Immunovant Reports Financial Results for the Quarter and Six Months Ended September 30, 2020

Company Ended the Quarter With Cash of Approximately $444 Million

NEW YORK, Nov. 12, 2020 (GLOBE NEWSWIRE) — Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases, today reported financial results for its fiscal second quarter and six months ended September 30, 2020.  Immunovant ended the quarter with approximately $444 million in cash.

“Our team made outstanding operational and strategic progress during the fiscal second quarter,” said Pete Salzmann, M.D., Chief Executive Officer of Immunovant.  “First, we reported positive topline results from our randomized, placebo-controlled trial of IMVT-1401 in patients with moderate-to-severe Myasthenia Gravis (MG). Second, we announced the appointment of Michael Elliott, MBBS, Ph.D., an accomplished industry leader in immunology, as Chief Scientific Officer.  And third, we further strengthened our balance sheet with approximately $188 million of net proceeds from a public equity offering,” he continued. 

“We plan to report results from the high-dose cohort of ASCEND WAIHA, an open-label Phase 2a clinical trial of IMVT-1401 in Warm Autoimmune Hemolytic Anemia (WAIHA), in the first quarter of calendar year 2021.  We plan to report results from ASCEND GO-2, a Phase 2b clinical trial of IMVT-1401 in patients with Thyroid Eye Disease (TED), in the first half of calendar year 2021.  We also plan to announce three new indications for IMVT-1401 by August 2021,” he added.

Financial Highlights for Fiscal Second Quarter Ended September 30, 2020

R&D Expenses: Research and development expenses increased by $1.7 million, from $10.3 million for the three months ended September 30, 2019 to $12.0 million for the three months ended September 30, 2020. The year-over-year increase was primarily driven by higher costs related to expansion of ongoing clinical trials, initiation of a non-clinical study and additional professional services.

G&A Expenses:  General and administrative expenses increased by $4.8 million, from $4.2 million for the three months ended September 30, 2019 to $9.0 million for the three months ended September 30, 2020. The year-over-year increase was primarily due to higher headcount, resulting in additional personnel costs and stock-based compensation expense.

Net Loss: Net loss was $20.8 million ($0.25 per common share) for the three months ended September 30, 2020, compared to $14.5 million ($0.38 per common share) for the three months ended September 30, 2019.  Net loss for the three months ended September 30, 2020 and 2019 included $3.4 million and $3.1 million, respectively, related to non-cash stock-based compensation expense.

Common Stock: As of September 30, 2020, there were 97,890,705 shares of the common stock issued and outstanding.

Financial Highlights for Fiscal Six Months Ended September 30, 2020

R&D Expenses: Research and development expenses were $28.9 million for the six months ended September 30, 2020, compared to $28.8 million for the six months ended September 30, 2019. Expenses in 2019 included $10.0 million related to the achievement of the first development and regulatory milestone under Immunovant’s license agreement with HanAll Biopharma Co., Ltd. Excluding the effects of this one-time milestone, research and development expenses increased by $10.1 million for the six months ended September 30, 2020 compared to the same period in the prior year. The year-over-year increase was primarily due to increases in contract manufacturing costs and non-clinical and clinical studies, driven by the expansion of clinical trial programs for the treatment of autoimmune diseases. Other increases include higher personnel-related expenses (including stock-based compensation expense) due to higher headcount to support clinical operations and increased professional services.

G&A Expenses: General and administrative expenses were $18.7 million for the six months ended September 30, 2020, compared to $5.8 million for the six months ended September 30, 2019. The year-over-year increase was primarily due to higher stock-based compensation expense and higher personnel-related costs, both of which were due to higher headcount. Other increases include higher legal and professional fees to support our growth and operations as a public company.

Net Loss: Net loss was $47.5 million ($0.61 per common share) for the six months ended September 30, 2020, compared to $34.5 million ($0.90 per common share) for the six months ended September 30, 2019.  Net loss for the six months ended September 30, 2020 and 2019 included $7.4 million and $3.7 million, respectively, related to non-cash stock-based compensation expense.

About Immunovant, Inc.

Immunovant, Inc. is a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases. Immunovant is developing IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies.

