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ATLANTA and AUSTIN, Texas, April 19, 2021 /PRNewswire/ — Parallel, one of the largest privately-held multi-state cannabis operators in the United States (U.S.), today announced it will make a $25 million dollar investment in a new state-of-the art cannabis cultivation, production and retail facility in Texas. This financial commitment expands Parallel’s ability to meet the growing patient demand for medical cannabis products in the Lone Star State. The planned 63,000 square-foot facility is expected to create hundreds of new jobs in the San Marcos region.

The company is also introducing its goodblend™ retail brand, as it is changing the name of Surterra Texas to goodblend Texas (goodblend). This is the second market where Parallel has introduced the goodblend name, joining goodblend Pennsylvania; over time the company will evaluate opportunities to roll-out the brand in its existing markets. The goodblend retail brand reflects Parallel’s intent to lead the way to the future of cannabis by providing its customers a trusted, consistent and seamless way for them to connect and learn, and to access innovative, high-quality cannabis products in a variety of form factors. The brand is about welcoming every type of customer and being an approachable source for our customers’ well-being. 

“With our $25 million dollar investment and name change to goodblend, we are strengthening our Texas roots to meet the needs of cannabis patients for the long term. We see high growth potential in the Texas cannabis market as every day more Texans choose cannabis to help improve their quality of life,” said William “Beau” Wrigley Jr., Chairman and CEO for Parallel. “The goodblend brand promise is to make customers feel so good about their experience that they come back again and again. The ethos of goodblend is based on Parallel’s commitment to compliance, quality, consistency and innovation, and on our actions to improve diversity, inclusivity and economic empowerment in the cannabis industry and to be a great employer and local community partner.”

Texas, one of the most populous states in the U.S., with nearly 30 million residents, created the Texas Compassionate Use Program in 2015, providing medical cannabis to qualifying patients.  Parallel’s goodblend retail brand (formerly Surterra Texas) provides patients access to high-quality cannabis products in a variety of form factors that are cultivated and produced locally in Texas to ensure the most consistent patient experience. It was the first cannabis operator in the state to offer patients medical cannabis in gummy and lozenge formats.

“We are thrilled to break ground today on our new facility in San Marcos. We look forward to creating economic empowerment opportunities in this community through new jobs and cannabis career-building programs,” said Marcus Ruark, President of goodblend Texas. “We are encouraged that there is a growing recognition, trust and demand for our medical cannabis products in Texas. While our customers will now know us as goodblend Texas, we will continue to offer registered patients with the state’s largest assortment of cannabis-based product formats.”

Medical cannabis patients across Texas already registered in the program, and those interested in learning more about cannabis, can access board certified prescribers, medical cannabis information, services, and products in the following ways:

• The goodblend Virtual Clinic is a service in which prospective patients can schedule consultations with a board-certified prescriber through a seamless experience. To get started, visittx.goodblend.com/clinic.
• 
  goodblend.com
  offers a wide variety of products, easy online ordering, and free contactless home delivery, often in as little as three days.
• goodblend’s partner clinics in Plano, Houston, Fort Worth, and San Antonio, provide registered patients a convenient way to pick up goodblend cannabis products at locations in major metropolitan areas.

Commitment to Social Equity 

Parallel is committed to advancing social equity through meaningful actions and partnerships that positively impact the communities in which it has operations, as well as the industry at large. Parallel has partnered with many industry advocacy organizations, including Minority Cannabis Business Association (MCBA), Cannaclusive, CultivatED, and CannabisLAB to drive their shared missions forward and to continue to address diversity and inclusion in the industry. To date, Parallel has focused its efforts across all markets on economic and job empowerment, and diversity and inclusion in the industry through job fairs, skills-building training and seminars, fellowships, and social equity grants, among other actions. Parallel is committed to increasing its diverse 1,700-person workforce, which is currently comprised of well over 30% of minority and female-identifying employees, and 40% of Parallel’s leadership team consists of female and minority representation. Parallel’s proposed slate of seven independent candidates to its public company board of directors, post-closing of the transaction with Ceres, is focused on including at least two female and three BIPOC directors. 

About Parallel

Parallel is one of the largest privately-held, vertically integrated, multi-state cannabis companies in the United States with a mission to pioneer well-being and improve the quality of life through cannabinoids. Parallel recently announced that it intends to become a public company through a definitive business combination agreement with Ceres Acquisition Corp. (“Ceres”) (NEO: CERE.U, CERE.WT; OTCQX: CERAF), a special purpose acquisition corporation (SPAC). Parallel has ongoing operations in four medical and adult-use markets under the retail brands of Surterra Wellness in Florida; goodblend in Texas; New England Treatment Access (NETA) in Massachusetts, and The Apothecary Shoppe in Nevada. Parallel also has a license under its goodblendPennsylvania brand for vertically integrated operations and up to six retail locations, in addition to a medical cannabis research partnership with the University of Pittsburgh School of Medicine. Subject to regulatory approval, Parallel will add Illinois as a sixth market when its recently announced acquisition of six Windy City Cannabis licenses is complete. Parallel has a diverse portfolio of high quality, proprietary and licensed consumer brands and products including Surterra Wellness, Coral Reefer, Float and Heights. Parallel operates approximately 50 locations nationwide, including 42 retail stores, and cultivation and manufacturing sites. Through its wholly-owned Parallel Biosciences subsidiary, it conducts advanced cannabis science and R&D for new product development in its facilities in Massachusetts, Florida, Texas and a facility in Budapest, Hungary through an exclusive license and partnership. Parallel follows rigorous operations and business practices to ensure the quality, safety, consistency and efficacy of its products and is building its business by following strong values and putting the well-being of its customers and employees first. Find more information at www.liveparallel.com, or on Instagram and LinkedIn.

