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PhaseBio Reports Fourth-Quarter and Full-Year 2020 Financial Results and Recent Business Highlights

PhaseBio Reports Fourth-Quarter and Full-Year 2020 Financial Results and Recent Business Highlights

Update on Phase 3 REVERSE-IT trial – enrollment ahead of schedule

Provides overview of bentracimab development program during virtual Investor & Analyst Day, March 15, 2021, 12 – 2 pm ET

Announced commercial supply agreement with BioVectra to support the development and commercialization of lead product candidate bentracimab

Expanded pivotal Phase 3 REVERSE-IT trial of bentracimab into Canada and the European Union, and dosed first patients outside the United States

MALVERN, Pa. & SAN DIEGO–(BUSINESS WIRE)–PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today reported financial results for the fourth-quarter and full-year ended December 31, 2020 and provided an update on clinical trial activities.

“Throughout 2020, PhaseBio made significant progress advancing our pipeline of therapies for serious cardiopulmonary diseases,” said Jonathan P. Mow, Chief Executive Officer of PhaseBio Pharmaceuticals. “Our progress was driven by the continued global expansion of the pivotal Phase 3 REVERSE-IT trial of our lead product candidate bentracimab, which has now enrolled more than half of the first 100 patients needed to support a BLA submission. We’ve generated this momentum by expanding the REVERSE-IT trial into Canada and the European Union, and we also recently announced a commercial supply agreement with BioVectra to support the continued development and eventual commercial supply of bentracimab, if approved.”

Mow continued, “Looking ahead into 2021, we are excited to continue advancing this pivotal program through key planned milestones including publishing Phase 2a data, announcing the interim analysis of the first 100 patients from the REVERSE-IT Phase 3 trial, initiating additional trial sites abroad, and working with key collaborators on our bentracimab commercialization plans. We also remain focused on advancing pemziviptadil for pulmonary arterial hypertension and are targeting to report Phase 2b data in the second half of 2021.”

Bentracimab (PB2452) Highlights

  • Accelerated Enrollment in Ongoing REVERSE-IT Phase 3 Clinical Trial: As of March 2021, the REVERSE-IT Phase 3 clinical trial had enrolled 60 of the first approximately 100 patients needed to support a Biologics License Application (BLA), nearly all of whom to date have required urgent surgery or an invasive procedure. PhaseBio is attempting to accelerate enrollment of patients with uncontrolled major or life-threatening bleeding, including by working to increase the number of enrolling clinical trial sites in the United States, Canada, and the European Union as it is believed that a broader site footprint will increase the probability of enrolling these patients. All of the first approximately 100 patients enrolled in the REVERSE-IT trial will be measured against the same VerifyNow® PRUTest biomarker that is the primary endpoint for all patients enrolled in the REVERSE-IT trial. The trial is enrolling faster than PhaseBio originally projected, and PhaseBio now expects to complete enrollment of the first 100 patients in mid-2021 and is targeting to submit a BLA for bentracimab in mid-2022, although those timelines could be impacted by the continued scope and duration of the COVID-19 pandemic. Bentracimab is a novel, human monoclonal antibody fragment that in earlier clinical trials has shown immediate and sustained reversal of the antiplatelet effects of Brilinta® (ticagrelor).
  • Announced Supply Agreement with BioVectra for Bentracimab to Support Development and Commercialization: In March 2021, PhaseBio announced a commercial scale supply agreement with BioVectra, an innovative global contract development and manufacturing organization (CDMO), for the production of bentracimab. Under the terms of the agreement, BioVectra will provide its integrated CDMO services for the manufacturing of the active pharmaceutical ingredient (API) of bentracimab for use in PhaseBio’s ongoing Phase 2b and Phase 3 clinical trials and for global commercial use if bentracimab receives regulatory approval.
  • Expanded REVERSE-IT Trial into the European Union and Dosed First Patients: In January 2021, PhaseBio announced that, working with its financing and co-development partner SFJ Pharmaceuticals, PhaseBio had expanded the REVERSE-IT trial into the European Union, having opened trial sites for enrollment and began dosing its first patients.
  • Expanded REVERSE-IT Trial into Canada and Dosed First Patients: In October 2020, PhaseBio announced that it had expanded the Phase 3 trial of bentracimab into Canada, where the first patients outside of the United States were enrolled and dosed. Cardiovascular disease remains a leading cause of mortality in the United States, Canada and globally. The company also announced that the global Phase 3 trial had been named REVERSE-IT (Rapid and SustainEd ReVERSal of TicagrElor – Intervention Trial).
  • Initiated Phase 3 Clinical Trial for Bentracimab: In March 2020, PhaseBio commenced the pivotal Phase 3 clinical trial to evaluate reversal of the antiplatelet effects of ticagrelor in patients with uncontrolled major or life-threatening bleeding or requiring urgent surgery or an invasive procedure.
  • Received PRIME Designation for Bentracimab from European Medicines Agency: In February 2020, bentracimab was granted PRIority MEdicines (PRIME) designation by the European Medicines Agency (EMA) for the reversal of the antiplatelet effects of ticagrelor in patients with uncontrolled major or life-threatening bleeding or requiring urgent surgery or an invasive procedure. The EMA prioritizes PRIME designated drugs for special support, including enhanced interactions and dialogue with the EMA during development, as well as a pathway for accelerated evaluation and review for marketing authorization.
  • Received Written Scientific Advice from EMA Confirming the Bentracimab Clinical Development Plan: In February 2020, PhaseBio received written guidance from the Committee for Medicinal Products for Human Use (CHMP) of the EMA that generally agreed with PhaseBio’s proposed development plan for bentracimab. After reviewing the Scientific Advice from CHMP, PhaseBio believes that the development plan for bentracimab has been designed to support regulatory filings in the European Union. PhaseBio similarly believes that the development plan for bentracimab has been designed to support regulatory filings in the United States based on feedback from the U.S. Food and Drug Administration.
  • Entered Into Financing and Co-Development Collaboration with SFJ Pharmaceuticals®: In January 2020, PhaseBio announced a financing and co-development collaboration with SFJ Pharmaceuticals (SFJ) to support the development of bentracimab. Under the terms of the agreement, SFJ agreed to fund up to $120 million to support the clinical development of bentracimab and to assume a central role in global clinical development and regulatory activities for bentracimab outside of the United States.

    From execution of the co-development agreement through December 31, 2020, SFJ Pharmaceuticals has funded or reimbursed $47.1 million of clinical trial costs and other expenses of the initial $90 million commitment under the agreement, leaving $42.9 million of funding remaining available to support the Phase 3 program through the end of 2021. PhaseBio is eligible to receive up to an additional $30 million of funding if specific, pre-defined clinical development milestones for bentracimab are met.

