DBV Technologies Announces Filing of its First Form 10-Q for the First Quarter of 2021

DBV Technologies Announces Filing of its First Form 10-Q for the First Quarter of 2021




DBV Technologies Announces Filing of its First Form 10-Q for the First Quarter of 2021

Montrouge, France, May 5, 2021

DBV Technologies Announces Filing of its First Form 10-Q for the First Quarter of 2021

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the filing of its first Form 10-Q for the quarter ended March 31, 2021 with the U.S. Securities and Exchange Commission (SEC).

This document can be accessed on the Investors & Media section of the Company’s website at www.dbv-technologies.com. In addition, this Form 10-Q is available on the SEC’s website at www.sec.gov.

About DBV Technologies 
DBV Technologies is developing Viaskin™, an investigational proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT™, DBV’s method of delivering biologically active compounds to the immune system through intact skin. With this new class of non-invasive product candidates, the Company is dedicated to safely transforming the care of food allergic patients. DBV’s food allergies programs include ongoing clinical trials of Viaskin Peanut. DBV Technologies has global headquarters in Montrouge, France, and North American operations in Summit, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345), part of the SBF120 index, and the Company’s ADSs (each representing one-half of one ordinary share) are traded on the Nasdaq Global Select Market (Ticker: DBVT).

DBV Investor Relations Contact
Anne Pollak
+ 1 (857) 529-2363
anne.pollak@dbv-technologies.com

DBV Media Contact
Angela Marcucci
+1 (646) 842-2393
angela.marcucci@dbv-technologies.com

 

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Vaxil Announces CEO Resignation

Vaxil Announces CEO Resignation




Vaxil Announces CEO Resignation

Not for distribution by US newswire or in United States

NESS-ZIONA, Israel, May 05, 2021 (GLOBE NEWSWIRE) — VAXIL BIO LTD. (“Vaxil” or the “Company”) (TSX VENTURE: VXL), an innovative immunotherapy biotech company specializing in cancer and infectious diseases, today announces that Mr. David Goren has provided notice that he will be resigning as the Company’s chief executive officer (“CEO”) to pursue other opportunities. The resignation will take effect on August 1, 2021 (the “Effective Date”). Mr. Goren has agreed that until the Effective Date, he will, in addition to continuing to fulfill his responsibilities as CEO, assist the Company’s board of directors (“Board“) in their search for a new CEO, which has already commenced.

The Board wishes to thank Mr. Goren for his contributions to the Company over the past two and a half years, and wishes him success in his future endeavors.

Mr. Goren remains a director of the Company.

ABOUT VAXIL

The company posts periodic updates through videos from the official company’s YouTube channel https://www.youtube.com/channel/UC0M029aN8g6beW09Drgt0dQ

Vaxil is an Israeli immunotherapy biotech company focused on its novel approach to targeting prominent cancer markers and infectious diseases. Its lead product ImMucin™ successfully completed a Phase 1/2 clinical trial in multiple myeloma for which it received orphan drug status from the FDA and EMA. The company aims to continue to develop ImMucin™, a COVID-19 and a tuberculosis vaccine / treatment that has demonstrated promising preliminary results with further preclinical evaluation planned. Additional indications and mAb candidates are under evaluation as immuno-oncology and infectious disease treatments alone and in combination with other treatments.

Vaxil exploits the unique properties of signal peptide domains on crucial proteins to develop targeted therapies against cancer targets and infectious disease pathogens. These signal peptide domains are identified by VaxHit™, Vaxil’s proprietary bioinformatic approach. These signal peptides induce a robust T- and B-cell response across wide and varied HLA subtypes, while acting as true, universal neoantigens. The peptide platform targets these cells by “educating” or specifically activating the immune system to recognize and attack the affected cells. In addition, Vaxil’s mAb platform directly recognizes the target protein expressed on malignant cells and recruits other elements of the immune system to lyse those cells.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Disclaimer: The Company cautions that COVID-19 Vaccine Development is still under early stage research and development and is not making any express or implied claims that it has the ability to eliminate the COVID-19 virus at this time. The TSX Venture Exchange Inc. has in no way passed upon the merits of the Company and has neither approved nor disapproved the contents of this press release. This news release contains forward-looking information, which involves known and unknown risks, uncertainties and other factors that may cause actual events to differ materially from current expectation. Important factors – including the availability of funds, the results of financing efforts, the results of exploration activities — that could cause actual results to differ materially from the Company’s expectations are disclosed in the Company’s documents filed from time to time on SEDAR (see www.sedar.com). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. This press release does not constitute an offer to sell or a solicitation of an offer to sell any of the securities described herein in the United States or elsewhere. These securities have not been, and will not be, registered in the United States Securities Act of 1933, as amended, or any state securities laws, and may not be offered or sold in the United States or to U.S. persons unless registered or exempt therefrom.

CONTACT INFORMATION
For further information please visit http://vaxil-bio.com/ or contact:
North Equities, info@northequities.com
David Goren, CEO — info@vaxil-bio.com, +972 (52) 720-6000
Company Youtube channel

Aeterna Zentaris Announces Results of 2021 Annual Meeting of Shareholders

Aeterna Zentaris Announces Results of 2021 Annual Meeting of Shareholders




Aeterna Zentaris Announces Results of 2021 Annual Meeting of Shareholders

CHARLESTON, S.C., May 05, 2021 (GLOBE NEWSWIRE) — Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the “Company”), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, today announced the results from its Annual General Meeting (“AGM”) held today, May 5, 2021.

The individuals noted below were elected as directors of the Company. The report on voting results provided by the Company’s transfer agent indicated the following:

Name of Nominee Votes For % Votes Withheld %
Peter Edwards 7,372,226 85.74 % 1,226,203 14.26 %
Carolyn Egbert 7,536,307 87.65 % 1,062,122 12.35 %
Gilles Gagnon 7,353,055 85.52 % 1,245,374 14.48 %
Klaus Paulini 7,917,497 92.08 % 680,932 7.92 %
Dennis Turpin 7,525,819 87.53 % 1,072,610 12.47 %

The Company would like to welcome Dennis Turpin to the board of directors.

Ernst & Young LLP was also appointed as the Company’s independent auditor at the AGM.

