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Lyra Therapeutics Announces Positive Topline Results for LANTERN Phase 2 Randomized Controlled Study of LYR-210 for the Treatment of Chronic Rhinosinusitis With and Without Nasal Polyps

• 7500 mcg dose of LYR-210 achieved statistically significant improvement in a composite of the 4 cardinal symptoms of CRS at weeks 16 (p=0.021), 20 (p=0.012) and 24 (p=0.016) compared to control.
  
  
• 7500 mcg dose of LYR-210 achieved statistically significant improvement in SNOT-22 score at weeks 8 (p=0.039), 16 (p=0.008), 20 (p=0.001) and 24 (p=0.001) compared to control.
  
  
• First nasal implant to achieve a benefit of up to six months after a single administration in clinical testing, as a potential alternative to surgery.
  
  
• Based on the LANTERN results, the company plans an end of Phase 2 FDA meeting in mid-2021 and to subsequently initiate a pivotal Phase 3 trial of LYR-210 in chronic rhinosinusitis.
  
  
• Lyra to hold a conference call to discuss the trial results today at 8:30 a.m. ET.

 

WATERTOWN, Mass.–(BUSINESS WIRE)–Lyra Therapeutics, Inc. (Nasdaq: LYRA), a clinical-stage therapeutics company focused on the development and commercialization of novel integrated drug and delivery solutions for the localized treatment of patients with ear, nose and throat (ENT) diseases, today announced positive topline results from the LANTERN Phase 2 study of LYR-210 for chronic rhinosinusitis (CRS).

The LANTERN study was a randomized, patient blinded, controlled clinical trial designed to evaluate the efficacy and safety of LYR-210 in adult patients with CRS, including patients with and without nasal polyps, who had not previously undergone sinus surgery. CRS is diagnosed when 2 or more of the 4 cardinal symptoms (4CS) of CRS (nasal obstruction, nasal discharge, facial pain/pressure, and reduction or loss of sense of smell) persist for 12 weeks or longer and when inflammation is confirmed via endoscopy or a CT scan.

The multi-center study enrolled 67 patients at sites in Europe, New Zealand and Australia. Patients in the study were randomized 1:1:1 into three groups: 7500 mcg (21 patients) or 2500 mcg (23 patients) of continuous mometasone furoate therapy, or control (23 patients).

LYR-210 is an investigational product candidate designed to be administered in-office, into the sinonasal passages, and to deliver a sustained release therapeutic up to six months at difficult-to-access nasal inflammation sites without the need for patient compliance, as a non-invasive alternative to surgery for patients who have failed medical management.

Topline Results

• Although not statistically significant at week 4, at the 7500 mcg dose, LYR-210 achieved statistically significant improvement in a composite score of the 4CS of CRS in favor of the treatment arm at weeks 16 (-1.47) (p=0.021), 20 (-1.61) (p=0.012) and 24 (-1.64) (p=0.016).
  
• Furthermore, the 7500 mcg dose of LYR-210 achieved statistically significant improvement in SNOT-22 score in favor of the treatment arm at weeks 8 (-12.2) (p=0.039), 16 (-15.0) (p=0.008), 20 (-18.4) (p=0.001), and 24 (-19.0) (p=0.001).
  
• LYR-210 was observed to be safe and well-tolerated at all doses in the study, and no treatment-related serious adverse events were reported. Adverse events were generally mild to moderate in nature and in line with the known safety profile of mometasone furoate.

“We are delighted to share this positive data from our LANTERN trial, which represents a major milestone for Lyra, and which shows the potential for LYR-210 to improve a composite of cardinal symptoms of CRS for up to 24 weeks. We believe this trial represents the first time a nasal implant has achieved six months of benefit for CRS patients via a single administration in clinical testing. These data are yet more remarkable given it was achieved during the COVID-19 pandemic, which caused us to curtail enrollment sooner than originally planned,” said Maria Palasis, PhD, CEO of Lyra Therapeutics. “Furthermore, the 4CS efficacy data is backed up by impressive SNOT-22 scores, supporting the potential pronounced treatment effect of LYR-210.”

Maria Palasis continued: “Importantly, this is the first time that a drug-releasing nasal implant has been observed to improve symptoms in both non-polyp and polyp patients, and also marks the first time such an implant has exhibited a dose response, which we believe validates our underlying XTreo™ platform. We believe these results confirm our pathway to regulatory submission, and we will move forward quickly to initiate a Phase 3 study in CRS, subject to a planned end-of-Phase 2 meeting with the FDA. In addition, we are continuing our development efforts for LYR-220, for CRS patients who have already undergone sinus surgery. I would like to thank everyone involved in the LANTERN study and look forward to updating you on our next steps as we seek to change the treatment paradigm for long-underserved CRS patients.”

Other takeaways from the LANTERN study include:

• While a strong treatment effect was observed at week 4, the LANTERN study’s primary endpoint of change from baseline in a composite of 4CS scores at week 4 was not met at either dose (7500 mcg: (-0.36) (p=0.306); 2500 mcg: (0.04) (p=0.525)), we believe primarily due to curtailed enrollment resulting from COVID-19.
  
• Given the comparable safety profile of LYR-210 at both 2500 mcg and 7500 mcg doses, Lyra anticipates progressing the LYR-210 program at the 7500 mcg dose level.
  
• Full results from the LANTERN study will be submitted for future presentation at an upcoming scientific meeting.
  
• Based on these results Lyra plans to initiate a pivotal Phase 3 study for LYR-210 in chronic rhinosinusitis for both non-polyp and polyp patients.

“The LANTERN study results are very exciting to those of us in the ENT community who are eager to embrace new treatment options for CRS, including alternatives to surgery. Based on my experience in Lyra’s Phase 1 and Phase 2 studies for LYR-210, I believe a drug-releasing nasal implant that may offer up to six months treatment would represent an important innovation for CRS patients,” said A/Prof Joanne Rimmer, an ENT surgeon and rhinologist at Monash Health, Associate Professor at Monash University in Melbourne, Australia, and an investigator in the LANTERN study. “The in-office procedure of placing LYR-210 into a patient’s nose is straightforward, suggesting that LYR-210 may have the potential to improve quality of life for patients who have failed medical management while offering an alternative to invasive surgical procedures.”

