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Endava Announces First Quarter Fiscal Year 2021 Results

Endava Announces First Quarter Fiscal Year 2021 Results

Q1 FY2021

15.5% Year on Year Revenue Growth to £95.1 million

16.9% Revenue Growth at Constant Currency

IFRS diluted EPS £0.12 compared to £0.26 in the prior year comparative period

Adjusted diluted EPS £0.26 compared to £0.24 in the prior year comparative period

LONDON–(BUSINESS WIRE)–
Endava plc(NYSE: DAVA) (“Endava” or the “Company”) a global provider of digital transformation, agile development and intelligent automation services, today announced results for the three months ended September 30, 2020, the first quarter of its 2021 fiscal year (“Q1 FY2021”).

“Endava delivered another strong quarter with revenue for Q1 FY2021 of £95.1 million, an increase of 15.5% Year on Year on a reported basis, and our pro-forma constant currency growth rate reflecting the sale of the Worldpay Captive was 20.1% Year on Year. The demand environment remains solid in all of our geographies and verticals,” said John Cotterell, Endava’s CEO.

FIRST QUARTER FISCAL YEAR 2021 FINANCIAL HIGHLIGHTS:

  • Revenue for Q1 FY2021 was £95.1 million, an increase of 15.5% compared to £82.4 million in the same period in the prior year.
  • Revenue growth rate at constant currency(a non-IFRS measure) was 16.9% for Q1 FY2021 compared to 21.5% in the same period in the prior year.
  • Profit before tax for Q1 FY2021 was £8.7 million compared to profit before tax of £17.5 million in the same period in the prior year.
  • Adjusted profit before tax (a non-IFRS measure) for Q1 FY2021 was £18.2 million, compared to £16.9 million in the same period in the prior year, or 19.2% of revenue, compared to 20.5% of revenue in the same period in the prior year.
  • Profit for the period was £6.7 million in Q1 FY2021, resulting in a diluted EPS of £0.12, compared to profit for the period of £14.5 million and diluted EPS of £0.26 in the same period in the prior year.
  • Adjusted profit for the period (a non-IFRS measure) was £14.7 million in Q1 FY2021, resulting in adjusted diluted EPS (a non-IFRS measure) of £0.26 compared to adjusted profit for the period of £13.6 million and adjusted diluted EPS of £0.24 in the same period in the prior year.

     

CASH FLOW:

  • Net cash from operating activities was £21.5 million in Q1 FY2021 compared to £15.4 million in the same period in the prior year.
  • Adjusted free cash flow (a non-IFRS measure) was £21.2 million in Q1 FY2021 compared to £13.5 million in the same period in the prior year.
  • At September 30, 2020, Endava had cash and cash equivalents of £70.0 million, compared to £101.3 million at June 30, 2020.

OTHER METRICS FOR THE QUARTER ENDED SEPTEMBER 30, 2020:

  • Headcount (including directors) reached 7,199 at September 30, 2020, with 6,204 average operational employees in Q1 FY2021, compared to a headcount of 5,904 at September 30, 2019 and 5,339 average operational employees in the same quarter of the prior year.
  • Number of clients with over £1 million in revenue on a rolling twelve months basis was 66 at September 30, 2020, compared to 62 at September 30, 2019.
  • Top 10 clients accounted for 39% of revenue in Q1 FY2021, compared to 41% at September 30, 2019.
  • By geographic region, 29% of revenue was generated in North America, 25% was generated in Europe, 43% was generated in the United Kingdom and 3% was generated in the rest of the world in Q1 FY2021. This compares to 27% in North America, 26% in Europe, 45% in the United Kingdom and 2% in the rest of the world in the same period in the prior year.
  • By industry vertical, 50% of revenue was generated from Payments and Financial Services, 28% from TMT and 22% from Other. This compares to 53% from Payments and Financial Services, 25% from TMT and 22% from Other in the same period in the prior year.

     

OUTLOOK:

At this time, the general economic environment remains fluid and it continues to be challenging to anticipate the ultimate full scope and duration of the impact of the COVID-19 pandemic. Endava is providing guidance for the second quarter of its 2021 fiscal year and its full 2021 fiscal year based upon what it currently sees in its markets.

Second Quarter Fiscal Year 2021:

Endava expects revenues will be in the range £102.0 m to £104.0 m, representing constant currency revenue growth of between 17.5% and 18.0%. Endava expects adjusted diluted EPS to be in the range of £0.25 to £0.26 per share.

The constant currency growth figure above excludes the Worldpay Captive, which Endava sold in August 2019, and, starting in the second quarter of fiscal 2021, will not be included in quarterly comparative financial metrics. Endava does not intend to refer to Worldpay Captive in future quarterly guidance.

Full Fiscal Year 2021:

Endava expects revenues will be in the range £419.0m to £421.0m, representing constant currency growth of between 20.0% and 20.5%. Endava expects adjusted diluted EPS to be in the range of £1.04 to £1.08 per share.

The constant currency growth figure now quoted for the full fiscal year 2021 guidance will still include the proforma adjustment for the Worldpay Captive, as it remains in the full year comparative.

This above guidance for Q2 Fiscal Year 2021 and the Full Fiscal Year 2021 assumes the exchange rates at the end of October (when the exchange rate was 1 British Pound to 1.29 US Dollar and 1.11 Euro).

Endava is not able, at this time, to provide an outlook for IFRS diluted EPS for Q2 FY2021 or FY2021 because of the unreasonable effort of estimating on a forward-looking basis certain items that are excluded from adjusted diluted EPS, including, for example, share-based compensation expense, amortisation of acquired intangible assets and foreign currency exchange (gains)/losses, the effect of which may be significant. Endava is also not able, at this time, to reconcile to an outlook for revenue growth not at constant currency because of the unreasonable effort of estimating foreign currency exchange gains/losses, the effect of which may be significant, on a forward-looking basis.

The guidance provided above is forward-looking in nature. Actual results may differ materially. See the cautionary note regarding “Forward-Looking Statements” below.

CONFERENCE CALL DETAILS:

The Company will host a conference call at 8:00 am EST today, November 12, 2020, to review its Q1 FY2021 results. To participate in Endava’s Q1 FY2021 earnings conference call, please dial in at least five minutes prior to the scheduled start time (866) 324-3683 or (509) 844-0959 for international participants, Conference ID 3084871.

Investors may listen to the call on Endava’s Investor Relations website at http://investors.Endava.com. The webcast will be recorded and available for replay until Friday, November 27, 2020.

ABOUT ENDAVA PLC:

Endava is a leading next-generation technology services provider and helps accelerate disruption by delivering rapid evolution to enterprises. Using distributed enterprise agile at scale, Endava collaborates with its clients, seamlessly integrating with their teams, catalysing ideation and delivering robust solutions. Endava helps its clients become digital, experience-driven businesses by assisting them in their journey from idea generation to development and deployment of products, platforms and solutions. It services clients in the following industries: Payments and Financial Services, TMT and “Other,” which includes Consumer Products, Retail, Mobility and Healthcare. Endava had 7,199 employees (including directors) as of September 30, 2020 located in offices in North America and Western Europe and delivery centres in Romania, Moldova, Bulgaria, Serbia, North Macedonia, Slovenia, Bosnia & Herzegovina, Argentina, Uruguay, Venezuela, and Colombia.

NON-IFRS FINANCIAL INFORMATION:

To supplement Endava’s Consolidated Statements of Comprehensive Income, Consolidated Balance Sheets and Consolidated Statements of Cash Flow presented in accordance with IFRS, the Company uses non-IFRS measures of certain components of financial performance. These measures include: revenue growth rate at constant currency, revenue growth at constant currency adjusted for the sale of Endava Technology SRL, also referred to as “the Worldpay Captive” to Worldpay on August 31, 2019, adjusted profit before tax, adjusted profit for the period, adjusted diluted EPS and adjusted free cash flow.

Revenue growth rate at constant currency is calculated by translating revenue from entities reporting in foreign currencies into British Pounds using the comparable foreign currency exchange rates from the prior period. For example, the average rates in effect for the fiscal quarter ended September 30, 2019 were used to convert revenue for the fiscal quarter ended September 30, 2020 and the revenue for the comparable prior period.

Revenue growth at constant currency adjusted for the sale of the Worldpay Captive is revenue growth at constant currency adjusted to exclude the impact of the sale of the Worldpay Captive.

Adjusted profit before tax (“Adjusted PBT”) is defined as the Company’s profit before tax adjusted to exclude the impact of share-based compensation expense, amortisation of acquired intangible assets, realised and unrealised foreign currency exchange gains and losses, and net gain on disposal of subsidiary. Share-based compensation expense, amortisation of acquired intangible assets and unrealized foreign currency gains are non-cash expenses. Adjusted PBT margin is Adjusted PBT as a percentage of total revenue.

Adjusted profit for the period is defined as Adjusted PBT together with the tax impact of these adjustments.

Adjusted diluted EPS is defined as Adjusted profit for the period, divided by weighted average number of shares outstanding – diluted.

Adjusted free cash flow is the Company’s net cash from operating activities, plus grants received, less net purchases of non-current assets (tangible and intangible).

Management believes these measures help illustrate underlying trends in the Company’s business and uses the measures to establish budgets and operational goals, communicated internally and externally, for managing the Company’s business and evaluating its performance. Management also believes the presentation of its non-IFRS financial measures enhances an investor’s overall understanding of the Company’s historical financial performance. The presentation of the Company’s non-IFRS financial measures is not meant to be considered in isolation or as a substitute for the Company’s financial results prepared in accordance with IFRS, and its non-IFRS measures may be different from non-IFRS measures used by other companies. Investors should review the reconciliation of the Company’s non-IFRS financial measures to the comparable IFRS financial measures included below, and not rely on any single financial measure to evaluate the Company’s business.

