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News Article | May 11, 2017
Site: globenewswire.com

DUBLIN, Ireland, May 11, 2017 (GLOBE NEWSWIRE) -- Nexvet Biopharma (Nasdaq:NVET) today announced its financial results for the three and nine month periods ended March 31, 2017. The Company is continuing a pivotal field efficacy and safety study for frunevetmab. This study is a placebo-controlled, randomized, double-blinded study with a target enrolment of 250 cats with osteoarthritis at approximately 20 clinical sites around the United States. As at March 31, 169 cats had been enrolled into the study. Enrolled cats are randomly assigned to receive frunevetmab or placebo at a 2:1 ratio. Each cat receives three doses, with each dose given 28 days apart. This study has received protocol concurrence from the Center for Veterinary Medicine (CVM) at the United States Food and Drug Administration (FDA) and will utilize a comparison of owner-assessed responses, before and after treatment, as its primary endpoint. The pivotal target animal safety study, which commenced in late October 2016, is examining the safety of frunevetmab in cats according to standard International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) guidance and a protocol concurred with the CVM. The in-life phase of the pivotal target animal safety study is complete and Nexvet expects to report data from both studies in the fourth quarter of calendar 2017. In support of the Company’s planned frunevetmab CMC technical section submission to the CVM, a third 200 liter batch of frunevetmab was successfully produced during the quarter at BioNua, the Company’s wholly-owned manufacturing facility, which is also being prepared for commercial manufacturing of Nexvet’s products. The first and second 200 liter batch of ranevetmab was also successfully produced during the quarter. In February 2017, the Company entered into a license agreement with Pfizer Inc. (“Pfizer”), pursuant to which the Company received a non-exclusive license to certain patents in the Pfizer portfolio for anti-NGF antibodies. The Company paid Pfizer a $1.0 million upfront license fee, and may pay Pfizer (i) additional amounts based on regulatory and sales milestones and (ii) a low, single-digit royalty based on net sales of the Company’s anti-NGF product candidates for the life of the relevant patents. In March 2017, the Company implemented a cost reduction program focused on early stage research programs and general and administrative activities, which resulted in a reduction of 11 employees.  The net cost reflected in the quarter was $0.8 million. In April 2017, Zoetis Inc., entered into an agreement to acquire the Company, by means of a “scheme of arrangement” under Irish law.  The Transaction Agreement provides that shareholders of the Company will be entitled to receive $6.72 in cash per ordinary share of the Company and values the Company at approximately $85 million. The Nexvet board has unanimously recommended this offer to shareholders in the absence of a superior offer.  The Company is expecting completion of the transaction in the second half of 2017. As of March 31, 2017, Nexvet had cash of $14.5 million. For the three months ended March 31, 2017, Nexvet reported a net loss of $6.0 million which reflected one off items, namely $1.0 million to Pfizer for a patent license and $0.8 million in cost reduction costs, compared to $5.7 million for the three months ended March 31, 2016. Net loss per share attributable to ordinary shareholders (basic and diluted) for the three months ended March 31, 2017 was $0.51, compared to $0.50 for the three months ended March 31, 2016. The net loss of $6.0 million for the three months ended March 31, 2017 included operating expenses of $7.2 million, reflecting $5.6 million in research and development expenses and $1.6 million in general and administrative expenses. Other income of $1.1 million comprised research and development income of $0.6 million, government grant income of $0.4 million and an exchange gain of $0.1 million. The net loss of $5.7 million for the three months ended March 31, 2016 included operating expenses of $5.9 million, reflecting $4.3 million in research and development expenses and $1.7 million in general and administrative expenses. Other income of $0.2 million comprised research and development income of $0.4 million offset by an exchange loss of $0.2 million. For the nine months ended March 31, 2017, Nexvet reported a net loss of $16.5 million which reflected one off items, namely $1.0 million to Pfizer for a patent license and $0.8 million in cost reduction costs, compared to $15.4 million for the nine months ended March 31, 2016. Net loss per share attributable to ordinary shareholders (basic and diluted) for the nine months ended March 31, 2017 was $1.41, compared to $1.34 for the nine months ended March 31, 2016. The net loss of $16.5 million for the nine months ended March 31, 2017 included operating expenses of $18.0 million, reflecting $12.8 million in research and development expenses and $5.2 million in general and administrative expenses. Other income of $1.5 million comprised research and development income of $1.6 million, government grant income of $0.8 million and interest income of $0.1 million, offset by an exchange loss of $1.0 million. The net loss of $15.4 million for the nine months ended March 31, 2016 included operating expenses of $17.1 million, reflecting $11.8 million in research and development expenses and $5.3 million in general and administrative expenses. Other income of $1.7 million comprised research and development income of $1.4 million, interest income $0.1 million and an exchange gain of $0.2 million. Nexvet is a clinical-stage biopharmaceutical company focused on transforming