Forward-Looking Statements

This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” and other similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning Immunovant’s clinical programs, including the number and timing of clinical programs, development initiatives and new indications for IMVT-1401; the potential efficacy of Immunovant’s product candidates for patients with autoimmune diseases; Immunovant’s expectations with respect to clinical development opportunities; and Immunovant’s statements and expectations regarding its balance sheet. All forward-looking statements are based on estimates and assumptions by Immunovant’s management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others, initial results or other preliminary analyses or results of early clinical trials may not be predictive final trial results or of the results of later clinical trials; the availability of data from clinical trials; the expectations for regulatory submissions and approvals; the continued development of Immunovant’s product candidates; Immunovant’s scientific approach and general development progress; the availability and commercial potential of Immunovant’s product candidates including the size of potentially addressable markets and degree of market acceptance; and the potential impact of the recent COVID-19 pandemic on Immunovant’s clinical development plans and timelines. These statements are also subject to a number of material risks and uncertainties that are described under the section titled “Risk Factors” in Immunovant’s most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q in each case filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

IMMUNOVANT, INC.

Condensed Consolidated Statements of Operations

(Unaudited, in thousands, except share and per share data)

    Three Months Ended
September 30,
  Six Months Ended
September 30,
    2020   2019   2020   2019
Operating expenses:                
Research and development (includes $999 and $1,476 of stock-based compensation expense for the three and six months ended September 30, 2020, respectively, and $2,307 and $2,372 of stock-based compensation expense for the three and six months ended September 30, 2019, respectively)(1)   $ 11,976       $ 10,331       $ 28,898       $ 28,807    
General and administrative (includes $2,362 and $5,866 of stock-based compensation expense for the three and six months ended September 30, 2020, respectively, and $830 and $1,337 of stock-based compensation expense for the three and six months ended September 30, 2019, respectively)(2)   8,998       4,163       18,662       5,748    
Total operating expenses   20,974       14,494       47,560       34,555    
Interest expense         249             249    
Other income, net   (225 )     (294 )     (151 )     (319 )  
Loss before provision for income taxes   (20,749 )     (14,449 )     (47,409 )     (34,485 )  
Provision for income taxes   40       33       88       56    
Net loss   $ (20,789 )     $ (14,482 )     $ (47,497 )     $ (34,541 )  
Net loss per common share – basic and diluted(3)   $ (0.25 )     $ (0.38 )     $ (0.61 )     $ (0.90 )  
Weighted-average common shares outstanding – basic and diluted(3)   84,353,438       38,590,381       77,623,132       38,590,381    

(1) Includes $68 and $176 of costs allocated from Roivant Sciences Ltd. for the three and six months ended September 30, 2020, respectively, and $1 and $152 of costs allocated from Roivant Sciences Ltd. for the three and six months ended September 30, 2019, respectively.
(2) Includes $173 and $337 of costs allocated from Roivant Sciences Ltd. for the  three and six months ended September 30, 2020, respectively, and $270 and $514 of costs allocated from Roivant Sciences Ltd. for the three and six months ended September 30, 2019, respectively.
(3) Retroactively restated for the reverse recapitalization.

IMMUNOVANT, INC.

Condensed Consolidated Balance Sheets

(Unaudited, in thousands, except share and per share data)

    September 30, 2020   March 31, 2020
Assets        
Current assets:        
Cash   $ 444,372       $ 100,571    
Prepaid expenses   5,854       5,460    
Income tax receivable   40       36    
Value-added tax receivable         3,009    
Total current assets   450,266       109,076    
Operating lease right-of-use assets   3,493          
Property and equipment, net   136       65    
Deferred offering costs         246    
Total assets   $ 453,895        $ 109,387     
Liabilities and Stockholders’ Equity    
Current liabilities:        
Accounts payable   $ 5,787       $ 1,190    
Accrued expenses   5,787       10,938    
Current portion of operating lease liabilities   1,102          
Due to Roivant Sciences Ltd.   134       3,190    
Total current liabilities   12,810       15,318    
Operating lease liabilities, net of current portion   2,679          
Total liabilities   15,489       15,318    
Commitments and contingencies        
Stockholders’ equity:(1)        
Series A preferred stock, par value $0.0001 per share, 10,000 shares authorized, issued and outstanding at September 30, 2020 and March 31, 2020            
Preferred stock, par value $0.0001 per share, 10,000,000 shares authorized, no shares issued and outstanding at September 30, 2020 and March 31, 2020            
Common stock, par value $0.0001 per share, 500,000,000 shares authorized, 97,890,705 shares issued and outstanding at September 30, 2020 and 500,000,000 shares authorized, 56,455,376 shares issued and 54,655,376 shares outstanding at March 31, 2020   10       5    
Additional paid-in capital   577,341       185,306    
Accumulated other comprehensive loss   (222 )     (16 )  
Accumulated deficit   (138,723 )     (91,226 )  
Total stockholders’ equity   438,406       94,069    
Total liabilities and stockholders’ equity   $ 453,895        $ 109,387     
         

(1) Retroactively restated for the reverse recapitalization.

