Market Newsdesk

CINCINNATI, Nov. 13, 2020 (GLOBE NEWSWIRE) — Meridian Bioscience, Inc. (NASDAQ: VIVO) today announced financial results for the fourth quarter and fiscal year ended September 30, 2020.

Fourth Quarter 2020 Highlights (Comparison to Fourth Quarter Fiscal 2019):

• Consolidated Net Revenue of $64.2 million, up 26% year-over-year
• Life Science segment delivers revenue of $34.4 million, up 97% year-over-year
• Diagnostics segment revenues decreased 11% year-over-year to $29.8 million, a stronger than expected rebound from Q3 FY20, up 38% quarter-over-quarter
• Launched various SARS-CoV-2 antibody pairs, designed for highly sensitive rapid antigen tests (for saliva and nasopharyngeal samples)

Full Fiscal Year 2020 Highlights (Comparison to Full Year Fiscal 2019):

• Consolidated Net Revenue of $253.7 million, up 26% year-over-year
• Life Science segment delivers record revenue of $132.5 million, up 106% year-over-year, with the contribution of $71.5 million from COVID-19 related products for immunological and molecular tests
• Diagnostics segment revenues decreased 11% year-over-year to $121.1 million, due to headwinds from COVID-19 pandemic in the second half
• Launched the Curian^® analyzer and HpSA^® assay, the first internally developed new product in several years
• Completed assay design lock of a PCR COVID-19 test on the Revogene^® system and preparing submission to the FDA for Emergency Use Authorization
• Closed the acquisition of Exalenz Bioscience, adding the BreathID^® instrument and its Urea Breath Test for H. pylori to the diagnostics product portfolio

Fourth Quarter Fiscal 2020 Results (Comparison to Fourth Quarter Fiscal 2019)

Consolidated revenue for the fourth quarter of fiscal 2020 increased 26% to $64.2 million, compared to $50.8 million last year.  Diagnostics segment revenues rebounded strongly from the pandemic headwinds seen in the third fiscal quarter, but were still down 11% year-over-year.  Life Science segment revenues were up 97%.  Our Diagnostics segment experienced a 23% decrease in revenues from our molecular products and revenues from our non-molecular assay products decreased 8%.  Our Life Science segment revenues for the quarter included $18.1 million in revenue from COVID-19 related products with $14.6 million coming from molecular products and $3.5 million coming from immunological products.

Reported operating income for the fourth quarter of fiscal 2020 was $9.5 million.  Operating expenses included: (i) higher research and development spending in the Diagnostics segment; (ii) acquisition-related costs in connection with the recent Exalenz acquisition; and (iii) purchase accounting amortization related to the acquisition of Exalenz in April 2020, as well as an upward adjustment in the fair value of the earnout obligation for the acquisition of the GenePOC business in 2019.  On an adjusted basis, operating income was $12.0 million, a margin of 19% (see non-GAAP financial measure reconciliation below).    

Jack Kenny, Chief Executive Officer, commented, “This was truly a transformative year for Meridian.  All our hard work over the previous two years prepared us to both weather the storm in Diagnostics and excel as a critical partner to the IVD industry battling a global pandemic.  Heading into fiscal 2021, we will build on the momentum in Diagnostics and continue the strength in Life Science to deliver another record year.”

Full Fiscal Year 2020 Results (Comparison to Full Year Fiscal 2019)

Consolidated revenue for the fiscal year ended September 30, 2020 increased 26% to $253.7 million, compared to $201.0 million in fiscal 2019.  Diagnostics segment revenues were down 11%, while Life Science segment revenues were up 106%.  Our Diagnostics segment experienced a 17% decrease in revenues from our molecular products and revenues from our non-molecular assay products decreased 10%.  Our Life Science segment revenues for the fiscal year included $71.5 million in revenue from COVID-19 related products with $52.2 million coming from molecular products and $19.3 million coming from immunological products.

Reported operating income for fiscal 2020 was $61.3 million.  Operating expenses included: (i) higher research and development spending in the Diagnostics segment; (ii) acquisition-related costs in connection with the recent Exalenz acquisition; and (iii) purchase accounting amortization related to the acquisitions of Exalenz and the GenePOC business in April 2020 and June 2019, respectively, as well as a net downward adjustment in the fair value of the earnout obligation for the acquisition of the GenePOC business.  On an adjusted basis, operating income was $61.7 million, a margin of 24% (see non-GAAP financial measure reconciliation below).   

Bryan Baldasare, Chief Financial Officer, commented, “Fiscal 2020 marked not only a record year in revenues and earnings, but also cash flows from operations, allowing us to repay borrowings under our revolving credit facility and increase our available credit capacity.”

