Market Newsdesk

LOS ANGELES, March 31, 2021 (GLOBE NEWSWIRE) — Glancy Prongay & Murray LLP (“GPM”) reminds investors of the upcoming May 3, 2021 deadline to file a lead plaintiff motion in the class action filed on behalf of investors who purchased or otherwise acquired Athenex, Inc. (“Athenex” or the “Company”) (NASDAQ: ATNX) common stock between August 7, 2019 and February 26, 2021, inclusive (the “Class Period”).

If you suffered a loss on your Athenex investments or would like to inquire about potentially pursuing claims to recover your loss under the federal securities laws, you can submit your contact information at https://www.glancylaw.com/cases/athenex-inc/. You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.

On March 1, 2021, before the market opened, Athenex disclosed receipt of a Complete Response Letter (“CRL”) from the FDA stating that the NDA would not be approved in its current form. According to the CRL, “the FDA indicated its concern of safety risk to patients in terms of an increase in neutropenia-related sequalae on the Oral Paclitaxel arm compared to the IV paclitaxel arm.” The Company stated that the “FDA also expressed concerns regarding the uncertainty over the results of the primary endpoint of objective response rate (ORR) at week 19 conducted by blinded independent centra review (BICR) [because] the BICR reconciliation and re-read process may have introduced unmeasured bias and influence on the BICR.” As a result, the FDA had recommended that Athenex conduct additional clinical trials and employ certain risk mitigation strategies to improve toxicity.

On this news, the Company’s stock price fell $6.64, or 55%, to close at $5.46 per share on March 1, 2021, thereby injuring investors.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) the data included in the Oral Paclitaxel plus Encequidar NDA presented a safety risk to patients in terms of an increase in neutropenia-related sequalae; (2) the uncertainty over the results of the primary endpoint of objective response rate (ORR) at week 19 conducted by BICR; (3) the BICR reconciliation and re-read process may have introduced unmeasured bias and influence on the BICR; (4) the Company’s Phase 3 study that was used to file the NDA was inadequate and not well-conducted in a patient population with metastatic breast cancer representative of the U.S. population, such that the FDA would recommended a new such clinical trial; (5) as a result, it was foreseeable that the FDA would not approve the Company’s NDA in its current form; and (6) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.

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If you purchased or otherwise acquired Athenex common stock securities during the Class Period, you may move the Court no later than May 3, 2021 to request appointment as lead plaintiff in this putative class action lawsuit. To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action. If you wish to learn more about this class action, or if you have any questions concerning this announcement or your rights or interests with respect to the pending class action lawsuit, please contact Charles Linehan, Esquire, of GPM, 1925 Century Park East, Suite 2100, Los Angeles, California 90067 at 310-201-9150, Toll-Free at 888-773-9224, by email to [email protected], or visit our website at www.glancylaw.com. If you inquire by email please include your mailing address, telephone number and number of shares purchased.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Contacts

Glancy Prongay & Murray LLP, Los Angeles
Charles Linehan, 310-201-9150 or 888-773-9224
[email protected]
www.glancylaw.com

Dallas, TX, March 31, 2021 (GLOBE NEWSWIRE) — Delaney Mcguire is a Peak Performance coach and founder of Life on Fire. His life mission: create a culture of empowerment for the young generation, helping people generate the tools to create success, happiness & fulfillment in their lives. Delaney grew up in an alcoholic household where generational habits consumed him even in his success. After college, he had a luxurious job working in corporate management – but without ever getting clear on what he wanted for his life he became deeply disconnected from his work, and from others – leading to binge drinking and partying that took him to soul crushing lows. Following a 3 year personal development journey, he lives his life in embodying what it means to ‘live on fire’ with passion, love & gratitude. Through his business Life on Fire, he educates 25+ Millennial leaders each month as a peak performance coach, hosting workshops for audiences of 600+ and facilitating retreats across the country. 