For more information on goodblend Texas and its products, access www.goodblend.com and www.facebook.com/goodblendtx.

Media Contact

Taylor Foxman

[email protected]

Forward Looking Statements

Certain information in this press release contains “forward-looking statements” and “forward-looking information” within the meaning of applicable Canadian securities legislation and U.S. securities law (referred to herein as forward-looking statements), including statements regarding the Transaction and expected future growth. Except for statements of historical fact, certain information contained herein constitutes forward-looking statements, which include, but are not limited to, statements related to activities, events or developments that Parallel or Ceres expects or anticipates will or may occur in the future, statements related to Parallel’s business strategy objectives and goals, and Parallel’s management’s assessment of future plans and operations which are based on current internal expectations, estimates, projections, assumptions and beliefs, which may prove to be incorrect. Forward-looking statements can often be identified by the use of words such as “may”, “will”, “could”, “would”, “should”, “anticipate”, ‘believe”, expect “, “intend”, “potential “, “estimate”, “budget”, “scheduled”, “plans”, “planned”, “forecasts”, “goals” and similar expressions or the negatives thereof. Such statements are made pursuant to the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995 and are based on Parallel’s management’s belief or interpretation of information currently available. Forward-looking statements are neither historical facts nor assurances of future performance. Forward-looking statements in this press release includes statements regarding: the Transaction; the consummation of the acquisition of Windy City; Parallel’s expansion strategy and plans to grow its market share in existing and new markets, including Illinois; Parallel’s investment in new technologies and products; the development and expansion of Parallel’s brands; and strategic acquisition opportunities. Forward-looking statements are based on a number of factors and assumptions made by management and considered reasonable at the time such information is provided, and forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. There can be no assurance that the transactions described herein will be completed or that, if completed, the combined public company will be successful.

Risk factors that could cause actual results, performance or achievement to differ materially from those indicated in the forward-looking statements include, but are not limited to the following: (i) the risk that the Transaction may not be completed in a timely manner or at all, which may adversely affect the price of Ceres’ securities, (ii) the risk that the Transaction may not be completed by Ceres’ qualifying transaction deadline and the potential failure to obtain an extension of the qualifying transaction deadline if sought by Ceres, (iii) the failure to satisfy the conditions to the consummation of the Transaction, including the approval of the Transaction by the stockholders of Ceres and Parallel, as applicable (iv), the receipt of certain governmental and regulatory approvals, (v) the lack of a third party valuation in determining whether or not to pursue the proposed Transaction, (vi) the occurrence of any event, change or other circumstance that could give rise to the termination of the business combination agreement, (vii) the impact of COVID-19 on Parallel’s business and/or the ability of the parties to complete the proposed Transaction, (viii) the effect of the announcement or pendency of the Transaction on Parallel’s business relationships, performance, and business generally, (ix) risks that the proposed Transaction disrupts current plans and operations of Parallel and potential difficulties in Parallel employee retention as a result of the proposed Transaction, (x) the outcome of any legal proceedings that may be instituted against Parallel or Ceres or their respective, directors, officers and affiliates related to the proposed Transaction, (xi) the risk that the combined public company’s securities will not be approved for listing on the NEO Exchange or, if approved, that the combined public company will be able to maintain the listing, (xii) the price of Ceres’ and the combined public company’s securities may be volatile due to a variety of factors, including changes in the competitive and highly regulated industries in which Parallel operates, variations in performance across competitors, changes in laws and regulations affecting Parallel’s business and changes in the combined capital structure and a return on securities of the combined public company is not guaranteed, (xiii) the ability to implement business plans, forecasts, and other expectations after the completion of the proposed Transaction, and identify and realize additional opportunities, (xiv) the risk of downturns and the possibility of rapid change in the highly competitive industry in which Parallel operates, (xv) the risk that Parallel and its current and future collaborators are unable to successfully develop and commercialize Parallel’s products, brands or services, or experience significant delays in doing so, (xvi) the risk that the combined public company may never sustain profitability, (xvii) the risk that the combined public company will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all, (xviii) the risk that the combined public company experiences difficulties in managing its growth and expanding operations, (xix) the risk that the pharmaceutical industry may attempt to dominate the cannabis industry, and in particular, legal marijuana, through the development and distribution of synthetic products which emulate the effects and treatment of organic marijuana, (xx) the agricultural risks related to insects, plant diseases, unstable growing conditions, water and electricity availability and cost, (xxi) the risk that may arise because cannabis continues to be a controlled substance under the United States Federal Controlled Substances Act, (xxii) the risk of product liability or regulatory lawsuits or proceedings relating to Parallel’s products and services, (xixii) the risk that the combined public company is unable to secure or protect its intellectual property, (xxiv) tax risks, including U.S. federal income tax treatment, (xxv) risks relating to the reliance of Parallel on key members of management, (xxvi) risks inherent in businesses related to the agricultural industry, (xxvii) risks relating to potentially unfavorable publicity or consumer perception, (xxviii) Parallel may be subject to the risk of competition from synthetic production and technological advances, (xxix) investors in the combined public company and its directors, officers and employees who are not U.S. citizens may be denied entry into the United States, (xxx) product recalls, (xxxi) results of future clinical research, (xxxii) difficulty attracting and retaining personnel, (xxxiii) fraudulent or illegal activity by employees, contractors and consultants; information technology systems and cyber-attacks, (xxxiv) security breaches, (xxxv) natural disasters and terrorism risk, (xxxvi) restricted access to banking, (xxxvii) risks related to the lending facilities, (xxxviii) risks of leverage, (xxxix) heightened scrutiny by regulatory authorities, (xI) risk of legal, regulatory or political change, (xli) general regulatory and licensing risks, (xlii) Parallel and the combined public company may be subject to the risk of changes in Canadian as well as U.S. federal, state and local laws or regulations, (xliii) limitations on ownership of licenses, (xliv) Nevada regulatory regime and transfer and grant of licenses, (xIv) regulatory action and approvals from the FDA, (xlvi) constraints on marketing products, (xlvii) anti-money laundering laws and regulation, (xlviii) the combined public company’s status as an “Emerging Growth Company” under United States securities laws, (xlix) discretion in the use of proceeds, (l) subsequent offerings will result in dilution to shareholders of the combined public company, (li) voting control, and (lii) unpredictability caused by capital structure and voting control. Readers are cautioned that the foregoing list is not exhaustive.

