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Lexicon Welcomes New ESC Heart Failure Treatment Guidelines Establishing SGLT Inhibitors as Standard of Care

New guidelines from the European Society of Cardiology recommend addition of SGLT inhibitors to standard of care for patients with acute and chronic heart failure.

Guidance underscores the benefits of SGLT inhibitors in significantly reducing risk of death due to cardiovascular causes or heart failure hospitalization.

THE WOODLANDS, Texas, Aug. 30, 2021 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) welcomes the new recommendation by the European Society of Cardiology (ESC) to add SGLT inhibitors as part of the standard of care for the prevention and treatment of heart failure (HF). SGLT inhibitors have been given a Class IA recommendation– the strongest endorsement– in updated clinical practice guidelines released by the ESC Heart Failure working group in the EU at its annual meeting, the ESC Congress 2021 – The Digital Experience.

Specifically, the guidelines recommend the following for the primary prevention of HF in patients with risk factors for its development:

  • “SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, sotagliflozin) are recommended in patients with diabetes at high risk of cardiovascular (CV) disease or with CV disease in order to prevent HF hospitalizations.”

The guidelines recommend the following for the treatment of patients with HF and diabetes or for the treatment of diabetes in HF:

  • “SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, sotagliflozin) are recommended in patients with type 2 diabetes mellitus (T2DM) at risk of CV events to reduce hospitalizations for HF, major CV events, end-stage renal dysfunction, and CV death.”
  • “SGLT2 inhibitors (dapagliflozin, empagliflozin, and sotagliflozin) are recommended in patients with T2DM and heart failure with reduced ejection fraction (HFrEF) to reduce hospitalizations for HF and CV death.”

The guidelines also addressed worsening heart failure, noting:

  • “The combined SGLT-1 and 2 inhibitor, sotagliflozin, has also been studied in patients with diabetes who were hospitalized with HF. The drug reduced CV death and hospitalization for HF.”
  • “Safety and better outcome have also been recently shown in a prospective randomized trial with sotagliflozin in diabetic patients hospitalized for HF, irrespective of their left ventricular ejection fraction (LVEF).”

“It is quite rare for an investigational drug to be listed in the guidelines prior to regulatory approval and we do not take the trust and confidence that ESC has placed in sotagliflozin lightly,” said Craig Granowitz, M.D., Ph.D., senior vice president and chief medical officer at Lexicon. “We know patients with heart failure suffer reduced quality of life and remain at high risk of hospitalization or death, and these new guidelines are a strong call to action to ensure patients receive the most effective therapies for acute and chronic heart failure. We continue to work diligently for these patients and plan to submit a New Drug Application with the U.S. Food and Drug Administration later this year for its review of sotagliflozin, as a therapy for people suffering from heart failure and living with type 2 diabetes.”

The full 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure can be found at escardio.org.

About Sotagliflozin

Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Sotagliflozin is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy, but has not yet been commercially launched. Sotagliflozin is not approved for use in any other indications, including heart failure.

About Lexicon Pharmaceuticals

Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through its Genome5000™ program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon advanced one of these medicines to market and has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, heart failure, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com.

Safe Harbor Statement

This press release contains “forward-looking statements,” including statements relating to Lexicon’s clinical development of and regulatory filings for sotagliflozin and the therapeutic and commercial potential of sotagliflozin.
This press release also contains forward-looking statements relating to Lexicon’s financial position and long-term outlook on its business, including the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of LX9211 and its other potential drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of LX9211, sotagliflozin and its other potential drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

For Inquiries:

Chas Schultz
Executive Director, Corporate Communications and Investor Relations
Lexicon Pharmaceuticals
(281) 863-3421
[email protected]



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Distinguished Scientific and Public Health Leaders to Join Enochian BioSciences’ Scientific Advisory Board for Potential Inhaled Treatment and Prevention of All COVID-19 and Influenza Variants

LOS ANGELES, Aug. 30, 2021 (GLOBE NEWSWIRE) — (NASDAQ: ENOB) – Enochian BioSciences, a company focused on gene-modified cellular and immune therapies for infectious diseases and cancer, announced the appointment of internationally renowned scientists and public health leaders to a Scientific Advisory Board (SAB) focused on potential inhaled treatment and prevention of any current or future variants of SARS-CoV-2 – the virus that causes COVID-19 – and Influenza.


  • Dr. Peter Pio
    t
    , KCMG, FRCP, FMedSci, Chairperson
     of the SAB, is the Handa Professor of Global Health, London School of Hygiene and Tropical Medicine, former founding Director of UNAIDS and co-discoverer of the Ebola virus. He is also a member of the US National Academy of Medicine.


  • Dr. Richard Whitley, MD
    , Distinguished Professor, University of Alabama Birmingham, is a leading basic and clinical researcher who has published more than 380 scientific articles.

“I have been working on pandemics for over 40 years, and was blown away by the brilliant creativity of the inventor, Dr. Serhat Gumrukçu, and the sophistication and elegance of the scientific approach to potentially treat and prevent any variants of SARS-CoV-2 and Influenza,” said Dr. Piot. “If the impressive results in animal models are confirmed in people, there is the potential to contribute significantly to fighting COVID-19. Perhaps as important, it is possible that Enochian’s products could prevent future pandemic threats from corona- and influenza viruses.”

“I am excited to be involved with Enochian BioSciences as they try to move quickly to advance products that could potentially be important to control and, ultimately end, the COVID-19 pandemic,” Dr. Whitley said. “The Delta variant reproduces so quickly that even vaccinated people with no symptoms can have as much virus in their airways as unvaccinated people, contributing to rapid spread. Enochian’s unique and innovative approach to kill cells infected with the virus in the nose, mouth and lungs could potentially both limit illness but also spread for a win-win.”

Dr. Mark Dybul, Enochian’s CEO said, “We are thrilled that some of the top experts in the world seem as excited as we are about the potential for our products to play a key role in combating COVID-19, but also the potential for them to help prevent two of the greatest pandemic threats for the future – Influenza and another Coronavirus. The experience and knowledge the SAB brings will help accelerate Enochian’s efforts to advance the research and, we hope, ultimately to save lives.”

About Enochian BioSciences, Inc.

Enochian BioSciences, Inc. is a biopharmaceutical company focused on developing innovative platforms for gene-modified cellular and immune therapies to potentially cure and treat deadly diseases. The company’s gene-modified cell and immune therapy platforms can potentially be applied to multiple indications, including HIV/AIDS, Hepatitis B, all Corona and Influenza viruses, and Oncology. For more information, please visit Enochianbio.com
  
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties, including but not limited to the success or efficacy of our pipeline. All statements other than historical facts are forward-looking statements, which can be identified by the use of forward-looking terminology such as “believes,” “plans,” “expects,” “aims,” “intends,” “potential,” or similar expressions. Actual events or results may differ materially from those projected in any of such statements due to various uncertainties, including as set forth in Enochian BioSciences’ most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Enochian BioSciences undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.