Delaney’s specialty in his coaching is “Flow State”. Flow state is used to elevate daily productivity up to 500% (which is shown in multiple peer-reviewed studies) without causing burnout. “Flow state is the secret to taking massive leaps towards our goals while still being able to sustain amazing relationships, wellbeing and have time for our passions,” he explains. “I teach my clients and audiences how they can infuse flow state into their day to be more productive, reduce distraction and stress, and ultimately build a more incredible life for themselves.”

Coaching is a blossoming field because a percentage of the population today has either anxiety or depression, some without anyone to confide in. Delaney believes that coaching is empowering enough to give the support needed to elevate people in their reach for deep fulfilment and wellbeing. It is especially helpful if someone is getting support by working with another who has expertise in the exact forms of transformation they are seeking. “When someone sees themselves taking strides towards the life they desire, they move from a place of victimhood and resentment to a place of passion and fire that they can share with those around them,” Delaney says. “This is why I do what I do! It is my belief that the world changes one empowered human at a time.” 

Through his Life on Fire coaching program, Delaney navigates his clients past fear and doubt to establish bulletproof routines where they are highly productive up to 15 hours per day, which reduces stress, and ultimately helps them build a more beautiful life for themselves and those they love. Flow state is extremely important and is data driven:

•  490% increase in skill acquisition for individuals in flow state (Advanced Brain Monitoring & DARPA)
•  500% Increase in productivity in leaders who regularly tapped into flow state (McKinsey & Co)
• 430% Increase in creative problem solving for subjects exposed to flow (University of Sydney)
•  3 days of elevated creativity following flow state activities (Harvard Research Study)

Infusing flow state into someone’s day and activities will help them “be more productive, reduce distraction and stress, and ultimately build a more incredible life for them.”

Delaney utilizes flow state in his own business and life, embracing a mindset of curiosity and growth. He encourages others starting a business to have a “growth mindset”. “Having a growth mindset is so key. Learn to value the daily repetitions over “success”. This prevents us from getting discouraged when things don’t work out perfectly, and cuts off our fear of failure at its knees,” He advises. “Most entrepreneurs fail because fear prevents them from going all in. When you become the person who is willing to embrace fear head on in pursuit of your goals, that’s where the magic happens.”

Something else quite magical and important to success is mentorship. According to Delaney investing in mentorship is what saved him years of trial and error. He had to acknowledge he couldn’t do things alone. “I failed 3 businesses before Life on Fire truly took off and stuck,” He said, remembering. “The number one thing that got me to where I am today was to acknowledge that I couldn’t do things alone. It was only when I went out of my way to invest in mentorship programs with leaders who could guide me along the path that I truly began to see results.”

Delaney’s journey has been a transformative change for his health, leadership, and business. Along the way he found a number of resources that help him find his purpose and “flow”. This has led him to encourage and be a support to others so that they can also find a flow state in their lives as well.

If you’d like to learn more about Delaney’s coaching services, you can find him at lifeonifre.io/coaching

Contact:
Delaney McGuire
Life on Fire
[email protected]

https://www.lifeonfire.io

BENSALEM, Pa., March 31, 2021 (GLOBE NEWSWIRE) — Law Offices of Howard G. Smith reminds investors that class action lawsuits have been filed on behalf of shareholders of the following publicly-traded companies. Investors have until the deadlines listed below to file a lead plaintiff motion.

Investors suffering losses on their investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in these class actions at 888-638-4847 or by email to [email protected].

