Month: September 2021

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

WM’s ICLM and TUV Unitary Global Payments Systems provide a fully operational and benign model for a functioning Cashless Society worldwide

NEW YORK and ST PETER PORT, Guernsey, Sept. 29, 2021 (GLOBE NEWSWIRE) — To create its Global Clearing System – a digital version of John Maynard Keynes’s proposed “International Clearing Union” – Global Telephony Provider Webtel.mobi (“WM”) also created a Global Unitary Payment System – with two Global Payment Facilities – the ICLM Payments and the TUV Digital Currency Payments (also known as “TUV Payments”).

Both Payment Systems have all the characteristics of Cash Payments and Digital Payments combined, are globally applicable, globally available, require no specialized equipment to function, have multicurrency wallets, enable multicurrency payments with FX Conversions in-wallet, and are equally available to Banked and Unbanked persons.

One of these Payment Systems – the ICLM Payments – is ultra-low cost to use, and the other – TUV Payments – is completely free to use.

These Payment Systems not only facilitate a “Cashless Society”, but have also already introduced a fully operational global Cashless Society system in a benign way. It is benign because this version of a Cashless Society preserves individuals’ privacy, freedom, and choice.

WM’s Payment Systems do not require a Central Bank issued Digital Currency or CBDC to function because WM’s TUV Digital Currency itself is already the equivalent of a Global CBDC.

WM’s Payment Systems – like all its other facilities – are not new. They were functional and operational in 2009, but WM spent nine years testing and perfecting them – and subjecting its system to multiple third-party Due Diligences worldwide – to ensure compliance and robustness before rebuilding its Platform 2 to provide these Facilities in an unrestricted manner internationally.

Access to WM’s services is only available to WM Members because it is a Closed-Loop Members-Only service. However, it is free and instant to join WM as a Member.

WM has one of the safest systems internationally in Security and Anti Money Laundering. WM’s Payment Systems synchronize, into one product, the characteristics of Cash and Digital Money with the ease of use of Cash and the safety of Digital Money. They also have the security of a closed, monitored system and transactions – ensuring robust security and Anti-Money Laundering capacities.

To load WM accounts, Members can transfer funds (”Stored Credit”) into their accounts using any means, and also purchase TUV Digital Currency from WM Agents (“VSMPs”) for cash. The system provides a Unitary and level playing field – and entry into a 21^st Century Digital Economy for all people – whether Banked or Unbanked. It renders even the concepts of “Banked” or “Unbanked” redundant – because the only differentiator is the method used to load funds (“Stored Credit”) onto WM Accounts.

All funds (“Stored Credit”) of WM Members is held in regulated Bank Accounts, so the WM System has permanent 100% liquidity, and all Payment and Settlement Transactions are carried out simultaneously in 1/100^th of a second.

WM’s ICLM Payments and TUV Payments are fully operational, and available to all WM Members on its platform. Examples of some of WM’s ICLM and TUV Payments Systems’ characteristics in comparison to other Payment Systems in the Offline Payments role are as follow:

OFFLINE PAYMENTS CHARACTERISTIC	CARD PAYMENTS	MOBILE PAYMENTS	CASH PAYMENTS	ICLM PAYMENTS	TUV PAYMENTS
Payments made Instantly	Yes	Yes	Yes	Yes	Yes
Functions 24/7/365	Yes	Yes	Yes	Yes	Yes
Funds Secure in Digital Wallets	Yes	Yes	No	Yes	Yes
Functions without a Physical or Digital Card	No	No	Yes	Yes	Yes
Has Combined Usability of Cash and Digital	No	No	No	Yes	Yes
Has Identical Usability to Cash	No	No	Yes	Yes	Yes
Pure Peer 2 Peer Transactions (PP2P)	No	No	Yes	Yes	Yes
Impossible to Carry Out Fraudulent Transactions	No	No	Yes	Yes	Yes
Impossible for Merchants to Incur Chargebacks	No	No	Yes	Yes	Yes
Instant No-Retention Settlement to Merchants	No	No	Yes	Yes	Yes
Payment Process without Intermediaries	No	No	Yes	Yes	Yes
Payment Process without Intermediary Fees	No	No	Yes	Yes	Yes
Receive Payments without Terminals/Equipment	No	No	Yes	Yes	Yes
Functions Alone Without Any Other Entities	No	No	Yes	Yes	Yes
Functions in all Countries and Territories	No	No	Yes	Yes	Yes
Merchant and Payer can Split Payment Fees	No	No	Yes	Yes	Yes
Self-Contained Unitary Global System	No	No	No	Yes	Yes
Uniform Global Security and Standards	No	No	No	Yes	Yes
Total Access from Any Smart Phone	No	No	No	Yes	Yes
Total Access from Any Pre-Smart Mobile Phone	No	No	No	Yes	Yes
Impossible for a 3rd Party to use if Stolen	No	No	No	Yes	Yes
Impossible for a 3rd Party to use if Lost	No	No	No	Yes	Yes
Impossible to Clone or Counterfeit	No	No	No	Yes	Yes
Clients can Pay in Multiple Currencies Globally	No	No	No	Yes	Yes
Clients Control FX Conversions	No	No	No	Yes	Yes
Merchants can Accept Multicurrency Payments	No	No	No	Yes	Yes
Merchants Control FX Conversions	No	No	No	Yes	Yes
Totally Free to Make and Receive Payments	No	No	Yes	0.25% to 1%	Yes