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may be identified by the use of terms and phrases such as “believe,” “expect,” “outlook,” “may,” “will”, and other similar terms and phrases. Such forward-looking statements include, but are not limited to, the statements regarding Endava’s projected financial performance for the second fiscal quarter of fiscal year 2021 and the full fiscal year 2021 and the challenges presented by the ongoing COVID-19 pandemic and the associated global economic uncertainty. Forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from the results anticipated by these forward-looking statements, including, but not limited to: Endava’s business, results of operations and financial condition may be negatively impacted by the COVID-19 pandemic and the precautions taken in response to the pandemic or if general economic conditions in Europe, the United States or the global economy worsen; Endava’s ability to manage its rapid growth or achieve anticipated growth; Endava’s ability to retain existing clients and attract new clients, including its ability to increase revenue from existing clients and diversify its revenue concentration; Endava’s ability to attract and retain highly- skilled IT professionals at cost-effective rates; Endava’s ability to penetrate new industry verticals and geographies and grow its revenue in current industry verticals and geographies; Endava’s ability to maintain favourable pricing and utilisation rates; Endava’s ability to successfully identify acquisition targets, consummate acquisitions and successfully integrate acquired businesses and personnel; the effects of increased competition as well as innovations by new and existing competitors in its market; Endava’s ability to adapt to technological change and innovate solutions for its clients; Endava’s ability to collect on billed and unbilled receivables from clients; Endava’s ability to effectively manage its international operations, including Endava’s exposure to foreign currency exchange rate fluctuations; Endava’s ability to remediate the identified material weaknesses and maintain an effective system of disclosure controls and internal control over financial reporting, and Endava’s future financial performance, including trends in revenue, cost of sales, gross profit, selling, general and administrative expenses, finance income and expense and taxes, as well as other risks and uncertainties discussed in the “Risk Factors” section of our Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on September 15, 2020. In addition, the forward-looking statements included in this press release represent Endava’s views and expectations as of the date hereof and are based on information currently available to Endava. Endava anticipates that subsequent events and developments may cause its views to change. Endava specifically disclaims any obligation to update the forward- looking statements in this press release except as required by law. These forward-looking statements should not be relied upon as representing Endava’s views as of any date subsequent to the date hereof.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

 

Three Months Ended

September 30

 

2020

2019

 

£’000

£’000

REVENUE

95,125

 

82,352

 

Cost of sales

 

 

Direct cost of sales

(57,476

)

(48,764

)

Allocated cost of sales

(4,732

)

(3,921

)

Total cost of sales

(62,208

)

(52,685

)

GROSS PROFIT

32,917

 

29,667

 

Selling, general and administrative expenses

(21,267

)

(17,340

)

OPERATING PROFIT

11,650

 

12,327

 

Net finance (expense) / income

(2,925

)

2,928

 

Gain on sale of subsidiary

—

 

2,215

 

PROFIT BEFORE TAX

8,725

 

17,470

 

Tax on profit on ordinary activities

(2,017

)

(2,958

)

PROFIT FOR THE PERIOD

6,708

 

14,512

 

OTHER COMPREHENSIVE INCOME

 

 

Items that may be reclassified subsequently to profit or loss:

 

 

Exchange differences on translating foreign operations

(847

)

(1,925

)

TOTAL COMPREHENSIVE INCOME FOR THE PERIOD ATTRIBUTABLE TO OWNERS OF THE PARENT

5,861

 

12,587

 

 

 

 

EARNINGS PER SHARE (EPS):

 

 

Weighted average number of shares outstanding – Basic

54,494,227

 

52,556,332

 

Weighted average number of shares outstanding – Diluted

56,639,638

 

55,422,182

 

Basic EPS (£)

0.12

 

0.28

 

Diluted EPS (£)

0.12

 

0.26

 

 

CONDENSED CONSOLIDATED BALANCE SHEETS

  

 

September 30, 2020 

June 30, 2020 

September 30, 2019 

 

£’000

 

£’000

 

£’000

(Restated) (1)

ASSETS – NON-CURRENT

 

 

 

Goodwill

104,780

 

56,885

 

 

36,251

 

 

Intangible assets

36,953

 

38,751

 

 

29,063

 

 

Property, plant and equipment

12,157

 

12,747

 

 

10,828

 

 

Lease right-of-use assets

49,020

 

51,134

 

 

37,382

 

 

Financial assets

772

 

639

 

 

1,066

 

 

Deferred tax assets

15,797

 

13,340

 

 

9,841

 

 

TOTAL

219,479

 

173,496

 

 

124,431

 

 

ASSETS – CURRENT

 

 

 

Trade and other receivables

92,743

 

82,614

 

 

67,901

 

 

Corporation tax receivable

2,613

 

2,922

 

 

793

 

 

Financial assets

584

 

584

 

 

617

 

 

Cash and cash equivalents

70,039

 

101,327

 

 

83,628

 

 

TOTAL

165,979

 

187,447

 

 

152,939

 

 

TOTAL ASSETS

385,458

 

360,943

 

 

277,370

 

 

LIABILITIES – CURRENT

 

 

 

Lease liabilities

11,102

 

11,132

 

 

8,564

 

 

Trade and other payables

66,078

 

58,599

 

 

48,095

 

 

Corporation tax payable

2,885

 

1,449

 

 

4,970

 

 

Contingent consideration

1,392

 

1,442

 

 

1,285

 

 

Deferred consideration

3,783

 

3,764

 

 

—

 

 

TOTAL

85,240

 

76,386

 

 

62,914

 

 

LIABILITIES – NON CURRENT

 

 

 

Lease liabilities

40,563

 

42,233

 

 

29,603

 

 

Deferred tax liabilities

5,691

 

5,861

 

 

1,950

 

 

Deferred consideration

5,079

 

—

 

 

—

 

 

Other liabilities

133

 

136

 

 

118

 

 

TOTAL

51,466

 

48,230

 

 

31,671

 

 

EQUITY

 

 

 

Share capital

1,099

 

1,099

 

 

1,089

 

 

Share premium

229

 

221

 

 

137

 

 

Merger relief reserve

25,527

 

25,527

 

 

21,573

 

 

Retained earnings

227,398

 

214,638

 

 

165,314

 

 

Other reserves

(4,664

)

(3,817

)

 

(3,502

)

 

Investment in own shares

(837

)

(1,341

)

 

(1,826

)

 

TOTAL

248,752

 

236,327

 

 

182,785

 

 

TOTAL LIABILITIES AND EQUITY

385,458

 

360,943

 

 

277,370

 

 

1) The restatement refers to a reclassification of £17,143,000 from share premium to merger relief reserve.

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 

Three Months Ended

September 30

 

2020

2019

 

£’000

£’000

OPERATING ACTIVITIES

 

 

Profit for the period

6,708

 

14,512

 

Income tax charge

2,017

 

2,958

 

Non-cash adjustments

12,417

 

1,956

 

Tax paid

152

 

(832

)

Net changes in working capital

176

 

(3,185

)

Net cash from operating activities

21,470

 

15,409

 

 

 

 

INVESTING ACTIVITIES

 

 

Purchase of non-current assets (tangible and intangible)

(641

)

(2,506

)

Proceeds from disposal of non-current assets

65

 

13

 

Acquisition of business / subsidiaries (net of cash acquired)

(50,790

)

(1,523

)

Proceeds from sale of subsidiary net of cash disposed of

—

 

2,578

 

Cash and cash equivalents acquired with subsidiaries

1,603

 

—

 

Interest received

27

 

199

 

Net cash used in investing activities

(49,736

)

(1,239

)

 

 

 

FINANCING ACTIVITIES

 

 

Proceeds from sublease

157

 

154

 

Repayment of borrowings

—

 

(9

)

Repayment of lease liabilities

(2,954

)

(2,156

)

Interest paid

(211

)

(166

)

Grant received

309

 

564

 

Issue of shares

8

 

9

 

Net cash from financing activities

(2,691

)

(1,604

)

Net change in cash and cash equivalents

(30,957

)

12,566

 

 

 

 

Cash and cash equivalents at the beginning of the period

101,327

 

70,172

 

Exchange differences on cash and cash equivalents

(331

)

890

 

Cash and cash equivalents at the end of the period

70,039

 

83,628

 

RECONCILIATION OF IFRS FINANCIAL MEASURES TO NON-IFRS FINANCIAL MEASURES

RECONCILIATION OF REVENUE GROWTH RATE AS REPORTED UNDER IFRS TO REVENUE GROWTH RATE AT CONSTANT CURRENCY:

 

Three Months ended

September 30

 

2020

2019

REVENUE GROWTH RATE AS REPORTED UNDER IFRS

15.5

%

24.0

%

Foreign exchange rates impact

1.4

%

(2.5

%)

REVENUE GROWTH RATE AT CONSTANT CURRENCY INCLUDING WORLDPAY CAPTIVE

16.9

%

21.5

%

Impact of Worldpay Captive

3.2

%

0.4

%

PRO-FORMA REVENUE GROWTH RATE AT CONSTANT CURRENCY ADJUSTED FOR THE SALE OF THE WORLDPAY CAPTIVE

20.1

%

21.9

%

 

RECONCILIATION OF ADJUSTED PROFIT BEFORE TAX AND ADJUSTED PROFIT FOR THE PERIOD:

 

Three Months Ended

September 30

 

2020

2019

 

£’000

£’000

PROFIT BEFORE TAX

8,725

 

17,470

 

Adjustments:

 

 

Share-based compensation expense

5,931

 

3,323

 

Amortisation of acquired intangible assets

1,166

 

896

 

Foreign currency exchange (gains)/losses, net

2,412

 

(2,553

)

Net gain on disposal of subsidiary

—

 

(2,215

)

Total adjustments

9,509

 

(549

)

ADJUSTED PROFIT BEFORE TAX

18,234

 

16,921

 

 

 

 

PROFIT FOR THE PERIOD

6,708

 

14,512

 

Adjustments:

 

 

Adjustments to profit before tax

9,509

 

(549

)

Tax impact of adjustments

(1,550

)

(393

)

ADJUSTED PROFIT FOR THE PERIOD

14,667

 

13,570

 

 

 

 

Diluted EPS (£)