Ebix, Inc. (NASDAQ: EBIX)
Class Period: November 9, 2020 – February 19, 2021
Lead Plaintiff Deadline: April 23, 2021

Throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that there was insufficient audit evidence to determine the business purpose of certain significant unusual transactions in Ebix’s gift card business in India during the fourth quarter of 2020; (2) that there was a material weakness in the Company’s internal controls over the gift or prepaid revenue transaction cycle; and (3) that the Company’s independent auditor was reasonably likely to resign over disagreements with Ebix regarding $30 million that had been transferred into a commingled trust account of Ebix’s outside legal counsel; and (4) that, as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

Apache Corporation (NASDAQ: APA)
Class Period: September 7, 2016 – March 13, 2020
Lead Plaintiff Deadline: April 26, 2021

Shareholders with $400,000 losses or more are encouraged to contact the firm

The complaint filed alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) Apache intentionally used unrealistic assumptions regarding the amount and composition of available oil and gas in Alpine High; (2) Apache did not have the proper infrastructure in place to safely and/or economically drill and/or transport those resources even if they existed in the amounts purported; (3) these misleading statements and omissions artificially inflated the value of Apaches operations in the Permian Basin; and (4) as a result, Defendants’ statements about its business, operations, and prospects, were materially false and misleading and/or lacked a reasonable basis at all relevant times.

MultiPlan Corporation f/k/a Churchill Capital Corp. III (NYSE: MPLN)
Class Period: July 12, 2020 – November 10, 2020
Lead Plaintiff Deadline: April 26, 2021

The complaint filed alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that MultiPlan was losing tens of millions of dollars in sales and revenues to Naviguard, a competitor created by one of MultiPlan’s largest customers, UnitedHealthcare, which threatened up to 35% of MultiPlan’s sales and 80% of its levered cash flows by 2022; (2) that sales and revenue declines in the quarters leading up to the Merger were not due to “idiosyncratic” customer behaviors as represented, but rather due to a fundamental deterioration in demand for MultiPlan’s services and increased competition, as payors developed competing services and sought alternatives to eliminating excessive healthcare costs; (3) that MultiPlan was facing significant pricing pressures for its services and had been forced to materially reduce its take rate in the lead up to the Merger by insurers, who had expressed dissatisfaction with the price and quality of MultiPlan’s services and balanced billing practices, causing MultiPlan to cut its take rate by up to half in some cases; (4) that, as a result of the foregoing, MultiPlan was set to continue to suffer from revenues and earnings declines, increased competition and deteriorating pricing dynamics following the Merger; (5) that, as a result of the foregoing, MultiPlan was forced to seek continued revenue growth and to improve its competitive positioning through pricey acquisitions, including through the purchase of the healthcare technology company HST for $140 million at a premium price from a former MultiPlan executive only one month after the Merger; and (6) that, as a result of the foregoing, Churchill III investors had grossly overpaid for the acquisition of MultiPlan in the Merger, and MultiPlan’s business was worth far less than represented to investors.

AgEagle Aerial Systems Inc. (NYSE: UAVS)
Class Period: September 3, 2019 – February 18, 2021
Lead Plaintiff Deadline: April 27, 2021

Shareholders with $10,000 losses or more are encouraged to contact the firm

The complaint filed alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) AgEagle did not have a partnership with Amazon and in fact never had any relationship with Amazon; (2) rather than correct the public’s understanding about a partnership with Amazon, defendants were actively contributing to the rumor that AgEagle had a partnership with Amazon; and (3) as a result, Defendants’ statements about its business, operations, and prospects, were materially false and misleading and/or lacked a reasonable basis at all relevant times.

To be a member of these class actions, you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action. If you wish to learn more about these class actions, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020, by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to [email protected], or visit our website at www.howardsmithlaw.com.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Contacts

Law Offices of Howard G. Smith
Howard G. Smith, Esquire
215-638-4847
888-638-4847
[email protected]
www.howardsmithlaw.com

York, Maine, March 31, 2021 (GLOBE NEWSWIRE) — FOR IMMEDIATE RELEASE

Award-winning specialty food producer Stonewall Kitchen announced today its acquisition of Vermont Coffee Company® based in Middlebury, Vermont.  Vermont Coffee Company is the best-selling brand of bagged organic coffee in grocery stores across the Northeast.  The company sources and blends high quality, certified organic arabica coffee from all of the leading coffee regions around the world, slow-roasting them in small batches to make coffees with big bold flavor.  Vermont Coffee Company is a brand with a purpose, and its distinctive “brown paper bag” packaging connotes values of freshness, and sustainability.  Blends are available in both whole bean and most recently in pre-ground form.