Pemziviptadil (PB1046) and Other Pipeline Highlights

  • Presented Data from Phase 1b/2a Trial of Pemziviptadil for the Treatment of Pulmonary Arterial Hypertension at Pulmonary Vascular Research Institute Virtual World Congress: In January 2021, PhaseBio announced presentation of data from a Phase 1b/2a pilot study highlighting three patients who received pemziviptadil (PB1046), the company’s first-in-class, sustained-release vasoactive intestinal peptide (VIP) analogue for the treatment of pulmonary arterial hypertension (PAH). The data, which were presented virtually at the 15th Pulmonary Vascular Research Institute (PVRI) World Congress on January 27, 2021, continue to highlight the favorable safety and tolerability profile of pemziviptadil, as well as clinically-meaningful, long-term improvement of six-minute walk test (6MWT) distance for one patient after 18 months of treatment. Additionally, the data demonstrate stability in functional status with no clinically-meaningful deterioration for two patients at two and six months after treatment. All three patients completed the study with no drug-related serious adverse events associated with study drug discontinuation and pemziviptadil appeared to be well tolerated.
  • Resumed Enrollment in Ongoing Phase 2b Trial of Pemziviptadil in PAH: In October 2020, PhaseBio announced that the ongoing Phase 2b trial of pemziviptadil in patients with PAH, named the VIP trial (Vasoactive Intestinal Peptide in adult patients with pulmonary arterial hypertension), resumed enrollment after a pause related to the impacts of the COVID-19 pandemic and re-prioritization of drug supply to the VANGARD trial. At the time of announcement, approximately one-third of the patients targeted for enrollment had completed the initial 16-week protocol, with approximately 90% of these patients electing to enroll in VIP EXTEND (Vasoactive Intestinal Peptide extension trial in adult patients with pulmonary arterial hypertension), the open label extension of the Phase 2b trial. PhaseBio is targeting to report results from the VIP in the second half of 2021, although that timeline could be impacted by the continued scope and duration of the COVID-19 pandemic.
  • Bolstered Pipeline with Acquisition of Novel Oral Aldosterone Synthase Inhibitor for Treatment-Resistant Hypertension: In January 2020, PhaseBio signed an agreement with Viamet Pharmaceuticals Holdings, LLC and its wholly-owned subsidiary, Selenity Pharmaceuticals (Bermuda), Ltd., under which PhaseBio acquired all of the assets and intellectual property rights related to certain novel aldosterone synthase inhibitors, including the company’s lead development compound, now called PB6440, being developed for treatment-resistant hypertension. In preclinical studies completed to date, PB6440 was observed to be a highly potent and selective inhibitor of aldosterone synthase (CYP11B2) versus the closely related steroid 11β-hydroxylase enzyme (CYP11B1). PB6440 demonstrated dose-dependent aldosterone reduction without a significant increase in 11-deoxycorticosterone or deoxycortisol in both rodent and primate models.

Operational Updates

  • Appointed New Member to the Board of Directors: In February 2020, Alex C. Sapir was appointed to the company’s board of directors.

Fourth-Quarter and Full-Year 2020 Financial Results

Cash Position

  • Cash and cash equivalents at December 31, 2020 were $28.1 million, compared to $74.0 million at December 31, 2019. The decrease reflects cash used in operating activities. 

Quarter Ending Dec. 31, 2020

  • Net loss for the quarter was $30.4 million, compared to a net loss of $11.3 million for the prior-year period.
  • Research and development expense increased to $22.4 million, as compared to $8.4 million for the same period in 2019, driven by an increase in manufacturing, clinical and nonclinical development activities related to bentracimab and pemziviptadil.
  • General and administrative expense decreased to $3.6 million, compared to $3.7 million for prior-year period.

Year Ending Dec. 31, 2020

  • Net loss for the year was $98.6 million, compared to a net loss of $39.2 million for the prior-year period.
  • Research and development expense increased to $72.1 million, as compared to $30.9 million for the same period in 2019, driven by an increase in manufacturing, clinical and nonclinical development activities related to bentracimab and pemziviptadil.
  • General and administrative expense increased to $13.1 million, compared to $11.2 million for prior-year period, primarily due to increases in professional services, personnel, and insurance-related expenses.

About PhaseBio

PhaseBio Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular and cardiopulmonary diseases. The company’s pipeline includes: bentracimab (PB2452), a novel reversal agent for the antiplatelet therapy ticagrelor; pemziviptadil (PB1046), a once-weekly vasoactive intestinal peptide receptor agonist for the treatment of pulmonary arterial hypertension; and PB6440, an oral agent for the treatment of resistant hypertension. PhaseBio’s proprietary elastin-like polypeptide technology platform enables the development of therapies with potential for less-frequent dosing and improved pharmacokinetics, including pemziviptadil, and drives both internal and partnership drug-development opportunities.

PhaseBio is located in Malvern, PA, and San Diego, CA. For more information, please visit www.phasebio.com, and follow us on Twitter @PhaseBio and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “intends,” “projects,” and “future” or similar expressions are intended to identify forward-looking statements.

Forward-looking statements include statements concerning or implying the conduct or timing of our clinical trials and our research, development and regulatory plans for our product candidates, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, and whether, if approved, these product candidates will be successfully distributed and marketed, as well as the success of our partnerships with SFJ Pharmaceuticals and BioVectra. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.

Risks regarding our business are described in detail in our Securities and Exchange Commission (“SEC”) filings, including in our Annual Report on Form 10-K for the year ended December 31, 2020. These forward-looking statements speak only as of the date hereof, and PhaseBio Pharmaceuticals, Inc. disclaims any obligation to update these statements except as may be required by law.

 

PhaseBio Pharmaceuticals, Inc.

Condensed Balance Sheets

(in thousands)
   

December 31,

2020

  

December 31,

2019

Assets:

  

Cash and cash equivalents

$

28,122

 

 

$

74,025

Other receivables, prepaid expenses and other current assets

 

12,027

 

 

 

4,798

Property and equipment, net

 

8,224

 

 

 

1,924

Operating lease right-of-use assets

 

1,927

 

 

 

1,715

Other non-current assets

 

57

 

 

 

32

Total assets

$

50,357

 

 

$

82,494

   

Liabilities and stockholders’ (deficit) equity:

  

Current portion of long-term debt

$

5,355

 

 

$

2,378

Accounts payable, accrued expenses and other current liabilities

 

9,605

 

 

 

6,101

Long-term debt, net

 

6,773

 

 

 

12,326

Operating lease liabilities, net

 

1,548

 

 

 

1,508

Development derivative liability

 

51,719

 

 

 

—

Other long-term liabilities

 

559

 

 

 

203

Stockholders’ (deficit) equity

 

(25,202

)

 

 

59,978

Total liabilities and stockholders’ (deficit) equity

$

50,357

 

 

$

82,494

 

PhaseBio Pharmaceuticals, Inc.

Statements of Operations

(in thousands, except share and per share amounts)
   

Quarter Ended December 31,

  

Year Ended December 31,

 

2020

 

 

2019

 

 

 

2020

 

 

2019

 

   

Revenue:

 

Grant revenue

$

—

 

$

689

 

 

$

320

 

$

1,786

 

Revenue under collaborative agreement

 

—

 

 

75

 

 

 

—

 

 

575

 

Total revenue

 

—

 

 

764

 

 

 

320

 

 

2,361

 

Operating expenses:

 

Research and development

 

22,367

 

 

8,381

 

 

 

72,088

 

 

30,911

 

General and administrative

 

3,611

 

 

3,663

 

 

 

13,088

 

 

11,186

 

Total operating expenses

 

25,978

 

 

12,044

 

 

 

85,176

 

 

42,097

 

Loss from operations

 

(25,978

)

 

(11,280

)

 

 

(84,856

)

 

(39,736

)

Other (expense) income

 

(4,397

)

 

(51

)

 

 

(13,709

)

 

489

 

Net loss

$

(30,375

)

$

(11,331

)

 

$

(98,565

)

$

(39,247

)

   

Net loss per common share, basic and diluted

$

(1.03

)

$

(0.39

)

 

$

(3.39

)

$

(1.43

)

   

Weighted average common shares outstanding, basic and diluted

 

29,397,718

 

 

28,762,962

 

 

 

29,056,304

 

 

27,493,558

 

 

Investor Contact:

John Sharp

PhaseBio Pharmaceuticals, Inc.

Chief Financial Officer

(610) 981-6506

[email protected]

Media Contact:

Will Zasadny

Canale Communications, Inc.