0.12

 

0.26

 

Adjusted diluted EPS (£)

0.26

 

0.24

 

 

RECONCILIATION OF NET CASH FROM OPERATING ACTIVITIES TO ADJUSTED FREE CASH FLOW

 

Three Months Ended

September 30

 

2020

2019

 

£’000

£’000

 

 

 

Net cash from operating activities

21,470

 

15,409

 

Adjustments:

 

 

Grant received

309

 

564

 

Net purchases of non-current assets (tangible and intangible)

(576

)

(2,493

)

Adjusted Free cash flow

21,203

 

13,480

 

SUPPLEMENTARY INFORMATION

SHARE-BASED COMPENSATION EXPENSE

 

Three Months Ended

September 30

2020

2019

 

£’000

£’000

 

 

 

Direct cost of sales

3,498

 

1,697

 

Selling, general and administrative expenses

2,433

 

1,626

 

Total

5,931

 

3,323

 

 

DEPRECIATION AND AMORTISATION

  

 

Three Months Ended

September 30

 

2020

2019

 

£’000

£’000

 

 

 

Direct cost of sales

3,570

 

2,751

 

Selling, general and administrative expenses

1,773

 

1,376

 

Total

5,343

 

4,127

 

 

EMPLOYEES, TOP 10 CUSTOMERS AND REVENUE SPLIT
 

 

Three Months Ended

September 30

 

2020

2019

 

 

 

Closing number of total employees (including directors)

7,199

 

5,904

 

Average operational employees

6,204

 

5,339

 

 

 

 

Top 10 customers %

39

%

41

%

Number of clients with > £1m of revenue (rolling 12 months)

66

 

62

 

 

 

 

Geographic split of revenue %

 

 

North America

29

%

27

%

Europe

25

%

26

%

UK

43

%

45

%

Rest of World (RoW)

3

%

2

%

Industry vertical split of revenue %

 

 

Payments and Financial Services

50

%

53

%

TMT

28

%

25

%

Other

22

%

22

%

 

INVESTOR CONTACT:

Endava Plc

Laurence Madsen, Investor Relations Manager

[email protected]

KEYWORDS: Europe United States United Kingdom North America New York

INDUSTRY KEYWORDS: Consulting Accounting Professional Services Finance

MEDIA:

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Director/PDMR Shareholding

NOTIFICATION AND PUBLIC DISCLOSURE IN ACCORDANCE WITH THE REQUIREMENTS OF THE EU MARKET ABUSE REGULATION OF TRANSACTIONS BY PERSONS DISCHARGING MANAGERIAL RESPONSIBILITIES

November 12, 2020

This notification is made in accordance with Article 19 of the EU Market Abuse Regulation

1. Details of the person discharging managerial responsibilities/person closely associated
First Name(s) Martina
Last Name(s) Hund-Mejean
2. Reason for the notification
Position/status Non-executive Director
Initial notification/amendments Initial notification
3. Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor
Full name of the entity Royal Dutch Shell plc
Legal Entity Identifier code 21380068P1DRHMJ8KU70
4. Details of the transaction(s) section to be repeated for (i) each type of instrument, (ii) each type of transaction, (iii) each date, (iv) each place where transactions have been conducted
Description of the financial instrument B American Depositary Share (ADS)
Identification Code US7802591070
Nature of the transaction Purchase of shares
Currency US Dollars
Price (Average) $30.34
Volume 9,211
Total $279,485.65

 
Aggregated information
Shares were PURCHASED in batches

 
  Batch 1 Batch 2 Batch 3 Batch 4
Volume 200 1200 1581 400
Price $30.28 $30.29 $30.30 $30.31
Total $6,056.00 $36,348.00 $47,904.30 $12,124.00
         
  Batch 5 Batch 6 Batch 7 Batch 8
Volume 100 1161 100 1200
Price $30.32 $30.33 30.34 $30.36
Total $3,032.00 $35,213.13 $3,034.00 $36,432.00
         
  Batch 9 Batch 10 Batch 11 Batch 12
Volume 500 769 900 900
Price $30.37 $30.38 $30.39 $30.40
Total $15,185.00 $23,362.22 $27,351.00 $27,360.00
         
  Batch 13  
Volume 200  
Price $30.42  
Total $6,084.00  

Date of Transaction November 11, 2020
Place of Transaction New York

Anthony Clarke
Deputy Company Secretary

ENQUIRIES

Shell Media Relations
International, UK, European Press: +44 20 7934 5550

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VSBLTY SELECTED BY PEERLESS-AV® TO INCORPORATE ITS SOFTWARE INTO INTEGRATED DIGITAL SIGNAGE KIOSKS

Audience Measurement, Content Management and Security Software Included in New Bundled Offering

Philadelphia, PA, Nov. 12, 2020 (GLOBE NEWSWIRE) — VSBLTY Groupe Technologies Corp. (CSE: VSBY) (Frankfurt: 5VS) (OTC: VSBGF) (“VSBLTY”), a leading provider of security and retail marketing technology, has inked an OEM agreement with Peerless-AV®, an award-winning designer and manufacturer of the highest quality audio and video solutions and accessories. The two technology companies are teaming to assimilate their solutions and services for the world’s fast-changing communications needs.

Peerless-AV will be utilizing VSBLTY technology to provide enhanced customer engagement and audience measurement using machine learning and computer vision, according to VSBLTY Co-founder & CEO Jay Hutton. “Our industry-leading VisionCaptor™ and DataCaptor™ software that combines motion graphics and interactive brand messaging with cutting-edge computer analytics will be incorporated into Peerless-AV digital signage kiosks,“ he added. “Not only does DataCaptor report demographics like gender, age range and sentiment, but it also gathers key analytics including dwell time, total views, unique visitors, percent looking at the screen, content interaction, as well as footfall traffic and heat maps detailing highest traffic times by day and hour,” Hutton concluded.

“VSBLTY technology will enrich our outdoor and indoor, integrated digital signage kiosks that we provide for retail, casino, corporate, healthcare and entertainment and sports venues around the world,” stated Nick Belcore, Executive Vice President of Peerless-AV. “In addition, VSBLTY’s AI-driven software, Vector™ will enable us to provide the advanced facial and object recognition capabilities that are so crucial to enhancing today’s security requirements.” He also pointed out that the technology is used to identify individuals—alone or in crowds—that are either persons of interest (from a curated list), or as an opt-in participant such as in a casino or retail loyalty program. “Equally as important,” Belcore said, “custom content can be delivered directly to loyalty program members, which has made our kiosks increasingly effective in casinos and retail stores.”

 

Investor Relations

CHF Capital Markets

Cathy Hume, CEO, +1-416-868-1079, x231

[email protected]

 

CONTACT: Linda Rosanio, 609-472-0877 

[email protected]

About VSBLTY (

www.vsblty.net

)

Headquartered in Philadelphia, VSBLTY (CSE: VSBY) (Frankfurt: 5VS) (OTC: VSBGF) (“VSBLTY”) is the world leader in Proactive Digital Display™, which transforms retail and public spaces as well as place-based media networks with SaaS-based audience measurement and security software that uses artificial intelligence and machine learning.

 

About Peerless-AV (
www.peerless-av.com
)


Driving Technology Through Innovation

For over 75 years, passion and innovation continue to drive Peerless-AV forward. We proudly design and manufacture the highest quality products, including outdoor displays and TVs, complete integrated kiosks, video wall mounting systems, professional carts and stands, and more. Whether a full-scale global deployment or custom project, Peerless-AV develops meaningful relationships and delivers world-class service. In partnership with Peerless-AV, you are trusting an award-winning team of experts who will support your business every step of the way.

Connect with Peerless-AV via social media on Twitter, Instagram, LinkedIn, Facebook, and YouTube.

Peerless-AV Media Contact

Alyssa Morrello, (732) 212-0823 x413

[email protected] 

LINDA ROSANIO
VSBLTY, INC
609-472-0877
[email protected]

Posted on

Apollomics, Inc. Receives China Investigational New Drug Approval for APL-102 to Initiate a Phase 1 Study

FOSTER CITY, Calif. and HANGZHOU, China, Nov. 12, 2020 (GLOBE NEWSWIRE) — Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of new tumor-targeting agents and immuno-oncology agents and their combination therapies, today announced that APL-102 has received China Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the initiation of a Phase 1 pharmacokinetic (PK) and tolerability study of APL-102 in patients with advanced solid tumors.

Dr. Guoliang Yu, the company’s Co-Founder, Chairman and CEO said that: “APL-102 is a small molecule multi-kinase inhibitor developed by us. It has demonstrated broad and potent antitumor activity in patient derived xenograft mouse models of liver cancer, breast cancer, colorectal cancer, gastric cancer, esophageal cancer and non-small cell lung cancer, demonstrated excellent oral bioavailability and relatively low toxicity in pre-clinical studies. APL-102 may not only be used as a single agent to treat patients, but also has a potential of being co-administered with immunotherapy and other treatments as a combination therapy.”

About APL-102

APL-102 is an oral, multi kinase inhibitor (mKi) targeting several key oncogenic drivers. APL-102 inhibits both receptor tyrosine kinase (RTKs) and serine/threonine-kinases, including: angiogenesis via vascular endothelial growth factor receptors (VEGFRs) and platelet-derived growth factor receptors (PDGFRs); mitogen-activated protein kinase (MAPK) pathway via B-RAF and C-RAF; RET, CSF1R, DDR1 and c-KIT.

Apollomics owns the global clinical development, production and commercial sales rights of APL-102.

About Apollomics, Inc.

Apollomics, Inc., incubated by OrbiMed Asia at inception, is an innovative biopharmaceutical company committed to the discovery and development of oncology mono- and combination- therapies that harness the immune system and target specific molecular pathways to eradicate cancer. The company’s existing pipeline consists of several development-stage assets including novel, humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and targeted therapies against uncontrolled growth signaling pathways. For more information, please visit www.apollomicsinc.com.