Parallel and Ceres undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws.

U.S. Disclaimer

Neither the securities of Ceres nor of Parallel have been registered under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act”), or any state securities laws and may not be offered and sold in the United States except pursuant to an exemption from the registration requirements of the U.S. Securities Act.

Any securities of either Ceres or Parallel sold in the United States will be “restricted securities” within the meaning of Rule 144 under the U.S. Securities Act. Such securities may be resold, pledged or otherwise transferred only pursuant to an effective registration statement under the U.S. Securities Act or pursuant to an applicable exemption from the registration requirements of the U.S. Securities Act.

Texas CUP License #0006

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SOURCE Parallel

BEVERLY HILLS, Calif., April 19, 2021 /PRNewswire/ — GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager (TriKE™) protein biologic technology platform, reported financial results for the fourth quarter and year ended December 31, 2020.

“2020 was a year of robust clinical progress and milestone achievements for GT Biopharma, which allowed us to accomplish a major corporate milestone in listing GT Biopharma on NASDAQ at the beginning of 2021.  The emerging data from our GTB-3550 TriKE™ program in hematological malignancies, MDS and AML, are encouraging in both safety and efficacy profiles.  The ongoing data profile has demonstrated significant differences from all other NK cell therapies and NK engager companies, making TriKE™ a monotherapy, off-the-shelf platform therapeutic.  TriKE™ exerts its therapeutic effect without the need for outside assistance in the form of combination therapies or the addition of supplemental progenitor-derived or autologous/allogenic NK cells.  As a result, TriKE™ therapy cost to patients will be far superior, significantly more economic than progenitor-derived or autologous/allogenic NK cell therapy companies’ offerings.  Additionally, the results generated from the GTB-3550 TriKE™ clinical trial reinforces its versatility, providing a clear rationale to proceed with additional programs in solid tumor and hematologic cancers.  As a result, in 2020 we formed a strong GMP manufacturing partnership with Cytovance Biologics to bring our TriKE™ product candidates forward for evaluation in the clinic,” said Anthony J. Cataldo, GT Biopharma’s Chairman and Chief Executive Officer.  “In the first quarter of 2021, we have achieved numerous clinical and operational milestones, which included garnering the attention of institutional investors and analyst research coverage as a result of our successful NASDAQ listing and public offering.  We transferred all TriKE™ GMP manufacturing to Cytovance, as we progress our solid tumor TriKE™ product candidates.  Additionally, the interim results from our ongoing Phase I/II clinical trial of GTB-3550 TriKE™ showed a 63.7% reduction in bone marrow blast (cancer cell killing) levels in patient 9; up from 61% in patient 7 at a lower dose for patients with MDS and AML.  We also added the University of Wisconsin-Madison as a second clinical trial site.  There will be more trials sites added, as we will soon proceed to the Phase II portion of our ongoing GTB-3550 TriKE™ clinical trial.  We look forward to building on this momentum throughout the year, particularly as we continue to dose escalate our GTB-3550 TriKE^TM in these incredibly difficult-to-treat relapsed/refractory AML and high-risk MDS patient populations.  We thank the patients and their families for their contribution, as we progress this novel, off-the-shelf monotherapy cancer therapeutic that uniquely works without outside supplemental engineered NK cells or the need for any combination drugs.”

Corporate Highlights

• Strengthened Leadership Team with Key Appointments to Executive Management, Board of Directors, and Scientific and Medical Advisory Board: In November 2020, GT Biopharma announced the appointment of Michael Handelman, CPA as Chief Financial Officer. Mr. Handelman was the former CFO of Iovance Biotherapeutics. Throughout 2020, GT Biopharma announced multiple appointments to its two boards. Bruce J. Wendel was named Vice Chairman and Independent Director of the Board of Directors, and Greg Berk, M.D., Michael Breen and Rajesh Shrotriya, M.D. were appointed as independent directors. Samir Taneja, M.D. and Philip Werthman, M.D., M.M.H. were appointed to the Company’s Scientific and Medical Advisory Board.

• Established and Expanded TriKE™ Partnership with Cytovance Biologics: In October 2020, GT Biopharma announced a partnership agreement with Cytovance Biologics for the exclusive GMP manufacturing of three TriKE™ product candidates. Under the terms of the agreement, Cytovance will manufacture TriKE™ product candidates in accordance with its proprietary Keystone® bacterial or mammalian expression systems. Subject to certain milestones by Cytovance, GT Biopharma has the option to pay Cytovance up to a total of $6 million. In December 2020, GT Biopharma issued $1 million to Cytovance as a first milestone payment. GT Biopharma’s agreement with Cytovance was further expanded in February 2021 for the manufacturing of all TriKE™ products.

Subsequent Event:

• Closed $28.7 Million Public Offering and Successful Listing on NASDAQ: In February 2021, GT Biopharma announced the successful completion of its NASDAQ up list, in addition to the simultaneous closing of its public offering, in which it raised $28.7 million. Further, the Company retired over $32 million in debt and consolidated its capital structure.