 

Founder Paul Ralston began roasting coffee in 1979 after purchasing an antique Royal No. 4 slotted-drum roaster which he set up in the window of his bakery in Bristol, Vermont. Twenty years later, the Vermont Coffee Company was born, and today offers over 25 blends from its 40,000 square foot state-of-the-art facility in Middlebury.  In 2018, the company became the first roaster in the nation to roast coffee using 100% renewable biogas, demonstrating its commitment to the environment and planet.  

 

 “We’re extremely excited to welcome Vermont Coffee Company to our growing family of specialty brands,” said John Stiker, Chief Executive Officer of Stonewall Kitchen. “Both of our companies are committed to craft manufacturing high quality products and creating meaningful experiences for people.  The Vermont Coffee Company products are sustainably sourced, 100% organic, and — most importantly – make a delicious cup of coffee!  We believe these deeply rooted values and commitment to quality make Vermont Coffee Company the perfect addition to our family.”

 

Added founder Paul Ralston, “I began my love affair with coffee by learning to roast through trial and error, and sharing those batches with friends. Forty years later, our mission remains “roasting coffee for friends” – which means being friends to our farmers, our customers, our community, and our planet.  As a purpose-driven company, finding the right home for our brand and the friends I’ve made was of the utmost importance to me.  I am extremely happy that Stonewall Kitchen will be the new home of Vermont Coffee Company and will continue roasting with our entire team here in Middlebury.  I’m also thrilled to announce that as part of their commitment to the community, Stonewall Kitchen is planning to open a new Vermont Coffee Company café in downtown Middlebury, with a target opening date of this fall.” 

 

Concluded Stiker, “We’re elated to have Vermont Coffee join the other great brands in our family made here in New England, from our flagship Stonewall Kitchen products made here in York, Maine, to the Village Candle brand made up the road in Wells, to the Vermont Village brand of apple cider vinegar products made in Vermont.  Combined with our other acquisitions from around the country, including the most recent acquisition of Urban Accents just last month, Vermont Coffee Company expands even further what we are able to offer our customers and guests. With our expertise in brand building, product development, and omni-channel distribution, we’re looking forward to having the team at Vermont Coffee Company join us in offering a wide range of unique, high quality and premium coffee products.”

 

Vermont Coffee Company marks Stonewall Kitchen’s second acquisition of 2021 and sixth acquisition overall. It acquired the Urban Accents® brand of spice mixes, seasonings, sauces, and gifts in early March.

About Stonewall Kitchen

Stonewall Kitchen is a leading specialty food and home goods producer headquartered in York, Maine.  Founded in 1991 by partners Jonathan King and Jim Stott, the two established the Stonewall Kitchen brand by selling jams and jellies at local farmers’ markets with a flavorful line of distinctive and high quality products. Over time, they expanded the brand to include sauces, condiments, crackers and baking mixes, always focusing on innovative product development, beautiful packaging, and exceptional guest service.  Today, Stonewall Kitchen is the premier specialty food and home goods platform in North America, home to a family of premium quality brands including the flagship Stonewall Kitchen brand; the Vermont Coffee Company brand of high quality, non-GMO, certified organic coffee; the Urban Accents brand of globally-inspired spice mixes, seasonings, and sauces; the Village Candle brand of fragranced candles, gifts and accessories; the Tillen Farms brand of pickled vegetables and cocktail cherries; the Napa Valley Naturals brand of olive oils, culinary oils, balsamic vinegars and wine vinegars; the Montebello brand of artisan organic pasta imported from Italy; the Vermont Village brand of organic apple sauce and apple cider  vinegars; and the Legal Sea Foods brand of restaurant-quality seafood sauces and condiments.  The company boasts more than 8,500 wholesale accounts nationwide and internationally; a thriving catalog and online division; a cooking school and café in York, Maine; and eleven retail Company Stores throughout New England. As winners of 30 prestigious awards from the Specialty Food Association and the recipient of the coveted Outstanding Product Line Honors three times, Stonewall Kitchen is proud to be one of the most awarded specialty food companies in the country.