Contact:

John Strumbos, Ph.D., MBA
Vice President, Finance and Strategy
Immunovant, Inc.
[email protected]

DIRTT announces conference schedule for the fourth quarter of 2020

CALGARY, Alberta, Nov. 12, 2020 (GLOBE NEWSWIRE) — DIRTT Environmental Solutions Ltd. (“DIRTT”, the “Company”, “we” or “us”) (NASDAQ: DRTT, TSX: DRT), an interior construction company that uses technology for client-driven design and manufacturing, is pleased to announce its plans to participate in the following investment conferences.

  • 11

    th

    Annual Craig-Hallum Alpha Select Conference

    Tuesday, November 17, 2020
  • Truist 2020 Industrials and Services Summit

    Tuesday, December 8, 2020

DIRTT will meet one-on-one with institutional investors at the conferences, which are both being held virtually. DIRTT’s updated investor presentation will be available in the investors section of the DIRTT website at dirtt.com/investors.

ABOUT DIRTT

DIRTT is a building process powered by technology. The Company uses its proprietary ICE® software to design, manufacture and install fully customized interior environments. The technology drives DIRTT’s advanced manufacturing and provides certainty on cost, schedule and final result. Complete interior spaces are constructed faster, cleaner and more sustainably. DIRTT’s manufacturing facilities are located in Phoenix, Savannah and Calgary. The Company works with over 75 partners throughout North America. DIRTT trades on Nasdaq under the symbol “DRTT” and on the Toronto Stock Exchange under the symbol “DRT”.

FOR FURTHER INFORMATION, PLEASE CONTACT

Kim MacEachern
Investor Relations, DIRTT
403-618-4539
[email protected]

Alimera Sciences Announces Real-World Clinical Data for ILUVIEN® to be Presented at the American Academy of Ophthalmology 2020 Virtual Conference

ATLANTA, Nov. 12, 2020 (GLOBE NEWSWIRE) — Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a leader in the commercialization and development of prescription ophthalmology treatments for the management of retinal diseases, today announces that new real-world clinical data for ILUVIEN® will be featured in 3 posters at the American Academy of Ophthalmology 2020 Virtual Conference. The posters will be available to registered attendees beginning Friday, November 13, 2020.

Posters include:

  • Abstract # 30064808: “Outcomes from the prospective IDEAL registry study – results achieved with the 0.2 µg/day fluocinolone acetonide implant” – Khoramnia, et. al.
  • Abstract # 30064802: “Three-year real-world outcomes from the IRISS registry study, using the 0.2 µg/day fluocinolone acetonide (FAc) implant” – Khoramnia, et. al.
  • Abstract # 30065140: “Predictive value IOP challenge and other safety measures of PALADIN 2yr. data” – Malik, et. al.

“ILUVIEN is a uniquely durable therapy, providing physicians the opportunity to reduce the recurrence of diabetic macular edema, and therefore reduce the need for frequent injections of the current standard of care,” said Rick Eiswirth, President and CEO of Alimera.“We are very excited to have these abstracts showcased at the American Academy of Ophthalmology, highlighting the longer term three-year outcomes that support ILUVIEN’s ability to give more DME patients the potential to see better, longer, with fewer injections.”

Registration to the conference can be accessed here.

A
bout ILUVIEN

ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant, injected into the back of the eye. With its CONTINUOUS MICRODOSING™ technology, ILUVIEN is designed to release submicrogram levels of fluocinolone acetonide, a corticosteroid, for up to 36 months, to reduce the recurrence of disease. ILUVIEN enables patients to maintain vision longer with fewer injections. ILUVIEN is approved in the U.S., Australia, Canada, Kuwait, Lebanon and the U.A.E. to treat diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. ILUVIEN is indicated in 17 European countries for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies and in 16 European countries for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIPU). Alimera does not have the contractual right to pursue approval to treat uveitis in the U.S., and therefore does not have a regulatory license in the U.S. to treat NIPU. For important safety information on ILUVIEN, see https://iluvien.com/#isi

About Alimera Sciences, Inc.

Alimera Sciences is a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals. Alimera is presently focused on diseases affecting the back of the eye, or retina, because these diseases are not well treated with current therapies and affect millions of people in our aging populations. For more information, please visit www.alimerasciences.com.