Fiscal 2021 Guidance

Our fiscal 2021 guidance reflects a big rebound of the Diagnostics segment and continued strong demand for our Life Science reagents used in COVID-19 assays.  We expect continued headwinds to our core diagnostics products through the first half, with anticipated full recovery in the second half of the fiscal year.  COVID-19 related diagnostics products are expected to supplement that recovery in the fiscal second quarter.  Life Science demand is expected to be strong throughout fiscal 2021, between $80 and $85 million, albeit, subject to the same quarter-to-quarter volatility that was seen in fiscal 2020.  Adjusted operating margin reflects significant investment in R&D and manufacturing, coupled with costs associated with the acquisition of Exalenz and annualization of headcount increases during fiscal 2020.  Gross margin is expected to be relatively flat on a consolidated basis, reflecting a modest improvement for Diagnostics driven by higher volumes from rebounding demand, and a modest decline for Life Science driven by investments to fortify capacity for larger scale manufacturing.  Diagnostics investment in new product development is forecast to be 18% of Diagnostics revenue as a result of costs for clinical trials delayed from fiscal 2020, which are added to anticipated spend on products advancing through the development pipeline.  Life Science is also investing in infrastructure across sales and R&D to support the new scale of the business.

Revenues

• Consolidated – $290 to $310 million
• Diagnostics segment – $140 to $150 million
• Life Science segment – $150 to $160 million

Adjusted Operating Margin

• Consolidated – 23.5% to 24.5%

Effective Tax Rate

• 23% to 24%

Adjusted Earnings Per Share on a Diluted Basis (based on 44.3M shares)

• $1.14 to $1.28

The higher tax rate compared to 2020 reflects a larger amount of taxable income coming from the United States.  Adjusted operating margin and adjusted earnings per share on a diluted basis for fiscal 2021 exclude costs associated with restructuring activities, changes in the fair value of the earnout obligation and selected legal matters that we expect to continue in fiscal 2021.  Current customer order patterns for our Life Science segment coupled with the current trends with the pandemic, indicate revenues for the segment could favor the first half of the fiscal year and are incorporated in our guidance.  Finally, this guidance reflects our current line of sight and assumes that we do not encounter any significant reductions in manufacturing capacity as a result of the pandemic causing either partial or full site closures for an extended period of time, or adversely affecting our supply chain for raw materials.

Financial Condition

At September 30, 2020, cash and equivalents were $53.5 million and the Company had $91.2 million of borrowing capacity under its $160.0 million commercial bank credit facility.  The Company’s bank-debt obligations under the bank credit facility totaled $68.8 million as of September 30, 2020.

Conference Call Information

Jack Kenny, Chief Executive Officer, and Bryan Baldasare, Executive Vice President and Chief Financial Officer, will host a conference call on Friday, November 13, 2020 beginning at 10:00 a.m. Eastern Time to discuss the fourth quarter and full fiscal year financial results and answer questions.  A presentation to accompany the quarterly and full fiscal year financial results and related discussion will be made available within the Investor Relations section of the Company’s website, www.meridianbioscience.com, prior to the conference call.

To participate in the live call by telephone from the U.S., dial (866) 443-5802, or from outside the U.S., dial (513) 360-6924, and enter the audience pass code 3958286.  A replay will be available for 14 days beginning at 1:00 p.m. Eastern Time on November 13, 2020 by dialing (855) 859-2056 or (404) 537-3406 and entering pass code 3958286.   

FOURTH QUARTER AND FISCAL 2020 UNAUDITED OPERATING RESULTS

(In Thousands, Except per Share Data)

The following table sets forth the unaudited comparative results of Meridian on a U.S. GAAP basis for the interim and annual periods of fiscal 2020 and fiscal 2019.

			Three Months Ended								Twelve Months Ended
			September 30,								September 30,
			2020				2019				2020				2019
Net revenues			$	64,153			$	50,846			$	253,667			$	201,014
Cost of sales				25,822				21,664				97,419				82,286
		Gross profit		38,331				29,182				156,248				118,728
Operating expenses
	Research and development			6,983				5,607				23,729				17,760
	Selling and marketing			7,210				7,140				26,486				27,995
	General and administrative			12,109				8,872				44,345				34,044
	Acquisition-related costs			462				363				3,890				1,808
	Change in fair value of contingent
	consideration obligation			1,135				–				(6,293	)			–
	Restructuring costs			67				1,138				687				2,839
	Selected legal costs			891				213				2,080				1,583
		Total operating expenses		28,857				23,333				94,924				86,029
Operating income				9,474				5,849				61,324				32,699
Other expense, net				(1,727	)			(493	)			(2,031	)			(1,142	)
	Earnings before income taxes			7,747				5,356				59,293				31,557
	Income tax provision			1,254				1,253				13,107				7,175
	Net earnings		$	6,493			$	4,103			$	46,186			$	24,382
Net earnings per basic common share			$	0.15			$	0.10			$	1.08			$	0.57
Basic common shares outstanding				42,940				42,711				42,855				42,571
Net earnings per diluted common share			$	0.15			$	0.10			$	1.07			$	0.57
Diluted common shares outstanding				43,642				42,916				43,174				42,899

					Three Months Ended										Twelve Months Ended
					September 30,										September 30,
					2020					2019					2020					2019
Adjusted Financial Measures
(see non-GAAP financial measure reconciliation below)
Operating income		$			12,029			$		7,563		$			61,688			$		38,929
Net earnings					8,289					5,399					46,301					29,142
Net earnings per diluted common share		$			0.19			$		0.13		$			1.07			$		0.68

Condensed Balance Sheet Data

		September 30,
		2020			2019
Cash and equivalents	$	53,514		$	62,397
Working capital		109,666			123,847
Long-term debt		68,824			75,824
Shareholders’ equity		247,629			190,967
Total assets		405,261			325,478

Segment Data

The following table sets forth the unaudited revenue and segment data for the interim and annual periods in fiscal 2020 and fiscal 2019 (in thousands).

