 

5,195,754

 

 

 

4,965,989

 

Adjusted EBITDA per share

 

$

0.38

 

 

$

0.56

 

 

James Tivy

The LGL Group, Inc.

[email protected]

(407) 298-2000

KEYWORDS: Florida United States North America

INDUSTRY KEYWORDS: Semiconductor Technology Aerospace Manufacturing Other Manufacturing Hardware

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NGM Bio Provides Business Highlights and Reports Third Quarter 2020 Financial Results

  • NGM continues to demonstrate the productivity of its research discovery engine and progress against its multi-therapeutic area pipeline:
       —   Initiated a Phase 2 clinical trial of NGM621, an anti-complement C3 antibody, in patients with geographic atrophy (GA)
       —   Announced expansion of oncology portfolio with first immuno-oncology candidate, NGM707, a novel dual antagonist antibody inhibiting ILT2 and ILT4
  • NGM has $287.9 million in cash, cash equivalents and marketable securities as of September 30, 2020
  • NGM will present first-in-human results from Phase 1 study of NGM621 in patients with GA at the upcoming American Academy of Ophthalmology (AAO) Virtual Annual Meeting on November 13, 2020
  • NGM will conduct an R&D Day showcasing its portfolio on December 9, 2020

SOUTH SAN FRANCISCO, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) — NGM Biopharmaceuticals, Inc. (NGM) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today provided business highlights and reported financial results for the quarter ended September 30, 2020.

“We made notable progress across our pipeline this past quarter, as we continue to pursue a portfolio of product candidates directed to biologically powerful targets,” said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM. “Since mid-July, we have initiated a Phase 2 clinical trial of NGM621, our anti-complement C3 antibody, designed to slow disease progression in people with geographic atrophy, and we have disclosed our first immuno-oncology development candidate, NGM707, a novel dual antagonist antibody inhibiting ILT2 and ILT4, designed to potentially improve patient immune responses to tumors.”

Dr. Woodhouse continued, “We look forward to our upcoming R&D Day on December 9th, where we will showcase not only our exciting portfolio of programs but also highlight the talented NGM scientists whose expertise, creativity and passion have enabled our track record of rapid innovation and sustained productivity.”

Key
Third
Quarter and Recent Highlights

Liver and metabolic diseases

  • Completed enrollment in Phase 2b ALPINE 2/3 study of aldafermin in NASH patients. NGM completed enrollment in the Phase 2b ALPINE 2/3 clinical study of aldafermin in patients with biopsy-confirmed NASH and stage 2 or 3 (F2-F3) liver fibrosis. The 24-week study will assess the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg doses of aldafermin compared to placebo. The primary objective of the ALPINE 2/3 study is to evaluate a dose response showing an improvement in liver fibrosis by ≥ 1 stage with no worsening of steatohepatitis at week 24. NGM expects to report topline findings from the study in the second quarter of 2021.
  • Ongoing
    enrollment in Phase 2b ALPINE 4 study of aldafermin in NASH patients with compensated cirrhosis. NGM continued enrollment in the Phase 2b ALPINE 4 study of aldafermin in patients with biopsy-confirmed compensated NASH cirrhosis (F4). The 48-week study is designed to enroll approximately 150 patients and will assess the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg doses of aldafermin compared to placebo.
  • Data from 24-week double
    blind, randomized, placebo-controlled Phase 2 study (Cohort 4) of aldafermin in NASH patients
    presented at The Digital International Liver Congress
    ™
    2020
    and
    published in

    Gastroenterology

    . Cohort 4 demonstrated statistically significant dual activity in both reversing fibrosis and resolving NASH. In the study, aldafermin continued to demonstrate a favorable tolerability profile. Cohort 4 was the final reported cohort from NGM’s adaptive Phase 2 clinical study of aldafermin in NASH, and the results observed in Cohort 4 were consistent with data from the three previous cohorts.