The Company is an “Eligible Interlisted Issuer” as such term is defined in the TSX Company Manual. As an Eligible Interlisted Issuer, the Company has relied on an exemption pursuant to Section 602.1 of the TSX Company Manual from Section 613 of the TSX Company Manual, the effect of which is that, subject to the satisfaction of certain conditions prescribed by the Toronto Stock Exchange, the Company will not have to comply with certain Canadian requirements in connection with the Company’s long-term incentive plan. As a result, shareholders were not asked to approve the unallocated entitlements under the Company’s long-term incentive plan at the AGM.

For full voting details please see the report of voting results of Aeterna as filed on SEDAR at www.sedar.com and EDGAR at www.sec.gov.

About Aeterna Zentaris Inc.

Aeterna Zentaris is a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products focused on areas of significant unmet medical need. The Company’s lead product, macimorelin, is the first and only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). The Company is leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD) in collaboration with Novo Nordisk.

Aeterna Zentaris is dedicated to the development of therapeutic assets and has recently taken steps to establish a growing pipeline to address unmet medical needs across a number of indications, including neuromyelitis optica spectrum disorder (NMOSD), primary hypoparathyroidism and an undisclosed neurodegenerative disease. Additionally, the Company is developing an oral prophylactic bacterial vaccine against SARS-CoV-2, the virus that causes COVID-19.

For more information, please visit www.zentaris.com and connect with the Company on Twitter, LinkedIn and Facebook.

Investor Contact:

Jenene Thomas
JTC Team
T (US): +1 (833) 475-8247
E: aezs@jtcir.com

Cardiol Therapeutics Announces $15 Million Bought Deal Public Offering

Cardiol Therapeutics Announces $15 Million Bought Deal Public Offering




Cardiol Therapeutics Announces $15 Million Bought Deal Public Offering

THIS NEWS RELEASE IS INTENDED FOR DISTRIBUTION IN CANADA ONLY AND IS NOT INTENDED FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES NOR FOR DISSEMINATION IN THE UNITED STATES.

OAKVILLE, Ontario, May 05, 2021 (GLOBE NEWSWIRE) — Cardiol Therapeutics Inc. (TSX: CRDL) (“Cardiol” or the “Company”), a clinical-stage biotechnology company focused on developing innovative anti-inflammatory therapies for the treatment of cardiovascular disease, is pleased to announce that it has entered into an agreement with Raymond James Ltd. as sole bookrunner, on behalf of a syndicate of underwriters (collectively the “Underwriters”) pursuant to which the Underwriters have agreed to purchase, on a bought deal basis, 4,167,000 units of the Company (“Units”) at a price of $3.60 per Unit for gross proceeds of approximately $15 million (the “Offering”).

Each Unit comprises one common share (each a “Common Share”) and one-half Common Share purchase warrant (each such full warrant, a “Warrant”). Each Warrant will entitle the holder thereof to purchase one Common Share at a price of $4.60 for a period of 36 months following the closing of the Offering.

The Company has granted the Underwriters an Over-Allotment Option, exercisable in whole or in part, at any time, and from time to time, for a period of 30 days following the closing of the Offering, to purchase at the Issue Price up to such number of an additional Units, Common Shares and Warrants as is equal to 15% of the number of Units sold pursuant to the Offering. The Underwriters can elect to exercise the Over-Allotment Option for Units only, Common Shares only, or Warrants only, or any combination thereof, to cover over-allotments, if any, and for market stabilization purposes.

The Company intends to use the net proceeds from the Offering to advance the Company’s research and clinical development programs, additional commercial product development, and for general corporate purposes.

The Units will be offered by way of prospectus supplement filed in each of the provinces of Canada (other than Quebec) to supplement the Company’s short form base shelf prospectus dated April 30, 2021.

The Offering is expected to close on or about May 12, 2021 and is subject to market and other customary conditions, including approval of the Toronto Stock Exchange, and the entering into of an underwriting agreement between the Company and the Underwriters.

The securities offered 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 applicable U.S. state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or “U.S. persons” (as such term is defined under Regulation S under the U.S. Securities Act) absent registration or an available exemption from the registration requirement 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 the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

About Cardiol Therapeutics

Cardiol Therapeutics Inc. (TSX: CRDL) is a clinical-stage biotechnology company focused on the research and clinical development of innovative anti-inflammatory therapies for the treatment of cardiovascular disease (“CVD”). The Company’s lead product, CardiolRx™, is a pharmaceutically produced oral cannabidiol formulation that is being investigated in a Phase II/III outcomes study in hospitalized patients testing positive for the COVID-19 virus. This potentially registrational trial is designed to evaluate the efficacy and safety of CardiolRx as a cardioprotective therapy to reduce mortality and major cardiovascular events in COVID-19 patients who have a prior history of, or risk factors for, CVD, and to investigate the influence CardiolRx has on key markers of inflammatory heart disease.

Cardiol is also planning to file an investigational new drug (“IND”) application for a Phase II international trial that will investigate the anti-inflammatory and anti-fibrotic properties of CardiolRx in patients with acute myocarditis, which remains the most common cause of sudden cardiac death in people under 35 years of age. In addition, Cardiol is developing a subcutaneous formulation of CardiolRx and other anti-inflammatory therapies for the treatment of chronic heart failure – a leading cause of death and hospitalization in North America, with associated annual healthcare costs in the U.S. alone exceeding $30 billion.

Cardiol recently commercialized Cortalex™ (cortalex.com), a pharmaceutically produced cannabidiol formulation developed to address underserved segments of the Canadian medicinal cannabidiol market.

For more information about Cardiol Therapeutics, please visit cardiolrx.com.

Cautionary statement regarding forward-looking information:

This news release contains “forward-looking information” within the meaning of applicable Canadian securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could or might occur in the future are “forward-looking information.” Forward looking information contained herein may include, but is not limited to, statements relating to: the Company’s focus on developing innovative anti-inflammatory therapies for the treatment of CVD; the number of Units, price per Unit and gross proceeds from the Offering; the composition of the Units and the terms of the Warrants; the terms of the Over-Allotment Option; the intended use of proceeds; the fact that the Units will be offered by way of prospectus supplement; the anticipated closing date and closing conditions for the Offering; and the fact that Cardiol plans to file an IND application. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company’s Annual Information Form dated March 31, 2021, as well as the risks and uncertainties associated with product commercialization, clinical studies and the risk that the Offering is not completed. These risks, uncertainties and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information. Any forward-looking information speaks only as of the date on which it is made and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events or results or otherwise.