 

For more information about Stonewall Kitchen, please visit: www.stonewallkitchen.com

For more information about Vermont Coffee Company, please visit: www.vermontcoffeecompany.com

 

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Attachments

• FOB_VTChorizontal_S-HiRes
• VTCpressrelease_S-HiRes

Janine Somers
Stonewall Kitchen, LLC.
(207) 351-2713
[email protected]

LOS ANGELES, March 31, 2021 (GLOBE NEWSWIRE) — Glancy Prongay & Murray LLP (“GPM”) reminds investors of the upcoming May 3, 2021 deadline to file a lead plaintiff motion in the class action filed on behalf of investors who purchased or otherwise acquired Renewable Energy Group, Inc. (“Renewable Energy” or the “Company”) (NASDAQ: REGI) securities between May 3, 2018 and February 25, 2021, inclusive (the “Class Period”).

If you suffered a loss on your Renewable Energy investments or would like to inquire about potentially pursuing claims to recover your loss under the federal securities laws, you can submit your contact information at https://www.glancylaw.com/cases/renewable-energy-group-inc/. You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.

On February 25, 2021, after the market closed, Renewable Energy issued a press release announcing its fourth quarter and full year 2020 financial results. Therein, the Company revealed that it would restate “$38.2 million in cumulative revenue from January 2018 through September 30, 2020” because Renewable Energy was not the “proper claimant for certain BTC payments on biodiesel it sold between January 1, 2017 and September 30, 2020.” Renewable Energy further stated that it had reached an agreement with the Internal Revenue Service “on a $40.5 million assessment, excluding interest” to correct these claims.

On this news, the Company’s share price fell $8.17, or 9.5%, over two consecutive trading sessions to close at $77.77 per share on February 26, 2021, on unusually heavy trading volume.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that due to failures in the diesel additive system, petroleum diesel was not periodically added to certain loads by the Company and was instead added by the Company’s customers; (2) that, as a result, Renewable Energy was not the proper claimant for certain BTC payments on biodiesel it sold between January 1, 2017 and September 30, 2020; (3) that, as a result, Renewable Energy’s revenue and net income were overstated for certain periods; (4) that there was a material weakness in the Company’s internal control over financial reporting related to the purchase and use of the petroleum diesel gallons when blending with biodiesel; and (5) that, as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

Follow us for updates on LinkedIn, Twitter, or Facebook.

If you purchased or otherwise acquired Renewable Energy securities during the Class Period, you may move the Court no later than May 3, 2021 to request appointment as lead plaintiff in this putative class action lawsuit. To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action. If you wish to learn more about this class action, or if you have any questions concerning this announcement or your rights or interests with respect to the pending class action lawsuit, please contact Charles Linehan, Esquire, of GPM, 1925 Century Park East, Suite 2100, Los Angeles, California 90067 at 310-201-9150, Toll-Free at 888-773-9224, by email to [email protected], or visit our website at www.glancylaw.com. If you inquire by email please include your mailing address, telephone number and number of shares purchased.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Contacts

Glancy Prongay & Murray LLP, Los Angeles
Charles Linehan, 310-201-9150 or 888-773-9224
[email protected]
www.glancylaw.com

LOS ANGELES, March 31, 2021 (GLOBE NEWSWIRE) —

Glancy Prongay & Murray LLP (“GPM”) reminds investors of the upcoming May 3, 2021 deadline to file a lead plaintiff motion in the class action filed on behalf of investors who purchased or otherwise acquired Velodyne Lidar, Inc. (“Velodyne” or “the Company”) (NASDAQ: VLDR) securities between  July 2, 2020 and March 17, 2021, inclusive (the “Class Period”).

