Market Newsdesk

• Verana Health a
  nalysis of American Academy of Ophthalmology IRIS
  
  ^®
  
  Registry presented in a late-breaking oral session

• Real-world clinical data show significant disease progression over a two-year period in more than 69,000 patients with GA, highlighting the urgent need for treatment

• Patients were nearly three times more likely to develop
  new onset 
  wet
  age-related macular degeneration
  (
  AMD
  )
  in an eye with GA when wet AMD had already been detected in the
  contralateral
  eye
  

WALTHAM, Mass., Nov. 13, 2020 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced findings from the largest retrospective database study in geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The analysis of the American Academy of Ophthalmology (AAO) IRIS^® (Intelligent Research in Sight) Registry, the nation’s first comprehensive clinical registry for eye disease, was conducted in partnership with Verana Health, the world’s leading data analysis group in retinal diseases. The study highlights the significant impact of GA progression on vision, underscoring the high unmet need for GA treatment in clinical practice. The data were presented today in a late-breaking oral session as part of the Retina Subspecialty Day at AAO 2020 Virtual.

The retrospective study included more than 69,000 patients diagnosed with GA and analyzed changes in visual acuity and disease progression for over two years, as well as the occurrence of concurrent wet AMD. GA is a complement-driven eye disease^1,2 that can lead to significant vision loss and affects approximately five million people around the world.^3,4  

“There is no approved therapy for GA and with new agents under development, it is essential to have a detailed understanding of disease progression in real-world clinical practice,” said Ehsan Rahimy, M.D., lead study author and surgical and medical vitreoretinal specialist at the Palo Alto Medical Foundation. “The data show that GA patients at their first encounter have useful vision that may be preserved if an effective treatment were available. The progressive loss of visual acuity observed in this study over a two-year period underscores the urgent need for a therapy to slow disease progression.” 

Key findings from the real-world clinical data show: 

• Progression from GA to new onset wet AMD was observed in 4.7% of patients with bilateral GA (GA in both eyes) and 13.3% of patients with wet AMD in the contralateral eye during the first 12 months. The rate at 24 months was 8.2% and 21.6% in bilateral GA and wet AMD in the contralateral eye, respectively.
• At the first study visit, patients presented with relatively preserved vision, especially in eyes with extrafoveal GA lesions (lesions outside the fovea, which is the central portion of the retina). However, patients with extrafoveal and foveal GA lesions progressively lost vision over time at a rate of approximately five letters per year. 
• A large proportion of GA patients did not return for a follow-up visit after two years. Of the GA patients potentially eligible for inclusion in the analysis, only 40% had a follow-up visit after two years and were ultimately included in the study.

“As we work to develop the first potential medicine for people with GA, we are committed to improving understanding of the disease. Our collaboration with Verana Health and the AAO IRIS^® Registry shows that wet AMD is not a rare occurrence in GA patients, and there is an opportunity to preserve vision if new treatments become available,” said Federico Grossi, M.D., Ph.D., chief medical officer of Apellis. “These results highlight the significant unmet need in GA, and we are working urgently to advance pegcetacoplan, a targeted C3 therapy, in two ongoing Phase 3 GA studies.” 

About the IRIS

^®

 Registry

The American Academy of Ophthalmology IRIS^® (Intelligent Research in Sight) Registry is the nation’s first electronic health record-based comprehensive eye disease and condition registry. As of September 2020, the registry features over 59.99 million unique patients and includes 16,030 clinicians. It is a centralized data repository and reporting tool that can analyze patient data to produce easy-to-interpret national and inter-practice benchmark reports and provide scientific information to improve public health. The reports can validate the quality of care ophthalmologists provide and pinpoint opportunities for improvement.

About Verana Health

Verana Health, Inc. partners with leading medical associations to transform clinical data into actionable real-world evidence. These partnerships enable Verana Health to harness the comprehensive data found in qualified clinical data registries and other specialty data sources to accelerate medical research and enhance patient care. Learn more at veranahealth.com.

About Geographic Atrophy (GA)  
GA is an advanced form of age-related macular degeneration (AMD), a leading cause of blindness. Excessive complement activation drives irreversible lesion growth in GA,⁵ and C3 is the only target to precisely control complement overactivation. Pegcetacoplan, studied in early and late-stage trials comprising a total of approximately 1,500 patients, is the only targeted C3 inhibitor being evaluated in late-stage trials to control lesion growth in GA.⁶ 

GA lesions affect the central portion of the retina, known as the macula, which is responsible for central vision. GA is progressive and irreversible, leading to central visual impairment and permanent loss of vision. Based on published studies, approximately one million people have GA in the United States and five million people have GA globally.^2,7 There are currently no approved treatments for GA. 