		Three Months Ended										Twelve Months Ended
		September 30,										September 30,
		2020			2019							2020				2019
Net Revenues – By Product Platform/Type
Diagnostics
	Molecular assays	$	4,648		$			6,074				$	21,907			$			26,283
	Non-molecular assays		25,153					27,325					99,225						110,399
	Total Diagnostics		29,801					33,399					121,132						136,682
Life Science
	Molecular reagents		22,703					5,764					78,431						23,261
	Immunological reagents		11,649					11,683					54,104						41,071
	Total Life Science		34,352					17,447					132,535						64,332
	Total Net Revenues	$	64,153		$			50,846				$	253,667			$			201,014

		Three Months Ended													Twelve Months Ended
		September 30,													September 30,
		2020							2019						2020							2019
Net Revenues – By Disease State/Geography
Diagnostics
	Gastrointestinal assays	$		15,396					$		16,958				$		55,040					$		68,982
	Respiratory illness assays			3,030							5,380						26,694							26,622
	Blood chemistry assays			5,026							5,275						17,534							18,639
	Other			6,349							5,786						21,864							22,439
	Total Diagnostics			29,801							33,399						121,132							136,682
Life Science
	Americas			6,795							5,092						37,391							19,441
	EMEA			17,115							7,241						58,125							28,850
	ROW			10,442							5,114						37,019							16,041
	Total Life Science			34,352							17,447						132,535							64,332
	Total Net Revenues	$		64,153					$		50,846				$		253,667					$		201,014
OPERATING INCOME
	Diagnostics	$		(4,174		)			$		2,728				$		3,885					$		25,390
	Life Science			17,234							5,007						68,826							17,581
	Corporate			(3,605		)					(1,923	)					(11,437		)					(10,373	)
	Eliminations			19							37						50							101
	Total Operating Income	$		9,474					$		5,849				$		61,324					$		32,699
	Geographic Regions Americas = North and Latin America EMEA = Europe, Middle East and Africa ROW = Rest of World

NON-GAAP FINANCIAL MEASURES

In this press release, we have supplemented our reported GAAP financial information with information on operating expenses, operating income, operating margin, net earnings, basic earnings per share and diluted earnings per share, each on an adjusted basis excluding the effects of acquisition-related costs, changes in fair value of the contingent consideration obligation, restructuring costs, and selected legal costs, each of which is a non-GAAP measure.  We have provided in the tables below reconciliations to the operating expenses, operating income, net earnings, basic earnings per share and diluted earnings per share amounts reported under U.S. Generally Accepted Accounting Principles for the fourth quarters and fiscal years ended September 30, 2020 and September 30, 2019. 

We believe this information is useful to an investor in evaluating our performance because:

1. These measures help investors to more meaningfully evaluate and compare the results of operations from period to period by removing the impacts of these non-routine items; and
    
2. These measures are used by our management for various purposes, including evaluating performance against incentive bonus achievement targets, comparing performance from period to period in presentations to our board of directors, and as a basis for strategic planning and forecasting.

These non-GAAP measures may be different from non-GAAP measures used by other companies.  In addition, the non-GAAP measures are not based on any comprehensive set of accounting rules or principles.  Non-GAAP measures have limitations, in that they do not reflect all amounts associated with our results as determined in accordance with U.S. GAAP.  Therefore, these measures should only be used to evaluate our results in conjunction with corresponding GAAP measures.

FOURTH QUARTER AND FISCAL YEAR

GAAP TO NON-GAAP RECONCILIATION TABLES

(In Thousands, Except per Share Data)

			Three Months								Twelve Months
			Ended September 30,								Ended September 30,
			2020				2019				2020				2019
Operating Expenses –
	U.S. GAAP basis		$	28,857			$	23,333			$	94,924			$	86,029
	Acquisition-related costs			(462	)			(363	)			(3,890	)			(1,808	)
	Change in fair value of contingent     consideration obligation			(1,135	)			–				6,293				–
	Restructuring costs			(67	)			(1,138	)			(687	)			(2,839	)
	Selected legal costs			(891	)			(213	)			(2,080	)			(1,583	)
	Adjusted Operating Expenses		$	26,302			$	21,619			$	94,560			$	79,799
Operating Income –
	U.S. GAAP basis		$	9,474			$	5,849			$	61,324			$	32,699
	Acquisition-related costs			462				363				3,890				1,808
	Change in fair value of contingent     consideration obligation			1,135				–				(6,293	)			–
	Restructuring costs			67				1,138				687				2,839
	Selected legal costs			891				213				2,080				1,583
	Adjusted Operating Income		$	12,029			$	7,563			$	61,688			$	38,929
Net Earnings –
	U.S. GAAP basis		$	6,493			$	4,103			$	46,186			$	24,382
	Acquisition-related costs, including gain     on currency hedge of purchase price *			212				273				2,751				1,381
	Change in fair value of contingent     consideration obligation *			867				–				(4,726	)			–
	Restructuring costs *			50				864				528				2,169
	Selected legal costs *			667				159				1,562				1,210
	Adjusted Earnings		$	8,289			$	5,399			$	46,301			$	29,142
Basic Earnings per Common Share –
	U.S. GAAP basis		$	0.15			$	0.10			$	1.08			$	0.57
	Acquisition-related costs, including gain     on currency hedge of purchase price			–				0.01				0.06				0.03
	Change in fair value of contingent     consideration obligation			0.02				–				(0.11	)			–
	Restructuring costs			–				0.02				0.01				0.05
	Selected legal costs			0.02				–				0.04				0.03
	Adjusted Basic EPS		$	0.19			$	0.13			$	1.08			$	0.68