If you suffered a loss on your Velodyne investments or would like to inquire about potentially pursuing claims to recover your loss under the federal securities laws, you can submit your contact information at https://www.glancylaw.com/cases/velodyne-lidar-inc/. You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.

On February 22, 2021, Velodyne announced that the Board had “removed David Hall as Chairman of the Board and terminated Marta Hall’s employment as Chief Marketing Officer of the Company” after the Audit Committee’s investigation “concluded that Mr. Hall and Ms. Hall each behaved inappropriately with regard to certain Board and Company processes, and failed to operate with respect, honesty, integrity, and candor in their dealings with Company officers and directors.” In addition, the Company announced that Velodyne’s Board formally censured Mr. Hall and Ms. Hall, but that they would remain directors of Velodyne.

On this news, Velodyne’s common stock fell $3.14, or approximately 15%, to close at $17.97 per share on February 22, 2021, on unusually heavy trading volume. Additionally, Velodyne’s warrants fell $1.47, or approximately 20%, to close at $5.90 per warrant on February 22, 2021.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that certain of Velodyne’s directors had failed to operate with respect, honesty, integrity, and candor in their dealings with the Company’s officers and directors; (2) that the Company was investigating the foregoing matters; and (3) that, as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially false and misleading and/or lacked reasonable basis at all relevant times.

Follow us for updates on LinkedIn, Twitter, or Facebook.

If you purchased or otherwise acquired Velodyne securities during the Class Period, you may move the Court no later than May 3, 2021 to request appointment as lead plaintiff in this putative class action lawsuit. To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action. If you wish to learn more about this class action, or if you have any questions concerning this announcement or your rights or interests with respect to the pending class action lawsuit, please contact Charles Linehan, Esquire, of GPM, 1925 Century Park East, Suite 2100, Los Angeles, California 90067 at 310-201-9150, Toll-Free at 888-773-9224, by email to [email protected], or visit our website at www.glancylaw.com. If you inquire by email please include your mailing address, telephone number and number of shares purchased.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Contacts

Glancy Prongay & Murray LLP, Los Angeles
Charles Linehan, 310-201-9150 or 888-773-9224
[email protected]
www.glancylaw.com

                                                                                                                                                                                                                     PRESS RELEASE

UPDATE ON MASITINIB PHASE 3 STUDY (AB12003) IN METASTATIC CASTRATE-RESISTANT PROSTATE CANCER (MCRPC) ELIGIBLE TO CHEMOTHERAPY

Paris, 31 March 2021, 6pm CET

AB Science SA (NYSE Euronext – FR0010557264 – AB) today provides an update on the expected timelines for the read-out of its masitinib Phase 3 study (AB12003) in metastatic castrate-resistant prostate cancer (mCRPC) eligible to chemotherapy.

Final results of study AB12003 will be available in April 2021.

About study AB12003

Study AB12003 is an international, multicenter, randomized, double blind, placebo-controlled, 2-parallel group, Phase 3 study in metastatic castrate resistant prostate cancer (mCRPC) eligible to chemotherapy. The study aims to compare the efficacy and safety of masitinib (6.0 mg/kg/day) in combination with docetaxel versus placebo in combination with docetaxel. Docetaxel is combined with prednisone.

The study primary endpoint is progression free survival (PFS).

The target patient population consists of adult males who have progressed to develop metastatic castrate resistant prostate cancer (mCRPC) after castration treatment (i.e. reduction of available androgen/testosterone/DHT by chemical or surgical means) and are therefore eligible for chemotherapy.

About castrate-resistant prostate cancer (CRPC)

Development of prostate cancer is often driven by male sex hormones called androgens, including testosterone. Castrate-resistant prostate cancer (CRPC) is defined by disease progression despite androgen depletion (hormone) therapy and may present as either a continuous rise in serum prostate-specific antigen (PSA) levels, the progression of pre-existing disease, and/or the appearance of new metastases. Metastatic CRPC (mCRPC) occurs when the cancer spreads to other parts of the body.