[email protected]

(619) 961-8848

KEYWORDS: United States North America California Pennsylvania

INDUSTRY KEYWORDS: Health Clinical Trials Research Science Pharmaceutical Cardiology Biotechnology

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UroGen Pharma Announces Sponsored Research Agreement with the Johns Hopkins University School of Medicine to Expand Immuno-Oncology Pipeline

UroGen Pharma Announces Sponsored Research Agreement with the Johns Hopkins University School of Medicine to Expand Immuno-Oncology Pipeline

Exploratory research at the Johns Hopkins University to study checkpoint inhibitors combined with RTGel™ in Glioblastoma Multiforme

PRINCETON, N.J.–(BUSINESS WIRE)–
UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced a strategic, exploratory immunotherapy sponsored research agreement with the Johns Hopkins University to study the potential of checkpoint inhibitors combined with RTGel™ in glioblastoma multiforme, or GBM, an aggressive and difficult to treat brain cancer. Johns Hopkins researchers expect to begin nonclinical research of RTGel combined with a PD-1 and a CTLA-4, respectively, in the second quarter of 2021.

UroGen’s proprietary RTGel technology is a reverse-thermal hydrogel that may increase dwell time of current therapies and exposure of active drugs, potentially improving the therapeutic effects of existing products.

“Local delivery of checkpoint inhibitors has the potential to fundamentally change the treatment paradigm for some of the most devastating cancers. We are excited to work with Johns Hopkins investigators on this exciting frontier in immunotherapy,” said Dr. Mark Schoenberg, Chief Medical Officer of UroGen Pharma. “This research will be an exciting addition to our current immuno-oncology pipeline, including UGN-302 which combines UGN-201, a toll-like receptor 7/8 agonist, with UGN-301, a CTLA-4 antagonist, for the treatment of high-grade non-muscle invasive bladder cancer. With our expanding programs in this field of research, we look forward to extending the potential of our RTGel platform in immunotherapy.”

The goal of this research is to further understand the efficacy of local delivery of immunotherapy to tumor draining lymph nodes, where anti-tumor T cells are primed by antigen presenting cells. Based on research at the Johns Hopkins University, sustained release of immunotherapy such as anti-PD-1 delivered directly to the lymph nodes, may target myeloid cells and T cells with PD-1 expression to enhance proliferation and anti-tumor activity of T cells. Successful use of lymph-node targeting therapies may reduce the toxicities associated with systemic administration of immunotherapy.

GBM is an aggressive malignant brain tumor with a five-year survival rate of less than five percent. GBM is difficult to treat and treatment options today are limited, and typically include surgery followed by radiation and chemotherapy. It is the most common primary brain tumor, with around 12,000 cases diagnosed per year in the United States.

About UroGen Pharma Ltd.

UroGen is a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options. UroGen has developed RTGel™ reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based platform technology that has the potential to improve therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. UroGen’s first commercial product, and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with low-grade non-muscle invasive bladder cancer, are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.urogen.com to learn more or follow us on Twitter, @UroGenPharma.

Forward Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation: the potential of UroGen’s proprietary RTGel technology platform to improve therapeutic profiles of existing drugs; the potential to expand the use of the RTGel platform in immunotherapy; the timing of expected initiation of the nonclinical research of RTGel combined with a PD-1 and a CTLA-4; the potential for local delivery of checkpoint inhibitors to fundamentally change the treatment paradigm for some cancers; and the potential for successful use of lymph-node targeting therapies to reduce the toxicities associated with systemic administration of immunotherapy. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: the timing and success of clinical trials and potential safety and other complications thereof; the ability to obtain regulatory approval within the timeframe expected, or at all; the ability to maintain regulatory approval; complications associated with commercialization activities, including complications resulting from the ongoing COVID-19 pandemic; the labeling for any approved product; the scope, progress and expansion of developing and commercializing UroGen’s product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; UroGen’s ability to attract or retain key management, members of the board of directors and personnel; and any negative effects on UroGen’s business, commercialization and product development plans caused by or associated with COVID-19. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Form 10-Q filed with the SEC on November 9, 2020, and other filings that UroGen makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and UroGen’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release.

INVESTOR CONTACT:

Sara Blum Sherman

Head of Investor Relations

[email protected]

609-467-4975

MEDIA CONTACT:

Eric Van Zanten

Senior Director, Communications

[email protected]

610-529-6219

KEYWORDS: New Jersey United States North America

INDUSTRY KEYWORDS: Science Biotechnology Research Pharmaceutical Oncology Health University Education

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Silverback Therapeutics Announces the Appointment of Dr. Maria Koehler to its Board of Directors

Silverback Therapeutics Announces the Appointment of Dr. Maria Koehler to its Board of Directors

SEATTLE–(BUSINESS WIRE)–
Silverback Therapeutics, Inc. (Nasdaq: SBTX) (“Silverback”), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, today announced the appointment of Maria Koehler, M.D., Ph.D. to Silverback’s Board of Directors.

“On behalf of the board of directors and senior management team at Silverback, I am pleased to welcome Maria to the board,” said Peter Thompson, M.D., Co-founder and Chair of the Silverback Board of Directors. “Maria is an accomplished biopharmaceutical veteran who has led world-class clinical development teams that have delivered transformative therapies to cancer patients. Her leadership and clinical experience will be invaluable at this stage of Silverback’s growth, as we advance our lead program SBT6050 through clinical development and drive additional assets into the clinic.”

Dr. Koehler joins the Silverback Board of Directors with more than 20 years of experience in the biopharmaceutical industry as a leader in clinical development. Board certified in hematology/oncology, she has experience in both early drug development and bringing new drugs to global markets, having developed strategies for all stages of cancer drug development and medical affairs. Dr. Koehler currently serves as the Chief Medical Officer at Repare Therapeutics, leading clinical strategy and overseeing all operations. Prior to joining Repare, Dr. Koehler was Chief Medical Officer at Bicycle Therapeutics. Prior to Bicycle, she was Vice President of Strategy and Innovation for Pfizer Oncology, where she led the development of palbociclib (IBRANCE) and contributed to the strategic direction of the oncology portfolio. Dr. Koehler received her M.D. and Ph.D. from the Silesian Medical School in Poland and has co-authored over 150 publications, book chapters, and patents.

“Silverback’s pipeline of tissue-targeted immuno-oncology agents, which harnesses both innate and adaptive immune responses, is an elegant approach to treating solid tumors,” said Dr. Koehler. “It is an important time for our industry as we bring forward more drugs with curative intent, and I am thrilled to join a passionate board of directors united by this vision.”

About Silverback Therapeutics

Silverback Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered and tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases. Silverback’s platform enables the strategic pairing of proprietary payloads that modulate key disease modifying pathways with monoclonal antibodies directed at specific disease sites. Initially, Silverback is creating a new class of targeted immuno-oncology agents that direct a TLR8 agonist myeloid cell activator to the tumor microenvironment in solid tumors to promote cancer cell killing. Silverback Therapeutics is located in Seattle, Washington. To learn more, visit www.silverbacktx.com.

Forward-Looking Statements

This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, Silverback’s ability to bring new treatments to patients in need, and the progress and expected timing of Silverback’s drug development programs and clinical trials. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Silverback may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings and applications, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties that Silverback faces, please refer to Silverback’s periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Silverback assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Miguel Arcinas

Silverback Therapeutics

(206) 736-7946

[email protected]

Media Contact:

Jason Spark

Canale Communications

(619) 849-6005

[email protected]

 

KEYWORDS: Washington United States North America

INDUSTRY KEYWORDS: Software Research Pharmaceutical Data Management Oncology Technology Public Relations/Investor Relations Clinical Trials Science Biotechnology Communications Health Other Science

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RevoluGROUP Canada Inc. RevoluPAY Completes Alipay, Union Pay and Phase 3 Country Integration

VANCOUVER, British Columbia, March 15, 2021 (GLOBE NEWSWIRE) — RevoluGROUP Canada Inc. (TSX-V: REVO), (Frankfurt: IJA2) (the “Company”) is pleased to announce that it has successfully concluded the technical integration of Alipay, Union Pay, and Phase 3 countries into RevoluPAY and RevoluSEND.