Contact Information:

Investor Contact:

Wilson W. Cheung
Chief Financial Officer
Telephone: +1-650-209-4436
Email: [email protected]

Company Contact:

Liping Zhang
Telephone: +86-571-83521933
Email: [email protected]

U.S. Media Contact:

Remy Bernarda
Corporate Communications
(415) 203-6386
[email protected]

China Media Contact:

Porda Havas International Finance Communications Group

  Terence Wong Ivy Lu
  General Manager Vice President
Telephone (852) 3150 6786 (86) 21 3397 8796
Email [email protected] [email protected]

Posted on

StorageVault Reports 2020 Third Quarter Results and Increases Dividend

TORONTO, Nov. 12, 2020 (GLOBE NEWSWIRE) — STORAGEVAULT CANADA INC. (“StorageVault” or the “Corporation”) (SVI-TSX-V) reported the Corporation’s 2020 third quarter results and increases its dividend. Iqbal Khan, Chief Financial Officer, commented:

“Our results continue to show the resiliency of our business – we achieved 3% year over year increase in same store revenue and 4% in NOI. These results place us in a strong position to finish the year and to enter into 2021. We are also very pleased to have announced the acquisition of $220 million of assets that are scheduled to close in Q4 2020.”

2020 Third Quarter Results

Revenue for the third quarter 2020 increased to $40.1 million compared to $37.3 million in Q3 2019 and net operating income (“NOI”), a non IFRS measure, grew to $27.5 million from $24.8 million for the comparative period. Our cash flow from operations increased year over year and when combined with our financing and investing activities resulted in a cash balance of $12.5 million at the end of the quarter. The Q3 2020 net loss of $6.3 million (net loss of $9.4 million for Q3 2019) is after $20.8 million of depreciation and amortization and deferred tax recovery recorded in the quarter of $3.0 million; both amounts are non-cash items.

Revenue and NOI from existing self storage stores increased by 3.1% and 4.0%, compared to the same period last year. Funds from operations (“FFO”), a non IFRS measure, were $11.6 million for Q3 2020 compared to $9.5 million in Q3 2019, a 21.7% increase year over year. Adjusted funds from operations (“AFFO”), a non IFRS measure, were $12.2 million for Q3 2020 compared to $10.8 million in Q3 2019, a 12.5% increase.

For a reconciliation of the above NOI, FFO, and AFFO amounts to IFRS, please see the Corporation’s Management’s Discussion & Analysis for the three and nine months ended September 30, 2020 filed on SEDAR at www.sedar.com.

2020 Nine Months Year to Date Results

Revenue for the nine months ended September 30, 2020 increased to $113.3 million from $97.8 million and NOI, a non-IFRS measure, grew to $75.9 million from $65.4 million, for the comparative period. For the nine months ended September 30, 2020, cash flow from operations was $30.0 million and when combined with our financing and investing activities resulted in a cash balance of $12.5 million. The net loss of $23.3 million for the nine months ended September 30, 2020 (net loss of $34.6 million for 2019) is after $61.5 million in depreciation and amortization, which was offset by a deferred tax recovery of $9.0 million; both non-cash items.

Despite the impacts of COVID-19, the pausing of rent increases, late charges and administrative fees for a significant portion of the year to date, our revenue and NOI from Existing Self Storage, a non-IFRS measure, increased by 4.3% and 4.6%, compared to the same period last year. FFO, a non-IFRS measure, were $29.2 million compared to $21.0 million for the same period in 2019, a 38.9% increase year over year. AFFO, a non-IFRS measure, were $31.5 million compared to $27.3 million for the same period in 2019, a 15.5% increase year over year.

For a reconciliation of the above NOI, FFO, and AFFO amounts to IFRS, please see the Corporation’s Management’s Discussion & Analysis for the three and nine months ended September 30, 2020 filed on SEDAR at www.sedar.com.

Increased Dividend

StorageVault is increasing its quarterly dividend by 0.5% beginning Q4 2020 to $0.002707 per common share.

The COVID-19 Pandemic

To continue to serve the strong demand for our services, we have modified our operations – installed plexiglass partitions, limit the number of customers in our offices to one at a time and continue to improve and offer our no-contact rental processes. Our teams are fully employed and clients are able to safely store and access their valuables. We continue to be extremely proud of our team for continuing to adapt to new processes and for being committed to providing exceptional client and community service.

As the third quarter progressed, we experienced stronger demand, resulting in increased leads, rentals, occupancy and rental rates. These positive trends resulted in the Corporation achieving strong same store revenue and NOI growth. While clients may be further impacted, including through unemployment, which may reduce the ability to pay, the Corporation has experienced no meaningful increases in accounts receivable.

Since the start of the COVID-19, the Corporation continued to execute on our strategies to attract clients through search engine marketing, improving our online presence, virtual community connection programs and the development of a national platform and initiatives to fulfill last mile storage needs. These efforts have allowed us to attract clients who are leveraging our national footprint to offer a complete storage, inventory management and mobilization solution through our self and portable storage and records management infrastructures. 

As at September 30, 2020, we continue to generate significant cash flows from our operations, with $12.5 million in cash on hand. Our balance sheet, along with our strong relationships with our lenders, provide us with sufficient borrowing capacity, refinancing and liquidity options to take advantage of acquisition opportunities that meet our requirements, such as the $220 million in acquisitions announced by the Corporation on November 2, 2020.

Our Strategy

StorageVault is focused on owning and operating storage in the top markets in Canada. Our goal is to have multiple stores in each market, with complementary portable storage units and records management storage services, to take advantage of economies of scale. Our growth strategy is focused on acquisitions, organic growth, expansion of our existing stores and expansion of our portable storage and record management businesses.

Further Information

For comprehensive disclosure of StorageVault’s performance for the three and nine months ended September 30, 2020 and its financial position as at such date, please see StorageVault’s Unaudited Interim Consolidated Financial Statements and Management’s Discussion and Analysis for the three and nine months ended September 30, 2020 filed on SEDAR at www.sedar.com.

Non-IFRS Financial Measures

Management uses both IFRS and Non-IFRS Measures to assess the financial and operating performance of the Corporation’s operations. These Non-IFRS Measures are not recognized measures under IFRS, do not have a standardized meaning under IFRS and are unlikely to be comparable to similar measures presented by other companies. The Non-IFRS Measures referenced in this news release include the following:

  1. Net Operating Income (“NOI”) – NOI is defined as storage and related services revenue less related property operating costs. NOI does not include interest expense or income, depreciation and amortization, corporate administrative costs, stock based compensation costs or taxes. NOI assists management in assessing profitability and valuation from principal business activities.
  2. Funds from Operations (“FFO”) – FFO is defined as net income (loss) excluding gains or losses from the sale of depreciable real estate, plus depreciation and amortization, stock based compensation expenses, and deferred income taxes; and after adjustments for equity accounted entities and non-controlling interests. The Corporation believes that FFO can be a beneficial measure, when combined with primary IFRS measures, to assist in the evaluation of the Corporation’s ability to generate cash and evaluate its return on investments as it excludes the effects of real estate amortization and gains and losses from the sale of real estate, all of which are based on historical cost accounting and which may be of limited significance in evaluating current performance.
  3. Adjusted Funds from Operations (“AFFO”) – AFFO is defined as FFO plus acquisition and integration costs. Acquisition and integration costs are one time in nature to the specific assets purchased in the current period or pending and are expensed under IFRS.
  4. Existing Self Storage – means stores that StorageVault has owned or leased since the beginning of the previous fiscal year.

NOI, FFO, AFFO and Existing Self Storage, should not be viewed as an alternative to, in isolation from, or superior to, net income or cash flow from operations, or results from StorageVault’s comprehensive operations, respectively, or other measures calculated in accordance with IFRS. NOI, FFO and AFFO should not be interpreted as an indicator of cash generated from operating activities and is not indicative of cash available to fund operating expenditures, or for the payment of cash distributions. Existing Self Storage should not be considered a measure of StorageVault’s comprehensive operations. NOI, FFO, AFFO and Existing Self Storage are simply additional measures of operating performance which highlight trends in StorageVault’s core business that may not otherwise be apparent when relying solely on IFRS financial measures. StorageVault’s management also uses these non-IFRS measures in order to facilitate operating performance comparisons from period to period and to prepare operating budgets. In addition, the Corporation’s definitions of NOI, FFO, AFFO and Existing Self Storage may differ from that of other issuers.

About StorageVault Canada Inc.

StorageVault owns and operates 202 storage locations in the provinces of British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Quebec, and Nova Scotia. StorageVault owns 154 of these locations plus over 4,600 portable storage units representing over 8.2 million rentable square feet.

