Calyxt to Present at the 2021 Canaccord Genuity AgriFood Tech Innovation Virtual Forum

PR Newswire

ROSEVILLE, Minn., Nov. 23, 2021 /PRNewswire/ — Calyxt, Inc. (Nasdaq: CLXT), a plant-based synthetic biotechnology company, today announced that management will present at the 2021 Canaccord Genuity AgriFood Tech Innovation Virtual Forum.

2021 Canaccord Genuity AgriFood Tech Innovation Virtual Forum

Date: Thursday, December 2, 2021
Time: 11:00 a.m. ET (8:00 a.m. PT)
Webcast: https://wsw.com/webcast/canaccord62/clxt/2475458

The presentation will be available for viewing and replay on the Investors section of Calyxt’s website at www.calyxt.com.

Management is also available for meetings during the conference, please reach out to the event organizers or [email protected] to schedule.

About Calyxt
Calyxt (Nasdaq: CLXT) is a plant-based synthetic biotechnology company. The Company leverages its proprietary PlantSpring™ technology platform to engineer innovative materials and products for its customers to help them meet their sustainability goals. Calyxt’s diversified offerings are primarily delivered through its proprietary BioFactory™ production system. For more information, visit www.calyxt.com


Contact:


Calyxt Media Contact:


Calyxt Investor Relations Contact:

 David Rosen

 Sherri Spear

 Argot Partners

 Argot Partners

 (212) 600-1902

 (212) 600-1902

 [email protected]

 [email protected]

 

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SOURCE Calyxt, Inc.

Vipergen Establishes Research Partnership with Aligos Therapeutics Focused on DNA Encoded Library (DEL)-Based Drug Discovery for Viral Infections and Liver Diseases

PR Newswire

COPENHAGEN, Denmark, Nov. 23, 2021 /PRNewswire/ — Vipergen, a leading provider of small-molecule drug discovery services based on DNA-encoded library (DEL) technologies, announced today the signing of a multi-target drug discovery agreement with Aligos Therapeutics, Inc. (Nasdaq: ALGS). Under the terms of the agreement, Vipergen will apply its high-fidelity DEL technology platforms to identify novel small-molecule compounds that bind to selected Aligos protein targets. Aligos will select hits for development into novel therapeutics for viral and liver diseases. Aligos will retain exclusive rights to globally commercialize any products resulting from the collaboration. Financial details of the agreement were not disclosed.

“We are delighted to collaborate with Aligos’ highly experienced team in its mission to develop best-in-class therapies that improve treatment outcomes in chronic hepatitis B, NASH, and coronavirus,” said Nils Hansen, PhD, Chief Executive Officer of Vipergen. “We look forward to applying our suite of DEL technologies to discover novel leads that help expand Aligos’ portfolio of differentiated drug candidates that target these significant unmet medical needs.”

About Vipergen ApS
Vipergen is a world-leading provider of small-molecule drug discovery services based on DNA-encoded library (DEL) technologies and is the first and only company capable of screening DELs inside a living cell. Vipergen provides its proprietary suite of leading-edge DEL technologies through funded discovery partnerships with leading pharmaceutical and biotechnology companies, including top pharmaceutical companies in the U.S., EU, and Japan. For more details about Vipergen and the YoctoReactor® (yR), Binder Trap Enrichment® (BTE), and Cellular Binder Trap Enrichment® (cBTE) drug discovery technology platforms, please visit www.vipergen.com.

Contact:

Mary Moynihan

M2Friend Biocommunications
+1 (802) 951-9600
[email protected]

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SOURCE Vipergen

Future Fintech Announces Plans to Launch Financial App in the UK

PR Newswire

NEW YORK, Nov. 23, 2021 /PRNewswire/ — Future FinTech Group Inc. (NASDAQ: FTFT) (“hereinafter referred to as “Future FinTech”, “FTFT” or “the Company”), a leading blockchain-based e-commerce business and a fintech service provider, announced today that its new subsidiary,  FTFT UK Limited (“FTFT UK”), held an inauguration ceremony on November 19, 2021 for the opening of its new office in London, during which FTFT UK announced that it has entered the beta testing phase for its mobile financial app which will enable customers to engage in a comprehensive suite of e-wallet activities. Representatives from the local business and financial sectors, including executives of MasterCard, JP Morgan Chase, China Mobile and Bank of China attended the event.

Mr. Shanchun Huang, CEO of FTFT, said, “We believe that we can leverage our core competencies by being part of the challenger banking sector, which provides digital banking services through apps or websites, and build a comprehensive financial services platform in the future that is highly competitive with traditional banking. Our ultimate goal is to become a leading financial technology company that provides customers with a high-quality digital financial services platform for a superior user experience.”

As announced on August 12, 2021, the Company’s FTFT UK subsidiary was incorporated as an operating base from which to develop fintech business in Europe. FTFT UK has been working to develop a financial ‘super app’ that will include a wide range of personal digital financial products and services including functionality for mobile payments, international transfers, wealth management options, membership rewards, on-the-spot discounts and proprietary industry-disruptive applications. The app has been designed to be especially useful for UK-bound international students since it will enable the opening of bank accounts and international money transfers which will help such students to save time and avoid unneeded hassles, so that they can quickly settle down and start their new lives in the UK.

FTFT UK has established partnerships and began the process of technical integration with leading fintech companies in the UK. Once regulatory registration and technical collaborations are finalized, the FTFT UK ‘super app’ will be ready to launch.

About Future FinTech Group Inc.

Future FinTech Group Inc. (“Future FinTech”, “FTFT” or the “Company”) is a leading blockchain e-commerce company and a service provider for financial technology incorporated in Florida. The Company’s operations include a blockchain-based online shopping mall platform, Chain Cloud Mall (“CCM”), an incubator for blockchain based application projects, and supply chain financing and services. The Company is also engaged in the development of blockchain based e-Commerce technology as well as financial technology. For more information, please visit http:/www.ftft.com/.


Safe Harbor Statement

Certain of the statements made in this press release are “forward-looking statements” within the meaning and protections of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions, and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause the actual results, performance, capital, ownership or achievements of the Company to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such as “may,” “will,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “estimate,” “continue,” “plan,” “point to,” “project,” “could,” “intend,” “target” and other similar words and expressions of the future.

All written or oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary notice, including, without limitation, those risks and uncertainties described in our annual report on Form 10-K for the year ended December 31, 2020 and our other reports and filings with SEC. Such reports are available upon request from the Company, or from the Securities and Exchange Commission, including through the SEC’s Internet website at 
http://www.sec.gov
. We have no obligation and do not undertake to update, revise or correct any of the forward-looking statements after the date hereof, or after the respective dates on which any such statements otherwise are made.

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SOURCE Future FinTech Group Inc.

The J.M. Smucker Co. Announces Fiscal 2022 Second Quarter Results

PR Newswire

ORRVILLE, Ohio, Nov. 23, 2021 /PRNewswire/ — The J.M. Smucker Co. (NYSE: SJM) today announced results for the second quarter ended October 31, 2021, of its 2022 fiscal year. Financial results for the second quarter of fiscal year 2022 reflect the divestiture of the Crisco® business on December 1, 2020, and the divestiture of the Natural Balance® business on January 29, 2021. All comparisons are to the second quarter of the prior fiscal year, unless otherwise noted.