RevoluPAY Adds Alipay and Union Pay

Further to the news release dated 16th February 2021, the Company has completed the integration of Alipay on schedule. Although not cited in the previous news release for commercial reasons, the Company has also integrated Union Pay within this active update.

About Union Pay

The integration of Union Pay represents a significant milestone for the Company. UnionPay is the largest card payment organization (debit and credit cards combined) in the world, offering mobile and online payments based on the total value of payment transactions, ahead of Visa and Mastercard. Founded on 26 March 2002, UnionPay is a Chinese financial services corporation headquartered in Shanghai, China. It provides bank card services and a major card scheme in mainland China and overseas. It is also the only interbank network in China that links all the automatic teller machines (ATMs) throughout the country. Also, an electronic funds transfer at the point of sale (EFTPOS) network. Over 80% of merchants in the United States accept UnionPay credit cards, and almost all ATMs accept UnionPay cards. In Canada, UnionPay cards are accepted nationwide. Over 90% of the local ATMs accept UnionPay cards for withdrawing Canadian dollars. Europe and most of Asia broadly accept Union Pay. RevoluPAY is now connected to the Union Pay network, including 868 Chinese banks.

Union Pay Card Issuers Outside of China

RevoluPAY is also now connected to cardholders at international Union Pay issuing banks: AGD Bank Myanmar, Askari Bank Pakistan, Australia Post, Baiduri Bank Brunei, Bangkok Bank Thailand, Banque Pour Le Commerce Exterieur Lao (BCEL) Laos, Bank Sinarmas Indonesia, BDO Unibank Philippines, DBS Bank Singapore, Halyk Bank Kazakhstan, Vietcombank Vietnam, Kasikornbank Thailand, Kazkommertsbank Kazakhstan, Krung Thai Bank Thailand, Lotte Card Bank Republic of Korea, Mitsubishi UFJ NICOS Bank Japan, Muganbank Azerbaijan, SCT Network Bank Nepal, Himalayan Bank Nepal, Nepal Investment Bank Nepal, NIC ASIA Bank Nepal, AmBank Malaysia, Public Bank Malaysia, Philippine National Bank Philippines, Sacombank Vietnam, Mitsui Sumitomo Bank Japan, Shinhan Bank Republic of Korea, United Overseas Bank Singapore, National Bank of Pakistan, 1LINK Bank Pakistan, Bank of China (Hong Kong), Bank of East Asia, Citibank, DBS Bank, Hana Bank, Hang Seng Bank, HSBC, OCBC Bank, OCBC Wing Hang Bank, and Standard Chartered Bank.

RevoluSEND Phase 3 Country Integration

As projected on the 16th February 2021, the Company is pleased to announce that the following countries: Bangladesh, Cambodia, China, Hong Kong, India, Indonesia, Malaysia, Pakistan, Philippines, Thailand, Vietnam are now active for RevoluPAY remittance deliveries and bank transfers through RevoluSEND.

Huobi White Label

Further to the news release dated 14th December 2020, the Company had planned to launch the entirely completed Huobi white-label platform before year-end. However, due to the recent positive developments surrounding Company advisor Erik Aaron Lara, assuming the role of European Co-CEO of DSDAQ, the Company is now exploring enhanced RevoluEX market penetration synergies with supplementary white label parties.

RevoluVIP Travel Division Update

The Company last updated shareholders concerning the RevoluVIP Travel club on the 1st June 2020. Management now considers it timely to provide shareholders with a fresh RevoluVIP update. Key traveler catalyst markets are reacting to both COVID vaccine success and decreasing case numbers. On March 12th, 2021, the French authorities lifted travel restrictions on numerous countries that usually generate high inbound tourism numbers. On March 11thU.S President Biden announced the 4th of July as a date on which Americans may be over the worst of the lockdowns and travel restrictions. United Kingdom Prime Minister Boris Johnson has revealed a similar return to normality for the 21st of June.

Consequently, web visits to RevoluVIP destination websites have risen sharply, with a significant uptick in web traffic for specific countries, allied to a renewed trickle of firm bookings. Consumer confidence is returning, and travelers are starting to investigate future trips for later in the year. The Company wishes to remind shareholders that it streamlined RevoluVIP operational costs significantly during the pandemic’s initial stages. These cost savings will remain in perpetuity since the Company seized the opportunity to renegotiate GDS access fees and analogous fixed costs permanently. RevoluVIP has continued to add suppliers during the interim, increase static destination content, and perfect the proprietary +140 country platform. The booking section’s look and feel are also undergoing a refresh, destined for release before the summer. Management believes that RevoluVIP is ideally situated to capture the expected rise in demand as consumers travel again while frugally seeking the net price travel offers available to Diamond Members of the travel club.

United States MSB License Update

Management at wholly-owned subsidiary RevoluGROUP USA Inc has advised that the Floridian Financial regulator expects to decide on the license granting next week. The National Multistate Licensing System & Registry’s (NMLS) Multistate Money Services Businesses Licensing Agreement (MMLA) for the planned twenty-seven (27) state licenses were previously petitioned, along with Washington.

Links Used in this News Release.

France COVID Update – https://shortly.cc/WqTT9
U.S. Biden COVID – https://shortly.cc/LTQMu
UK Johnson COVID – https://shortly.cc/MU2Ci
RevoluVIP Destinations – https://revoluvip.com/pages/info/sites
Erik A Lara DSDAQ – https://shortly.cc/uaVpm
RevoluVIP Club Membership – https://www.revoluvip.club/

About RevoluPAY®

The Company’s flagship Neobanking technology is RevoluPAY®, the Apple and Android multinational payment app. Conceived entirely in-house, RevoluPAY features proprietary, sector-specific technology of which the resulting source code is the Company’s intellectual property. RevoluPAY’s built-in features include Remittance Payments, Forex, Crypto-to-fiat exchange, Retail and Hospitality payments, Real Estate Payments, pay-as-you-go phone top-ups, Gift Cards & Online Credits, Utility Bill payments, Leisure payments, Travel Payments, etc. RevoluPAY employs blockchain protocols and is squarely aimed at the worldwide multi-billion dollar Open Banking sector and + $595 billion family remittance market. RevoluPAY® is operated by the European wholly-owned subsidiary RevoluPAY EP S.L situated in Barcelona. RevoluPAY is a dual-licensed Canadian FINTRAC and European PSD2 payment institution 6900 under the auspices of E.U. Directive 2015/2366 with EU Passporting. RevoluGROUP Canada Inc. controls five wholly-owned subsidiaries on four continents.

About
RevoluGROUP Canada Inc.
:

RevoluGROUP Canada Inc. is a multi-asset, multidivisional publicly traded Canadian Company deploying advanced technologies in; Banking, Mobile Apps, Money Remittance, Mobile Phone Top-Ups, EGaming, Healthcare Payments, Esports, Invoice factoring, Online Travel, Vacation Resort, Blockchain Systems, and Fintech app sectors. Click here to read more.

For further information on RevoluGROUP Canada Inc. (TSX-V: REVO), visit the Company’s website at www.RevoluGROUP.com. The Company has approximately 174,630,592 shares issued and outstanding.

RevoluGROUP Canada, Inc.

“Steve Marshall”

______________________
STEVE MARSHALL
CEO

For further information, contact:
RevoluGROUP Canada Inc.
Telephone: (604) 332 5355
Facsimile: (604) 687 3119
Email: [email protected]

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER (AS THAT TERM IS DEFINED IN POLICIES OF THE TSX VENTURE EXCHANGE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

This release includes certain statements that may be deemed to be “forward-looking statements”. All statements in this release, other than statements of historical facts, that address events or developments that management of the Company expects, are forward-looking statements. Although management believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance, and actual results or developments may differ materially from those in the forward-looking statements. The Company undertakes no obligation to update these forward-looking statements if management’s beliefs, estimates or opinions, or other factors, should change. Factors that could cause actual results to differ materially from those in forward-looking statements, include market prices, exploration and development successes, continued availability of capital and financing, and general economic, market or business conditions. Please see the public filings of the Company at www.sedar.com for further information.