“CRS is a chronic, lifelong condition, and there continues to be a need for innovation for the millions of people suffering from this inflammatory disease. As such, the LANTERN results are very encouraging, particularly as there are currently no FDA-approved therapeutic treatments for CRS patients without nasal polyps, despite that patient population representing approximately 70-90% of all CRS patients,” said Robert Kern, MD, Chair of Otolaryngology, Head and Neck Surgery, at Northwestern Medical Center and Professor of Otolaryngology at the Feinberg School of Medicine at Northwestern. “I believe this innovative long-acting investigational treatment has the potential to make a meaningfully positive impact on patients’ quality of life and offer an appealing alternative to invasive medical procedures.”

Conference Call

The company plans to host a conference call to discuss the results today at 8:30 am ET. Individuals interested in listening to the conference call may do so by dialing (833) 519 1249 for domestic callers, or (914) 800 3822 for international callers and reference conference ID: 5134448; or from the webcast link in the investor relations section of the company’s website at: www.lyratherapeutics.com.

The live webcast can be accessed here and will be available in the investor relations section on the company’s website for 30 days following the completion of the call. In light of reduced call center resources during this time of required social-distancing, Lyra requests that listeners who do not plan on participating in the question and answer session listen to the live webcast rather than dialing in by phone.

LANTERN Phase 2 Trial Design

The Phase 2 LANTERN study was conducted in 67 adult patients with CRS, including patients with and without nasal polyps who had not undergone sinus surgery. Patients in the study were randomized 1:1:1 into three groups to receive in-office bilateral nasal administration of either one of two long-acting dose levels of LYR-210, 7500 mcg (21 patients) or 2500 mcg (23 patients) of continuous anti-inflammatory drug therapy, mometasone furoate, or control (23 patients). The multi-center study was conducted at sites in Europe, New Zealand and Australia.

The trial was originally designed to enroll 99 evaluable patients with the potential to increase to up to 150 patients and was initiated in May 2019. However, in light of developments relating to the COVID-19 global pandemic we discontinued enrollment at 67 patients in our Phase 2 LANTERN clinical trial. As a result of the decrease in the number of patients enrolled from planned (99) to actually enrolled (67) patients in our Phase 2 LANTERN clinical trial, a greater magnitude of change in composite score of the seven-day average of four cardinal symptoms from baseline at week 4 and/or a smaller standard deviation associated with the change from baseline at week 4 was required in order for the trial to achieve statistical significance for the primary endpoint.

About Lyra Therapeutics

Lyra Therapeutics, Inc. is a clinical-stage therapeutics company focused on the development and commercialization of novel integrated drug and delivery solutions for the localized treatment of patients with ear, nose and throat (ENT) diseases. The company’s lead product candidate, LYR-210, is designed to deliver up to six months of continuous anti-inflammatory drug therapy to the sinonasal passages for the treatment of chronic rhinosinusitis (CRS) in patients who have not undergone surgery for the disease. Lyra is also developing LYR-220 for CRS patients who have undergone a prior surgery and have persistent disease. Beyond CRS, the company believes its XTreo™ platform, comprised of drug administered through a bioresorbable polymeric matrix, has the potential to address other disease areas by precisely, consistently and locally delivering medicines for sustained periods with a single administration.

For more information, please visit www.lyratherapeutics.com and follow us on LinkedIn and Twitter @LyraTx.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the company’s lead product candidate LYR-210, the presentation of top-line results relating to the Company’s Phase 2 LANTERN clinical trial for LYR-210 and the Company’s plans to initiate a pivotal Phase 3 study for LYR-210 in CRS for both non-polyp and polyp patients. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the fact that the company has incurred significant losses since inception and expects to incur losses for the foreseeable future; the company’s need for additional funding, which may not be available; the company’s limited operating history; the fact that the company has no approved products; the fact that the company’s product candidates are in various stages of development; the fact that the company may not be successful in its efforts to identify and successfully commercialize its product candidates; the fact that clinical trials required for the company’s product candidates are expensive and time-consuming, and their outcome is uncertain; the fact that the FDA may not conclude that certain of the company’s product candidates satisfy the requirements for the Section 505(b)(2) regulatory approval pathway; the company’s inability to obtain required regulatory approvals; effects of recently enacted and future legislation; the possibility of system failures or security breaches; effects of significant competition; the fact that the successful commercialization of the company’s product candidates will depend in part on the extent to which governmental authorities and health insurers establish coverage, adequate reimbursement levels and pricing policies; failure to achieve market acceptance; product liability lawsuits; the fact that the company relies on third parties for the manufacture of materials for its research programs, pre-clinical studies and clinical trials; the company’s reliance on third parties to conduct its preclinical studies and clinical trials; the company’s inability to succeed in establishing and maintaining collaborative relationships; the company’s reliance on certain suppliers critical to its production; failure to obtain and maintain or adequately protect the company’s intellectual property rights; failure to retain key personnel or to recruit qualified personnel; difficulties in managing the company’s growth; effects of natural disasters; the fact that the global pandemic caused by COVID-19 could adversely impact the company’s business and operations, including the company’s clinical trials; the fact that the price of the company’s common stock may be volatile and fluctuate substantially; significant costs and required management time as a result of operating as a public company and any securities class action litigation. These and other important factors discussed under the caption “Risk Factors” in the company’s Quarterly Report on Form 10-Q filed with the SEC on November 10, 2020 and its other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change.

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Media Contact:

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[email protected]

Investor Contact:

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KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Health Other Health Clinical Trials General Health Pharmaceutical Biotechnology

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Posted on December 7, 2020 8:03 am

LivaNova Announces Board Appointment and Board Leadership Changes

LivaNova Announces Board Appointment and Board Leadership Changes

LONDON–(BUSINESS WIRE)–
LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, today announced a series of enhancements to the Company’s governance.

Todd Schermerhorn has been appointed to the Board of Directors, effective December 3. Schermerhorn has 35 years of experience in global healthcare, including 27 years at C.R. Bard Inc. where he held various positions of increasing responsibility on the finance team, which culminated with his nine-year tenure as Chief Financial Officer. He was a Director of Thoratec Corporation and The Spectranetics Corporation, and currently serves on the Boards of Metabolon Inc. and The Travelers Companies Inc., where he is the Independent Lead Director and chairs its Risk Committee.