For further information, please contact:

David Elsley, President & CEO +1-289-910-0850
david.elsley@cardiolrx.com

Trevor Burns, Investor Relations +1-289-910-0855
trevor.burns@cardiolrx.com

Ortho Clinical Diagnostics Reports First Quarter 2021 Results

Ortho Clinical Diagnostics Reports First Quarter 2021 Results




Ortho Clinical Diagnostics Reports First Quarter 2021 Results

First Quarter Revenue Growth Exceeds Company’s Expectations at 24.2%, Supporting Increase in 2021 Guidance

RARITAN, N.J., May 05, 2021 (GLOBE NEWSWIRE) — Ortho Clinical Diagnostics Holdings plc (Nasdaq: OCDX), one of the world’s largest pure-play in-vitro diagnostics (IVD) companies, today announced financial results for the first quarter ended April 4, 2021.

Highlights

  • First quarter revenue increased 24.2% to $506.8 million, or 21.8% in constant currency
  • Core revenue grew 23.5% to $499.3 million for the quarter, or 21.1% in constant currency basis
  • Operating Income increased 382% to $57.4 million from $11.9 million last year
  • Net loss was $39.1 million, or ($0.19) per diluted share, while Adjusted net income was $54.9 million, or $0.26 per diluted share in the first quarter of 2021
  • First quarter Adjusted EBITDA rose 49% to $152.4 million and Adjusted free cash flow rose 54% to ($13.1) million year over year
  • Company raised 2021 guidance to 9% to 11% Core revenue growth in constant currency and Adjusted EBITDA growth to 14.0% to 16.5%

First Quarter 2021 Financial Highlights

“We started off the year strong with continued momentum in our base business that was supplemented by our COVID-19 testing solutions,” said Chris Smith, chairman and chief executive officer, Ortho Clinical Diagnostics. “Our Core revenue excluding our COVID-assay products was up 14%, as our commercial excellence programs continue to show strong returns and as many of our geographies are seeing an accelerating recovery from the impact of the global pandemic. We’re confident in our ability to carry this momentum forward for the rest of the year, and beyond while executing against our strategic priorities. As a result, we’ve increased our 2021 outlook for both the top and bottom lines.”

$ in millions, other than per share amounts

Quarter Ended Change
April 4, 2021 March 29, 2020 as reported constant currency
Revenue $506.8 $407.9 24.2% 21.8%
Core Revenue $499.3 $404.3 23.5% 21.1%
Gross Profit Margin 51.0% 47.7% 330 bps
Income from Operations $57.4 $11.9 382.4%
EPS (GAAP) ($0.19) ($0.69) 72.5%
Adjusted Diluted EPS $0.26 ($0.01) n/a
Adjusted Free Cash Flow ($13.1) ($28.4) 53.9%
Adjusted EBITDA $152.4 $102.0 49.4%
  • Core revenue, which excludes contract manufacturing and other licensing revenue, increased to $499.3 million dollars in the first quarter of 2021, compared with $404.3 million in the similar period last year, or a 21.1% increase on constant currency terms
  • Net loss for the first quarter was ($39.1) million, or ($0.19) per share, compared with net loss of ($101.2) million, or ($0.69) per share, in the first quarter of 2020
  • Adjusted EBITDA for the first quarter was $152.4 million, an increase of 49.4% as compared to $102.0 million in the prior year period
  • Adjusted free cash flow for the first quarter was ($13.1) million, compared with ($28.4) million in the prior year period

Results by Segment

“During the quarter, we experienced top-line growth across each of our geographies and saw particular strength in our largest segment, Americas, which was up nearly 29% for the period,” said Smith. “This was driven by pronounced growth in both Clinical Labs and Transfusion Medicine. Growth in our other three segments gained momentum throughout the quarter, and China had a particularly strong rebound with 11% top-line growth on a constant currency basis.”

Revenues by segment were as follows:

$ millions

Quarter Ended Change
April 4, 2021 March 29, 2020 as reported constant currency
Americas $321.4 $250.5 28.3% 28.8%
EMEA $68.5 $58.7 16.8% 8.2%
Greater China $55.0 $46.3 18.7% 10.6%
Other $61.9 $52.4 18.2% 15.1%
Total Revenue $506.8 $407.9 24.2% 21.8%

Balance Sheet and Liquidity

As of April 4, 2021, the Company had $153.8 million of cash and cash equivalents, compared to $132.8 million of cash and cash equivalents on January 3, 2021. Total debt at April 4, 2021 was $2.4 billion, a 36% decrease compared with $3.7 billion on January 3, 2021.

During the first quarter:

  • The Company completed its IPO in early February 2021, including full exercise of the over-allotment option by the underwriters, and raised approximately $1.4 billion in net proceeds that were used primarily for debt reduction.
  • Ortho created additional financial flexibility by amending its revolving credit facility in February 2021 to upsize from $350 million to $500 million and extend the maturity date to 2026.
  • The Company received credit ratings upgrades by both Moody’s and S&P Global after reducing debt with the IPO proceeds.

Fiscal Year 2021 Outlook

The Company today raised financial guidance for the fiscal year 2021 as follows:

  Fiscal Year 2021 Prior Guidance
FY 2021
Core Revenue $1.93 – $1.96 billion $1.86 – $1.9 billion
Constant Currency Core Revenue Growth 9% – 11% 7% – 9%
Adjusted EBITDA $520 – $532 million $504 – $517 million
Adjusted EBITDA Growth 14% -16.5% 10% – 13%
Adjusted Diluted EPS $0.64 – $0.69 $0.57 – $0.63

“We closed the first quarter very strong, and we are pleased to raise our outlook for all of our key performance indicators in 2021,” said Joseph Busky, chief financial officer, Ortho Clinical Diagnostics. “Our successful initial public offering and sustained annual cash flow generation are allowing us to strengthen our balance sheet and explore expansion opportunities within our current markets as well as through entry into additional high-growth markets that would complement our current businesses. We have the right strategy and the right team to drive long-term shareholder value and remain focused on driving further product innovation, commercial excellence and operational efficiency across our organization. We look forward to continuing to execute at a high level throughout fiscal year 2021.”

Conference Call Information

Ortho Clinical Diagnostics will hold a conference call to discuss its first quarter 2021 results today, at 5:00pm ET.

Interested parties can access the call and accompanying presentation on the “Investors” portion of the Company’s website at https://ir.orthoclinicaldiagnostics.com. Presentation materials will also be posted to the “Investors” portion of the website at the time of the call. Those unable to access the webcast may join the call via phone by dialing (833) 362-0203 (domestic) or (914) 987-7672 (international) and entering Conference ID number 1883187.