Once people have joined WM as Members and loaded Stored Credit onto their accounts, they can start using the ICLM Payments of TUV Payments Systems immediately – to make or receive payments. The only requirement is a Smart Phone – or a Pre-Smart Phone (which still comprise 50% of Mobile Phones in use) – and the ITAN Number and Registered Mobile Number of the WM Member they want to pay. That is all.

ITAN Numbers (“Inter-TEL.mobi Account Numbers”) are the unique Account Numbers issued to all WM Members when they join, and the Registered Mobile Number is the member’s Mobile Phone Number.

For Merchants to notify clients they accept ICLM and TUV Payments of WM’s unique Global Account Numbering system, they simply need to display this sign, and indicate they accept payment in only one currency, only some currencies or in all currencies.

As all WM Members can execute in-wallet Currency Conversions or Currency Swaps within WM, it makes no difference whether only one currency or all currencies are accepted. This is because all Members can convert before paying or after receiving payments. Examples of the Merchant notifications for accepting ICLM and TUV Payments are as follow:

	We Accept ICLM and TUV Payments						We Accept ICLM and TUV Payments
	Our ITAN:	WM1234567891234567891234					Our ITAN:	WM9876543219876543219876
	Our Mobile:	+XX 1234 567 890					Our Mobile:	+XX 9876 543 210
	Payment Currencies Accepted:		All Currencies				Payment Currencies Accepted:		USD only
	Instant Confirmation by Text:		Yes				Instant Confirmation by Text:		Yes

Resources:

Media Contact:
Nick Lambert: wm@thoburns.com

Video on WM’s Regulatory Compliance:
https://youtu.be/u522lVsGIJI

Video on The Capacities of the WM System:
https://youtu.be/XYBrCikUhn8

Research Reports on the Capacities of the WM System:
https://tinyurl.com/TUVresearch

WM’s urls:
https://webtel.mobi/pc (Tablets / Laptops / Desktops)
https://webtel.mobi (Smart Phones)
https://webtel.mobi/wap (Pre-Smart Mobile Phones)

ADG20 Continues to be Well Tolerated in Healthy Volunteers with Prolonged Half-Life and Serum Virus Neutralization Activity Observed out to Six Months in Ongoing Phase 1 Study

Data from Quantitative Systems Pharmacology/Whole-Body Physiologically Based Pharmacokinetic Modeling Support Evaluation of 300 mg Intramuscular Dose of ADG20 Given as a Single Intramuscular Injection in Ongoing Phase 2/3 Studies

Data to be Presented During IDWeek 2021 and 19^th Annual Discovery on Target Conference

WALTHAM, Mass., Sept. 29, 2021 (GLOBE NEWSWIRE) — Adagio Therapeutics, Inc., (Nasdaq: ADGI) a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, today announced new data from the company’s COVID-19 antibody program. Updated, six-month data from its ongoing Phase 1 study of ADG20 in healthy participants and data validating the selection of the 300 mg intramuscular (IM) dose given as a single injection that is being evaluated in the company’s ongoing global Phase 2/3 treatment (STAMP) and prevention (EVADE) clinical trials will be presented during four poster sessions at the Infectious Disease Society of America’s IDWeek 2021, being held from Sept. 29 – Oct. 3, 2021. In addition, Adagio’s chief scientific officer, Laura Walker, Ph.D., will present a subset of the ADG20 Phase 1 data as well as background on the identification and optimization of this differentiated antibody clinical candidate in an oral presentation at the 19^th Annual Discovery on Target Conference on Sept. 30, 2021.

“The continued strength of the safety and pharmacokinetic data from our Phase 1 study is encouraging and further underscores the potential impact an antibody like ADG20 – which was designed to be potent, broadly neutralizing and delivered as a single IM injection – could have on people with or at risk of COVID-19,” said Lynn Connolly, M.D., Ph.D., chief medical officer of Adagio. “These Phase 1 data combined with our dose selection strategy, which relied on our innovative modeling approach, have allowed us to initiate and advance our pivotal trials of ADG20 in the treatment and prevention of COVID-19. We anticipate these data will support an Emergency Use Authorization (EUA) application in the first quarter of 2022, which could enable us to bring an important treatment option to patients.”