In addition, Hugh Morrison has decided not to stand for re-election at the LivaNova 2021 Annual General Meeting of Shareholders and will retire after five years of service on the Board, and nine years of service on the Board of Cyberonics Inc. prior to the merger with Sorin S.p.A. to form LivaNova. Upon Morrison’s retirement, Schermerhorn will become Chair of the Audit and Compliance Committee.

“Todd is a highly respected leader within the medical technology and healthcare fields. His deep financial knowledge specific to medical devices will enable him to be an immediate contributor and will enrich our Board,” said Dr. Sharon O’Kane, Nominating and Corporate Governance Committee Chair. “On behalf of the Board, I welcome Todd and look forward to him sharing his insight, expertise and financial acumen in his capacity as Audit and Compliance Committee Chair.”

Daniel J. Moore, LivaNova Chair of the Board said, “I feel very honored to have worked so closely with Hugh for the last five years as we have seen LivaNova grow into the medical device leader that it is today. The guidance, counsel and dedication that Hugh brought to the Board and our team at LivaNova was unparalleled. We all wish Hugh the best as he moves on to his next endeavor.”

The Company also announced that Moore will rotate from the role of Board Chair, effective as of the Annual General Meeting of Shareholders in 2021 (2021 AGM). Moore will remain a Director. William Kozy, who currently serves on the Nominating and Corporate Governance Committee, will succeed Moore as Chair at that time. Kozy joined the LivaNova Board in 2018 and also serves on the Board of Cooper Companies, Inc. He previously served as Executive Vice President and Chief Operating Officer of Becton, Dickinson and Company, a global medical technology company, until his retirement in 2016.

In addition, LivaNova announced that Dr. Arthur L. Rosenthal will rotate from the role of Chair of the Compensation Committee, following the 2021 AGM. Rosenthal will remain a Director. Stacy Enxing Seng, who currently serves on the Compensation Committee, will assume the Chair role at that time. Enxing Seng joined the Board in 2019 and is also a Director of Sonova Holding AG and Hillrom Holdings Inc. She serves as a Venture Partner with Lightstone Ventures, a venture capital group focused on medical technology and biotechnology-related investments.

These Board leadership changes are pursuant to recently revised provisions in the Company’s Corporate Governance Guidelines, which provide that the Board will consider rotation of the Chair of the Board and Committee Chairs after a Chair has served for approximately five successive years and after balancing the benefits of rotation against the benefits of continuity, experience and expense.

Moore said, “The actions we announced today were driven by our Nominating and Corporate Governance committee and underscore our commitment to leading corporate governance and helping to further enhance the Board’s independent oversight. Bill has been a strong voice in the boardroom over the past two years and we look forward to continuing to benefit from his expertise as Chair. The LivaNova Board remains committed to taking actions to enhance our governance program and position the Board to achieve its objective of maximizing value for shareholders.”

About LivaNova

LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. LivaNova’s advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals and healthcare systems. Headquartered in London, LivaNova has a presence in more than 100 countries worldwide. For more information, please visit www.livanova.com.

Safe Harbor Statement

This news release contains “forward-looking statements” concerning our goals, beliefs, expectations, strategies, objectives, plans and underlying assumptions and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding enhancements to the Company’s governance. Actual results may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, as supplemented by any risk factors contained in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. We undertake no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.

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LivaNova PLC Investor Relations and Media Contacts

Melissa Farina, +1 (281) 228-7262

VP, Investor Relations

[email protected]

Deanna Wilke, +1 (281) 727-2764

VP, Corporate Communications

[email protected]

KEYWORDS: Texas Europe United States United Kingdom North America

INDUSTRY KEYWORDS: Medical Supplies Medical Devices Health Manufacturing Other Manufacturing Biotechnology

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ClearBridge MLP and Midstream Fund Inc. Announces Unaudited Balance Sheet Information as of November 30, 2020

NEW YORK–(BUSINESS WIRE)–
ClearBridge MLP and Midstream Fund Inc. (NYSE: CEM) announced today the unaudited statement of assets and liabilities, the net asset value and asset coverage ratio of the Fund as of November 30, 2020.

As of November 30, 2020, the Fund’s net assets were $281.5 million, and its net asset value per share was $20.19.

The Fund’s asset coverage ratio under the Investment Company Act of 1940 (the “1940 Act”) with respect to senior indebtedness was 542% and the Fund’s asset coverage ratio under the 1940 Act with respect to total leverage was 315%.

	As of November 30, 2020
	Amount (millions)		Per Share
Investments	$                   398.0		$                 28.55
Cash and Cash Equivalents	4.4		0.31
Other Assets	12.2		0.88
Total Assets	$                   414.6		$                 29.74
Senior Notes*	$                     76.1		$                   5.46
Loans Outstanding*	–		–
Mandatory Redeemable Preferred Shares*	55.0		3.94
Total Leverage	$                   131.1		$                   9.40
Income Tax Payable	$                         –		$                       –
Deferred Tax Liability	–		–
Other Liabilities	2.0		0.15
Total Liabilities	$                       2.0		$                   0.15
Net Assets	$                   281.5		$                 20.19
Outstanding Shares	13,942,046
* The Fund’s asset coverage ratio under the 1940 Act with respect to senior indebtedness was 542%.
* The Fund’s asset coverage ratio under the 1940 Act with respect to total leverage was 315%.
Top Ten Equity Holdings (as of  November 30, 2020)**
	Market Value
Name	(millions)		% of Investments		***
Enterprise Products Partners LP	$                     36.3		9.1%
MPLX LP	$                     35.5		8.9%
Energy Transfer LP	$                     27.2		6.8%
Magellan Midstream Partners LP	$                     27.1		6.8%
Williams Cos. Inc.	$                     23.7		6.0%
ONEOK Inc.	$                     23.2		5.8%
Targa Resources Corp.	$                     19.9		5.0%
DCP Midstream LP	$                     18.5		4.6%
Enbridge Inc.	$                     16.5		4.1%
Kinder Morgan Inc.	$                     16.2		4.1%
	$                   244.1		61.2%
**    Subject to change at any time
***   Percent of Total Equity Investments

ClearBridge MLP and Midstream Fund Inc. is a non-diversified, closed-end management investment company, which is advised by Legg Mason Partners Fund Advisor, LLC (“LMPFA”) and subadvised by ClearBridge Investments, LLC (“ClearBridge”). LMPFA and ClearBridge are wholly-owned subsidiaries of Franklin Resources, Inc. (“Franklin Resources”).