About Pegcetacoplan (APL-2)  
Pegcetacoplan is an investigational, targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. Pegcetacoplan is a synthetic cyclic peptide conjugated to a polyethylene glycol polymer that binds specifically to C3 and C3b. Apellis is evaluating pegcetacoplan in several clinical studies across hematology, ophthalmology, nephrology, and neurology. Pegcetacoplan was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and the treatment of geographic atrophy, and received orphan drug designation for the treatment of C3 glomerulopathy (C3G) by the FDA and European Medicines Agency. For additional information regarding our clinical trials, visit https://apellis.com/our-science/clinical-trials. 

About Apellis  
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that is committed to leveraging courageous science, creativity, and compassion to deliver life-changing therapies. Leaders in targeted C3 therapies, we aim to develop transformative therapies for a broad range of debilitating diseases that are driven by excessive activation of the complement cascade, including those within hematology, ophthalmology, nephrology, and neurology. For more information, please visit http://apellis.com. 

Apellis Forward-Looking Statement 
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the implications of preliminary clinical data. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether the company’s clinical trials will be fully enrolled and completed when anticipated; whether preliminary or interim results from a clinical trial will be predictive of the final results of the trial; whether results obtained in preclinical studies and clinical trials will be indicative of results that will be generated in future clinical trials; whether pegcetacoplan will successfully advance through the clinical trial process on a timely basis, or at all; whether the results of the company’s clinical trials will warrant regulatory submissions and whether pegcetacoplan will receive approval from the FDA or equivalent foreign regulatory agencies for GA, PNH, CAD, C3G, IC-MPGN, ALS or any other indication when expected or at all; whether, if Apellis’ products receive approval, they will be successfully distributed and marketed; and other factors discussed in the “Risk Factors” section of Apellis’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 2, 2020 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.  

Media Contact: 
Mark Dole 
[email protected] 
+1 617 997 3484 

Investor Contact: 
Argot Partners 
[email protected]
+1 212 600 1902 

¹ Weber, BHF, Issa, PC, et al. The Role of the Complement System in Age-Related Macular Degeneration.  
Dtsch Arztebl Int 2014; 111(8): 133–8.  
² Heesterbeek, TJ, Lechanteur YTE, et al. Complement activation levels are related to disease stage in AMD. Invest Ophthalmol Vis Sci. 2020;61(3):18.  
³ Rudnicka AR, Jarrar Z, Wormald R, et al. Age and gender variations in age-related macular degeneration prevalence in populations of European ancestry: a meta-analysis. Ophthalmology 2012;119:571–580. 
⁴ Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health 2014;2:e106–116. 
⁵ Seddon, JM, Rosner, B. Validated prediction models for macular degeneration progression and predictors of visual acuity loss identify high-risk individuals. Am J Ophthalmol 2019;198:223–261.  
⁶ Yates, JRW, Sepp T, et al. Complement C3 Variant and the Risk of Age-Related Macular Degeneration. N Engl J Med 2007; 357. 
⁷ Weber, BHF, Issa, PC, et al. The Role of the Complement System in Age-Related Macular Degeneration. Dtsch Arztebl Int 2014; 111(8): 133–8. 

NEW YORK, Nov. 13, 2020 (GLOBE NEWSWIRE) — Zhang Investor Law announces a class action lawsuit on behalf of shareholders who bought shares of Zosano Pharma Corporation (NASDAQ: ZSAN) between February 13, 2017 and September 30, 2020, inclusive (the “Class Period”).

To join the class action, go to http://zhanginvestorlaw.com/join-action-form/?slug=zosano-pharma-corporation&id=2478 or call Sophie Zhang, Esq. toll-free at 800-991-3756 or email [email protected] for information on the class action.

如果您想加入这个集体诉讼案，请在这里提交您的信息。http://zhanginvestorlaw.com/join-action-form/?slug=zosano-pharma-corporation&id=2478

If you wish to serve as lead plaintiff, you must move the Court before the November 30, 2020 DEADLINE.   A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. 

According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose: (a) the Company’s clinical results reflected differences in zolmitriptan exposures observed between subjects receiving different lots; (b) pharmacokinetic studies submitted in connection with the Company’s New Drug Application (“NDA”) included patients exhibiting unexpected high plasma concentrations of zolmitriptan; (c) as a result of the foregoing differences among patient results, the U.S. Food and Drug Administration (“FDA”) was reasonably likely to require further studies to support regulatory approval of Qtrypta; (d) as a result, regulatory approval of Qtrypta was reasonably likely to be delayed; and (e) as a result of the foregoing, defendants’ public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.

Lead plaintiff status is not required to seek compensation.  You may retain counsel of your choice.  You may remain an absent class member and take no action at this time.