			Three Months													Twelve Months
			Ended September 30,													Ended September 30,
			2020							2019						2020							2019
Diluted Earnings per Common Share –
	U.S. GAAP basis		$	0.15						$		0.10				$		1.07					$		0.57
	Acquisition-related costs, including gain     on currency hedge of purchase price			–								0.01						0.06							0.03
	Change in fair value of contingent     consideration obligation			0.02								–						(0.11		)					–
	Restructuring costs			–								0.02						0.01							0.05
	Selected legal costs			0.02								–						0.04							0.03
	Adjusted Diluted EPS		$	0.19						$		0.13				$		1.07					$		0.68
	*    Net of tax.

FORWARD-LOOKING STATEMENTS
The Private Securities Litigation Reform Act of 1995 provides a safe harbor from civil litigation for forward-looking statements accompanied by meaningful cautionary statements. Except for historical information, this report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, which may be identified by words such as “continues”, “estimates”, “anticipates”, “projects”, “plans”, “seeks”, “may”, “will”, “expects”, “intends”, “believes”, “signals”, “should”, “can” and similar expressions or the negative versions thereof and which also may be identified by their context. All statements that address operating performance or events or developments that Meridian expects or anticipates will occur in the future, including, but not limited to, statements relating to per share diluted earnings, sales, product demand, revenue, operating margin, other guidance and the impact of COVID-19 on our business and prospects, are forward-looking statements. Such statements, whether expressed or implied, are based upon current expectations of the Company and speak only as of the date made. Specifically, Meridian’s forward-looking statements are, and will be, based on management’s then-current views and assumptions regarding future events and operating performance. Meridian assumes no obligation to publicly update or revise any forward-looking statements even if experience or future changes make it clear that any projected results expressed or implied therein will not be realized.  These statements are subject to various risks, uncertainties and other factors that could cause actual results to differ materially, including, without limitation, the following:

Meridian’s operating results, financial condition and continued growth depends, in part, on its ability to introduce into the marketplace enhancements of existing products or new products that incorporate technological advances, meet customer requirements and respond to products developed by Meridian’s competition, its ability to effectively sell such products and its ability to successfully expand and effectively manage increased sales and marketing operations. While Meridian has introduced a number of internally developed products and acquired products, there can be no assurance that it will be successful in the future in introducing such products on a timely basis or in protecting its intellectual property, and unexpected or costly manufacturing costs associated with its introduction of new products or acquired products could cause actual results to differ from expectations. Meridian relies on proprietary, patented and licensed technologies. As such, the Company’s ability to protect its intellectual property rights, as well as the potential for intellectual property litigation, would impact its results. Ongoing consolidations of reference laboratories and formation of multi-hospital alliances may cause adverse changes to pricing and distribution. Recessionary pressures on the economy and the markets in which our customers operate, as well as adverse trends in buying patterns from customers, can change expected results. Costs and difficulties in complying with laws and regulations, including those administered by the United States Food and Drug Administration, can result in unanticipated expenses and delays and interruptions to the sale of new and existing products, as can the uncertainty of regulatory approvals and the regulatory process (including the currently ongoing study and other FDA actions regarding the Company’s LeadCare products). The international scope of Meridian’s operations, including changes in the relative strength or weakness of the U.S. dollar and general economic conditions in foreign countries, can impact results and make them difficult to predict. One of Meridian’s growth strategies is the acquisition of companies and product lines. There can be no assurance that additional acquisitions will be consummated or that, if consummated, will be successful and the acquired businesses will be successfully integrated into Meridian’s operations. There may be risks that acquisitions may disrupt operations and may pose potential difficulties in employee retention, and there may be additional risks with respect to Meridian’s ability to recognize the benefits of acquisitions, including potential synergies and cost savings or the failure of acquisitions to achieve their plans and objectives. Meridian cannot predict the outcome of future goodwill impairment testing and the impact of possible goodwill impairments on Meridian’s earnings and financial results. Meridian cannot predict the possible impact of U.S. health care legislation enacted in 2010 – the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act – and any modification or repeal of any of the provisions thereof initiated by Congress or the presidential administration, and any similar initiatives in other countries on its results of operations. Efforts to reduce the U.S. federal deficit, breaches of Meridian’s information technology systems, trade wars, increased tariffs, and natural disasters and other events could have a materially adverse effect on Meridian’s results of operations and revenues. In the past, the Company has identified a material weakness in our internal control over financial reporting, which has been remediated, but the Company can make no assurances that a material weakness will not be identified in the future, which if identified and not properly corrected, could materially adversely affect our operations and result in material misstatements in our financial statements. Meridian also is subject to risks and uncertainties related to disruptions to or reductions in business operations or prospects due to pandemics, epidemics, widespread health emergencies, or outbreaks of infectious diseases such as the coronavirus disease COVID-19.  In addition to the factors described in this paragraph, as well as those factors identified from time to time in our filings with the Securities and Exchange Commission, Part I, Item 1A Risk Factors of our most recent Annual Report on Form 10-K contains a list and description of uncertainties, risks and other matters that may affect the Company. Readers should carefully review these forward-looking statements and risk factors, and not place undue reliance on our forward-looking statements.