On July 31, 2020, Franklin Resources acquired Legg Mason, Inc. (“Legg Mason”) in an all-cash transaction. As a result of the transaction, LMPFA and ClearBridge, previously wholly-owned subsidiaries of Legg Mason, became wholly-owned subsidiaries of Franklin Resources.

This financial data is unaudited.

The Fund files its semi-annual and annual reports with the Securities and Exchange Commission (“SEC”), as well as its complete schedule of portfolio holdings for the first and third quarters of each fiscal year as an exhibit to its reports on Form N-PORT. These reports are available on the SEC’s website at www.sec.gov. To obtain information on Form N-PORT or a semi-annual or annual report from the Fund, shareholders can call 1-888-777-0102.

For more information about the Fund, please call 1-888-777-0102 or consult the Fund’s website at www.lmcef.com. Hard copies of the Fund’s complete audited financial statements are available free of charge upon request.

Data and commentary provided in this press release are for informational purposes only. Franklin Resources and its affiliates do not engage in selling shares of the Fund.

Category: Financials

Source: Franklin Templeton

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Investor Contact: Fund Investor Services 1-888-777-0102

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Banking Professional Services Finance

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Posted on December 7, 2020 8:03 am

ClearBridge Energy Midstream Opportunity Fund Inc. Announces Unaudited Balance Sheet Information as of November 30, 2020

ClearBridge Energy Midstream Opportunity Fund Inc. Announces Unaudited Balance Sheet Information as of November 30, 2020

NEW YORK–(BUSINESS WIRE)–
ClearBridge Energy Midstream Opportunity Fund Inc. (NYSE: EMO) announced today the unaudited statement of assets and liabilities, the net asset value and asset coverage ratio of the Fund as of November 30, 2020.

As of November 30, 2020, the Fund’s net assets were $237.8 million, and its net asset value per share was $17.13. The Fund’s asset coverage ratio under the Investment Company Act of 1940 (the “1940 Act”) with respect to senior indebtedness was 610% and the Fund’s asset coverage ratio under the 1940 Act with respect to total leverage was 342%.

	As of November 30, 2020
	Amount (millions)			Per Share
Investments	$	316.7		$	22.82
Cash and Cash Equivalents		14.3			1.03
Other Assets		6.2			0.45
Total Assets	$	337.2		$	24.30
Senior Notes*	$	45.1		$	3.25
Loans Outstanding*		10.0			0.72
Mandatory Redeemable Preferred Shares*		43.1			3.11
Total Leverage	$	98.2		$	7.08
Income Tax Payable	$	–		$	–
Deferred Tax Liability		–			–
Other Liabilities		1.2			0.09
Total Liabilities	$	1.2		$	0.09
Net Assets	$	237.8		$	17.13
Outstanding Shares		13,879,684
* The Fund’s asset coverage ratio under the 1940 Act with respect to senior indebtedness was 610%.
* The Fund’s asset coverage ratio under the 1940 Act with respect to total leverage was 342%.
Top Ten Equity Holdings (as of November 30, 2020)**
	Market Value
Name	(millions)			% of Investments			***
MPLX LP	$	28.9			9.1	%
Enterprise Products Partners LP	$	24.3			7.7	%
Targa Resources Corp.	$	20.1			6.4	%
Magellan Midstream Partners LP	$	19.3			6.1	%
Western Midstream Partners LP	$	18.6			5.9	%
Energy Transfer LP	$	15.1			4.8	%
DCP Midstream LP	$	14.6			4.6	%
Williams Cos. Inc.	$	14.1			4.5	%
Cheniere Energy Partners LP	$	13.6			4.3	%
BP Midstream Partners LP	$	12.1			3.8	%
	$	180.7			57.2	%
** Subject to change at any time
*** Percent of Total Equity Investments

During the month ended November 30, 2020, the Fund repurchased in the open market and retired 155,790 of its common shares under the stock repurchase plan for a total amount of $1,980,774.

ClearBridge Energy Midstream Opportunity Fund Inc. is a non-diversified, closed-end management investment company, which is advised by Legg Mason Partners Fund Advisor, LLC (“LMPFA”) and subadvised by ClearBridge Investments, LLC (“ClearBridge”). LMPFA and ClearBridge are wholly owned subsidiaries of Franklin Resources, Inc. (“Franklin Resources”).

On July 31, 2020, Franklin Resources acquired Legg Mason, Inc. (“Legg Mason”) in an all-cash transaction. As a result of the transaction, LMPFA and ClearBridge, previously wholly-owned subsidiaries of Legg Mason, became wholly-owned subsidiaries of Franklin Resources.

This financial data is unaudited.

The Fund files its semi-annual and annual reports with the Securities and Exchange Commission (“SEC”), as well as its complete schedule of portfolio holdings for the first and third quarters of each fiscal year as an exhibit to its reports on Form N-PORT. These reports are available on the SEC’s website at www.sec.gov. To obtain information on Form N-PORT or a semi-annual or annual report from the Fund, shareholders can call 1-888-777-0102.

For more information about the Fund, please call 1-888-777-0102 or consult the Fund’s website at www.lmcef.com. Hard copies of the Fund’s complete audited financial statements are available free of charge upon request.

Data and commentary provided in this press release are for informational purposes only. Franklin Resources and its affiliates do not engage in selling shares of the Fund.

Category: Financials

Source: Franklin Templeton

View source version on businesswire.com: https://www.businesswire.com/news/home/20201207005420/en/

Investor Contact: Fund Investor Services 1-888-777-0102

 

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Finance Banking Professional Services Elections/Campaigns Public Policy/Government

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Posted on December 7, 2020 8:03 am

RMR Mortgage Trust Announces Regular Quarterly Distribution to Common Shareholders

RMR Mortgage Trust Announces Regular Quarterly Distribution to Common Shareholders

NEWTON, Mass.–(BUSINESS WIRE)–RMR Mortgage Trust (Nasdaq: RMRM) today announced its regular quarterly distribution to common shareholders. The distribution of $0.10 per common share will be paid on or about December 31, 2020 to holders of record of common shares as of the close of business on December 22, 2020. RMRM’s distribution was approved by its Board of Trustees under RMRM’s managed distribution policy in accordance with exemptive relief issued by the Securities and Exchange Commission.