Clinical Highlights

• Presented Interim Results for GTB-3550 TriKE^TM for the Treatment of High-Risk MDS and Refractory/Relapsed AML at the 62^nd American Society of Hematology (ASH) Annual Meeting: 

• In December 2020, GT Biopharma presented promising proof-of-principle interim results from its lead product candidate, GTB-3550 TriKE™, at ASH in an oral presentation. As of the data cut-off date, six out of seven enrolled patients were evaluable and displayed no signs of clinical immune activation or serious adverse events across all dose cohorts. Data demonstrated that the first patient from the 5 mcg/kg/day cohort achieved stable disease after one course of GTB-3550 TriKE™ therapy and the first patient from the 25 mcg/kg/day cohort achieved AML blast level decrease from 18% to 12% by morphological analysis after one course of GTB-3550 TriKE™ therapy.  Correlative studies also have shown reproducible NK cell activity across all evaluable patients with NK cell activation increasing during early treatment. Of note, NK cell proliferation started at day 3, is maximal at day 8 and maintained above baseline at days 15 and 22.
• Additional clinical data from a patient with HR-MDS were presented, demonstrating that GTB-3550 TriKE™ safely activated and harnessed native NK cell’s cancer killing ability in a target-directed fashion with no adverse events or dose limiting toxicities. Successful bone marrow blast level reduction from 12% prior to treatment to 4.6% post-treatment was determined by morphological assessment. The patient also achieved stable hematologic parameters, including normal platelet counts throughout therapy.
• Expanded Clinical Programs with HER2 TriKE^TM for the Treatment of Breast and Gastrointestinal Cancers:  In December 2020, GT Biopharma announced the initiation of clinical development for TriKE^TM therapy for the treatment of HER2+, HER3+ and HER2+/HER3+ heterodimer complex breast cancer and gastrointestinal cancers.

• Published Results on B7H3-Targeted TriKE^TM Potential to Enhance NK-Cell Immunotherapy in Solid Tumors:  In October 2020, GT Biopharma announced the publication of results conducted by researchers at the University of Minnesota and Massachusetts General Hospital/Harvard Medical School in the journal, Cancers, in an article entitled “NK-Cell-Mediated Targeting of Various Solid Tumors Using B7-H3 Tri-Specific Killer Engager In Vitro and In Vivo.” Results indicated that a B7H3-targeted TriKE^TM has the potential to enhance NK cell immunotherapy in solid tumor settings, particularly where B7H3 is highly expressed on solid tumor surfaces.

Subsequent Events:

• Updated Interim Results from GTB-3550 TriKE^TM Clinical Program for the Treatment of MDS and AML:  In March 2021, GT Biopharma announced updated interim results from the Phase I/II Expansion clinical trial of GTB-3550 TriKE™ for the treatment of high-risk myelodysplastic syndromes (MDS) and refractory/relapsed acute myeloid leukemia (AML) from 9 patients.  Results demonstrated up to 63.7% reduction in bone marrow blast levels.  All patients treated to date displayed no signs of any grade of cytokine release syndrome (CRS) across all dose cohorts.  GTB-3550 TriKE™ is currently being administered to patients at doses significantly higher than the reported maximum tolerated dose (MTD) for continuous infusion of recombinant human interleukin-15 (IL-15).

• GTB-3550 TriKE™ Interim Results Presented at Innate Killer Summit 2021: In March 2021, Dr. Jeffrey S. Miller, M.D., GT Biopharma’s Consulting Chief Medical Officer and Deputy Director of the Masonic Cancer Center at the University of Minnesota, presented updated interim Phase I/II clinical trial results for GTB-3550 TriKE™, being evaluated for the treatment of MDS and AML at the Innate Killer Summit 2021. Dr. Miller’s presentation “NK Cell Therapeutics:  Off-the-shelf Strategies to Increase Activity and Specificity” highlighted the clinical power of immune engagement with IL-15 containing TriKEs.

• Announced Preclinical Results from ROR1 TriKE^TM for the Treatment of Prostate Cancer:  In March 2021, GT Biopharma announced preclinical in vitro cell assay results demonstrating the ROR1 TriKE^TM was found to be effective at promoting NK cell killing of prostate cells.  Significant NK cell activation and interferon gamma production was also observed as a result of ROR1 TriKE^TM engagement.

Fourth Quarter and Year End 2020 Financial Results:

• Cash Position:  As of December 31, 2020, cash, cash equivalents and investments were $5.3 million, compared to $0.3 million as of December 31, 2019.  The increase in cash, cash equivalents and investments was primarily due to proceeds from the issuance of convertible notes payable of $12.5 million, offset by cash used in operating activities of $7.3 million.

• Research and Development Expenses:  Research and development expenses were $233 thousand for the fourth quarter of 2020, compared to $8 thousand for the same period in 2019. Research and development expenses were $485 thousand for the full year 2020, compared to $1.7 million for the full year 2019.  The decrease in research and development expenses for the full year 2020 was primarily due to the reduction of consultant and clinical expenses.  The Company anticipates clinical costs to increase significantly in 2021.

• General Administrative Expenses:  General administrative expenses were $2.0 million for the fourth quarter of 2020, compared to $0.9 million for the same period in 2019. General administrative expenses were $6.3 million for the full year 2020, compared to $9.8 million for the full year 2019.  The decrease in general administrative expenses for the full year 2020 was primarily attributable to the reduction of stock compensation costs.

• Net Income (Loss):  Net loss was $14.9 million for the fourth quarter of 2020, compared to a net loss of $1.5 million for the same period in 2019.  Net loss was $28.3 million for the full year 2020, resulting in basic and diluted net loss per share of $(6.45).  Net loss was $38.6 million for the full year 2019, resulting in basic and diluted net loss per share of $(11.42) before effect of reverse split. Net loss for the full year 2020 was attributable to a loss from operations of $6.8 million and total other expenses of $21.5 million.  Net loss for the full year 2019 was primarily attributable to the loss from operations of $16.0 million and total other expenses of $22.6 million.

