Market Newsdesk

FORT WAYNE, Ind., March 08, 2021 (GLOBE NEWSWIRE) — Vera Bradley, Inc. (NASDAQ: VRA; “Vera Bradley” or the “Company”), a leading American bag and luggage company and iconic lifestyle brand, announced today it will celebrate its ongoing partnership with New Hope Girls, a for women, by women non-profit based in the Dominican Republic, by launching a new limited-edition handbag collection on International Women’s Day, March 8, 2021. This is the third consecutive year Vera Bradley and New Hope Girls have released a co-branded collection in honor of International Women’s Day.

The New Hope Girls + Vera Bradley collection includes two of New Hope Girls’ top-selling styles – a zip pouch and hobo bag – designed and sewn in the Dominican Republic by New Hope Girls’ artisans. Each style is available in a navy-grounded floral pattern (“Rain Forest Canopy Navy”) and a patchwork pattern (“Rain Forest Patchwork”), both created exclusively for the partnership, and include a special hang tag featuring the story and signature of the woman who created it. Vera Bradley will donate 75% of the collection’s sales to directly support the non-profit’s purpose of providing rescue, refuge and restoration to girls and women from the darkest and most difficult places.

Joy Reyes, Executive Director of New Hope Girls, commented on the partnership, “Vera Bradley holds a special place in our hearts for the countless ways the Company and the people behind the brand have blessed our organization. This International Women’s Day marks the 10-year anniversary of New Hope Girls’ founding, and I couldn’t think of a better way to celebrate the occasion than by launching our third New Hope Girls + Vera Bradley collection!”

Since 2016, Vera Bradley has rallied behind New Hope Girls and its selfless mission to better the lives of the women and girls in its care. To improve the efficiency of New Hope Girls’ sewing operations, Vera Bradley designed a fully-equipped workshop with self-sustaining industrial sewing machines and transformed the community room into a welcoming and sacred space. Additionally, Vera Bradley has offered ongoing business mentoring and assisted in training the women with sewing and designing techniques to improve their craft and help them grow as artisans and individuals.

“Caring and creating brighter, more joyful lives for girls and women everywhere is stitched into the fabric of Vera Bradley’s brand. Supporting New Hope Girls is one of the many ways we’ve committed to making a positive impact in our global community,” said Rob Wallstrom, Chief Executive Officer of Vera Bradley. “The work New Hope Girls does to give women and girls a sense of purpose is inspiring. The organization provides women with jobs to support their families, and provides girls with a home, education, shelter and safety. This International Women’s Day, we’re proud to raise awareness for New Hope Girls and direct 75% of New Hope Girls + Vera Bradley collection sales to help the organization expand its reach and continue to thrive.”

The New Hope Girls + Vera Bradley collection is now available in Vera Bradley Full Line stores and online at verabradley.com. For more information, please visit www.verabradley.com and www.newhopegirls.co.

ABOUT VERA BRADLEY, INC.


Vera Bradley, Inc. operates two unique lifestyle brands – Vera Bradley and Pura Vida. Vera Bradley and Pura Vida are complementary businesses, both with devoted, emotionally-connected, and multi-generational female customer bases; alignment as causal, comfortable, affordable, and fun brands; positioning as “gifting” and socially-connected brands; strong, entrepreneurial cultures; a keen focus on community, charity, and social consciousness; multi-channel distribution strategies; and talented leadership teams aligned and committed to the long-term success of their brands.

Vera Bradley, based in Fort Wayne, Indiana, is a leading designer of women’s handbags, luggage and other travel items, fashion and home accessories, and unique gifts. Founded in 1982 by friends Barbara Bradley Baekgaard and Patricia R. Miller, the brand is known for its innovative designs, iconic patterns, and brilliant colors that inspire and connect women unlike any other brand in the global marketplace.

In July 2019, Vera Bradley, Inc. acquired a 75% interest in Creative Genius, Inc., which also operates under the name Pura Vida Bracelets (“Pura Vida”). Pura Vida, based in La Jolla, California, is a rapidly growing, digitally native, and highly engaging lifestyle brand founded in 2010 by friends Paul Goodman and Griffin Thall. Pura Vida has a differentiated and expanding offering of bracelets, jewelry, and other lifestyle accessories.