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Scholar Rock Presents TOPAZ Interim Analysis Data for Apitegromab in Spinal Muscular Atrophy at the 2021 Muscular Dystrophy Association (MDA) Virtual Clinical & Scientific Conference

Scholar Rock Presents TOPAZ Interim Analysis Data for Apitegromab in Spinal Muscular Atrophy at the 2021 Muscular Dystrophy Association (MDA) Virtual Clinical & Scientific Conference

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, today announced its oral and poster presentations at the 2021 Muscular Dystrophy Association (MDA) Virtual Clinical & Scientific Conference, being held March 15-18.

Both presentations will include six-month interim analysis data from the TOPAZ Phase 2 clinical trial evaluating the potential of apitegromab, a highly selective inhibitor of latent myostatin, in improving motor function in patients with Type 2 and Type 3 Spinal Muscular Atrophy (SMA). Top-line clinical data from TOPAZ for the full 12-month treatment period are expected in the second quarter of 2021.

Oral presentation details:

  • Title: Apitegromab, a Novel High-Affinity Anti-proMyostatin Monoclonal Antibody for Treating Spinal Muscular Atrophy: Results of a Phase 2 Interim Analysis
  • Date and Time: Thursday, March 18, 2021, 2:00-2:15 pm EST
  • Presenter: Amy Place, PhD, MBA, MS, RD, CLT on behalf of the apitegromab development team

Poster presentation details:

  • Title: Apitegromab, a Novel High-Affinity Anti-Promyostatin Monoclonal Antibody for Treating Spinal Muscular Atrophy: Results of a Phase 2 Interim Analysis (Poster #51)
  • Dates: Virtual poster presentations are available to view on the virtual conference platform from March 15-18, 2021

About Apitegromab

Apitegromab is a selective inhibitor of the activation of myostatin and is an investigational product candidate for the treatment of patients with spinal muscular atrophy (SMA). Myostatin, a member of the TGFβ superfamily of growth factors, is expressed primarily by skeletal muscle cells, and the absence of its gene is associated with an increase in muscle mass and strength in multiple animal species. Scholar Rock believes the inhibition of the activation of myostatin with apitegromab may promote a clinically meaningful improvement in motor function.

A Phase 2 clinical trial in patients with Type 2 and Type 3 SMA is ongoing (NCT03921528). The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) designation, and the European Commission (EC) has granted Orphan Medicinal Product Designation, to apitegromab for the treatment of SMA. The effectiveness and safety of apitegromab have not been established and apitegromab has not been approved for any use by the FDA or any other regulatory agency.

About Scholar Rock

Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. Scholar Rock is creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, fibrosis and anemia. Scholar Rock’s approach to targeting the molecular mechanisms of growth factor activation enabled it to develop a proprietary platform for the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level. By developing product candidates that act in the disease microenvironment, the Company intends to avoid the historical challenges associated with inhibiting growth factors for therapeutic effect. Scholar Rock believes its focus on biologically validated growth factors may facilitate a more efficient development path. For more information, please visit https://scholarrock.com/ or follow Scholar Rock on Twitter (@ScholarRock) and LinkedIn (https://www.linkedin.com/company/scholar-rock/).

Scholar Rock® is a registered trademark of Scholar Rock, Inc.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Scholar Rock’s future expectations, plans and prospects, including without limitation, Scholar Rock’s expectations regarding its growth, strategy, progress and timing of its clinical trials for apitegromab, SRK-181, and other product candidates and indication selection and development timing, its cash runway, the ability of any product candidate to perform in humans in a manner consistent with earlier nonclinical, preclinical or clinical trial data, and the potential of its product candidates and proprietary platform. The use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify such forward-looking statements. All such forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include Scholar Rock’s ability to provide the financial support, resources and expertise necessary to identify and develop product candidates on the expected timeline, the data generated from Scholar Rock’s nonclinical and preclinical studies and clinical trials, competition from third parties that are developing products for similar uses, Scholar Rock’s ability to obtain, maintain and protect its intellectual property, the success of Scholar Rock’s current and potential future collaborations, including its collaboration with Gilead, Scholar Rock’s dependence on third parties for development and manufacture of product candidates including to supply any clinical trials, Scholar Rock’s ability to manage expenses and to obtain additional funding when needed to support its business activities and establish and maintain strategic business alliances and new business initiatives, and the impacts of public health pandemics such as COVID-19 on business operations and expectations, as well as those risks more fully discussed in the section entitled “Risk Factors” in Scholar Rock’s Annual Report on Form 10-K for the year ended December 31, 2020, as well as discussions of potential risks, uncertainties, and other important factors in Scholar Rock’s subsequent filings with the Securities and Exchange Commission. Any forward-looking statements represent Scholar Rock’s views only as of today and should not be relied upon as representing its views as of any subsequent date. All information in this press release is as of the date of the release, and Scholar Rock undertakes no duty to update this information unless required by law.

Scholar Rock:

Investors/Media

Catherine Hu

[email protected]

Media:

Ariane Lovell

Finn Partners

[email protected]

917-565-2204

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Health FDA Clinical Trials General Health Pharmaceutical Biotechnology

MEDIA:

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Eledon Pharmaceuticals Strengthens Leadership Team with Chief Medical Officer and Chief Financial Officer Hires

Jeff Bornstein, M.D. to serve as Chief Medical Officer and Paul Little as Chief Financial Officer

IRVINE, Calif., March 15, 2021 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN), a clinical stage biopharmaceutical company focused on developing life-changing, targeted medicines for persons undergoing organ or cellular transplantation, as well as those living with immunological diseases, today announced the appointments of Paul Little as Chief Financial Officer, effective today, and Jeff Bornstein, M.D. as Chief Medical Officer, effective April 5, 2021.

“Both Jeff and Paul are seasoned biopharmaceutical executives, and I am thrilled to welcome them to the Eledon team as we advance our Phase 2 trial of AT-1501 in ALS while planning to initiate up to three more Phase 2 trials in the coming months,” stated David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon Pharmaceuticals. “Jeff and Paul round out a top-tier leadership team that I believe positions us to achieve long term success for the benefit of patients and shareholders alike.”

Dr. Bornstein’s experience includes nearly 20 years of research and development roles in the biopharmaceutical industry. He most recently served as Vice President, Head of Clinical Sciences, Gastroenterology at Takeda Pharmaceuticals. Prior to Takeda, he led development programs at Biogen, Gilead Sciences, Elan Pharmaceuticals, as well as at several earlier stage biotech companies. Dr. Bornstein earned his Doctor of Medicine from McGill University. He completed his residency in internal medicine at McGill University and his fellowship in gastroenterology at Duke University Medical Center where he also served on the faculty as an Assistant Professor of Medicine. He has authored or co-authored more than 45 scientific and medical publications.

“I’m thrilled to join Eledon and to guide the development of AT-1501, a novel antibody targeting the CD40 ligand co-stimulatory signaling pathway. Modulating CD40 ligand biology may have therapeutic effects in transplantation and a range of immuno-inflammatory diseases and may help unlock a functional cure in Type 1 diabetes,” stated Dr. Bornstein. “I am eager to contribute to the advancement of AT-1501 in important disease indications where we may have profound positive effects on the lives of patients.”

