BDSI BioDelivery Sciences International Inc.

4.44
+0.11  (+3%)
Previous Close 4.33
Open 4.41
52 Week Low 2.85
52 Week High 7.21
Market Cap $444,734,514
Shares 100,165,431
Float 94,007,583
Enterprise Value $421,737,316
Volume 697,107
Av. Daily Volume 971,091
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Drug Pipeline

Drug Stage Notes
BEMA Buprenorphine
Pain
Approved
Approved
Approved October 26, 2015.
Clonidine gel
Painful diabetic neuropathy (PDN)
Phase 2b
Phase 2b
Phase 2b data released December 13, 2016 - primary endpoints not met.
BEMA Buprenorphine/Naloxone (BNX) - BUNAVAIL
Opioid dependence
Approved
Approved
Approved June 6, 2014.

Latest News

  1. RALEIGH, N.C., May 29, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today announced that Jeffrey Bailey, Interim Chief Executive Officer, and Terry Coelho, Chief Financial Officer, will present at two upcoming investor conferences in June. The management team will also host one-on-one investor meetings at the conferences.

    Presentation Details:

    Event: Jefferies Virtual Healthcare Conference
    Date: Tuesday, June 2, 2020
    Time: 3:00pm Eastern Time
    Webcast: http://wsw.com/webcast/jeff126/bdsi/  

    Event: William Blair 40th Annual Growth Stock Conference
    Date: Thursday, June 11, 2020
    Time: 8:40am…

    RALEIGH, N.C., May 29, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today announced that Jeffrey Bailey, Interim Chief Executive Officer, and Terry Coelho, Chief Financial Officer, will present at two upcoming investor conferences in June. The management team will also host one-on-one investor meetings at the conferences.

    Presentation Details:

    Event: Jefferies Virtual Healthcare Conference
    Date: Tuesday, June 2, 2020
    Time: 3:00pm Eastern Time
    Webcast: http://wsw.com/webcast/jeff126/bdsi/  

    Event: William Blair 40th Annual Growth Stock Conference
    Date: Thursday, June 11, 2020
    Time: 8:40am Central Time / 9:40am Eastern Time
    Webcast: http://www.wsw.com/webcast/blair56/bdsi/

    A replay of the presentations will be archived on the Company's website and made available for 60 days.
                 
    ABOUT BIODELIVERY SCIENCES INTERNATIONAL, INC.

    BioDelivery Sciences International, Inc. (NASDAQ:BDSI) is a commercial-stage specialty pharmaceutical company dedicated to patients living with chronic conditions. BDSI has built a portfolio of products that includes utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA®) technology to develop and commercialize, either on its own or in partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs. BDSI's marketed products address serious and debilitating conditions, including chronic pain, opioid dependence, and opioid-induced constipation.

    © 2020 BioDelivery Sciences International, Inc.  All rights reserved.

    Contact:

    Terry Coelho
    Chief Financial Officer
     

    Bob Yedid
    LifeSci Advisors
    (646) 597-6989
     

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  2. RALEIGH, N.C., May 11, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc (NASDAQ:BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today announced that Jeffrey A. Bailey, a member of the Company's Board of Directors, has been named Interim Chief Executive Officer (CEO), effective today. Mr. Bailey succeeds Herm Cukier as CEO.

    "On behalf of the Board and our entire Company, I am excited that Jeff Bailey has agreed to serve as Interim CEO," stated Peter Greenleaf, Chairman of the Board of Directors of BDSI. "The Board thanks Herm Cukier for his leadership during a transformative time in the Company's history, and we wish him the best in the future…

    RALEIGH, N.C., May 11, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc (NASDAQ:BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today announced that Jeffrey A. Bailey, a member of the Company's Board of Directors, has been named Interim Chief Executive Officer (CEO), effective today. Mr. Bailey succeeds Herm Cukier as CEO.

    "On behalf of the Board and our entire Company, I am excited that Jeff Bailey has agreed to serve as Interim CEO," stated Peter Greenleaf, Chairman of the Board of Directors of BDSI. "The Board thanks Herm Cukier for his leadership during a transformative time in the Company's history, and we wish him the best in the future."

    "Jeff Bailey has a terrific track record of leading organizations and delivering shareholder value," stated Kevin Kotler, Chair of the Nominating & Corporate Governance Committee and founder of Broadfin Capital.  "We look forward to his help in refining and driving our long-term strategic plan."