A replay of the conference call will be available a few hours after the event on the investor relations section of the Company’s website, under the events section.

About Ortho Clinical Diagnostics

Ortho Clinical Diagnostics (Nasdaq: OCDX) is one of the world’s largest pure-play in vitro diagnostics (IVD) companies.

More than 800,000 patients across the world are impacted by Ortho’s tests each day. Because Every Test Is A LifeTM, Ortho provides hospitals, hospital networks, clinical laboratories and blood banks around the world with innovative technology and tools to ensure test results are fast, accurate, and reliable. Ortho’s customized solutions enhance clinical outcomes, improve efficiency, overcome lab staffing challenges and reduce costs.

From launching the first product to determine Rh+ or Rh- blood type, developing the world’s first tests for the detection of antibodies against HIV and hepatitis C, introducing patented dry-slide technology and marketing the first U.S. Food and Drug Administration-authorized high-volume antibody and antigen tests for COVID-19, Ortho has been a pioneering leader in the IVD space for over 80 years. 

The Company is powered by Ortho CareTM, an award-winning, holistic service and support program that ensures best-in-class technical, field and remote service to laboratories in more than 130 countries and territories around the globe.  

For more information, visit Ortho’s website or social media channels: LinkedInTwitterFacebook and YouTube

Forward Looking Statements

This Press Release may contain “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. Such forward-looking statements reflect, among other things, our current expectations and anticipated results of operations, all of which are subject to known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements, market trends, or industry results to differ materially from those expressed or implied by such forward-looking statements. Therefore, any statements contained herein that are not statements of historical fact may be forward-looking statements and should be evaluated as such. Without limiting the foregoing, the words as “anticipate,” “expect,” “suggest,” “plan,” “believe,” “intend,” “project,” “forecast,” “estimates,” “targets,” “projections,” “should,” “could,” “would,” “may,” “might,” “will,” and the negative thereof and similar words and expressions are intended to identify forward-looking statements. Factors that might materially affect such forward looking statements include: the ongoing global coronavirus (COVID-19) pandemic; increased competition; manufacturing problems or delays or failure to develop and market new or enhanced products or services; adverse developments in global market, economic and political conditions; our ability to obtain additional capital on commercially reasonable terms may be limited or non-existent; our inability to implement our strategies for improving growth or to realize the anticipated benefits of any acquisitions and divestitures, including as a result of difficulties integrating acquired businesses with, or disposing of divested businesses from, our current operations; a need to recognize impairment charges related to goodwill, identified intangible assets and fixed assets; our ability to operate according to our business strategy should our collaboration partners fail to fulfill their obligations; risk that the insurance we will maintain may not fully cover all potential exposures; product recalls or negative publicity may harm our reputation or market acceptance of our products; decreases in the number of surgical procedures performed, and the resulting decrease in blood demand; fluctuations in our cash flows as a result of our reagent rental model; terrorist acts, conflicts, wars and natural disasters that may materially adversely affect our business, financial condition and results of operations; the outcome of legal proceedings instituted against us and/or others; risks associated with our non-U.S. operations, including currency translation risks, the impact of possible new tariffs and compliance with applicable trade embargoes; the effect of the United Kingdom’s withdrawal from the European Union; our inability to deliver products and services that meet customers’ needs and expectations; failure to maintain a high level of confidence in our products; significant changes in the healthcare industry and related industries that we serve, in an effort to reduce costs; reductions in government funding and reimbursement to our customers; price increases or interruptions in the supply of raw materials, components for our products, and products and services provided to us by certain key suppliers and manufacturers; our ability to recruit and retain the experienced and skilled personnel we need to compete; work stoppages, union negotiations, labor disputes and other matters associated with our labor force; consolidation of our customer base and the formation of group purchasing organizations; unexpected payments to any pension plans applicable to our employees; our inability to obtain required clearances or approvals for our products; failure to comply with applicable regulations, which may result in significant costs or the suspension or withdrawal of previously obtained clearances or approvals; the inability of government agencies to hire, retain or deploy personnel or otherwise prevent new or modified products from being developed, cleared or approved or commercialized in a timely manner; disruptions resulting from former President Trump’s invocation of the Defense Production Act; our inability to maintain our data management and information technology systems; data corruption, cyber-based attacks, security breaches and privacy violations; our inability to protect and enforce our intellectual property rights or defend against intellectual property infringement suits against us by third parties; risks related to changes in income tax laws and regulations; risks related to our substantial indebtedness; our ability to generate cash flow to service our substantial debt obligations; and risks related to the ownership of our ordinary shares, including the fact that we are a “controlled company” within the meaning of the corporate governance standards of Nasdaq. Unless legally required, we assume no obligation to update any such forward-looking information to reflect actual results or changes in the factors affecting such forward-looking information.

Non-GAAP Financial Measures

This press release contains financial measures, such as constant-currency growth rate, adjusted EBITDA, adjusted net income, adjusted diluted EPS and adjusted free cash flow, which are considered non-GAAP financial measures under applicable U.S. Securities and Exchange Commission rules and regulations. These non-GAAP financial measures should be considered supplemental to, and not a substitute for, financial information prepared in accordance with U.S. generally accepted accounting principles (GAAP). Adjusted EBITDA, adjusted net income, adjusted diluted EPS and adjusted free cash flow eliminate impacts of certain non-cash, unusual or other items that that we do not consider indicative of our ongoing operating performance. The Company’s definitions of these non-GAAP measures may differ from similarly titled measures used by others. The Company generally uses these non-GAAP financial measures to facilitate management’s financial and operational decision-making, including evaluation of the Company’s historical operating results, comparison to competitors’ operating results and determination of management incentive compensation. These non-GAAP financial measures reflect an additional way of viewing aspects of the Company’s operations that, when viewed with GAAP results and the reconciliations to corresponding GAAP financial measures, may provide a more complete understanding of factors and trends affecting the Company’s business. Because non-GAAP financial measures exclude the effect of items that will increase or decrease the Company’s reported results of operations, management strongly encourages investors to review the Company’s consolidated financial statements and publicly filed reports in their entirety. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the tables accompanying this release. For example, such reconciling items include the impact of unrealized foreign currency exchange gains or losses, gains or losses that are unusual or nonrecurring in nature, as well as discrete taxable events. We cannot estimate or project these items and they may have a substantial and unpredictable impact on our results presented in accordance with GAAP. Some columns and rows within tables may not add due to rounding. Percentages have been calculated using actual, non-rounded figures.