Retinal diseases

  • Initiated Phase 2 CATALINA study of NGM621 in patients with GA. In July, NGM began the Phase 2 CATALINA study, a multicenter, randomized, double-masked, sham-controlled clinical trial to evaluate the safety and efficacy of intravitreal (IVT) injections of NGM621 in patients with GA secondary to age-related macular degeneration. NGM anticipates enrolling 240 patients diagnosed with GA in one or both eyes.
  • NGM will present
    results from a
    Phase 1
    study of
    NGM621 in patients with GA at
    the
    American Academy of Ophthalmology (AAO) Virtual Annual Meeting on November
    13, 2020 at 10:00 a.m
    .
    ET
    . NGM completed the Phase 1 study with single- and multiple-dose IVT injections of NGM621 in patients with GA. The AAO presentation will be the first-in-human data presented on NGM621 in GA.

Cancer

  • Expanded o
    ncology portfolio with
    f
    irst i
    mmuno-oncology development candidate, NGM707, a dual
    antagonist a
    ntibody i
    nhibiting ILT2 and ILT4
    . These receptors represent key myeloid and lymphoid checkpoints, and may restrict anti-tumor immunity, enable tumors to evade immune detection and contribute to T cell checkpoint resistance. NGM plans to initiate first-in-human testing of NGM707 in mid-2021 in patients with advanced solid tumors.
  • Ongoing
    enrollment in Phase 1a/1b study of NGM120 in patients with cancer anorexia/cachexia syndrome
    (CACS) and cancer. NGM continues to enroll patients in a Phase 1a/1b clinical study to evaluate NGM120, a first-in-class antagonistic antibody that binds glial cell-derived neurotrophic factor receptor alpha-like (GFRAL) and inhibits GDF15 signaling, for the potential treatment of CACS and cancer. CACS is the uncontrolled wasting of both skeletal muscle and fat that is a common co-morbidity of cancer and is associated with shortened survival in cancer patients.

Merck Collaboration

Merck has a one-time option to license NGM pipeline programs – other than aldafermin and NGM395 – following human proof-of-concept trials under the terms of the companies’ ongoing strategic collaboration. Upon exercising any such option, Merck would lead global product development and commercialization for the resulting products, if approved. Prior to Merck initiating a Phase 3 study for a licensed program, NGM may elect to either receive milestone and royalty payments or to co-fund development and participate in a global cost and revenue share arrangement of up to 50%. The agreement also provides NGM with the option to participate in the co-promotion of any co-funded program in the United States. In January 2019, Merck exercised its first option under the collaboration to license MK-3655, previously referred to as NGM313.

Third
Quarter Financial Results

  • For the quarter ended September 30, 2020, NGM reported a net loss of $29.8 million, compared to a net loss of $10.9 million for the corresponding period in 2019.
  • Related party revenue from our collaboration with Merck for the quarter ended September 30, 2020 was $23.5 million, compared to $21.6 million for the corresponding period in 2019.
  • Research and development expenses for the quarter ended September 30, 2020 were $47.0 million, compared to $29.0 million for the corresponding period in 2019. The increase in research and development expenses was mainly attributable to increases in external research and development expenses associated with the advancement of NGM’s growing pipeline, primarily related to our aldafermin, NGM621, NGM120 and NGM707 programs, and personnel-related expenses driven by increased headcount.
  • General and administrative expenses for the quarter ended September 30, 2020 were $6.5 million, compared to $5.6 million for the corresponding period in 2019. The increase in general and administrative expenses was primarily attributable to increases in personnel-related expenses driven by increased headcount, as well as external expenses to support our operations as a public company.
  • Cash, cash equivalents and short-term marketable securities were $287.9 million as of September 30, 2020, compared to $344.5 million as of December 31, 2019.

About NGM Biopharmaceuticals, Inc.