EXECUTIVE SUMMARY

  • Net sales increased $16.0 million, or 1 percent. Net sales excluding divestitures and foreign currency exchange increased 8 percent.
  • Net income per diluted share was $1.90, a decrease of 6 percent. Adjusted earnings per share was $2.43, an increase of 2 percent.
  • Cash from operations was $165.1 million, a decrease of 56 percent. Free cash flow was $105.9 million, compared to $326.3 million in the prior year.
  • The Company updated its full-year fiscal 2022 financial outlook.

CHIEF EXECUTIVE OFFICER REMARKS

“Our second quarter results, including comparable net sales growth of 8 percent, exceeded our expectations and demonstrated sustained momentum for our business and strong execution by our talented employees in what remains a dynamic operating environment,” said Mark Smucker, President and Chief Executive Officer. “We delivered robust organic top-line growth across each of our segments, reflecting consumers’ continued desire for our brands and the successful implementation of initial pricing actions.”

“We are pleased with our ability to increase our net sales and adjusted earnings per share expectations for the fiscal year despite increasing cost inflation and continued supply chain disruption. We remain confident that the actions we are taking to execute our strategy are positioning us to deliver sustainable growth and create shareholder value over the long term.”

SECOND QUARTER CONSOLIDATED RESULTS

Three Months Ended October 31,

2021

2020

% Increase
(Decrease)

(Dollars and shares in millions, except per share data)


Net sales

$2,050.0

$2,034.0

1

%


Operating income

$311.8

$380.8

(18)

%

Adjusted operating income

387.9

408.8

(5)

%


Net income per common share – assuming dilution

$1.90

$2.02

(6)

%

Adjusted earnings per share – assuming dilution

2.43

2.39

2

%


Weighted-average shares outstanding – assuming dilution

108.4

114.2

(5)

%

Net Sales

Net sales increased 1 percent. Excluding noncomparable net sales in the prior year of $135.7 million for the divested Crisco® and Natural Balance® businesses, as well as $5.6 million of favorable foreign currency exchange, net sales increased $146.1 million, or 8 percent.

The increase in comparable net sales was due to favorable volume/mix and higher net price realization for each of the Company’s U.S. Retail segments and for International and Away From Home. 

Operating Income

Gross profit decreased $106.7 million, or 13 percent, reflecting higher costs, primarily driven by increased commodity, manufacturing, transportation, and packaging costs, and the noncomparable impact of the Crisco® and Natural Balance® divestitures, partially offset by increased pricing and favorable volume/mix. Operating income decreased $69.0 million, or 18 percent, primarily driven by the decrease in gross profit, partially offset by a $35.1 million decrease in selling, distribution, and administrative (“SD&A”) expenses. 

Adjusted gross profit decreased $55.8 million, or 7 percent, with the difference from generally accepted accounting principles (“GAAP”) results being the exclusion of the change in net cumulative unallocated derivative gains and losses and special project costs. Adjusted operating income decreased $20.9 million, or 5 percent, further reflecting the exclusion of amortization and other special project costs.

Interest Expense, Other Income (Expense), and Income Taxes

Net interest expense decreased $4.8 million, primarily as a result of reduced debt outstanding as compared to the prior year.

Net other expense decreased $29.5 million, primarily due to the lapping of a $27.9 million noncash pre-tax pension settlement charge in the prior year related to the Company’s Canadian defined benefit pension plan, which was excluded from adjusted net income.

The effective income tax rate was 23.4 percent compared to 24.0 percent in the prior year. The adjusted effective income tax rate was 23.5 percent, compared to 24.0 percent in the prior year.

Cash Flow and Debt

Cash provided by operating activities was $165.1 million, compared to $378.7 million in the prior year, primarily reflecting an increase in working capital requirements, as compared to the prior year, mostly due to the timing of payments for accounts payable and accrued liabilities, and a decrease in net income adjusted for noncash items. Free cash flow was $105.9 million, compared to $326.3 million in the prior year, reflecting the decrease in cash provided by operating activities and a $6.8 million increase in capital expenditures. Net debt proceeds in the quarter totaled $1.4 million.

FULL-YEAR OUTLOOK

The Company updated its full-year fiscal 2022 guidance as summarized below:

Current

Previous

Net sales increase vs prior year

(0.5)% – 0.5%

(2.5)% – (1.5)%

Adjusted earnings per share

$8.35 – $8.75

$8.25 – $8.65

Free cash flow (in millions)

$700

$800

Capital expenditures (in millions)

$400

$380

Adjusted effective income tax rate

24.0%

24.0%

The pandemic and related implications, along with cost inflation and volatility in supply chains, continue to impact financial results and cause uncertainty and risk for the fiscal year 2022 outlook. Any manufacturing or supply chain disruption, inclusive of any labor shortages, whether related to illness, vaccine requirements, or other factors, as well as changes in consumer mobility and purchasing behavior, retailer inventory levels, and macroeconomic conditions could materially impact actual results. While the broader outlook remains uncertain, the Company continues to focus on managing the elements it can control, including taking the necessary steps to minimize the impact of cost inflation and any business or labor disruption. This guidance reflects performance expectations based on the Company’s current understanding of the environment.

Net sales are expected to range from down 0.5 percent to up 0.5 percent compared to the prior year, which incorporates an impact of $355.6 million related to the divested Crisco® and Natural Balance® businesses. On a comparable basis, net sales are expected to increase approximately 4.5 percent at the mid-point of the net sales guidance range, reflecting a deceleration in at-home consumption trends, more than offset by higher net pricing across multiple categories, continued double-digit net sales growth for the Smucker’s® Uncrustables® brand, and a recovery in away from home channels. The increase in net sales guidance reflects stronger than anticipated demand in the second quarter and remainder of the year, as well as incremental net pricing actions in the remainder of the fiscal year in response to higher costs.

Adjusted earnings per share is expected to range from $8.35 to $8.75, based on 108.3 million shares outstanding. The earnings guidance reflects the updated net sales outlook, adjusted gross profit margin to range from 35.0 to 35.5 percent, and SD&A expenses down approximately 7 percent compared to the prior year. The adjusted effective income tax rate is expected to be 24.0 percent, and free cash flow is expected to be approximately $700 million, with capital expenditures of $400 million.

SECOND QUARTER SEGMENT RESULTS

(Dollar amounts in the segment tables below are reported in millions.)

U.S. Retail Pet Foods

Net

Sales

Segment
Profit

Segment
Profit Margin

FY22 Q2 Results

$701.6

$99.6

14.2%

Increase (decrease) vs prior year

(1)%

(20)%

-340bps

Net sales decreased $7.1 million. Excluding $50.8 million of noncomparable net sales in the prior year related to the divested Natural Balance® business, net sales increased $43.7 million, or 7 percent. Higher net price realization across the portfolio increased net sales by 4 percentage points. Volume/mix increased net sales by 2 percentage points, primarily driven by the Milk-Bone®, Meow Mix®, and 9Lives® brands, as well as private label pet food, partially offset by decreases for the Pup-Peroni® and Kibbles ‘n Bits® brands.

Segment profit decreased $25.3 million, primarily reflecting higher commodity, manufacturing, and transportation costs, partially offset by the higher net pricing. 