the therapeutic market for companion animals, such as dogs and cats, by developing and commercializing novel, species-specific biologics. Nexvet’s proprietary PETization platform is designed to rapidly design monoclonal antibodies (mAbs) that are recognized as “self” or “native” by an animal’s immune system, a property Nexvet refers to as “100% species-specificity.” Nexvet’s product candidates build upon the safety and efficacy data from clinically tested human therapies, thereby reducing clinical risk and development cost. Nexvet is leveraging diverse global expertise and incentives to build a vertically integrated biopharmaceutical company, which conducts drug discovery in Australia, conducts clinical development in the United States and Europe and conducts manufacturing in Ireland. This press release contains 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 (the “Exchange Act”). Forward looking statements consist of all statements other than statements of historical fact, including statements regarding our future results of operations and financial position, potential acquisition by Zoetis, ability to access financing on acceptable terms or at all, results of any current or future pivotal study, future expenditures relating to our lead product candidates, time for completion of any of our studies or facilities upgrades, ability to develop our pipeline of product candidates, business strategy, prospective products, ability to successfully manufacture our own product candidates, ability to meet conditions for the receipt of government grants, time for regulatory submissions or ability to qualify for conditional licensure or obtain product approvals, research and development costs, timing and likelihood of success, plans and objectives of management for future operations, and future results of current and anticipated products.  These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward looking statements.  The words “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “plan,” “potential,” “predict,” “project,” “position,” “seek,” “should,” “target,” “will,” “would,” or the negative of these terms or other similar expressions are intended to identify forward looking statements, although not all forward looking statements contain these identifying words.  These forward looking statements are based on current expectations, estimates, forecasts and projections about our business and the industry in which we operate, and management’s beliefs and assumptions are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors. Factors that could cause actual results to differ materially from our expectations expressed in this report include those summarized under Risk Factors in our reports on Forms 10-Q and 10-K and the other documents we file from time to time with the Securities and Exchange Commission.  Given these risks and uncertainties, you should not place undue reliance on these forward looking statements.  Also, forward looking statements represent management’s beliefs and assumptions only as of the date of this press release.  Except as required by law, we do not intend, and undertake no obligation, to revise or update these forward looking statements or to update the reasons actual results could differ materially from those anticipated in these forward looking statements, even if new information becomes available in the future.


Company to Host an Investor Conference Call Tomorrow at 10:00 AM EDT BOSTON, MA--(Marketwired - May 10, 2017) - Pieris Pharmaceuticals, Inc. ( : PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for cancer, respiratory and other diseases, today reported financial results for the first quarter of 2017 and provided an update on the Company's recent developments, including: During the first quarter of 2017, Pieris announced two significant partnerships. In January, the Company announced a global, multi-target, multi-year alliance in immuno-oncology with Servier to jointly pursue up to eight bispecific therapeutic programs, including Pieris' proprietary dual checkpoint inhibitor, PRS-332. Under the terms of the alliance, Pieris received an upfront payment of EUR30.0 million (approximately $32.3 million), and stands to receive, collectively, up to EUR1.7 billion (approximately $1.8 billion) in success-based milestone payments and up to double-digit royalties from potential sales. Pieris and Servier will jointly develop PRS-332, with Pieris retaining all commercial rights in the United States and Servier having commercial rights in the rest of the world. Pieris has the option, at a predefined time point, to co-develop and retain commercial rights in the United States for up to three programs beyond PRS-332. In February, Pieris announced that it had granted ASKA Pharmaceutical Co. an exclusive option to license development and commercial rights in Japan for its most advanced drug candidate, PRS-080, to treat anemia in dialysis-dependent patients. Under the terms of the agreement, Pieris received an option payment of $2.75 million, and should ASKA exercise its option to develop and commercialize PRS-080 following positive results from the forthcoming Phase 2a study, Pieris would be eligible for more than $80 million in combined option exercise fee and milestone payments stemming from successful commercialization of PRS-080 in the first indication in Japan. Pieris may receive further development milestones for additional indications, as well as in other countries within the ASKA territory, and may receive double-digit royalties on net sales of PRS-080 up to the mid- to high-teens. Following the close of the first quarter, the Company also announced a global strategic co-development and co-commercialization respiratory-focused alliance including PRS-060 with AstraZeneca. Details