ABOUT NEW HOPE GIRLS


New Hope Girls is a non-profit organization that provides jobs for vulnerable women and refuge for girls rescued out of the darkest places in the Dominican Republic. Women sew and create beautiful bags in the New Hope Girls workshop, with 100% of the net proceeds supporting the New Hope Girls safe house. The organization’s mission is to “create a place of light and life for girls and women from dark and difficult places, restoring identity and purpose for the future.” For more information about New Hope Girls, visit www.newhopegirls.co or follow at @newhope.girls on Instagram and New Hope Girls on Facebook.

CONTACTS


Vera Bradley Investors:
Julia Bentley, VP of Investor Relations and Communications 
[email protected]
(260) 207-5116

Vera Bradley Media: 
877-708-VERA (8372)
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/6e40a9e2-0c7f-4245-8388-dadef2f84949

ATLANTA, March 08, 2021 (GLOBE NEWSWIRE) — Select Interior Concepts, Inc. (NASDAQ: SIC), a premier installer and nationwide distributor of interior building products, today announced the Company is expanding the markets it serves, adding Boise, Idaho to its 31 existing Residential Design Services (RDS) locations. The greenfield expansion positions SIC’s RDS subsidiary to support and extend a key partnership with Woodbridge Pacific Group, LLC, a developer of architecturally distinctive homes in premier areas.

Chief Executive Officer L.W. (Bill) Varner, Jr. commented, “We are excited to announce RDS’s geographic expansion into the fast-growing Boise, Idaho market in support of one of our longest and most important partnerships. For more than two decades, RDS has worked closely with Woodbridge as it built high-quality homes in some of Southern California’s most desirable locations. We look forward to providing the same top-quality interior design installation services in a new region, in the process helping both RDS and Woodbridge grow and serve a new group of homebuyers seeking superior homes in attractive locations.”

Through its partnership with Woodbridge, RDS will provide design and installation work for multiple communities to be built in the Boise Metropolitan Area. Construction is scheduled to commence in several phases beginning in mid-2021.

ABOUT SELECT INTERIOR CONCEPTS

Select Interior Concepts is a premier installer and nationwide distributor of interior building products with leading market positions in highly attractive markets. Headquartered in Atlanta, Georgia, Select Interior Concepts is listed on the NASDAQ. The Residential Design Services segment provides integrated design, sourcing and installation solutions to customers, in the selection of a broad array of interior products and finishes, including flooring, cabinets, countertops, window treatments, and related interior items. The Architectural Surfaces Group segment distributes natural and engineered stone through a national network of distribution centers and showrooms under proprietary brand names such as PentalQuartz and MetroQuartz. For more information, visit: www.selectinteriorconcepts.com.

ABOUT WOODBRIDGE PACIFIC GROUP, LLC

Woodbridge Pacific Group, LLC is dedicated to crafting premium communities and homes by selecting premier areas, talented architects, designers, and craftsman to create a truly beautiful and unique home. Its homes have received industry accolades for their design and execution. Woodbridge closed nearly 200 homes in the Southern California market during 2020 and has served the Southern California markets for years.

FORWARD-LOOKING STATEMENTS

This press release includes 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, as amended, and, as such, may involve known and unknown risks, uncertainties and assumptions. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “estimate,” “intend,” “could,” “should,” “would,” “may,” “seek,” “plan,” “might,” “will,” “expect,” “predict,” “project,” “forecast,” “potential,” “continue,” and other forms of these words or similar words or expressions or the negatives thereof. Forward-looking statements are based on historical information available at the time the statements are made and are based on management’s reasonable belief or expectations with respect to future events. Forward-looking statements are subject to risks, uncertainties, and other factors, including, but not limited to, risks and uncertainties relating to the COVID 19 pandemic (including those contained in our Form 8-K filed on May 5, 2020) and those factors contained in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 (our “Annual Report”) and the other reports we file with the SEC, that may cause the Company’s actual results, level of activity, performance or achievement to be materially different from the results or plans expressed or implied by such forward-looking statements. All forward-looking statements in this press release are qualified by the factors, risks and uncertainties contained in our Annual Report. Forward-looking statements should not be read as a guarantee of future performance or results, and will not necessarily be accurate indications of the times at or by which such performance or results will be achieved. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update any forward-looking statement to reflect future events, developments or otherwise, except as may be required by applicable law.