About Meridian Bioscience, Inc.

Meridian is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. Through discovery and development, we provide critical life science raw materials used in immunological and molecular tests for human, animal, plant, and environmental applications. Through diagnosis, we provide diagnostic solutions in areas including gastrointestinal and upper respiratory infections and blood lead level testing. We build relationships and provide solutions to hospitals, reference laboratories, research centers, veterinary testing centers, physician offices, diagnostics manufacturers, and biotech companies in more than 70 countries around the world.

Meridian’s shares are traded on the NASDAQ Global Select Market, symbol VIVO. Meridian’s website address is www.meridianbioscience.com.

Contact:

Charlie Wood
Vice President – Investor Relations
Meridian Bioscience, Inc.
Phone:  +1 513.271.3700
Email:  [email protected]

BOSTON JERUSALEM, Nov. 13, 2020 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule therapeutics, announced it will report business and financial results for the quarter ended September 30, 2020 on November 19, 2020, before the U.S. financial markets open.

Entera’s management will host a conference call on Thursday, November 19, 2020 at 8:30 a.m. ET to discuss the results for the quarter. A question-and-answer session will follow Entera’s remarks. To participate on the live call, please dial (855) 547-3865 (US) or (409) 217-8787 (international) and provide the conference ID “9495026” five to ten minutes before the start of the call.

To access a live audio webcast of the presentation on the “Investor Relations” page of Entera’s website, please click here. A replay of the webcast will be archived on Entera’s website for approximately 45 days following the presentation.

About Entera Bio

Entera is a leader in the development of orally delivered large molecule therapeutics for use in areas with significant unmet medical need where adoption of injectable therapies is limited due to cost, convenience and compliance challenges for patients. The Company’s proprietary, oral drug delivery technology is designed to address the technical challenges of poor absorption, high variability, and the inability to deliver large molecules to the targeted location in the body through the use of a synthetic absorption enhancer to facilitate the absorption of large molecules, and protease inhibitors to prevent enzymatic degradation and support delivery to targeted tissues. The Company’s most advanced product candidates, EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism are in Phase 2 clinical development. Entera also licenses its technology to biopharmaceutical companies for use with their proprietary compounds and, to date, has established a collaboration with Amgen Inc. For more information on Entera Bio, visit www.enterabio.com.

Contact:

Jonathan Lieber, CFO
Tel: +001 617-362-3579
[email protected]

Company Management and Principal Investigator of ReSPECT to Discuss Interim Data

Webinar Scheduled for Thursday, November 19, 2020 at 4:30 – 5:30 p.m. ET

AUSTIN, Texas, Nov. 13, 2020 (GLOBE NEWSWIRE) — Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing novel, personalized and targeted therapies for rare and difficult to treat cancers, today announced it will host a webinar on Thursday, November 19, 2020, 4:30 to 5:30 p.m. ET. The call will follow a poster presentation of new interim data from the ongoing National Institutes of Health-sponsored ReSPECT™ Phase 1 clinical trial evaluating the Company’s lead investigational asset, Rhenium NanoLiposome (RNL™), in patients with recurrent glioblastoma (GBM) at the 2020 Society for Neuro-Oncology (SNO) Annual Meeting.

The webinar will feature a discussion of the interim safety, tolerability, dosing, feasibility and efficacy data from the ongoing ReSPECT trial. Andrew J. Brenner, M.D., Ph.D., Associate Professor of Medicine, Neurology, and Neurosurgery at The University of Texas, Health Services Center at San Antonio, will provide an update on the ReSPECT trial and provide insight on the trial data.

Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics, and Gregory D. Stein, M.D., M.B.A., Senior Vice President, Clinical Development of Plus Therapeutics, will discuss the technology behind RNL as well as the current treatment landscape and unmet medical need in treating patients with recurrent GBM.

The sixth and final dose escalation cohort of the ReSPECT trial is underway and is expected to fully enroll by the end of 2020. In September 2020, the FDA granted both Orphan Drug designation and Fast Track designation to RNL for the treatment of patients with recurrent glioblastoma. Additional details about the ReSPECT trial are available at clinicaltrials.gov (NCT01906385).