Contact: [email protected]

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Cleveland-Cliffs Announces Executive Management Promotions

Cleveland-Cliffs Announces Executive Management Promotions

CLEVELAND–(BUSINESS WIRE)–
Cleveland-Cliffs Inc. (NYSE: CLF) todayannounced the promotion of three key leaders at the executive level, effective September 1, 2021. The announcement comes as Cliffs seeks to broaden its already robust raw material portfolio by expanding its scrap recycling presence, an activity that will fall under a newly created division named Cleveland-Cliffs Services. The ongoing steel business stays within Cleveland-Cliffs Steel, an already existing Cleveland-Cliffs Inc.’s division.

  • Clifford T. Smith, currently EVP, Chief Operating Officer, has been promotedto EVP & President, Cleveland-Cliffs Steel. He will continue to lead operations and commercial for all business segments including Steelmaking, Tooling and Stamping, and Tubular Components.
  • Keith A. Koci,currently EVP, Chief Financial Officer, has been promoted to EVP & President, Cleveland-Cliffs Services. He will assume corporate responsibility for procurement, logistics, IT, and scrap recycling. He will lead the growth of Cliffs’ raw material portfolio, with a primary emphasis on expanding Cliffs’ presence in the domestic scrap recycling market.
  • Celso L. Goncalves, currently SVP, Finance & Treasurer, has been promoted to EVP, Chief Financial Officer. He will lead the financial organization for Cleveland-Cliffs Inc., assuming executive responsibility for Finance, Accounting, Tax, Treasury and Investor Relations. He will also continue to lead key strategic corporate and business development initiatives.

All three individuals will report directly to Lourenco Goncalves, Cleveland-Cliffs Inc. Chairman, President and CEO, who said, “Today’s announcement represents the formation of the ideal leadership structure for our recently transformed company going forward, with promotions to the three members of my core team. Cliff Smith, Keith Koci and Celso Goncalves have been critical contributors to our remarkable transformation over the past two years, and I will rely on them to continue to execute on our strategic objectives. I plan to be in this seat for the long term, and the collaboration of these three executives and their work with me are paramount to the continued success of our company.”

Mr. Goncalves added, “First, Cliff has been and will continue to be my second in command at Cleveland-Cliffs, and the success of the integration of our two major acquisitions speaks to his effective leadership. Second, in this new era of steel decarbonization, scrap will become precious metal, and Keith’s deep background in M&A makes him the perfect person to lead this venture. And finally, through his successful career both in investment banking and here at Cliffs leading our capital structure transformation initiatives, Celso has perfected the skills I need in a CFO at this time.”

Executive Biographies

Clifford T. Smith joined Cleveland-Cliffs in 2003, and has served as Executive Vice President, Chief Operating Officer (January 2019 – present); and Executive Vice President, Business Development (April 2015 – January 2019). Prior to these roles, he has also held various senior management positions including oversight of Seaborne Iron Ore, Latin American Operations and Cliffs Michigan Operations. Prior to joining Cliffs, Mr. Smith held mine management positions with Asarco, Southern Peru Copper Corporation, and Amax Coal. He received a B.S. in mining engineering from the South Dakota School of Mines and Technology.

Keith A. Koci joined Cleveland-Cliffs in 2019, and has served as Executive Vice President, Chief Financial Officer for his entire tenure. Prior to joining Cliffs, Mr. Koci served most recently as Senior Vice President and Chief Financial Officer for Metals USA. He also previously held the roles of Senior Vice President, Business Development; Vice President, Corporate Controller; Director of Budgeting; and Regional Controller for Metals USA. Mr. Koci graduated from the University of Illinois – Chicago with a B.S. in Business Administration.

Celso L. Goncalves joined Cleveland-Cliffs in 2016, and has served as Senior Vice President, Finance & Treasurer (March 2020 – Present); Vice President, Treasurer (December 2017 – March 2020); and Assistant Treasurer (September 2016 – December 2017). Prior to joining Cliffs, Mr. Goncalves worked in Investment Banking at Deutsche Bank in New York and at Jefferies in New York and São Paulo, Brazil. Mr. Goncalves earned his M.B.A. from the Tepper School of Business at Carnegie Mellon University and his B.S. from the Marshall School of Business at the University of Southern California.

About Cleveland-Cliffs Inc.

Cleveland-Cliffs is the largest flat-rolled steel producer in North America. Founded in 1847 as a mine operator, Cliffs also is the largest manufacturer of iron ore pellets in North America. The Company is vertically integrated from mined raw materials and direct reduced iron to primary steelmaking and downstream finishing, stamping, tooling, and tubing. The Company serves a diverse range of markets due to its comprehensive offering of flat-rolled steel products and is the largest supplier of steel to the automotive industry in North America. Headquartered in Cleveland, Ohio, Cleveland-Cliffs employs approximately 25,000 people across its mining, steel and downstream manufacturing operations in the United States and Canada. For more information, visit www.clevelandcliffs.com.

MEDIA CONTACT:

Patricia Persico

Director, Corporate Communications

(216) 694-531

INVESTOR CONTACT:

Paul Finan

Vice President, Investor Relations

(216) 694-654

KEYWORDS: Ohio United States North America

INDUSTRY KEYWORDS: Natural Resources Aftermarket Steel Automotive Engineering Automotive Manufacturing Mining/Minerals Manufacturing

MEDIA:

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Agios To Present at September Investor Conferences

CAMBRIDGE, Mass., Aug. 30, 2021 (GLOBE NEWSWIRE) — Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism developing and delivering innovative treatments for genetically defined diseases, today announced that the company is scheduled to present at the following September investor conferences:

  • Citi’s 16

    th

    Annual Biopharma Virtual Conference 
    Panel: Sickle Cell, Beta-Thal, ITP & PKD – Measuring Industry Progress in Benign Hematology
    Friday, September 10 at 12:30 p.m. ET
  • 2021 Cantor Virtual Global Healthcare Conference 
    Monday, September 27 at 8:00 a.m. ET

Live webcasts of the presentations can be accessed under “Events & Presentations” in the Investors section of the company’s website at www.agios.com. Replays of the webcasts will be archived on the Agios website for at least two weeks following each presentation.