Phase 1 Trial Update
Adagio is evaluating ADG20 in a Phase 1 randomized, double-blind, placebo-controlled single ascending-dose study to assess safety and tolerability, pharmacokinetics (PK), immunogenicity, and serum virus neutralizing activity of ADG20 ex vivo against SARS-CoV-2. Data from a six-month evaluation timepoint confirmed the extended half-life of ADG20, which approached 100 days based on data from the 300 mg IM dose that was given as a single injection. In addition, 50% serum virus neutralization titers at six months after a 300 mg IM dose of ADG20 were similar to observed peak titers with the mRNA-1273 vaccine and exceeded those achieved with the AZD1222 vaccine series. Importantly, ADG20 was well tolerated with no study drug-related adverse events (AEs), serious AEs, or injection-site or hypersensitivity reactions reported through a minimum of three months follow-up across all cohorts. Participants will continue to be followed through 12 months to assess safety and tolerability, PK, immunogenicity and serum virus neutralizing activity.

Phase 1 Poster Information: (633) Preliminary Results from a Phase 1 Single Ascending-Dose Study Assessing Safety, Serum Viral Neutralizing Antibody Titers (sVNA), and Pharmacokinetic (PK) Profile of ADG20: an Extended Half-Life Monoclonal Antibody Being Developed for the Treatment and Prevention of Coronavirus Disease (COVID-19)

Dose Selection Strategy
To support dose selection for Adagio’s global Phase 2/3 STAMP and EVADE clinical trials, the company modified an existing quantitative systems pharmacology whole-body physiologically-based pharmacokinetic (QSP/PBPK) model to better characterize the PK of extended half-life monoclonal antibodies in serum and key sites of viral replication in the respiratory tract. Adagio’s model adequately a priori predicted the observed ADG20 serum PK in non-human primates (NHPs) and humans. The model was further optimized based on data from Adagio’s Phase 1 clinical trial and then applied for dose selection for STAMP and EVADE.

For the STAMP treatment trial, data compiled to date suggest that the 300 mg IM regimen has a projected ability to rapidly achieve and maintain target concentrations at key tissue sites of viral replication, including the ability to attain near complete (> 90%) and durable (> 28-day) SARS-CoV-2 receptor occupancy across a range of baseline viral loads. Further, for the EVADE prevention trial, data compiled to date suggest the 300 mg IM regimen has a projected ability to rapidly exceed target serum concentrations in the majority of simulated patients and to maintain potentially effective concentrations for up to 12 months.

Dose Selection Poster Information

• (1086) A Whole-Body Quantitative System Pharmacology Physiologically-Based Pharmacokinetic (QSP/PBPK) Model that a priori Predicts Intramuscular (IM) Pharmacokinetics of ADG20: an Extended Half-life Monoclonal Antibody Being Developed for the Treatment and Prevention of Coronavirus Disease (COVID-19)
• (1089) Use of a Whole-Body Quantitative System Pharmacology Physiologically-Based Pharmacokinetic (QSP/PBPK) Model to Support Dose Selection of ADG20: an Extended Half-Life Monoclonal Antibody Being Developed for the Prevention of Coronavirus Disease (COVID-19)
• (1088) A Whole-Body Quantitative System Pharmacology Physiologically-Based Pharmacokinetic (QSP/PBPK) Model to Support Dose Selection of ADG20: an Extended Half-Life Monoclonal Antibody Being Developed for the Treatment of Coronavirus Disease (COVID-19)

The STAMP and EVADE clinical trials are currently ongoing and enrolling patients globally. For more information, please visit clincialtrials.gov.

About ADG20
ADG20, a monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses, is being developed for the prevention and treatment of COVID-19, the disease caused by SARS-CoV-2. ADG20 was designed and engineered to possess high potency and broad neutralization against SARS-CoV-2 and additional clade 1 sarbecoviruses, by targeting a highly conserved epitope in the receptor binding domain. ADG20 displays potent neutralizing activity against the original SARS-CoV-2 strain as well as all known variants of concern. ADG20 has the potential to impact viral replication and subsequent disease through multiple mechanisms of action, including direct blocking of viral entry into the host cell (neutralization) and elimination of infected host cells through Fc-mediated innate immune effector activity. ADG20 is administered by a single intramuscular injection, and was engineered to have a long half-life, with a goal of providing both rapid and durable protection. Adagio is advancing ADG20 through multiple clinical trials on a global basis.