U.S. Retail Coffee

Net

Sales

Segment
Profit

Segment
Profit Margin

FY22 Q2 Results

$645.1

$207.8

32.2%

Increase (decrease) vs prior year

8%

3%

-180bps

Net sales increased $50.4 million. Volume/mix increased net sales by 5 percentage points, driven by the Dunkin’® and Café Bustelo®  brands. Net price realization increased net sales by 3 percentage points, primarily reflecting list price increases and trade spend reductions for roast and ground products.

Segment profit increased $5.7 million, primarily reflecting higher net pricing and the increased contribution from volume/mix, partially offset by higher commodity costs.

U.S. Retail Consumer Foods

Net

Sales

Segment
Profit

Segment
Profit Margin

FY22 Q2 Results

$441.2

$111.0

25.2%

Increase (decrease) vs prior year

(8)%

(18)%

-300bps

Net sales decreased $37.9 million. Excluding $75.1 million of noncomparable net sales in the prior year related to the divested Crisco® business, net sales increased $37.2 million, or 9 percent. Volume/mix increased net sales by 6 percentage points, driven by Smucker’s® Uncrustables® frozen sandwiches and Jif® peanut butter. Higher net price realization contributed 3 percentage points of growth, primarily driven by Smucker’s® Uncrustables® frozen sandwiches and Smucker’s® fruit spreads.

Segment profit decreased $24.3 million, reflecting the noncomparable segment profit in the prior year related to the divested Crisco® business. Comparable segment profit growth from favorable volume/mix and higher net pricing was partially offset by higher manufacturing, transportation, ingredient, and packaging costs.

International and Away From Home

Net

Sales

Segment
Profit

Segment
Profit Margin

FY22 Q2 Results

$262.1

$40.4

15.4%

Increase (decrease) vs prior year

4%

2%

-30bps

Net sales increased $10.6 million. Excluding $9.8 million of noncomparable net sales in the prior year related to the divested Crisco® business and $5.6 million of favorable foreign currency exchange, net sales increased $14.8 million, or 6 percent. Comparable net sales growth of 25 percent for the Away from Home operating segment was partially offset by a 10 percent decline for the Company’s International operating segment. Volume/mix for the combined businesses increased net sales by 5 percentage points, primarily driven by increases for coffee, portion control spreads, and Smucker’s® Uncrustables® frozen sandwiches in away from home channels, partially offset by a decrease for baking mixes and ingredients in the International operating segment. Net price realization contributed a 1 percentage point increase.

Segment profit increased $0.9 million, primarily reflecting the increased contribution from volume/mix, higher net pricing, and favorable foreign currency exchange, partially offset by increased commodity costs and the noncomparable segment profit in the prior year related to the divested Crisco® business.

Financial Results Discussion and Webcast

At approximately 7:00 a.m. Eastern Standard Time today, the Company will post to its website at investors.jmsmucker.com a pre-recorded management discussion of its fiscal 2022 second quarter financial results, a transcript of the discussion, and supplemental materials. At 9:00 a.m. Eastern Standard Time today, the Company will webcast a live question and answer session with Mark Smucker, President and Chief Executive Officer, and Tucker Marshall, Chief Financial Officer. The live webcast and replay can be accessed at investors.jmsmucker.com.

The J.M. Smucker Co. Forward-Looking Statements

This press release contains forward-looking statements, such as projected net sales, operating results, earnings, and cash flows that are subject to risks and uncertainties that could cause actual results to differ materially from future results expressed or implied by those forward-looking statements. The risks, uncertainties, important factors, and assumptions listed and discussed in this press release, which could cause actual results to differ materially from those expressed, include: the impact of the COVID-19 pandemic on the Company’s business, industry, suppliers, customers, consumers, employees, and communities, particularly with respect to the Company’s Away From Home business; disruptions or inefficiencies in the Company’s operations or supply chain, including any impact of the COVID-19 pandemic and labor shortages resulting from, among other things, the implementation of vaccination requirements; volatility of commodity, energy, and other input costs; risks associated with derivative and purchasing strategies the Company employs to manage commodity pricing and interest rate risks; the availability of reliable transportation on acceptable terms, including any impact of the COVID-19 pandemic; the ability to achieve cost savings related to restructuring and cost management programs in the amounts and within the time frames currently anticipated; the ability to generate sufficient cash flow to continue operating under the Company’s capital deployment model, including capital expenditures, debt repayment, dividend payments, and share repurchases; the ability to implement and realize the full benefit of price changes, and the impact of the timing of the price changes to profits and cash flow in a particular period; the success and cost of marketing and sales programs and strategies intended to promote growth in the Company’s businesses, including product innovation; general competitive activity in the market, including competitors’ pricing practices and promotional spending levels; the impact of food security concerns involving either the Company’s products or its competitors’ products; the impact of accidents, extreme weather, natural disasters, and pandemics (such as COVID-19); the concentration of certain of the Company’s businesses with key customers and suppliers, including single-source suppliers of certain key raw materials and finished goods, and the Company’s ability to manage and maintain key relationships; impairments in the carrying value of goodwill, other intangible assets, or other long-lived assets or changes in the useful lives of other intangible assets or other long-lived assets; the impact of new or changes to existing governmental laws and regulations and their application, including tariffs and COVID-19 vaccination requirements; the outcome of tax examinations, changes in tax laws, and other tax matters; foreign currency exchange rate and interest rate fluctuations; and risks related to other factors described under “Risk Factors” in other reports and statements filed with the Securities and Exchange Commission, including the Company’s most recent Annual Report on Form 10-K. The Company undertakes no obligation to update or revise these forward-looking statements, which speak only as of the date made, to reflect new events or circumstances.

About The J.M. Smucker Co.

Each generation of consumers leaves their mark on culture by establishing new expectations for food and the companies that make it. At The J.M. Smucker Co., it is our privilege to be at the heart of this dynamic with a diverse portfolio that appeals to each generation of people and pets and is found in nearly 90 percent of U.S. homes and countless restaurants. This includes a mix of iconic brands consumers have always loved such as Folgers®, Jif® and Milk-Bone® and new favorites like Café Bustelo®,Smucker’s® Uncrustables®and Rachael Ray® Nutrish®. By continuing to immerse ourselves in consumer preferences and acting responsibly, we will continue growing our business and the positive impact we have on society. For more information, please visit jmsmucker.com.

The J.M. Smucker Co. is the owner of all trademarks referenced herein, except for the following, which are used under license: Dunkin’® is a trademark of DD IP Holder LLC, and Rachael Ray® is a trademark of Ray Marks II LLC.

The Dunkin’®brand is licensed to The J.M. Smucker Co. for packaged coffee products sold in retail channels such as grocery stores, mass merchandisers, club stores, e-commerce and drug stores. This information does not pertain to products for sale in Dunkin’®restaurants.

 

The J.M. Smucker Co.