    Mr. Bailey has an accomplished record in leading both public and private healthcare companies where he has leveraged his diverse leadership experiences in various functional areas including commercial, supply chain and business development, as well as in-licensing and transactions.  His experiences include a 20+ year career at Johnson & Johnson/Janssen Pharmaceutica as well as a tenure as Operating Unit President at Novartis Pharmaceuticals, Chief Commercial Officer at King Pharmaceuticals, Chief Operating Officer at Fougera Pharmaceuticals, and Chairman and CEO of Neurovance.  Mr. Bailey also served as President and CEO of Lantheus Medical Imaging, Inc, taking the company public in 2015.  Most recently, he was the CEO of IlluminOss Medical, Inc, which was acquired last month.

    "I look forward to working with the BDSI team in taking the Company to the next level," stated Jeff Bailey.  "BDSI has therapeutically differentiated products that really make a difference in patients' lives.  We have so much opportunity in front of us."

    Mr. Bailey has served as Chairman of Aileron Therapeutics since March 2018 and as a Board Member of Madison Vaccines, a privately held biopharmaceutical company, since October 2017.   Mr. Bailey received a Bachelor of Science Degree from Rutgers University.

    ABOUT BIODELIVERY SCIENCES INTERNATIONAL, INC.

    BioDelivery Sciences International, Inc. (NASDAQ:BDSI) is a commercial-stage specialty pharmaceutical company dedicated to patients living with chronic conditions. BDSI has built a portfolio of products that includes utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA®) technology to develop and commercialize, either on its own or in partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs. BDSI's marketed products address serious and debilitating conditions, including chronic pain, opioid dependence, and opioid-induced constipation.

    © 2020 BioDelivery Sciences International, Inc.  All rights reserved.

    Contact:

    Terry Coelho, Chief Financial Officer
    (919) 551-5281
    e-mail:

     

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  3. First Quarter Total Company Net Sales Increased 94% versus Prior Year to $38.3 Million

    First Quarter BELBUCA® Net Sales Increased 79% versus Prior Year to $33.5 Million

    Conference Call and Webcast Scheduled for 4:30 PM EST Today

    RALEIGH, N.C., May 07, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today reported strong financial results for the first quarter ended March 31, 2020, as well as the following operational and performance highlights.

    Key Business Highlights

    • Total Company net revenue for the first quarter increased by 94% versus the prior year period to a record level of $38.3…

    First Quarter Total Company Net Sales Increased 94% versus Prior Year to $38.3 Million

    First Quarter BELBUCA® Net Sales Increased 79% versus Prior Year to $33.5 Million

    Conference Call and Webcast Scheduled for 4:30 PM EST Today

    RALEIGH, N.C., May 07, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today reported strong financial results for the first quarter ended March 31, 2020, as well as the following operational and performance highlights.

    Key Business Highlights

    • Total Company net revenue for the first quarter increased by 94% versus the prior year period to a record level of $38.3 million. This growth was driven by BELBUCA sales of $33.5 million, an increase of 79% versus the prior year period, and Symproic® sales of $4.2 million.
    • Total BELBUCA prescriptions reached an all-time high of 99,400 during the first quarter, representing year-over-year prescription volume growth of more than 52%.
    • Total Symproic prescriptions were more than 16,100 in the first quarter, representing growth of 19% versus the prior year period.
    • Achieved record number of unique prescribers during the quarter for both BELBUCA and Symproic.
    • Continued to expand BELBUCA Medicare patient access with the addition of more than two million covered lives, the vast majority of which have preferred access to BELBUCA, through a national PBM.
    • Expanded BELBUCA commercial coverage within two important regional plans representing nearly 900,000 lives that can receive BELBUCA without being required to first fail two CII long-acting opioids.
    • Strong financial position driven by performance and positive cash flow of $6.7 million in the quarter.

    "I am very pleased by the success and momentum we achieved during the first quarter," stated Herm Cukier, CEO of BDSI. "Both BELBUCA and Symproic prescriptions were experiencing considerable growth before the start of the COVID-19 pandemic, helping deliver strong first quarter results. I am also very proud of how the organization rapidly transitioned our efforts to virtual connectivity with our prescribers, ensured continuity of supply, and continued to provide valuable service to patients. While these are unprecedented and uncertain times, I remain very confident in the clinical value of our products and the long-term prospects for the company." 