CONTACTS:

Investor Relations:

Josh Large
(470) 548-7370
[email protected]

PRESS RELEASE

March 8, 2021

Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced it received feedback from the U.S. Food and Drug Administration (FDA) providing further clarity on a regulatory path for Tesomet in the treatment of hypothalamic obesity (HO). Based on this feedback, Saniona is proceeding with plans to initiate a Phase 2b study in HO in the first half of this year.

“There is currently no medicine approved for hypothalamic obesity, a rare disease secondary to hypothalamic injury, characterized by intractable weight gain and complicated by uncontrollable hunger,” said Rudolf Baumgartner, M.D., Chief Medical Officer and Head of Clinical Development at Saniona. “We are encouraged by this feedback from the FDA and look forward to continuing a constructive dialogue with them as we prepare to initiate our Phase 2b clinical trial with Tesomet.”

Saniona previously announced that the FDA had highlighted the potential for off-label use of Tesomet in the general obese population. As a result, Saniona submitted a response proposing a Risk Evaluation and Mitigation Strategy (REMS), which is often used to restrict commercial distribution to the appropriate patients suffering from an unmet medical need. The FDA indicated overall agreement with this proposal and stated Saniona should demonstrate that HO fulfills the criteria for an unmet medical need. Saniona further proposed including 24-hour ambulatory blood pressure monitoring (ABPM) and Holter (electrocardiogram) monitoring as part of the HO program. The agency stated that robust data from these analyses could be useful in determining the level of cardiovascular assessment needed in Phase 3. The agency also acknowledged the challenge of conducting 24-hour monitoring in HO patients and said the analyses could be conducted in a separate study in general obese people.

Saniona expects to file an Investigational New Drug (IND) application and initiate its planned Phase 2b clinical trial in HO in the first half of this year. In a 24-week, double-blind, randomized, placebo-controlled Phase 2 trial in HO, Tesomet was well-tolerated, and treated patients demonstrated statistically significant reductions in body weight and clinically meaningful improvements in waist circumference and glycemic control. These improvements were maintained during an additional 24-week open-label extension, with no clinically meaningful differences in heart rate or blood pressure observed. Saniona is also evaluating Tesomet for the treatment of Prader-Willi syndrome (PWS) and plans to begin a Phase 2b trial in this indication in the first half of this year.

For more information, please contact

Trista Morrison, Chief Communications Officer, Saniona. Office: + 1 (781) 810-9227. Email: [email protected]

The information was submitted for publication, through the agency of the contact person set out above, at 14:00 CET on 8 March 2021.

About Saniona

Saniona is a biopharmaceutical company focused on discovering, developing, and delivering innovative treatments for rare disease patients around the world. The company’s lead product candidate, Tesomet, is in mid-stage clinical trials for the rare diseases Prader-Willi syndrome and hypothalamic obesity. Saniona also has a broad pipeline derived from its proprietary ion channel discovery platform, with lead candidate SAN711 entering Phase 1 studies for rare neuropathic disorders. Saniona intends to develop and commercialize its rare disease products internally. The company has out-licensed other programs, which may provide future supplemental revenue. Saniona is based in Copenhagen, Denmark and Boston, Mass., U.S. The company’s shares are listed on Nasdaq Stockholm Small Cap (OMX: SANION). Read more at www.saniona.com.

About Tesomet

Tesomet is an investigational fixed-dose combination therapy of tesofensine (a triple monoamine reuptake inhibitor) and metoprolol (a beta-1 selective blocker). Saniona is advancing Tesomet for hypothalamic obesity and Prader-Willi syndrome, two severe rare disorders characterized by obesity and loss of appetite control. The programs are currently in clinical development. Saniona holds worldwide rights to Tesomet and is actively evaluating opportunities to advance this treatment globally.

About Hypothalamic Obesity (HO)

Hypothalamic obesity (HO) is a rare disorder caused by injury to the hypothalamus, most commonly sustained during surgery to remove a rare, noncancerous tumor called a craniopharyngioma (CP). HO is characterized by rapid, excessive and intractable weight gain that persists despite limited food intake. Patients may have hyperphagia, an uncontrollable hunger, and may display abnormal food seeking behaviors such as stealing food. Additional symptoms may include memory impairment, attention deficit, excessive daytime sleepiness and lethargy, issues with impulse control, depression, and suicide. HO patients are also at increased risk of developing obesity-related comorbid conditions such as type 2 diabetes, non-alcoholic fatty liver disease, hypertension, stroke, and congestive heart failure. Ultimately CP survivors with hypothalamic injury report at least three times higher 20-year mortality than CP survivors without hypothalamic injury. There are no medications approved specifically for HO, and there is no cure for this disease. Many HO patients are treated with approaches used for general obesity such as surgery, medication and lifestyle counseling, but these are often ineffective. The prevalence of HO is estimated to be between 10,000 and 25,000 in the U.S. and between 16,000 and 40,000 in Europe. It occurs most often in children and older adults, creating a burden for both patients and families.

