Bioblast Pharma Reports First Quarter 2017 Financial Results

TEL AVIV, Israel, May 26, 2017 (GLOBE NEWSWIRE) — Bioblast Pharma Ltd. (Nasdaq:ORPN), a clinical-stage, orphan disease-focused biotechnology company, today announced financial results for the first quarter ended March 31, 2017.

First Quarter 2017 Financial Results and Cash Position

  • R&D Expenses: Research and development expenses were $1.1 million for the quarter ended March 31, 2017, compared to $1.9 million for the same period in 2016. The decrease was primarily related to reduced clinical trial related activities, specifically as our planned Phase 2b clinical study in Ocular Pharyngeal Muscular Dystrophy (OPMD) patients has not yet been initiated; the decrease in costs was slightly offset by increased preclinical activities related to required toxicity studies.
  • Pre-Commercial Expenses: Pre-commercial expenses were $0.4 million for the quarter ended March 31, 2017, compared to $0.8 million for the same period in 2016.
  • G&A Expenses: General and administrative expenses were $1.1 million for the quarter ended March 31, 2017, compared to $1.9 million for the same period in 2016. The decrease was primarily related to downsizing of the management team, which took effect primarily in the second quarter of 2016, offset by costs related to a terminated securities offering announced on April 6, 2017.
  • Net Loss: For the quarter ended March 31, 2017, net loss attributable to holders of ordinary shares was ($2.7) million, or ($0.16) per basic and diluted share, as compared to a net loss of ($4.6) million, or ($0.32) per share, for the same period in 2016.
  • Cash Position: Cash, cash equivalents and short-term bank deposits as of March 31, 2017, were $7.1 million, compared to $9.9 million as of December 31, 2016, primarily reflecting our first quarter operating expenditures. Additional funding beyond our existing cash resources will be required to entirely cover the cost of the Phase 2b clinical study and the underlying expenses of our operations while the study is ongoing. Should we be unable to obtain the additional funding required to continue our clinical activity, we may need to reduce our activities and to explore strategic alternatives until we have sufficient resources.

About Bioblast

Bioblast Pharma is a clinical-stage biotechnology company committed to developing clinically meaningful therapies for patients with rare and ultra-rare genetic diseases with a lead drug candidate, trehalose 90mg/mL solution, in Phase 2 development.  Bioblast was founded in 2012 and is traded on the NASDAQ under the symbol “ORPN.” For more information, please visit our website, www.BioblastPharma.com, the content of which is not incorporated herein by reference.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, we are using forward looking statements when we discuss plans to conduct a Phase 2b clinical study, the design and timing of such study, and the company’s expected need for additional funding or possible need to reduce activities or pursue other alternatives. In addition, historic results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest similar conclusions or those historic results referred to in this press release will be interpreted in a similar way in light of additional research and clinical and preclinical trial results. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Because such statements deal with future events and are based on Bioblast Pharma Ltd.’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Bioblast Pharma could differ materially from those described in or implied by the statements in this press release, including those discussed under the heading “Risk Factors” in Bioblast Pharma’s Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on February 24, 2017, and in any subsequent filings with the SEC. Except as otherwise required by law, Bioblast Pharma disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.

 
Bioblast Pharma Ltd.
 
Consolidated Statement of Operations
 
(U.S. dollars in thousands, except share and per share amounts)
 
  Three Months Ended
  March 31
    2017       2016  
  (Unaudited)   (Unaudited)
       
Research and development $ 1,099     $ 1,858  
Pre-commercialization   406       772  
General and administrative   1,135       1,862  
Total operating expenses   2,640       4,492  
Loss from operations   (2,640 )     (4,492 )
       
Financial income, net   8       27  
       
Loss before taxes on income   (2,632 )     (4,465 )
       
Taxes on income   40       129  
       
Net loss $ (2,672 )   $ (4,594 )
       
Net loss attributable to Ordinary shareholders $ (2,672 )   $ (4,594 )
       
Net loss per share attributable to Ordinary shareholders – basic and diluted $ (0.16 )   $ (0.32 )
       
Weighted average number of Ordinary shares outstanding – basic and diluted   16,391,770       14,467,984  
       

Bioblast Pharma Ltd. 
 