For further information, contact Mr. Steven Scott or Mr. Iqbal Khan:

Tel: 1-877-622-0205
[email protected]

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Information: This news release contains “forward-looking information” within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, included herein are forward-looking information. In particular, this news release contains forward-looking information regarding: statements regarding StorageVault’s expected future performance; the proposed $220 million of previously announced acquisitions, including the potential closing date of such proposed acquisitions and financing options available to StorageVault to complete such proposed acquisitions; StorageVault’s response to the COVID-19 pandemic, the potential anticipated impact of COVID-19 on StorageVault’s expected future performance, the impact of COVID-19 on its customers’ ability to pay for services provided by StorageVault and StorageVault’s beliefs regarding its ability to navigate the pandemic; positive trends StorageVault is experiencing including stronger demand, resulting in increased leads, rentals, occupancy and rental rates; StorageVault’s ability to attract new clients; statements regarding StorageVault’s liquidity position and its ability to meet liquidity requirements and to take advantage of acquisition opportunities as a result of its liquidity position; and StorageVault’s strategic objectives, goals, growth strategy and focus, including focusing on acquisitions, improving StorageVault’s operational performance, expansion of StorageVault’s existing stores and expansion of StorageVault’s portable storage and records management businesses. There can be no assurance that such forward-looking information will prove to be accurate, and actual results and future events could differ materially from those anticipated in such forward-looking information. This forward-looking information reflects StorageVault’s current beliefs and is based on information currently available to StorageVault and on assumptions StorageVault believes are reasonable. These assumptions include, but are not limited to: the level of activity in the storage business and the economy generally; consumer interest in StorageVault’s services and products; competition and StorageVault’s competitive advantages; trends in the storage industry, including macro-trends in relation to increased growth and growth in the portable storage business; the availability of attractive and financially competitive asset acquisitions in the future; the potential closing of previously announced acquisitions, if any, continuing to proceed as they have progressed to date and StorageVault’s continued response and ability to navigate the COVID-19 pandemic being consistent with, or better than, its ability and response to date. Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of StorageVault to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; delay or failure to receive board or regulatory approvals; the actual results of StorageVault’s future operations; competition; changes in legislation, including environmental legislation, affecting StorageVault; the timing and availability of external financing on acceptable terms; conclusions of economic evaluations and appraisals; lack of qualified, skilled labour or loss of key individuals; and risks related to the COVID-19 pandemic including various recommendations, orders and measures of governmental authorities to try to limit the pandemic, including travel restrictions, border closures, non-essential business closures, service disruptions, quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, economic activity, financing, supply chains and sales channels, and a deterioration of general economic conditions including a possible national or global recession; the impact that the COVID-19 pandemic may have on StorageVault may include: a short-term delay in payments from customers, an increase in accounts receivable and an increase of losses on accounts receivable; decreased demand for the services that StorageVault offers; and a deterioration of financial markets that could limit StorageVault’s ability to obtain external financing. A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in StorageVault’s disclosure documents on the SEDAR website at www.sedar.com. Although StorageVault has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Forward-looking information contained in this news release is expressly qualified by this cautionary statement. The forward-looking information contained in this news release represents the expectations of StorageVault as of the date of this news release and, accordingly, is subject to change after such date. However, StorageVault expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law.

Posted on

FDA grants a Breakthrough Device Designation for Spiderwort Spinal Cord Technology

Ottawa, Nov. 12, 2020 (GLOBE NEWSWIRE) — Spiderwort Inc., a Canadian medical device company developing innovative biomaterials for regenerative medicine, is pleased to announce that the U.S. Food and Drug Administration (FDA) has designated CelluBridgeTM, Spiderwort’s  Spinal Cord Scaffold Implant, as a “Breakthrough Device”.

The FDA Breakthrough Devices program creates a path for innovators to get their medical devices to market faster. The program targets novel devices that have the potential to provide patients with a more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases and conditions. This program provides patients and health care providers with timely access to these medical devices by expediting medical devices development, assessment, and review, while preserving the statutory standards consistent with the FDA’s mission to protect and promote public health.

“While this designation is a great achievement for our team, and a validation of our technology, I am most excited for the patients whose lives we will be able to change with our biomaterial,” said Charles M. Cuerrier, CEO and co-founder of Spiderwort. “This designation will enable us to efficiently interact with the FDA in order to increase the speed at which we will initiate our clinical trials”.

Spiderwort’s revolutionary biomaterial uses a plant-based cellulose scaffolding to create a framework that supports the regeneration of healthy tissues. The biomaterial is composed of microchannels which guide regenerating neurons through damaged regions of the spinal cord after a traumatic injury. Preclinical studies are demonstrating the promise of this approach for restoring motor function.

“We are pushing the limits of science every day to bring something remarkable into the world,” said Andrew E. Pelling, Chief Science Officer and co-founder of Spiderwort.  “Spiderwort was born from curiosity-driven exploration, and the results have the potential to significantly improve patients lives.”

Spiderwort also recently announced the closing of its $2.5 million USD Series Seed round of financing, led by Horizons Ventures. The company is preparing for its Series A round of financing in 2021 as it moves closer to clinical testing. 

Daily progress in the Spiderwort labs is moving the company closer to the day when they will revolutionize the bioscience and biotechnology sectors, and improve the lives of millions.

ABOUT SPIDERWORT

Spiderwort Inc. is a biotechnology company with a transformative platform of cellulose-based biomaterials that will serve as the scaffolds for the regenerative medicine of the future. Spiderwort’s biomaterials have shown promise in the treatment of Spinal Cord Injuries and soft tissue regeneration. Spiderwort is led by CEO Charles M. Cuerrier and inspired by the work of TED Fellow Andrew E. Pelling. Learn more at spiderwortbio.com.

Attachments 

Spencer Callaghan
Spiderwort Inc.
[email protected]

Posted on

Silo Pharma, Inc. Announces Filing of Three U.S. Provisional Patent Applications


Each Provisional Patent Application Relates to Psilocybin

NEW YORK , Nov. 12, 2020 (GLOBE NEWSWIRE) — Silo Pharma, Inc. (OTCQB: SILO) a developmental stage biopharmaceutical company focused on the use of psilocybin as a therapeutic, today announced the filing of three distinct U.S. Provisional Patent applications with the U.S. Patent and Trademark Office (“USPTO”) pertaining to the central nervous system delivery of unique anti-inflammatory therapeutics coupled with psilocybin.

“Each of these provisional patents relates to the continued research and development of the central nervous system-homing peptides covered by the UMD option agreement to deliver certain compounds,” stated Eric Weisblum, Chairman and CEO of Silo Pharma.” We are excited to have taken this important action with respect to our recently announced collaboration with UMD.”

A provisional patent application is a critical step on the road to commercial viability. As the climate for intellectual property rights becomes more and more competitive, a provisional patent application successfully establishes an early effective filing date and allows the patent applicant or a licensee to ascribe the phrase “patent pending” to any product development and methodologies associated with the patent’s subject matter.

“These patent applications, together with Silo’s efforts to bring scientific talent, resources, and industry leaders together, allows the Company to continue its development of novel therapeutics in the psychedelic category”, stated Mr. Weisblum.

About Silo Pharma 


Silo Pharma is a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research for people suffering from indications such as depression, PTSD, Parkinson’s, and other rare neurological disorders. Silo’s mission is to identify assets to license and fund the research which we believe will be transformative to the well-being of patients and the health care industry.  For more information, visit www.silopharma.com.

Safe Harbor and Forward-Looking Statements

This news release contains “forward-looking statements” within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential” and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties and other factors that could cause the actual results of Silo Pharma, Inc. (“Silo” or “the Company”) to differ materially from the results expressed or implied by such statements, including changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this presentation, whether as a result of new information, future events or otherwise, after the date of this presentation or to reflect the occurrence of unanticipated events except as required by law.



Investor Relations Contact

:                                      


Hayden IR

Brett Maas
646-536-7331
Email: [email protected]

Posted on

Ionis’ pioneering antisense technology to be featured in multiple presentations at American Heart Association (AHA) Scientific Sessions 2020

– Ionis’ novel antisense medicine targeting PCSK9 demonstrates best-in-class potential for the treatment of patients with high cholesterol at risk for cardiovascular disease

PR Newswire

CARLSBAD, Calif., Nov. 12, 2020 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), announced today the upcoming presentations of clinical and non-clinical data for several of its investigational antisense medicines for cardiovascular disease at the American Heart Association (AHA) Scientific Sessions 2020, to be held virtually November 13-17, 2020. 

Two of the abstracts accepted for presentation will provide new data from studies of ION449, also known as AZD8233 for subcutaneous administration and AZD6615 for oral administration. ION449 is an investigational antisense medicine targeting PCSK9, which is integrally involved in the regulation of LDL-cholesterol. ION449 is being developed as part of a collaboration between Ionis and the biopharmaceutical company AstraZeneca. Data presented include a study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending subcutaneous doses of ION449 in patients with elevated LDL-cholesterol and a separate pre-clinical study evaluating this investigational medicine for once-daily oral dosing.

Additional presentations by Ionis scientists will include a review of RNA-targeted treatments designed to inhibit the production of apolipoprotein C-III (apoC-III) and lipoprotein(a) or Lp(a). The apoC-III protein is an independent cardiovascular risk factor that regulates triglyceride metabolism in the blood. Ionis’ AKCEA-APOCIII-LRx is an investigational LIgand-Conjugated Antisense (LICA) medicine designed to inhibit the production of apoC-III for patients who are at risk for cardiometabolic disease due to elevated triglyceride levels. AKCEA-APOCIII-LRx is expected to start a Phase 3 study in patients with familial chylomicronemia syndrome (FCS) by year end. Elevated Lp(a) is an independent, genetic risk factor for cardiovascular disease that cannot be well controlled with lifestyle modifications such as diet or exercise or with treatment using existing lipid-lowering therapies. Ionis’ pelacarsen is an investigational LICA medicine designed to reduce the production of apolipoprotein(a) in patients who are at risk for cardiometabolic disease due to high Lp(a). Pelacarsen is currently in a Phase 3 cardiovascular outcomes study.

Following are presentations of Ionis programs and collaborations:

Cardiovascular Seminars:

  • Friday, November 13, 11:10 a.m. CST ‘Experimental Therapy for APOCIII Lowering: ASO, siRNA,’ Rosanne Crooke, Ph.D., senior strategic consultant at Ionis
  • Friday, November 13, 11:20 a.m. CST ‘Experimental Therapy for Lp(a) Lowering,’ Sotirios “Sam” Tsimikas, M.D., Ph.D., senior vice president, clinical development and leader, cardiovascular franchise

Poster Presentations in Collaboration with AstraZeneca:

  • Friday, November 13, 9:00 a.m. CST ‘An Oral Antisense Oligonucleotide for PCSK9 Inhibition in Humans’ (Poster #P244)
  • Friday, November 13, 9:00 a.m. CST ‘Single Dose Safety, Pharmacokinetics, and Pharmacodynamics of a Potent PCSK9 Synthesis Inhibitor, AZD8233, in Subjects With Elevated LDL Cholesterol’ (Poster #MP515)

A full list of presentations can be found on the AHA Scientific Sessions website.