Forward Looking Statements

This press release contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, Alimera’s beleif that ILUVIEN reduces the need for frequent injections of the current standard of care. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors include but are not limited to the willingness of physicians to consider ILUVIEN as an alternative to the current standard of care, as well as the factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Alimera’s Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020, June 30, 2020, and September 30, 2020 which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov.

All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. Alimera cautions investors not to rely too heavily on the forward-looking statements Alimera makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). Alimera undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

For press inquiries:

Jules Abraham
for Alimera Sciences
917-885-7378
[email protected]
For investor inquiries:

Scott Gordon
for Alimera Sciences
[email protected]

        

Murphy USA to Participate in Upcoming Investor Conference

EL DORADO, Ark., Nov. 12, 2020 (GLOBE NEWSWIRE) — Murphy USA Inc. (NYSE: MUSA) will be participating virtually at the Stephens Annual Investment Conference on Wednesday, November 18th, 2020 at 3:00 PM ET. The webcast can be accessed through the Investor Relations section of Murphy USA’s website at http://ir.corporate.murphyusa.com.

About Murphy USA

Murphy USA (NYSE:MUSA) is a leading retailer of gasoline and convenience merchandise with nearly 1,500 sites located primarily in the Southwest, Southeast and Midwest United States. The company and its team of nearly 10,000 employees serve an estimated 1.7 million customers each day through its network of retail gasoline stations in 25 states. The majority of Murphy USA’s sites are located in close proximity to Walmart stores. The company also markets gasoline and other products at standalone stores under the Murphy Express brand. Murphy USA ranks 262 among Fortune 500 companies.

Source: Murphy USA Inc. (NYSE: MUSA)

Investor Contact:

Christian Pikul – Vice President of Investor Relations and FP&A
[email protected]

Mitchell Freer – Investor Relations Analyst
[email protected]

PetVivo Holdings, Inc. Announces Sponsored Research Agreement with Colorado State University for Osteoarthritis Treatment Study.

MINNEAPOLIS, Nov. 12, 2020 (GLOBE NEWSWIRE) — OTCQB: (PETV) PetVivo Holdings, Inc. (OTCQB: PETV) an emerging biomedical device company focused on the commercialization of innovative medical therapeutics for pets is pleased to announce the entry into a sponsored research agreement with Colorado State University (“CSU”) College of Veterinary Medicine and Biomedical Sciences to engage in a clinical study involving the treatment of osteoarthritis in canines through the administration of PetVivo’s proprietary medical device, KUSH®.

Felix Duerr, DVM, associate professor of small animal orthopedics, will serve as Principal Investigator for the research project. Dr. Duerr established and now oversees CSU’s Orthopedic Medicine and Mobility program. His clinical interests include sports medicine and rehabilitation, and minimally invasive surgery, including arthroscopy.

“The study designed by the team is novel and he hopes the research will lead to new ways to treat osteoarthritis, which affects up to 20% of all dogs, no matter the age,” said Dr. Duerr.

KUSH is a medical device that is administered by intraarticular injection in afflicted joints of animals, such as dogs and horses, for the treatment of osteoarthritis. The product is intended to provide a lubricious cushion between the bones to reinforce cartilage. A primary objective of PetVivo is to commercialize beneficial medical device products, such as KUSH, to further enhance the lives and happiness of companion animals and their owners.

About PetVivo Holdings, Inc.

For more information about PetVivo and Kush, please contact [email protected] or visit https://petvivo.com/

PetVivo Holdings Inc. (OTCQB: PETV) is an emerging biomedical device company currently focused on the manufacturing, commercialization and licensing of innovative medical devices and therapeutics for companion animals. The Company’s strategy is to leverage human therapies for the treatment of companion animals in a capital and time efficient way. A key component of this strategy is the accelerated timeline to revenues for veterinary medical devices, which enter the market much earlier than more stringently regulated pharmaceuticals and biologics.

PetVivo has a pipeline of seventeen products for the treatment of animals and people. A portfolio of eighteen patents protects the Company’s biomaterials, products, production processes and methods of use. The Company’s lead product Kush, a veterinarian-administered, intraarticular injection for the treatment of osteoarthritis in dogs and horses, is scheduled for expanded commercial sale later this year.