Mr. Little has over 30 years of financial, operations, business strategy and leadership experience in global public companies. Before joining Eledon, Mr. Little served as Chief Financial Officer of Sientra Inc., where he led finance, investor relations, information technology, and manufacturing. During his tenure at Sientra, Mr. Little successfully led multiple public financing rounds while strengthening the balance sheet and driving organizational and operational efficiencies to accelerate revenue growth while improving cash flow. Prior to Sientra, Mr. Little served as Chief Operating Officer for Candela Medical (formerly Syneron-Candela) where he led the Company’s global supply chain and service organization and helped lead the execution of the growth strategy culminating in the sale of the company. Before Candela Medical, Mr. Little served as Vice President, Finance and Commercial Operations for Allergan PLC’s Medical Aesthetics division and as a key member of the senior leadership team, helped build Allergan into the global market leader for medical aesthetics. In this role, Mr. Little built the commercial finance, commercial operations and customer operations functions from the ground up and led the financial assessment and integration of over $3 billion in M&A activities. He joined Allergan from Conagra Brands and began his career in public accounting at KPMG. Mr. Little holds a B.A. in Business Economics from the University of California, Santa Barbara.

“I believe Eledon’s lead clinical candidate, AT-1501, is a best-in-class asset with potential across several indications, creating multiple opportunities for long-term value creation,” stated Mr. Little. “I look forward to working with the team in driving the company toward its financial and operational goals.”

About Eledon Pharmaceuticals and AT-1501

Eledon Pharmaceuticals (f/k/a Novus Therapeutics, Inc.) is a clinical-stage biotechnology company using its expertise in targeting the CD40L pathway to develop potential treatments for persons living with an autoimmune disease, persons undergoing organ or cell-based transplantation, and for persons living with ALS. The company’s lead compound in development is AT-1501, a humanized IgG1 anti-CD40L antibody with high affinity for CD40 ligand (CD40L, also called CD154), a well-validated biological target with broad therapeutic potential. The CD40L/CD40 pathway is widely recognized for its prominent role in immune regulation. CD40L is primarily expressed on activated CD4+ T cells, platelets and endothelial cells while the CD40 receptor is constitutively expressed on antigen presenting cells such as B cells, macrophages, and dendritic cells. By blocking CD40L and not the CD40 receptor, AT-1501 inhibits both the CD40 and CD11 costimulatory signaling pathways, providing the potential for improved efficacy compared to anti-CD40 receptor approaches. Blocking CD40L also increases polarization of CD4+ lymphocytes to Tregs, a specialized subpopulation of T cells that act to suppress an immune response, thus creating a more tolerogenic environment, which is especially important for autoimmune diseases and in the transplant setting. Furthermore AT-1501 is an IgG1 antibody specifically engineered to cripple the Fc effector function to potentially improve safety, as well as to potentially provide pharmacokinetic, pharmacodynamic, and dosing advantages compared to other approaches. Eledon is headquartered in Irvine, Calif. For more information, please visit the company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: @Eledon_Pharma and LinkedIn.

Notice of Issuance of Inducement Grants

Pursuant to their employment agreements, Dr. Bornstein and Mr. Little will be awarded options to purchase a total of 170,000 and 160,000 shares of Common Stock, respectively, subject to a four-year vesting schedule (the “Inducement Grants”). The Inducement Grants will have an exercise price equal to the closing price of the Company’s common stock on the date of grant. The Inducement Grants have been approved by the Compensation Committee of the Board of Directors. The Inducement Grants will be issued outside of the Company’s stockholder-approved equity incentive plans as inducement grants in accordance with Nasdaq Listing Rule 5635(c)(4).

Forward-Looking Statements

This press release contains forward-looking statements that involves substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about its strategy, future operations, development of its product candidates, expected timing for initiation of future clinical trials and expected timing for receipt of data from its clinical trials, as well as , other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, although not all forward-looking statements include such identifying words. Forward-looking statements include but are not limited to statements regarding: risks related to market conditions; expectations regarding the timing for the commencement of future clinical trials; expectations regarding the success of clinical trials; the clinical utility of the company’s product candidates; the company’s estimates regarding expenses and cash runway; and the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the SEC, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Corey Davis, Ph.D.
LifeSci Advisors, LLC
[email protected] 
212.915.2577

Source: Eledon Pharmaceuticals, Inc.



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VBI Vaccines to Present at Oppenheimer 31st Annual Healthcare Conference

VBI Vaccines to Present at Oppenheimer 31st Annual Healthcare Conference

CAMBRIDGE, Mass.–(BUSINESS WIRE)–
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that Jeff Baxter, President and Chief Executive Officer, and David E. Anderson, Ph.D., Chief Scientific Officer, will participate in an analyst-led fireside chat at the Oppenheimer 31st Annual Healthcare Conference on Wednesday, March 17 at 10:40 AM ET.

Presentation Details:

– Event: Oppenheimer 31st Annual Healthcare Conference

– Presenters: Jeff Baxter, President and CEO, and David E. Anderson, Ph.D., Chief Scientific Officer

– Date: Wednesday, March 17, 2021

– Time: 10:40 – 11:10 AM ET

– Webcast:https://wsw.com/webcast/oppenheimer9/vbiv/2737603

A recording of the webcast will be available on the “Events and Presentations” page of the Company’s website: https://www.vbivaccines.com/investors/events-and-presentations/.

About VBI Vaccines Inc.

VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.

Website Home: http://www.vbivaccines.com/

News and Resources: http://www.vbivaccines.com/news-and-resources/

Investors: http://www.vbivaccines.com/investors/

Cautionary Statement on Forward-looking Information

Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 2, 2021, and filed with the Canadian security authorities at sedar.com on March 2, 2021, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.

VBI

Nicole Anderson

Director, Corporate Communications & IR

Phone: (617) 830-3031 x124

Email: [email protected]

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: Research Infectious Diseases FDA Clinical Trials Other Health Biotechnology Pharmaceutical Health Science Oncology

MEDIA:

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Baker Hughes Announces Date for First Quarter 2021 Earnings Release and Webcast

Baker Hughes Announces Date for First Quarter 2021 Earnings Release and Webcast

HOUSTON & LONDON–(BUSINESS WIRE)–
Baker Hughes (NYSE: BKR) will hold a webcast on Wednesday, April 21, 2021 to discuss the results for the first quarter ending March 31, 2021. The webcast is scheduled to begin at 8:00 a.m. Eastern Time (7:00 a.m. Central Time). A press release announcing the results will be issued at 6:30 a.m. Eastern Time (5:30 a.m. Central Time).

To access the webcast, listeners should visit the Baker Hughes website at: investors.bakerhughes.com. An archived version will be available on the website following the webcast.

About Baker Hughes:

Baker Hughes (NYSE: BKR) is an energy technology company that provides solutions to energy and industrial customers worldwide. Built on a century of experience and with operations in over 120 countries, our innovative technologies and services are taking energy forward – making it safer, cleaner and more efficient for people and the planet. Visit us at bakerhughes.com.

Investor Relations

Jud Bailey

+1 281-809-9088

[email protected]

Media Relations

Thomas Millas

+1 713-879-2862

[email protected]

KEYWORDS: Europe United States United Kingdom North America Texas

INDUSTRY KEYWORDS: Oil/Gas Energy

MEDIA:

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IntelGenx Announces Strategic Partnership with atai Life Sciences and Proposed TSX Graduation

SAINT LAURENT, Quebec, and NEW YORK, March 15, 2021 (GLOBE NEWSWIRE) — IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQB:IGXT) (the “Corporation”) today announced that its wholly owned subsidiary, IntelGenx Corp. (“IntelGenx”), a leader in pharmaceutical films, has agreed to the terms of a strategic partnership with atai Life Sciences (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, including an equity investment by atai, pursuant to which atai will initially acquire an approximate 25% interest in the Corporation. The Corporation also announced that atai has granted to IntelGenx a secured loan in the amount of US$2,000,000.