About Adagio Therapeutics
Adagio (Nasdaq: ADGI) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential. The company’s portfolio of antibodies has been optimized using Adimab’s industry-leading antibody engineering capabilities and is designed to provide patients and clinicians with a powerful combination of potency, breadth, durable protection (via half-life extension), manufacturability and affordability. Adagio’s portfolio of SARS-CoV-2 antibodies includes multiple, non-competing broadly neutralizing antibodies with distinct binding epitopes, led by ADG20. Adagio has secured manufacturing capacity for the production of ADG20 with third-party contract manufacturers to support the completion of clinical trials and initial commercial launch. For more information, please visit www.adagiotx.com.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “intends,” “projects,” and “future” or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, the timing, progress and results of our preclinical studies and clinical trials of ADG20, including the timing of our planned EUA application, initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs; our ability to obtain and maintain regulatory approvals for, our product candidates; our ability to identify patients with the diseases treated by our product candidates and to enroll these patients in our clinical trials; our manufacturing capabilities and strategy; and our ability to successfully commercialize our product candidates. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation, those risks described under the heading “Risk Factors” in Adagio’s prospectus filed with the Securities and Exchange Commission (“SEC”) on August 6, 2021 and in Adagio’s future reports to be filed with the SEC, including Adagio’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021. Such risks may be amplified by the impacts of the COVID-19 pandemic. Forward-looking statements contained in this press release are made as of this date, and Adagio undertakes no duty to update such information except as required under applicable law.

Contacts:
Media Contact:
Dan Budwick, 1AB
Dan@1abmedia.com

Investor Contact:
Monique Allaire, THRUST Strategic Communications
monique@thrustsc.com

Philogen Provides Corporate Update

• Nidlegy™ and Fibromun on track with planned timelines in pivotal clinical trials
• Use of Nidlegy™ in non-melanoma skin cancer expanded in Phase II clinical trials
• Early evidence of potent activity of Fibromun in combination with Standard of Care in last line patients with Glioblastoma and Soft Tissue Sarcoma
• Clinical experience with OncoFAP confirms preclinical results, recently published in Proceedings of the National Academy of Sciences U.S.A.
• Positive net financial position of €96.077M compared to €104.668M at 31 March 2021 (€44.238M at 31 December 2020)
• Philogen’s management team will hold a Webinar to discuss the news on Wednesday 29^th of September 2021 at 12:00 ET / 17:00 BST / 18:00 CEST (Please find the link to this Webinar here)

Siena (Italy), 29 September 2021 – Philogen S.p.A., a clinical-stage biotechnology company focused on antibody- and small molecule-based targeted therapeutics announces its Interim Results for the six month period ended 30^th June 2021 and provides an update regarding recent corporate developments.

Dario Neri, CEO of Philogen, commented on the results for the year and the evolution of the business:

“ Following our recent listing, I am delighted to report that Philogen has made significant progress both in our clinical and pre-clinical stage pipeline, showing curative potential in difficult to treat preclinical models of cancer.

Development for pivotal clinical trials is progressing on track. We expect to complete patient enrollment in the European Phase III clinical trial of Nidlegy™ in melanoma by mid-2022. With respect to the two European clinical trials of Fibromun in newly diagnosed and second recurrence sarcoma, completion of recruitment of the respective patients is expected by the end of 2023.

Clinical trials in patients with last line Glioblastoma or with last line Soft Tissue Sarcoma, for which objective responses are very rarely observed using Standard of Care drugs, are showing signs of potent clinical activity when Fibromun is added to the treatment.

I am also pleased to see that we are making progress in the clinical development of small molecules targeted therapeutics. OncoFAP, our proprietary targeting platform directed against Fibroblast Activation Protein, is revealing a significant ability to selectively localize both primary and heavily disseminated tumors in patients. This Nuclear Medicine validation paves the way for the implementation of innovative therapeutic strategies.

Philogen remains committed to the development of pharmaceutical products with game changing potential for difficult to treat conditions and is well capitalized to aggressively perform its industrial plan.“