About Ionis Pharmaceuticals, Inc.
As the leader in RNA-targeted drug discovery and development, Ionis has created an efficient, broadly applicable, drug discovery platform called antisense technology that can treat diseases where no other therapeutic approaches have proven effective. Our drug discovery platform has served as a springboard for actionable promise and realized hope for patients with unmet needs. We created the first and only approved treatment for all patients, children and adults with spinal muscular atrophy, as well as the world’s first RNA-targeted therapeutic approved for the treatment of polyneuropathy in adults with hereditary transthyretin amyloidosis. Our sights are set on all the patients we have yet to reach with a pipeline of more than 40 novel medicines designed to potentially treat a broad range of disease, including neurological, cardio-renal, metabolic, infectious, and pulmonary diseases.

To learn more about Ionis visit www.ionispharma.com and follow us on Twitter @ionispharma.

IONIS FORWARD-LOOKING STATEMENT
This press release includes forward-looking statements regarding Ionis’ business, the therapeutic and commercial potential of our products, Ionis’ technologies and products in development. Any statement describing Ionis’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. Ionis’ forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Ionis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Ionis’ programs are described in additional detail in Ionis’ annual report on Form 10-K for the year ended December 31, 2019, and the most recent Form 10-Q quarterly filing, which are on file with the SEC. Copies of these and other documents are available from the Company.

In this press release, unless the context requires otherwise, “Ionis,” “Company,” “we,” “our,” and “us” refers to Ionis Pharmaceuticals and its subsidiaries.

Ionis Pharmaceuticals™ is a trademark of Ionis Pharmaceuticals, Inc.

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ionis-pioneering-antisense-technology-to-be-featured-in-multiple-presentations-at-american-heart-association-aha-scientific-sessions-2020-301171533.html

SOURCE Ionis Pharmaceuticals, Inc.

Posted on

Sol-Gel Technologies Reports Third Quarter 2020 Financial Results and Corporate Update

  • Epsolay®
    PDUFA goal date set for April 26, 2021

  • Twyneo® New Drug Application
    submitted
    to the
    U.S.
    FDA

  • Top-line generic product revenue of $2.1 million in 3Q 2020

  • In
    October
    2020
    ,
    signed
    an 11th
    generic product
    collaboration agreement with Perrigo

NESS ZIONA, Israel, Nov. 12, 2020 (GLOBE NEWSWIRE) — Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced financial results for the third quarter ended September 30, 2020 and provided clinical and regulatory updates on its programs.

“The third quarter was highlighted by a major achievement for Sol-Gel, as our first New Drug Application (NDA) for Epsolay for the treatment of inflammatory lesions of rosacea was accepted by the Federal Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) goal date set for April 26, 2021. We now look forward to the NDA acceptance of our second proprietary product, Twyneo, for the treatment of acne vulgaris,” commented Dr. Alon Seri-Levy, Chief Executive Officer of Sol-Gel. “Also, after the close of the third quarter, we expanded our collaboration with Perrigo to develop an eleventh generic product candidate. While we are successfully expanding our partnership with Perrigo, we continue to focus on our own branded product candidates, Epsolay and Twyneo. We are working towards commercializing both treatments, if approved, in 2021, either on our own or with a partner that has a significant U.S. dermatology presence.”

Corporate Highlights and Recent Developments

  • Sol-Gel announced FDA acceptance of NDA for Epsolay (benzoyl peroxide, 5%, cream) with a PDUFA goal date set for April 26, 2021. If approved, Epsolay has the potential to be the first FDA-approved, single-agent benzoyl peroxide prescription drug product for the treatment of inflammatory lesions of rosacea.
  • Sol-Gel submitted an NDA for Twyneo (benzoyl peroxide, 3%, and tretinoin, 0.1%, cream) to the FDA in the beginning of October. If approved, Twyneo has the potential to be the first FDA-approved acne treatment that contains fixed-dose combination of benzoyl peroxide and tretinoin.
  • Sol-Gel was informed by its collaboration partner that the launch of an FDA-approved generic drug is expected in the second quarter of 2021. Annual sales of the brand name product exceeded $180 million in the United States in 2019.
  • Bausch Health Companies, Inc. (NYSE:BHC) initiated patent infringement action in the U.S. District Court for the District of New Jersey on August 31, 2020 regarding Perrigo Company plc’s (NYSE; TASE: PRGO) Abbreviated New Drug Application (ANDA) for a generic version of Duobrii® (halobetasol propionate and tazarotene) lotion, a product in which Sol-Gel and Perrigo previously entered into a collaboration agreement. In July 2020, Perrigo filed first-to-file Paragraph IV Certification for Duobrii®.
  • In preparation for commercial launch of proprietary products, and as part of Sol-Gel’s go-to-market strategy, the Company has opened a US headquarters in Whippany, NJ.
  • In October 2020, Sol-Gel signed an additional collaboration agreement with Perrigo for the development, manufacturing and commercialization of a new generic product candidate, the eleventh product collaboration between the companies.
  • The enrollment of patients in the Phase 1 proof-of-concept study with SGT-210, a novel, topical, epidermal growth factor receptor inhibitor in patients with punctate palmoplantar keratoderma has been affected by the COVID-19 pandemic. The Company expects to be able to provide an update regarding the timing of top-line results by year-end.
  • Pre-clinical testing of tapinarof, an aryl hydrocarbon receptor (AhR) agonist, and roflumilast, a phosphodiesterase 4 (PDE4) inhibitor, is progressing for various, new dermatological indications. The Company is also conducting pre-clinical studies in psoriasis to compare the tapinarof/roflumilast combination to each individual active ingredient. A total of 24 provisional patent applications for these projects have been submitted to date. 

Financial Results for the Three Months ended
September
30, 2020

Revenue in the third quarter of 2020 was $2.1 million. The revenue was mainly due to sales of a generic product from a collaboration arrangement with Perrigo. While revenue increased compared to the previous quarter, it is still adversely affected by the COVID-19 pandemic.   In addition, due to the entry of an additional generic version of Zovirax® (acyclovir) cream, 5%, marketed by Amneal Pharmaceuticals Inc., we expect revenue from our generic products to decrease until the expected launch of a second generic drug in the second quarter of 2021 as detailed above.

Research and development expenses were $7.9 million in the third quarter of 2020 compared to $9.9 million during the same period in 2019. The decrease of $2.0 million was mainly attributed to a decrease of $5.9 million in clinical trial expenses for Epsolay and Twyneo partially offset by an increase of $3.4 million in regulatory expenses mainly related to the PDUFA fee for Twyneo.

General and administrative expenses were $3.0 million in the third quarter of 2020 compared to $2.5 million during the same period in 2019. The increase of $0.5 million was mainly attributed to an increase of $0.4 million in commercialization expenses and of $0.1 million in patent-related expenses.

Sol-Gel reported a loss of $8.6 million for the third quarter of 2020 compared to loss of $7.4 million for the same period in 2019.

As of September 30, 2020, Sol-Gel had $27.4 million in cash, cash equivalents and deposits, and $29.9 million in marketable securities for a total balance of $57.3 million. Sol-Gel expects its existing cash resources will enable funding of operational and capital expenditure requirements into the third quarter of 2021.

About Sol-Gel Technologies

Sol-Gel is a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases. Sol-Gel leverages its proprietary microencapsulation technology platform for the development of Twyneo, under investigation for the treatment of acne vulgaris, and Epsolay, under investigation for the treatment of inflammatory lesions of rosacea. The Company’s pipeline also includes SGT-210, an early-stage topical epidermal growth factor receptor inhibitor, erlotinib, under investigation for the treatment of palmoplantar keratoderma, and preclinical assets tapinarof and roflumilast. For additional information, please visit www.sol-gel.com.

About Epsolay®

Epsolay is an investigational topical cream containing encapsulated benzoyl peroxide, 5%, for the treatment of papulopustular rosacea. Epsolay utilizes a patented technology process to encapsulate benzoyl peroxide within silica-based microcapsules to create a barrier between the medication and the skin. The slow migration of medication from the microcapsules is designed to deliver an effective dose of benzoyl peroxide onto the skin, while reducing the ability of benzoyl peroxide to induce skin irritation, such as erythema, burning and stinging. If approved, Epsolay has the potential to be the first FDA-approved single-active benzoyl peroxide prescription drug product. Epsolay is not approved by the FDA and the safety and efficacy has not been established.

About Papulopustular Rosacea

Papulopustular rosacea is a chronic and recurrent inflammatory skin disorder that affects nearly 5 million Americans. The condition is common, especially in fair-skinned people of Celtic and northern European heritage. Onset is usually after age 30 and typically begins as flushing and subtle redness on the cheeks, nose, chin or forehead. If left untreated, rosacea can slowly worsen over time. As the condition progresses the redness becomes more persistent, blood vessels become visible and pimples often appear. Other symptoms may include burning, stinging, dry skin, plaques and skin thickening.

About Twyneo®

Twyneo is an investigational, fixed-dose combination of encapsulated benzoyl peroxide, 3%, and encapsulated tretinoin, 0.1%, cream for the treatment of acne vulgaris. If approved, it will be the first acne treatment that contains a fixed-dose combination of benzoyl peroxide and tretinoin, which are separately encapsulated in silica using Sol-Gel’s proprietary microencapsulation technology. Tretinoin and benzoyl peroxide are widely prescribed separately as a combination treatment for acne; however, benzoyl peroxide causes degradation of the tretinoin molecule, thereby potentially reducing its effectiveness if used at the same time or combined in the same formulation. The silica-based microcapsule is designed to protect tretinoin from oxidative decomposition by benzoyl peroxide, thereby enhancing the stability of the active drug ingredients. The silica-based shell is also designed to release the ingredients slowly over time to provide a favorable efficacy and safety profile. Twyneo is not approved by the FDA and the safety and efficacy has not been established.