Unaudited Condensed Consolidated Statements of Income

Three Months Ended October 31,

Six Months Ended October 31,

2021

2020

% Increase
(Decrease)

2021

2020

% Increase
(Decrease)

(Dollars and shares in millions, except per share data)

Net sales

$2,050.0

$2,034.0

1

%

$3,908.0

$4,005.8

(2)

%

Cost of products sold

1,338.5

1,215.8

10

%

2,557.1

2,412.2

6

%


Gross Profit

711.5

818.2

(13)

%

1,350.9

1,593.6

(15)

%


Gross margin


34.7


%


40.2


%


34.6


%


39.8


%

Selling, distribution, and administrative expenses

347.7

382.8

(9)

%

671.7

740.3

(9)

%

Amortization

55.4

59.5

(7)

%

110.8

119.1

(7)

%

Other special project costs

1.3

n/m

3.1

n/m

Other operating expense (income) – net

(4.7)

(4.9)

(4)

%

(5.9)

(7.7)

(23)

%


Operating Income

311.8

380.8

(18)

%

571.2

741.9

(23)

%


Operating margin


15.2


%


18.7


%


14.6


%


18.5


%

Interest expense – net

(40.3)

(45.1)

(11)

%

(83.4)

(91.2)

(9)

%

Other income (expense) – net

(2.7)

(32.2)

(92)

%

(13.8)

(33.6)

(59)

%


Income Before Income Taxes

268.8

303.5

(11)

%

474.0

617.1

(23)

%

Income tax expense

62.8

72.7

(14)

%

114.1

149.3

(24)

%


Net Income

$206.0

$230.8

(11)

%

$359.9

$467.8

(23)

%


Net income per common share

$1.90

$2.02

(6)

%

$3.32

$4.10

(19)

%


Net income per common share – assuming
dilution

$1.90

$2.02

(6)

%

$3.32

$4.10

(19)

%


Dividends declared per common share

$0.99

$0.90

10

%

$1.98

$1.80

10

%

Weighted-average shares outstanding

108.4

114.2

(5)

%

108.3

114.1

(5)

%

Weighted-average shares outstanding –
assuming dilution

108.4

114.2

(5)

%

108.4

114.1

(5)

%

 

The J.M. Smucker Co.

Unaudited Condensed Consolidated Balance Sheets 

October 31, 2021

April 30, 2021

(Dollars in millions)


Assets


Current Assets

Cash and cash equivalents

$155.3

$334.3

Trade receivables – net

659.1

533.7

Inventories

1,100.2

959.9

Other current assets

94.2

113.8


Total Current Assets

2,008.8

1,941.7


Property, Plant, and Equipment – Net

2,015.2

2,001.5


Other Noncurrent Assets

Goodwill

6,022.3

6,023.6

Other intangible assets – net

5,930.4

6,041.2

Other noncurrent assets

264.1

276.2


Total Other Noncurrent Assets

12,216.8

12,341.0


Total Assets

$16,240.8

$16,284.2


Liabilities and Shareholders’ Equity


Current Liabilities

Accounts payable

$1,031.0

$1,034.1

Current portion of long-term debt

1,152.9

Short-term borrowings

320.0

82.0

Other current liabilities

539.5

598.5


Total Current Liabilities

1,890.5

2,867.5


Noncurrent Liabilities

Long-term debt, less current portion

4,308.8

3,516.8

Other noncurrent liabilities

1,755.1

1,775.1


Total Noncurrent Liabilities

6,063.9

5,291.9


Total Shareholders’ Equity

8,286.4

8,124.8


Total Liabilities and Shareholders’ Equity

$16,240.8

$16,284.2

 

The J.M. Smucker Co.

Unaudited Condensed Consolidated Statements of Cash Flow

Three Months Ended October 31,

Six Months Ended October 31,

2021

2020

2021

2020

(Dollars in millions)


Operating Activities

Net income

$206.0

$230.8

$359.9

$467.8

Adjustments to reconcile net income to net cash
provided by (used for) operations:

Depreciation

60.5

54.1

119.0

108.2

Amortization

55.4

59.5

110.8

119.1

Pension settlement loss (gain)

2.5

30.6

6.2

30.6

Share-based compensation expense

5.3

7.5

10.6

13.4

Other noncash adjustments – net

3.4

3.5

6.5

7.3

Make-whole payments included in financing activities

7.0

Changes in assets and liabilities:

Trade receivables

(92.7)

(79.3)

(125.6)

(24.2)

Inventories

5.5

1.0

(140.8)

(97.5)

Other current assets

30.2

8.2

38.2

8.5

Accounts payable

(36.7)

66.4

(8.2)

107.5

Accrued liabilities

(9.4)

58.7

(53.3)

65.8

Income and other taxes

(65.4)

(67.5)

(18.0)

(24.1)

Other – net

0.5

5.2

(9.4)

5.3


Net Cash Provided by (Used for) Operating Activities

165.1

378.7

302.9

787.7


Investing Activities

Additions to property, plant, and equipment

(59.2)

(52.4)

(127.2)

(129.0)

Other – net

(3.8)

0.7

(15.8)

28.1


Net Cash Provided by (Used for) Investing Activities

(63.0)

(51.7)

(143.0)

(100.9)


Financing Activities

Short-term borrowings (repayments) – net

(46.2)

(16.1)

237.8

31.7

Proceeds from long-term debt

797.6

797.6

Repayments of long-term debt, including make-whole
payments

(750.0)

(200.0)

(1,157.0)

(500.0)

Capitalized debt issuance costs

(10.2)

(10.2)

Quarterly dividends paid

(106.9)

(102.3)

(204.1)

(202.4)

Purchase of treasury shares

(0.7)

(1.6)

(7.5)

(6.2)

Proceeds from stock option exercises

0.7

4.0

0.7

Other – net

0.9

0.8

0.6

0.4


Net Cash Provided by (Used for) Financing Activities

(115.5)

(318.5)

(338.8)

(675.8)

Effect of exchange rate changes on cash

(0.1)

0.5

(0.1)

3.5

Net increase (decrease) in cash and cash equivalents

(13.5)

9.0

(179.0)

14.5

Cash and cash equivalents at beginning of period

168.8

396.6

334.3

391.1


Cash and Cash Equivalents at End of Period

$155.3

$405.6

$155.3

$405.6

 

The J.M. Smucker Co.

Unaudited Supplemental Schedule

Three Months Ended October 31,

Six Months Ended October 31,

2021

% of

Net Sales

2020

% of

Net Sales

2021

% of

Net Sales

2020

% of

Net Sales

(Dollars in millions)

Net sales

$2,050.0

$2,034.0

$3,908.0

$4,005.8

Selling, distribution, and
administrative expenses:

Marketing

121.4

5.9

%

125.3

6.2

%

219.9

5.6

%

247.0

6.2

%

Selling

54.1

2.6

%

58.3

2.9

%

116.1

3.0

%

124.1

3.1

%

Distribution

70.7

3.4

%

70.4

3.5

%

139.1

3.6

%

140.2

3.5

%

General and administrative

101.5

5.0

%

128.8

6.3

%

196.6

5.0

%

229.0

5.7

%

Total selling, distribution, and
administrative expenses

$347.7

17.0

%

$382.8

18.8

%

$671.7

17.2

%

$740.3

18.5

%

Amounts may not add due to rounding.

 

The J.M. Smucker Co.