NGM is a biopharmaceutical company focused on discovering and developing novel therapeutics based on scientific understanding of key biological pathways underlying liver and metabolic diseases, retinal diseases and cancer. We leverage our biology-centric drug discovery approach to uncover novel mechanisms of action and generate proprietary insights that enable us to move rapidly into proof-of-concept studies and deliver potential first-in-class medicines to patients. At NGM, we aspire to operate one of the most productive research and development engines in the biopharmaceutical industry, with multiple programs in clinical development. Visit us at www.ngmbio.com for more information.

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. Words such as “will,” “planned,” “pursue,” “look forward,” “expects,” ‘designed to,” “anticipates,” “plans,” “potential,” “aspire” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to NGM’s intentions to present at future events; the productivity of NGM’s research and advancement of NGM’s clinical and preclinical pipeline; the continued progress of, and the timing of enrollment and results of, NGM’s clinical trials, including timing of topline results of the ALPINE 2/3 study and the presentation of data from the Phase 1 study of NGM621 in patients with GA; and the design, timing, enrollment, safety, tolerability and efficacy of, and continued development of, NGM’s product candidates, including aldafermin, NGM621, NGM707 and NGM120. Because such statements deal with future events and are based on NGM’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of NGM could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success, including risks related to failure or delays in successfully enrolling or completing clinical studies, the risk that the results obtained to date in NGM’s clinical trials may not be indicative of results obtained in subsequent pivotal or other late-stage trials, and the risk that NGM’s ongoing or future clinical studies in humans may show that aldafermin is not a tolerable and effective treatment for NASH patients; the ongoing COVID-19 pandemic, which has adversely affected, and could materially and adversely affect in the future, our business and operations; the time-consuming and uncertain regulatory approval process; NGM’s reliance on third-party manufacturers for aldafermin and its other product candidates; the sufficiency of NGM’s cash, cash equivalents and short-term marketable securities and need for additional capital; and other risks and uncertainties affecting NGM and its development programs, as well as those discussed in the sections titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors” in our quarterly report on Form 10-Q for the quarter ended June 30, 2020 and future filings and reports that NGM makes from time to time with the United States Securities and Exchange Commission. Except as required by law, NGM assumes no obligation to update these forward-looking statements, or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements.

Investor Contact:

Alex Schwartz
[email protected]		 Media Contact:

Liz Melone
[email protected]

                                     
NGM BIOPHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except share and per share amounts)

(Unaudited)
 
        Three Months Ended     Nine Months Ended  
        September
 
30, 		    September
 
30, 		 
        2020     2019     2020     2019  
Related party revenue $ 23,482     $ 21,568     $ 67,601     $ 72,461  
Operating expenses:                              
Research and development   46,979       28,953       123,912       87,299  
General and administrative     6,460       5,612       19,849       17,208  
Total operating expenses   53,439       34,565       143,761       104,507  
Loss from operations     (29,957 )     (12,997 )     (76,160 )     (32,046 )
Interest income     260       1,984       1,823       5,138  
Other income (expense), net     (68 )     96       (159 )     54  
Net loss   $ (29,765 )   $ (10,917 )   $ (74,496 )   $ (26,854 )
Net loss per share, basic and diluted   $ (0.43 )   $ (0.17 )   $ (1.09 )   $ (0.60 )
Weighted average shares used to compute net loss per share, basic and diluted     68,815,696       65,948,207       68,174,654       44,828,596  
 
(1)   In April 2019, the Company completed its initial public offering (IPO) and concurrent private placement with Merck Sharp & Dohme Corp., in which the Company issued an aggregate of 7,521,394 and 4,121,683 shares of common stock, respectively, and all of the then outstanding shares of convertible preferred stock were automatically converted into shares of common stock upon the closing of the IPO.