Zhang Investor Law represents investors worldwide. Attorney Advertising. Prior results do not guarantee similar outcomes.

Zhang Investor Law P.C.
99 Wall Street, Suite 232
New York, New York 10005
[email protected]
tel: (800) 991-3756

KING OF PRUSSIA, Pa., Nov. 13, 2020 (GLOBE NEWSWIRE) — Nocopi Technologies, Inc. (OTC Pink: NNUP), a developer of specialty reactive inks used in entertainment, toy and educational products as well as in document and product authentication technologies to combat fraud, today announced results for its third quarter ended September 30, 2020 (Q3’20). Nocopi’s SEC filings are available here, https://bit.ly/35gTldx

Nocopi Chairman and CEO Michael Feinstein, commented, “Nocopi achieved another quarter of double digit revenue growth driven principally by growing demand for our specialty ink technologies used in toy and entertainment products. Specialty ink sales reached the second highest level in recent periods during the third quarter as our entertainment customers ramped production activity in anticipation of the holiday selling season. We are optimistic that this expanded production activity will support strong holiday sales levels that would contribute to future royalty income for Nocopi. That leading indicator combined with recent team efforts on new products which are variants of our ink technology plus expanded distribution channels led by existing partners sets Nocopi up for success in the next year.”

“COVID-related factors continued to negatively impact overall consumer spending at physical stores during the third quarter, however this trend was offset somewhat by solid increases in online sales activity. The net effect was a lower level of product sell-through that caused a lower level of revenues from licenses, royalties and fees in Q3’20 versus the year ago period.

“Similarly, we continued to experience weakness in our smaller anticounterfeiting and anti-product diversion applications for our specialty ink technologies, principally due to COVID-19-related plant closures and budget and procurement freezes. We are optimistic that these markets will return to more normal levels of activity as we progress into FY 2021.

“Nocopi’s Q3’20 cash collections were strong, with the company closing the quarter with $2.5M in working capital, including $1.4M of cash and $1.0M in accounts receivable. This compares favorably with Q4’19 working capital of $1.8M, including $0.7M of cash, and $1.4M of accounts receivable and Q2’20 working capital of $2.1M, including $1.1M in cash and $1.1M in accounts receivable. Our financial position puts Nocopi in a very strong position to manage our business over the foreseeable future and the ability to weather future unforeseen circumstances whether those be unique to COVID-19 or other economic factors. Given that access to capital is both challenging and expensive for microcap companies, we feel it is essential that we proceed carefully in developing a prudent capital allocation strategy.”

Q
3
Highlights

• Revenues rose 18% to $755,000, driven by a 34% increase in specialty ink product sales.
• Revenue from licenses, royalties and fees declined 19% to $153,300, and were pressured by a slight decrease in earned royalties from our major licensees in the entertainment and toy industries compared to Q3 ‘19 due to the closure of some retail locations where their products are sold.
• Gross profit of $425,500 was relatively unchanged though gross margin declined to 56% from 67% compared to Q3 ’19 on increased product and shipping costs and a lower percentage of higher-margin royalty income within Nocopi’s revenue mix.
• Net income decreased to $163,100 from $206,800 in Q3’19, due to higher salary and consulting expenses and lower gross margin.
• Working capital, including $1.5M of cash, increased to $2.5M at 9/30/20 compared to working capital of $1.8M at year-end 2019.
• Book value increased to $3.2M at 9/30/20 compared to $2.8M at year-end 2019.

Q
3
’20
Results

Q3’20 revenues rose 18% to $754,800 reflecting a 34% increase in product and other sales, principally due to higher specialty ink shipments to the entertainment and toy product market, offset by a 19% decline in licenses, royalties and fees, due primarily to the Covid-19 related reduction in sell-through of entertainment products using Nocopi technologies as well as temporary disruptions of customer activity in security applications also resulting from the pandemic. Royalty revenue in the Q3’20 and Q3’19 periods do not reflect the receipt of quarterly guaranteed royalty payments of $100,000 received by Nocopi pursuant to a four-year license extension that went into effect July 1, 2019. The payments are reflected in the Company’s balance sheet and statement of cash flows but are not recorded as revenue.

Gross profit decreased to $425,500, or 56% of revenues in Q3’20, from $429,500, or 67% of revenues in Q3 ’19, principally due to higher raw material costs and shipping expense related to the COVID-19 pandemic, as well as a smaller relative contribution from higher-margin royalty revenue. However, the Company’s gross margin improved sequentially to 56% in Q3 ’20 compared to 51% in Q2 ’20 due to a change in the mix toward higher margin products in the quarter.