Investors:
IR@orthoclinicaldiagnostics.com

Media:
media@orthoclinicaldiagnostics.com

ORTHO CLINICAL DIAGNOSTICS HOLDINGS PLC  
Consolidated Statements of Loss  
(Unaudited)  
(In millions, except per share data)  
               
  Fiscal First Quarter Ended  
  April 4, 2021     March 29, 2020  
Net revenue $ 506.8     $ 407.9  
Cost of revenue, excluding amortization of intangible assets   248.2       213.2  
Gross profit   258.6       194.7  
Selling, marketing and administrative expenses   131.5       117.4  
Research and development expense   28.9       23.6  
Amortization of intangible assets   33.4       33.0  
Other operating expense, net   7.4       8.8  
Income from operations   57.4       11.9  
Interest expense, net   43.4       52.2  
Tax indemnification income, net   (0.2 )     (2.5 )
Other expense, net   50.0       59.3  
Loss before provision for income taxes   (35.8 )     (97.1 )
Provision for income taxes   3.3       4.1  
Net loss $ (39.1 )   $ (101.2 )
Basic and diluted net loss per common share $ (0.19 )   $ (0.69 )
Basic and diluted weighted-average common shares outstanding   206.2       146.3  

ORTHO CLINICAL DIAGNOSTICS HOLDINGS PLC  
Consolidated Balance Sheets  
(Unaudited)  
(In millions)  
                 
    April 4, 2021     January 3, 2021  
Cash and cash equivalents   $ 153.8     $ 132.8  
Accounts receivable     324.1       318.7  
Inventories     291.1       278.7  
Other current assets     150.8       127.0  
Property, plant and equipment, net     805.6       832.0  
Goodwill     576.1       580.1  
Intangible assets, net     983.4       1,016.7  
Deferred income taxes     7.8       8.0  
Other assets     99.8       107.5  
Total assets   $ 3,392.5     $ 3,401.5  
                 
Accounts payable   $ 130.3     $ 146.2  
Accrued liabilities     260.9       284.7  
Deferred revenue     34.3       35.5  
Current portion of borrowings     139.4       160.0  
Long-term borrowings     2,240.3       3,558.5  
Employee-related obligations     38.9       39.3  
Other liabilities     103.8       120.8  
Deferred income taxes     68.0       67.3  
Total liabilities     3,015.9       4,412.3  
Total stockholders’ equity (deficit)     376.6       (1,010.8 )
Total liabilities and stockholders’ equity (deficit)   $ 3,392.5     $ 3,401.5  

ORTHO CLINICAL DIAGNOSTICS HOLDINGS PLC  
Consolidated Statements of Cash Flows  
(Unaudited)  
(In millions)  
    Fiscal First Quarter Ended  
    April 4, 2021     March 29, 2020  
Cash used in operating activities   $ (9.9 )   $ (17.5 )
Cash used in investing activities     (10.7 )     (18.3 )
Cash provided by financing activities     41.1       316.2  
Effect of exchange rate changes on cash     (0.2 )     (2.5 )
Increase in cash     20.3       277.9  
Cash, cash equivalents and restricted cash at beginning of period     144.2       84.0  
Cash, cash equivalents and restricted cash at end of period   $ 164.5     $ 361.9  
                 
    April 4, 2021     March 29, 2020  
Reconciliation to amounts within the consolidated balance sheets:                
Cash and cash equivalents   $ 153.8     $ 349.8  
Restricted cash included in Other assets     10.7       12.1  
Cash, cash equivalents and restricted cash   $ 164.5     $ 361.9  

ORTHO CLINICAL DIAGNOSTICS HOLDINGS PLC  
Reconciliation of GAAP to non-GAAP results  
(Unaudited)  
    Fiscal First Quarter Ended  
(Dollars in millions)   April 4, 2021     March 29, 2020  
Net loss   $ (39.1 )   $ (101.2 )
Interest expense, net     43.4       52.2  
Provision for income taxes     3.3       4.1  
Depreciation and amortization     82.7       79.8  
Loss on extinguishment of debt     50.5       10.0  
Stock-based compensation     3.5       1.6  
Restructuring and severance related costs (a)     1.3       2.4  
Tax indemnification income, net     (0.2 )     (2.5 )
Foreign currency exchange losses (b)           49.3  
Other adjustments (c)     6.9       6.3  
Adjusted EBITDA   $ 152.4     $ 102.0  
                 
    Fiscal First Quarter Ended  
(Dollars in millions)   April 4, 2021     March 29, 2020  
Net loss   $ (39.1 )   $ (101.2 )
Intangible amortization     33.4       33.0  
Loss on extinguishment of debt     50.5       10.0  
Stock-based compensation     3.5       1.6  
Restructuring and severance related costs (a)     1.3       2.4  
Foreign currency exchange losses (b)           49.3  
Other adjustments (c)     6.9       6.3  
Total adjustments     95.6       102.6  
Tax effect of reconciling items (d)     (2.0 )     (3.3 )
Discrete tax items (e)     0.3        
Adjusted net income (loss)   $ 54.9     $ (1.9 )
Adjusted basic EPS   $ 0.27     $ (0.01 )
Adjusted diluted EPS   $ 0.26     $ (0.01 )

(a) Represents restructuring and severance costs related to several discrete initiatives intended to strengthen operational performance and to support building our commercial capabilities including a project announced in fiscal year ended January 3, 2016 to outsource equipment manufacturing operations in Rochester, New York and a project announced in fiscal year ended December 30, 2018 to transfer certain production lines among facilities.
(b) For fiscal quarter ended March 29, 2020, this represents non-cash unrealized gains and losses resulting from the remeasurement of transactions denominated in foreign currencies primarily related to intercompany loans.  In fiscal year 2021, the Company initiated programs to mitigate the impact of foreign currencies related to intercompany loans in our results and, as a result, such non-cash net unrealized losses were approximately $22 million for the fiscal quarter ended April 4, 2021.  Given we expect these programs to continue to mitigate the impact in future periods, we will not be adjusting-our Adjusted EBITDA and Adjusted Net Income for non-cash unrealized gains and losses resulting from the remeasurement of transactions denominated in foreign currencies starting in the first quarter of fiscal 2021.
(c) Represents miscellaneous other adjustments related to unusual items impacting our results including the elimination of management fees, non-cash derivative mark-to-market (gain) loss and certain asset write-downs. See information below:

    Fiscal First Quarter Ended  
($ in millions)   April 4, 2021     March 29, 2020  
EU medical device regulation transition costs   $ 0.9     $ 1.1  
Principal shareholder management fee     0.8       0.8  
Derivative mark-to-market loss     0.6       1.0  
Other     4.6       3.4  
Total other adjustments   $ 6.9     $ 6.3  

(d) Non-GAAP adjustments were tax effected based on the nature of the expense and related jurisdiction, many of which are impacted by valuation allowances resulting in little to no tax impact.