MAIN EVENTS FOR THE FIRST HALF 2021 AND RECENT HIGHLIGHTS

Proprietary products

• Nidlegy™ is a pharmaceutical product, proprietary to Philogen, consisting of two active ingredients, L19-IL2 and L19-TNF. The L19 antibody is specific for the B domain of Fibronectin, a protein expressed in tumors (and other diseases), but absent in most healthy tissues. Interleukin 2 (IL2) and Tumor Necrosis Factor (TNF) are inflammatory cytokines with anti-tumor activities.
  • Phase III studies in Stage IIIB/C melanoma – New centers opened with the goal of accelerating patient enrollment in both the U.S. and Europe;
  • European Phase III study in Stage III B/C melanoma – enrolled 168 patients as of June 30, 2021. In addition, after the close of the 2021 financial year and up to the present date, additional 13 patients have been recruited after the close of the year, reaching a total number of 181 patients;
  • U.S. Phase III study in Stage III B/C melanoma – signed contract with a Contract Research Organization to open up to 38 clinical centers to add to ongoing study;
  • US Phase II study in stage IV melanoma – revised clinical protocol submission to US Food and Drug Administration is expected;
  • European Phase II study in non-melanoma skin cancers – Promising clinical data at ten months post-treatment on Nidlegy™ in patients with basal cell carcinoma. The clinical trial features the participation of clinical centers in Germany, Switzerland and Poland. Additional countries are planned to be involved in Phase II studies;
• Fibromun is a pharmaceutical product, proprietary to Philogen, consisting of the L19 antibody fused to TNF.
  • Soft tissue sarcoma – Opening of new clinical centres in Germany, Spain, Italy, Poland and the United States, with the aim of accelerating enrolment in the three ongoing clinical trials (two European and one American);
  • European Phase II study in soft tissue sarcoma with at least two recurrences (i.e., ≥ third line of treatment) – Completed patient enrollment in the Run-in portion of the study. The objective of this phase is to confirm drug tolerability and to monitor early signs of efficacy in a limited number of patients. In this setting, Fibromun is administered in combination with Dacarbazine. An objective response has been observed. The historical objective response rate for this population is 4.3% (Garcia-del-Muro et al., J Clin Oncol 2011, 29,2528). The randomized phase is planned to begin, subject to approval by the Data and Safety Monitoring Board;
  • Glioblastoma (i.e., grade IV glioma) – Completed a Parallel Scientific Advice (PSA) with the European Medicines Agency and the U.S. Food and Drug Administration in June 2021. The development plan for the treatment of glioblastoma and the proposed strategy for marketing authorisation have been discussed and agreed with the relevant authorities. Philogen will follow the recommendations that were provided during the PSA;
  • Phase II study in Grade III-IV wildtype IDH glioma at first relapse/recurrence – Promising interim survival benefits observed in the European Phase I/II study, in which Fibromun is being studied as monotherapy. Data on Progression Free Survival at six months from the start of treatment are being completed, while data on Overall Survival will be consolidated by the end of 2021;
  • Phase I/II study in glioblastoma at first relapse/recurrence – monitoring of Safety, presence of Objective Responses and Progression Free Survival in patients treated during the dose escalation portion (i.e., Phase I of the study). The first patient in the trial, treated with Fibromun plus Lomustine, exhibited a tumor shrinkage of 74% at 18 weeks and of 92% at 24 weeks. The patient (and the ones who have been treated after him, for whom follow-up time is still insufficient) will continue to be monitored at regular intervals. The historical objective response rate for this patient population upon Lomustine treatment is 4.3% and responses of this magnitude and duration are virtually never observed (Wick et al., J Clin Oncol 2010, 28,1168).
• OncoFAP is a small organic molecule, proprietary to Philogen group, with affinity for Fibroblast Activation Protein (FAP). The product has the ability to selectively localize in a variety of metastatic solid tumors.
  • Excellent targeting capabilities of OncoFAP in patients with various tumor types. Clinicians at the Department of Nuclear Medicine of the University Hospital Münster have used OncoFAP radiolabeled with gallium-68 (OncoFAP-68Ga) to detect neoplastic lesions of both primary and metastatic origin. Of note is the intense uptake in the tumor and the low absorption in healthy organs (including kidneys) after only 1h after intravenous administration of the drug. Thus, imaging results in cancer patients confirmed the excellent properties of OncoFAP observed in preclinical models, which have recently been published by the Philogen group in the Proceedings of the National Academy of Sciences U.S.A.;
  • Several international Phase I/II clinical trials are currently being designed, with the aim of studying OncoFAP-68Ga (diagnostic agent) and OncoFAP-177Lu (diagnostic and therapeutic agent) in a larger number of patients with different types of cancer. These studies will provide an indication of which tumor(s) will be the focus of clinical trials. These studies are expected to begin in 2022.

Licensed products

• Continue partnerships on Dodekin (Confidential Partner) and Dekavil (Pfizer);
• ABBV-022 is a product generated and out-licensed by Philogen. The drug consists of the cytokine interleukin 22 fused to a monoclonal antibody;
  • Start of a phase I clinical trial for the treatment of ulcerative colitis

GMP

• The structural work on the second GMP production plant, located at the Philogen site in Rosia (Siena), was completed on schedule in line with the business plan. The new plant has been designed to meet the highest regulatory standards for the production of therapeutic protein-based drugs and will be used for the production of commercial pharmaceuticals and clinical trial drug products. The installation and validation of the process machines at the new GMP site is expected to be completed in the first quarter of 2022, following which authorization from the Italian competent authority (AIFA) will be sought for the production and marketing of the drugs. It should be noted that the Company already has a production site in Montarioso that is authorized by AIFA solely for the production of experimental drugs for clinical trials;