Q3’20 operating expenses increased to $255,400 from $210,400 in Q3’19, reflecting increased operational and administrative expense including higher salaries and professional fees. In late 2019, Nocopi expanded its ink production operations and staffing to support expected future growth.

Reflecting lower gross profit and higher operating expenses Nocopi’s net income declined to $163,100, or $0.002 per diluted share, in Q3’20, compared to $206,800, or $0.003 per diluted share, in Q3’19.

Nocopi’s cash flow from operations increased to $768,500 in the first nine months of 2020 compared to $399,400 in the year-ago period.

About Nocopi Technologies (
www.nocopi.com
)

Nocopi develops and markets specialty reactive inks for unique, mess-free applications in the entertainment, toy and educational product markets. Nocopi also develops and markets document and product authentication technologies designed to combat fraudulent document reproduction, product counterfeiting and/or unauthorized product diversion. Nocopi derives revenue from technology licensing agreements as well as from the sale of its proprietary inks and other products to licensees and/or their licensed printers. Nocopi’s products and systems include trade secrets as well as patented technologies.

Safe Harbor for Forward-Looking Statements

This release may contain projections and other “forward-looking statements” relating to Nocopi’s business, that are often identified by the use of “believes,” “expects” or similar expressions. Forward-looking statements involve a number of estimates, assumptions, risks and uncertainties that may cause actual results to differ materially from those anticipated. Forward-looking statements may address uncertainties regarding customer preferences or demand for products incorporating Nocopi technology that underlie the company’s revenue expectations, the company’s ability to develop new products and new product applications, the financial condition of customers and the timeliness of their payments, the impact of fluctuations in currencies, global trade and shipping markets, etc. Actual results could differ from those projected due to numerous factors and uncertainties, and Nocopi can give no assurance that such statements will prove to be correct nor that Nocopi’s actual results of ‎operations, financial condition and performance will not differ materially from those reflected or implied by its forward-‎looking statements. Investors should refer to the risk factors outlined in Nocopi’s Form 10-K, 10-Q and other SEC reports available at www.sec.gov/edgar. Forward-looking statements are made as of the date of this news release; Nocopi assumes no obligation to update these statements.

Twitter – Investors:
@NNUP_IR

Investor & Media Contacts

Chris Eddy or David Collins
Catalyst IR
212-924-9800 or [email protected]

Nocopi Technologies, Inc.



Statements of Operations



(unaudited)

Nocopi Technologies, Inc.



Balance Sheets

PHILADELPHIA, Nov. 13, 2020 (GLOBE NEWSWIRE) — Kehoe Law Firm, P.C. is investigating potential securities claims on behalf of investors of MultiPlan Corporation (“MultiPlan” or the “Company”) (NYSE: MPLN) to determine whether the Company engaged in securities fraud or other unlawful business practices.

INVESTORS WHO PURCHASED, OR OTHERWISE ACQUIRED,
THE SECURITIES OF MULTIPLAN CORPORATION AND SUFFERED SIGNIFICANT LOSSES
ARE ENCOURAGED TO
COMPLETE KEHOE LAW FIRM’S

SECURITIES CLASS ACTION QUESTIONNAIRE

OR CONTACT
KEVIN CAULEY, DIRECTOR, BUSINESS DEVELOPMENT
,
(215) 792-6676, EXT. 80
2
,

[email protected]

,

[email protected]

,
TO DISCUSS THE 

SECURITIES INVESTIGATION

OR POTENTIAL LEGAL CLAIMS
.

Muddy Waters Research published a report (“MultiPlan: Private Equity Necrophilia Meets The Great 2020 Money Grab”), which, among other things, stated that “MPLN is in the process of losing its largest client, UnitedHealthcare (‘UHC’). UHC has formed a competitor to [MultiPlan] that offers significantly lower prices and fewer conflicts of interest. The competitor is called Naviguard.”

Muddy Waters Research also reported that MultiPlan “. . . was already in financial decline, and its financial statements were engineered to obscure this existing deterioration.” Further, according to Muddy Waters Research, “. . . in 2018, [MultiPlan] released revenue reserves, dropping them from approximately 30% to 10% of revenue, which . . . enabled [MultiPlan] to show 2018 EBITDA growth amid shrinking sales.”

On this news,
MultiPlan’s
stock dropped $1.72 per share, or 19.7%, to close at $7.01 on November 11, 2020

Kehoe Law Firm, P.C., with offices in New York and Philadelphia, is a multidisciplinary, plaintiff–side law firm dedicated to protecting investors from securities fraud, breaches of fiduciary duties, and corporate misconduct.  Combined, the partners at Kehoe Law Firm have served as Lead Counsel or Co-Lead Counsel in cases that have recovered more than $10 billion on behalf of institutional and individual investors.   

This press release may constitute attorney advertising.