 
NGM BIOPHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands
)

(Unaudited)
 
    September
 
30, 		    December
 
31, 		 
    2020     2019  
Assets                
Current assets:                
Cash and cash equivalents   $ 253,976     $ 245,598  
Short-term marketable securities     33,973       98,913  
Related party receivable from collaboration     7,215       5,206  
Prepaid expenses and other current assets     7,076       5,531  
Total current assets     302,240       355,248  
Property and equipment, net     15,773       19,475  
Restricted cash     1,499       1,874  
Other non-current assets     6,570       3,806  
Total assets   $ 326,082     $ 380,403  
Liabilities and stockholders’ equity              
Current liabilities:                
Accounts payable   $ 1,613     $ 9,026  
Accrued liabilities     28,579       22,991  
Deferred rent, current     2,938       2,829  
Deferred revenue, current     4,586       4,872  
Total current liabilities     37,716       39,718  
Deferred rent, non-current     7,179       9,392  
Other non-current liabilities     4,315       —  
Early exercise stock option liability     169       574  
Total liabilities     49,379       49,684  
Commitments and contingencies                
Stockholders’ equity:                
Preferred stock, $0.001 par value; 10,000,000 shares authorized;
no shares issued or outstanding as of September 30, 2020 and
December 31, 2019, respectively		     —       —  
Common stock, $0.001 par value; 400,000,000 shares authorized;
68,934,767 and 66,960,279 shares issued and outstanding as of
September 30, 2020 and December 31, 2019, respectively		     69       67  
Additional paid-in capital     547,259       526,771  
Accumulated other comprehensive gain     15       25  
Accumulated deficit     (270,640 )     (196,144 )
Total stockholders’ equity     276,703       330,719  
Total liabilities and stockholders’ equity   $ 326,082     $ 380,403  

Posted on

Annexon Expands Classical Complement Platform into Neurodegenerative Diseases of the Brain with Initiation of Huntington’s Disease Clinical Program

– First patient dosed in Phase 2 study of ANX005 C1q targeted mAb –

SOUTH SAN FRANCISCO, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) — Annexon, Inc. (“Annexon”) (Nasdaq: ANNX), a clinical stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the brain, body and eye, today announced that it has initiated a Phase 2 study, dosing the first patient with its full-length monoclonal antibody ANX005 in Huntington’s Disease (HD). The Phase 2 trial in HD expands Annexon’s classical complement platform into neurodegenerative diseases of the brain and highlights the pioneering research of the company’s co-founder, the late Dr. Ben Barres, former member of the National Academy of Sciences and Chair of Neurobiology, Stanford University. Aberrant activation of C1q plays a significant role in the neurodegenerative process by causing synapse loss, chronic neuroinflammation and eventual neuronal death.

“Huntington’s Disease is a devastating, progressive movement disorder with no cure and no approved therapeutic options available to patients and their families,” commented Sanjay Keswani, MBBS, BSc, FRCP, Chief Medical Officer of Annexon. “In neurodegenerative conditions like HD, our goal is to disrupt the disease course by inhibiting harmful classical complement activity, including synapse loss, that leads to neurodegeneration and cognitive impairment. We are excited to advance ANX005 and look forward to initial results from our Phase 2 trial in the second half of 2021.”

“Annexon targets the initiating protein of the classical complement pathway, C1q, which uniquely binds to synapses in the brain and appears to cause inappropriate synapse elimination during chronic neurodegenerative disease, such as HD,” stated Beth Stevens, PhD, Associate Professor of Neurology, Children’s Hospital Boston and former postdoctoral scholar in Dr. Barres’ lab. “Inhibiting C1q and protecting functioning synapses may benefit patients with neurodegenerative conditions.”

About the Clinical Trial
and ANX005

The Phase 2 open-label trial is enrolling up to 24 patients and is designed to assess safety, tolerability and biomarkers of target engagement and impact on neurodegeneration.

ANX005 is an IV formulated monoclonal antibody designed to inhibit C1q and the entire classical complement pathway. ANX005 is designed to treat patients with antibody-mediated autoimmune and complement-mediated neurodegenerative disorders. In addition to the HD indication, Annexon has completed a Phase 1b clinical trial of ANX005 in Guillain-Barré Syndrome (GBS) and has received fast track and orphan drug designations from the U.S. Food and Drug Administration for the treatment of GBS.