Unaudited Reportable Segments

Three Months Ended October 31,

Six Months Ended October 31,

2021

2020

2021

2020

(Dollars in millions)

Net sales:

U.S. Retail Pet Foods

$701.6

$708.7

$1,349.6

$1,401.3

U.S. Retail Coffee

645.1

594.7

1,188.3

1,165.6

U.S. Retail Consumer Foods

441.2

479.1

876.8

968.3

International and Away From Home

262.1

251.5

493.3

470.6

Total net sales

$2,050.0

$2,034.0

$3,908.0

$4,005.8

Segment profit:

U.S. Retail Pet Foods

$99.6

$124.9

$179.5

$250.2

U.S. Retail Coffee

207.8

202.1

359.1

384.7

U.S. Retail Consumer Foods

111.0

135.3

229.7

266.8

International and Away From Home

40.4

39.5

73.3

70.4

Total segment profit

$458.8

$501.8

$841.6

$972.1

Amortization

(55.4)

(59.5)

(110.8)

(119.1)

Interest expense – net

(40.3)

(45.1)

(83.4)

(91.2)

Change in net cumulative unallocated derivative gains
and losses

(13.3)

31.5

(15.5)

47.7

Cost of products sold – special project costs

(6.1)

(10.7)

Other special project costs

(1.3)

(3.1)

Corporate administrative expenses

(70.9)

(93.0)

(130.3)

(158.8)

Other income (expense) – net

(2.7)

(32.2)

(13.8)

(33.6)

Income before income taxes

$268.8

$303.5

$474.0

$617.1

Segment profit margin:

U.S. Retail Pet Foods

14.2

%

17.6

%

13.3

%

17.9

%

U.S. Retail Coffee

32.2

%

34.0

%

30.2

%

33.0

%

U.S. Retail Consumer Foods

25.2

%

28.2

%

26.2

%

27.6

%

International and Away From Home

15.4

%

15.7

%

14.9

%

15.0

%

Non-GAAP Financial Measures

The Company uses non-GAAP financial measures, including: net sales excluding divestitures and foreign currency exchange; adjusted gross profit; adjusted operating income; adjusted income; adjusted earnings per share; earnings before interest, taxes, depreciation, amortization, and impairment charges related to intangible assets (“EBITDA (as adjusted)”); and free cash flow, as key measures for purposes of evaluating performance internally. The Company believes that investors’ understanding of its performance is enhanced by disclosing these performance measures. Furthermore, these non-GAAP financial measures are used by management in preparation of the annual budget and for the monthly analyses of its operating results. The Board of Directors also utilizes certain non-GAAP financial measures as components for measuring performance for incentive compensation purposes.

Non-GAAP financial measures exclude certain items affecting comparability that can significantly affect the year-over-year assessment of operating results, which include amortization expense and impairment charges related to intangible assets; divestiture, acquisition, integration, and restructuring costs (“special project costs”); gains and losses related to the sale of a business; the net change in cumulative unallocated gains and losses on commodity and foreign currency exchange derivative activities (“change in net cumulative unallocated derivative gains and losses”); and other one-time items that do not directly reflect ongoing operating results. Income taxes, as adjusted is calculated using an adjusted effective income tax rate that is applied to adjusted income before income taxes and reflects the exclusion of the previously discussed items, as well as any adjustments for one-time tax-related activities, when they occur. While this adjusted effective income tax rate does not generally differ materially from the GAAP effective income tax rate, certain exclusions from non-GAAP results can significantly impact the adjusted effective income tax rate.

These non-GAAP financial measures are not intended to replace the presentation of financial results in accordance with U.S. GAAP. Rather, the presentation of these non-GAAP financial measures supplements other metrics used by management to internally evaluate its businesses and facilitate the comparison of past and present operations and liquidity. These non-GAAP financial measures may not be comparable to similar measures used by other companies and may exclude certain nondiscretionary expenses and cash payments. A reconciliation of certain non-GAAP financial measures to the comparable GAAP financial measure for the current and prior year periods is included in the “Unaudited Non-GAAP Financial Measures” tables. The Company has also provided a reconciliation of non-GAAP financial measures for its fiscal 2022 outlook. 

The J.M. Smucker Co.

Unaudited Non-GAAP Financial Measures

Three Months Ended October 31,

Six Months Ended October 31,

2021

2020

Increase
(Decrease)

%

2021

2020

Increase
(Decrease)

%

(Dollars in millions)

Net sales reconciliation:

Net sales

$2,050.0

$2,034.0

$16.0

1

%

$3,908.0

$4,005.8

($97.8)

(2)

%


Crisco® divestiture

(84.9)

84.9

4

(164.4)

164.4

4


Natural Balance® divestiture

(50.8)

50.8

2

(106.8)

106.8

3

Foreign currency exchange

(5.6)

(5.6)

(16.0)

(16.0)

Net sales excluding divestitures
and foreign currency exchange

$2,044.4

$1,898.3

$146.1

8

%

$3,892.0

$3,734.6

$157.4

4

%

Amounts may not add due to rounding.

 

The J.M. Smucker Co.

Unaudited Non-GAAP Financial Measures

Three Months Ended October 31,

Six Months Ended October 31,

2021

2020

2021

2020

(Dollars in millions, except per share data)

Gross profit reconciliation:

Gross profit

$711.5

$818.2

$1,350.9

$1,593.6

Change in net cumulative unallocated derivative
gains and losses

13.3

(31.5)

15.5

(47.7)

Cost of products sold – special project costs

6.1

10.7

Adjusted gross profit

$730.9

$786.7

$1,377.1

$1,545.9


% of net sales


35.7


%


38.7


%


35.2


%


38.6


%

Operating income reconciliation:

Operating income

$311.8

$380.8

$571.2

$741.9

Amortization

55.4

59.5

110.8

119.1

Change in net cumulative unallocated derivative
gains and losses

13.3

(31.5)

15.5

(47.7)

Cost of products sold – special project costs

6.1

10.7

Other special project costs

1.3

3.1

Adjusted operating income

$387.9

$408.8

$711.3

$813.3


% of net sales


18.9


%


20.1


%


18.2


%


20.3


%

Net income reconciliation:

Net income

$206.0

$230.8

$359.9

$467.8

Income tax expense

62.8

72.7

114.1

149.3

Amortization

55.4

59.5

110.8

119.1

Change in net cumulative unallocated derivative
gains and losses

13.3

(31.5)

15.5

(47.7)

Cost of products sold – special project costs

6.1

10.7

Other special project costs

1.3

3.1

Other one-time items:

Pension plan termination settlement charge (A)

27.9

27.9

Adjusted income before income taxes

$344.9

$359.4

$614.1

$716.4

Income taxes, as adjusted

81.1

86.2

144.5

173.2

Adjusted income

$263.8

$273.2

$469.6

$543.2

Weighted-average common shares outstanding

108.1

113.7

108.0

113.6

Weighted-average participating shares outstanding

0.3

0.5

0.3

0.5

Total weighted-average shares outstanding

108.4

114.2

108.3

114.1

Dilutive effect of stock options

0.1

Total weighted-average shares outstanding – assuming
dilution

108.4

114.2

108.4

114.1

Adjusted earnings per share – assuming dilution

$2.43

$2.39

$4.33

$4.76

(A) Represents the nonrecurring pre-tax settlement charge related to the purchase of a group annuity contract to transfer the obligations of the Company’s Canadian defined benefit pension plan to an insurance company.

 

The J.M. Smucker Co.