About GTB-3550 TriKE™

GTB-3550 is the Company’s first TriKE™ product candidate being initially developed for the treatment AML.  GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15.  The natural killer (NK) cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill.  We intend to study GTB-3550 in CD33 positive leukemias such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies.

About GT Biopharma, Inc.

GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based on our proprietary TriKE™ NK cell engager platform.  Our TriKE™ platform is designed to harness and enhance the cancer killing abilities of a patient’s immune system’s natural killer cells (NK cells).  GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE™ technology. For more information, please visit gtbiopharma.com.

Forward-Looking Statements

This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict, including statements regarding the potential acquisition, the likelihood of closing the potential transaction, our clinical focus, and our current and proposed trials.  Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believes”, “hopes”, “intends”, “estimates”, “expects”, “projects”, “plans”, “anticipates” and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking.  Our forward-looking statements are not a guarantee of performance, and actual results could differ materially from those contained in or expressed by such statements.  In evaluating all such statements, we urge you to specifically consider the various risk factors identified in our Form 10-K for the fiscal year ended December 31, 2020, in the section titled “Risk Factors” in Part I, Item 1A, filed with the Securities and Exchange Commission (the “SEC”) on April 16, 2021 any of which could cause actual results to differ materially from those indicated by our forward-looking statements.

Our forward-looking statements reflect our current views with respect to future events and are based on currently available financial, economic, scientific, and competitive data and information on current business plans.  You should not place undue reliance on our forward-looking statements, which are subject to risks and uncertainties relating to, among other things:  (i) the sufficiency of our cash position and our ongoing ability to raise additional capital to fund our operations, (ii) our ability to complete our contemplated clinical trials, or to meet the FDA’s requirements with respect to safety and efficacy, (iii) our ability to identify patients to enroll in our clinical trials in a timely fashion, (iv) our ability to achieve approval of a marketable product, (v) design, implementation and conduct of clinical trials, (vii) the results of our clinical trials, including the possibility of unfavorable clinical trial results, (vii) the market for, and marketability of, any product that is approved, (viii) the existence or development of treatments that are viewed by medical professionals or patients as superior to our products, (ix) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, and social conditions, and (x) various other matters, many of which are beyond our control.  Should one or more of these risks or uncertainties develop, or should underlying assumptions prove to be incorrect, actual results may vary materially and adversely from those anticipated, believed, estimated, or otherwise indicated by our forward-looking statements.

We intend that all forward-looking statements made in this press release will be subject to the safe harbor protection of the federal securities laws pursuant to Section 27A of the Securities Act, to the extent applicable.  Except as required by law, we do not undertake any responsibility to update these forward-looking statements to take into account events or circumstances that occur after the date of this press release.  Additionally, we do not undertake any responsibility to update you on the occurrence of any unanticipated events which may cause actual results to differ from those expressed or implied by these forward-looking statements.

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SOURCE GT Biopharma, Inc.

BEIJING, April 19, 2021 /PRNewswire/ — Scienjoy Holding Corporation (“Scienjoy”, the “Company”) (NASDAQ: SJ), a leading live entertainment mobile streaming platform in China, today announced that it has entered into a strategic partnership with Jiada Hexin (Beijing) Science and Technology Ltd. (“Jiada Hexin”), an online-to-offline (O2O) aesthetic medicine platform. The two companies will launch a live streaming aesthetic medicine platform that uses Scienjoy’s proprietary technologies to bring together customers, live streaming broadcasters and aesthetic medicine institutions.

In China trusted live streaming influencers are helping consumers navigate the new and complex world of aesthetic medicine. At the same time, institutions are increasingly moving online to places like Jiada Hexin’s O2O platform to connect efficiently with consumers, while consumers seek out these platforms to keep up to date with new aesthetic treatments. Online and live stream influencers have become a key part of aesthetic medicine marketing, offering personal experience sharing that has demystified the process, increased transparency and ultimately helped consumers make more informed decisions. According to the 2021 “China Aesthetic Medicine Market Outlook Report” jointly released by Deloitte and Meituan, China’s aesthetic medicine market already reached RMB197.5 billion in 2020 and by 2023 is expected to exceed RMB300 billion. Backed by growing consumer acceptance and low market penetration, the sector presents outsized opportunities for growth.  

Scienjoy and Jiada Hexin’s joint aesthetic medicine platform will combine Jiada Hexin’s existing network of over 200 certified institutions with Scienjoy’s pool of over 300,000 seasoned live streaming broadcasters. The majority of Scienjoy’s broadcasters fit the core aesthetic medicine demographic: women in their 20s and 30s with disposable income who are interested in maintaining a healthy and young appearance. This new platform will allow existing live streaming broadcasters to engage with viewers and attract new beauty broadcasters. In 2019, Scienjoy began incubating medical aesthetics-related initiatives to test popularity with broadcasters and existing users. The current iteration, the LikeMei Mini Program launched in November last year, has been integrated and tested on Scienjoy’s platforms and shown strong positive user feedback.

On the technical and feature side, the new aesthetic medicine platform will use Scienjoy’s proprietary artificial intelligence (AI) image analysis technology to help interested customers explore treatment options. AI has become a core component of Scienjoy’s business, with proprietary AI technology a key pillar of its live streaming platforms and an area of continued research and development. When users upload photos or videos to the platform, Scienjoy’s AI image analysis will accurately identify areas for attention, suggest different treatment options to the user and provide before and after image comparisons. The AI-generated “after” image will let early-stage potential customers explore and learn about their options before they are ready to contact a treatment provider. Combined with live streaming broadcaster personal experience sharing, and the ability of users to talk with aesthetic medicine professionals directly on the platform, AI technology helps to provide a well-rounded experience for users to explore and learn. These AI and broadcaster tools will help users to learn about the options and outcomes even before they connect with one of the over 200 aesthetic medicine institutions in Jiada Hexin’s network.