of this alliance are summarized below, and were also previously disclosed in a May 3, 2017 press release. During the first quarter, the Company made substantial advances across its key pipeline programs, covering all of its lead therapeutic areas: "During the first quarter of 2017 and the early part of the second quarter, we have built dramatically on the foundational work that was put into place last year. We have secured two global and transformative alliances in our two core therapeutic areas of immuno-oncology and respiratory diseases, and an important regional alliance for our anemia program, PRS-080, as we seek to divest that asset in a careful manner while we focus our organization on high-value therapies within immunology. Our partnerships with global leaders like AstraZeneca and Servier, and regional partners like ASKA, have generated approximately $80 million in cash flow in 2017, while our combined partnerships could result in more than $4.5 billion in potential milestone payments, plus royalties from future product sales, not to mention opportunities for direct commercial sales for several products in the United States. With our current balance sheet, we have the financial resources to invest more robustly into our proprietary pipeline, while extending our financial runway through a series of critical value inflection points," said Stephen Yoder, President and CEO of Pieris. "We also advanced our clinical and preclinical programs, and remain on track to take our wholly-owned lead IO asset, PRS-343, into a Phase 1 trial during the current quarter, while planning to advance our now-partnered lead respiratory asset, PRS-060, into first in human trials in the second half of this year in collaboration with AstraZeneca, in addition to making steady progress across all of our additional partnerships. Based on not only the corporate milestones achieved to date, but also the additional corporate milestones we intend to achieve later this year, we continue to believe that 2017 can be the most value-creating year in the history of our company." Cash Position -- Cash and cash equivalents totalled $55.2 million as of March 31, 2017, compared to $29.4 million as of December 31, 2016. This increase in cash was driven primarily by the upfront payment received from Servier and the option payment received from Aska, offset principally by $8.8 million operating expenditures during the quarter. R&D Expense­ -- Research and development expenses were $5.4 million for the quarter ended March 31, 2017, compared to $3.7 million for the quarter ended March 31, 2016. The $1.7 million increase was primarily attributable to a $0.9 million increase in pre-clinical development, CMC, and clinical costs for PRS-343 as we carry out IND-enabling studies and a $0.5 million net increase in CMC and other costs associated with PRS-060 as we continue IND-enabling studies. G&A Expense -- General and administrative expenses for the quarter ended March 31, 2017 were $4.0 million, compared to $2.0 million for the quarter ended March 31, 2016. The $2.0 million increase in G&A expenses was primarily due to $0.8 million in higher personnel related costs, including stock compensation, $0.9 million increase for professional fees principally on account of success-based fees, and $0.3 million increase in for administrative travel, recruiting, and other administrative costs. Net Loss -- Net loss was $8.0 million or ($0.19) per share for the quarter ended March 31, 2017, compared to a net loss $4.2 million or ($0.10) per share for the quarter ended March 31, 2016. Pieris management will host a conference call beginning at 10:00 AM Eastern Daylight Time on Thursday, May 11, 2017, to discuss the first quarter financial results and provide a corporate update. To access the call, participants may dial 877-407-8920 (US & Canada) or 1-412-902-1010 (International) at least 10 minutes prior to the start of the call. An archived replay of the call will be available by dialling 877-660-6853 (US & Canada) or 1-201-612-7415 (International) and providing the Conference ID #: 13652361. Pieris is a clinical-stage biotechnology company that discovers and develops Anticalin® protein-based drugs to target validated disease pathways in a unique and transformative way. Our pipeline includes immuno-oncology multi-specifics tailored for the tumor microenvironment, an inhaled Anticalin protein to treat uncontrolled asthma and a half-life-optimized Anticalin protein to treat anemia. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies. Anticalin is a registered trademark of Pieris. For more information, visit www.pieris.com. This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to novel technologies and methods; our business and product development plans; the timing and progress of our studies, our liquidity and ability to fund our future operations; our ability to achieve certain milestones and receive future milestone or royalty payments; or market information. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, our ability to raise the additional funding we will need to continue to pursue our business and product development plans; the inherent uncertainties associated with developing new products or technologies and operating as a development stage company; our ability to develop, complete clinical trials for, obtain approvals for and commercialize any of our product candidates; competition in the industry in which we operate and market conditions. These forward-looking statements are made as of the date of this press release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents we file with the SEC available at www.sec.gov, including without limitation the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and the Company's Quarterly Reports on Form 10-Q.