RMRM has also decided to retain any presently undistributed net long-term capital gains realized by RMRM in calendar year 2020 and to pay the required U.S. federal capital gains tax thereon. IRS Form 2439, Notice to Shareholders of Undistributed Long-Term Capital Gains, will be mailed to shareholders in February 2021.

The following table provides RMRM’s estimated distribution sources for the distribution declared today on common shares for the quarter ending December 31, 2020 from the sources indicated pursuant to Section 19(a) of the Investment Company Act of 1940, as amended or the 1940 Act.

	Quarter					Year to date
		Per Share		% of			Per Share		% of
Source		Amount		Distribution			Amount		Distribution
Net investment income	$	0.10		100.00%		$	0.55		87.30%
Net realized short term capital gains	$	0.00		0.00%		$	0.00		0.00%
Net realized long term capital gains	$	0.00		0.00%		$	0.08		12.70%
Return of capital	$	0.00		0.00%		$	0.00		0.00%
Total distribution	$	0.10		100.00%		$	0.63		100.00%

RMRM’s net investment income is based on an estimate of the excess of cash distributions received from its investments less its operating expenses, interest expense and distributions to preferred shareholders for the periods presented. A substantial amount of RMRM’s income was derived from investments in real estate investment trusts, or REITs, which generally will characterize distributions to their shareholders, including RMRM, as ordinary income, net capital gain or return of capital. However, it is not possible for RMRM to characterize distributions received from REITs during interim periods because the REIT issuers do not report the tax characterization of their distributions until subsequent to year end. Therefore, it is likely that some portion of RMRM’s net investment income, and thus RMRM’s distributions to its common shareholders estimated to be from net investment income, will be recharacterized as net capital gain and/or return of capital subsequent to year end.

You should not draw any conclusions about the RMRM’s investment performance from the amount of this distribution or from the terms of RMRM’s managed distribution policy. The amounts and sources of distribution reported in this press release are only estimates and are not being provided for tax reporting purposes. The actual amounts and sources of the amounts for tax reporting purposes will depend upon RMRM’s investment experience during the remainder of its fiscal year and may be subject to changes based on tax regulations. RMRM will send you a Form 1099-DIV for the calendar year that will tell you how to report these distributions for federal income tax purposes.

RMRM Performance and Distribution Rate Information Based on Net Asset Value:

RMRM’s year to date cumulative total return for 2020 (January 1, 2020 through November 30, 2020) is set forth below. RMRM’s average annual total return for the five-year period ending November 30, 2020 is also set forth below.

Year to date: January 1, 2020 to November 30, 2020
Cumulative total return1	(19.81%)
Cumulative distribution rate2	2.76%
Five year period ending November 30, 2020
Average annual total return3	1.62%
Current annualized distribution rate4	2.09%

1. The cumulative total return is the percentage change in net asset value, or NAV, per common share from the last completed fiscal year to the NAV per common share on the last day of the period indicated assuming distributions paid are reinvested at NAV per common share on the ex-dividend dates.
2. Cumulative distribution rate is the cumulative distribution per common share declared in 2020 as of the date of this press release as a percentage of the NAV per common share as of November 30, 2020.
3. Average annual total return is the annualized percentage change in NAV over the five year period ending November 30, 2020, assuming distributions paid are reinvested at NAV per common share on the ex-dividend dates.
4. The current annualized distribution rate is the current annualized distribution rate as a percentage of the NAV per common share as of November 30, 2020.

Performance results reflect past performance and are no guarantee of future results. Investment return and principal value of shares will fluctuate so that shares, when sold, may be worth more or less than their original cost. Current performance may be higher or lower than the performance data quoted.

About RMR Mortgage Trust (Nasdaq: RMRM)

RMRM has historically operated as a closed end investment company advised by RMR Advisors LLC (the “Advisor”). The Advisor is a wholly owned subsidiary of The RMR Group LLC, an alternative asset management company. The RMR Group LLC is the majority owned operating subsidiary of The RMR Group Inc. (Nasdaq: RMR), which is headquartered in Newton, MA. On April 16, 2020, shareholders approved RMRM’s conversion from a registered investment company to a commercial mortgage real estate investment trust and amended RMRM’s fundamental investment policies and restrictions to permit RMRM to pursue its new business. RMRM is in the process of realigning its portfolio so that it is no longer an “investment company” under the Investment Company Act of 1940 (the “1940 Act”) and has applied to the Securities and Exchange Commission (the “SEC”) for an order under the 1940 Act declaring that RMRM has ceased to be a registered investment company (the “Deregistration Order”). RMRM is in the process of selling its existing equity securities investments and further transitioning its portfolio into commercial mortgage loans. If the SEC issues the Deregistration Order, the Board of Trustees anticipates RMRM would thereafter terminate its existing investment advisory agreement and enter into a new management agreement with an affiliate of its Advisor to provide day-to-day management.

WARNINGS REGARDING FORWARD-LOOKING STATEMENTS

This press release contains statements that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. These forward-looking statements are based upon RMRM’s present intent, beliefs and expectations, but forward-looking statements are not guaranteed to occur and may not occur for numerous reasons, some of which are beyond RMRM’s control. For example:

• This press release describes RMRM’s distribution of $0.10 per common share as a regular quarterly distribution and refers to RMRM’s managed distribution policy. The implications of these statements may be that RMRM will consistently pay a distribution of $0.10 per share for each quarter. In fact, the amount of distributions paid by RMRM in the future will depend primarily upon RMRM’s future earnings. RMRM can provide no assurance that its future earnings will be sufficient to enable RMRM to pay a fixed quarterly distribution of $0.10 per share. The Board of Trustees of RMRM may amend, terminate or suspend the managed distribution policy at any time, which could result in a reduction of the quarterly distribution amount or a complete elimination of the quarterly distribution.
• On April 16, 2020, RMRM shareholders approved a change in RMRM’s business from a registered investment company to a commercial mortgage REIT and amended RMRM’s fundamental investment policies and restrictions to permit RMRM to pursue its new business. Among other investment policy changes, RMRM’s fundamental investment objectives of earning and paying a high level of current income to common shareholders, with capital appreciation as a secondary objective, have been replaced with a non-fundamental primary objective to balance capital preservation with generating attractive risk adjusted returns. RMRM is in the process of realigning its portfolio so that it is no longer an “investment company” under the Investment Company Act of 1940 and has filed an application with the Securities and Exchange Commission for a deregistration order. RMRM has sold most of the equity securities investments that previously comprised its investment portfolio and intends to sell its remaining existing equity securities investments and further transition its portfolio into commercial mortgages as opportunities within its new business mandate arise and subject to applicable compliance requirements and other business considerations. Although RMRM anticipates seeking to maintain a quarterly distribution on its common shares as high as reasonably practicable, RMRM has experienced a decline in its cash flow from earnings during its transition to a commercial mortgage REIT. This decline in cash flows could continue for an extended period if RMRM is unable to establish income streams from commercial mortgage originations or invests in temporary investments with lower yields such as agency whole pool certificates. The distribution described in this press release represents a continued reduction in the historical amount of RMRM’s quarterly common share distribution as a result of these factors and as a result of a decline in income resulting from the impact of the COVID-19 pandemic described below.
• The current economic situation resulting from the unprecedented measures taken around the world to combat the spread of COVID-19 may continue to contribute to severe market disruptions, volatility and reduced economic activity. Furthermore, measures taken to mitigate the impacts of COVID-19 may have long term negative effects on the U.S. and worldwide financial markets and economies and may cause further economic uncertainties in the United States and worldwide. It is difficult to predict how long the financial markets and economic activity will continue to be impacted by these events and the effects of these or similar events in the future on the U.S. economy and financial markets. In addition to being impacted by these events, RMRM’s ability to pay quarterly common share distributions may also be impacted by a number of other factors, including the availability of capital gains, interest paid on borrowings, the extent of RMRM’s leverage and the amount of RMRM’s expenses. Additionally, periods of market volatility may continue to occur in response to the pandemic or other events outside of RMRM’s control. These events have had, and may continue to have, a significant negative impact on RMRM’s performance, net asset value, income, operating results and ability to pay distributions, as well as the performance, income, operating results and viability of issuers in which it invests. There is no assurance that RMRM will always be able to pay distributions of a particular size, or that a distribution will consist solely of net investment income and/or realized capital gains.
• This press release includes various information regarding the estimated sources for the distribution on RMRM common shares that was declared today as well as various RMRM performance, returns and distribution metrics and information. The ultimate sources of RMRM’s distributions will depend on RMRM’s investment performance and experience for 2020 and the sources of the distributions it receives on its investments. For these and other reasons, the estimated sources may subsequently change and prove to be inaccurate. Further, RMRM’s performance returns and distribution metrics for 2020 and other periods may differ significantly from the amounts listed in this press release.

For these and other reasons, investors should not place undue reliance upon RMRM’s forward-looking statements. Except as required by law, RMRM does not intend to update or change any forward-looking statements as a result of new information, future events or otherwise.

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Kevin Barry, Manager, Investor Relations

(617) 658-0776

www.rmrmortgagetrust.com

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INDUSTRY KEYWORDS: Banking Professional Services Finance

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Palliare Announces Organizational Changes

New Group CEO and Board member appointed

GALWAY, Ireland–(BUSINESS WIRE)–
Palliare, an emerging company with the vision to create a safer operating room, has appointed John O’Dea as Group CEO. He will oversee the US launch of the company’s EVA15 insufflator, which combines continuous pressure insufflation and surgical smoke evacuation, and the EndoTrap™ endoscopist protection system in early 2021. Mr. O’Dea was previously CEO of Crospon, an Irish medical device company and developer of the Endoflip™ endoscopic diagnostic system, prior to its acquisition by Medtronic in 2017. Caroline O’Dea will continue in her current role as Managing Director of the Irish operation of Palliare.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201207005202/en/

The company is also pleased to announce the appointment of Giovanni Di Napoli to the Board of Directors. Mr. Di Napoli is currently President of the Gastrointestinal Operating Unit within the Medical Surgical Portfolio at Medtronic.

Commenting on the CEO appointment, Scott Flora, Chairman, said, “We are delighted to welcome John O’Dea into a full-time executive role within the Palliare group of companies, to lead the US launch of the recently FDA-cleared EVA15 insufflator and surgical smoke evacuation system, and to complete product development of the LeakTrap™ and EndoTrap™ surgical and endoscopic safety products being funded as part of the EU PORSAV project.”

Commenting on the new Board appointment, Scott Flora, Chairman said, “We are pleased to welcome Giovanni Di Napoli to the Board. As the company broadens its portfolio to encompass endoluminal insufflation and, in particular, new endoluminal surgery technologies, his deep global experience in endoscopic surgery will bring a new and valued dimension and mindset to the Board.”

About the EVA15 Insufflator

The EVA15 insufflator and smoke evacuation system is the first product from Palliare, designed to create a safer operating room environment and deliver best-in-class insufflation and smoke evacuation performance to meet the particular demands of laparoscopic, endoluminal, endoscopic, and robotic surgical procedures.

About Palliare

Palliare Ltd was founded in 2018 as a spinout from Irish gastro-diagnostic company Crospon, which was acquired by Medtronic (NYSE:MDT) in 2017. Based in Galway, Ireland, Palliare is dedicated to advancing the state of the art in smoke evacuation and insufflation technologies for laparoscopic, endoluminal, endoscopic and robotic surgery. For more information about Palliare, visit www.palliare.com.

About PORSAV

PORSAV (Protecting OR Staff from Aerosolized Virus) is an EU-funded project that emanated out of collaborative work between Palliare and Professor Ronan Cahill of University College Dublin. The early work took place in Ireland in March 2020, at the beginning of the COVID-19 crisis, when, in most parts of the world, laparoscopic surgery was shutting down due to perceived infection risks to staff. There is an urgent need to study the nature and risks associated with standard surgical practice in the face of aerosolized COVID-19 virus, potentially infecting staff due to gas leaks from the abdomen during surgery. By increasing our understanding and knowledge of surgical aerosol leaks, and capturing these leaks with innovative medical devices, PORSAV makes the operating environment safer for surgeons, staff, and patients, and enables surgery services to be re-opened in the wake of the pandemic. For more information about PORSAV, visit https://porsav.eu/.

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For Further Information please contact

Robyn Douglas

Palliare

Ph. (860) 685-1345

Email : [email protected]

KEYWORDS: Ireland Europe

INDUSTRY KEYWORDS: Biotechnology FDA Surgery Medical Devices Health

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Giovanni Di Napoli Director (Photo: Business Wire)

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John O’Dea Group CEO (Photo: Business Wire)

IQVIA Supports Collaborative Forum of Top Pharma Leaders to Advance the Use and Acceptance of Real World Evidence

DANBURY, Conn. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–
IQVIA™ (NYSE: IQV) said today that it is pleased to be a supporter of the Real World Evidence Leadership Forum, agroup consisting of senior RWE executives from 18 major pharmaceutical companies. The forum acts as a non-competitive collaboration to understand, discuss and respond to internal and external RWE challenges and opportunities with a single expert voice and the aim of improving outcomes for patients globally.

“As the world increasingly appreciates the importance of data from the real world setting to improve patient outcomes, it is critical to engender trust in how these data are used, protect patient privacy and ensure the highest scientific quality,” said Dan Simpson, vice president, Real World Solutions and member of the IQVIA team supporting the forum. “This group of industry leaders is at the forefront of guiding how industry players and the healthcare system are making the most of this opportunity to improve patients’ lives.”

One of the top priorities of the RWE Leadership Forum is to clarify the way pharma and healthcare can work together to establish trust-based relationships, which will unlock unique value for society, the medical community and patients.

Its first publication, Strengthening pharma’s contract with society: the value of trusted partnerships between pharma and healthcare facilitated by real-world data,¹ describes how pharma can build trusted relationships around a common purpose and the role real-world data plays in establishing those collaborations.

Another paper, Bridging the Gap Between RCTs and RWE Through Endpoint Selection, which discusses the value in bridging the industry disconnect between randomized clinical trials (RCTs) and RWE with a view to promoting the use of RWE in the RCT environment, has recently been published in Therapeutic Innovation & Regulatory Science.²

Additional publications are in development with the goal of having them appear in peer-reviewed journals throughout the year.

The forum meets twice a year to discuss issues facing RWE in the industry, develop an aligned position on these issues and select priorities for its working groups to address.

“The benefit of the roundtable approach is that we can come together to tackle shared problems in the pre-competitive space, drawing on our collective experience to propose solutions that industry as a whole could adopt,” said Jonathan Plumb, VP, Global Head of Market Access & Strategic Pricing, RWE & HEOR at Ferring Pharmaceuticals and co-chair of the forum. “Broad company representation helps us amplify the message that industry is ready and willing to engage and be part of the solution.”

For more information on the RWE Leadership Forum, please visit this resource page (https://secure.constellation.iqvia.com/RWELeadershipForum).

About IQVIA

IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. Formed through the merger of IMS Health and Quintiles, IQVIA applies human data science — leveraging the analytic rigor and clarity of data science to the ever-expanding scope of human science — to enable companies to reimagine and develop new approaches to clinical development and commercialization, speed innovation and accelerate improvements in healthcare outcomes. Powered by the IQVIA CORE™, IQVIA delivers unique and actionable insights at the intersection of large-scale analytics, transformative technology and extensive domain expertise, as well as execution capabilities. With approximately 68,000 employees, IQVIA conducts operations in more than 100 countries.

IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures. To learn more, visit www.iqvia.com.

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¹https://www.futuremedicine.com/doi/full/10.2217/cer-2019-0183

²https://link.springer.com/article/10.1007/s43441-020-00193-5

View source version on businesswire.com: https://www.businesswire.com/news/home/20201207005273/en/

Tor Constantino, IQVIA Media Relations ([email protected])

+1.484.567.6732

Andrew Markwick, IQVIA Investor Relations ([email protected])

+1.973.257.7144

KEYWORDS: North Carolina Connecticut United States North America

INDUSTRY KEYWORDS: Technology Research Practice Management Biotechnology Managed Care Health Pharmaceutical Data Management Science

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Posted on December 7, 2020 8:03 am

Five-Year Data on Ropeginterferon Alfa-2b Illustrate Durable Response at Five Years in People With Polycythemia Vera

Five-Year Data on Ropeginterferon Alfa-2b Illustrate Durable Response at Five Years in People With Polycythemia Vera

Presentation at Virtual ASH Annual Meeting found treatment with ropeginterferon alfa-2b at five years reduced drivers of disease progression, including allelic burden

BURLINGTON, Mass.–(BUSINESS WIRE)–PharmaEssentia Corporation (TPEx: 6446), a global biopharmaceutical innovator leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced long-term results with ropeginterferon alfa-2b, an investigational product, which showed patients with polycythemia vera (PV) experienced durable rates of hematologic and molecular responses after five years of treatment.¹ These results were featured as an oral presentation at the virtual 62^nd American Society of Hematology (ASH) Annual Meeting and Exposition and presented by author Heinz Gisslinger, M.D. of Medical University Vienna in Austria. Ropeginterferon alfa-2b (INN, PharmaEssentia) was invented and is manufactured by PharmaEssentia. This clinical study was conducted and sponsored by AOP Orphan Pharmaceuticals.

PV is a rare, chronic blood cancer that occurs when the bone marrow produces excessive red blood cells, causing the blood to be thicker than normal and potentially leading to a range of complications.^2,3 Most cases are caused by a JAK2 V617F mutation^2,3 and, without proper management, PV can progress into myelofibrosis and malignancies, including acute myeloid leukemia.⁴

“As a clinician treating a chronic blood cancer, it’s valuable to see data on how ropeginterferon alfa-2b can help more patients achieve complete hematologic control of their polycythemia vera over time,” said Jean-Jacques Kiladjian, M.D., Ph.D. of Saint-Louis Hospital and Paris Diderot University in France and study author. “It’s particularly encouraging to observe the sustained molecular response in this five-year data, as this will be a critical measure to help us manage disease progression in this population.”