Unaudited Non-GAAP Financial Measures

Three Months Ended October 31,

Six Months Ended October 31,

2021

2020

2021

2020

(Dollars in millions)

EBITDA (as adjusted) reconciliation:

Net income

$206.0

$230.8

$359.9

$467.8

Income tax expense

62.8

72.7

114.1

149.3

Interest expense – net

40.3

45.1

83.4

91.2

Depreciation

60.5

54.1

119.0

108.2

Amortization

55.4

59.5

110.8

119.1

EBITDA (as adjusted)

$425.0

$462.2

$787.2

$935.6


% of net sales


20.7


%


22.7


%


20.1


%


23.4


%

Free cash flow reconciliation:

Net cash provided by (used for) operating activities

$165.1

$378.7

$302.9

$787.7

Additions to property, plant, and equipment

(59.2)

(52.4)

(127.2)

(129.0)

Free cash flow

$105.9

$326.3

$175.7

$658.7

 

The following tables provide a reconciliation of the Company’s fiscal 2022 guidance for estimated adjusted earnings per share and free cash flow.

Year Ending April 30, 2022

Low

High

Net income per common share – assuming dilution reconciliation:

Net income per common share – assuming dilution

$6.17

$6.57

Change in net cumulative unallocated derivative gains and losses (A)

0.43

0.43

Amortization

1.54

1.54

Special project costs

0.18

0.18

Adjusted effective income tax rate impact

0.03

0.03

Adjusted earnings per share

$8.35

$8.75

(A) We are unable to project derivative gains and losses on a forward-looking basis as these will vary each quarter based on market conditions and derivative positions taken. The change in unallocated derivative gains and losses in the table above reflects the net impact of the gains and losses that have been recognized in our GAAP results and excluded from non-GAAP results as of October 31, 2021, adjusted for the gains and losses expected to be allocated to non-GAAP results for the year ended April 30, 2022.

Year Ending
April 30, 2022

(Dollars in
millions)

Free cash flow reconciliation:

Net cash provided by operating activities

$1,100

Additions to property, plant, and equipment

(400)

Free cash flow

$700

 

 

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SOURCE The J.M. Smucker Co.

Amryt Provides Update on Regulatory Review Process for Oleogel-S10

Amryt Provides Update on Regulatory Review Process for Oleogel-S10

FDA
PDUFA
goal date extended by three months to
February 28, 2022

EMA CHMP opinion now expected
in
January 2022

DUBLIN, Ireland, and Boston MA, November
23
, 2021, Amryt (Nasdaq: AMYT, AIM: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today announces that the US Food and Drug Administration (“FDA”) has extended the review period for the New Drug Application (“NDA”) for Oleogel-S10 for the treatment of the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (“EB”), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.

The FDA extended the Prescription Drug User Fee Act (“PDUFA”) goal date to allow time to review additional analyses of data previously submitted by Amryt. The submission of this additional information has been determined by the FDA to constitute a Major Amendment to the NDA, resulting in an extension of the PDUFA goal date by three months to February 28, 2022. This is a standard review extension period to allow the FDA additional time to review information already submitted by Amryt. At the same time, the FDA also issued a new Information Request regarding existing study data in order to continue the FDA’s evaluation of Amryt’s NDA.

In June 2021, Amryt received confirmation from the FDA that its NDA for Oleogel-S10 had been accepted and granted priority review. The PDUFA goal date extension has no impact on the priority review status of Oleogel-S10.

The European Medicines Agency (“EMA”) review process for Oleogel-S10 in EB is ongoing and Amryt is in the process of responding to the remaining Major Objections in the List of Outstanding Issues sent by the EMA. The Committee for Medicinal Products for Human Use (“CHMP”) opinion is now expected in January 2022.

Dr Joe Wiley, CEO of Amryt Pharma, commented:

We are well positioned to address the
se
regulatory
requests
from our existing data
within the time period
s
required and w
e look forward to
our
continued productive discussions
as the
regulatory agencies
complete their review.
If approved, w
e
are
confident
in
the potential for
Oleogel-S10
to be an effective therapy for patients suffering from this terrible condition
and are ready to launch what will be the first to market novel therapy
in EB
.”

Amryt’s previously issued revenue guidance for FY 2021 in the range of $220M – $225M which represents growth of 20% to 23% on FY 2020 is unaffected by the new regulatory timelines.

About
Epidermolysis Bullosa

Epidermolysis Bullosa (EB) is a rare and devastating group of hereditary disorders of the skin, mucous membranes, and internal epithelial linings characterized by extreme skin fragility and blister development. Patients with severe forms of EB suffer from severe, chronic blistering, ulceration and scarring of the skin, mutilating scarring of the hands and feet, joint contractures, strictures of the esophagus and mucous membranes, a high risk of developing aggressive squamous cell carcinomas, infections and risk of premature death. The global market opportunity for EB is estimated by the Company to be in excess of $1.0 billion.

About Amryt

Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets.

Amryt’s commercial business comprises three orphan disease products – metreleptin (Myalept®/ Myalepta®); oral octreotide (Mycapssa®); and lomitapide (Juxtapid®/ Lojuxta®).

Myalept®/Myalepta® (metreleptin) is approved in the US (under the trade name Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name Myalepta®) as an adjunct to diet for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. For additional information, please follow this link.

Mycapssa® (oral octreotide) is approved in the US for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Mycapssa® is the first and only oral somatostatin analog approved by the FDA. Mycapssa® has also been submitted to the EMA for regulatory approval. For additional information, please follow this link.

Juxtapid®/Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia (“HoFH”) in the US, Canada, Colombia, Argentina and Japan (under the trade name Juxtapid®) and in the EU, Israel and Brazil (under the trade name Lojuxta®). For additional information, please follow this link.

Amryt’s lead development candidate, Oleogel-S10 (Filsuvez®) is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (“EB”), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. Filsuvez® has been selected as the brand name for Oleogel-S10. The product does not currently have regulatory approval to treat EB and is under review by the FDA and EMA.

Amryt’s pre-clinical gene therapy candidate, AP103, offers a potential treatment for patients with Dystrophic EB, and the polymer-based delivery platform has the potential to be developed for the treatment of other genetic disorders.

Amryt also intends to develop oral medications that are currently only available as injectable therapies through its Transient Permeability Enhancer (TPE®) technology platform. For more information on Amryt, including products, please visit www.amrytpharma.com.

This announcement contains inside information for the purposes of article 7 of the Market Abuse Regulation (EU) 596/2014.  The person making this notification on behalf of Amryt is Rory Nealon, CFO/COO and Company Secretary.

Financial Advisors        
Shore Capital (Daniel Bush, Mark Percy, John More) are NOMAD and Joint Broker to Amryt in the UK. Stifel (Ben Maddison) are Joint Broker to the company in the UK.

Forward-Looking Statements

This announcement may contain forward-looking statements and the words “expect”, “anticipate”, “intends”, “plan”, “estimate”, “aim”, “forecast”, “project” and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Amryt’s present and future business strategies and the environment in which Amryt expects to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond Amryt’s ability to control or estimate precisely, such as future market conditions, the course of the COVID-19 pandemic, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Amryt’s ability to obtain financing, changes in the political, social and regulatory framework in which Amryt operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information that may arise in connection with it. Such forward-looking statements reflect the Company’s current beliefs and assumptions and are based on information currently available to management.
Contacts

Joe Wiley, CEO / Rory Nealon, CFO/COO, +353 (1) 518 0200, [email protected]

Daniel Bush, Shore Capital, NOMAD +44 (0) 207 408 4090, [email protected]

Tim McCarthy, LifeSci Advisors, LLC, +1 (212) 915 2564, [email protected]

Amber Fennell, Consilium Strategic Communications, +44 (0) 203 709 5700, [email protected]



COMPASS Pathways granted fifth US patent for crystalline psilocybin

London, UK – 23 November 2021

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that it has been granted its fifth patent by the US Patent and Trademark Office (USPTO). This is COMPASS’s 10th patent overall, with five now granted in the US, two in the UK, one in Germany and two in Hong Kong.