Consolidated Balance Sheet Data
 
(U.S. dollars in thousands, except share amounts)
 
  March 31, 2017   December 31, 2016
  (Unaudited)   (Audited)
ASSETS      
CURRENT ASSETS:      
Cash and cash equivalents $ 4,100     $ 6,871  
Short-term bank deposits   3,017       3,007  
Receivables and prepaid expenses   682       663  
Total current assets   7,799       10,541  
               
LONG-TERM ASSETS:              
Long-term assets   19       18  
Property and equipment, net   68       71  
Total long-term assets   87       89  
               
TOTAL ASSETS $ 7,886     $ 10,630  
               
LIABILITIES AND SHAREHOLDERS’ EQUITY              
CURRENT LIABILITIES:              
Trade payables $ 543     $ 700  
Other accounts payable   1,075       1,231  
Total current liabilities   1,618       1,931  
               
               
LONG-TERM LIABILITIES          
               
SHAREHOLDERS’ EQUITY:              
Ordinary shares of NIS 0.01 par value – 50,000,000 shares authorized at March 31, 2017 and December 31, 2016; 16,391,770 issued and outstanding shares at March 31, 2017 and December 31, 2016   45       45  
Additional paid-in capital   48,704       48,463  
Accumulated deficit   (42,481 )     (39,809 )
Total stockholders’ equity   6,268       8,699  
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $ 7,886     $ 10,630  
       

Bioblast Pharma Ltd.
 
Consolidated Cash Flow Data
 
(U.S. dollars in thousands)
 
  Three Months Ended
  March 31
    2017       2016  
  (Unaudited)   (Unaudited)
Cash flows from operating activities      
Net loss $ (2,672 )   $ (4,594 )
Adjustments to reconcile net loss to net cash used in operating activities:      
Depreciation and disposal of property and equipment   5       6  
Share based compensation   241       751  
Interest on short-term deposit   (10 )     (34 )
Changes in operating assets and liabilities:      
Decrease (increase) in receivables and prepaid expenses   (22 )     338  
Decrease (increase) in long-term assets   2       (25 )
Decrease in trade payables   (157 )     (506 )
Increase (decrease) in other accounts payable   (156 )     61  
Increase in long-term liabilities         55  
       
Net cash used in operating activities   (2,769 )     (3,948 )
       
Cash flow from investing activities      
       
Purchase of property and equipment   (2 )     (8 )
Net cash used in investing activities   (2 )     (8 )
       
Cash flow from financing activities      
       
Issuance of shares and warrants, net         6,196  
Net cash provided by financing activities         6,196  
       
Increase (decrease) in cash and cash equivalents   (2,771 )     2,240  
Cash and cash equivalents, beginning of the year   6,871       7,286  
       
Cash and cash equivalents, end of the year $ 4,100     $ 9,526  
       
Supplemental Non-Cash Financing Activities:      
Issuance expenses yet to be paid as of March 31,2016 $     $ 107  
       
Supplemental disclosure of cash flow information:      
Cash paid for  taxes $     $ 104  
       

 

INVESTOR CONTACT:
Matthew P. Duffy
Managing Director
LifeSci Advisors, LLC
Telephone:  212-915-0685
Matthew@LifeSciAdvisors.com

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BioNovelus, Inc. Announces Resignation of Chief Financial Officer and Appointment of Interim Chief Financial Officer and Update of Prior Coffee Rust Press Release

Phoenix, May 26, 2017 (GLOBE NEWSWIRE) — / BioNovelus, Inc. (ONOV), whose CR-10 Biofungicide is a non-toxic solution for safe and effective pre- and post-harvest applications, today announced that Chief Financial Officer Mark R. Johnson has left the Company to pursue other interests.

Effective immediately, Company founder and CEO Jean Ekobo will assume the role of interim CFO until a permanent successor to Mr. Johnson is named.

BioNovelus is part of the award-winning business incubator program at the Center for Entrepreneurial Innovation in Phoenix, Arizona.

“We are grateful for Mr. Johnson’s support and encouragement through the beginning of our incubation phase,” said Ekobo. “His wisdom and assistance with our financial statements have been greatly appreciated.”

About CR-10 Biofungicide and Disinfectant
CR-10 is a proven, biodegradable, non-toxic solution that kills most bacteria, fungi, and spores rapidly, safely and effectively. It is a new generation of biofungicide and biodisinfectant with a unique mode of action. BioNovelus management believes that CR-10 has a broad range of uses in crop protection before harvest, as well as post-harvest sanitation.