Prostate cancer is the most common cause of cancer in men, with 137.9 new cases per 100,000 men per year [1]. The estimated prevalence of people living with prostate cancer is 113 per 100,000 [2], with approximately 15% of the patients having metastatic castrate-resistant prostate cancer (mCRPC) eligible to chemotherapy [3]. As such, population with metastatic castrate-resistant prostate cancer (mCRPC) eligible to chemotherapy is around 75,000 in the EU and 50,000 in the USA.

Prostate cancer is also the second most common cause of cancer death in men, with the highest rates being in North America, Australia, and Northern and Central Europe. Although the overall 5-year survival rate for prostate cancer is very high, up to 20% of men who undergo state-of-the art treatment for prostate cancer will develop CRPC within 5 years, and at least 84% of these will have metastases at the time of CRPC diagnosis [1]. Practically all patients with metastatic disease become resistant to androgen-deprivation therapy. Median survival for those with mCRPC ranges from approximately 15 to 36 months in recent studies, and 5-year survival is only 28% [1].

References
[1] Crawford ED, Petrylak D, Sartor O. Navigating the evolving therapeutic landscape in advanced prostate cancer. Urol Oncol. 2017 May;35S:S1-S13. doi: 10.1016/j.urolonc.2017.01.020.
[2] Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394–424.
[3] Scher 2015 – PLoSONE – Symptomatic mCRPC that has not been treated with or not progressed on chemotherapy

About masitinib

Masitinib is a new orally administered tyrosine kinase inhibitor that targets mast cells and macrophages, important cells for immunity, through inhibiting a limited number of kinases. Based on its unique mechanism of action, masitinib can be developed in a large number of conditions in oncology, in inflammatory diseases, and in certain diseases of the central nervous system. In oncology due to its immunotherapy effect, masitinib can have an effect on survival, alone or in combination with chemotherapy. Through its activity on mast cells and microglia and consequently the inhibition of the activation of the inflammatory process, masitinib can have an effect on the symptoms associated with some inflammatory and central nervous system diseases and the degeneration of these diseases.

About AB Science

Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action are key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, often lethal with short term survival or rare or refractory to previous line of treatment.
AB Science has developed a proprietary portfolio of molecules and the Company’s lead compound, masitinib, has already been registered for veterinary medicine and is developed in human medicine in oncology, neurological diseases, and inflammatory diseases. The company is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB).

Further information is available on AB Science’s website:
www.ab-science.com.

Forward-looking Statements – AB Science

This press release contains forward-looking statements. These statements are not historical facts. These statements include projections and estimates as well as the assumptions on which they are based, statements based on projects, objectives, intentions and expectations regarding financial results, events, operations, future services, product development and their potential or future performance.

These forward-looking statements can often be identified by the words “expect”, “anticipate”, “believe”, “intend”, “estimate” or “plan” as well as other similar terms. While AB Science believes these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict and generally beyond the control of AB Science and which may imply that results and actual events significantly differ from those expressed, induced or anticipated in the forward-looking information and statements. These risks and uncertainties include the uncertainties related to product development of the Company which may not be successful or to the marketing authorizations granted by competent authorities or, more generally, any factors that may affect marketing capacity of the products developed by AB Science, as well as those developed or identified in the public documents filed by AB Science with the Autorité des Marchés Financiers (AMF), including those listed in the Chapter 4 “Risk Factors” of AB Science reference document filed with the AMF on November 22, 2016, under the number R. 16-078. AB Science disclaims any obligation or undertaking to update the forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq. of the AMF General Regulations.

For additional information, please contact:

AB Science

Financial Communication & Media Relations
[email protected]

Media Relations – USA

RooneyPartners

Jeffrey Freedman
[email protected]

+1 646 432 0191

Media Relations – France

NewCap

Arthur Rouillé
[email protected]

+33 (0)1 44 71 00 15

 

Attachment

• Update Prostate VEng VF