(e) We exclude deferred tax resulting from changes in tax law and expiration of statutes, adjustments for uncertain tax positions, and other unusual items not related to current operating results.

    Fiscal First Quarter Ended  
($ in millions)   April 4, 2021     March 29, 2020  
Net cash used in operating activities – GAAP   $ (9.9 )   $ (17.5 )
Adjustments:                
Net cash used in investing activities – GAAP     (10.7 )     (18.3 )
Unusual or non-recurring payments     7.5       7.4  
Adjusted free cash flow (f)   $ (13.1 )   $ (28.4 )

(f) The Company defines free cash flow as net cash flow from operations accounted for under GAAP less net cash used in investing activities accounted for under GAAP plus or minus any unusual or non-recurring payments.

ORTHO CLINICAL DIAGNOSTICS HOLDINGS PLC  
Reconciliation of GAAP to non-GAAP results  
Core and Non-Core Revenue and Revenue by Segment  
(Unaudited)  
    Fiscal first quarter ended                          
    April 4,
2021
    March 29,
2020
    Percent Change     Currency Impact     Constant Currency Growth Rate (a)  
Core Revenue   $ 499.3     $ 404.3       23.5 %   $ 9.2       21.1 %
Non-Core Revenue     7.5       3.6       106.4 %           106.4 %
Net Revenue   $ 506.8     $ 407.9       24.2 %   $ 9.2       21.8 %
                                         
                                         
Segment net revenue                                        
Americas   $ 321.4     $ 250.5       28.3 %   $ (0.7 )     28.8 %
EMEA     68.5       58.7       16.8 %     4.8       8.2 %
Greater China     55.0       46.3       18.7 %     3.7       10.6 %
Other     61.9       52.4       18.2 %     1.6       15.1 %
Net revenue   $ 506.8     $ 407.9       24.2 %   $ 9.2       21.8 %

(a) The term “constant currency” means we have translated local currency revenues for all reporting periods into U.S. dollars using the same comparable foreign currency exchange rates. This additional non-GAAP financial information is not meant to be considered in isolation from or as substitute for financial information prepared in accordance with GAAP. 

 

 

Bravo Welcomes Anthony Vance, Chief Growth Officer, To Its Growing Team

Bravo Welcomes Anthony Vance, Chief Growth Officer, To Its Growing Team




Bravo Welcomes Anthony Vance, Chief Growth Officer, To Its Growing Team

CLEVELAND, May 05, 2021 (GLOBE NEWSWIRE) — Bravo Wellness, one of the nation’s top employee wellness solution providers, is pleased to announce the addition of Anthony “Tony” Vance as Chief Growth Officer. Vance will lead Bravo’s commercial team of sales, marketing and account management in this newly created role.

Vance brings significant C-Level experience in healthcare and technology, having served in senior executive roles at two national health insurance companies where he lead broker strategy, analytics and digital marketplace initiatives. Most recently, Vance served as Chief Commercial Officer at Curi, where he spearheaded the transformation and rebranding from its traditional medical malpractice insurance provider into a multi-faceted financial services organization for physicians, physician groups, and hospital chains. As a veteran in the healthcare industry, Vance will become a strategic player in building the vision and solutions Bravo brings to its clients and broker partners.

“Tony’s track record as an innovator in the healthcare space, and as a leader who knows how to build sustainable value, will bolster the strength of our team,” stated Jim Pshock, founder and CEO of Bravo. “I’m excited to add such a collaborative executive and to continue our investments in our people and our technology. Our commitment to being the number one wellness provider for employers who care about reducing preventable health risks and closing gaps in care has never been stronger.”

About Bravo
Founded in 2008, Bravo is one of the largest employee wellness program administrators in the nation, serving nearly 2 million participants annually. Their data-driven approach has established proven models for reducing preventable health risks and closing gaps in care. For more information, visit www.bravowell.com

CONTACT: For more information, please contact:
Bravo Marketing at 877.662.7286

Terminal Stage 4 Brain Tumor Patient Colin Clark Beating the Odds, Doing ‘IronmanForHope’ to Raise Money for Hospices on Hawai’i

Terminal Stage 4 Brain Tumor Patient Colin Clark Beating the Odds, Doing ‘IronmanForHope’ to Raise Money for Hospices on Hawai’i




Terminal Stage 4 Brain Tumor Patient Colin Clark Beating the Odds, Doing ‘IronmanForHope’ to Raise Money for Hospices on Hawai’i

KONA, HI, May 05, 2021 (GLOBE NEWSWIRE) — Colin Clark is doing an ‘IronmanForHope’ on August 7, 2021 to raise money for the Hospice of Kona and the North Hawaii Hospice on the island of Hawai’i where he resides. In early 2020, Clark was diagnosed with a terminal brain tumor – stage 4 Glioblastoma – at Cedars Sinai in Los Angeles. 

Glioblastoma is the most aggressive form of brain cancer that can occur at any age and has a 14-month average survival rate after initial diagnosis. According to the NIH, the number of new diagnoses made annually is 2 to 3 per 100,000 people in the United States and Europe. GBM accounts for 12% to 15% of all intracranial tumors and 50% to 60% of astrocytic tumors.

After being diagnosed and a grueling 42 days of surgeries, radiation and chemotherapy, Clark was paralyzed on the left side of his body. Through his determination and the help of his incredible medical team, he regained his ability to walk. He then returned to his home on the island of Hawai’i but was unable to walk more than 50 meters. 

“Bruises come with life and collecting the scars proves that we showed up for it,” said Colin Clark, former Regional Vice President of Four Seasons Hotels and Resorts. 

Clark remains laser-focused on getting physically stronger and living longer. He is now training to do an ‘IronmanForHope’ that follows the Ironman® World Championship course, a 2.4-mile open water swim off Kailua-Kona pier, a 112-mile bike ride through the lava fields to Hawi and back, followed by a 26-mile marathon.