About Agios

Agios is focused on discovering and developing novel investigational medicines to treat genetically defined diseases through scientific leadership in the field of cellular metabolism. The company’s most advanced drug candidate is a first-in-class pyruvate kinase R (PKR) activator, mitapivat, that is currently being evaluated for the treatment of three distinct hemolytic anemias. In addition to its active late-stage clinical pipeline, Agios has multiple novel, investigational therapies in clinical and preclinical development. For more information, please visit the company’s website at www.agios.com.

Contacts

Investors:

1AB
Steve Klass
[email protected]

Media:

Jessi Rennekamp, 857-209-3286
Director, Corporate Communications
[email protected] 



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VBL Therapeutics Resumes U.S. Enrollment in OVAL Phase 3 Trial as FDA Authorizes Clinical Use of VB-111 Batches Produced in Modiin Facility

  • U.S. FDA CMC clearance of VB-111 produced in Modiin, Israel facility an important milestone toward potential commercialization
  • OVAL Phase 3 trial evaluating VB-111 in platinum resistant ovarian cancer has recruited nearly 80% of target enrollment; remains on track to complete enrollment in 1Q22
  • OVAL PFS readout expected in 2H22 may support BLA submission

TEL AVIV, Israel, Aug. 30, 2021 (GLOBE NEWSWIRE) — VBL Therapeutics (NASDAQ: VBLT) today announced enrollment of new patients in VB-111 studies in the Unites States will resume immediately following authorization by the U.S. Food and Drug Administration (FDA) Chemistry, Manufacturing and Controls (CMC) Group to use new batches of ofranergene obadenovec (VB-111) produced in VBL’s commercial-scale GMP Modiin, Israel facility in clinical studies in the United States.

In June, VBL was notified by the FDA that clearance of new VB-111 batches for clinical use in the United States was pending the completion of a technical review by the CMC group, which focused on the comparability of VB-111 manufacturing between different source sites. VBL prepared and submitted the requested data and documentation to the FDA in early August and the FDA has now provided clearance for VBL to use new batches of VB-111 produced in its commercial-scale facility located in Modiin, Israel. VBL has sufficient FDA-cleared batches and will resume patient recruitment in the OVAL trial in the United States.

The OVAL trial evaluating VB-111 in ovarian cancer is planned to enroll approximately 400 patients globally and nearly 80% of patients have already been recruited. The trial has two primary endpoints: progression free survival (PFS) and overall survival (OS). Successfully meeting either primary endpoint has the potential to support a biologics license application (BLA). Meeting the PFS endpoint, with a readout anticipated in the second half of 2022, could accelerate BLA submission by approximately one year, subject to discussions with the FDA, compared to original projections based on the readout of the OS primary endpoint that remains anticipated in 2023.

About VB-111 (ofranergene obadenovec; `ofra-vec`)

VB-111 is an investigational anti-cancer gene-therapy agent in development to treat a wide range of solid tumors. VB-111 is a unique biologic agent designed to use a dual mechanism to target solid tumors. Its mechanism combines the blockade of tumor vasculature with an anti-tumor immune response. VB-111 is administered as an IV infusion once every 6-8 weeks. It has been observed in past clinical research to be generally well-tolerated in >300 cancer patients and demonstrated activity signals in an “all comers” Phase 1 trial as well as in three tumor-specific Phase 2 studies. VB-111 has received orphan designation for the treatment of ovarian cancer by the European Commission. VB-111 has also received orphan drug designation in both the United States and Europe, and fast track designation in the United States, for prolongation of survival in patients with recurrent glioblastoma. VB-111 demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer and recurrent platinum-resistant ovarian cancer (NCT01711970).

About the OVAL Trial (

NCT03398655

)

OVAL (VB-111-701/GOG-3018) is an international Phase 3 randomized pivotal registration-enabling clinical trial comparing a combination of VB-111 and paclitaxel to placebo plus paclitaxel, in patients with platinum-resistant ovarian cancer. The trial is planned to enroll approximately 400 adult patients. OVAL is conducted in collaboration with the GOG Foundation, Inc., an independent international non-profit organization with the purpose of promoting excellence in the field of gynecologic malignancies.

About VBL Therapeutics

Vascular Biogenics Ltd., operating as VBL Therapeutics (VBL), is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for cancer and immune or inflammatory indications. VBL has developed three platform technologies: a gene-therapy based platform for targeting newly formed blood vessels with focus on cancer, an antibody-based platform targeting MOSPD2 for anti-inflammatory and immuno-oncology applications, and the lecinoxoids platform, comprised of a family of small-molecules for immune-related indications. VBL’s lead oncology product candidate, ofranergene obadenovec (VB-111; `ofra-vec`), is an investigational, first-in-class, targeted anti-cancer gene-therapy agent in development to treat a wide range of solid tumors. VB-111 is currently being studied in a Phase 3 registration-enabling trial for platinum-resistant ovarian cancer. To learn more about VBL Therapeutics, please visit vblrx.com or follow the company on LinkedIn, Twitter, YouTube or Facebook.

About The GOG Foundation, Inc.

The GOG Foundation, Inc. (GOG) is a not-for-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. The GOG is committed to maintaining the highest standards in clinical trials development, execution, analysis and distribution of results. The GOG is the only group in the United States that focuses its research on women with pelvic malignancies, such as cancer of the ovary, uterus and cervix. The GOG is multi-disciplinary in its approach to clinical trials, and includes gynecologic oncologists, medical oncologists, pathologists, radiation oncologists, nurses, statisticians, basic scientists, quality of life experts, data managers and administrative personnel.

Forward Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. These forward-looking statements may include, but are not limited to, statements regarding anticipated timing of PFS and OS readouts for OVAL trial of VB-111, ability of PFS readout to support BLA submission, and expected enrollment in the OVAL trial. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, the risk that historical clinical trial results may not be predictive of future trial results, that financial resources do not last for as long as anticipated, and that VBL may not realize the expected benefits of its intellectual property protection. In particular, the addition of PFS as a primary endpoint in the OVAL trial is not assurance that the trial will meet either of its primary endpoints, that it will do so within any particular time frame, or that VBL will obtain positive results to support any marketing application or further development of this candidate.  A further list and description of these risks, uncertainties and other risks can be found in VBL’s regulatory filings with the U.S. Securities and Exchange Commission, including in its annual report on Form 20-F for the year ended December 31, 2020, and subsequent filings with the SEC. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. VBL undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

CONTACT:

Catherine Day
+1-917-763-2709
[email protected]



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Rocket Pharmaceuticals Announces $26.4 Million Private Placement

Rocket Pharmaceuticals Announces $26.4 Million Private Placement

CRANBURY, N.J.–(BUSINESS WIRE)–
Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, today announces a securities purchase agreement with a fund affiliated with RTW Investments, LP, the Company’s largest shareholder, for the purchase of an aggregate of 812,516 shares of common stock, par value $0.01 per share, at a purchase price of $32.48 per share, the closing price on August 27, 2021, for aggregate gross proceeds of approximately $26.4 million to the Company before offering expenses. The private placement is expected to close on or about August 31, 2021, subject to the satisfaction of customary closing conditions. Rocket expects to use the net proceeds from the private placement to continue to advance and expand its pipeline of product candidates, for research and development expenses and for working capital.