Webcast Details

A live webinar with accompanying slides will be available in the Events page of the ‘Investors’ section of the Plus Therapeutics website or by clicking here. Individuals can participate in an interactive Q&A session by submitting pertinent questions via the webcast platform.

Please log in approximately 10 minutes prior to the scheduled start time. The archived webcast will be available in the Events section of the Company’s website for 90 days.

A live audio conference will be available by dialing (833) 340-0285 (toll-free) or (236) 712-2475 and entering Conference ID 6095968.

Andrew J. Brenner, M.D., Ph.D.

Dr. Brenner is a nationally known expert in the treatment of brain and breast cancers, with a particular research interest in developing new treatments. He has served on multiple committees and panels including for the National Institutes of Health, National Cancer Institute, Department of Defense Breast Cancer Research Program, and others. He has also served on advisory committees for a number of companies to help direct development of new drugs. His laboratory work developing new treatments has been funded by the Food and Drug Administration, National Cancer Institute, and Cancer Prevention and Research Institute of Texas. He has published nearly 50 original research articles in peer reviewed journals. Dr. Brenner is a member of the Plus Therapeutics Scientific Advisory Board.

About Plus Therapeutics, Inc.

Plus Therapeutics (Nasdaq: PSTV) is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Company’s drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at PlusTherapeutics.com and ReSPECT-Trials.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains certain statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements, other than statements of historical fact, that address activities, events or developments that we intend, expect, project, believe or anticipate and similar expressions or future conditional verbs such as will, should, would, could or may occur in the future are forward-looking statements. Such statements are based upon certain assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements about: the Company’s potential to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers; the Company’s potential to develop drug candidates currently in its product pipeline; and the Company’s potential to develop additional drugs outside of its current pipeline. The forward-looking statements included in this press release are subject to a number of additional material risks and uncertainties, including but not limited to: the risk that the Company is not able to successfully develop product candidates that can leverage the U.S. FDA’s accelerated regulatory pathways; and the risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.

Investor Contact
Peter Vozzo
Westwicke/ICR
(443) 377-4767
[email protected]

Media Contact
Terri Clevenger
Westwicke/ICR
(203) 856-4326
[email protected]

SAN FRANCISCO, Nov. 13, 2020 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) and affiliate Navire Pharma, Inc. announced today that the first patient has been dosed in a Phase 1 clinical trial of its SHP2 inhibitor (BBP-398) in patients with solid tumors driven by mutations in the MAPK signaling pathway, including RAS and receptor tyrosine kinase genes. BBP-398 was developed through a collaboration with The University of Texas MD Anderson Cancer Center’s Therapeutics Discovery division.

In this two-part Phase 1 study, safety and preliminary anti-tumor activity will be examined. Part 1 is a dose escalation to establish the recommended Phase 2 dose (RP2D) of BBP-398. Part 2 will examine preliminary anti-tumor activity in four cohorts of patients with certain molecular alterations. Those cohorts include advanced KRAS G12C mutant non-small cell lung carcinoma (NSCLC), advanced KRAS G12C mutant non-NSCLC, advanced solid tumors with other MAPK pathway mutations and advanced EGFR-mutant NSCLC. David S. Hong, professor of Investigational Cancer Therapeutics at MD Anderson, will serve as the lead principal investigator for the study.

The primary objective of the study is to evaluate the safety of BBP-398 in advanced cancer patients, with secondary objectives assessing preliminary anti-tumor activity, including objective response rates and duration of response. Patients enrolling in the study must have a diagnosis of advanced (primary or recurrent) or metastatic solid tumor with potentially susceptible genomic alterations in the MAPK pathway (excluding BRAF V600X).

“SHP2 inhibitors have the potential to be effective additions to the therapeutic arsenal for difficult-to-treat cancers by overcoming multiple mechanisms that tumors use to evade treatments,” said Eli Wallace, Ph.D., chief scientific officer of oncology at BridgeBio, Navire’s parent company. “This study is a critical step in understanding the potential that BBP-398 has for patients with tumors driven by RAS or other MAPK-pathway activating mutations and informing our future clinical development activities.”

SHP2, a conserved protein tyrosine phosphatase, plays a critical role in cell signaling and growth, which are important in the progression of cancer. As SHP2 regulates receptor tyrosine kinase signaling pathways commonly overly activated in cancer, targeting SHP2 may offer a potential new approach to treat this disease.

BBP-398 was initially discovered and developed by a team of scientists in MD Anderson’s Institute for Applied Cancer Science (IACS) and Translational Research to Advance Therapeutics and Innovation in Oncology (TRACTION) platforms, both engines within the Therapeutics Discovery division. The ongoing research is supported by Navire through a global licensing and development agreement with MD Anderson.

About BridgeBio Pharma

BridgeBio is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio’s pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development. For more information visit bridgebio.com.