Attachment

• FDA feedback HO press release 03.08.21

ASML reports transactions under its current share buyback program

VELDHOVEN, the Netherlands – ASML Holding N.V. (ASML) reports the following transactions, conducted under ASML’s current share buyback program.

Date	Total repurchased shares	Weighted average price	Total repurchased value
1-Mar-21	67,858	475.37	32,257,969.61
2-Mar-21	67,354	478.93	32,257,938.78
3-Mar-21	68,857	468.47	32,257,700.45
4-Mar-21	72,316	446.07	32,257,708.86
5-Mar-21	73,990	435.97	32,257,516.49

ASML’s current share buyback program was announced on 22 January 2020, and details are available on our website at https://www.asml.com/en/news/share-buyback

This regular update of the transactions conducted under the buyback program is to be made public under the Market Abuse Regulation (Nr. 596/2014).

Media Relations Contacts	Investor Relations Contacts
Monique Mols, phone +31 6 528 444 18	Skip Miller, phone +1 480 235 0934
	Marcel Kemp, phone +31 40 268 6494

CRESSKILL, N.J. and JERUSALEM, March 08, 2021 (GLOBE NEWSWIRE) — BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in the advanced non-invasive treatment of brain disorders, today announced that Christopher von Jako, Ph.D., President and Chief Executive Officer, will present at the Oppenheimer 31st Annual Healthcare Conference taking place on March 16-18, 2021. The Company will also host one-on-one investor meetings at the conference.

Details on the presentation can be found below.

Date:	Tuesday, March 16, 2021
Time:	10:00 AM ET
Webcast Link:	https://wsw.com/webcast/oppenheimer9/bway/2729199

About BrainsWay

BrainsWay is a commercial stage medical device company focused on the development and sale of non-invasive neurostimulation products using the Company’s proprietary Deep Transcranial Magnetic Stimulation (Deep TMS) platform technology. The Company received marketing authorization from the U.S. Food and Drug Administration (FDA) for its products for a variety of patient populations, including in 2013 for patients with major depressive disorder (MDD), in 2018 for patients with obsessive-compulsive disorder (OCD), and in 2020 for patients with smoking addiction. BrainsWay is currently conducting clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders.

Contacts:
BrainsWay:
Hadar Levy
SVP and General Manager
[email protected]

Investors:
Bob Yedid
LifeSci Advisors
646-597-6989
[email protected]        

UTRECHT, The Netherlands and CAMBRIDGE, Mass., March 08, 2021 (GLOBE NEWSWIRE) — Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics^® and Triclonics^®), today announced that Bill Lundberg, M.D., Chief Executive Officer, will participate in a fireside chat at the 33rd Annual Roth Conference on Monday, March 15 at 2:00 p.m. ET.

The live webcast of the presentation will be available on the Investors page of the Company’s website, https://ir.merus.nl. An archived presentation will be available on the Merus website for a limited time.

About Merus


Merus is a clinical-stage oncology company developing innovative full-length human bispecific and trispecific antibody therapeutics, referred to as Multiclonics^®. Multiclonics^® are manufactured using industry standard processes and have been observed in preclinical and clinical studies to have several of the same features of conventional human monoclonal antibodies, such as long half-life and low immunogenicity. For additional information, please visit Merus’ website, http://www.merus.nl and https://twitter.com/MerusNV.