News Article | May 11, 2017
Site: www.prweb.com

The Cranberry Marketing Committee (CMC) is pleased to announce its sponsorship of the 25th annual Wildwood Ultimate Beach Frisbee Tournament, a two-day competition taking place in Wildwood, NJ, July 29-30. One of the largest events of its kind in the world, Wildwood 25 will draw hundreds of teams composed of nearly 8,000 players. Players range in age from teen to late 50s, and they’ll be attending from locales all over the globe. “This event dovetails nicely with our desire to expose new audiences of health-conscious individuals to the flavor, versatility and health benefits of cranberry products,” said Executive Director Michelle Hogan. “Containing a variety of vitamins and nutrients, including potassium, fiber and Vitamin C, dried cranberries are the perfect on-the-go snack for these athletes.” New Jersey is one of four major cranberry producing regions in the country and is home to the oldest cranberry growers’ association, the American Cranberry Growers Association. Additionally, Rutgers, The State University of New Jersey, houses the Philip E. Marucci Center for Blueberry and Cranberry Research and Extension, which was established in 1918 and generates research vital to the cranberry industry. “We’re always excited to reach new audiences, but it’s even sweeter when we can do so in one of our growing regions,” said Hogan. “Educating consumers on the 200-year-old history of cranberry growing in this country and making them aware of local product is as important to us as the fruit’s health aspects.” About the Cranberry Marketing Committee The Cranberry Marketing Committee (CMC) promotes the worldwide use and consumption of US-grown cranberries. The CMC was established as a Federal Marketing Order in 1962 to ensure a stable, orderly supply of good quality product.


News Article | May 12, 2017
Site: globenewswire.com

Expands ADAPTIR Portfolio and Announces New Bispecific Candidate; Presents Data at the 2016 PEPTALK Conference Showcasing Advantages of the ADAPTIR™ Platform SEATTLE, May 12, 2017 (GLOBE NEWSWIRE) -- Aptevo Therapeutics Inc. (Nasdaq:APVO), a biotechnology company focused on developing novel oncology and hematology therapeutics, today provided a business review and reported its financial results for the first quarter ended March 31, 2017. “Aptevo made important strides in early 2017 in both our development and commercial portfolios,” said Marvin L. White, President and Chief Executive Officer.  “Most notably, we expanded our ADAPTIR™ portfolio with the advancement of a new immuno-oncology bispecific antibody candidate, APVO436, engineered to simultaneously target the cell surface receptors CD123 and CD3 to promote redirected T-cell cytotoxicity (RTCC).  New preclinical data highlight the antibody-like half-life, stability and potent activity of this molecule.  The team has made exceptional progress advancing APVO436 and other ADAPTIR candidates and we are on track to provide additional information around our investigational new drug (IND) strategy for these candidates later this year.” “Also during the first quarter, we were pleased to announce that Aptevo had resumed commercial production of IXINITY,” continued Mr. White.  “As a result, we did not experience a supply interruption of IXINITY as originally anticipated.  Our proactive and transparent communications with the Hemophilia B community, and the tremendous support of people taking IXINITY enabled us to retain over 90% of patients.  I continue to be grateful to our IXINITY family for their patience and encouragement during the last few months. With new IXINITY supply anticipated to be available soon, we have aggressively resumed our new patient acquisition efforts and look forward to returning IXINITY to its growth trajectory.” Cash Position:  Aptevo had cash, cash equivalents, and marketable securities as of March 31, 2017 totaling $61.3 million. Product Sales Revenue:  Total product sales revenue was $7.4 million for the first three months ended March 31, 2017, compared to $7.9 million for the same period in 2016.  