Coffee Rust Update
Phase I Testing in Guatemala Still Underway for Organic Coffee Rust-Fighting CR-10

In a press release dated February 27, 2017, the Company shared its positive results during the first round of testing done by Anacafé, the Guatemalan Coffee Association. This release revealed that important first steps had been taken towards the goal of showing CR-10 efficacy validation by Anacafé, something that would make successful marketing of the biodegradable and non-toxic product possible in the region.

To further clarify that release while Anacafé has not validated the biofungicide CR-10 for commercial sale, CR-10 has been approved to enter Phase II of Anacafé’s testing and the Company will provide further updates as this testing continues.

“Anacafé is an esteemed organization,” says BioNovelus CEO and President, Jean Ekobo. “Their potential validation means a great deal to us and having reached an agreement to continue pursuing the validation process with this institution is very good news.”

About CEI
The Center for Entrepreneurial Innovation (CEI), a comprehensive business incubator centrally located in Phoenix, Arizona, provides the services, space and support critical to the development of these early-stage and startup companies.

Forward-Looking Statements
This news release includes forward-looking statements covered by the Private Securities Litigation Reform Act of 1995. Because such statements deal with future events, they are subject to various risks and uncertainties and actual results for the fiscal year 2017 and beyond could differ materially from the Company’s current expectations. Forward-looking statements are identified by words such as “anticipates,” “projects,” “expects,” “plans,” “intends,” “believes,” “estimates,” “targets,” and other similar expressions that indicate trends and future events.
Factors that could cause the Company’s results to differ materially from forward looking statements regarding the efficacy of the crop restoration and results of CR-10  and  registration approval  include the lack of capital needed to complete testing, the lack of experience with pursuing approval of this product and modifications and receipt of information that may be demanded by the registration of the CR-10 formula and the delays in the various government approval processes unrelated to the product itself. Factors that could cause lower rates of success in CR-10 eradication of fungi include the method and timing of applications of CR-10, the impact of heavy rainfall, the strength of fungi contamination, and other environmental conditions resulting in re-infection. Factors that may impact transactions with Mexican and Central American distributors include the alternatives of genetically modified crops, products of competitors, government approvals, and pricing.
There is no assurance of when registrations will be obtained for CR-10 and various applications. There is no assurance that the coffee rust application will prove commercially viable. There is no assurance that any transaction will be done with Mexican and Central American distributors.
Factors that could cause the Company’s results to differ materially from those expressed in forward-looking statements include, without limitation, variation in demand and acceptance of the Company’s products and services, general business and economic conditions beyond the Company’s control the consequences of competitive factors in the marketplace including the ability to attract and retain customers, results of continuous improvement and other cost-containment strategies, and the Company’s success in attracting and retaining key personnel. The Company undertakes no obligation to revise or update forward-looking statements because of new information, since these statements may no longer be accurate or timely.
Certain statements in this news release may contain forward-looking information within the meaning of Rule 175 under the Securities Act of 1933, and are subject to Rule 3B-6 under the Securities Exchange Act of 1934, and are subject to the safe harbor created by those rules. All statements, other than statements of fact, included in this press release, including, without limitation, statements regarding potential plans and objectives of the Company, are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and other results and further events could differ materially from those anticipated in such statements. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements.

For more information, contact http://bionovelus.com

Media contact: 
Nathalie Ekobo, 
Marketing & Communications Director 
BioNovelus, Inc. 
+1 602-888-3424 
Info@BioNovelus.com

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Endocyte to Announce Updated Data on EC1456 and EC1169 at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting

WEST LAFAYETTE, Ind., May 26, 2017 (GLOBE NEWSWIRE) — Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, today announced that two posters will be presented on its lead, clinical-stage assets, EC1456 and EC1169, at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting being held June 2 – 6, 2017, in Chicago.

Updated data will be presented on EC1456-01, a two part phase 1 dose escalation (Part A) and expansion (Part B) study. The presentation includes data for 87 Part A treated patients with advanced solid tumors and 6 Part B treated patients with FR-positive non-small cell lung cancer (NSCLC) as of the data cutoff on May 18, 2017. All patients were imaged to assess folate receptor expression with 99mTc-etarfolatide (FR expression not an eligibility criteria for Part A). Preliminary data from our first patient enrolled in the EC1456 ovarian surgical study, EC1456-02, will also be presented.