Financial Highlights

• Revenues from contracts with customers amounting to €1.548M (€2.308M at 30 June 2020)
• EBITDA of negative €8.107M (negative €5.646M at 30 June 2020)
• EBIT of negative €8.860M (negative €6.352M at 30 June 2020)
• Net loss of €8.653M (net loss of €8.424M at 30 June 2020)
• Positive net financial position of €96.077M compared to €104.668M at 31 March 2021 (€44.238M at 31 December 2020)

Philogen Group Description

Philogen is an Italian-Swiss company active in the biotechnology sector, specialised in the research and development of pharmaceutical products for the treatment of highly lethal diseases. The Group mainly discovers and develops targeted anticancer drugs, exploiting high-affinity ligands for tumour markers (also called tumour antigens). These ligands – human monoclonal antibodies or small organic molecules – are identified using Antibody Phage Display Libraries and DNA-Encoded Chemical Libraries technologies.

The Group’s main therapeutic strategy for the treatment of these diseases is represented by the so-called tumor targeting. This approach is based on the use of ligands capable of selectively delivering very potent therapeutic active ingredients (such as pro-inflammatory cytokines) to the tumor mass, sparing healthy tissues. Over the years, Philogen has mainly developed monoclonal antibody-based ligands that are specific for antigens expressed in tumor-associated blood vessels, but not expressed in blood vessels associated with healthy tissues. These antigens are usually more abundant and more stable than those expressed directly on the surface of tumor cells. This approach, so called vascular targeting, is used for most of the projects pursued by the Group.

The Group’s objective is to generate, develop and market innovative products for the treatment of diseases for which medical science has not yet identified satisfactory therapies. This is achieved by exploiting (i) proprietary technologies for the isolation of ligands that react with antigens present in certain diseases, (ii) experience in the development of products targeted at the tissues affected by the disease, (iii) experience in drug manufacturing and development, and (iv) an extensive portfolio of patents and intellectual property rights.

Although the Group’s drugs are primarily oncology applications, the targeting approach is also potentially applicable to other diseases, such as certain chronic inflammatory diseases.

FOR MORE INFORMATION:

Philogen – Investor Relations

IR@philogen.com – Emanuele Puca | Investor Relations

Consilium Strategic Communications contacts

Mary-Jane Elliott, Davide Salvi

Philogen@consilium-comms.com

The Distinguished Gentleman’s Drive attracts thousands of vintage automotive enthusiasts in its first-ever global charity drive, raising $200,000 for men’s mental health and prostate cancer research. DGD 2022 date is set for Sept. 26, 2021.

SYDNEY, Sept. 29, 2021 (GLOBE NEWSWIRE) — On Sunday, Sept. 26, 2021, thousands of dapper drivers took part in the world’s largest and most stylish vintage automotive event. The first event of its kind, The Distinguished Gentleman’s Drive’s inaugural event focused on establishing flagship drives around the world to raise awareness and capture content within local communities. With the premise that all drivers must be behind the wheel of a pre-1980s vehicle and be dressed to suit, the event successfully took place in over 145 cities and 55 countries around the world, connecting 4,000 drivers to its causes of prostate cancer and men’s mental health.

The event raised over $200,000 USD for its charity partner Movember, which is the world’s leading global organization focused solely on men’s health. The funds raised through The Distinguished Gentleman’s Drive will be directed toward prostate cancer research and men’s mental health programs.

Founder of The Distinguished Gentleman’s Drive, Mark Hawwa, reflects on the inaugural event.

“It’s been surreal to experience the success of The Distinguished Gentleman’s Drive within its first year. What we were able to achieve, along with the support from all our volunteers and participants, is exciting. We surpassed every expectation for our inaugural year, raising more than what The Distinguished Gentleman’s Ride did in its first year as a fundraising event. We’re proud to be able to bring classic automotive enthusiasts together and continue building upon our passion for men’s health and motoring.”

Every drive around the world features a unique selection of cars and drivers, encouraging folks to get out on the open road to celebrate the life and connection that is made through pre-’80s machines. Drivers’ dapper style and gentlemanly conduct perfectly complement classic cars with raising funds and awareness for men’s health.

Click here for DGD 2021 Global Media Photography

The Distinguished Gentleman’s Drive will return on Sunday, Sept. 25, 2022. Anyone looking to take part in their local drive or start one of their own, please subscribe at www.gentlemansdrive.com.

For more information, contact: Ramsey Sayed | ramsey@gentlemansdrive.com.