The decrease in product sales revenue was primarily related to revenue associated with WinRho, which decreased by $0.9 million in the first quarter of 2017. Cost of Product Sales:  Cost of product sales decreased by $3.0 million, or 86%, to $0.5 million for the three months ended March 31, 2017 from $3.5 million for the three months ended March 31, 2016. This decrease was due to a one-time, non-cash adjustment in the first quarter of 2017 in the amount of $3.0 million relating to a settlement agreement executed between Aptevo and CMC ICOS Biologics, Inc., in relation to certain batches of IXINITY produced in 2015 that did not meet manufacturing specifications. The settlement is reflected as a reduction in Aptevo’s cost of product sales in the first quarter of 2017. Research and Development Expenses:  Research and development expenses decreased by $2.2 million, or 27%, to $5.9 million for the three months ended March 31, 2017, from $8.1 million for the corresponding period in 2016.  The decrease was primarily due to a decrease in manufacturing process development costs related to IXINITY and the timing of certain ADAPTIR clinical trial activities.  Our principal research and development expenses for the three months ended March 31, 2017 are summarized in the table below. Selling, General and Administrative Expenses:  Selling, general and administrative expenses for the three months ended March 31, 2017 were $10.6 million, compared to $9.4 million for the same period in 2016.  The increase in SG&A expenses in the first quarter of 2017 was primarily due to increased marketing expenses, personnel costs due to the spin-off, and consulting expenses. Net Loss:  Aptevo’s net loss for the three months ended March 31, 2017 was $9.9 million or ($0.48) per share, compared to $12.9 million or ($0.64) per share for the corresponding period in 2016. Credit Agreement Amendment:  Aptevo and MidCap Financial Trust agreed to amend a credit agreement initially executed in August 2016.  The amendment (1) modifies the minimum net commercial product revenue requirements which Aptevo is required to achieve on a rolling twelve-month basis; (2) extends the time period through which the Company can draw the second tranche from August 2017 to March 2018; (3) increases the exit fee from 5.75% for repayment or prepayment to 6.75% and; (4) permits MidCap to obtain an affirmative lien on Aptevo’s intellectual property, upon the earlier of (i) the Company’s draw down of the second tranche or (ii) the Company’s cash balance descending below a minimum cash threshold of $25 million. Aptevo Therapeutics Inc. is a biotechnology company focused on novel oncology and hematology therapeutics to meaningfully improve patients’ lives. Aptevo’s core technology is the ADAPTIR™ (modular protein technology) platform. Aptevo has four commercial products in the areas of hematology and infectious diseases, as well as various investigational stage product candidates in immuno-oncology. This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including, without limitation, statements regarding Aptevo’s outlook, financial performance or financial condition, our technology and related pipeline, collaboration and partnership opportunities, commercial portfolio, Aptevo’s future growth rates, Aptevo’s ability to timely manufacture its products, and any other statements containing the words “believes,” “expects,” “anticipates,” “intends,” “plans,” “forecasts,” “estimates,” “will” and similar expressions are forward-looking statements. These forward-looking statements are based on Aptevo’s current intentions, beliefs and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo’s expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not undertake to update any forward-looking statement to reflect new information, events or circumstances. There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements, including possible negative effects on our business operations, assets or financial results as a result of the separation; a deterioration in our business or prospects; the ability of our contractors and suppliers to supply product and materials; our ability and the ability of our contractors and suppliers to maintain compliance with cGMP and other regulatory obligations; the results of regulatory inspections; adverse developments in our customer-base or markets and our ability to retain patients; adverse developments in the U.S. or global capital markets, credit markets or economies generally; and changes in regulatory, social and political conditions. Additional risks and factors that may affect results are set forth in our filings with the Securities and Exchange Commission, including Aptevo’s most recent Annual Report on Form 10-K, as filed on March 15, 2017, and our subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement.