About Acne Vulgaris

Acne vulgaris is a common multifactorial skin disease that according to the American Academy of Dermatology affects approximately 40 to 50 million people in the United States. The disease occurs most frequently during childhood and adolescence (affecting 80% to 85% of all adolescents) but it may also appear in adults. Acne patients suffer from the appearance of lesions on areas of the body with a large concentration of oil glands, such as the face, chest, neck and back. These lesions can be inflamed (papules, pustules, nodules) or non-inflamed (comedones). Acne can have a profound effect on the quality of life of those suffering from the disease. In addition to carrying a substantial risk of permanent facial scarring, the appearance of lesions may cause psychological strain, social withdrawal and lowered self-esteem.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to,
statements regarding the PDUFA goal date for Epsolay (benzoyl peroxide, 5%, cream)
,
the expectation that the FDA will accept the NDA for Twyneo
and
the timing of commercialization of Epsolay and Twyneo
,
expectation that revenue from our generic products will continue
to
decrease until the expected launch
of a second
FDA-approved generic drug in the second quarter of 2021
. These forward-looking statements include information about possible or assumed future results of our business, financial condition,
results
of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information we have when those statements are made or our management’s current expectation and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important
factors that could cause such differences include, but are not limited to, risks relating to the effects of COVID-19 (coronavirus) as well as the following factors: (
i
) the adequacy of our financial and other resources, particularly in light of our history of recurring losses and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; (ii) our ability to complete the development of our product candidates; (iii) our ability to find suitable co-development partners; (iv) our ability to obtain and maintain regulatory approvals for our product candidates in our target markets
,
the
potential delay in receiving such regula
tory approvals
and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) our ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our ability to establish adequate sales, marketing and distribution channels; (ix) acceptance of our product candidates by healthcare professionals and patients; (x) the possibility that we may face third-party claims of intellectual property infringement; (xi) the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their products; (xii) intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; (xiii) potential product liability claims; (xiv) potential adverse federal, state and local government regulation in the United States, Europe or Israel; and (xv) loss or retirement of key executives and research scientists. These and other important factors discussed in the Company’s Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 24, 2020 and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. Except as required by law, we undertake no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements.



SOL-GEL TECHNOLOGIES LTD.

CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)

  December 31,


 		  September 30,
  2019


 		  2020 
A s
s
e t s 		          
CURRENT ASSETS:           
Cash and cash equivalents $ 9,412   $ 6,007
Bank deposit   –    21,400
Marketable securities   40,966    29,875
Receivables from collaborative arrangements   4,120    2,180
Prepaid expenses and other current assets   1,293     1,200
TOTAL CURRENT ASSETS   55,791     60,662
           
NON-CURRENT ASSETS:          
Restricted long-term deposits   472    1,285
Property and equipment, net   2,314    2,048
Operating lease right-of-use assets   2,040    1,658
Funds in respect of employee rights upon retirement   684     687
TOTAL NON-CURRENT ASSETS   5,510     5,678
           
TOTAL ASSETS $ 61,301   $ $66,340
Liabilities and shareholders’ equity          
CURRENT LIABILITIES:          
Accounts payable $ 1,710   $  1,121
Other accounts payable           4,123      5,469
Current maturities of operating leases   672      508
TOTAL CURRENT LIABILITIES   6,505      7,098
           
LONG-TERM LIABILITIES –          
Operating leases liabilities    1,373      1,105
Liability for employee rights upon retirement    958      980
TOTAL LONG-TERM LIABILITIES    2,331      2,085
COMMITMENTS                  
TOTAL LIABILITIES    8,836      9,183
           
SHAREHOLDERS’ EQUITY:          
Ordinary Shares, NIS 0.1 par value – authorized: 50,000,000 as of December 31, 2019 and September 30, 2020; issued and outstanding: 20,402,800 and 23,000,782 as of December 31, 2019 and September 30, 2020, respectively.   561      635
Additional paid-in capital    203,977      231,397
Accumulated deficit   (152,073)     (174,875)
TOTAL SHAREHOLDERS’ EQUITY    52,465      57,157
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $ 61,301   $  66,340

(The amounts are stated in U.S. dollars in thousands, except share and per share data)

SOL-GEL TECHNOLOGIES LTD.

CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)

  Nine months ended

September 30


 		  Three months ended

September 30
    2019     2020     2019     2020  
COLLABORATION REVENUES $ 18,884   $ 6,714  

$

   

4,733

   $ 2,116  
RESEARCH AND DEVELOPMENT EXPENSES   32,146     22,248     9,913     7,867  
GENERAL AND ADMINISTRATIVE EXPENSES   5,816     8,014     2,484     3,018  
TOTAL OPERATING LOSS   19,078     23,548     7,664     8,769  
FINANCIAL INCOME, NET   (1,071 )   (746 )   (311 )   (149 )
LOSS FOR THE PERIOD $ 18,007   $ 22,802   $ 7,353   $ 8,620  
BASIC AND DILUTED LOSS PER ORDINARY SHARE $ 0.94     1.02   $ 0.37     0.37  
                         
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE   19,230,070     22,431,096     19,787,194     22,997,708  



For further information, please contact:

Sol-Gel Contact:
Gilad Mamlok
Chief Financial Officer
+972-8-9313433

Investor Contact:
Lee M. Stern
Solebury Trout
+1-646-378-2922
[email protected]

Source: Sol-Gel Technologies Ltd. 

Posted on

IMV Inc. Announces Third Quarter 2020 Financial Results and Provides Clinical Update

IMV Inc. Announces Third Quarter 2020 Financial Results and Provides Clinical Update

  • Identification of PD-L1 as a potential Biomarker with 86% of clinical responses in patients with r/r DLBCL in our combination trial with Merck’s Keytruda®
  • Cash and cash equivalents of $54.7M as of September 30th, 2020
  • Expanded Board of Directors and strengthened management team
  • Reviewing data presented at SITC on a conference call and webcast today at 8:00 a.m. ET

DARTMOUTH, Nova Scotia–(BUSINESS WIRE)–
IMV Inc. (the “Company” or “IMV”) (TSX: IMV; NASDAQ: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines against infectious diseases, announces financial results for the third quarter ended September 30, 2020 and provides an update on its clinical and operational progress.

“Biomarkers predictive of responses can be game-changing in the development of new treatments for cancer. We are extremely happy to share our success this week in finding a potential predictive biomarker that is associated with a very high level of clinical efficacy in patients with relapsed/refractory DLBCL. The PD-L1 biomarker is well recognized and already approved for multiple cancer indications and this finding brings us closer to an accelerated path to market for DPX-Survivac in this high unmet medical need patient population.”

“In addition to this significant milestone, we continued to make progress across our pipeline and corporate development objectives steadily advancing development in other cancer indications as well as our vaccine against COVID-19,” said Fred Ors, Chief Executive Officer at IMV.

Third quarter 2020 and Recent Operational Highlights:

DPX-Survivac

Phase 2 SPiReL Study in Relapsed / Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL)

SPiReL is an investigator-initiated Phase 2 study evaluating DPX-Survivac/CPA in combination with Keytruda® (pembrolizumab) in r/r DLBCL. The study is led by Dr. Neil Berinstein, MD, FFCP©, ABIM, hematologist-oncologist at the Odette Cancer Centre at Sunnybrook Health Sciences Centre in Toronto, Ontario.

As of October 30, 2020, 24 patients have been enrolled across six clinical sites in Canada. As reported in May 2020, the study has already met its primary efficacy endpoint.

On November 11, 2020, Dr. Berinstein delivered a poster presentation at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting. As of the data cut-off date of this presentation, 18 pre-treatment samples from 18 patients enrolled in the SPiReL study were available for biomarker analysis and thirty-nine percent (7/18) of these patients had pre-treatment tumors that were classified as PD-L1 positive.

Key findings for this population include:

  • 6/7 subjects demonstrated a partial response (PR) or complete response (CR), resulting in an Objective Response Rate (ORR) of 86% (3 CR and 3 PR) and no clinical response (PR or CR) has been observed in the PD-L1 negative population (n=11); and
  • Observed 100% Disease Control Rate (DCR) defined as Stable Disease, PR or CR.

On the strength of these results, IMV is working on the design of the next clinical study in r/r DLBCL. The Company plans to engage with the U.S. Food and Drug Administration (FDA) as soon as possible to identify the best path toward registration.

Phase 2 DeCidE1 Study in Advanced Recurrent Ovarian Cancer

DeCidE1 is a Phase 2 multicenter, randomized, open-label study to evaluate the safety and efficacy of DPX-Survivac/CPA. This Phase 2 arm enrolled 22 patients with recurrent, advanced platinum-sensitive and/or resistant ovarian cancer.

IMV intends to present top line data during a virtual key opinion leader meeting on December 3, 2020 at 8:00 am ET.

Phase 2 Basket Trial in Multiple Advanced Metastatic Solid Tumors

The Basket Trial is an open label, multi-center Phase 2 study, evaluating the safety and efficacy of DPX-Survivac/CPA in combination with Keytruda® across five cohorts of patients with bladder cancer, liver cancer (hepatocellular carcinoma), ovarian cancer (with and without CPA), NSCLC and tumors shown to be positive for the microsatellite instability high (MSI-H) biomarker.

As of October 30, 2020, a total of 106 patients out of the planned 184 patients have been enrolled across all five indications at 19 clinical sites in Canada and the US.

As noted previously, the COVID-19 pandemic has impacted data collection and verification from this study. The Company intends to report results in the first quarter of 2021 to coincide with seasonal healthcare industry conferences.

DPX-COVID-19

In October 2020, IMV announced that in consultation with Health Canada, it intends to combine its original Phase 1 and 2 studies into a single trial with the potential to accelerate the clinical development and the timeline of the overall project. The design of this study will incorporate the same two-age strata cohorts (18-55 years old and over 55 years old) as originally planned.

Subject to the approval of Health Canada and after the completion and submission of the preclinical safety, GLP toxicology and challenge studies, the Phase 1/2 trial is expected to be approved and initiated before the end of 2020.

Additional funding and Increased Manufacturing Capacity

In October 2020, IMV announced that the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) will provide advisory services and up to $5.4 million in funding to support the continuation of clinical trials for its DPX-COVID-19 vaccine candidate. This funding is milestone based and will be dependent upon the achievement of certain objectives. To date, IMV has secured more than $10 million to fund its DPX-COVID-19 development efforts and other non-dilutive funding requests are ongoing.