The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the “SEC”) registering the resale of the common shares issued in the private placement upon the purchasers’ request.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation, or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

About Rocket Pharmaceuticals, Inc.

Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) (“Rocket”) is advancing an integrated and sustainable pipeline of genetic therapies that aim to correct the root cause of complex and rare childhood disorders. The company’s platform-agnostic approach enables it to design the best potential therapy for each indication, creating potentially transformative options for patients afflicted with rare genetic diseases. Rocket’s clinical programs using lentiviral vector (LVV)-based gene therapy are for the potential treatment of Fanconi Anemia (FA), a difficult to treat genetic disease that leads to bone marrow failure and potentially cancer, Leukocyte Adhesion Deficiency-I (LAD-I), a severe pediatric genetic disorder that causes recurrent and life-threatening infections which are frequently fatal, Pyruvate Kinase Deficiency (PKD) a rare, monogenic red blood cell disorder resulting in increased red cell destruction and mild to life-threatening anemia and Infantile Malignant Osteopetrosis (IMO), a bone marrow-derived disorder. Rocket’s first clinical program using adeno-associated virus (AAV)-based gene therapy is for Danon disease, a devastating, pediatric heart failure condition. For more information about Rocket, please visit www.rocketpharma.com.

Rocket Cautionary Statement Regarding Forward-Looking Statements

Various statements in this release concerning the closing of the private placement, the anticipated use of proceeds therefrom and expected sufficiency thereof, Rocket’s future expectations, plans and prospects, including without limitation, Rocket’s expectations regarding its guidance for 2021 in light of COVID-19, the closing of the private placement and Rocket’s uses therefrom, Rocket’s expected cash runway and Rocket’s ability to advance its integrated and sustainable pipeline of genetic therapies for rare childhood disorders, may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward-looking statements, which often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “will give,” “estimate,” “seek,” “will,” “may,” “suggest” or similar terms, variations of such terms or the negative of those terms. Although Rocket believes that the expectations reflected in the forward-looking statements are reasonable, Rocket cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Rocket’s ability to monitor the impact of COVID-19 on its business operations and take steps to ensure the safety of patients, families and employees, the interest from patients and families for participation in each of Rocket’s ongoing trials, our expectations regarding the delays and impact of COVID-19 on clinical sites, patient enrollment, trial timelines and data readouts, our expectations regarding our drug supply for our ongoing and anticipated trials, actions of regulatory agencies, which may affect the initiation, timing and progress of pre-clinical studies and clinical trials of its product candidates, Rocket’s dependence on third parties for development, manufacture, marketing, sales and distribution of product candidates, the outcome of litigation, and unexpected expenditures, as well as those risks more fully discussed in the section entitled “Risk Factors” in Rocket’s Annual Report on Form 10-K for the year ended December 31, 2020, filed March 1, 2021 with the SEC. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and Rocket undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Media

Kevin Giordano

Director, Corporate Communications

[email protected]

Investors

Mayur Kasetty, M.D.

Director, Business Development & Operations

[email protected]

KEYWORDS: New Jersey United States North America

INDUSTRY KEYWORDS: Biotechnology Pharmaceutical Genetics Health

MEDIA:

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Catalent to Extend Leadership in Rapidly Growing Nutraceuticals Market with Proposed $1 Billion Acquisition of Bettera, a Leading Gummies Manufacturer

Catalent to Extend Leadership in Rapidly Growing Nutraceuticals Market with Proposed $1 Billion Acquisition of Bettera, a Leading Gummies Manufacturer

SOMERSET, N.J.–(BUSINESS WIRE)–
Catalent, Inc. (NYSE: CTLT), the leading global provider of development sciences and manufacturing platforms for medicines, including biotherapeutics; cell and gene therapies; and consumer health products, today announced that it has reached an agreement to acquire Bettera Holdings, LLC, a major manufacturer in the high-growth gummy, soft chew, and lozenge segments of the nutritional supplements market, for $1 billion, subject to customary adjustments. Currently a portfolio company of Highlander Partners, LP, Bettera will complement and accelerate the growth of Catalent’s global softgel and oral dose formulation and manufacturing business to provide consumer health innovators with unrivalled choice, formulation expertise, and high-quality, scalable manufacturing solutions to help bring new products to market.

Bettera is a market leader with broad and difficult-to-replicate expertise in successfully developing and producing consumer-preferred products for nutraceutical, functional, and botanical ingredients, and has four production facilities in the U.S. The acquisition will enable Catalent to expand its current consumer health technology platform with a wider range of technologies and ready-to-market product libraries, as well as a variety of packaging options to meet customers’ branding needs. Bettera will complement and leverage Catalent’s network of consumer health manufacturing sites across North and South America, Europe, and Japan, offering formulation development, delivery and supply solutions to the global consumer health and beauty markets. The combination will unlock significant commercial synergies as Catalent brings the unique offerings of each company to their respective high-quality customer bases.

“As the leading global innovator of softgel and oral technologies, Catalent has a strong, long-standing presence in the rapidly expanding consumer health and nutraceutical marketplace. This acquisition allows us to significantly accelerate the growth of our consumer health business and offer customers access to the substantial potential in gummies, soft chews, and lozenges, which are experiencing double-digit growth,” commented Dr. Aris Gennadios, President, Softgel and Oral Technologies, Catalent. “This acquisition is a key strategic move for Catalent’s Consumer Health business, where our leadership in manufacturing technologies and formulation can offer customers more product development opportunities and add manufacturing capacity in this dynamic and fast-growing segment.”

“Bettera was established with a vision to serve the needs of consumers who want to experience the benefits of nutritional supplements through more enjoyable and convenient dose forms,” stated Jeff L. Hull, President and CEO of Highlander Partners. “Catalent has long had a similar vision, combined with specialized expertise, a history of successful innovation, a wide range of offerings, and the resources to help Bettera continue to grow and meet customer and consumer needs. Together, Catalent Consumer Health and Bettera are well positioned to continue Bettera’s mission of serving consumers and participating in the long-term growth of the self-care market.”