“We believe that with a combination of Scienjoy’s proprietary technologies, talented broadcasters and Jiada Hexin’s O2O aesthetic medicine experience, our strategic cooperation will create value for both sides,” commented Victor He, chairman and CEO of Scienjoy. “This partnership demonstrates how Scienjoy continues to look for new applications for our proprietary technology to generate growth and expand our industry reach.”

About Scienjoy Holding Corporation

Founded in 2011, Scienjoy is a leading mobile live streaming platform in China, and its core mission is to build a live streaming service matrix that delivers pleasant experience to users. With approximately 250 million registered users, Scienjoy currently operates four brands of live streaming platforms, consisting of: Showself, Lehai, Haixiu, and BeeLive (including Mifeng, BeeLive Chinese version, and BeeLive International for international markets). Scienjoy adopts multi-platform operation strategies and is committed to providing high quality and value-added services for users with innovative thinking. Based on the in-depth understanding and research of the live streaming industry and user behavior, Scienjoy is devoted to building a second life world in which the virtual world and the reality are integrated within the live streaming scenario, deeply integrating the industry through diversified live broadcasting scenarios, and empowering the industry by building a content-rich and vibrant Live Streaming Full Ecosystem. For more information, please visit http://ir.scienjoy.com/.

About Jiada Hexin (Beijing) Science and Technology Ltd. (“Jiada Hexin”)

Jiada Hexin, headquartered in Beijing, is an O2O aesthetic platform that connects consumers with over 200 institutions across mainland China. The platform serves to let consumers explore and research aesthetic medicine products and institutions. Jiada Hexin is committed to creating an integrated aesthetics medicine service platform to meet the diverse and personalized needs of its customers and help respected institutions efficiently reach their target audience.

Safe Harbor Statement

Certain statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the Company’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. Important factors, among others, are: the ability to manage growth; ability to identify and integrate other future acquisitions; ability to obtain additional financing in the future to fund capital expenditures; fluctuations in general economic and business conditions; costs or other factors adversely affecting our profitability; litigation involving patents, intellectual property, and other matters; potential changes in the legislative and regulatory environment; a pandemic or epidemic. The forward-looking statements contained in this release are also subject to other risks and uncertainties, including those more fully described in the Company’s filings with the Securities and Exchange Commission (“SEC”) from time to time. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. Such information speaks only as of the date of this release.

Media Relations Contact

Greta Bradford

ICR Inc.
[email protected]
+86 178-8882-8731

Investor Relations Contacts

Ray Chen

VP, Investor relations
Scienjoy Holding Corporation
+86-010-64428188
[email protected]

Jack Wang

ICR Inc.
+1 (212) 537-9254
[email protected] 

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SOURCE Scienjoy Holding Corporation

THOUSAND OAKS, Calif., April 19, 2021 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced the launch of Biomarker Assist™, a program to help more patients with metastatic (stage IV) non-small cell lung cancer (NSCLC) gain access to biomarker testing. Biomarker testing at the time of diagnosis is a critical first step in getting patients on the right treatment. Through Biomarker Assist™, eligible patients may save on biomarker testing.

Professional clinical guidelines, including the College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), the Association for Molecular Pathology (AMP) and the American Society of Clinical Oncology (ASCO) recommend comprehensive biomarker testing of multiple genes simultaneously—for both actionable and emerging biomarkers—for patients diagnosed with advanced NSCLC regardless of clinical characteristics such as age, race or smoking status.¹

“Approximately half of all patients with non-small cell lung cancer have oncogene biomarkers, yet despite the integral role that biomarkers play in lung cancer to identify patients who may benefit from targeted therapies, many patients are not tested,” said Darryl Sleep, M.D., chief medical officer and senior vice president of Global Medical at Amgen.^2,3 “Amgen is excited to launch Biomarker Assist™, a patient support program that demonstrates our commitment to closing the gap in testing rates. Based on a patient’s biomarker status, clinicians and patients can make informed decisions on personalized treatment plans and targeted therapies which have significantly improved the prognosis for many patients.”

NSCLC is a heterogeneous disease associated with different driver mutations that are responsible for cancer development and growth.¹ There are currently seven different actionable driver mutations in NSCLC with a number of emerging therapies under investigation for other molecular mutational drivers, including KRAS.

“The advancement of personalized medicine has transformed the treatment of lung cancer leading to the development of innovative targeted immunotherapies and personalized treatment plans for patients,” said Jennifer C. King, Ph.D., chief scientific officer of GO2 Foundation for Lung Cancer. “Over the last decade, the cancer community has learned a great deal about precision medicine, particularly for non-small cell lung cancer, but if patients aren’t getting comprehensive biomarker testing, then they are less likely to benefit from all of the therapeutic advancements. We welcome programs like Amgen’s Biomarker Assist™ because we need support from all stakeholders, including industry, so that comprehensive biomarker testing becomes universal for everyone who is diagnosed with lung cancer.”

About Amgen Biomarker Assist™
Biomarker Assist™ is comprised of two programs: the Next Generation Sequencing (NGS) Affordability Program and the KRAS Single Gene Test (SGT) Program. The NGS Affordability Program offers assistance to eligible patients with out-of-pocket costs for a comprehensive biomarker panel for patients who have advanced or metastatic (stage IV) NSCLC. This panel must include the KRAS gene. The program is for commercially or privately insured patients. The KRAS Single Gene Test Program will provide a KRAS Mutation Analysis at no cost to any eligible patient, regardless of a patient’s results and insurance. Patients will receive results from participating NeoGenomics Laboratories. Both programs are valid for testing performed through Dec. 31, 2021. To learn more about eligibility for these programs and read the full Terms and Conditions, visit www.BiomarkerAssist.com or contact 1-888-4ASSIST with questions.