To increase its current manufacturing capacity, IMV has entered a collaboration with a global manufacturing partner and initiated transfer and scale-up activities of DPX-COVID-19. This collaboration has the potential to bring two additional production sites in India and Europe with capacity to produce several hundred million doses of DPX-COVID-19.

Corporate Update

On November 10, 2020, Andrew Hall joined IMV as Chief Business Officer. Mr. Hall was previously Executive Director, Business Development and Global Alliances at Celgene.

In July 2020, Michael P. Bailey was appointed to the board of directors. Mr. Bailey currently serves as President and Chief Executive Officer and a member of the board of directors at AVEO Oncology.

Upcoming Milestones

Over the course of upcoming quarters, the Company expects to deliver the following milestones:

  • DPX-Survivac

    • Additional Phase 2 clinical results from the DLBCL combination at the American Society of Hematology (ASH) annual meeting to be held virtually on December 6, 2020
    • Top line Phase 2 clinical results from the ovarian cancer trial on December 3, 2020
    • Updated Phase 2 clinical results from the basket trial in Q1 2021
  • DPX-COVID-19

    • Initiation of Phase 1/2 clinical trial with DPX-COVID-19 in 2020
    • Preliminary Phase 1/2 results in Q1 2021

Overview of Third quarter 2020 Financial Results

On September 30, 2020, the Company had cash and cash equivalents of $54,700,000 and working capital of $55,875,000, compared with $14,066,000 and $13,199,000, respectively at December 31, 2019. This primarily reflects proceeds from the $25,100,000 private placement completed on May 7th, the 6,841,773 common shares issued for gross proceeds of US$30 million (CAD$40.8 million) under its March and June At-The-Market facilities and $2,276,000 from the exercise of 611,888 common share warrants. Based on its current operating plan, IMV expects its current cash position will be sufficient to fund operations for more than the next 12 months.

Research and development expenses increased by $889,000 during the quarter ended September 30, 2020, compared to Q3 2019. These increases are mainly due to pre-clinical development for DPX-COVID-19, which is offset by an increase in government assistance, and to a lesser extent, also attributable to personnel costs due to an increase in headcount. The increase in research and development expenses is partly offset by a decrease in travel, DPX-SurMAGE preclinical development and costs related to the DeCidE1 Phase 2 study of DPX-Survivac/CPA, in patients with advanced recurrent ovarian cancer.

General and administrative expenses increased by $1,064,000 for the quarter ended September 30, 2020 compared to Q3 2019. This increase is explained by an increase in insurance premium and to a lesser extent is also attributable to an increase in foreign exchange loss. This increase is partly offset by a decrease of $223,000 in legal and professional fees and a decrease of $170,000 in travel due to COVID-19 travel restrictions.

The net loss and comprehensive loss of $8,327,000 ($0.13 per share) for the quarter ended September 30, 2020 was $431,000 higher than the net loss and comprehensive loss of $7,896,000 ($0.16 per share) for the quarter ended September 30, 2019.

For the nine-month period ended September 30, 2020, the net loss and comprehensive loss of $25,259,000 was $6,369,000 higher than the net loss and comprehensive loss for the nine-month period ended September 30, 2019. This relates mainly to a $5,161,000 increase in R&D expenses and a $3,000,000 increase in general and administrative expenses partly compensated by a $1,556,000 increase in government assistance mainly towards COVID-19 vaccine development.

For the nine months ended September 30, 2020, IMV’s cash burn rate, defined as net loss for the period adjusted for operations not involving cash (interest on lease obligation, depreciation, accretion of long-term debt, stock-based compensation and DSU compensation), was $23,566,000.

As of November 11, 2020, the number of issued and outstanding common shares was 67,093,547 and a total of 4,490,791 stock options, deferred share units and warrants were outstanding.

The Company’s unaudited interim condensed consolidated results of operations, financial condition and cash flows for the quarter ended September 30, 2020 and the related management’s discussion and analysis (MD&A) are available on SEDAR at www.sedar.com and on EDGARat www.sec.gov/edgar.

Conference Call and Webcast Information

Management will host a conference call and webcast today, November 12, 2020, at 8:00 a.m. ET. Financial analysts are invited to join the conference call by dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (international) using the conference ID# 6146758. Other interested parties will be able to access the live audio webcast at this link.

About IMV

IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of cancer-targeted immunotherapies and vaccines based on the Company’s proprietary delivery platform (DPX). This patented technology leverages a novel mechanism of action that enables the activation of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a novel cancer target: survivin. IMV is currently assessing DPX-Survivac in advanced ovarian cancer, as well as a combination therapy in multiple clinical studies with Merck. IMV is also developing a DPX-based vaccine to fight against COVID-19. Visit www.imv-inc.com and connect with us on Twitter and LinkedIn.

Cautionary Language Regarding Forward-Looking Statements

This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In the press release, such forward-looking statements include, but are not limited to, statements regarding the Company’s progress in developing a DPX-based vaccine candidate against COVID-19, the Company’s belief that the DPX-based platform creates the opportunity for production of a COVID-19 vaccine, the Company’s belief in the potential efficacy of its DPX-based vaccine against COVID-19, the anticipated timing of the Company’s preclinical assays, studies and clinical trials related to its DPX-based vaccine against COVID-19 and the expected impact of COVID-19 on the Company’s other clinical studies and trials and its operations generally. Such statements should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks and uncertainties affecting the Company and its products.

The Company assumes no responsibility to update forward-looking statements in this press release except as required by law. These forward-looking statements involve known and unknown risks and uncertainties and those risks and uncertainties include, but are not limited to, the Company’s ability to develop a DPX-based vaccine candidate against the COVID-19 through the successful and timely completion of preclinical assays, studies and clinical trials, the receipt of all regulatory approvals by the Company to commence and then continue clinical studies and trials, and, if successful, the commercialization of its proposed vaccine candidate related to COVID-19, the Company’s ability to raise sufficient capital, including potentially through grant awards available in Canada, to fund such clinical studies and trials and the production of any COVID-19 vaccine, the ultimate applicability of any third-party research and studies in related coronavirus and SARS studies and sequencing, the Company’s ability to enter into agreements with the proposed lead investigators to assist in the clinical development on its vaccine candidate related to COVID-19, the Company’s ability to collaborate with governmental authorities with respect to such clinical development, the coverage and applicability of the Company’s intellectual property rights to any vaccine candidate related to COVID-19, the ability of the Company to manufacture any vaccine candidate related to COVID-19 rapidly and at scale, the ability for the Company to accurately assess and anticipate the impact of COVID-19 on the Company’s other clinical studies and trials and operations generally and other risks detailed from time to time in the Company’s ongoing filings and in its annual information form filed with the Canadian regulatory authorities on SEDAR as www.sedar.com and with the United States Securities and Exchange Commission on EDGAR at www.sec/edgar. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read the Company’s continuous disclosure documents which are available on SEDAR and on EDGAR.

 

IMV INC.

Unaudited Interim Condensed Consolidated Statements of Loss and Comprehensive Loss

(In thousands of Canadian dollars, except for share and per share amounts)

 

 

Three-months ended

September 30

 

Nine-months ended

September 30

 

2020

$

 

2019

$

 

2020

$

 

2019

$

Income

 

 

 

 

 

 

Subcontract revenue

3

 

13

 

3

 

26

Interest Income

85

 

151

 

209

 

405

Total income

88

 

164

 

212

 

431

Expenses

 

 

 

 

 

 

 

Research and development

6,541

 

5,652

 

18,628

 

13,467

General and administrative

3,699

 

2,635

 

9,778

 

6,778

Government assistance

(1,684)

 

(606)

 

(3,649)

 

(2,093)

Accreted interest and valuation adjustments

(141)

 

379

 

714

 

1,169

Total operating expenses

8,415

 

8,060

 

25,471

 

19,321

Net loss and comprehensive loss

(8,327)

 

(7,896)

 

(25,259)

 

(18,890)

Basic and diluted loss per share

(0.13)

 

(0.16)

 

(0.44)

 

(0.38)

Weighted-average shares outstanding

65,970,269

 

50,615,488

 

58,025,986

 

49,324,232

 

IMV INC.

Unaudited Interim Condensed Consolidated Statements of Financial Position

(In thousands of Canadian dollars, except for share and per share amounts)

 

September 30,

 

December 31,

 

2020

2019

Assets

 

 

 

Current assets

 

 

 

Cash and cash equivalents

$

54,700

$

14,066

Accounts receivable

 

1,663

 

845

Prepaid expenses

 

7,191

 

3,032

Investment tax credits receivable

 

1,588

 

1,661

Total current assets

 

65,142

 

19,604

Property and equipment

 

2,833

 

2,830

Total assets

$

67,975

$

22,434

 

Liabilities and Equity

 

 

 

Current liabilities

 

 

 

Accounts payable, accrued and other liabilities

$

8,236

$

6,157

Amounts due to directors

 

62

 

60

Current portion of long-term debt

 

843

 

88

Current portion of lease obligations

 

126

 

100

Total current liabilities

 

9,267

 

6,405

Lease obligation

 

1,234

 

1,208

Long-term debt

 

8,670

 

8,373

Total liabilities

 

19,171

 

15,986

Equity

 

48,804

 

6,448

Total liabilities and equity

$

67,975

$

22,434

 

Investor Relations

Marc Jasmin, Senior Director, Investor Relations, IMV

O: (902) 492-1819, ext: 1042 

M: (514) 617-9481

E: [email protected]

Irina Koffler, Managing Director, LifeSci Advisors

O: (646) 970-4681 

M: (917) 734-7387 

E: [email protected]

Media

Delphine Davan, Director of Communications, IMV

M: (514) 968-1046 

E: [email protected]

KEYWORDS: United States North America Canada

INDUSTRY KEYWORDS: Science Biotechnology Research Pharmaceutical Oncology Health Infectious Diseases Clinical Trials

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