The new patent, US Patent No 11,180,517, covers methods of treating treatment-resistant depression (TRD) with crystalline psilocybin as well as with oral dosage forms of crystalline psilocybin with an excipient. Crystalline psilocybin is used in COMP360, COMPASS’s synthesised psilocybin formulation being developed for psilocybin therapy in TRD.

George Goldsmith, CEO and Co-founder, COMPASS Pathways, said: “This 10th patent is a strong testament to our innovation. Patents enable us to continue to do the highest quality clinical research so we can work to bring therapies to patients who are suffering with serious mental health challenges and have few options.”  

About COMPASS Pathways 

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. www.compasspathways.com

Availability of other information about COMPASS Pathways 

Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-looking statements 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “could”, “work to”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, COMPASS’s business strategy and goals, its ability to bring its products to patients, the benefits of additional patent protection to help enhance our clinical research and achieve our commercialisation strategy and goals, and COMPASS’s expectations regarding the benefits of its psilocybin therapy. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond COMPASS’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties, and other factors include, among others: preclinical research and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic; and those risks and uncertainties described under the heading “Risk Factors” in COMPASS’s annual report on Form 20-F filed with the US Securities and Exchange Commission (SEC) on 9 March 2021 and in subsequent filings made by COMPASS with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS’s current expectations and speak only as of the date hereof.

Enquiries

Media: Tracy Cheung, [email protected], +44 7966 309024
Investors: Stephen Schultz, [email protected], +1 401 290 7324



Tonix Pharmaceuticals Announces FDA Clearance of the IND for Potentiated Intranasal Oxytocin (TNX-1900) for the Prevention of Migraine Headache in Chronic Migraineurs

Approximately Four Million in U.S. Suffer from Chronic Migraine

Development of TNX-1900 Also Planned for Treatment of Episodic Migraine, Craniofacial Pain and Insulin Resistance

CHATHAM, N.J., Nov. 23, 2021 (GLOBE NEWSWIRE) —  Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) Application to support the initiation of a Phase 2 study of TNX-1900* (intranasal potentiated oxytocin) for the prevention of migraine headache in chronic migraineurs. The program is expected to qualify for the 505(b)(2) pathway for FDA approval, which is available to new formulations of an approved drug.

“We are excited to have received the FDA’s IND clearance to begin clinical trials for TNX-1900 in prevention of migraine headaches in chronic migraineurs,” said Seth Lederman, M.D., President and CEO of Tonix. “An estimated four million individuals in the United States suffer from chronic migraine. We believe that by engaging and stimulating oxytocin receptors in the trigeminal ganglia, TNX-1900 has the potential to help chronic migraine sufferers. TNX-1900 contains magnesium, which potentiates the action of oxytocin at oxytocin receptors in animal models. We expect to begin enrollment in the TNX-1900 Phase 2 study in the second half of 2022.” Dr. Lederman added, “We also plan to develop TNX-1900 for craniofacial pain as well as insulin resistance. A related intranasal potentiated oxytocin product candidate, TNX-2900*, is under development for the treatment of Prader-Willi syndrome.”

*TNX-1900 and TNX-2900 are investigational new drugs and have not been approved for any indication.

About Migraine

Migraine is a neurological condition that manifests in throbbing headache, often on one side of the head, that lasts at least four hours. It can also be accompanied by nausea, vomiting, visual disturbances, and sensitivity to bright light, strong smells, and loud noises1. Epidemiological studies indicate that globally, approximately 1.2 billion individuals suffer from migraines annually.2 In the U.S., approximately 39 million Americans suffer from migraines and among these individuals, approximately four million experience chronic migraines (15 or more headache days per month).2  

About TNX-1900

TNX-1900 (intranasal potentiated oxytocin) is a proprietary formulation of oxytocin in development as a candidate for prophylaxis of chronic migraine and for the treatment of craniofacial pain, insulin resistance and related conditions. In 2020, TNX-1900 was acquired from Trigemina, Inc. and licensed from Stanford University. TNX-1900 is a drug-device combination product, based on an intranasal actuator device that delivers oxytocin into the nose. Oxytocin is a naturally occurring human hormone that acts as a neurotransmitter in the brain. Oxytocin has no recognized addiction potential. It has been observed that low oxytocin levels in the body can lead to increase in migraine headache frequency, and that increased oxytocin levels can relieve migraine headaches. Certain other chronic pain conditions are also associated with decreased oxytocin levels. Migraine attacks are caused, in part, by the activity of pain-sensing trigeminal nerve cells which, when activated, release of CGRP which binds to receptors on other nerve cells and starts a cascade of events that is believed to result in headache. Oxytocin when delivered via the nasal route, concentrates in the trigeminal system3 resulting in binding of oxytocin to receptors on neurons in the trigeminal system, inhibiting transmission of pain signals and the release of CGRP.4 Blocking CGRP release is a distinct mechanism compared with CGRP antagonist and anti-CGRP antibody drugs, which block the binding of CGRP to its receptor. With TNX-1900, the addition of magnesium to the oxytocin formula enhances oxytocin receptor binding5 as well as its effects on trigeminal neurons and craniofacial analgesic effects in animal models7. Intranasal oxytocin has been well tolerated in several clinical trials in both adults and children6. Targeted nasal delivery results in low systemic exposure and lower risk of non-nervous system, off-target effects which could potentially occur with systemic CGRP antagonists such as anti-CGRP antibodies8. For example, CGRP has roles in dilating blood vessels in response to ischemia, including in the heart. We believe nasally targeted delivery of oxytocin could translate into selective blockade of CGRP release in the trigeminal ganglion and not throughout the body, which could be a potential safety advantage over systemic CGRP inhibition. In addition, daily dosing is more quickly reversible, in contrast to monthly or quarterly dosing, as is the case with anti-CGRP antibodies, giving physicians and their patients greater control. We intend to initiate a Phase 2 study in chronic migraine in the second half of 2022. We also plan to develop TNX-1900 for treatment of episodic migraine, craniofacial pain and insulin resistance. Tonix has a license with the University of Geneva to use TNX-1900 for the treatment of insulin resistance and related conditions. TNX-2900* is another intranasal potentiated oxytocin-based therapeutic candidate, being developed for the treatment of Prader-Willi syndrome, or PWS. The technology for TNX-2900 was licensed from the French National Institute of Health and Medical Research. PWS, an orphan condition, is a rare genetic disorder of failure to thrive in infancy, associated with uncontrolled appetite later in childhood.