An update also will be provided for EC1169-01, a two-part phase 1 dose escalation (Part A) and expansion (Part B) study in patients with metastatic castration-resistant prostate cancer (mCRPC). The presentation includes data for the expansion phase (Part B) for 24 taxane-exposed mCRPC patients and 16 taxane-naïve mCRPC patients as of the data cutoff on May 15, 2017. All patients were imaged to assess PSMA expression with 99mTc-EC0652 (PSMA expression not an eligibility criteria).

The posters will be available on Endocyte’s website following presentation at the conference.

Presentations are as follows:

Abstract #:   2576
Title:   Phase 1 dose escalation study of the folate receptor-targeted small molecule drug conjugate EC1456
Presenter:   Dr. Wael Harb, Horizon Oncology Center
When:   Monday, June 5, 8:00 a.m. – 11:30 a.m. CDT
Session Title:   Poster Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
     
     
Abstract #:   5038
Title:   Phase 1 study of the PSMA-targeted small-molecule drug conjugate EC1169 in patients with metastatic castrate-resistant prostate cancer (mCRPC)
Presenter:   Dr. Michael Morris, Memorial Sloan Kettering Cancer Center
When:   Monday, June 5, 1:15 p.m. – 4:45 p.m. CDT
Session Title:   Poster Session: Genitourinary (Prostate) Cancer
     

About EC1456

EC1456 is an investigational therapeutic SMDC constructed of a high affinity FR-targeting ligand conjugated through a spacer and bioreleasable linker system to a potent cytotoxic microtubule inhibitor, tubulysin B hydrazide (TubBH). Patient FR-status is determined using the investigational companion imaging agent, etarfolatide. EC1456 is currently being evaluated in a phase 1 study in patients with advanced solid tumors (Part A) and FR-positive NSCLC (Part B) (ClinicalTrials.gov Identifier: NCT01999738) and a phase 1 exploratory study in patients with ovarian cancer undergoing surgery (ClinicalTrials.gov Identifier: NCT03011320).

About EC1169

EC1169 is an investigational therapeutic SMDC constructed of a high affinity prostate specific membrane antigen (PSMA)-targeting ligand conjugated through a bioreleasable linker system to a potent microtubule inhibitor, TubBH. Patient PSMA-status is determined using the investigational companion imaging agent, EC0652. EC1169 is currently being evaluated in a phase 1 study in patients with metastatic castration-resistant prostate cancer (mCRPC) (ClinicalTrials.gov Identifier: NCT02202447).

About Endocyte

Endocyte is a biopharmaceutical company and leader in developing targeted therapies for the treatment of cancer and other serious diseases.  Endocyte uses its proprietary drug conjugation technology to create novel SMDCs and companion imaging agents for personalized targeted therapies.  The company’s SMDCs actively target receptors that are over-expressed on diseased cells, relative to healthy cells.  This targeted approach is designed to enable the treatment of patients with highly active drugs at greater doses, delivered more frequently and over longer periods of time than would be possible with the untargeted drug alone.  The companion imaging agents are designed to identify patients whose disease over-expresses the target of the therapy and who are therefore more likely to benefit from treatment. For additional information, please visit Endocyte’s website at www.endocyte.com.

Endocyte Forward-Looking Statement

Certain of the statements made in this press release are forward looking, such as those relating to the company’s development programs and upcoming milestones. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that the company may experience delays in the completion of its clinical trials (whether caused by competition, adverse events, patient enrollment rates, shortage of clinical trial materials, regulatory issues or other factors); risks that data from its clinical trials may not be indicative of subsequent clinical trial results; risks related to the safety and efficacy of the company’s product candidates; risks that early stage preclinical data may not be indicative of subsequent data when expanded to additional pre-clinical models or to subsequent clinical data; risks that evolving competitive activity and intellectual property landscape may impair the company’s ability to capture value for the technology; estimates of the potential markets for its product candidates; estimates of the capacity of manufacturing and other facilities required to support its product candidates; projected cash needs; and expected future revenues, operations, expenditures and cash position. More information about the risks and uncertainties faced by Endocyte, Inc. is contained in the company’s periodic reports filed with the Securities and Exchange Commission. Endocyte, Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT: 
Stephanie Ascher, Stern Investor Relations, Inc., (212) 362-1200, stephanie@sternir.com

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