CONTACT:

John Lai, CEO
PetVivo Holdings, Inc.
Email: [email protected]
(952) 405-6216
5251 Edina Industrial Blvd.
Minneapolis, MN 55439
www.petvivo.com

Forward-Looking commercial Statements:

The foregoing material may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar matters that are not historical facts. These statements may be preceded by, followed by, or include the words “aim,” “anticipate,” “believe,” “estimate, “expect,” “forecast,” “intend,” “likely,” “outlook,” “plan,” “potential,” “project,” “projection,” “seek,” “can,” “could,” “may,” “should,” “would,” “will,” the negatives thereof and other words and terms of similar meanings. We caution that such statements may be subject to uncertainties and that actual results could differ materially from the forward-looking statements. There is no assurance that any forward-looking statements will materialize. Readers accordingly should not place undue reliance on these forward-looking statements, which do not reflect unknown or unanticipated events or circumstances occurring after the date of these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

Attachment

AutoWeb Enhances Efficiencies and Ability to Match Car Shoppers with its Product Offerings Using MotiveMetrics’ Unique Linguistics Technology

Industry Leader Continues to Evolve its Capabilities to Maximize Operational Performance and Support its Customers’ Marketing Objectives

TAMPA, Fla., Nov. 12, 2020 (GLOBE NEWSWIRE) — AutoWeb, Inc. (Nasdaq: AUTO), a robust digital marketing platform providing digital advertising solutions for automotive dealers and OEMs, has made significant advancements in its ability to match consumer search queries with its portfolio of marketing solutions while creating operational efficiencies that maximize the company’s investment in paid search marketing. The enhanced capabilities and performance metrics, enabled by AutoWeb’s collaboration with Palo Alto, Calif.-based MotiveMetrics, support the company’s transformational efforts by contemporizing and modernizing a foundational element of its business.

AutoWeb recently deployed MotiveMetrics’ +AI software for search engine marketing (SEM), which is powered by an artificial intelligence enabled linguistics engine. The technology, which targets the most relevant experience for a consumer’s search query intent, dynamically creates and manages millions of marketing communications at scale. Using deep learning, natural language generation and processing, and machine learning to match keywords to consumer intent unlocks opportunities that drive increased consumer engagement and improved economics.

“We are relentlessly focused on improving the performance of our digital marketing investments and as part of our evolution we must think about traffic acquisition in a completely different way to drive efficiency and a better financial outcome for the business,” said Dan Ingle, COO of AutoWeb. “Working with MotiveMetrics has enabled us to execute that seamlessly while allowing us to deliver significant operational improvements with its entrepreneurial approach, unique products and cutting-edge use of technology.”

Using software to optimize AutoWeb’s ad environments at scale has not only improved the performance of AutoWeb’s bottom line; it has enhanced the responsiveness of its Google and Bing ads accounts to changes like seasonality (elections, holidays, pandemics, etc.), as well as changes in trends or publisher algorithms. This has improved overall performance and importantly, it has smoothed out those results and made AutoWeb’s digital business more consistent and predictable.

MotiveMetrics partners closely with AutoWeb to tackle some of the more complex challenges of operating within the major search engine platforms with a focus on optimizing AutoWeb’s marketing spend and maximizing its team’s productivity. Through the use of MotiveMetrics’ products, AutoWeb has been able to quickly identify and deploy the most successful campaigns and strategies without the historical delays associated with more manual processes. The increased speed of these learning cycles allows AutoWeb to continuously improve the accuracy of matching consumer searches with its digital marketing efforts. This relevance drives higher quality scores which generates economic benefit in the form of more targeted and efficient traffic acquisition spend.

“Scale and complexity are our sweet spot, which has made AutoWeb an ideal partner,” said Jon Piron, VP of Sales at MotiveMetrics. “The results we are seeing exceeded both AutoWeb’s and our expectations, and our teams’ collaborative relationship enabled us to realize even higher overall ratings and efficiencies. With the industry constantly shifting, it’s essential digital marketing companies think creatively in their approach to traffic acquisition, and we are pleased our solutions are successfully supporting AutoWeb’s performance and operational goals.”

About AutoWeb, Inc.

AutoWeb, Inc. provides high-quality consumer leads, clicks and associated marketing services to automotive dealers and manufacturers throughout the United States. The company also provides consumers with robust and original online automotive content to help them make informed car-buying decisions. The company pioneered the automotive Internet in 1995 and has since helped tens of millions of automotive consumers research vehicles; connected thousands of dealers nationwide with motivated car buyers; and has helped every major automaker market its brand online.

Investors and other interested parties can receive AutoWeb news alerts by accessing the online registration form at investor.autoweb.com/alerts.cfm.