News Article | May 12, 2017
Site: globenewswire.com

Expands ADAPTIR Portfolio and Announces New Bispecific Candidate; Presents Data at the 2016 PEPTALK Conference Showcasing Advantages of the ADAPTIR™ Platform SEATTLE, May 12, 2017 (GLOBE NEWSWIRE) -- Aptevo Therapeutics Inc. (Nasdaq:APVO), a biotechnology company focused on developing novel oncology and hematology therapeutics, today provided a business review and reported its financial results for the first quarter ended March 31, 2017. “Aptevo made important strides in early 2017 in both our development and commercial portfolios,” said Marvin L. White, President and Chief Executive Officer.  “Most notably, we expanded our ADAPTIR™ portfolio with the advancement of a new immuno-oncology bispecific antibody candidate, APVO436, engineered to simultaneously target the cell surface receptors CD123 and CD3 to promote redirected T-cell cytotoxicity (RTCC).  New preclinical data highlight the antibody-like half-life, stability and potent activity of this molecule.  The team has made exceptional progress advancing APVO436 and other ADAPTIR candidates and we are on track to provide additional information around our investigational new drug (IND) strategy for these candidates later this year.” “Also during the first quarter, we were pleased to announce that Aptevo had resumed commercial production of IXINITY,” continued Mr. White.  “As a result, we did not experience a supply interruption of IXINITY as originally anticipated.  Our proactive and transparent communications with the Hemophilia B community, and the tremendous support of people taking IXINITY enabled us to retain over 90% of patients.  I continue to be grateful to our IXINITY family for their patience and encouragement during the last few months. With new IXINITY supply anticipated to be available soon, we have aggressively resumed our new patient acquisition efforts and look forward to returning IXINITY to its growth trajectory.” Cash Position:  Aptevo had cash, cash equivalents, and marketable securities as of March 31, 2017 totaling $61.3 million. Product Sales Revenue:  Total product sales revenue was $7.4 million for the first three months ended March 31, 2017, compared to $7.9 million for the same period in 2016.  The decrease in product sales revenue was primarily related to revenue associated with WinRho, which decreased by $0.9 million in the first quarter of 2017. Cost of Product Sales:  Cost of product sales decreased by $3.0 million, or 86%, to $0.5 million for the three months ended March 31, 2017 from $3.5 million for the three months ended March 31, 2016. This decrease was due to a one-time, non-cash adjustment in the first quarter of 2017 in the amount of $3.0 million relating to a settlement agreement executed between Aptevo and CMC ICOS Biologics, Inc., in relation to certain batches of IXINITY produced in 2015 that did not meet manufacturing specifications. The settlement is reflected as a reduction in Aptevo’s cost of product sales in the first quarter of 2017. Research and Development Expenses:  Research and development expenses decreased by $2.2 million, or 27%, to $5.9 million for the three months ended March 31, 2017, from $8.1 million for the corresponding period in 2016.  The decrease was primarily due to a decrease in manufacturing process development costs related to IXINITY and the timing of certain ADAPTIR clinical trial activities.  Our principal research and development expenses for the three months ended March 31, 2017 are summarized in the table below. Selling, General and Administrative Expenses:  Selling, general and administrative expenses for the three months ended March 31, 2017 were $10.6 million, compared to $9.4 million for the same period in 2016.  The increase in SG&A expenses in the first quarter of 2017 was primarily due to increased marketing expenses, personnel costs due to the spin-off, and consulting expenses. Net Loss:  Aptevo’s net loss for the three months ended March 31, 2017 was $9.9 million or ($0.48) per share, compared to $12.9 million or ($0.64) per share for the corresponding period in 2016. Credit Agreement Amendment:  Aptevo and MidCap Financial Trust agreed to amend a credit agreement initially executed in August 2016.  The amendment (1) modifies the minimum net commercial product revenue requirements which Aptevo is required to achieve on a rolling twelve-month basis; (2) extends the time period through which the Company can draw the second tranche from August 2017 to March 2018; (3) increases the exit fee from 5.75% for repayment or prepayment to 6.75% and; (4) permits MidCap to obtain an affirmative lien on Aptevo’s intellectual property, upon the earlier of (i) the Company’s draw down of the second tranche or (ii) the Company’s cash balance descending below a minimum cash threshold of $25 million. Aptevo Therapeutics Inc. is a biotechnology company focused on novel oncology and hematology therapeutics to meaningfully improve patients’ lives. Aptevo’s core technology is the ADAPTIR™ (modular protein technology) platform. Aptevo has four commercial products in the areas of hematology and infectious diseases, as well as various investigational stage product candidates in immuno-oncology. This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including, without limitation, statements regarding Aptevo’s outlook, financial performance or financial condition, our technology and related pipeline, collaboration and partnership opportunities, commercial portfolio, Aptevo’s future growth rates, Aptevo’s ability to timely manufacture its products, and any other statements containing the words “believes,” “expects,” “anticipates,” “intends,” “plans,” “forecasts,” “estimates,” “will” and similar expressions are forward-looking statements. These forward-looking statements are based on Aptevo’s current intentions, beliefs and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo’s expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not undertake to update any forward-looking statement to reflect new information, events or circumstances. There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements, including possible negative effects on our business operations, assets or financial results as a result of the separation; a deterioration in our business or prospects; the ability of our contractors and suppliers to supply product and materials; our ability and the ability of our contractors and suppliers to maintain compliance with cGMP and other regulatory obligations; the results of regulatory inspections; adverse developments in our customer-base or markets and our ability to retain patients; adverse developments in the U.S. or global capital markets, credit markets or economies generally; and changes in regulatory, social and political conditions. Additional risks and factors that may affect results are set forth in our filings with the Securities and Exchange Commission, including Aptevo’s most recent Annual Report on Form 10-K, as filed on March 15, 2017, and our subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement.