Clark’s three world-renowned ‘IronmanForHope’ coaches Dave Scott, 6-time Ironman Kona World Champion; Alistair Brownlee, a 2-time Olympic Gold Medalist Triathlon; and David Wild, an Ironman and Ironman Coach, are collaborating to train Clark.

Scott said: “The daunting challenge of the Ironman World Championship is thinking too deeply about the length and enormity of exercising from dawn to darkness. What if your goal is to complete the Ironman after overcoming brain cancer? Leading up to his Ironman, Colin will undoubtedly have an endless barrage of physical hurdles; however, his mind and his resiliency to never give up are an inspiration for all of us.”

Clark’s goal for completing the ‘IronmanForHope’ is to raise funds for the Hospice of Kona and North Hawaii Hospice. Both hospices provide quality, in-home, compassionate services for patients and families needing care and support during the various stages of life; 100% of all funds raised will be split evenly between the hospices. U.S. and international donations can be made via http://www.ironmanforhope.org; US donations can also be made by texting 71777 with the word IronmanForHope. 

Additional Resources

Ironman® is a registered trademark. All rights reserved.

Media Contact:
Colin Clark
colinpeterclark@yahoo.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ff29b86b-d279-421d-9453-be3c81bc6a85

Summit Therapeutics’ Rights Offering Nearing Expiration Date; Robert W. Duggan Declares Intention to Fully Oversubscribe in the Rights Offering

Summit Therapeutics’ Rights Offering Nearing Expiration Date; Robert W. Duggan Declares Intention to Fully Oversubscribe in the Rights Offering




Summit Therapeutics’ Rights Offering Nearing Expiration Date; Robert W. Duggan Declares Intention to Fully Oversubscribe in the Rights Offering

Cambridge, MA, May 5, 2021 – Summit Therapeutics Inc. (NASDAQ: SMMT) today announced that it is nearing the previously-announced expiration date for its rights offering of 5:00 pm Eastern Daylight Time on May 10, 2021 (the “Expiration Date”).  Importantly, for stockholders whose shares of our common stock are held in a brokerage account or are otherwise not registered directly with the Company, the deadline to exercise their subscription rights with their respective brokerage firms may be as soon as today, Wednesday May 5.  Examples of brokerage firms with whom shareholders may have accounts include E*TRADE, Charles Schwab, and other personal, financial, or online brokers.  Information regarding specific broker-related deadlines can be obtained directly from the broker.

As a reminder with respect to the rights offering, it is for up to 14,312,977 shares of the Company’s common stock, par value $0.01 (the “Shares,” and each, a “Share”) based on the Initial Price (as further defined below) with an aggregate offering value of up to $75,000,000.  The subscription rights will expire and have no value if they are not exercised prior to the Expiration Date.

In addition, Mr. Robert W. Duggan, the Company’s Chairman, Chief Executive Officer, and majority shareholder, has advised the Board of Directors today that, in addition to exercising all of his basic subscription rights, he will exercise his oversubscription rights to purchase all additional Shares of common stock that remain unsubscribed at the expiration of the rights offering.

The subscription price per Share shall be equal to the lesser of (i) $5.24 per share (the “Initial Price”) or (ii) the volume weighted-average price of the Company’s common stock for the ten consecutive trading days through and including the Expiration Date (the “Alternate Price”).  The subscription price per Share will determine the final number of Shares issuable, and subsequently the pro rata number of Shares to which Stockholders can subscribe. 

A prospectus supplement relating to the offering was filed with the US Securities and Exchange Commission (the “SEC”) on April 21, 2021 and is available on the SEC’s website.  Questions about the offering and requests for copies of the prospectus relating to the rights offering may be directed to Broadridge Corporate Issuers Solutions, Inc., the Company’s information and subscription agent for the rights offering, at the email address and telephone number provided at the end of this release.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.  The rights offering is made pursuant to the Company’s shelf registration statement on Form S-3, which became effective on October 15, 2020, and the prospectus supplement containing the detailed terms of the rights offering filed with the SEC.  Any offer will be made only by means of a prospectus forming part of the registration statement.

Contact Summit Investor Relations:
Dave Gancarz
Vice President, Investor Relations & Corporate Strategy
david.gancarz@summitplc.com

General Inquiries: 
investors@summitplc.com

Rights Offering Information and Subscription Agent:
Broadridge Corporate Issuer Solutions, Inc.
+1 855 793 5068
shareholder@broadridge.com

Summit Forward-looking Statements

Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, the impact of the COVID-19 pandemic on the Company’s operations and clinical trials and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and 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 uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, global public health crises, including the coronavirus COVID-19 outbreak, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of filings that the Company makes with the Securities and Exchange Commission. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

Benasource Selects Acupath Laboratories to Bring COVID-19 Saliva PCR Assay to Independent Pharmacies Across the Country

Benasource Selects Acupath Laboratories to Bring COVID-19 Saliva PCR Assay to Independent Pharmacies Across the Country




Benasource Selects Acupath Laboratories to Bring COVID-19 Saliva PCR Assay to Independent Pharmacies Across the Country

PLAINVIEW, N.Y. , May 05, 2021 (GLOBE NEWSWIRE) — Acupath Laboratories, Inc., a leading provider of sub-specialized anatomic and molecular pathology services, today announced it will provide COVID-19 saliva PCR testing for select independent pharmacies through Benasource, a leading group purchasing organization and provider of telemedicine solutions and digital pharmacy savings. By working together, Acupath and Benasource will help empower locally owned and operated pharmacies to meet the COVID testing needs of customers quickly and efficiently.

The Benasource team understands the needs of today’s independent pharmacies to offer a full range of health solutions, including COVID vaccinations and testing. Benasource currently works with 135 independent pharmacies across the country to help ensure they remain competitive in the marketplace.

“Supplying our member pharmacies with easy to implement COVID-19 PCR testing options is important,” said Vinesh Darji, president of Benasource. “The Acupath team understands not only the complex regulatory and compliance landscape, but the importance of fast turnaround time of results. The lab’s depth of experience, coupled with a simple work flow, made them the ideal partner for this initiative.”

Acupath’s saliva PCR assay is currently available at over 40 independent pharmacies and will expand to additional Benasource pharmacies in the coming weeks. For a full list of locations, click here.