The acquisition is expected to close before the end of 2021, and includes the transfer of substantially all of the approximately 500 employees, and product development, manufacturing, and packaging assets of Bettera Holdings, headquartered in Plano, Texas, including its production facilities in California, Indiana, New Jersey, and Virginia.

The acquisition is subject to customary terms and closing conditions. Catalent will pay the purchase price for this all-cash acquisition at closing using a combination of cash on hand, existing credit facilities and, depending on market conditions, new debt financing. The closing of the acquisition is not contingent on any financing activity. Catalent intends to file a Current Report on Form 8-K with the Securities and Exchange Commission with further details concerning the acquisition.

Centerview Partners LLC is serving as financial advisor to Catalent, and Fried, Frank, Harris, Shriver & Jacobson LLP is serving as Catalent’s legal counsel.

Notes for Editors

About Catalent, Inc.

Catalent Inc. [NYSE: CTLT], an S&P 500® company, is the leading global provider of development sciences and manufacturing platforms for medicines, including biotherapeutics; cell and gene therapies; and consumer health products. With almost 90 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance, and ensuring reliable global clinical and commercial product supply. Catalent’s workforce exceeds 17,000 people, including more than 2,500 scientists and technicians, at more than 50 facilities on four continents, and in fiscal year 2021, it generated $4 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com.

More products. Better treatments. Reliably supplied.™

Forward-Looking Statements

This release contains both historical and forward-looking statements. All statements other than statements of historical fact, are, or may be deemed to be, forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the expected consummation of the Bettera acquisition. These forward-looking statements generally can be identified by the use of statements that include phrases such as “believe,” “expect,” “anticipate,” “intend,” “estimate,” “plan,” “project,” “foresee,” “likely,” “may,” “will,” “would,” or other words or phrases with similar meanings. Similarly, statements that describe Catalent’s objectives, plans, or goals are, or may be, forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Catalent’s expectations and projections. Some of the factors that could cause actual results to differ include, but are not limited to, the following: the current or future effects of the COVID-19 pandemic on Catalent’s and its clients’ or suppliers’ businesses; participation in a highly competitive market and increased competition that may adversely affect Catalent’s business; demand for its offerings, which depends in part on its customers’ research and development and the clinical and market success of their products; product and other liability risks that could adversely affect Catalent’s results of operations, financial condition, liquidity and cash flows; failure to comply with existing and future regulatory requirements; failure to provide quality offerings to customers could have an adverse effect on Catalent’s business and subject it to regulatory actions and costly litigation; problems providing the highly exacting and complex services or support required; global economic, political and regulatory risks to Catalent’s operations; inability to enhance existing or introduce new technology or service offerings in a timely manner; inadequate patents, copyrights, trademarks and other forms of intellectual property protections; fluctuations in the costs, availability, and suitability of the components of the products Catalent manufactures, including active pharmaceutical ingredients, excipients, purchased components and raw materials; changes in market access or healthcare reimbursement in the United States or internationally; fluctuations in the exchange rate of the U.S. dollar against other currencies; adverse tax legislative or regulatory initiatives or challenges or adjustments to Catalent’s tax positions; loss of key personnel; risks generally associated with information systems; inability to complete any future acquisition, including the pending acquisition of Bettera, or other transaction that may complement or expand its business or divest of non-strategic businesses or assets and difficulties in successfully integrating acquired businesses and realizing anticipated benefits of such acquisitions; risks associated with timely and successfully completing, and correctly anticipating the future demand predicted for, capital expansion projects at existing facilities, offerings and customers’ products that may infringe on the intellectual property rights of third parties; environmental, health and safety laws and regulations, which could increase costs and restrict operations; labor and employment laws and regulations or labor difficulties, which could increase costs or result in operational disruptions; additional cash contributions required to satisfy Catalent’s existing pension plan obligations; substantial leverage that may limit its ability to raise additional capital to fund operations and react to changes in the economy or in the industry; and exposure to interest-rate risk to the extent of its variable-rate debt preventing it from meeting its obligations under its indebtedness. For a more detailed discussion of these and other factors, see the information under the caption “Risk Factors” in Catalent’s Annual Report on Form 10-K for the fiscal year ended June 30, 2021, filed August 30, 2021. All forward-looking statements speak only as of the date of this release or as of the date they are made, and Catalent does not undertake to update any forward-looking statement as a result of new information or future events or developments except to the extent required by law.

Media:

Chris Halling

+44 (0)7580 041073

[email protected]

Richard Kerns

+44 (0)161 728 5880

[email protected]

Investors:

Paul Surdez

+1 (732) 537-6325

[email protected]

KEYWORDS: New Jersey United States North America

INDUSTRY KEYWORDS: Biotechnology Genetics Health

MEDIA:

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Akoustis Reports Fiscal Fourth Quarter and Full Year Results


  • Fiscal 2021 Annual Revenue of $6.6M Representing an Increase of 270% Year-Over-Year

  • Filter Product Revenue Increased 68% Sequentially, and Over 440% Year-Over-Year

  • Robust Customer Activity and Design Win Pipeline in 5G Mobile, WiFi CPE, Infrastructure and Other Markets

  • XBAW Filters Entering Production in Core WiFi 6E and Network Infrastructure Segments in 2H CY2021

  • Company to Host Investor Update Call Today at 8:00 am EDT


Charlotte, N.C., Aug. 30, 2021 (GLOBE NEWSWIRE) —
Akoustis Technologies, Inc. (NASDAQ: AKTS) (“Akoustis” or the “Company”), an integrated device manufacturer (IDM) of patented bulk acoustic wave (BAW) high-band RF filters for mobile and other wireless applications, announced today a 270% year-over-year increase in revenue to $6.6 million for the 2021 fiscal year ended June 30, 2021. Q4 fiscal 2021 revenue was $2.2 million, within the Company’s previously guided range, despite continuing headwinds stemming from both the Coronavirus and semiconductor supply chain challenges. The Company had $88.3 million in cash as of June 30, 2021.

Akoustis will host an investor call to provide a business update and outlook, followed by a Q & A session this morning at 8:00 a.m. EDT. The call-in numbers are 877-407-3982 (domestic) or +01 201-493-6780 (international). The conference call will be webcast live on the Company’s website and will be available for playback at the following URL: https://ir.akoustis.com/ir-calendar.