This five-year data from the PROUD-PV/CONTINUATION-PV studies demonstrates the short- and long-term effects of ropeginterferon alfa-2b among PV patients. The majority of patients (81.8%) maintained hematocrit levels less than 45 percent without the need for phlebotomy and had low rates of thromboembolic events (4.2%). With long-term treatment, patients also experienced significantly reduced median allele burden (7.3% vs. 37.3% at baseline).

More than two-thirds of patients (69.1%) who received ropeginterferon alfa-2b experienced a molecular response, which was accompanied by a low risk of disease progression. During the entire study period, there was one reported case of progression to myelofibrosis and no cases of leukemic transformation among those treated with ropeginterferon alfa-2b. Importantly, more than half of the participants in the study (58.5%) achieved complete response, including both a well-controlled hematocrit without needing phlebotomy as well as a molecular response –parameters known to influence the risk of progression in PV. No new safety or tolerability signals were identified in the study period. Over the entire treatment period, treatment-related adverse events and discontinuation rates were similar among the treatment groups. The rate of grade ≥3 drug-related adverse events in each study arm was 16.5 percent.¹

“These are the first and longest phase 3 studies to evaluate an interferon in polycythemia vera, a disease where there are significant unmet needs to help more patients control the disease and help to reduce the risk of progression to more deadly malignancies,” said Raymond Urbanski, M.D., Ph.D., Head of U.S. Clinical Development and Medical Affairs for PharmaEssentia. “These results reinforce and strengthen previously reported findings on this novel long-acting interferon and its potential to offer benefit to the community.”

PharmaEssentia submitted a Biologics License Application to the U.S. Food and Drug Administration (FDA) for review of ropeginterferon alfa-2b earlier this year and anticipates an agency decision in early 2021.

About the Ropeginterferon Alfa-2b Clinical Trials

PROUD-PV is a randomized, controlled, multicenter phase 3 study that evaluated the efficacy, safety and tolerability of ropeginterferon alfa-2b compared to hydroxyurea in 257 adult patients with polycythemia vera (PV) new to cytoreductive treatment or treated with hydroxyurea for less than three years. The study met the primary endpoint of noninferior complete hematological response rate at 12 months and secondary outcomes included hematologic response rate at three, six and nine months, mutant JAK2 allelic burden changes, and molecular response rate, among others. The study was conducted by AOP Orphan Pharmaceuticals in Europe.

CONTINUATION-PV is an open-label, multicenter, phase 3b extension of the PROUD-PV study assessing the long-term safety and efficacy of ropeginterferon alfa-2b compared to best available therapy in 171 patients with PV. Efficacy assessments included hematologic parameters, phlebotomy need, JAK2V617F allele burden, and molecular response defined by modified ELN criteria. An interim analysis was performed once all patients were treated for five years. Results from the studies were published in The Lancet Haematology earlier this year.

About Ropeginterferon alfa-2b

Ropeginterferon alfa-2b is a novel, long-acting, mono-pegylated proline interferon aimed to be administered once every two weeks or longer. Ropeginterferon alfa-2b has Orphan Drug designation for treatment of polycythemia vera (PV) in the United States. Marketed as Besremi^® in Europe, the product was approved by the European Medicines Agency (EMA) in 2019. The novel ropeginterferon alfa-2b was invented and is manufactured by PharmaEssentia in its Taichung plant, which was cGMP certified by TFDA in 2017 and by the EMA in January 2018.

About Polycythemia Vera

Polycythemia Vera (PV) is a cancer originating from a disease-initiating stem cell in the bone marrow resulting in a chronic increase of red blood cells, white blood cells, and platelets. This condition may result in cardiovascular complications such as thrombosis and embolism, as well as transformation to secondary myelofibrosis or leukemia. While the molecular mechanism underlying PV is still subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of JAK2.⁴

About PharmaEssentia

PharmaEssentia Corporation (TPEx: 6446) is a rapidly growing biopharmaceutical innovator. Leveraging deep expertise and proven scientific principles, the company aims to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, with one product already approved in Europe and a diversifying pipeline. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today the company is expanding its global presence with operations in the U.S., Japan, China, and Korea, along with a world-class biologics production facility in Taichung. For more information, visit our website or find us on LinkedIn.

Forward Looking Statement

Some of the statements included in this press release, particularly those relating to the results of clinical trials, the clinical benefits to be derived from ropeginterferon alfa-2b, regulatory submissions and the timing of any such review, approvals, the commercial opportunity and competitive positioning, and any business prospects for ropeginterferon alfa-2b, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and similar legislation and regulations under Taiwanese law. Among the factors that could cause our actual results to differ materially are the following: acceptance of the BLA filing does not represent final evaluation of the adequacy of the data submitted in the BLA; whether the FDA will complete its review of the BLA on a timely basis; the risk that the FDA ultimately denies approval of the BLA; whether the FDA concurs with our interpretation of our phase 3 study results, supportive data, or the conduct of the studies; whether, ropeginterferon alfa-2b, if approved, will be successfully launched and marketed; and other risk factors identified from time to time in our reports filed with any global securities regulator or agency. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website, and the FDA website, is not incorporated by reference into this press release and is included for reference purposes only. 

¹ Gisslinger, H, Klade, C, et. al. Long-Term Use of Ropeginterferon Alpha-2b in Polycythemia Vera: 5-Year Results from a Randomized Controlled Study and Its Extension. Presentation #481 in Session #634. Presented virtually at the 62^nd American Society of Hematology (ASH) Annual Meeting and Exposition; December 5-8.

² Mehta J, Wang H, Iqbal SU, Mesa R. Epidemiology of Myeloproliferative Neoplasms in the United States. Leuk Lymphoma. 2014 Mar;55(3):595-600.

³ Mesa R, et al. Patient-Reported Outcomes Data from REVEAL at the Time of Enrollment (Baseline): A Prospective Observational Study of Patients With Polycythemia Vera in the United States. Clin Lymphoma Myeloma Leuk. 2018 Sep;18(9):590-596. doi: 10.1016/j.clml.2018.05.020.

⁴ Cerquozzi S, Tefferi A. Blast Transformation and Fibrotic Progression in Polycythemia Vera and Essential Thrombocythemia: A Literature Review of Incidence and Risk Factors. Blood Cancer Journal (2015) 5, e366; doi:10.1038/bcj.2015.95.

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Kellie Hotz, [email protected]

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: Oncology Health Clinical Trials Research Science Pharmaceutical Biotechnology

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