About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do. 

For more information, follow us on www.twitter.com/amgenoncology.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or any collaboration to manufacture therapeutic antibodies against COVID-19), or the integration of Otezla^® (apremilast) into our business (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Global economic conditions may magnify certain risks that affect our business.  Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.

CONTACT: Amgen, Thousand Oaks
Megan Fox, 805-447-1423 (media)
Arvind Sood, 805-447-1060 (investors)

References

1. Pennell NA, Arcila ME, Gandara DR, West H. Biomarker Testing for Patients With Advanced Non-Small Cell Lung Cancer: Real-World Issues and Tough Choices. Am Soc Clin Oncol Educ Book. 2019;39:531-542.
2. Pakkala S, et al. JCI Insights. 2018;3:e120858.
3. Gutierrez ME, Choi K, Lanman RB, et al. Genomic Profiling of Advanced Non-Small Cell Lung Cancer in Community Settings: Gaps and Opportunities. Clin Lung Cancer. 2017;18:651-659.

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SOURCE Amgen

WARRINGTON, Pa., April 19, 2021 /PRNewswire/ — Windtree Therapeutics, Inc. (NasdaqCM: WINT) (“Windtree” or the “Company”), a biotechnology and medical device company focused on advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders, today announced it has filed a Track One prioritized application with the United States Patent and Trademark Office (USPTO) for a patent stemming from an application it filed previously under the Patent Cooperation Treaty (PCT). Under this USPTO program, the new istaroxime patent is expected to receive examination and final disposition within one year of priority status being granted, rather than the customary three years of examination anticipated by the USPTO for non-prioritized examinations.

Windtree is taking steps to strengthen the istaroxime patent estate since it is the Company’s lead pipeline asset. “With such high unmet need for patients in the disease areas we are studying istaroxime, we are focusing on ensuring our patent estate has the most protection possible. If we are successful in our clinical studies and eventually gain regulatory approval, our plan is for istaroxime to be well prepared and protected in the commercialization stage,” said Craig Fraser, CEO and President of Windtree. Istaroxime is currently being developed in early cardiogenic shock and in acute heart failure (AHF).

Early cardiogenic shock is a life-threatening state of lack of heart function and blood flow to vital organs that is associated with high risk of mortality, despite intensive monitoring and current treatments. Based on the need in this area, regulatory precedent exists for an approval in shock settings based upon improvements in blood pressure with an acceptable safety profile. The Company is currently executing an international randomized double blind placebo controlled study to assess the effect of istaroxime in patients with early cardiogenic shock due to heart failure. This study will include 60 patients (30 assigned to istaroxime and 30 assigned to placebo) receiving study drug infusion over 24 hours. The primary endpoint will evaluate systolic blood pressure over six hours after initiating the infusion. Secondary endpoints will include characterization of blood pressure changes over 24 hours, the number of patients requiring rescue therapy (vasopressors, inotropes or mechanical devices), assessment of renal function and measures associated with safety and tolerability.

After successfully completing positive phase 2a and phase 2b studies in acute heart failure, the next steps in development are focused on optimizing therapy and employing study enrichment strategies to create a strong phase 3 and partnership position. With adequate resources, we plan to conduct an additional phase 2b clinical trial that will enroll approximately 300 patients globally. The trial will focus on enrolling acute heart failure patients with low blood pressure and those who are diuretic resistant, two of the specific patient populations that we believe could particularly benefit from the unique profile and potential ability of istaroxime to increase cardiac function, increase blood pressure and improve renal function. This trial has been designed to collect data on measures that may serve as primary endpoints in a phase 3 clinical trial, and will potentially extend the infusion time beyond 24 hours. The company is currently preparing for the trial start and to secure full clinical funding for the trial with a focus on business development and partnership.

About Windtree Therapeutics

Windtree Therapeutics, Inc. is advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders to treat patients in moments of crisis. Using new clinical approaches, Windtree is developing a multi-asset franchise anchored around compounds with an ability to activate SERCA2a, with lead candidate istaroxime being developed as a first-in-class treatment for acute heart failure and early cardiogenic shock in heart failure. Windtree has also focused on developing AEROSURF® as a non-invasive surfactant treatment for premature infants with respiratory distress syndrome, and is facilitating transfer of clinical development of AEROSURF® to its licensee in Asia, Lee’s HK, while Windtree evaluates other uses for its synthetic KL4 surfactant for the treatment of acute pulmonary conditions including lung injury due to viral, chemical and radiation induced insults. Also in its portfolio is rostafuroxin, a novel precision drug product targeting hypertensive patients with certain genetic profiles.

For more information, please visit the Company’s website at www.windtreetx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Examples of such risks and uncertainties include: risks and uncertainties associated with the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the Company’s clinical trials or disruption in supply chain; the success and advancement of the clinical development programs for istaroxime, AEROSURF®, KL4 surfactant and the Company’s other product candidates; the Company’s ability to secure significant additional capital as and when needed; the Company’s ability to access the debt or equity markets; the Company’s ability to manage costs and execute on its operational and budget plans; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; risks related to technology transfers to contract manufacturers and manufacturing development activities; delays encountered by the Company, contract manufacturers or suppliers in manufacturing drug products, drug substances, aerosol delivery systems (ADS) and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including that: (i) the FDA or other regulatory authorities may not agree with the Company on matters raised during regulatory reviews, may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of the Company’s product candidates, and (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals and risks related to the Company’s efforts to maintain and protect the patents and licenses related to its product candidates; risks related to the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; and the rate and degree of market acceptance of the Company’s product candidates, if approved. These and other risks are described in the Company’s periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release
 

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SOURCE Windtree Therapeutics, Inc.