Investor and Media Inquiries:

Jillian Connell
Merus N.V.
Investor Relations and Corporate Communications
617-955-4716
[email protected]

Kathleen Farren
Merus N.V.
Communications Specialist
617-230-4165
[email protected]

Presenting Innovative Small and Mid-Cap Companies in Healthcare, Industrials, Electric Vehicles, TMT, and Consumer Products

NEW YORK, March 08, 2021 (GLOBE NEWSWIRE) — M Vest LLC an online investment bank and digital community built for issuers, investors, and thought leaders to share information and access investment opportunities through capital raisings of Regulation D and Regulation A Offerings, and its sister company Maxim Group LLC, a full-service investment banking, securities and wealth management firm, are adding a third day to their Inaugural Emerging Growth Virtual Conference. The conference will now take place on March 17, 18, and 19th from 9:00 am-5:00 pm EST featuring roundtable discussions with C-suite executives moderated by Maxim Research Analysts, fireside chats with live Q&A, and presentations from hundreds of issuers both domestically and internationally.

During this virtual conference, you will hear from healthcare leaders treating a broad range of indications; cannabis entrepreneurs exploring the changing landscape; tech innovators changing how we work and play, and industrial executives setting new standards. We will feature roundtable discussions, issuer presentations, fireside chats, and live Q&A with company CEOs moderated by Maxim Research Analysts.

Sponsors include Ellenoff Grossman and Schole, LLP, Loeb and Loeb LLP, Continental Stock Transfer and Trust Co., Equiniti, Pryor Cashman LLP, Harter Seacrest & Emery, Schiff Hardin LLP, Marcum LLP, Meridian Risk Management, and Crescendo Communications.  

To learn more about presenting and attending, sign up for M-Vest HERE.

ABOUT M VEST LLC


M Vest LLC is an online investment bank and digital community built for issuers, investors, and thought leaders to share information and access investment opportunities through capital raisings of Regulation D and Regulation A Offerings. Founded in 2017 and headquartered in New York City, M-Vest provides insights on current equity market trends, hosts presentations from public companies, and provides access to capital for emerging growth companies. M-Vest hosts live conferences and webinars featuring CEOs discussing the latest developments in their industries. M Vest LLC is a registered broker-dealer with the U.S. Securities and Exchange Commission (SEC), is a member of FINRA and SIPC, and is a sister company of Maxim Group, LLC.

ABOUT MAXIM GROUP LLC Maxim Group is a full-service investment banking, securities and wealth management firm headquartered in New York. The Firm provides a full array of financial services including investment banking; private wealth management; and global institutional equity, fixed-income and derivatives sales & trading, equity research and prime brokerage services. Maxim Group is a registered broker-dealer with the U.S. Securities and Exchange Commission (SEC) and the Municipal Securities Rulemaking Board (MSRB). Member of FINRA SIPC, and NASDAQ. To learn more about Maxim Group, visit maximgrp.com.

Media Contact:    

Beth Amorosi, AMO Communications
917-208-7489 
[email protected]

NEW YORK, March 08, 2021 (GLOBE NEWSWIRE) — Aspen Group, Inc. (“AGI”) (Nasdaq: ASPU), an education technology holding company, today announced that Aspen University received the final required state and board of nursing regulatory approvals for their new Bachelor of Science in Nursing (BSN) Pre-Licensure program in Nashville, Tennessee, with permission to commence marketing and begin to enroll first-year pre-requisite students effective immediately.

“Aspen University’s BSN Pre-Licensure degree is our highest LTV program. Following the Nashville opening, we will have successfully launched five locations in four states since 2018. We’re targeting to begin our initial (years 2-3) core program term in Nashville in August 2021, in clinical partnership with NorthCrest Medical Center, Trust Point Hospital, and Nashville General Hospital, among others,” stated Michael Mathews, Aspen Group Chairman and CEO. “The majority of Aspen University’s BSN Pre-Licensure students are part-time and full-time working adults, and we strive to cater to their needs. We offer the majority of our BSN Pre-Licensure program curriculum online, together with an on-ground applied learning component offered with day and night/weekend program options, unlike the traditional on-campus five-day-a-week day program format. In addition to affordable tuition and flexible payment options, the ability to work while attaining a life-changing degree makes our program very popular. Aspen Group’s strategic roadmap targets having 12 operational BSN Pre-licensure locations throughout the western and southern United States by 2025.”