    First Quarter 2020 Financial Results

    Total Company Net Revenue for the first quarter of 2020 was $38.3 million, an increase of 94% compared to $19.8 million in the first quarter of 2019, and an increase of 21% compared to $31.6 million in the fourth quarter of 2019.

    BELBUCA Net Sales for the first quarter of 2020 were $33.5 million, an increase of 79% compared to $18.7 million in the first quarter of 2019, and an increase of 18% compared to $28.3 million in the fourth quarter of 2019.

    Symproic Net Sales for the first quarter were $4.2 million, an increase of 54% compared to $2.7 million in the fourth quarter of 2019.

    BUNAVAIL Net Sales for the first quarter were $0.1 million compared to $1.1 million in the first quarter of 2019. In March of this year, the Company announced the planned discontinuation of marketing of BUNAVAIL in 2020.

    Total Operating Expenses for the first quarter of 2020 were $26.7 million, compared to $23.8 million in the fourth quarter of 2019 and $17.0 million in the first quarter of 2019.

    GAAP Net Income for the first quarter of 2020 was $5.0 million, or $0.05 per share,  compared to GAAP net loss of $0.7 million, or ($0.01) per share, for the fourth quarter of 2019 and GAAP net loss of $3.8 million, or ($0.05) per share, in the first quarter of 2019.

    EBITDA in the first quarter of 2020 was $7.8 million, or 20% of net sales, compared to $4.1 million in the fourth quarter of 2019 and $0.1 million in the first quarter of 2019.

    Non-GAAP Net Income for the quarter was $8.3 million and reflects GAAP net income excluding stock-based compensation and non-cash amortization of intangible assets.

    Cash Position: As of March 31, 2020, cash and cash equivalents were approximately $70.6 million, compared to $63.9 million in the fourth quarter of 2019, reflecting positive cash flow of $6.7 million in the first quarter of 2020.

    2020 Net Sales Guidance:

    Given the uncertainty surrounding the COVID-19 pandemic, the Company is withdrawing its 2020 BELBUCA and Total Company net sales guidance, previously introduced in November 2019.

    Conference Call & Webcast Details

    BioDelivery Sciences will host a conference call and webcast today, May 7, 2020, at 4:30 p.m. ET to present first quarter 2020 results and to provide a business update.  Dial-in details are as follows:

    Date:  Thursday, May 7, 2020
    Time: 4:30 PM Eastern Time
    Domestic: 800-289-0571
    International: 720-543-0206
    Conference ID: 6176462
    Webcast: http://public.viavid.com/index.php?id=139300

    ABOUT BIODELIVERY SCIENCES INTERNATIONAL, INC.

    BioDelivery Sciences International, Inc. (NASDAQ:BDSI) is a commercial-stage specialty pharmaceutical company dedicated to patients living with chronic conditions. BDSI has built a portfolio of products that includes utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA®) technology to develop and commercialize, either on its own or in partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs. BDSI's marketed products address serious and debilitating conditions, including chronic pain, opioid dependence, and opioid-induced constipation.

    CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS

    This press release and any statements of employees, representatives, and partners of BioDelivery Sciences International, Inc. ("BDSI") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to BDSI's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of BDSI's management and are subject to significant risks and uncertainties, including those detailed in BDSI's filings with the Securities and Exchange Commission. Actual results (including, without limitation, the continued growth in BELBUCA net sales and total company net revenue in 2020 may differ materially from those set forth or implied in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond BDSI's control) including the risk that the current coronavirus pandemic impacts on our supply chain, commercial partners, patients and their physicians and the healthcare facilities in which they work, and our personnel are greater than we anticipate, as well as those set forth in our 2019 annual report on Form 10-K filed with the US Securities and Exchange Commission and subsequent filings. BDSI undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.

    Non-GAAP Financial Measures

    This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the United States, or GAAP, including non-GAAP net income and EBITDA. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies.

    Non-GAAP net income adjusts for one-time and non-cash charges by excluding the following from GAAP net income: stock-based compensation expense, amortization of intangible assets, amortization of certain warrant discount costs, and the financial impact of certain one-time items that are non-recurring, including the impact of the discontinuation of marketing of BUNAVAIL.

    EBITDA excludes net interest, including both interest expenses and interest income, provision for (benefit from) income taxes and depreciation and amortization.