More information can be found at www.annexonbio.com or www.clinicaltrials.gov, identifier NCT04514367, or the HD Coalition for Patient Engagement https://www.huntingtonsociety.ca/hdcope/.        

About Annexon, Inc.

Annexon is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the brain, body and eye. The company’s pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Annexon is deploying a disciplined, biomarker-driven development strategy designed to establish that its product candidates are engaging the target at a well-tolerated therapeutic dose in the intended tissue compartments. For more information, visit www.annexonbio.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. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about: advancement of the company’s clinical and preclinical programs and timing of clinical results; the potential benefits of inhibiting C1q; and the implementation of the company’s business model and strategic plans for its business and product candidates. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the company’s history of net operating losses; the company’s ability to obtain necessary capital to fund its clinical programs; the early stages of clinical development of the company’s product candidates; the effects of COVID-19 or other public health crises on the company’s clinical programs and business operations; the company’s ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company’s product candidates; the company’s reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company’s ability to adequately maintain intellectual property rights for its product candidates. These and other risks are described in greater detail under the section titled “Risk Factors” contained in the company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2020 filed with the Securities and Exchange Commission (SEC) on September 9, 2020 and the company’s other filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
Sylvia Wheeler
[email protected]

Alexandra Santos
[email protected]

Media Contact:
Caroline Rufo, Ph.D.
[email protected]

Posted on

SIGA Technologies Chief Scientific Officer to Participate at NCT Asia Virtual Conference on November 13, 2020

NEW YORK, Nov. 12, 2020 (GLOBE NEWSWIRE) — SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health security market, today announced that Dr. Dennis Hruby, Chief Scientific Officer, will participate in a panel discussion at the Non-Conventional Threats (NCT) Asia Virtual Conference.

The panel discussion titled, “COVID-19: Insights on an Epidemic Outbreak” will take place at 12:00 p.m. Malaysia Time on Friday, November 13, 2020 with Dr. Hruby speaking as one member of the panel at the conference.

“With the COVID-19 pandemic continuing its devastating global impact, preparedness for the possibility of future pandemics are of increasing importance for governments worldwide. We look forward to providing information about TPOXX in addressing a potential smallpox outbreak, which is far more lethal than COVID-19,” said Dr. Hruby.

ABOUT SIGA TECHNOLOGIES, INC. and TPOXX

®

SIGA Technologies, Inc. is a commercial-stage pharmaceutical company focused on the health security market. Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks (biodefense market), vaccines and therapies for emerging infectious diseases, and health preparedness. Our lead product is TPOXX®, also known as tecovirimat and ST-246®, an orally administered and IV formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. TPOXX® is a novel small-molecule drug and the US maintains a stockpile of 1.7 million courses in the Strategic National Stockpile under Project BioShield. The oral formulation of TPOXX® was approved by the FDA for the treatment of smallpox in 2018. The full label is here: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fce826ab-4d6a-4139-a2ee-a304a913a253. In September 2018, SIGA signed a contract potentially worth more than $600 million with BARDA for additional procurement and development related to both oral and intravenous formulations of TPOXX®. For more information about SIGA, please visit www.siga.com.

About Smallpox

1

Smallpox is a contagious, disfiguring and often deadly disease that has affected humans for thousands of years. Naturally occurring smallpox was eradicated worldwide by 1980, the result of an unprecedented global immunization campaign. Samples of smallpox virus have been kept for research purposes. This has led to concerns that smallpox could someday be used as a biological warfare agent. A vaccine can prevent smallpox, but the risk of the current vaccine’s side effects is too high to justify routine vaccination for people at low risk of exposure to the smallpox virus.