The new Aspen University location in Nashville will follow the BSN Pre-Licensure structure established initially in Phoenix. Nashville will operate as a full-time, accelerated three-year (nine semester) program specifically designed for students who do not currently hold a state registered nursing license and/or who have no prior nursing experience. The 120-credit program is offered at a total cost of attendance of less than $50,000. Students enter one of two program components:

• Year 1 – the Pre-Professional Nursing (PPN) component is offered fully online for students that have completed less than the required 41 pre-requisite general education credits. Year 1 tuition is $7,000 or less, depending on the number of credits needed to satisfy the pre-requisite requirements. Students can use Aspen’s monthly payment method to pay Year 1 courses;
• Years 2-3 – the Nursing Core component which prepares students to sit for the NCLEX.

The Nashville site will be located at 1809 Dabbs Avenue, which is situated on Interstate 40 east of downtown Nashville, four miles west of the Nashville airport. Aspen University will begin enrolling first year PPN students in Nashville starting in April 2021; Core nursing students (Years 2-3) in August, 2021.

About Aspen Group, Inc.

Aspen Group, Inc. is an education technology holding company that leverages its infrastructure and expertise to allow its two universities, Aspen University and United States University, to deliver on the vision of making college affordable again. For more information, visit www.aspu.com.

Forward-Looking Statements:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans with respect to new campus openings, and the timing of our Nashville program. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Important factors that could cause actual results to differ from those in the forward-looking statements include the continued demand of nursing students for the new programs, national and local economic factors including the substantial impact of the COVID-19 pandemic on the economy, and the competitive impact from the trend of public non-profit universities offering online education. Other risks are included in our filings with the SEC including our Form 10-K for the year ended April 30, 2020 and the prospectus supplement dated August 31, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.        

Contact Information:

Hayden IR
Kimberly Rogers
(385) 831-7337
[email protected]        

SOUTH SAN FRANCISCO, Calif., March 08, 2021 (GLOBE NEWSWIRE) — Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that the company delivered a presentation on its SARS-CoV-2 3CL_pro inhibitor candidate, ALG-097111, at the 28^th Conference on Retroviruses and Opportunistic Infections, being held virtually March 6 to March 10, 2021, during the meeting’s Science Spotlight sessions on Saturday, March 6. Aligos performed all research in collaboration with Belgian University KU Leuven, in particular its Centre for Drug Design and Discovery (CD3), and the Rega Institute for Medical Research.

“Along with our collaborators at CD3 and the Rega Institute, we are proud to have shown what we believe is the first instance of in vivo evidence of SARS-CoV-2 inhibition with a therapeutic candidate in the class of SARS-CoV-2 3CL_pro inhibitor compounds,” said Pierre J.M.B. Raboisson, Pharm.D. Ph.D., Executive Vice President, Head of Small Molecule Medicinal Chemistry and European Site Head at Aligos. “We have also observed highly specific, selective activity in vitro that is consistent with the robust viral inhibition we see in aggressive animal models of infection. These findings represent a significant advance toward a highly targeted therapeutic candidate that is urgently needed as the COVID-19 pandemic persists.”

The presentation, titled “The 3CL_pro Inhibitor ALG-097111 Potently Inhibits SARS-CoV-2 Replication in Hamsters,” demonstrated that Aligos’ nonclinical SARS-CoV-2 therapeutic candidate, ALG-097111, potently inhibited SARS-CoV-2 replication in vivo in the lungs of SARS-CoV-2-infected hamsters, one of the most severe animal models of SARS-CoV-2 infection available. When ALG-097111 was dosed in hamsters challenged with SARS-CoV-2, the authors observed a robust and significant 3.5 log₁₀ (RNA copies/mg) reduction of the viral RNA copies and 3.7 log₁₀ (TCID₅₀/mg) reduction in the infectious virus titers in the lungs. These results provide the first in vivo validation for the SARS-CoV-2 3-chymotrypsin-like cysteine protease (3CL_pro), an essential SARS-CoV-2-encoded enzyme, as a promising therapeutic target in COVID-19.

The anti-SARS-CoV-2 activity of ALG-097111 was confirmed in human small airway epithelial cell cultures: when ALG-097111 was added at a concentration of 1µM to the basolateral side of the cultures, the compound significantly reduced viral RNA yield at the apical site of the culture by over 3 log₁₀ RNA copies/mg.

ALG-097111 also demonstrated high specificity (IC₅₀ = 7 nM) and selectivity in vitro for the viral protease relative to the similar human protease cathepsin L (IC₅₀ > 10 µM), whose inhibition presents potential safety and efficacy concerns for other 3CL_pro inhibitors in development.