    The Company's management and board of directors utilize these non-GAAP financial measures to evaluate the Company's performance. The Company provides these non-GAAP measures of the Company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the Company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income and EBITDA are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, non-GAAP net income and EBITDA should not be considered measures of our liquidity.

    A reconciliation of certain GAAP to non-GAAP financial measures has been provided in the tables included in this press release.

    © 2020 BioDelivery Sciences International, Inc.  All rights reserved.

    Contact:

    Tirth Patel
    Director of Investor Relations
    (919) 582-0294

    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
    CONDENSED CONSOLIDATED BALANCE SHEETS
    (U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)
    (Unaudited)

      March 31,
    2020
      December 31,
    2019
    ASSETS      
    Current assets:      
    Cash and cash equivalents $ 70,613     $ 63,888  
    Accounts receivable, net 45,114     38,790  
    Inventory, net 15,003     11,312  
    Prepaid expenses and other current assets 2,600     3,769  
    Total current assets 133,330     117,759  
    Property and equipment, net 1,995     2,075  
    Goodwill 2,715     2,715  
    License and distribution rights, net 58,576     60,309  
    Other intangible assets, net     47  
    Total assets $ 196,616     $ 182,905  
    LIABILITIES AND STOCKHOLDERS' EQUITY      
    Current liabilities:      
    Accounts payable and accrued liabilities $ 60,931     $ 53,993  
    Total current liabilities 60,931     53,993  
    Notes payable, net 58,634     58,568  
    Other long-term liabilities 463     580  
    Total liabilities 120,028     113,141  
    Commitments and contingencies      
    Stockholders' equity:      
    Preferred Stock, 5,000,000 shares authorized; Series A Non-Voting Convertible Preferred Stock. $0.001 par value, 0 and 2,093,155 shares outstanding at March 31, 2020 and December 31, 2019, respectively; Series B Non-Voting Convertible Preferred Stock, $0.001 par value, 443 and 618 shares outstanding at March 31, 2020 and December 31, 2019, respectively.     2  
    Common Stock, $0.001 par value; 175,000,000 shares authorized at March 31, 2020 and December 31, 2019, respectively; 99,821,408 and 96,189,074 shares issued; 99,805,917 and 96,173,583 shares outstanding at March 31, 2020 and December 31, 2019, respectively. 99     96  
    Additional paid-in capital 438,163     436,306  
    Treasury stock, at cost,15,491 shares, as of March 31, 2020 and December 31, 2019. (47 )   (47 )
    Accumulated deficit (361,627 )   (366,593 )
    Total stockholders' equity 76,588     69,764  
    Total liabilities and stockholders' equity $ 196,616     $ 182,905  
                   

    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    (U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)
    (Unaudited)

       Three months ended
      March 31, 2020   Dec. 31, 2019 March 31, 2019
    Revenues:        
    Product sales $ 37,715     $ 30,450   $ 19,759  
    Product royalty revenues 563       1,187   2  
    Contract revenues         8  
    Total Revenues: 38,278       31,637   19,769  
    Cost of sales 5,560       7,264   4,052  
    Expenses:        
    Selling, general and administrative 26,736       23,759   16,989  
    Total Expenses: 26,736       23,759   16,989  
    Income (loss) from operations 5,982       614   (1,272 )
    Interest expense (1,293 )     (1,308 ) (2,561 )
    Other expense, net (1 )     (1 )  
    Income (loss) before income taxes $ 4,688     $ (695 ) $ (3,833 )
    Income tax benefit 278       (1 )  
    Net income (loss) attributable to common stockholders $ 4,966     $ (696 ) $ (3,833 )
    Basic        
    Weighted average common stock shares outstanding 97,118,267       92,118,497   71,344,831  
    Basic earnings (loss) per share $ 0.05     $ (0.01 ) $ (0.05 )
    Diluted        
    Weighted average common stock shares outstanding 106,965,762       92,118,497   71,344,831  
    Diluted earnings (loss) per share $ 0.05     $ (0.01 ) $ (0.05 )
                         
                         

    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
    (U.S. DOLLARS, IN THOUSANDS)
    (Unaudited)