As part of the strategic partnership, IntelGenx will exclusively partner with atai to develop compounds for the prevention or treatment of mental health diseases or disorders, including compounds that have psychedelic, entactogenic and/or oneirophrenic properties.

“This transaction with atai is truly transformational for IntelGenx, catapulting us into a leadership position within the novel therapeutics field of psychedelics while, at the same time, providing the requisite financial resources to continue to advance our robust portfolio of other innovative pharmaceutical film product candidates towards commercialization,” said Dr. Horst G. Zerbe, CEO of IntelGenx. “We look forward to building a strong partnership.”

“We continue to believe that the combination of our development candidates with IntelGenx’s film technology holds strong clinical promise in the treatment of mental health disorders. The film technology avoids first-pass metabolism and may allow for the delivery of compounds that are non-orally bioavailable. Further, eliminating first-pass metabolism may reduce the serum concentrations of metabolites, potentially improving safety and tolerability,” said Florian Brand, CEO of atai. “We are delighted to progress from collaborators to partners, making IntelGenx’s film technology an integral part of our platform.”

The partnership and investment are subject to the approval of the TSX Venture Exchange (the “Exchange”) and approval of the shareholders of the Corporation (the “Shareholders”) and will be subject to certain customary closing conditions. Shareholders will be asked to consider and vote on the proposed transaction with atai at the Corporation’s Annual Meeting of Shareholders (the “Meeting”) on May 11, 2021.

Strategic Development Agreement

Under a strategic development agreement, atai and IntelGenx will cooperate to conduct research and development projects in areas relating to the parties’ respective technologies. A portion of the funds (20%) that the Corporation receives through atai’s equity investment under the securities purchase agreement described below will be available to be credited against the costs to IntelGenx of the research and development projects. So long as atai maintains certain levels of its initial equity ownership in the Corporation, IntelGenx will work exclusively with atai in the field of compounds for the prevention or treatment of mental health diseases or disorders or compounds that have psychedelic, entactogenic and/or oneirophrenic properties, but excluding certain specific compounds and veterinary applications.

The commercialization of any technologies that result from the research and development projects under the strategic development agreement will be subject to agreements to be negotiated, as well as to specified pricing and royalty terms for manufacturing conducted by IntelGenx or third parties.

Securities Purchase Agreement

Under a securities purchase agreement, atai has agreed to purchase 37,300,000 shares of common stock of the Corporation (the “Shares”) and 22,380,000 warrants (the “Warrants”) for aggregate gross proceeds of US$12,346,300 (the “Investment”) following receipt of Shareholders’ approval at the Meeting. Each Warrant will entitle atai to purchase one Share at a price of US$0.35 for a period of three years from closing of the initial investment.

The securities purchase agreement also provides atai with the right to subscribe (in cash, or in certain circumstances, atai equity) for up to 130,000,000 additional units (“Additional Units”) for a period of three years from the closing of the initial investment. Each Additional Unit will be comprised of (i) one share of common stock (an “Additional Share”) and (ii) one half of one warrant (each whole warrant, an “Additional Warrant”). The price for the Additional Units will be (i) until the date which is 12 months following the closing, US$0.331 (subject to certain exceptions), and (ii) following the date which is 12 months following the closing, the lower of (A) a 20% premium to the market price on the date of purchase, and (B) US$0.50 if purchased in the second year following closing and US$0.75 if purchased in third year following closing. Each Additional Warrant will entitle atai, for a period of three years from the date of issuance, to purchase one Share at the lesser of either (i) a 20% premium to the price of the corresponding Additional Share, or (ii) the price per share under which shares of the Corporation are issued under convertible instruments that were outstanding on February 16, 2021, the date on which the parties entered into a non-binding letter of intent to enter into a definitive securities purchase agreement (“Outstanding Convertibles”), provided that atai may not exercise Additional Warrants to purchase more than the lesser of (x) 44,000,000 common shares of the Corporation, and (y) the number of common shares issued by the Corporation under Outstanding Convertibles.

Under the securities purchase agreement, the Corporation also granted atai a pro-rata equity participation right for any issuances of new securities, subject to certain exceptions.

Following the initial closing, atai will hold approximately 25% (approximately 35% on a partially diluted basis) of the issued and outstanding Shares and therefore become a new “Control Person” of the Corporation as such term is defined under the policies of the Exchange. Based on the number of issued and outstanding Shares and outstanding convertible instruments on the date hereof, assuming the full exercise of its option to acquire the Additional Units and exercise of the Initial Warrants and Additional Warrants, atai would hold approximately 60% (approximately 60% on a partially diluted basis) of the issued and outstanding Shares.

Proposed Graduation to the Toronto Stock Exchange

Under the securities purchase agreement, the Corporation has agreed to use reasonable efforts to list its Shares on the Toronto Stock Exchange with a target to achieve such listing shortly after the initial closing contemplated by the securities purchase agreement and the Corporation intends to promptly submit a listing application to the Toronto Stock Exchange. Any listing of the Corporation’s common shares on the Toronto Stock Exchange is subject to the Corporation meeting all of the listing requirements of and obtaining the approval of the Toronto Stock Exchange.

Purchaser Rights Agreement

Under the purchaser rights agreement, atai will have the right to appoint nominees in the same proportion to the number of Board members of the Corporation as the Shares then held by atai, registration rights, and financial and other information rights.

The Corporation will have the right to terminate the purchaser rights agreement if atai ceases to own a certain amount of the Corporation’s equity.

Term Loan

atai has granted to IntelGenx a secured loan in the amount of US$2,000,000. The loan is repayable on the date that is 120 days following the date of the Meeting, but in any event not later than September 30, 2021. The securities purchase agreement provides that an amendment is to be entered into at the initial closing of the atai investment under which the maturity date will be following the first closing of a subscription for Additional Units if the proceeds from such subscription amount to at least $3,000,000. The loan provides for the possibility of an additional advance to IntelGenx of up to US$500,000, subject to certain conditions. The loan is guaranteed by the Corporation and secured by all of present and future fixed assets of IntelGenx, excluding any intellectual property or technology controlled or owned by IntelGenx.

IntelGenx has applied approximately US$800,000 from the loan to fully repay the outstanding amount on the Corporation’s credit facilities with the Bank of Montreal. IntelGenx intends to use the balance of the loan for general working capital purposes.

About IntelGenx

IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.

IntelGenx’s superior film technologies, including VersaFilm®, DisinteQ™, VetaFilm™ and transdermal VevaDerm™, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions.

IntelGenx’s highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’s state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit www.intelgenx.com.

About atai

atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai is headquartered in Berlin, with offices in New York, San Diego and London. For more information, please visit www.atai.life.

Disclaimer

The Shares, Warrants, Additional Units, Additional Warrants, Additional Shares and shares of common stock of the Corporation issuable on exercise of the Warrants and the Additional Warrants have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or any state securities laws, and may not be offered or sold in the United States, or to or for the account or benefit of, persons in the United States or U.S. Persons (as defined in Regulation S under the U.S. Securities Act) absent registration or an applicable exemption from the registration requirements of the U.S. Securities Act and applicable U.S. state securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of securities of the Corporation in any jurisdiction in which such offer, solicitation or sale would be unlawful.