About Navire Pharma

Navire Pharma, an affiliate of BridgeBio, in collaboration with MD Anderson’s Therapeutics Discovery division, is developing inhibitors of SHP2 as targeted therapeutics for the treatment of multiple cancers. Together with patients and physicians, the company aims to bring safe, effective treatments to market as quickly as possible. For more information, please visit navirepharma.com

BridgeBio Pharma 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, and Section 21E of the Securities Exchange Act of 1934, as amended, 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 Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to Navire Pharma’s clinical development plans, clinical trial results, timing and completion of clinical trials, Phase 1 study design and objectives, competitive environment, and clinical and therapeutic potential of BBP-398, an SHP2 inhibitor, 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, Navire Pharma’s ability to continue its planned clinical development for BBP-398 and the timing and success of any such continued clinical development, the therapeutic potential of BBP-398, an SHP2 inhibitor, in patients with solid tumors driven by mutations in the MAPK signaling pathway, including RAS and receptor tyrosine kinase genes, and the continuing success of Navire Pharma’s collaboration with The University of Texas MD Anderson Cancer Center’s Institute for Applied Cancer Sciences, as well as those set forth in the Risk Factors section of BridgeBio Pharma, Inc.’s most recent Quarterly Report on Form 10-Q and our other SEC filings. Except as required by law, we and Navire Pharma assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:

Grace Rauh
BridgeBio Pharma
[email protected]
917-232-5478

Source: BridgeBio Pharma, Inc.

 

Both programs have
successfully
escalated to
dose
levels
demonstrating
pharmacodynamic
activity
without dose
–
limiting toxicities

Detailed
clinical data
for
each
program
to be presented at
a
medical
conference
in the first half of 2021

CAMBRIDGE, Mass., Nov. 13, 2020 (GLOBE NEWSWIRE) — Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, today announced that both of its lead clinical programs, SRF617 (targeting CD39) and SRF388 (targeting IL-27), have achieved predefined criteria for advancement into combination and expansion stages of the ongoing Phase 1 trials. These criteria include safety, successful escalation to a biologically relevant dose, target engagement and meaningful pharmacodynamic activity in the ongoing Phase 1 trials.

“As we initiated the Phase 1 clinical trials just eight months ago, we are extremely pleased with the progress both of our lead product programs have made to date,” said Jeff Goater, chief executive officer. “With the updates announced today, both SRF617 and SRF388 are well-positioned to advance into the key next stages of the ongoing trials in the coming months and ultimately deliver meaningful clinical benefits to patients suffering with cancer.”

“We are very encouraged by these data and our clinical progress to date with SRF617 and SRF388,” said Rob Ross, M.D., chief medical officer. “Both of these programs are highly innovative, next-generation immunotherapies with the potential to provide novel treatment options to patients with cancer. We look forward to advancing each of these programs into the next stage of the ongoing Phase 1 studies and presenting detailed clinical updates at a medical conference in the first half of 2021.”

SRF617
Highlights:

• The open label, Phase 1/1b clinical trial of SRF617 was initiated in March 2020 and is enrolling patients with a variety of advanced solid tumors. Summary results from nine patients treated across three dose levels (20 mg, 70 mg and 200 mg intravenously every two weeks) include:
  • No dose limiting toxicities have been observed and SRF617 has been well-tolerated.
  • Target occupancy on B cells has increased in a dose-dependent manner, and importantly, within the 200 mg cohort, the goal of meaningful, sustained target occupancy has been achieved. Surface Oncology has already demonstrated that target occupancy is directly correlated with CD39 enzymatic inhibition.
  • Prolonged stable disease (>5 months) has been seen in one patient with NSCLC who had progressed on prior anti-PD-1 treatment.
• While dose escalation will continue because of the lack of dose-limiting toxicities, SRF617 has achieved a dose that supports advancement of the program into the planned combination expansion cohorts (additional details provided below). We anticipate that the combination cohorts will likely begin enrolling in late 2020.
• Surface Oncology plans to present detailed initial clinical results from the ongoing Phase 1/1b trial of SRF617 at a medical conference in the first half of 2021.
• In May 2020, Surface Oncology announced a clinical collaboration with Merck (NYSE: MRK) to evaluate the safety and efficacy of combining SRF617 with Merck’s KEYTRUDA^® (pembrolizumab), the first anti-PD-1 therapy approved in the United States. This combination will be studied as a future component of the ongoing first-in-human Phase 1/1b study of SRF617 and will be evaluated in patients with solid tumors, with a focus on patients with gastric cancer and those who have developed resistance to checkpoint inhibition — both areas of high unmet need.
• In addition, as part of the clinical development plan, Surface Oncology will initiate SRF617 combinations with gemcitabine and abraxane in patients with pancreatic cancer and SRF617 in combination with AB928, an A_2A/A_2B small molecule inhibitor, in clinical collaboration with Arcus Biosciences (NYSE: RCUS) in patients with prostate cancer.