       Three months ended
      March 31, 2020   Dec. 31, 2019 March 31, 2019
    Operating activities:        
    Net income (loss) $ 4,966     $ ( 696 ) $ (3,833 )
    Adjustments to reconcile net loss to net cash flows from operating activities        
    Depreciation 21       1,592   85  
    Accretion of debt discount and loan costs 65       67   634  
    Amortization of intangible assets 1,781       1,896   1,289  
    Provision for inventory obsolescence 405       140   149  
    Stock-based compensation expense 1,520       1,438   1,141  
    Changes in assets and liabilities:        
    Accounts receivable (6,324 )     (5,368 ) (2,381 )
    Inventories (4,096 )     (685 ) (2,002 )
    Prepaid expenses and other assets 1,169       1,106   218  
    Accounts payable and accrued liabilities 6,920       17,432   1,814  
    Taxes payable (40 )      
    Net cash flows provided by (used in) operating activities 6,387       16,922   (2,886 )
    Investing activities:        
    Product Acquisitions       (10,011 )  
    Disposal of property and equipment         (79 )
    Net cash flows used in investing activities       (10,011 ) (79 )
    Financing activities:        
    Proceeds from exercise of stock options 338       1,127   472  
    Debt issuance costs       (13 )  
    Net cash flows provided by financing activities 338       1,114   472  
    Net change in cash and cash equivalents 6,725       8,025   (2,493 )
    Cash and cash equivalents at beginning of period 63,888       55,863   43,822  
    Cash and cash equivalents at end of period $ 70,613      $   63,888   $ 41,329   
                         

    BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES 
    RECONCILIATION OF NON-GAAP METRICS 
    (U.S. DOLLARS, IN THOUSANDS) 
    (Unaudited)

    Reconciliations of non-GAAP metrics to most directly comparable U.S. GAAP financial measures:

    The following tables reconcile net income/(loss)earnings and computations (in thousands) under GAAP to a Non-GAAP basis.

      Three Months Ended
    Reconciliation of GAAP net income/(loss) to EBITDA (non-GAAP) March 31, 2020
    Dec. 31, 2019 
    March 31, 2019
    GAAP net income/(loss) $ 4,966   $ (696 ) $ (3,833 )
    Add back:      
    Provision for income taxes (278 )   1    
    Net interest expense 1,294     1,308   2,561  
    Depreciation and amortization 1,802     3,491   1,375  
    EBITDA $ 7,784   $ 4,104   $ 103  
    Reconciliation of GAAP net income/(loss) to Non-GAAP net income/(loss)      
    GAAP net income/(loss) 4,966     (696 ) (3,833 )
    Non-GAAP adjustments:      
    Stock-based compensation expense 1,520     1,438   1,142  
    Amortization of intangible assets 1,781     1,899   1,289  
    Amortization of warrant discount       269  
    Non-recurring financial impact – BUNAVAIL discontinuation     3,750    
    Non-GAAP net income/(loss) $ 8,267   $ 6,391   $ (1,133 )
                       

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  4. Completes concurrent financing of ~$22 million led by Orbimed Advisors, LLC

    Lead program, a proprietary long-acting GLP-1 receptor agonist, starting Phase 2 trial for Short Bowel Syndrome (SBS), an underserved, orphan condition

    Continued Phase 3 trial of larazotide; first and only drug for celiac disease

    Multiple inflection points with the start of a Phase 2 SBS trial in 2H 2020 and top-line results in 2021

    RALEIGH, NC / ACCESSWIRE / April 30, 2020 / Innovate Biopharmaceuticals, Inc. (NASDAQ:INNT), today announced the completion of its previously announced merger with privately-held RDD Pharma, Ltd. Following the completion of the merger, Innovate is changing its name to 9 Meters Biopharma, Inc. ("9 Meters" or the "Company") and will continue trading…

    Completes concurrent financing of ~$22 million led by Orbimed Advisors, LLC

    Lead program, a proprietary long-acting GLP-1 receptor agonist, starting Phase 2 trial for Short Bowel Syndrome (SBS), an underserved, orphan condition

    Continued Phase 3 trial of larazotide; first and only drug for celiac disease

    Multiple inflection points with the start of a Phase 2 SBS trial in 2H 2020 and top-line results in 2021

    RALEIGH, NC / ACCESSWIRE / April 30, 2020 / Innovate Biopharmaceuticals, Inc. (NASDAQ:INNT), today announced the completion of its previously announced merger with privately-held RDD Pharma, Ltd. Following the completion of the merger, Innovate is changing its name to 9 Meters Biopharma, Inc. ("9 Meters" or the "Company") and will continue trading on NASDAQ with the ticker symbol NMTR, effective May 4, 2020.