Forward-Looking Information

This document may contain forward-looking information which involves substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the U.S. Securities Act. Forward-looking information or forward-looking statements by their nature are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Corporation at the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. Words such as “expects”, “continue”, “will”, “anticipates” and “intends” or similar expressions are intended to identify forward-looking statements. More particularly and without limitation, this document contains forward-looking statements and information regarding a planned strategic cooperation with and an investment by atai and an intended graduation to the TSX. Because these forward-looking statements are subject to a number of risks and uncertainties, the Corporation’s actual results, objectives and plans could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include failure to obtain Shareholder approval; failure to obtain required approvals from regulators or security exchanges; failure to satisfy other conditions to closing under the Securities Purchase Agreement; the cooperation with atai under the strategic development agreement may not result in projects that are successful or that can be monetized by the Corporation; and the cooperation with atai may prevent the Corporation from pursuing cooperation with other partners or other opportunities. The foregoing list is not exhaustive of the factors that may affect the forward-looking statements. Some of the important risks and uncertainties that could affect forward-looking statements are discussed under the heading “Risk Factors” in the Corporation’s annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities at www.sedar.com. Forward-looking statements are made based on management’s beliefs, estimates and opinions on the date the statements are made, and the Corporation assumes no obligation to update any such forward-looking statements except as required by law. Moreover, all forward-looking information contained herein is subject to certain assumptions. Investors are cautioned against attributing undue certainty to forward-looking statements.

All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

Each of the TSX Venture Exchange and OTCQB has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Contact Information

For IntelGenx:

Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
[email protected]

Or

Andre Godin, CPA, CA
President and CFO
IntelGenx Technologies Corp.
(514) 331-7440 ext 203
[email protected]

For atai Life Sciences:

Investor Contact:
Greg Weaver
ATAI – Chief Financial Officer
Email: [email protected]

Media Contact:
Anne Donohoe
KCSA Strategic Communications
Phone: +1 (212) 896-1265
Email: [email protected]



Posted on

Pebblebrook Hotel Trust Announces the 9th Annual Pebby Award Nominations

Pebblebrook Hotel Trust Announces the 9th Annual Pebby Award Nominations

Recognizing the Year’s Best Hotels

HOLLYWOOD, Calif.–(BUSINESS WIRE)–
Pebblebrook Hotel Trust (NYSE: PEB) (the “Company”) today announced the nominations for its Ninth Annual Pebby Awards. The Pebby Award nominees were chosen for their outstanding accomplishments in 2020, as determined by the Company.

This year’s highly anticipated nominees include a mix of Pebby veterans and newcomers. Many hotels and resorts earned several nominations: Argonaut Hotel, Chaminade Resort & Spa and LaPlaya Beach Resort & Club lead the field with four nominations each while Hotel Chicago Downtown, Autograph Collection and The Nines, a Luxury Collection Hotel, Portland are close behind with three nominations each. The impressive list of critically acclaimed nominees will surely produce one of the most unpredictable Pebby Awards ceremonies ever.

“Despite the challenges posed by the COVID-19 pandemic, we successfully navigated through a difficult year thanks to our cast and crew,” said Jon E. Bortz, Chairman, President and Chief Executive Officer of Pebblebrook Hotel Trust. “A big congratulations to our property teams who have been nominated for a prestigious Pebby Award.”

And the nominees are…

Best Picture – For best overall performance by a hotel in 2020, based on operating execution and profitability, in addition to adapting to the challenging environment created by the COVID-19 pandemic.

  • Hotel Zetta San Francisco
  • LaPlaya Beach Resort & Club
  • Skamania Lodge
  • Southernmost Beach Resort
  • The Liberty, a Luxury Collection Hotel, Boston
  • The Westin Copley Place, Boston

Best Directing – For best overall leadership and comprehensive expense management in 2020.

  • Embassy Suites San Diego Bay – Downtown
  • Hotel Chicago Downtown, Autograph Collection
  • Hotel Vintage Portland
  • Le Méridien Delfina Santa Monica
  • Sofitel Philadelphia at Rittenhouse Square
  • The Management Team for Hotel Spero and The Marker San Francisco
  • W Boston

Best Actor / Actress– For best overall effort made by a hotel team to positively impact their community and/or neighborhood and help raise awareness for social justice and equity.

  • Argonaut Hotel
  • Chaminade Resort & Spa
  • Harbor Court Hotel San Francisco
  • Hotel Zena Washington DC
  • The Nines, a Luxury Collection Hotel, Portland
  • Viceroy Washington DC

Best Live Action Short Film – For best “skeleton crew” management, honoring the temporarily suspended hotel with the most dedicated management team.

  • Harbor Court Hotel San Francisco
  • Hotel Chicago Downtown, Autograph Collection
  • Hotel Palomar Los Angeles Beverly Hills
  • L’Auberge Del Mar
  • The Management Team for Argonaut Hotel and Hotel Zoe Fisherman’s Wharf
  • The Management Team for Chamberlain West Hollywood Hotel, Grafton on Sunset, Le Parc Suite Hotel and Montrose West Hollywood
  • The Westin Michigan Avenue Chicago

Best Visual Effects – For best overall performance during a major renovation, following the Company’s standard of “relentless pursuit of continuous improvement” and maintaining a pleasant and professional demeanor while going through disruptions, surprises and great inconveniences.

  • Chaminade Resort & Spa
  • Embassy Suites San Diego Bay – Downtown
  • Hotel Zena Washington DC
  • Le Parc Suite Hotel
  • San Diego Mission Bay Resort
  • The Westin San Diego Gaslamp Quarter
  • Viceroy Santa Monica Hotel

Best Music (Original Score) – For outstanding implementation of new health protocols and creative operating practices in a COVID-19 world.

  • Hilton San Diego Gaslamp Quarter
  • LaPlaya Beach Resort & Club
  • Le Méridien Delfina Santa Monica
  • Paradise Point Resort & Spa
  • Solamar Hotel
  • W Los Angeles – West Beverly Hills

Best Cinematography – For best implementation of energy conservation programs and green initiatives to reduce energy, water and waste to limit a hotel’s carbon footprint.

  • Argonaut Hotel
  • Chaminade Resort & Spa
  • Hotel Zoe Fisherman’s Wharf
  • LaPlaya Beach Resort & Club

Best Documentary – For best overall implementation of accounting standards and controls, including success in minimizing credit card chargebacks and overall expense management.

  • Argonaut Hotel
  • Hilton San Diego Gaslamp Quarter
  • Hotel Chicago Downtown, Autograph Collection
  • Hotel Palomar Los Angeles Beverly Hills
  • L’Auberge Del Mar
  • The Marker Key West Harbor Resort
  • Viceroy Santa Monica Hotel 

Best Animated Feature Film – For best overall adoption of food and beverage concepts while adhering to social distancing and other COVID-19 protocols to keep customers and team members safe.

  • BALEEN at LaPlaya Beach Resort & Club
  • Departure Restaurant at The Nines, a Luxury Collection Hotel, Portland
  • Harborside Grill at Hyatt Regency Boston Harbor
  • The View, a Treeside Restaurant at Chaminade Resort & Spa
  • Tidal at Paradise Point Resort & Spa
  • Urban Farmer Restaurant at The Nines, a Luxury Collection Hotel, Portland

The Ninth Annual Pebby Award winners will be announced on Friday, April 23, 2021 starting at 3:00 PM ET. Join us on Twitter @PebblebrookPEB to receive live updates as the Pebby Winners are announced. Please also visit our web site at www.pebblebrookhotels.com to learn more about our hotels and the well-regarded management teams leading them.

About Pebblebrook Hotel Trust

Pebblebrook Hotel Trust (NYSE: PEB) is a publicly-traded real estate investment trust (“REIT”) and the largest owner of urban and resort lifestyle hotels in the United States. The Company owns 53 hotels, totaling approximately 13,200 guest rooms across 14 urban and resort markets with a focus on the west coast gateway cities. For more information, visit www.pebblebrookhotels.com and follow us at @PebblebrookPEB.

For additional information or to receive press releases via email, please visit our website at www.pebblebrookhotels.com

Raymond D. Martz, Chief Financial Officer, Pebblebrook Hotel Trust – (240) 507-1330

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: REIT Lodging Commercial Building & Real Estate Construction & Property Travel

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