About The Distinguished Gentleman’s Ride

The Distinguished Gentleman’s Ride unites classic and vintage style motorcycle riders all over the world to raise funds and awareness for prostate cancer research and men’s mental health. The Distinguished Gentleman’s Ride was founded in Sydney, Australia, in 2012 by Mark Hawwa. Since then, the event has raised over $31.5 million USD, connecting the global motorcycling community to their health. Visit www.gentlemansride.com for more.

Related Files

DGD21_PR.pdf

Related Images

Image 1: Two Dapper Gents Driving in DGD Lisbon, 2021

Photograph from The Distinguished Gentleman’s Drive 2021 in Lisbon, Portugal. Photographed by Manuel Portugal Photography.

This content was issued through the press release distribution service at Newswire.com.

Attachment

• Two Dapper Gents Driving in DGD Lisbon, 2021

“Conscience is like a beautiful and fragrant flower. When in blossom, the fragrance will enliven the world and be smelled by all.” ~ Dr. Hong, Tao-Tze

LOS ANGELES, Sept. 28, 2021 (GLOBE NEWSWIRE) — Tai Ji Men Qigong Academy in Los Angeles celebrated its 21st birthday on September 26, 2021. Because the Delta variant of COVID-19 is rapidly spreading, the anniversary celebration was conducted virtually, and everyone was invited to participate in the wonderful event by watching it online.

For the past 21 years, under the leadership of Dr. Hong, Tao-Tze, the Academy has held various life wisdom and health symposiums as well as cultural exchange activities, and it has engaged in numerous international events to promote a culture of conscience, love, and peace, with the goal of improving global citizens’ physical, mental, and spiritual health. In recent years, Tai Ji Men has been promoting the “Movement of An Era of Conscience” and the “International Day of Conscience” to awaken the conscience in the people of the world. During the SARS outbreak in 2002 and during the COVID-19 pandemic, which started in the end of 2019, Tai Ji Men produced videos featuring epidemic prevention guidelines, including Three Don’ts, Five Do’s, and Six Tips as well as a trilogy on COVID-19 prevention measures: Antiviral Combat, The War Against Virus, and Anti Pandemic Battle. It has been sharing these videos with global citizens, hoping that everyone will stay safe, healthy, and happy and that the pandemic will end soon.

Many community leaders offered certificates of recognition or delivered congratulatory video messages in honor of the Academy’s 21st anniversary, acknowledging the contributions of the leader and members of Tai Ji Men for the community, the United States, and the world as Tai Ji Men has been widely promoting the culture of qigong and martial arts as well as a culture of love, peace, and conscience.

U.S. Congresswoman Young Kim said, “For 21 years, Tai Ji Men Qigong Academy has served as a home and a center for self-improvement for many of our community members through martial arts and qigong. I want to thank you for fostering our future leaders, physically, mentally and spiritually.”

California State Senator Josh Newman presented a California Senate Certificate of Recognition to the Academy and stated in his video message, “Despite the pandemic, your academy has continued to thrive, serving as a vital pillar to our community by reaffirming the spirit of universal brotherhood, etiquette, and conscience during a time when such an example is vitally needed across our state and across our country as a whole.”

California Assemblyman Phillip Chen said, “I really appreciate all they’ve done for our community and also for the state of California,” commending Tai Ji Men for improving people’s wellness and health through martial arts and qigong. He also honored Tai Ji Men Qigong Academy and Dr. Hong, Tao-Tze with a California Legislature Assembly Resolution respectively in recognition of their contributions.

Diamond Bar City Council Member Andrew Chou said that the pandemic has been hard on everybody and that Tai Ji Men’s work is very important in maintaining people’s physical and mental health. “I understand that throughout the pandemic, you have been actively hosting virtual events both locally and internationally. And also throughout social media, you have continued to share preventive measures to overcome anxiety and stress caused by the pandemic. So thank you again for all you do and congratulations on your 21st anniversary,” he added.

Walnut Valley Unified School District Board President Layla Abou-Taleb said, “I want to congratulate the Tai Ji Men Qigong Academy for 21 years of service to the community. You play an important role and we really, truly appreciate it and wishing you a better year, this coming year for all our students and our community.”

In addition to the aforementioned video messages and certificates of recognition, Tai Ji Men also received certificates of recognition from other leaders and entities, including California State Senator Connie M. Leyva, Mayor Eric Ching of the City of Walnut, Arcadia Mayor Sho Tay, and the City Council of Montclair.