FORWARD-LOOKING STATEMENTS

This press release contains certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are subject to various known and unknown risks and uncertainties, and SIGA cautions you that any forward-looking information provided by or on behalf of SIGA is not a guarantee of future performance. More detailed information about SIGA and risk factors that may affect the realization of forward-looking statements, including the forward-looking statements in this press release, is set forth in SIGA’s filings with the Securities and Exchange Commission, including SIGA’s Annual Report on Form 10-K for the year ended December 31, 2019, and in other documents that SIGA has filed with the SEC. SIGA urges investors and security holders to read those documents free of charge at the SEC’s web site at http://www.sec.gov. Interested parties may also obtain those documents free of charge from SIGA. Forward-looking statements are current only as of the date on which such statements were made, and except for our ongoing obligations under the United States of America federal securities laws, we undertake no obligation to update publicly any forward-looking statements whether as a result of new information, future events, or otherwise.

The information contained in this press release does not necessarily reflect the position or the policy of the Government and no official endorsement should be inferred.

Contacts:

Investors

David Carey
212-867-1768
[email protected]

Media

Stephanie Seiler
206-713-0124
[email protected]

______________________________________

1 http://www.mayoclinic.org/diseases-conditions/smallpox/basics/definition/con-20022769

Posted on

IMPORTANT NOV. 24 DEADLINE Pawar Law Group Announces a Securities Class Action Lawsuit Against Garrett Motion Inc. – GTXMQ

NEW YORK, Nov. 12, 2020 (GLOBE NEWSWIRE) — Pawar Law Group announces that a class action lawsuit has been filed on behalf of shareholders who purchased shares of Garrett Motion Inc. (OTC: GTXMQ) from October 1, 2018 through September 18, 2020, inclusive (the “Class Period”). The lawsuit seeks to recover damages for Garrett Motion Inc. investors under the federal securities laws.

To join the class action, go here or call Vik Pawar, Esq. toll-free at 888-589-9804 or email [email protected] for information on the class action.

According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) due to its agreement to indemnify and reimburse Honeywell for certain asbestos-related liability, Garrett was saddled with an unsustainable level of debt; (2) as a result, Garrett had a highly leveraged capital structure that posed significant challenges to its overall strategic and financial flexibility; (3) as a result of the foregoing, Garrett’s ability to gain or hold market share was impaired; (4) as a result of the foregoing, the Company was reasonably likely to seek bankruptcy protection; and (5) as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

If you wish to serve as lead plaintiff, you must move the Court no later than November 24, 2020. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

No class has been certified. Until a class is certified, you are not represented by counsel unless you hire one. You may hire counsel of your choice. You may also do nothing at this time and be an absent member of the class. Your ability to share in any future recovery is not dependent upon being a lead plaintiff.

Pawar Law Group represents investors from around the world. Attorney advertising. Prior results do not guarantee or predict a similar outcome with respect to any future matter.

Contact:  
Vik Pawar, Esq.  
Pawar Law Group  
20 Vesey Street, Suite 1410  
New York, NY 10007  
Tel: (917) 261-2277  
Fax: (212) 571-0938  
[email protected]  

 

Posted on

Kelly® to Participate in J.P. Morgan’s 2020 Ultimate Services Investor Conference

TROY, Mich., Nov. 12, 2020 (GLOBE NEWSWIRE) — Kelly (Nasdaq: KELYA) (Nasdaq: KELYB), a leading specialty talent solutions provider, today announced it will participate in the J.P. Morgan Ultimate Services Investor Conference on Thursday, November 19, 2020.

Peter Quigley, president and CEO, Olivier Thirot, executive vice president and chief financial officer, and James Polehna, senior vice president and corporate secretary, will participate in virtual one-on-one meetings. A copy of Kelly’s Q3 2020 Investor Presentation is available at kellyservices.com.

About Kelly
®

Kelly Services, Inc. (Nasdaq: KELYA, KELYB) connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. We’re always thinking about what’s next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 440,000 people around the world, and we connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice.  Revenue in 2019 was $5.4 billion. Visit kellyservices.com and let us help with what’s next for you.


ANALYST & MEDIA


CONTACT:



James


Polehna



(248)


244-4586


[email protected]

Posted on

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: