Month: September 2021

Prestigious International Awards Program Recognizes Outstanding Information Security Products and Companies

NEW YORK, Sept. 30, 2021 (GLOBE NEWSWIRE) — Cobwebs Technologies, an industry-leading provider of AI-driven automated digital risk protection platform, today announced that it has been named the winner of the “Threat Intelligence Platform of the Year” award in the fifth annual CyberSecurity Breakthrough Awards program conducted by CyberSecurity Breakthrough, a leading independent market intelligence organization that recognizes the top companies, technologies, and products in the global information security market today.

Cobwebs’ threat intelligence platform automatically extracts critical insights from big data with advanced and powerful AI machine learning algorithms. Cobwebs’ platform assists analysts in identifying threat actors while uncovering connections and groups across the web using automated advanced search capabilities.

The Cobwebs platform empowers users to gain deep insights and substantial intelligence, including locations, context, internal relations, group structures, hierarchies, and more. Cobwebs’ non-intrusive methods for expedited results and efficacy reveal threat actors and collect real-time intelligence.

“We are incredibly proud to receive this recognition from CyberSecurity Breakthrough. Our platform is delivering an unprecedented level of threat intelligence, reducing uncertainty for our customers, while also aiding them in identifying potential future threats and opportunities,” said Udi Levy, CEO, and co-founder at Cobwebs Technologies. “Cobwebs is committed to our valued customers and we remain focused on delivering the next-generation digital risk protection solutions by continuously investing in our capabilities and people.”

The mission of the CyberSecurity Breakthrough Awards is to honor excellence and recognize the innovation, hard work, and success in a range of information security categories, including Cloud Security, Threat Detection, Risk Management, Fraud Prevention, Mobile Security, Email Security, and many more. This year’s program attracted more than 4,000 nominations from over 20 different countries throughout the world.

“Today’s current threat landscape is best served by threat intelligence that offers a strategic perspective,” said James Johnson, managing director, CyberSecurity Breakthrough. “There’s an advantage to identifying the types of threats a company is most likely to encounter. Gathering and analyzing data, mainly from web-based sources, provides a greater understanding of the current threat environment as well any future risks. Cobwebs’ breakthrough solution helps organizations maintain continuity in an unpredictable and volatile environment and we are thrilled to recognize the Company for winning the ‘Threat Intelligence Platform of the Year’ award.”

About Cobwebs Technologies

Cobwebs Technologies is an industry-leading AI-driven, automated Threat Intelligence platform. The Cobwebs platform provides real-time valuable and actionable insights that enable organizations to detect and expose unknown threats and threat actors to prevent criminal activity while maintaining business continuity and viability. Cobwebs’ Threat Intelligence solution combined with human expertise produces superior security intelligence that disrupts adversaries.

About CyberSecurity Breakthrough

Part of Tech Breakthrough, a leading market intelligence and recognition platform for global technology innovation and leadership, the CyberSecurity Breakthrough Awards program is devoted to honoring excellence in information security and cybersecurity technology companies, products, and people. The CyberSecurity Breakthrough Awards provide a platform for public recognition around the achievements of breakthrough information security companies and products in categories including Cloud Security, Threat Detection, Risk Management, Fraud Prevention, Mobile Security, Web, and Email Security, UTM, Firewall and more. For more information visit CyberSecurityBreakthrough.com.

For further information, please contact us @: info@cobwebs.com

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New Model Validates Hollywood’s Newest Revenue Stream via Blockchain Distribution

BEVERLY HILLS, Calif., Sept. 29, 2021 (GLOBE NEWSWIRE) — In a groundbreaking venture, global NFT distribution and viewing platform VUELE^™ grossed nearly six figures bringing in 32.86267 ETH ($93,435) with the release of eleven total NFT drops of feature film thriller ZERO CONTACT starring Oscar-winning Best Actor Anthony Hopkins. The “Platinum Edition” NFT alone sold for 20 ETH ($56,860).

As the first feature film NFTs distributed by VUELE^™, the ZERO CONTACT NFT drops mark an incredible new step for the feature film distribution industry as well as film collecting and fan engagement.

“In just these few short days, we’ve seen a community form around our film, enhanced fan engagement, and also proved a new revenue stream in the industry. We think this is ground-breaking,” said Rick Dugdale, Co-Founder of VUELE^™ and Director/Producer of ZERO CONTACT. “Our goal was to earn the respect of the NFT space in order for us to create staying power and help blaze a new path for filmmakers. Not only is this now a proven distribution model, but we will be able to create new film financing structures moving forward.”

Each winning NFT allows for the lucky winner to be edited into the film with a personal Zero Contact shoot and edit. In addition, each winner receives signed digital artwork of the film poster, the “making of” the film, Crypto Generative Art by REMO x Dcsan and a VUELE “Golden Ticket.” The “Platinum” 1 of 1 winner also receives a walk-on role in the Zero Contact Universe.

About VUELE^™
VUELE^™ [pronounced VIEW-lee] is the first direct-to-consumer, full-length feature film viewing and distribution platform delivering feature films and digital collectible entertainment content as NFTs. Users will be able to become owners of exclusive, limited edition film, and collector NFT content which they can watch, collect, sell, and trade on the vuele.io platform. VUELE^™ provides movie fans and collectors alike with the ultimate consumer-focused digital collection and viewing platform. VUELE^™ is a joint venture between Enderby Entertainment and CurrencyWorks Inc. For more, visit: www.vuele.io

Media Contact
media@vuele.io

bant.io has become the first B2B lead generation organization to deal in cryptocurrency.

LONDON, Sept. 29, 2021 (GLOBE NEWSWIRE) — bant.io, the all-in-one B2B lead generation and sales acceleration service, is pushing at the boundaries of conventional business practice.

The B2B lead generation agency will now accept cryptocurrency as payment for its services from late September 2021.

With a clear focus on driving growth in companies that want to sell more and sell faster, bant.io delivers by automating customer acquisition with data-driven experiments and a scientific lead generation method that gains B2B customers for their clients.

The inclusion of cryptocurrency means that bant.io will naturally be more flexible and responsive when helping marketing agencies, SaaS, and technology companies identify and automatically engage with their ideal customers, using proven cross-channel lead generation strategies.

“Over the last five years, we’ve innovated B2B lead generation while offering one of the most flexible payment plans in the industry. Now, by accepting cryptocurrency in addition to the fiat currencies, we intend to provide our customers with an even more flexible and seamless payment flow, which will also address the growing needs of the industry,” said Founder Andrei Breaz.

bant.io empowers brands and companies to drive high-converting sales conversations through unique strategies by leveraging their AI-powered lead generation solution, including email, social outreach, managed PPC, retargeting, and a powerful sales chatbot.

These unique strategies have served over 2,000+ companies globally, but the pandemic triggered a surge in entrepreneurship, fuelling a startup boom, resulting in higher demand for bant.io‘s services and lead guarantee model.

“The global startup ecosystem is evolving and shifting, with more startups created and more investments made. bant.io has strived to remain nimble and stay ahead of changes and trends, which is why we have revitalized our payment processes in preparation for this rapidly growing startup economy,” said COO Jaclyn Curtis.

bant.io leverages the top 3 percent high-performing messages with data from 12,000+ high-converting campaigns to create qualified dialogue-driven sales opportunities.

bant.io‘s proprietary algorithm uses natural language processing (NLP) and optimizes PPC ads for conversions to generate more qualified traffic to the website. The algorithm also uses a customized retargeting solution that can accurately track B2B bounced traffic and other relevant decision-makers from the same company across different channels and devices and help convert it into new leads & sales. Its powerful, code-free, rule-based logic sales chatbot module allows businesses to create an automated digital assistant that extends their sales teams.

With a white-label service, bant.io handles the entire rebranding set up for their clients within 48 hours after signup, along with hosting and maintenance. Clients can create their pricing and set their margins.

bant.io helps growing companies who want to sell more and sell quicker, automating customer acquisition with data-driven experiments and making failure impossible. For more information about the scientific lead generation method to gain B2B customers, visit https://bant.io.

Media Relations:

Stephen Cotter
pr@bant.io
Download our Media Kit

+44 (0) 203 0954 931 (London)
+1 (347) 923-6900 (New York)

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Report Validates Security Protocols of Delphix’s Masking, Compliance, and SaaS Capabilities

REDWOOD CITY, Calif., Sept. 29, 2021 (GLOBE NEWSWIRE) — Delphix, the industry leading data company for DevOps, today announced that it has successfully completed a Type 1 System and Organization Controls (SOC) 2 examination for the Delphix Data Control Tower (DCT). The examination, conducted by Schellman & Company, LLC (Schellman), found that Delphix has suitably designed controls to meet the SOC 2 criteria for the Security, Availability and Confidentiality Trust Services Categories as of July 31, 2021.

“With the growing threat of ransomware, data security and trust are non-negotiable in today’s business environment,” said Douglas Barbin, Managing Principal at Schellman. “The Type 1 SOC 2 examination demonstrates Delphix’s commitments to its customers and their security and compliance initiatives.”

SOC 2 reports are attestation reports that opine on controls at an organization relevant to the security, availability, and confidentiality of the system or services. Type 1 reports attest to the design and implementation of an organization’s controls as of a review date.

The Delphix Data Control Tower provides a single API endpoint enabling teams to automate a range of complex, critical data operations, including centrally managing enterprise application data with a SaaS interface, rapidly delivering test data through APIs, and finding and masking sensitive data for compliant test environments to safely automate CI/CD pipelines. The company has built a robust control framework to meet the security, availability, and confidentiality commitments made to customers.

“The increase in cyber attacks has made security top of mind. This attestation further confirms the robustness and compliance of our security protocols,” said Pritesh Parekh, Chief Trust & Security Officer, VP of Engineering at Delphix. “As more and more enterprises become data companies, we are committed to providing them the best and most secure data solutions for DevOps.”

Earlier this year, the company announced that the Delphix DevOps Data Platform had achieved SAP certified integration with SAP NetWeaver® and SAP S/4HANA®. It also released new data compliance capabilities that help Salesforce customers unlock the strategic value of Salesforce® data while maintaining data privacy compliance.

About Delphix
Delphix is the industry leading data company for DevOps.

Data is critical for testing application releases, modernization, cloud adoption, and AI/ML programs. We provide an automated DevOps data platform for all enterprise applications. Delphix masks data for privacy compliance, secures data from ransomware, and delivers efficient, virtualized data for CI/CD.

Our platform includes essential DevOps APIs for data provisioning, refresh, rewind, integration, and version control. Leading companies, including UKG, Choice Hotels, J.B.Hunt, and Fannie Mae, use Delphix to accelerate digital transformation. For more information, visit www.delphix.com or follow us on LinkedIn, Twitter, and Facebook.

For more information, contact:
Aarthi Rayapura
Director, Editorial & Content
aarthi.rayapura@delphix.com

TORONTO, Sept. 29, 2021 (GLOBE NEWSWIRE) —

• Reported diluted earnings per share of $0.21
• Mutual fund gross sales of $790 million for the third quarter of 2021, an improvement of 61% year-over-year
• Mutual fund net sales of $288 million for the quarter
• Total assets under management and fee-earning assets¹ of $43.4 billion

AGF Management Limited (AGF or the Company) (TSX: AGF.B) today announced financial results for the third quarter ended August 31, 2021.

AGF reported total assets under management and fee-earning assets¹ of $43.4 billion compared to $36.5 billion as at August 31, 2020.

“As we head into the final months of 2021, we are well-positioned to execute against our strategic priorities and will aim to continue to gain momentum with a focus on increasing sales, evolving our client-base and looking for opportunities to diversify our business,” said Kevin McCreadie, Chief Executive Officer and Chief Investment Officer, AGF.

“Despite the challenges of the pandemic, this year we have made strides expanding into the private alternatives space and are seeing the results of growing interest into our fee-based series and separately managed accounts,” added McCreadie.

AGF’s mutual funds net sales improved $310 million year-over-year, with total net sales of $288 million in Q3 2021, compared to net redemptions of $22 million in Q3 2020. Excluding net flows from institutional clients invested in mutual funds, retail mutual fund net sales were $288 million for the quarter compared to net redemptions of $4 million in the comparative period of 2020. AGF mutual fund gross sales for the quarter totaled $790 million, a 61% improvement over prior year.

Mutual fund sales momentum continued into September with AGF reporting mutual fund net sales of $80 million as at September 24, 2021 compared to net redemptions of $11 million for the same time last year. Mutual fund gross sales were up 51% year-over-year.

“Delivering on our strategic growth strategy, this quarter we deployed capital and diversified partnerships within our private alternatives business,” said Adrian Basaraba, Senior Vice-President and Chief Financial Officer. “The opportunities within this space have allowed us to realize value for our shareholders and grow our assets and revenue streams.”

“We are targeting continued growth while keeping expense management top of mind with the goal of improving margins,” added Basaraba.

Key Business Highlights:

• AGF in partnership with the SAF Group (SAF) announced the launch of AGF SAF Private Credit Limited Partnership and AGF SAF Private Credit Trust. The new offerings provide both institutional and retail investors access to the benefit of private credit investing.
• AGF announced an evolution of its strategic partnership with SAF. The partnership is focused on providing investors access to unique private alternative opportunities leveraging AGF’s operations and distribution reach coupled with SAF’s private credit investment management expertise. AGF and SAF have agreed to a definitive agreement along with a distribution arrangement as an alternative to AGF exercising its option to acquire management contracts of select SAF funds.
• In June 2021, one of AGF’s long-term private alternative investments, SAF Jackson Management LP (SAFJM LP), was fully monetized, with a final cash distribution of $5.9 million received. As part of this transaction, AGF through its joint venture ownership interest in the manager received $2.4 million of carried interest.
• AGF announced a strategic private equity partnership with First Ascent Ventures (First Ascent) focused on investing in emerging technology companies that are building the next generation of disruptive, fast growing enterprise B2B software companies. AGF has made a $30 million cornerstone investor commitment to First Ascent’s second fund and is a member of the Limited Partner Advisory Committee of the fund.
• AGF International Advisors Company Limited has been accepted as a signatory to the UK Stewardship Code, recognized globally as a best-practice benchmark in investment stewardship.
• Building on its commitment to diversity and inclusion, AGF announced a multi-year partnership for the creation of the AGF Scholarship Fund for Indigenous students with Indspire, a national Indigenous organization that invests in the education of Indigenous people, enabling their success through financial awards, resources and role models.

• Judy Goldring, AGF’s President and Head of Global Distribution, was elected Vice-Chair of The Investment Funds Institute of Canada (IFIC)’s Board of Directors. She will serve a two-year term supporting IFIC’s commitment to further strengthen the integrity of Canada’s investment funds industry and foster a strong, stable investment sector for the benefit of investors and the association’s Members.

For further information on AGF’s pandemic response plan statement visit AGF.com.

Financial Highlights:

“When it comes to expense management, we continue to take a thoughtful approach that has allowed our core expenses and operations to remain relatively consistent as we continue to see an increase in success-based expenses,” added Basaraba.

• Management, advisory, administration fees and deferred sales charges were $112.4 million for the three months ended August 31, 2021, compared to $94.9 million in 2020. The increase in revenue is attributable to higher net sales, increase in AUM and higher average revenue rate as a result of product mix.
• The continued increase in mutual fund sales in the third quarter along with increased corporate development activity drove higher selling, general and administrative costs in the period. Selling, general and administrative costs were $50.1 million for the three months ended August 31, 2021, compared to $46.1 million in 2020. This increase in variable costs was partially offset by management’s continued focus on cost control.
• EBITDA before commissions for the three months ended August 31, 2021 was $37.5 million, compared to $62.6 million in the prior year comparative period. Excluding reported earnings from S&WHL, adjusted EBITDA before commissions for the three months ended August 31, 2021 was $37.5 million, compared to $21.3 million in the prior year comparative period.
• DSC commissions for the three months ended August 31, 2021 were $14.1 million, compared to $8.9 million in the prior year comparative period.
• Net income for the three months ended August 31, 2021 was $14.9 million ($0.21 diluted EPS), compared to $47.3 million ($0.60 diluted EPS) in the prior year comparative period. Adjusted net income for the three months ended August 31, 2021 was $14.9 million ($0.21 adjusted diluted EPS), compared to $14.8 million ($0.19 adjusted diluted EPS) in the prior year comparative period. Excluding reported earnings from S&WHL, adjusted diluted earnings per share was $0.08 in the comparative prior year period. The increase is primarily due to the growth in mutual fund sales as well as the income generated from AGF’s interest in private alternative managers and long-term investments.

		Three months ended									Nine months ended
			August 31,			May 31,			August 31,			August 31,			August 31,
	(in millions of Canadian dollars, except per share data)		2021			2021			20201			2021			20201
	Income
	Management, advisory, administration fees
	and deferred sales charges	$	112.4		$	108.6		$	94.9		$	323.9		$	283.2
	Share of profit of joint ventures		2.2			0.1			0.6			3.1			1.3
	Other income from fee-earning arrangements		0.7			0.4			–			1.1			–
	Dividend income (S&WHL)		–			–			41.3			–			45.8
	Fair value adjustments and other income		7.8			0.4			1.9			11.7			4.3
	Total Income	$	123.1		$	109.5		$	138.7		$	339.8		$	334.6
	Selling, general and administrative		50.1			47.1			46.1			145.2			131.6
	Deferred selling commissions		14.1			17.7			8.9			47.4			31.7
	EBITDA before commissions2		37.5			28.2			62.6			92.2			114.1
	Adjusted EBITDA before commissions2		37.5			28.2			30.1			92.2			81.6
	EBITDA		23.4			10.5			53.7			44.8			82.4
	Net income		14.9			5.0			47.3			25.5			63.5
	Adjusted net income2		14.9			5.0			14.8			25.5			31.0
	Diluted earnings per share		0.21			0.07			0.60			0.35			0.80
	Adjusted diluted earnings per share2		0.21			0.07			0.19			0.35			0.39
	Free cash flow2		21.5			10.4			15.5			42.4			36.1
	Dividends per share		0.09			0.08			0.08			0.25			0.24
	Long-term debt		–			–			194.3			–			194.3

	(end of period)	Three months ended
			August 31,			May 31,			February 28,			November 30,			August 31,
	(in millions of Canadian dollars)		2021			2021			2021			2020			2020
	Mutual fund assets under management (AUM)3	$	23,792		$	22,290		$	21,394		$	20,322		$	19,232
	Institutional, sub-advisory and ETF accounts AUM		10,302			9,713			9,403			9,638			9,252
	Private client AUM		7,073			6,689			6,300			6,043			5,773
	Private alternatives AUM4,5		99			134			142			227			178
	Total AUM4	$	41,266		$	38,826		$	37,239		$	36,230		$	34,435
	Private alternatives fee-earning assets4,5		2,094			1,983			2,012			2,038			2,029
	Total AUM and fee-earning assets5	$	43,360		$	40,809		$	39,251		$	38,268		$	36,464
	Net mutual fund sales (redemptions)3		288			408			385			88			(22)
	Average daily mutual fund AUM3		23,104			22,011			21,118			19,487			18,879

_{¹ Refer to Note 3 in the 2020 Consolidated Financial Statements for more information on the adoption of IFRS 16.
² EBITDA before commissions (earnings before interest, taxes, depreciation, amortization and deferred selling commissions), and Free Cash Flow are not standardized measures prescribed by IFRS. The Company utilizes non-IFRS measures to assess our overall performance and facilitate a comparison of quarterly and full-year results from period to period. They allow us to assess our investment management business without the impact of non-operational items. These non-IFRS measures may not be comparable with similar measures presented by other companies. These non-IFRS measures and reconciliations to IFRS, where necessary, are included in the Management’s Discussion and Analysis available at www.agf.com.
³ Mutual fund AUM includes retail AUM, pooled fund AUM and institutional client AUM invested in customized series offered within mutual funds.
⁴ Total AUM and Private alternatives AUM have been reclassified and restated to exclude co-investment AUM for comparative purposes.
⁵ Fee-earning assets represents assets in which AGF has carried interest ownership and earns recurring fees but does not have ownership interest in the managers.}

For further information and detailed financial statements for the third quarter ended August 31, 2021, including Management’s Discussion and Analysis, which contains discussions of non-IFRS measures, please refer to AGF’s website at www.agf.com under ‘About AGF’ and ‘Investor Relations’ and at www.sedar.com.

Conference Call

AGF will host a conference call to review its earnings results today at 11 a.m. ET.

The live audio webcast with supporting materials will be available in the Investor Relations section of AGF’s website at www.agf.com or at https://edge.media-server.com/mmc/p/357jk6jw. Alternatively, the call can be accessed toll-free in North America by dialing 1 (800) 708-4540 (Passcode #: 50216247).

A complete archive of this discussion along with supporting materials will be available at the same webcast address within 24 hours of the end of the conference call.

About AGF Management Limited

Founded in 1957, AGF Management Limited (AGF) is an independent and globally diverse asset management firm. AGF brings a disciplined approach to delivering excellence in investment management through its fundamental, quantitative, alternative and high-net-worth businesses focused on providing an exceptional client experience. AGF’s suite of investment solutions extends globally to a wide range of clients, from financial advisors and individual investors to institutional investors including pension plans, corporate plans, sovereign wealth funds and endowments and foundations.

AGF has investment operations and client servicing teams on the ground in North America, Europe and Asia. With over $43 billion in total assets under management and fee-earning assets, AGF serves more than 700,000 investors. AGF trades on the Toronto Stock Exchange under the symbol AGF.B.

AGF Management Limited shareholders, analysts and media, please contact:

Adrian Basaraba
Senior Vice-President and Chief Financial Officer
416-865-4203, InvestorRelations@agf.com

Courtney Learmont
Vice-President, Finance
647-253-6804, InvestorRelations@agf.com

Caution Regarding Forward-Looking Statements

This press release includes forward-looking statements about the Company, including its business operations, strategy and expected financial performance and condition. Forward-looking statements include statements that are predictive in nature, depend upon or refer to future events or conditions, or include words such as ‘expects,’ ‘estimates,’ ‘anticipates,’ ‘intends,’ ‘plans,’ ‘believes’ or negative versions thereof and similar expressions, or future or conditional verbs such as ‘may,’ ‘will,’ ‘should,’ ‘would’ and ‘could.’ In addition, any statement that may be made concerning future financial performance (including income, revenues, earnings or growth rates), ongoing business strategies or prospects, fund performance, and possible future action on our part, is also a forward-looking statement. Forward-looking statements are based on certain factors and assumptions, including expected growth, results of operations, business prospects, business performance and opportunities. While we consider these factors and assumptions to be reasonable based on information currently available, they may prove to be incorrect. Forward-looking statements are based on current expectations and projections about future events and are inherently subject to, among other things, risks, uncertainties and assumptions about our operations, economic factors and the financial services industry generally. They are not guarantees of future performance, and actual events and results could differ materially from those expressed or implied by forward-looking statements made by us due to, but not limited to, important risk factors such as level of assets under our management, volume of sales and redemptions of our investment products, performance of our investment funds and of our investment managers and advisors, client-driven asset allocation decisions, pipeline, competitive fee levels for investment management products and administration, and competitive dealer compensation levels and cost efficiency in our investment management operations, as well as general economic, political and market factors in North America and internationally, interest and foreign exchange rates, global equity and capital markets, business competition, taxation, changes in government regulations, unexpected judicial or regulatory proceedings, technological changes, cybersecurity, the possible effects of war or terrorist activities, outbreaks of disease or illness that affect local, national or international economies (such as COVID-19), natural disasters and disruptions to public infrastructure, such as transportation, communications, power or water supply or other catastrophic events, and our ability to complete strategic transactions and integrate acquisitions, and attract and retain key personnel. We caution that the foregoing list is not exhaustive. The reader is cautioned to consider these and other factors carefully and not place undue reliance on forward-looking statements. Other than specifically required by applicable laws, we are under no obligation (and expressly disclaim any such obligation) to update or alter the forward-looking statements, whether as a result of new information, future events or otherwise. For a more complete discussion of the risk factors that may impact actual results, please refer to the ‘Risk Factors and Management of Risk’ section of the 2020 Annual MD&A.

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_{¹ Fee-earning assets represents assets in which AGF has carried interest ownership and earns recurring fees but does not have ownership interest in the managers.}

Helsinn Group and BridgeBio Pharma’s Affiliate QED Therapeutics Announce Health Canada Conditional Approval of TRUSELTIQ™ (infigratinib) for Patients with Cholangiocarcinoma

– Health Canada Issues Conditional Approval of TRUSELTIQ under Project Orbis (September 27^th, 2021)

LUGANO, Switzerland, and PALO ALTO, CA, September 29, 2021 – Helsinn Group and BridgeBio Pharma, Inc. (Nasdaq: BBIO), through its affiliate QED Therapeutics, Inc., today announced that Health Canada has approved TRUSELTIQ™ (infigratinib), a small molecule kinase inhibitor that targets fibroblast growth factor receptor (FGFR), under the Notice of Compliance with Conditions (NOC/c) policy, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (CCA) with a FGFR2 fusion or other rearrangement.

An NOC/c is a form of market approval granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada. Products authorized under Health Canada’s NOC/c policy are intended for the treatment, prevention or diagnosis of a serious, life-threatening or severely debilitating illness. They have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment. In addition, they either respond to a serious unmet medical need in Canada or have demonstrated a significant improvement in the benefit/risk profile over existing therapies. Health Canada has provided access to this product on the condition that sponsors carry out additional clinical trials to verify the anticipated benefit within an agreed upon time frame.

“This is an important next step in growing TRUSELTIQ’s global reach. We are pleased to have achieved this milestone for patients with previously-treated locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 fusion or other rearrangement,” said Riccardo Braglia, Helsinn Group Vice Chairman and CEO. “The conditional approvals from the U.S. FDA and Health Canada mark the beginning of our journey delivering this medicine to patients in need. We look forward to working to enter further markets in the months and years ahead and working closely with BridgeBio as we make strides to reach patients.”

“We are grateful for our first international approval and the opportunity to reach patients outside the United States who are searching for options to treat FGFR2-fusion-driven cholangiocarcinoma. Helsinn has an impressive track record of advancing and commercializing oncology therapies around the globe and we partnered with them earlier this year in the hope of reaching as many patients with FGFR-driven cancers as possible,” said BridgeBio CEO and Founder Neil Kumar, Ph.D. “We believe infigratinib may be able to treat other FGFR-driven conditions and we will continue to evaluate its safety and efficacy in urothelial carcinoma and other areas of unmet need.”

Under Project Orbis, an initiative of the FDA, Oncology Center of Excellence that allows for concurrent submission and review of oncology drugs among participating international regulatory agencies, TRUSELTIQ received accelerated approval from the U.S. Food and Drug Administration (FDA) in May 2021. An additional marketing application for infigratinib is currently under review in Australia.

Helsinn Group has exclusive commercial rights for TRUSELTIQ in Canada with BridgeBio eligible for tiered royalties as a percentage of net sales as part of the global collaboration and license agreement entered into between the two companies in March 2021.

As part of this agreement, BridgeBio and Helsinn Group’s affiliate, Helsinn Therapeutics U.S., Inc., are jointly responsible for commercialization activities for TRUSELTIQ in the U.S. and will share U.S. profits and losses on an equal basis. Helsinn Group will have exclusive commercialization rights on infigratinib outside of the U.S., excluding China, Hong Kong and Macau. BridgeBio will be eligible for tiered royalties as a percentage of adjusted net sales, and payments totaling up to approximately $2.45 billion USD in the aggregate. Helsinn Group will fund the majority of ongoing and future research and development related to infigratinib in oncology. BridgeBio previously entered a strategic collaboration with LianBio for development and commercialization of infigratinib in oncology indications in China, Hong Kong and Macau.

About TRUSELTIQ™ (infigratinib)

TRUSELTIQ (infigratinib) is a small molecule kinase inhibitor that targets FGFR, which obtained accelerated approval by FDA and was conditionally approved by Health Canada for the treatment of adults with previously treated, unresectable locally advanced or metastatic CCA with a FGFR2 fusion or other rearrangement.

Prior to initiation of TRUSELTIQ therapy, FGFR2 fusion or rearrangement should be established using a validated test.

Clinical effectiveness of TRUSELTIQ is based on overall response rate (ORR) and duration of response (DoR) from a single-arm Phase 2 trial in patients with specific FGFR2 fusion or other rearrangements.

Infigratinib is not FDA- or Health Canada-approved for any other indication in the United States and Canada, and is not approved for use by any other health authority.

About Cholangiocarcinoma (CCA)

CCA represents an aggressive group of malignancies that form in the bile ducts. The incidence of this serious and fatal disease varies considerably worldwide. As the disease is usually asymptomatic at early-stages, CCA typically presents at diagnosis as locally advanced or metastatic disease with a poor prognosis. In this respect, the five-year survival rate for patients affected by metastatic CCA is 2%. Depending on the anatomical site of origin, CCAs are classified into two subtypes: intrahepatic (iCCA – 10% of total) and extrahepatic (eCCA – 90% of total) CCA. Approximately 10% to 16% of iCCA harbor FGFR2 genetic alterations.^{1, 2, 3}

About Helsinn Group

Helsinn is a Swiss Biopharmaceutical Group with an innovative R&D pipeline in cancer supportive care and oncology therapeutics, strategically investing in a fully integrated targeted therapy structure to develop, manufacture and commercialize small molecules in precision medicine with higher market potential, thanks to a consolidated track record, a solid revenue stream in B2B and strong cash flow and cash position.

Helsinn is building market differentiation in B2C in the U.S. and China and is owned by a third-generation healthcare entrepreneurial family.

Since 1976, Helsinn has been improving the lives of patients, guided by core family values of respect, integrity and quality, through a unique integrated licensing business model, and by collaborating with success in about 190 countries with long-standing partners who share our values.

The Group’s pharmaceutical business (Helsinn Healthcare S.A.) is headquartered in Lugano, Switzerland with operating subsidiaries in the U.S. (Helsinn Therapeutics (U.S.) Inc.) and China (Helsinn Pharmaceuticals (Beijing) Co., Ltd.) which market products directly in these countries. The company has additional operating subsidiaries in Switzerland (Helsinn Advanced Synthesis S.A., an active pharmaceutical ingredient manufacturer) and Ireland (Helsinn Birex Pharmaceuticals Ltd., a drug product manufacturer).

Helsinn Group plays an active and central role in promoting social transformation in favor of people and the environment. Corporate social responsibility is at the heart of everything we do, which is reinforced in the company’s strategic plan by a commitment to sustainable growth.

For more information, please visit helsinn.com and follow us on Twitter, LinkedIn and Vimeo.

About BridgeBio Pharma, Inc.

BridgeBio Pharma (BridgeBio) is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio’s pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company’s first two approved therapies. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn and Twitter.

BridgeBio Pharma, Inc. Forward-Looking Statements

This press release contains forward-looking statements.  Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions.  We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act, and are making this statement for purposes of complying with those safe harbor provisions.  These forward-looking statements, including statements relating to: the co-commercialization by QED Therapeutics, Inc. (QED) and partner Helsinn Group (Helsinn) of TRUSELTIQ™ (infigratinib) for the treatment of patients with previously-treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement in Canada; Helsinn’s exclusive commercialization rights outside of the United States and in Canada, excluding China, Hong Kong and Macau; the potential for infigratinib to treat a range of FGFR-driven conditions, including other cancers; the safety profile of TRUSELTIQ for the treatment of patients with FGFR2 fusion driven CCA, including the most common adverse reactions and drug interactions; plans for the supply, manufacturing and distribution of TRUSELTIQ; the incidence and survival rate of CCA; the current -approved TRUSELTIQ dosage and administration; the planned approval of TRUSELTIQ by foreign regulatory authorities and the necessary clinical trial results, and timing and completion of regulatory submissions related thereto; and the competitive environment and clinical and therapeutic potential of TRUSELTIQ; reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made.  Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved.  Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation: the safety, tolerability and efficacy profile of TRUSELTIQ observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; despite having ongoing interactions with the FDA, Health Canada or other regulatory agencies, the FDA, Health Canada or such other regulatory agencies may not agree with QED’s regulatory approval strategies, components of QED’s filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data; the fact that accelerated approval of TRUSELTIQ was granted by Health Canada based on overall response rate and duration of response, and continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s); QED and/or Helsinn may encounter delays in meeting manufacturing or supply timelines or disruptions in their distribution plans for TRUSELTIQ; whether and when any regulatory submissions may be filed in various foreign jurisdictions and ultimately approved by foreign regulatory authorities; the continuing success of the BridgeBio and Helsinn global collaboration and licensing agreement and the co-commercialization efforts thereunder; Helsinn’s ability to commercialize TRUSELTIQ outside of the United States and in Canada, excluding China, Hong Kong and Macau; and potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; as well as those set forth in the Risk Factors section of BridgeBio Pharma, Inc.’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent SEC filings, which are available on the SEC’s website at www.sec.gov.  Except as required by law, each of BridgeBio and QED disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. Moreover, BridgeBio and QED operate in a very competitive environment in which new risks emerge from time to time. These forward-looking statements are based on each of BridgeBio’s and QED’s current expectations, and speak only as of the date hereof.

References

¹ Dhanasekaran, R., Hemming, A. W., Zendejas, I., George, T., Nelson, D. R., Soldevila-Pico, C., Firpi, R. J., Morelli, G., Clark, V., Cabrera, R. “Treatment outcomes and prognostic factors of intrahepatic cholangiocarcinoma”. Oncology Reports 29.4 (2013): 1259-1267.

² Patel N, Benipal B. Incidence of cholangiocarcinoma in the USA from 2001 to 2015: a US cancer statistics analysis of 50 states. Cureus 2019; 11: e3962.

³ Cancer.net. Bile Duct Cancer (Cholangiocarcinoma): Statistics. https://www.cancer.net/cancer-types/bile-duct-cancer-cholangiocarcinoma/statistics (accessed Aug 30, 2021).

⁴ Javle M, Raychowdhury S, Kelley RK et al. Infigratinib (BGJ398) in previously treated patients with advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements: mature results from a multicentre, open-label, single-arm, phase 2 study. The Lancet Gastroenterology & Hepatology Published Online August 3, 2021 https://doi.org/10.1016/S2468-1253(21)00196-5

TRUSELTIQ is a trademark of Helsinn Group.

Helsinn Group Media Contact:
Paola Bonvicini

Group Head of Communication

Tel: +41 (0) 91 985 21 21

Info-hhc@helsinn.com

BridgeBio Media Contact:

Grace Rauh

grace.rauh@bridgebio.com

(917) 232-5478