Aligos CEO Lawrence Blatt, Ph.D., MBA, added, “As the COVID-19 pandemic evolves, new strains of SARS-CoV-2 have emerged that may be resistant to vaccine-mediated immune responses. We therefore see a significant need to develop treatment options that effectively block SARS-CoV-2 replication in patients who either have not been vaccinated or who are infected with vaccine-resistant strains. The demonstration of potent preclinical activity in Aligos’ viral protease inhibitor candidate is an important advancement toward this goal.”

About Aligos

Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the discovery and development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation statements regarding the advancement of any Aligos SARS-CoV-2 3CLpro inhibitor compound (e.g., ALG-097111) as a targeted therapeutic candidate and the development of treatment options that effectively block SARS-CoV-2 replication in patients who either have not been vaccinated or who are infected with vaccine resistant strains. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including Aligos’s clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Aligos’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the effects on our business of the worldwide COVID-19 pandemic. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’s prospectus filed with the Securities and Exchange Commission on October 19, 2020, and its future periodic reports to be filed with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.

Media Contact

Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
[email protected]

Investor Contact

Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
[email protected] 

MINNEAPOLIS, March 08, 2021 (GLOBE NEWSWIRE) — Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, today announced management will participate in three upcoming virtual investor conferences:

• H.C. Wainwright Global Life Sciences Conference: March 9-10, 2021
• 33rd Annual ROTH Conference: March 15-17, 2021
• Maxim Emerging Growth Conference: March 17-18, 2021

For more information or to schedule a one-on-one meeting with management, please contact your conference representative or [email protected].

About SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Recently observed serious visual adverse events are being evaluated and the FDA has issued a partial clinical hold for the impacted study pending Panbela’s evaluation and response. The safety data and PMI profile observed in the current Panbela sponsored current clinical trial provides potential support for continued evaluation of the compound in a randomized clinical trial, subject to Panbela’s submission of a complete response and the FDA’s removal of the partial clinical hold.  For more information, please visit https://clinicaltrials.gov/ct2/show/NCT03412799.

About Panbela

Panbela Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing disruptive therapeutics for patients with urgent unmet medical needs. The company’s initial product candidate, SBP-101, is for the treatment of patients with metastatic pancreatic ductal adenocarcinoma, the most common type of pancreatic cancer. Panbela Therapeutics, Inc. is dedicated to treating patients with pancreatic cancer and exploring SBP-101’s potential for efficacy in combination with other agents and in treating other types of cancer. Further information can be found at: www.panbela.com. Panbela Therapeutics, Inc. common stock is listed on The Nasdaq Stock Market LLC under the symbol PBLA. 

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements,” including within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “believes,” “continue,” “dedicated,” “expect,” “intend,” “may,” “plan,” and “seek.” Examples of forward-looking statements include, among others, statements we make regarding future determinations of the characteristics of SBP-101 and its effectiveness, removal of the partial clinical hold, publication of results, other trial activities and the timing of the same. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations, and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially and adversely from the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: (i) our ability to obtain additional funding to complete a randomized clinical trial; (ii) progress and success of our Phase 1 clinical trial; (iii) the impact of the current COVID-19 pandemic on our ability to complete monitoring and reporting in our current clinical trial; (iv) our ability to demonstrate the safety and effectiveness of our SBP-101 product candidate (v) our ability to obtain regulatory approvals for our SBP-101 product candidate in the United States, the European Union or other international markets; (vi) the market acceptance and level of future sales of our SBP-101 product candidate; (vii) the cost and delays in product development that may result from changes in regulatory oversight applicable to our SBP-101 product candidate; (viii) the rate of progress in establishing reimbursement arrangements with third-party payors; (ix) the effect of competing technological and market developments; (x) the costs involved in filing and prosecuting patent applications and enforcing or defending patent claims; and (xi) such other factors as discussed in Part I, Item 1A under the caption “Risk Factors” in our most recent Annual Report on Form 10-K, any additional risks presented in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Any forward-looking statement made by us in this press release is based on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement or reasons why actual results would differ from those anticipated in any such forward-looking statement, whether written or oral, whether as a result of new information, future developments or otherwise. 

Contact Information:

Investors:
James Carbonara
Hayden IR
(646) 755-7412
[email protected]

Media:
Tammy Groene
Panbela Therapeutics, Inc.
(952) 479-1196
[email protected]