SRF388
Highlights:

• The open label, Phase 1 clinical trial of the first-in-class antibody SRF388 was initiated in April 2020 and is enrolling patients with a variety of advanced solid tumors. Summary results from nine patients treated across five dose levels (0.003, 0.03, 0.1, 0.3 and 1 mg/kg intravenously every four weeks) include:
  • No dose limiting toxicities have been observed and SRF388 has been well tolerated.
  • While dose escalation will continue because of the lack of dose-limiting toxicities, SRF388 has already achieved maximal inhibition of the IL-27 signaling pathway at the 0.3mg/kg dose, as measured in whole blood from patients treated on the trial. Planned monotherapy Phase 2 expansion cohorts in liver cancer and kidney cancer are on track to begin enrolling patients in the first half of 2021.
  • Prolonged stable disease (>6 months) has been noted in one patient with kidney cancer, who had progressed on prior anti-PD-1 treatment. Notably, kidney cancer is one of the predefined indications of interest for SRF388 based on clear demonstration of pathway activation in clinical samples. No patients with liver cancer have been enrolled in the dose escalation portion of the trial to date.
• Surface Oncology plans to present detailed initial clinical results from the ongoing Phase 1 trial of SRF388 at a medical conference in the first half of 2021.
• The clinical development plan for SRF388 is based on compelling translational research that indicates that IL-27 is upregulated and functional in both kidney cancer and liver cancer. This work is supported in part by a study presented at the 2020 American Association for Cancer Research Annual Meeting demonstrating that high levels of IL-27 correlate strongly with the risk of developing liver cancer. The presentation can be found here.
• SRF388 recently received Orphan Drug designation and Fast Track designation for the treatment of hepatocellular carcinoma from the FDA.

About SRF617
:

SRF617 is a fully human antibody designed to inhibit the enzymatic activity of CD39, allowing for a dual mechanism of action to promote anti-tumor immunity via reduction of immunosuppressive adenosine in addition to increasing levels of immunostimulatory ATP. A substantial body of research supports a role for CD39 in allowing cancer to evade immune responses. For example, in gastric cancer, immune cells within the tumor often express high levels of CD39, which may impair an overall anti-cancer immune response even in the presence of an anti-PD-1 antibody. In preclinical studies, SRF617 has exhibited strong affinity for and inhibition of CD39, the ability to reduce adenosine and increase ATP levels and anti-tumor activity both as a single agent and in combination with multiple therapeutic agents.

About SRF388
:

SRF388 is a fully human anti-IL-27 antibody designed to inhibit the activity of this immunosuppressive cytokine. Surface Oncology has identified particular tumor types, including liver and kidney cancer, where IL-27 appears to play an important role in the immunosuppressive tumor microenvironment and may contribute to resistance to treatment with checkpoint inhibitors. SRF388 targets the rate-limiting p28 subunit of IL-27, and preclinical studies have shown that treatment with SRF388 blocks the immuno-suppressive biologic effects of IL-27, resulting in immune cell activation in combination with other cancer therapies and potent anti-tumor effects as a monotherapy. Furthermore, Surface Oncology has identified a potential biomarker associated with IL-27 that may be useful in helping identify patients most likely to respond to SRF388.

About Surface Oncology:

Surface Oncology is an immuno-oncology company developing next-generation antibody therapies focused on the tumor microenvironment. Its pipeline includes two wholly-owned lead programs targeting CD39 (SRF617) and IL-27 (SRF388), a clinical-stage collaboration with Novartis targeting CD73 (NZV930), and two preclinical programs, each focused primarily on activating natural killer cells (via targeting PVRIG, also known as CD112R (SRF813)), or depleting regulatory T cells (via targeting CCR8 (SRF114)). Surface’s novel cancer immunotherapies are designed to achieve a clinically meaningful and sustained anti-tumor response and may be used alone or in combination with other therapies. For more information, please visit www.surfaceoncology.com.

Cautionary Note Regarding Forward-Looking Statements:

Certain statements set forth in this press release constitute “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as “believes,” “expects,” “plans,” “potential,” “would,” or similar expressions, and the negative of those terms. These forward-looking statements are based on Surface Oncology’s management’s current beliefs and assumptions about future events and on information currently available to management.

Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Surface Oncology’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. These risks include, but are not limited to, risks and uncertainties related to Surface Oncology’s ability to successfully develop SRF388, SRF617, SRF813 and its other product candidates through current and future milestones or regulatory filings on the anticipated timeline, if at all, the therapeutic potential of Surface Oncology’s product candidates, the risk that results from preclinical studies or early clinical trials may not be representative of larger clinical trials, the risk that Surface Oncology’s product candidates, including SRF388, SRF617 and SRF813, will not be successfully developed or commercialized, the risks related to Surface Oncology’s dependence on third-parties in connection with its manufacturing, clinical trials and preclinical studies, and the potential impact of COVID-19 on our clinical and preclinical development timelines and results of operations. Additional risks and uncertainties that could affect Surface Oncology’s future results are included in the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ending December 31, 2019 and our Quarterly Report on Form 10-Q for the quarter ending March 31, 2020, both of which are available on the Security and Exchange Commission’s website at www.sec.gov and Surface Oncology’s website at www.surfaceoncology.com.

Additional information on potential risks will be made available in other filings that Surface Oncology makes from time to time with the Securities and Exchange Commission. In addition, any forward-looking statements contained in this press release are based on assumptions that Surface Oncology believes to be reasonable as of this date. Except as required by law, Surface Oncology assumes no obligation to update these forward-looking statements, or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements.

Contacts:

Investors
Matt Lane
[email protected]
617-901-7698

Media
Matthew Corcoran
mcorcoran@tenbridgecommunications.com
617-866-7350