1
https://www.mayoclinic.org/diseases-conditions/migraine-headache/symptoms-causes/syc-20360201



2Burch et al., Migraine: Epidemiology, Burden, and Comorbidity, Neurol Clin 37 (2019) 631–649.
3Yeomans DC, et al. TranslPsychiatry. 2021. 11(1):388.
4Tzabazis A, et al. Cephalalgia. 2016. 36(10):943-50.
5Antoni FA and Chadio SE. Biochem J. 1989. 257(2):611-4.
6Yeomans, DC et al. 2017. US patent US2017368095
7Cai Q, et al., Psychiatry Clin Neurosci. 2018. Mar;72(3):140-151.
8MaassenVanDenBrink A, et al. Trends PharmacolSci. 2016. 37(9):779-788

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of immunology and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes COVID-19-related product candidates to prevent and treat COVID-19, to treat Long COVID as well as to detect functional T cell immunity to SARS-CoV-2. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL1 (cyclobenzaprine HCl sublingual tablets), is in mid-Phase 3 development for the management of fibromyalgia. TNX-13002 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial before year end. Tonix’s lead vaccine candidate for COVID-19, TNX-18003, is a live replicating vaccine based on Tonix’s recombinant pox vaccine (RPV) platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects to start a Phase 1 study in humans in the second half of 2022. Tonix is developing TNX-21004, an in vivo diagnostic to measure the presence of functional T cell immunity to SARS-CoV-2 and intends to initiate a first-in-human clinical study in the first quarter of 2022. TNX-35005 (sangivamycin) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. Finally, TNX-102 SL is a small molecule drug being developed to treat Long COVID, a chronic post-COVID condition, and is also in the pre-IND stage. Tonix expects to conduct a Phase 2 study in Long COVID in the first half of 2022. Tonix’s immunology portfolio also includes biologics to address immunosuppression, cancer, and autoimmune diseases.


1

TNX-102 SL is an investigational new drug and has not been approved for any indication.


2

TNX-1300 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.


3

TNX-1800 is an investigational new biologic and has not been approved for any indication. TNX-1800 is based on TNX-801, live horsepox virus vaccine for percutaneous administration, which is in development to protect against smallpox and monkeypox. TNX-801 is an investigational new biologic and has not been approved for any indication.


4

TNX-2100 is an investigational new biologic and has not been approved for any indication
.


5

TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the “SEC”) on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)

Tonix Pharmaceuticals
[email protected]
(862) 904-8182

Olipriya Das, Ph.D. (media)

Russo Partners
[email protected]
(646) 942-5588

Peter Vozzo (investors)

ICR Westwicke
[email protected]
(443) 213-0505



Par Pacific Management to Participate in Investor Conferences

HOUSTON, Nov. 23, 2021 (GLOBE NEWSWIRE) — Par Pacific Holdings, Inc. (NYSE: PARR) (“Par Pacific”) today announced that members of its management team will participate in the following conferences.

  • Cowen 2021 Energy Summit on December 1, 2021, virtually
  • Goldman Sachs 2022 Global Energy and Clean Technology Conference on January 6, 2022 in Aventura, FL

The most current investor presentation is available on the Investors section of Par Pacific’s website at www.parpacific.com.


About Par Pacific

Par Pacific Holdings, Inc. (NYSE: PARR), headquartered in Houston, Texas, owns and operates market-leading energy, infrastructure, and retail businesses. Par Pacific’s strategy is to acquire and develop businesses in logistically complex markets. Par Pacific owns and operates one of the largest energy networks in Hawaii with 94,000 bpd of operating refining capacity, a logistics system supplying the major islands of the state and 90 retail locations. In the Pacific Northwest and the Rockies, Par Pacific owns and operates 60,000 bpd of combined refining capacity, related multimodal logistics systems, and 30 retail locations.  Par Pacific also owns 46% of Laramie Energy, LLC, a natural gas production company with operations and assets concentrated in Western Colorado. More information is available at www.parpacific.com.

For more information contact:

Ashimi Patel
Senior Manager, Investor Relations
(832) 916-3355
[email protected]



Prelude Therapeutics to Participate at the 4th Annual Evercore ISI HealthCONx Conference

WILMINGTON, Del., Nov. 23, 2021 (GLOBE NEWSWIRE) — Prelude Therapeutics Inc. (Nasdaq: PRLD), a clinical-stage precision oncology company, today announced that Kris Vaddi, PhD, Chief Executive Officer, will participate in a fireside chat at the 4th Annual Evercore ISI HealthCONx Conference taking place on Wednesday, December 1, 2021 at 9:15 am ET.

A live webcast of the fireside chat will be available on the “Investors” page under the “Events & Presentation” section of the Prelude website, where a replay of the fireside chat will be available for a limited time.

About Prelude Therapeutics

Prelude Therapeutics is a clinical-stage precision oncology company developing innovative, potential best-in-class molecules targeting critical cancer cell pathways involved in cancer pathogenesis. Prelude’s initial clinical candidates, PRT543 and PRT811, are potent, selective, oral PRMT5 inhibitors in Phase 1 development for the treatment of advanced solid tumors, primary and secondary CNS cancers and select myeloid malignancies. PRT1419, a potent and selective MCL1 inhibitor, is in Phase 1 development for patients with relapsed/refractory hematologic malignancies and solid tumors. PRT2527, a highly selective CDK9 inhibitor, is anticipated to begin Phase 1 clinical development by year-end as a monotherapy in patients with selected solid tumors. In addition, the Company’s pipeline includes PRT-SCA2, a SMARCA2 protein degrader, PRT-K4, a highly selective kinase inhibitor, and additional discovery stage programs.

Investor Contacts:

Stacey Jurchison
Executive Director, Corporate Affairs
[email protected]

Melissa Forst
Argot Partners
212.600.1902
[email protected]

Media Contact:

Paige Donnelly
Argot Partners
212.600.1902
[email protected]



Oncorus to Present at Upcoming Investor Conferences

CAMBRIDGE, Mass., Nov. 23, 2021 (GLOBE NEWSWIRE) — Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, today announced that President and Chief Executive Officer, Theodore (Ted) Ashburn, M.D., Ph.D., will participate in two upcoming virtual investor conferences:

  • 33

    rd

    Annual Piper Sandler Virtual Healthcare Conference: A corporate presentation will be available on-demand starting Monday, November 22nd at 10:00 a.m. ET.
  • Evercore ISI 4th Annual HealthCONx Conference: Fireside chat on Wednesday, December 1st, 2021 at 4:45 p.m. ET.

A webcast of each conference presentation will be available under the Investors & Media section of Oncorus’ website at https://investors.oncorus.com/. A replay of the presentations will be archived on Oncorus’ site for 30 days following the event.

About Oncorus

At Oncorus, we are focused on driving innovation to deliver next-generation viral immunotherapies to transform outcomes for cancer patients. We are advancing a portfolio of intratumorally (iTu) and intravenously (IV) administered viral immunotherapies for multiple indications with significant unmet need based on our oncolytic Herpes Simplex Virus (HSV) Platform and Synthetic viral RNA (vRNA) Immunotherapy Platform.

Designed to deliver next-generation viral immunotherapy impact, our HSV Platform improves upon key characteristics of this therapeutic class to enhance systemic activity. Our lead HSV program, ONCR-177, is designed to be directly administered into a tumor, resulting in high local concentrations of the therapeutic agent and its five encoded transgenes, as well as low systemic exposure to the therapy, which could limit systemic toxicities. Our pioneering Synthetic vRNA Immunotherapy Platform involves a highly innovative, novel combination of RNA- and oncolytic virus-based modalities designed to realize the potential of RNA medicines for cancer. Our lead IV-administered Synthetic vRNA Immunotherapy clinical candidates, ONCR-021 and ONCR-788, are both currently in IND-enabling studies.

Please visit www.oncorus.com to learn more.

Media Contact:                                
Liz Melone
[email protected]
                
Investor Contact:
Stern Investor Relations
Julie Seidel
[email protected]