“COVID-19 testing will remain necessary for several more months to protect the unvaccinated and minimize the spread of variants,” said Jeff Boschwitz, Ph.D., general manager, COVID-19 testing, Acupath Laboratories. “Benasource is helping its member pharmacies provide additional value to their customers by offering non-invasive COVID-19 PCR testing solutions.”

With saliva testing, the collection process is faster, less burdensome, and lower cost than with nasal swabs which makes it ideal for businesses, schools, and retail pharmacy chains. To provide their sample, a person drips a small amount of saliva into a small tube while being observed by trained personnel.

Acupath’s traditional business is in cancer diagnostics. The company launched its FDA Emergency Use Authorization (EUA)-authorized COVID-19 real-time PCR assay in May 2020 to support its clients who required COVID-19 test results for their employees as well as to screen patients in advance of elective surgery.

COVID testing services are currently available at no charge to all U.S. residents through insurance or the CARES Act.

For more information on Acupath’s COVID-19 testing options, visit https://covid19.acupath.com/
or email COVID19@acupath.com.

About Benasource
Benasource represents a singular approach in group purchasing that enables independent pharmacies to achieve their financial goals by reducing their annual cost of goods by 2-3 percent. Powered by strategic alliances with wholesalers and vendors of every stripe, membership is renewable on a year-by-year basis, free of long-term contracts. Other features of the program include low minimum purchase requirements and access to preferred partners in marketing, digital media, and other areas to help support organic growth. For more information, visit www.benasource.com.

About Acupath Laboratories, Inc.
Founded in 1998 and based in Plainview, New York, Acupath is a provider of sub-specialized anatomic pathology services focused on the following specialties; Urology, Gastroenterology, Dermatology, Women’s Health, Otolaryngology, Podiatry, and Hematology / Oncology. Acupath offers an extensive test menu on both a global and TC/PC basis, processes over 500,000 specimens annually, and is the first lab worldwide to offer URO17™, an innovative new immunocytochemistry test for the detection of bladder cancer, recently designated as a “Breakthrough Device” by the FDA. In 2020, the laboratory quickly pivoted to offer COVID-19 testing in response to the global pandemic. Acupath is accredited by the New York State Department of Health, the Joint Commission, and the College of American Pathologists.

CONTACT: Media Contact:
Jennifer Leckstrom
RoseComm for Acupath
jleckstrom@rosecomm.com
215-681-0770

Generex Provides Clarification on Its Ii-Key COVID-19 Complete Vaccine China Partnership Agreement

Generex Provides Clarification on Its Ii-Key COVID-19 Complete Vaccine China Partnership Agreement




Generex Provides Clarification on Its Ii-Key COVID-19 Complete Vaccine China Partnership Agreement

MIRAMAR, Fla., May 05, 2021 (GLOBE NEWSWIRE) — Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (“Generex” or the “Company”), an innovative and integrated healthcare holding company with end-to-end solutions for patient centric care including the development of its innovative “Complete Vaccine” to fight SARS-CoV-2, today provided guidance on the terms of its agreement with Beijing Youfeng Biological Technology, Ltd (Youfeng-BI) in connection with the $2,000,000 payment made by Youfeng-BI to GNBT and its subsidiary NuGenerex Immuno-Oncology, Inc. (NGIO) on or about April 27, 2021. Under the terms of this agreement:

  If YouFeng-BI conducts phase I, phase II, phase III clinical trials in accordance with ICH guidelines to support commercial approval of the Ii-Key SARS-Cov-2 vaccine by the NMPA (the Chinese FDA), then:  
     
  (1) YouFeng will provide the clinical data to Generex for its US FDA and the international approvals in its current contracts as available; and  
     
  (2) YouFeng shall have the exclusive sales rights in any country other than US, Canada and the countries, territories under GNBT’s current licensed out contracts, and Mexico, Ecuador, Peru and Colombia with respects to li-key SARS-Cov-2 vaccine (provided that YouFeng complies with clauses (1) and makes a commitment to execute clause (3) of this paragraph); and  
     
  (3) Upon the technology is recognized by NMPA through this li-key SARS-Cov-2 vaccine, YouFeng will execute the payment terms of license fee for the entire Ii-key platform referred to in a contract previously executed by GNBT.  

Although YouFeng will obtain the exclusive sales rights mentioned above upon the satisfaction of the conditions mentioned above, Generex and NGIO will maintain worldwide patent rights to the Ii-Key SARS-Cov-2 vaccine, except for China.

Additionally, Youfeng has agreed to provide GNBT with (i) a complete development plan outlining the regulatory path, data requirements, pre-clinical and clinical studies planned, and regulatory filing timeline and (ii) copies of all NMPA filings to date and in the future.

Generex CEO, Joseph Moscato said, “We are pleased that our Chinese partners have paid Generex $2 million dollars for our vaccine development expertise which will subsidize the costs of research, development, and technology transfer in support of their NMPA submission, and we look forward to the approval of the Ii-Key Complete Vaccine.”

About Generex Biotechnology Corp.
Generex Biotechnology is an integrated healthcare holding company with end-to-end solutions for patient centric care from rapid diagnosis through delivery of personalized therapies. Generex is building a new kind of healthcare company that extends beyond traditional models providing support to physicians in an MSO network, and ongoing relationships with patients to improve the patient experience and access to optimal care.

About NuGenerex Immuno-Oncology
NuGenerex Immuno-Oncology, a subsidiary of Generex Biotechnology, is a clinical stage oncology company developing immunotherapeutic peptide vaccines for cancer and infectious disease based on the CD4 T-Cell activation platform, Ii-Key. NuGenerex Immuno-Oncology (NGIO) has been spun out of Generex as a separate public company to advance the platform Ii-Key technology, particularly in combination with the immune checkpoint inhibitors for the treatment of cancer. NGIO is currently engaged in a Phase II clinical trial of its lead cancer immunotherapeutic vaccine AE37 in combination with pembrolizumab (Merck’s Keytruda®) for the treatment of triple negative breast cancer. The company has also turned its Ii-Key technology on infectious disease, responding to the coronavirus pandemic with a SARS-CoV-2 vaccine development program.

Cautionary Note Regarding Forward-Looking Statements
This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as “expects,” “plan,” “believes,” “will,” “achieve,” “anticipate,” “would,” “should,” “subject to” or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Generex Contact:

Generex Biotechnology Corporation

Joseph Moscato
646-599-6222

Todd Falls
1-800-391-6755 Extension 222
investor@generex.com