Forward-Looking Statements Disclaimer

The statements contained in this press release that are not historical facts are forward-looking statements under the federal securities laws. Words such as “anticipates,” “could,” “may,” “estimates,” “expects,” “projects,” “intends,” “pending,” “plans,” “believes,” “will” and words of similar substance, or the negative of those words, used in connection with any discussion of future operations or financial performance identify forward-looking statements. In particular, statements regarding expectations and opportunities, new product expectations and capabilities, projections, statements regarding future events, and our outlook regarding our performance and growth are forward-looking statements. These forward-looking statements are not guarantees of future performance and involve assumptions and risks and uncertainties that are difficult to predict. Actual outcomes and results may differ materially from what is expressed in, or implied by, these forward-looking statements. AutoWeb undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Among the important factors that could cause actual results to differ materially from those expressed in, or implied by, the forward-looking statements are changes in general economic conditions; the financial condition of automobile manufacturers and dealers; disruptions in automobile production; changes in fuel prices; the economic impact of terrorist attacks, political revolutions or military actions; failure of AutoWeb’s internet security measures; dealer attrition; pressure on dealer fees; increased or unexpected competition; the failure of new products and services to meet expectations; failure to retain key employees or attract and integrate new employees; actual costs and expenses exceeding charges taken by AutoWeb; changes in laws and regulations; costs of legal matters, including, defending lawsuits and undertaking investigations and related matters; and other matters disclosed in AutoWeb’s filings with the Securities and Exchange Commission. Investors are strongly encouraged to review the company’s Annual Report on Form 10-K for the year ended December 31, 2019 and other filings with the Securities and Exchange Commission for a discussion of risks and uncertainties that could affect the business, operating results or financial condition of AutoWeb and the market price of the AutoWeb’s stock.

Media
Contact:

Beth P. Quezada
Communications & Culture Manager
AutoWeb, Inc.
949.862.1391
[email protected]

Hill International to Provide Owner’s Representative/Project Management Services for HRL Laboratories, LLC

PHILADELPHIA and MALIBU, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) — Hill International (NYSE:HIL) (Hill), the global leader in managing construction risk, announced today that it has been selected to provide owner’s representative/project management (OR/PM) services to HRL Laboratories (HRL) overseeing the design and construction of backup power at HRL’s Malibu headquarters as the owner’s representative.

High-tech research and development company HRL’s Malibu campus is comprised of multiple buildings housing office space, laboratories, and industrial facilities, which need to be protected against power bumps and outages. “It is important for any business to maintain operations during power outages,” says Hill Senior Vice President and Deputy Regional Manager John Skoury, P.E. “Especially in California, where earthquakes and wildfires can unexpectedly disrupt power, having an alternative power source is essential. HRL’s new project will not only help guard against lost time and money, but also minimize safety hazards in laboratories during a power failure. Our team looks forward to providing OR/PM services to deliver the project successfully.”

Hill will provide a variety of OR/PM services during the project lifecycle. During design, Hill will work closely with the design team to meet HRL’s requirements and acquire required permitting from the City of Malibu.

During construction, Hill’s responsibilities will include creating a risk-management process and project controls, reviewing and advising on all project plans and documents, managing project budgets and schedules, and troubleshooting unexpected problems. Hill will also serve as the main liaison between HRL and contractors. Especially important during the COVID-19 pandemic, Hill will help to ensure the safety of all workers. The project is expected to conclude in 2022.

“We’re thrilled to support HRL Laboratories on this project,” says Hill Chief Executive Office Raouf Ghali. “We understand the important research being carried out by the company and hope that our own contribution allows HRL’s work to proceed without interruption. We also look forward to supporting any future project needs HRL may have.”

About Hill International

Hill International, with approximately 2,700 professionals in 69 offices worldwide, provides program management, project management, construction management, and other consulting services to clients in a variety of market sectors. Engineering News-Record magazine recently ranked Hill as the eighth-largest construction management firm in the United States. For more information on Hill, please visit our website at www.hillintl.com.

Forward Looking Statements

Certain statements contained herein may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, and it is our intent that any such statements be protected by the safe harbor created thereby. Except for historical information, the matters set forth herein including, but not limited to, any statements of belief or intent, any statements concerning our plans, strategies, and objectives for future operations are forward-looking statements. These forward-looking statements are based on our current expectations, estimates and assumptions and are subject to certain risks and uncertainties. Although we believe that the expectations, estimates, and assumptions reflected in our forward-looking statements are reasonable, actual results could differ materially from those projected or assumed in any of our forward-looking statements. Important factors that could cause our actual results to differ materially from estimates or projections contained in our forward-looking statements are set forth in the Risk Factors section and elsewhere in the reports we have filed with the Securities and Exchange Commission, including that unfavorable global economic conditions may adversely impact our business, our backlog may not be fully realized as revenue, and our expenses may be higher than anticipated. We do not intend, and undertake no obligation, to update any forward-looking statement.

Hill International, Inc.

Elizabeth J. Zipf, LEED AP BD+C
Senior Vice President
(215) 309-7707
[email protected]

The Equity Group
, Inc.

Devin Sullivan
Senior Vice President
(212) 836-9608
[email protected]

Vaxart Announces Additional Data from Hamster Challenge Study of its Oral COVID-19 Vaccine

Robust Immune Response and Significantly Reduce Viral Load

SOUTH SAN FRANCISCO, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) — Vaxart, Inc., (NASDAQ: VXRT), a clinical-stage biotechnology company developing oral vaccines that are administered by tablet rather than by injection, announced today additional results from its Hamster Challenge Study:

  • Significant reduction in lung viral load of 4-5 logs in hamsters that received two oral vaccine doses, as compared to non-vaccinated animals.
  • Potent induction of antibody response, with serum IgG antibody titers above 10,000 in hamsters that received two oral vaccine doses.
  • Oral vaccination protected as well as intranasal vaccination against intranasal challenge with respect to key indicators: protection from weight loss, protection from increase in lung weight, viral load reduction, and induction of serum IgG antibodies, demonstrating that mucosal protection by both routes of administration was comparable.

As previously announced, all hamsters that received two oral doses of Vaxart’s COVID-19 vaccine candidate showed no systemic weight loss, a key indicator of protection against COVID-19 in this animal model. By contrast, the unvaccinated animals lost approximately 9% total weight. Additionally, unvaccinated hamsters had over two times (2x) the relative lung weight of orally vaccinated hamsters, a sensitive indicator of serious disease that correlates with the viral load findings.

“These additional data provide further evidence supporting the efficacy potential of our oral COVID-19 vaccine candidate,” said Andrei Floroiu, chief executive officer of Vaxart. “In addition, we believe that our room-temperature-stable oral tablet vaccine would be a more convenient, more practical solution to the COVID-19 pandemic as compared to cold-chain dependent injectable vaccines.”

The study evaluated Vaxart’s recombinant adenoviral vaccine, with doses administered at 0 and 4 weeks. Animals were challenged with SARS-CoV-2 at week 8. Hamsters are considered an excellent model for assessing COVID-19 infection since they can be infected via the intranasal route, and, if infected, they demonstrate clinical symptoms such as weight loss, labored breathing and ruffled fur. Furthermore, hamsters also develop lung issues similar to those seen in humans. Images of hamsters infected with SARS-CoV-2 reveal severe lung injury comparable to what has been observed in infected human lungs, including severe, multi-lobular ground glass opacity, and regions of lung inflammation.

About Vaxart

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using tablets that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart has believes that its proprietary tablet vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Its development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immuno-oncology indication. Vaxart has filed broad domestic and international patents covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.

Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart’s strategy, prospects, plans and objectives, results from preclinical and clinical trials, commercialization agreements and licenses, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “should,” “believe,” “could,” “potential,” “will,” “expected,” “plan” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart’s ability to develop (including enrolling a sufficient number of subjects and manufacturing sufficient quantities of its product candidates) and commercialize its COVID-19 vaccine candidate and preclinical or clinical results and trial data (including plans with respect to the COVID-19 vaccine product candidates); expectations regarding the timing and nature of future announcements including, those related to clinical trials and results of preclinical studies; Vaxart’s expectations with respect to the important advantages it believes its oral vaccine platform can offer over injectable alternatives, particularly for coronaviruses; the potential applicability of results seen in our preclinical studies or trials to those that may be seen in human studies or clinical trials; the expected role of mucosal immunity in blocking transmission of COVID-19; and Vaxart’s expectations with respect to the effectiveness of its products or product candidates, including Vaxart’s potential role in mitigating the impact of COVID-19 globally. Vaxart may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials or preclinical studies, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial and preclinical study data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart’s product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart’s product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart’s or its partners’ control, including the recent outbreak of COVID-19; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; that Vaxart may not be able to obtain, maintain and enforce necessary patent and other intellectual property protection; that Vaxart’s capital resources may be inadequate; Vaxart’s ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the “Risk Factors” sections of Vaxart’s Quarterly and Annual Reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.