Jeff Shealy, founder and CEO of Akoustis, stated, “Despite the ongoing macro headwinds, Akoustis delivered record XBAW™ filter shipments in Q4 FY21. Furthermore, our existing design win pipeline supports a return to double-digit sequential revenue growth in the December quarter, as we ramp volume XBAW™ RF filter solutions to multiple customers across the WiFi 6, WiFi 6E, 5G network infrastructure and defense markets.”

Mr. Shealy continued, “We continue to experience strong demand and a growing sales funnel for our WiFi 6E, 5G mobile and CBRS XBAW™ filters. Importantly, our efforts in 5G mobile have been rewarded with the recently announced foundry agreement and, as we announced this morning, that we have shipped early 5G mobile filter prototypes to our tier-1 mobile customer and are on-track to deliver two fully qualified filters next calendar year.”

Akoustis is actively delivering volume production of its WiFi 6 tandem filter solutions, shipping multiple 5G small cell XBAW™ filter solutions, delivering initial designs of its new 5G mobile filter solutions to multiple customers and is now entering the market with its new WiFi 6E coexistence XBAW™ filter solutions.

Given the rapidly growing sales funnel activity as well as ongoing interaction with customers regarding expected ramps in 5G mobile, WiFi 6 and WiFi 6E in calendar 2022, the Company plans to increase the annual production capacity at its New York fab by the end of calendar 2021 to approximately 500 million filters per year.

Recent Business Highlights

  • XBAW™ filter shipments up over 68% sequentially
  • Shipped first XBAW™ filter sample to tier-1 RF component customer for evaluation and characterization
  • Announced foundry agreement with tier-2 RF front-end module customer for the manufacture of filters for 5G mobile
  • Entered into agreement with tier-1 PC chipmaker for the development of WiFi 6E RF diplexer product for the personal computing market
  • Added two of three current WiFi 6E reference design partners for multiple platforms
  • Announced new 5 GHz WiFi 6E solution with 5.6 GHz and 6.6 GHz XBAW™ filter modules
  • Received design win for 5.5 GHz and 6.5 GHz WiFi 6E XBAW™ filters from carrier-focused gateway OEM
  • Shipped new 5.6 GHz and 6.6 GHz WiFi 6E filter modules to tier-1 consumer-focused OEM
  • Received design win for 5.5 GHz and 6.5 GHz WiFi 6E XBAW™ filters from new tier-1 enterprise-class customer
  • Continued commercial production for tier-1 consumer-focused tri-band WiFi 6 product, which is currently available for sale in both online and retail box stores
  • Achieved robust sampling of WiFi 6E filters to tier-1 and tier-2 OEMs, ODMs and SoC customers
  • Received two design wins for our 3.6 GHz XBAW™ filter for a Citizens Broadband Radio Service Customer
  • Received an order for the development of a new 3.8 GHz XBAW™ filter from an existing defense customer
  • Continued DARPA direct-to-phase II (DP2) contract to advance design and manufacturing of XBAW™ technology for filters and other sensors
  • Expanded XBAW™ patent portfolio to 52 issued and licensed patents plus 82 patents pending

Akoustis currently has 15 commercial XBAW™ filters in its product catalog, and recently introduced 5.6 GHz and 6.6 GHz WiFi 6E coexistence filter modules, which when qualified, will bring the number of catalog products to 17. Current product catalog filters include a 5.6 GHz WiFi filter, a 5.2 GHz WiFi filter, a 5.5 GHz WiFi-6E filter, a 6.5 GHz WiFi 6E filter, three small cell 5G network infrastructure filters including two Band n77 filters and one Band n79 filter, a 3.8 GHz filter and five S-Band filters for defense phased-array radar applications, a 3.6 GHz filter for the CBRS 5G infrastructure market and a C-Band filter for the unmanned aircraft systems (UAS) market. The Company is also developing several new filters for the sub-7 GHz bands targeting 5G mobile device, network infrastructure, WiFi CPE and defense markets.

Fourth Fiscal Quarter and Fiscal Year Financial Performance

Akoustis Technologies, Inc.
Consolidated Statements of Operations
 (In thousands, except per share data)
                         
  For the     For the   For the   For the
Three Months Three Months   Year Year
Ended Ended   Ended Ended
June 30, June 30,   June 30, June 30,
2021 2020   2021 2020
                   
Revenue $ 2,157     $ 366    $         6,618     $        1,790
                         
Cost of revenue   3,427       1,074   10,651       2,414
                         
Gross profit            (1,270)                    (708)              (4,033)                   (624)
                         
Operating expenses                        
Research and development   6,905       4,787   24,076       20,523
General and administrative expenses   3,602       2,733   13,285       10,891
Total operating expenses   10,507       7,520   37,361       31,414
                         
Loss from operations          (11,777)                 (8,228)           (41,394)             (32,038)
                         
Other (expense) income                        
Interest (expense) income  $  

             32

     $  

      (1,316)

  

$

  

       (5,130)

      

$

  

     (4,573)
Rental income   —                        18   —       181
Change in fair value of contingent real estate liability   —       —   —       445
Gain on extinguishment of debt   1,624       —   1,624       —
Change in fair value of derivative liabilities    —                    (551)   744                   (155)
Total Other (expense) income              1,656                 (1,849)              (2,762)                (4,102)
Net loss  

$

       (10,121)    

$

         (10,077)  

$

        (44,156)    

$

        (36,140)
                         
Net loss per common share – basic and diluted  

$

            (0.20)    

$

               (0.27)  

$

              (1.02)    

$

              (1.07)
                         
Weighted average common shares outstanding – basic and diluted   50,589,380       36,838,828   43,426,602       33,698,502

Akoustis Technologies, Inc.
Consolidated Balance Sheets
(In thousands, except per share data)
               
    June 30,     June 30,
    2021     2020
           
Assets              
               
Assets:              
Cash and cash equivalents   $ 88,322     $ 44,308
Accounts receivable     1,170       351
Inventory     1,390       136
Other current assets     2,314       1,408
Total current assets     93,196       46,203
               
Property and equipment, net     30,730       23,605
Intangibles, net     572       544
Operating lease right-of-use asset, net     471       699
Restricted cash     —       100
Other assets     25       282
Total Assets   $ 124,994     $ 71,433
               
Liabilities and Stockholders’ Equity              
               
Current Liabilities:              
Accounts payable and accrued expenses   $ 6,954     $ 5,899
Operating lease liability-current     270       231
Deferred revenue     41       —
Total current liabilities     7,265       6,130
               
Long-term Liabilities:              
Convertible notes payable, net     —       21,628
Operating lease liability-non current     202       472
Loans payable     —       1,591
Other long-term liabilities     117       117
Total long-term liabilities     319       23,808
               