    In addition, the Company announced the signing of approximately $22 million in new financing, led by Orbimed Advisors, LLC, and the signing of the previously announced merger with Naia Rare Diseases, a company developing a proprietary long acting GLP-1 for the treatment of Short Bowel Syndrome. In the financing the Company will issue units consisting of preferred stock and warrants, at a price of $0.5894 per unit, on an as converted to common stock basis. The combined Company will be focused on developing urgently needed treatments for patients with rare, orphan diseases and unmet needs in GI. The combined Company will have two late-stage lead assets funded to their next key inflection points, which include the initiation of a Phase 2 trial in short bowel syndrome in 2H 2020 with top-line results expected in 2021, and the receipt of top-line results for an ongoing Phase 3 trial in celiac disease in 2021.

    "9 Meters Biopharma plans to deliver meaningful science and treatments for patients and providers which will translate into multiple inflection points for investors. This includes a novel approach with the first and only long-acting GLP-1 receptor agonist for the treatment of short bowel syndrome, and the first-ever drug in a Phase 3 trial for celiac disease," said John Temperato, President & Chief Executive Officer of 9 Meters.

    Mark Pimentel, M.D. FRCPC, Director of the Gastrointestinal Motility Program and Laboratory and Executive Director of the Medically Associated Science and Technology (MAST) program at Cedars-Sinai Medical Center added, "People living with short bowel syndrome have unmet motility needs and this long-acting GLP-1 agonist is one of the only compounds in development to directly address these by potentially allowing for elimination of parenteral nutrition and an improvement in quality of life."

    Benjamin Lebwohl, MD, MS, Louis and Gloria Flanzer Scholar at the Columbia University Medical Center and Director of Clinical Research at The Celiac Disease Center at Columbia University commented, "It has become abundantly clear that there has been a rising incidence of celiac disease and an increasing recognition of the difficulties of strict gluten avoidance with an impact on long-term outcomes in people with this condition, affecting health and quality of life. Though the gluten-free diet is effective, its challenges and limitations pose a significant unmet need in this population."

    The Board of Directors has extensive industry experience and includes Mark Sirgo, PharmD former CEO of BioDelivery Sciences (NASDAQ:BDSI) and board member of Salix Pharmaceuticals, as Chairman of the Board, Nissim Darvish, M.D., Ph.D., Senior Managing Director of OrbiMed Advisors, Lorin Johnson, Ph.D., founder of Salix Pharmaceuticals and Sandeep Laumas, M.D., former Chairman of Innovate.

    9 Meters management team is composed of industry veterans who bring an established track record of in-licensing, developing and commercializing multi-billion-dollar assets in gastroenterology. The executive team is led by John Temperato, President & Chief Executive Officer and member of the Board of Directors, and also includes Edward J. Sitar, Chief Financial Officer, Patrick Griffin, M.D. FACP, Chief Medical Officer, Nir Barak M.D., Senior Vice President of Clinical Affairs and Sireesh Appajosyula, PharmD, Senior Vice President of Corporate Development & Operations. The Company will be headquartered in Raleigh, NC.

    9 Meters BioPharma will host its first virtual "R&D Day" for analysts and investors from 1:00 pm to 2:30 pm EDT on May 13, 2020. The virtual R&D Day will include presentations from John Temperato, CEO, Mark Pimentel, M.D. FRCPC and Benjamin Lebwohl, M.D., M.S. with a focus on the Company's clinical development pipeline. The webcast will be available under "Events & Presentations" in the Investors section of the 9 Meters website www.9meters.com.

    William Blair & Company, L.L.C. acted as sole lead placement agent for the concurrent capital raise.

    GP Nurmenkari, Inc., National Securities, Westpark Capital, and Wynston Hill Capital acted as co-placement agents in connection with the concurrent financing. Sheppard, Mullin, Richter & Hampton LLP and Agmon & Co. Rosenberg Hacohen & Co. served as legal counsel to Innovate. Wyrick Robbins Yates & Ponton LLP and Shibolet & Co. served as legal counsel to RDD.

    Conference Call and Webcast
    Management will host a conference call on Monday, May 4th at 08:30 AM EDT for investors regarding this announcement with details as follows:

    Conference Call and Webcast Details:
    Date: May 4, 2020
    Time: 08:30 AM EDT
    Toll-free: 877-407-9716
    International: 201-493-6779
    Webcast URL: http://public.viavid.com/index.php?id=139683

    The archived webcast will be available on the Investors section of the 9 Meters website.