Contacts:  
   
Media Relations Investor Relations
   
Gloria Gasaatura David R. Holmes
LifeSci Communications LifeSci Advisors, LLC
Tel: (646) 970-4688 Tel: (646) 970-4995
[email protected] [email protected]

Madison Realty Capital Originates $50 Million Loan for Luxury Rental Apartment Building in Pompano Beach, Florida

New York, Nov. 12, 2020 (GLOBE NEWSWIRE) — Madison Realty Capital, a New York City based real estate private equity firm focused on debt and equity investment strategies, today announced that it has originated a $50 million loan for Invesca Development Group (“Invesca”) to refinance the ENVY, a 214-unit, 11-story luxury rental building, in Pompano Beach, Florida. 

Madison originally provided Invesca, a best-in-class developer, with a $102 million construction loan for the ENVY and another Invesca property, Pixl Apartments in Plantation, Florida, in April 2020.

“Pompano Beach is an attractive neighborhood that has seen an influx of new job opportunities as more employers, such as Amazon, expand their presence in South Florida, and specifically Broward County,” said Josh Zegen, Managing Principal and Co-Founder of Madison Realty Capital. “As the property’s existing lender, we were uniquely positioned to provide Invesca with a bespoke and compelling $50 million transitional lease up financing package for the first large scale luxury multifamily development in the area. Notably, Invesca was able to complete the project and lease up 50 percent of the building ahead of expectations, a true testament to their execution capabilities, and we are pleased to expand our relationship.”

Situated at the corner of East Atlantic Boulevard and Southeast Fourth Way within the Koi master-planned community for Pompano Beach, the ENVY offers top-tier amenities geared toward a healthy lifestyle, such as a cardio center, rooftop pool with cabanas, spa, pet spa, wine lounge, Zen garden, and outdoor movie theater. ENVY is comprised of three floors for parking and commercial space on Atlantic Avenue and eight floors for residential and common areas.

 

About Madison Realty Capital (MRC)

Madison Realty Capital (MRC) is a New York City based real estate private equity firm focused on debt and equity investment strategies with regional offices in key markets including Los Angeles and Dallas. Founded in 2004, MRC has closed on approximately $13 billion of transactions in the multifamily, retail, office, industrial and hotel sectors. The firm manages investments in the United States on behalf of a global investor base. MRC is a fully integrated firm with over 60 employees across all real estate investment, development, and property management disciplines. Among other industry recognitions, MRC has been named to the Commercial Observer’s prestigious “Power 100” list of New York City real estate players and is consistently cited as one of the industry’s top construction lenders.

Nathaniel Garnick/Grace Cartwright
Gasthalter & Co.
(212) 257-4170
[email protected]

iBio to Participate in Alliance Global Partners’ Virtual Healthcare Symposium

BRYAN, Texas, Nov. 12, 2020 (GLOBE NEWSWIRE) —  iBio, Inc. (NYSEA:IBIO) (“iBio” or the “Company”), a biotech innovator and biologics contract manufacturing organization, today announced that management will participate in Alliance Global Partners’ Virtual Healthcare Symposium on November 19, 2020.

In addition to participating in a series of one-on-one meetings with institutional investors throughout the day, iBio will participate on a panel hosted by Jim Molloy, Alliance Global Partners’ Managing Director, Equity Research Biotechnology & Specialty Pharmaceuticals, entitled “The Next Wave in COVID-19 Treatments: After PFE, AZN, MRNA & the Rest, What Should we Look for in the Next Set of COVID-19 Diagnostics and Treatments?”

Due to the format of the event, no webcast will be available.

About iBio, Inc.

iBio is a global leader in plant-based biologics manufacturing. Its FastPharming® System combines vertical farming, automated hydroponics, and glycan engineering technologies to rapidly deliver high-quality monoclonal antibodies, vaccines, bioinks and other proteins. The Company’s subsidiary, iBio CDMO LLC, provides FastPharming Contract Development and Manufacturing Services. iBio’s Glycaneering Development Service includes an array of new glycosylation technologies for engineering high-performance recombinant proteins. Additionally, iBio is developing proprietary products, which include IBIO-100 for the treatment of fibrotic diseases, and vaccines for infectious diseases. For more information, visit www.ibioinc.com.

Contact:

Stephen Kilmer
iBio, Inc.
Investor Relations
(646) 274-3580
[email protected]