DENVER, April 19, 2021 /PRNewswire/ – SSR Mining Inc. (NASDAQ: SSRM) (TSX: SSRM) (ASX: SSR) (“SSR Mining” or the “Company”) today announced that it has received acceptance from the Toronto Stock Exchange (“TSX”), to initiate a Normal Course Issuer Bid (the “NCIB”) permitting SSR Mining to purchase for cancellation up to 10,000,000 common shares of the Company (“Common Shares”), representing 4.5% of SSR Mining’s total issued and outstanding Common Shares. As of April 9, 2021, SSR Mining had 220,193,975 issued and outstanding Common Shares.  

SSR Mining believes that the market price of its Common Shares does not always reflect its underlying fundamental value and future growth prospects. SSR Mining’s purchase of its Common Shares under the NCIB will supplement the existing base dividend and is part of its previously announced capital allocation framework for returning excess cash to shareholders.

SSR Mining may purchase Common Shares under the NCIB over the next twelve-month period beginning April 21, 2021 and ending April 20, 2022. Any purchases made under the NCIB will be effected through the facilities of the TSX, NASDAQ and/or alternative Canadian and United States trading systems. Any purchases made pursuant to the NCIB will be made in accordance with the rules of the TSX and will be made at market price at the time of purchase. Under the NCIB, other than purchases made under block purchase exemptions, the Company may purchase up to 144,221 Common Shares on the TSX during any trading day, which represents approximately 25% of 576,887 Common Shares, such number being the average daily trading volume on the TSX for the most recently completed six calendar months prior to the TSX’s acceptance of the notice of the NCIB.

In connection with the NCIB, the Company has entered into an automatic share purchase plan with a designated broker (the “ASPP”). The ASPP is intended to allow for the purchase of Common Shares under the NCIB at times when it would ordinarily not be permitted to purchase shares due to regulatory restrictions and customary self-imposed blackout periods.  The ASPP is also intended to meet the requirements of a Rule 10b5-1 trading plan under the U.S. Securities Exchange Act of 1934, and transactions under the ASPP will be conducted in accordance with Rule 10b-18 under the U.S. Securities Exchange Act of 1934.

About SSR Mining

SSR Mining Inc. is a leading, free cash flow focused intermediate gold company with four producing assets located in the USA, Turkey, Canada, and Argentina, combined with a global pipeline of high-quality development and exploration assets in the USA, Turkey, Mexico, Peru, and Canada. In 2020, the four operating assets produced approximately 711,000 gold-equivalent ounces.  SSR Mining is listed under the ticker symbol SSRM on the NASDAQ and the TSX, and SSR on the ASX.

SSR Mining Contacts

F. Edward Farid, Executive Vice President, Chief Corporate Development Officer 

SSR Mining Inc. 
E-Mail: [email protected]
Phone: +1 (888) 338-0046 or +1 (604) 689-3846

To receive SSR Mining’s news releases by e-mail, please register using the SSR Mining website at

www.ssrmining.com

.

Cautionary Note Regarding Forward-Looking Statements

This news release includes certain statements that constitute forward-looking information within the meaning of applicable securities laws, including statements related to the Company’s NCIB and ASPP (“forward-looking statements”). All statements in this news release, other than statements of historical fact, which address events, results, outcomes or developments that SSR Mining expects to occur are forward-looking statements. Forward-looking statements are generally, but not always, identified by the use of forward-looking terminology such as “expects”, is “expected”, “anticipates”, “plans” or “is planned”, “trends”, “estimates”, “intends” or “potential” or variations of such words and phrases and similar expressions or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved or the negative connotation of such terms.

SSR Mining cautions readers not to place undue reliance on the forward-looking statements in the information and content on this news release as a number of factors could cause actual future results, conditions, actions or events to differ materially from the targets, outlooks, expectations, goals, estimates or intentions expressed in the forward-looking statements. These factors include, but are not limited to: changes in the Company’s cash position and its ability to repurchase shares, changes in the financial markets, changes in applicable laws and governmental regulations, fluctuations in the price of gold, fluctuations in relative currency values, risks related to obtaining and maintaining necessary permits and the unpredictability of and fluctuation in the trading price of the Company’s common shares.

Additional risk factors and details with respect to risk factors affecting the Company are set out in the Company’s latest Annual Information Form and MD&A, each under the heading “Risk Factors”, available on the SEDAR website at www.sedar.com or on EDGAR at www.sec.gov. The foregoing should be reviewed in conjunction with the information found in this news release. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether written or oral, or whether as a result of new information, future events or otherwise, except as required by applicable law.

All references to “$” in this press release are to U.S. dollars unless otherwise stated.

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SOURCE SSR Mining Inc.

MCKINNEY, Texas, April 19, 2021 /PRNewswire/ — Globe Life Inc. (NYSE: GL) will release First Quarter 2021 earnings after the market closes on Wednesday, April 21, 2021.  At that time a copy of the Company’s Q1 – 2021 earnings press release and any other financial and statistical information about the quarter will be available on the Company’s website at https://investors.globelifeinsurance.com/ under Financial Reports and Other Financial Information.  In conjunction with the First Quarter 2021 Earnings Release of Globe Life Inc. you are invited to listen to a conference call that will be broadcast live over the Internet on Thursday, April 22, 2021 at 11:00 am Eastern (10:00 am Central).

First Quarter Conference Call


Thursday, April 22, 2021



11:00 a.m. (Eastern)

Listen live and as a replay at
https://investors.globelifeinsurance.com/
under Calls and Meetings

or

Call-In Number: 

1-334-323-0501

(Pass Code:  Globe Life Inc.)

Globe Life Inc. is a holding company specializing in life and supplemental health insurance for “middle income” Americans marketed through multiple distribution channels including direct to consumer, and exclusive and independent agencies. 

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SOURCE Globe Life Inc.