    About 9 Meters Biopharma

    9 Meters Biopharma, Inc. is a rare, orphan and unmet needs focused GI company. The Company is advancing NM-002, a proprietary long-acting GLP-1 agonist into Phase 2 trial for Short Bowel Syndrome (SBS), a rare, orphan disease, as well as larazotide, a Phase 3 tight junction regulator being evaluated for patient-reported symptom improvement in non-responsive celiac disease.

    For more information, please visit www.9meters.com.

    Forward-looking Statements

    This press release includes forward-looking statements based upon the Company's current expectations. Forward-looking statements involve risks and uncertainties, and include, but are not limited to, the potential effects of the ongoing coronavirus outbreak and related mitigation efforts on the Company's clinical, financial and operational activities; the Company's continued listing on Nasdaq; expectations regarding future financings; the future operations of the Company; the nature, strategy and focus of the Company; the development and commercial potential and potential benefits of any product candidates of the Company; anticipated preclinical and clinical drug development activities and related timelines, including the expected timing for data and other clinical and preclinical results; the Company having sufficient resources to advance its pipeline; and any other statements that are not historical fact. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: (i) uncertainties associated with the clinical development and regulatory approval of product candidates; (ii) risks related to the inability of the Company to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs; (iii) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; (iv) risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; (v) the the impact of COVID-19 on our operations, clinical trials or proposed merger and future financings and (vi) risks associated with the possible failure to realize certain anticipated benefits of the proposed Merger and the Naia acquisition, including with respect to future financial and operating results. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. These and other risks and uncertainties are more fully described in periodic filings with the SEC, including the factors described in the section entitled "Risk Factors" in Innovate Biopharmaeuticals. Inc. Annual Report on Form 10-K for the year ended December 31, 2019 and in other filings that Innovate has made and future filings the Company will make with the SEC. You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof or as of the dates indicated in the forward-looking statements. The company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

    Corporate contact

    Edward J. Sitar
    Chief Financial Officer
    9 Meters BioPharma, Inc.

    www.9meters.com

    Media contact

    Amy Jobe, Ph.D.
    LifeSci Communications, LLC

    315-879-8192

    Investor contact

    Corey Davis, PhD
    LifeSci Advisors, LLC

    212-915-2577

    SOURCE: Innovate Biopharmaeuticals. Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/587899/9-Meters-Biopharma-a-Rare-Orphan-and-Unmet-Needs-GI-Focused-Company-is-Created-with-the-Transformative-Merger-Between-Innovate-Biopharmaceuticals-and-RDD-Pharma

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  5. RALEIGH, N.C., April 28, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today announced that it will report its first quarter 2020 financial results after the close of the U.S. financial markets on Thursday, May 7, 2020. The Company will host a conference call and webcast at 4:30 PM Eastern Time to discuss the results and provide an update on business operations.

    Conference Call Dial-In & Webcast Information:

    Date:  Thursday, May 7, 2020
    Time: 4:30 PM Eastern Time
    Domestic: 800-289-0571
    International: 720-543-0206
    Conference ID: 6176462
    Webcast: http://public.viavid.com/index.php?id=139300

    RALEIGH, N.C., April 28, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ:BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today announced that it will report its first quarter 2020 financial results after the close of the U.S. financial markets on Thursday, May 7, 2020. The Company will host a conference call and webcast at 4:30 PM Eastern Time to discuss the results and provide an update on business operations.

    Conference Call Dial-In & Webcast Information:

    Date:  Thursday, May 7, 2020
    Time: 4:30 PM Eastern Time
    Domestic: 800-289-0571
    International: 720-543-0206
    Conference ID: 6176462
    Webcast: http://public.viavid.com/index.php?id=139300

    About BioDelivery Sciences International, Inc.
    BioDelivery Sciences International, Inc. (NASDAQ:BDSI) is a commercial-stage specialty pharmaceutical company dedicated to patients living with chronic conditions. BDSI has built a portfolio of products that includes utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA®) technology to develop and commercialize, either on its own or in partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs. BDSI's marketed products address serious and debilitating conditions, including chronic pain, opioid dependence, and opioid-induced constipation.

    © 2020 BioDelivery Sciences International, Inc. All rights reserved.

    Contact:
    Tirth T. Patel
    Director of Investor Relations

    (919) 582-0294

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