Total Liabilities     7,584       29,938
               
Stockholders’ Equity              
Preferred Stock, par value $0.001: 5,000,000 shares authorized; none issued and outstanding     —       —
Common stock, $0.001 par value; 100,000,000 shares authorized; 51,235,764 and 37,990,380 shares issued and outstanding at June 30, 2021 and June 30, 2020, respectively     51       38
Additional paid in capital     265,130       145,072
Accumulated deficit     (147,771 )     (103,615
Total Stockholders’ Equity     117,410       41,495
Total Liabilities and Stockholders’ Equity   $ 124,994     $ 71,433

The following Non-GAAP measures should not be considered a substitute for, or superior to, financial measures calculated in accordance with GAAP. These non-GAAP measures exclude significant expenses that are required by GAAP to be recorded in the Company’s financial statements and are subject to inherent limitations. Please see reconciliations to comparable GAAP measures below and descriptions of these non-GAAP measures under “Non-GAAP Measures.”

Non-GAAP Operating Loss and Non-GAAP Net Loss for the three months ending June 30, 2021 and 2020 were as follows:

Akoustis Technologies, Inc.  
Unaudited Reconciliations of Non-GAAP Financial Measures  
       
  Three Months Ended  
  June 30, 2021 June 30, 2020  
(in thousands)  
GAAP operating loss $                       (11,777) $                        (8,228)  
Common stock issued for services                              2,109                             1,626  
       
Non-GAAP operating loss $                         (9,668) $                        (6,602)  
       
       
  Three Months Ended  
  June 30, 2021 June 30, 2020  
(in thousands)  
GAAP net loss $                    (10,121)  $                   (10,077)  
Gain on extinguishment of debt                          (1,625)                               551  
Debt discount amortization                                      –                                 925  
Common stock issued for services                            2,109                            1,626  
       
Non-GAAP net loss $                        (9,638) $                       (6,975)  
       
Weighted average common shares outstanding – basic and diluted                     50,589,380                    36,838,828  
Non-GAAP net loss per common share – basic and diluted $                           (0.19) $                          (0.19)  
       
       
  Twelve Months Ended  
  June 30, 2021 June 30, 2020  
(in thousands)  
GAAP operating loss $                       (41,394) $                      (32,038)  
Common stock issued for services                              8,192                              6,734  
       
Non-GAAP operating loss $                       (33,202) $                      (25,304)  
       
       
  Twelve Months Ended  
  June 30, 2021 June 30, 2020  
(in thousands)  
GAAP net loss $                    (44,156) $                   (36,140)  
Change in fair value of contingent real estate liability                                      –                               (446)  
Change in fair value of derivative liabilities                                 (744)                                 155  
Gain on extinguishment of debt                             (1,625)                                    –    
Debt discount amortization                               4,406                              3,258  
Common stock issued for services                               8,192                              6,734  
       
Non-GAAP net loss  $                       (33,928)  $                      (26,439)  
       
Weighted average common shares outstanding – basic and diluted                     43,426,602                    33,698,502  
Non-GAAP net loss per common share – basic and diluted  $                           (0.78)  $                          (0.78)  



Non-GAAP Measures

We regularly review a number of metrics, including Non-GAAP Operating Loss and Non-GAAP Net Loss, which are not financial measures calculated in accordance with generally accepted accounting principles in the United States (“GAAP”). Non-GAAP Operating Loss represents operating loss before common stock issued for services. Non-GAAP Net Loss represents net loss before change in fair value of contingent real estate liability, change in fair value of derivative liabilities, debt discount amortization, gain on extinguishment of debt and common stock issued for services. The Company believes these non-GAAP measures provide useful information to management, investors and financial analysts regarding certain financial and business trends relating to the Company’s financial condition and results of operations. We use these non-GAAP measures to evaluate our business, measure our performance, identify trends affecting our business, formulate financial projections and make strategic decisions.

About Akoustis Technologies, Inc.

Akoustis® (http://www.akoustis.com/) is a high-tech BAW RF filter solutions company that is pioneering next-generation materials science and MEMS wafer manufacturing to address the market requirements for improved RF filters – targeting higher bandwidth, higher operating frequencies and higher output power compared to incumbent polycrystalline BAW technology deployed today. The Company utilizes its proprietary XBAWTM manufacturing process to produce bulk acoustic wave RF filters for mobile and other wireless markets, which facilitate signal acquisition and accelerate band performance between the antenna and digital back end. Superior performance is driven by the significant advances of high-purity, single-crystal and associated piezoelectric materials and the resonator-filter process technology which drives electro-mechanical coupling and translates to wide filter bandwidth. 

Akoustis plans to service the fast growing multi-billion-dollar RF filter market using its integrated device manufacturer (IDM) business model. The Company owns and operates a 120,000 sq. ft. ISO-9001:2015 registered commercial wafer-manufacturing facility located in Canandaigua, NY, which includes a class 100 / class 1000 cleanroom facility – tooled for 150-mm diameter wafers – for the design, development, fabrication and packaging of RF filters, MEMS and other semiconductor devices. Akoustis Technologies, Inc. is headquartered in the Piedmont technology corridor near Charlotte, North Carolina.