Jason Wang, a Tai Ji Men member who immigrated to the U.S. with his parents 20 years ago and grew up with the Tai Ji Men Qigong Academy in Los Angeles, had a lot to say about the Academy’s 21st birthday. Since he is 6-foot-3 and in good shape, it’s difficult to imagine that he had serious health issues as a child and had to go to the doctor frequently for asthma and allergies. He said, “There was one time I was jumping on a bed with my cousin, and I ended up having to go to the hospital because of the asthma attack.” “After joining Tai Ji Men, my health has improved tremendously. I no longer was getting any asthma attack,” he said. Last year, he was blessed with a new baby. He was already very busy with his work, and the new addition to his family made him even busier. He gained a better understanding of the reminder from his Shifu (master) at Tai Ji Men: “Those who use their time wisely can find time to accomplish a lot.” He has learned to manage his time well so that he can balance life and work. He also learned to think positively. He shared a piece of advice from his master by saying, “You can live a day happy, or you can live a day sad or angry. So why would you want to live your day in anger or in sadness?” Jason said that practicing Tai Ji Men Qigong helps him replenish his energy, and he expressed his gratitude for Dr. Hong: “Shifu has taught me a lot. So from his teaching, I’m able to utilize that in my personal life and my work life. And he has just helped me become a better person.”

Munni Irone, founder of the Art 4 Peace Awards, met Tai Ji Men members at an international conference many years ago and decided to join to practice qigong and cultivate her heart. She shared some of the benefits of practicing Tai Ji Men Qigong: “It kept me very centered. It kept me from having stress. I work long hours without any stress because it allows me to do that. Tai Ji Men Qigong has numerous different benefits, not only just health benefits. There is a social benefit, emotional, and spiritual benefit.” She continued by saying, “Your skin is better. You have more energy. You are also very successful in business because people trust someone that has good energy. So you create your Qi; you create your energy to be successful.” She said that she used to suffer from back problems, but that she is now in much better shape. She said, “Shifu is a very kind and very influential and compassionate human being, who is also helpful in creating this beautiful family of love and peace.” “In Tai Ji Men you can be in any faith and religion. It really doesn’t matter because this is something on a different level for mental, spiritual, and physical spirituality, so I’m very blessed to be part of this beautiful family. I’m very thankful for Dr. Hong, for creating this wonderful family where you can center so many people,” she added.

Tai Ji Men Qigong has benefited not only many adults but also children. A group of children who practice Tai Ji Men Qigong revealed some of the most important lessons they’ve learned at Tai Ji Men, and it’s clear from their sharing that the concepts of love, peace, and conscience have been imprinted in their hearts to extend their horizons in life. Nathan, 12, said, “Shifu taught me to be kind, nice, and happy.” Mayra, 10, said, “Shifu has taught me to always love myself and follow my conscience and do the right thing.” Avery, 10, said, “I love Tai Ji Men because it taught me that if I don’t know what’s right or wrong, I follow my conscience. It also taught me qigong to bring peace to the world and to love myself and others, no matter what.” Cameron, 8, said, “Shifu told me that practicing qigong will help me calm myself down, and he also told me that love and peace can make the world a better place.” Aaron, 11, said, “Shifu taught me qigong and life lessons that would improve my life and my quality of life, that makes me not depressed and not too emotional at hard times.” Rylan, 9, said, “Shifu taught me qigong to be brave and to know what is right and what is wrong.” Leon, 10, said, “Shifu taught me to do qigong to improve my health, and he also taught me to control my anger.”

Tai Ji Men invites everyone to read the uplifting stories of Tai Ji Men members from all walks of life on its website at www.taijimen.org, to replenish positive energy. Tai Ji Men encourages people to listen to their conscience, think positively, do good deeds, and collaborate to bring the pandemic to an end as soon as possible!

Tai Ji Men Qigong Academy: Tai Ji Men is an ancient menpai (similar to school) of qigong, martial arts, and self-cultivation. It has carried forward the wisdom of Daoist philosophy, one of the highest philosophies of humankind. It is an international nonprofit cultural organization. Its contemporary zhang-men-ren (grandmaster), Dr. Hong, Tao-Tze established the Tai Ji Men Qigong Academy in 1966, and since then it has grown to 15 academies worldwide. In 2016, it commemorated its 50th anniversary, a major milestone in its history, with big celebrations and spectacular cultural performances in Los Angeles, San Francisco, and Taiwan.

Dr. Hong teaches his dizi (similar to disciples) methods to achieve physical, mental, and spiritual balance, and tens of thousands of families have benefited from his teaching. At Tai Ji Men, martial arts and wisdom have been passed down from the shifu (master) to his dizi. Through this time-honored tradition, the shifu and dizi promote the Tai Ji Men culture and martial arts around the world while embodying what is true, good, and beautiful as well as spreading the ideas of conscience, love, and peace. Over the past half-century, the shifu and dizi have self-funded trips to over 300 cities in 101 nations to conduct more than 3,000 cultural performances and exchanges and have been recognized as “International Ambassadors of Peace and Goodwill.”

Media Contact:
Lily Chen
Representative
info@taijimenla.org
626-202-5268

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3ff274db-6012-4b58-bf66-64d620ced1fc