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Oncolytics Biotech® Reports Third Quarter 2024 Financial Results and Operational Highlights

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BRACELET-1 data showing impressive overall survival benefit in HR+/HER2- metastatic breast cancer affirms pelareorep + paclitaxel combination should be evaluated in a registrational study

Upcoming GOBLET milestones include updated efficacy data from anal cancer cohort and safety run-in data from the modified FOLFIRINOX pancreatic cancer cohort

Cash position of $19.6 million as of September 30, 2024

Management hosting conference call and webcast today at 8:30 a.m. ET

SAN DIEGO and CALGARY, AB, Nov. 12, 2024 /PRNewswire/ — Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced third quarter financial results and operational highlights.

 

 

Wayne Pisano, Chair of Oncolytics’ Board of Directors and Interim CEO, stated, “With positive BRACELET-1 results, we have two randomized phase two studies confirming pelareorep’s potential in HR+/HER2- metastatic breast cancer. After discussions with regulators and key opinion leaders and based on an estimated overall survival benefit of more than a year provided by pelareorep-based therapy, a registration-enabling study that is designed to support an accelerated approval is the next logical step for the development of pelareorep.” Pisano continued, “We continue to develop our gastrointestinal cancer program and look forward to presenting updated efficacy data from our anal cancer cohort and safety data from our new modified FOLFIRNOX pancreatic cancer cohort. Both of these indications represent a significant unmet medical need, and we have shown pelareorep provides the potential to meaningfully improve patient outcomes. This coming year will be critical for pelareorep, as well as for Oncolytics, and I’ve never been more confident in the potential pelareorep can deliver to cancer patients in need.”

Third Quarter Highlights

BRACELET-1 data exceeds expectations, providing clear evidence of pelareorep’s ability to improve outcomes in patients with advanced HR+/HER2- breast cancer (link to press release), demonstrating progression-free survival of 12.1 months for pelareorep + paclitaxel compared to 6.4 months for paclitaxel alone, yielding a benefit of 5.7 months. Additionally, 64% of patients treated with pelareorep + paclitaxel lived at least two years compared to only 33% of patients treated with paclitaxel alone. Overall survival could not be calculated as more than half of the pelareorep + paclitaxel patients were alive at the end of the study. Assuming the remaining patients survived only until their next planned follow-up visit, the median overall survival would have been 32.1 months, which compares favorably to the 18.2 months recorded for patients who received paclitaxel monotherapy.

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Financial Highlights

  • As of September 30, 2024, the Company reported $19.6 million in cash and cash equivalents. The Company has a projected cash runway through key milestones and into 2025.
  • The net loss for the third quarter of 2024 was $9.5 million, compared to a net loss of $9.9 million for the third quarter of 2023. The basic and diluted loss per share was $0.12 in the third quarter of 2024, compared to a basic and diluted loss per share of $0.14 in the third quarter of 2023.
  • Research and development expenses for the third quarter of 2024 were $6.8 million, compared to $5.8 million for the third quarter of 2023. The increase was primarily due to higher manufacturing expenses and clinical trial expenses.  
  • General and administrative expenses for the third quarter of 2024 were $3.1 million, compared with $5.2 million for the third quarter of 2023. The decrease was primarily due to lower investor relations activities and transaction costs as part of our public offering in 2023.
  • Net cash used in operating activities for the nine months ended September 30, 2024 was $19.1 million, compared to $22.3 million for the nine months ended September 30, 2023. The decrease reflected non-cash working capital changes, partly offset by higher net operating activities in 2024.

Recent and Anticipated Milestones

  • H1 2025: Finalize master protocol for the adaptive registration-enabling trial for pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab in first-line pancreatic ductal adenocarcinoma (PDAC) with the Global Coalition for Adaptive Research (GCAR) and submit it to the FDA
  • H1 2025: Safety run-in data from cohort 5 of the GOBLET study, investigating pelareorep and modified FOLFIRNOX (mFOLFIRINOX) with or without atezolizumab in newly diagnosed pancreatic cancer
  • H1 2025: updated efficacy data from cohort 4 of the GOBLET study, investigating pelareorep and atezolizumab in second-line or later anal cancer
  • Mid 2025: First patient enrolled in registration-enabling study evaluating pelareorep and paclitaxel in metastatic HR+/HER2- breast cancer
  • H2 2025: Initial efficacy results from cohort 5 of the GOBLET study, investigating pelareorep and mFOLFIRINOX with or without atezolizumab in newly diagnosed pancreatic cancer

Webcast and Conference Call

Management will host a conference call for analysts and investors at 8:30 a.m. ET today, November 12, 2024. To access the call, please dial (888) 510-2154 (North America) or (437) 900-0527 (International), and if needed, provide Conference ID: 68336. To join the conference call without operator assistance, please click here. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics’ website, available by clicking here, and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 660-6345 (North America) or (289) 819-1450 (International) and using replay code: 68336#.

ONCOLYTICS BIOTECH INC.

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

(unaudited)

(in thousands of Canadian dollars, except share amounts)

As at

September 30,
2024

December 31,
2023

Assets

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Current assets

Cash and cash equivalents

$              19,598

$                       34,912

Other receivables

104

15

Prepaid expenses

2,119

3,246

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Warrant derivative

1,092

Total current assets

22,913

38,173

Property and equipment

422

282

Right-of-use assets

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927

365

Total assets

$              24,262

$                       38,820

Liabilities and Shareholders’ Equity

Current liabilities

Accounts payable and accrued liabilities

$                 6,922

$                         3,572

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Other liabilities

489

332

Lease liabilities

251

133

Warrant derivative

200

Total current liabilities

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7,662

4,237

Contract liability

6,730

6,730

Lease liabilities

813

290

Total liabilities

15,205

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11,257

Commitments

Shareholders’ equity

Share capital

  Authorized: unlimited

  Issued: September 30, 2024 – 77,074,089

  December 31, 2023 – 74,423,960

434,460

430,906

Contributed surplus

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43,640

42,116

Accumulated other comprehensive income

653

544

Accumulated deficit

(469,696)

(446,003)

Total shareholders’ equity

9,057

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27,563

Total liabilities and shareholders’ equity

$              24,262

$                       38,820

 

 

ONCOLYTICS BIOTECH INC.

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

(unaudited)

(in thousands of Canadian dollars, except share amounts)

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Three Months Ended
September 30,

Nine Months Ended
September 30,

2024

2023

2024

2023

Expenses

   Research and development

$              6,794

$              5,811

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$            17,095

$            13,051

   General and administrative

3,105

5,237

9,450

11,891

Loss before the following

(9,899)

(11,048)

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(26,545)

(24,942)

   Change in fair value of warrant derivative

229

515

1,333

439

   Foreign exchange (loss) gain

(122)

310

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579

(83)

   Interest income, net

261

305

1,047

837

Loss before income taxes

(9,531)

(9,918)

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(23,586)

(23,749)

   Income tax expense

(12)

(7)

(107)

(54)

Net loss

(9,543)

(9,925)

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(23,693)

(23,803)

Other comprehensive (loss) income items that may be
reclassified to net loss

  Translation adjustment

(69)

101

109

(7)

Net comprehensive loss

$            (9,612)

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$            (9,824)

$          (23,584)

$          (23,810)

Basic and diluted loss per common share

$              (0.12)

$              (0.14)

$              (0.31)

$              (0.36)

Weighted average number of shares (basic and
diluted)

77,016,848

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69,803,255

76,120,580

65,565,890

 

 

ONCOLYTICS BIOTECH INC.

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

(unaudited)

(in thousands of Canadian dollars)

Share Capital

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Contributed
Surplus

Accumulated
Other
Comprehensive
Income

Accumulated
Deficit

Total

As at December 31, 2022

$           404,040

$             40,051

$                     662

$         (418,251)

$             26,502

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Net loss and other comprehensive loss

(7)

(23,803)

(23,810)

Issued pursuant to stock option plan

662

(256)

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406

Issued pursuant to “At the Market” Agreement

9,128

9,128

Issued pursuant to public offering

17,724

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638

18,362

Share issue costs

(2,728)

(2,728)

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Share-based compensation expense

1,158

1,158

As at September 30, 2023

$           428,826

$             41,591

$                     655

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$         (442,054)

$             29,018

As at December 31, 2023

$           430,906

$             42,116

$                     544

$         (446,003)

$             27,563

Net loss and other comprehensive income

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109

(23,693)

(23,584)

Issued pursuant to incentive share award plan

3

(3)

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Issued pursuant to “At the Market” Agreement

4,062

4,062

Issued pursuant to warrant derivative exercised

71

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71

Share issue costs

(582)

(582)

Share-based compensation expense

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1,527

1,527

As at September 30, 2024

$           434,460

$             43,640

$                     653

$         (469,696)

$                9,057

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ONCOLYTICS BIOTECH INC.

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

(in thousands of Canadian dollars) 

Nine Months Ended September 30,

2024

2023

Operating Activities

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Net loss for the period

$               (23,693)

$              (23,803)

Depreciation – property and equipment

92

62

Depreciation – right-of-use-assets

234

234

Share-based compensation expense

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1,527

1,158

Compensation warrant expenses

151

Interest expense on lease liabilities

99

53

Unrealized foreign exchange (gain) loss

(544)

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21

Change in fair value of warrant derivative

(1,333)

(439)

Net change in non-cash working capital

4,498

239

Cash used in operating activities

(19,120)

(22,324)

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Investing Activities

Acquisition of property and equipment

(233)

(5)

Maturities of marketable securities

20,230

Cash (used in) provided by investing activities

(233)

20,225

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Financing Activities

Proceeds from exercise of stock options

406

Proceeds from exercise of warrant derivative

65

Proceeds from “At the Market” equity distribution agreement, net

3,480

8,790

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Proceeds from public offering

21,359

Payment of lease liabilities

(248)

(303)

Cash provided by financing activities

3,297

30,252

(Decrease) increase in cash and cash equivalents

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(16,056)

28,153

Cash and cash equivalents, beginning of period

34,912

11,666

Impact of foreign exchange on cash and cash equivalents

742

162

Cash and cash equivalents, end of period

$                 19,598

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$                39,981

 

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic, including pelareorep’s potential in HR+/HER2- metastatic breast cancer and the estimated overall survival benefit of pelareorep-based therapy; our belief that pelareorep is poised to advance to a registration-enabling study; continued development of our gastrointestinal cancer program; our expectations regarding the presentation of efficacy and safety data from anal and pancreatic cancer cohorts; the potential market and commercial opportunities for pelareorep; our confidence in pelareorep’s potential to meaningfully improve patient outcomes; Oncolytics’ projected cash runway; our plan to conduct a registration-enabling study to assess pelareorep-based combination therapy in patients with advanced HR+/HER2- breast cancer and the anticipated timing thereof; and other statements related to anticipated developments in Oncolytics’ business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

 

Company Contact

Jon Patton

Director of IR & Communication

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[email protected]

Investor Relations for Oncolytics

Timothy McCarthy

LifeSci Advisors

+1-917-679-9282

[email protected]

 

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Newmark Advises URW in €172.5 Million Office Sale

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PARIS, Nov. 13, 2024 /PRNewswire/ — Newmark announces the firm has advised Unibail-Rodamco-Westfield (URW) in the €172.5 million sale of the 140,846 square-foot (13,085 square-meter) office portion of Les Ateliers Gaîté, a mixed-use property in the prominent Montparnasse district of Paris. Newmark Deputy Chief Business Officer Emmanuel Frénot arranged the transaction between URW and buyers Swiss Life Asset Managers and Norges Bank Investment Management.

“Advising URW on the sale of this asset, with its exceptional location and exemplary environmental approach, just a few months after the opening of our Paris office makes us particularly proud and highlights our ongoing momentum,” said Frénot. “This transaction confirms the recovery signals we have been sensing since the end of the second quarter of 2024 and suggests an increase in activity in the office segment for 2025.”

Les Ateliers Gaîté, delivered in 2022, includes around 100 retail shops, restaurants and services, as well as a hotel, offices, housing and a public library. The office space is leased long-term to coworking operator Wojo, establishing its Parisian flagship.

Newmark opened its flagship Paris office in March, hiring several of the city’s most respected brokers, including Francois Blin and Frénot to lead the team, Antoine Salmon and Vianney d’Ersu as Co-Heads of Retail Leasing, Managing Directors Jérôme De Laboulaye, Nicolas Coutant and Alexandre Gotti as President, France. The office is now home to nearly 40 leading French commercial real estate professionals, including a market-leading research team.

About Newmark
Newmark Group, Inc. (Nasdaq: NMRK), together with its subsidiaries (“Newmark”), is a world leader in commercial real estate, seamlessly powering every phase of the property life cycle. Newmark’s comprehensive suite of services and products is uniquely tailored to each client, from owners to occupiers, investors to founders, and startups to blue-chip companies. Combining the platform’s global reach with market intelligence in both established and emerging property markets, Newmark provides superior service to clients across the industry spectrum. For the twelve months ended September 30, 2024, Newmark generated revenues of over $2.6 billion. As of that same date, Newmark’s company-owned offices, together with its business partners, operated from nearly 170 offices with more than 7,800 professionals around the world. To learn more, visit nmrk.com or follow @newmark.

Discussion of Forward-Looking Statements about Newmark
Statements in this document regarding Newmark that are not historical facts are “forward-looking statements” that involve risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements. These include statements about the Company’s business, results, financial position, liquidity, and outlook, which may constitute forward-looking statements and are subject to the risk that the actual impact may differ, possibly materially, from what is currently expected. Except as required by law, Newmark undertakes no obligation to update any forward-looking statements. For a discussion of additional risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see Newmark’s Securities and Exchange Commission filings, including, but not limited to, the risk factors and Special Note on Forward-Looking Information set forth in these filings and any updates to such risk factors and Special Note on Forward-Looking Information contained in subsequent reports on Form 10-K, Form 10-Q or Form 8-K.

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Aker ASA: 2024 Employee Share Purchase Program

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OSLO, Norway, Nov. 13, 2024 /PRNewswire/ — Aker ASA (“Aker”) has today carried out its employee share purchase program for the year. Participants in the share purchase program were offered a discount of 20 per cent on the closing share price as of 13 November 2024. Hence, each participant paid NOK 443.20 per share. All shares will be locked in for a period of three years from delivery of the shares, during which the employees will not be able to sell the shares.

The following persons discharging managerial responsibilities in Aker have purchased shares:

– Svein Oskar Stoknes has acquired 1,400 shares. Mr. Stoknes’ total shareholding in Aker after the acquisition will be 11,400 shares.
– Lene Landøy has acquired 1,000 shares. Mrs. Landøy’s total shareholding in Aker after the acquisition will be 1,911 shares.
– Charlotte Håkonsen has acquired 500 shares. Mrs. Håkonsen’s total shareholding in Aker after the acquisition will be 2,493 shares.
– Christina Chappell Schartum has acquired 162 shares. Mrs. Schartum’s total shareholding in Aker after the acquisition will be 795 shares.
Fredrik Berge has acquired 250 shares. Mr. Berge’s total shareholding in Aker after the acquisition will be 630 shares.

Please see attached notifications for persons discharging managerial responsibilities in Aker in accordance with Regulation EU 596/2014 (MAR) article 19.

Aker sold a total of 10,480 own shares in connection with the program. Following the transactions, Aker will hold 14,745 own shares.

Investor contact:
Fredrik Berge, Head of Investor Relations Aker ASA
Tel: +47 45 03 20 90
E-mail: [email protected] 

This information is subject to the disclosure requirements in Regulation EU 596/2014 (MAR) article 19 number 3 and the Norwegian Securities Trading Act § 5 -12.

This information was brought to you by Cision http://news.cision.com

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Cayman Enterprise City Receives Two Prestigious Awards from the Financial Times’ fDi Intelligence Global Free Zones of the Year 2024

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Highly Commended in Americas for Knowledge Zones and Honourable Mention for Higher Education Initiatives

GEORGE TOWN, Cayman Islands, Nov. 13, 2024 /PRNewswire/ — Cayman Enterprise City (CEC) has been recognised with two prestigious awards by fDi Intelligence, a division of the Financial Times, as part of its 2024 Global Free Zones of the Year Awards. CEC was highly commended in the Americas under the new Knowledge Zones category and received an honourable mention for its contributions to higher education and workforce development.

This marks the seventh consecutive year that the Cayman Islands special economic zones (SEZs) operated by CEC have been awarded by the Financial Times. These long-standing awards spotlight the growing success of CEC’s SEZs which continue to play a pivotal role in advancing Cayman’s innovation-driven economy. The highly competitive fDi awards, evaluated by a global judging panel, recognise free zones that excel in creating value for their regions, with a focus on sectors such as technology, business services, and financial services.

CEC’s recognition in the Knowledge Zones category is particularly notable for its efforts to create a vibrant, tech-focused ecosystem in close proximity to major North American markets. The panel praised CEC for its streamlined immigration and business support services, which have attracted a diverse range of industries including legal tech, decentralised finance, and precious metals.

Education remains a cornerstone of CEC’s mission. In 2023 alone, more than 4,200 Caymanians and residents participated in education and career development opportunities offered through CEC’s non-profit arm, Enterprise Cayman. The zone has also supported the creation of 41 new Cayman-born businesses projects, emphasising its commitment to fostering entrepreneurship within the Cayman Islands.

As part of CEC’s workforce development initiatives, Enterprise Cayman, focuses on bridging the education and earnings gap for Caymanians. This commitment to higher education and skills training earned CEC an honourable mention in this year’s awards. Danielle Myles of fDi Intelligence stated, “[CEC’s] non-profit Enterprise Cayman is working to close the education and earnings gap for Caymanians by offering training, internships, mentoring, networking, and career-focused training.”

CEC’s Chief Executive Officer, Charlie Kirkconnell, commented on the award wins, saying, “We are incredibly proud to be recognised once again by fDi Intelligence. These awards are a testament to the hard work of our team and the thriving community of global businesses that have chosen CEC as their home. Our focus on innovation and education continues to drive our success, and we remain committed to helping our members and the Cayman Islands achieve even greater heights.”

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CEC, now home to over 380 companies, provides a comprehensive business support program, offering cost-effective operations, tailored work environments, and streamlined processes that make it one of the most attractive destinations for foreign direct investment (FDI) in the region. The recognition by fDi Intelligence further cements CEC’s role as a key driver of economic diversification and growth in the Cayman Islands.

For more information, visit www.caymanenterprisecity.com.

FOR MORE INFORMATION:
Contact: Kaitlyn Elphinstone
Call: +1 345 945-3722
Call Toll Free: From North America +1 (866) 945 1511
Email: [email protected] 
Website: www.caymanenterprisecity.com  LinkedIn: @CaymanEnterpriseCity
Instagram: @CaymanEnterpriseCity
Facebook: @CaymanEnterpriseCity
YouTube: @ceccayman

About Cayman Enterprise City 

Cayman Enterprise City (CEC) is an award-winning development project which consists of three special economic zones focused on attracting knowledge-based and specialised-services businesses to set up a physical presence in the Cayman Islands. The zones included within CEC are Cayman Tech City, Cayman Commodities & Derivatives Centre and Cayman Maritime & Aviation City. With a dedicated Government Authority, licensing fee concessions and guaranteed fast-track processes, CEC enables international companies to quickly and efficiently establish a Cayman Islands office, which in turn enables them to generate active business income within a tax neutral environment.

About Enterprise Cayman

Enterprise Cayman is a non-profit organisation (NPO) powered by Cayman Enterprise City in partnership with Cayman Islands’ special economic zone companies (SEZCos). The organisation, which applies the Theory of Change (TOC) methodology, provides Caymanians and residents with access to high-quality learning experiences and opportunities to develop and launch new business ventures, to pursue careers within the technology and innovation sectors, and to join a dynamic network of industry professionals. Let’s grow the next generation of Caymanian innovators and entrepreneurs with Enterprise Cayman!

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