Forward-Looking Statements

This document includes “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements about our estimates, expectations, beliefs, intentions, plans or strategies for the future (including our possible future results of operations, business strategies, competitive position, potential growth opportunities, potential market opportunities and the effects of competition), and the assumptions underlying such statements. Forward-looking statements include all statements that are not historical facts and typically are identified by use of terms such as “may,” “might,” “would,” “will,” “should,” “could,” “project,” “expect,” “plan,” “strategy,” “anticipate,” “attempt,” “develop,” “help,” “believe,” “think,” “estimate,” “predict,” “intend,” “forecast,” “seek,” “potential,” “possible,” “continue,” “future,” and similar words (including the negative of any of the foregoing), although some forward-looking statements are expressed differently. Forward-looking statements are neither historical facts nor assurances of future results, performance, events or circumstances. Instead, these forward-looking statements are based on management’s current beliefs, expectations and assumptions and are subject to risks and uncertainties. Factors that could cause actual results to differ materially from those currently anticipated include, without limitation, risks relating to our ability to obtain adequate financing and sustain our status as a going concern; our limited operating history; our inability to generate revenues or achieve profitability;  the results of our research and development activities; our inability to achieve acceptance of our products in the market; the impact of a pandemic or epidemic or a natural disaster, including the COVID-19 pandemic, on our operations, financial condition and the worldwide economy, including its impact on our ability to access the capital markets; general economic conditions, including upturns and downturns in the industry; shortages in supplies needed to manufacture our products, or needed by our customers to manufacture devices incorporating our products; our limited number of patents; failure to obtain, maintain, and enforce our intellectual property rights; our inability to attract and retain qualified personnel; our reliance on third parties to complete certain processes in connection with the manufacture of our products; product quality and defects; existing or increased competition; our ability to successfully manufacture, market and sell products based on our technologies; our ability to meet the required specifications of customers and achieve qualification of our products for commercial manufacturing in a timely manner; our ability to successfully scale our New York wafer fabrication facility and related operations while maintaining quality control and assurance and avoiding delays in output; the rate and degree of market acceptance of any of our products; our ability to achieve design wins from current and future customers; contracting with customers and other parties with greater bargaining power and agreeing to terms and conditions that may adversely affect our business; risks related to doing business in foreign countries, including China; any security breaches, cyber-attacks or other disruptions compromising our proprietary information and exposing us to liability; our failure to innovate or adapt to new or emerging technologies; our failure to comply with regulatory requirements; results of any arbitration or litigation that may arise; stock volatility and illiquidity; dilution caused by any future issuance of common stock or securities that are convertible into or exercisable for common stock; our failure to implement our business plans or strategies; and our ability to maintain effective internal control over financial reporting. These and other risks and uncertainties are described in more detail in the Risk Factors and Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of the Company’s most recent Annual Report on Form 10-K and in subsequently filed Quarterly Reports on Form 10-Q. Considering these risks, uncertainties and assumptions, the forward-looking statements regarding future events and circumstances discussed in this document may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements included in this document speak only as of the date hereof and, except as required by law, we undertake no obligation to update publicly or privately any forward-looking statements, whether written or oral, for any reason after the date of this document to conform these statements to new information, actual results or to changes in our expectations. 



COMPANY:
Tom Sepenzis
Akoustis Technologies
VP of Corporate Development & IR
(980) 689-4961
[email protected]

The Del Mar Consulting Group, Inc.
Robert B. Prag, President
(858) 794-9500
[email protected]

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Origin Materials to Participate in the Bank of America Securities Sustainability and the Circular Economy Investor Summit

Origin Materials to Participate in the Bank of America Securities Sustainability and the Circular Economy Investor Summit

WEST SACRAMENTO, Calif.–(BUSINESS WIRE)–Origin Materials, Inc. (“Origin,” “Origin Materials,” or the “Company”) (Nasdaq: ORGN, ORGNW), the world’s leading carbon negative materials company with a mission to enable the world’s transition to sustainable materials, today announced that it will participate in the Bank of America Securities Sustainability and the Circular Economy Investor Summit on September 1, 2021.

Interested investors and other parties can watch the replay of the presentation by visiting the Company’s Investor Relations website at https://investors.originmaterials.com.

About Origin Materials

Headquartered in West Sacramento, Origin Materials is the world’s leading carbon negative materials company. Origin’s mission is to enable the world’s transition to sustainable materials. Over the past 10 years, Origin has developed a platform for turning the carbon found in inexpensive, plentiful, non-food biomass such as sustainable wood residues into useful materials while capturing carbon in the process. Origin’s patented technology platform can help revolutionize the production of a wide range of end products, including clothing, textiles, plastics, packaging, car parts, tires, carpeting, toys, and more with a ~$1 trillion addressable market. In addition, Origin’s technology platform is expected to provide stable pricing largely decoupled from the petroleum supply chain, which is exposed to more volatility than supply chains based on sustainable wood residues. Origin’s patented drop-in core technology, economics and carbon impact are supported by a growing list of major global customers and investors.

For more information, visit www.originmaterials.com.

Investors: [email protected]

Media: [email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Packaging Chemicals/Plastics Environment Manufacturing

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Trevena Announces Two OLINVYK® Abstracts Highlighting Safety Data Accepted at ANESTHESIOLOGY® 2021

CHESTERBROOK, Penn., Aug. 30, 2021 (GLOBE NEWSWIRE) — Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced the acceptance of two abstracts at ANESTHESIOLOGY® 2021. Both abstracts highlight safety data from the OLINVYK (oliceridine) injection program. The meeting is sponsored by the American Society of Anesthesiologists and will be held on October 8th to 12th in San Diego, California.

“I am pleased to have the opportunity to present additional compelling data from the OLINVYK development program,” said Mark A. Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena. “The selection of one of our posters as a top research abstract is encouraging and speaks to the continued interest from the medical community in OLINVYK’s unique profile.”

Poster details:

  • E-Poster #1: “Elevated Body Mass Index Does Not Affect Adverse Events Associated With Oliceridine, An Intravenous Opioid Agonist” with lead author Joseph F. Answine, M.D., Assistant Professor of Anesthesiology, Penn State Health Milton S. Hershey Medical Center.
    • Selected by the Committee on Scientific Advisory to be included in a special in-person poster session on October 9th.
  • E-Poster #2: “Safety Of Intravenous Oliceridine In Patients With Renal Impairment: Findings From A Phase 3 Open-label Study” with lead author Ashraf S. Habib, M.D., Professor of Anesthesiology, Duke University School of Medicine.

The posters are embargoed until the date and time of presentation. Upon conclusion of the conference, they can be found at https://www.trevena.com/publications.

About OLINVYK® (oliceridine) injection

OLINVYK is a new chemical entity approved by the FDA in August 2020. OLINVYK contains oliceridine, a Schedule II controlled substance with a high potential for abuse similar to other opioids. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK is available in 1 mg/1 mL and 2 mg/2 mL single-dose vials, and a 30 mg/30 mL single-patient-use vial for patient-controlled analgesia (PCA). Approved PCA doses are 0.35 mg and 0.5 mg and doses greater than 3 mg should not be administered. The cumulative daily dose should not exceed 27 mg. Please see Important Safety Information, including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.

About Trevena

Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK® (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company’s novel pipeline is based on Nobel Prize winning research and includes four differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, TRV045 for diabetic neuropathic pain and epilepsy, and TRV027 for acute respiratory distress syndrome and abnormal blood clotting in COVID-19 patients.

For more information, please visit www.Trevena.com 

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “objective,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “ongoing,” or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company’s clinical trials or any future trials of any of the Company’s investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company’s assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company’s intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

For more information, please contact:

Investor Contact:

Dan Ferry
Managing Director
LifeSci Advisors, LLC
[email protected]
(617) 430-7576

PR & Media Contact:

Sasha Bennett
Associate Vice President
Clyde Group
[email protected]
(239) 248-3409