News Article | May 11, 2017
Site: globenewswire.com

DUBLIN, Ireland, May 11, 2017 (GLOBE NEWSWIRE) -- Nexvet Biopharma (Nasdaq:NVET) today announced its financial results for the three and nine month periods ended March 31, 2017. The Company is continuing a pivotal field efficacy and safety study for frunevetmab. This study is a placebo-controlled, randomized, double-blinded study with a target enrolment of 250 cats with osteoarthritis at approximately 20 clinical sites around the United States. As at March 31, 169 cats had been enrolled into the study. Enrolled cats are randomly assigned to receive frunevetmab or placebo at a 2:1 ratio. Each cat receives three doses, with each dose given 28 days apart. This study has received protocol concurrence from the Center for Veterinary Medicine (CVM) at the United States Food and Drug Administration (FDA) and will utilize a comparison of owner-assessed responses, before and after treatment, as its primary endpoint. The pivotal target animal safety study, which commenced in late October 2016, is examining the safety of frunevetmab in cats according to standard International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) guidance and a protocol concurred with the CVM. The in-life phase of the pivotal target animal safety study is complete and Nexvet expects to report data from both studies in the fourth quarter of calendar 2017. In support of the Company’s planned frunevetmab CMC technical section submission to the CVM, a third 200 liter batch of frunevetmab was successfully produced during the quarter at BioNua, the Company’s wholly-owned manufacturing facility, which is also being prepared for commercial manufacturing of Nexvet’s products. The first and second 200 liter batch of ranevetmab was also successfully produced during the quarter. In February 2017, the Company entered into a license agreement with Pfizer Inc. (“Pfizer”), pursuant to which the Company received a non-exclusive license to certain patents in the Pfizer portfolio for anti-NGF antibodies. The Company paid Pfizer a $1.0 million upfront license fee, and may pay Pfizer (i) additional amounts based on regulatory and sales milestones and (ii) a low, single-digit royalty based on net sales of the Company’s anti-NGF product candidates for the life of the relevant patents. In March 2017, the Company implemented a cost reduction program focused on early stage research programs and general and administrative activities, which resulted in a reduction of 11 employees.  The net cost reflected in the quarter was $0.8 million. In April 2017, Zoetis Inc., entered into an agreement to acquire the Company, by means of a “scheme of arrangement” under Irish law.  The Transaction Agreement provides that shareholders of the Company will be entitled to receive $6.72 in cash per ordinary share of the Company and values the Company at approximately $85 million. The Nexvet board has unanimously recommended this offer to shareholders in the absence of a superior offer.  The Company is expecting completion of the transaction in the second half of 2017. As of March 31, 2017, Nexvet had cash of $14.5 million. For the three months ended March 31, 2017, Nexvet reported a net loss of $6.0 million which reflected one off items, namely $1.0 million to Pfizer for a patent license and $0.8 million in cost reduction costs, compared to $5.7 million for the three months ended March 31, 2016. Net loss per share attributable to ordinary shareholders (basic and diluted) for the three months ended March 31, 2017 was $0.51, compared to $0.50 for the three months ended March 31, 2016. The net loss of $6.0 million for the three months ended March 31, 2017 included operating expenses of $7.2 million, reflecting $5.6 million in research and development expenses and $1.6 million in general and administrative expenses. Other income of $1.1 million comprised research and development income of $0.6 million, government grant income of $0.4 million and an exchange gain of $0.1 million. The net loss of $5.7 million for the three months ended March 31, 2016 included operating expenses of $5.9 million, reflecting $4.3 million in research and development expenses and $1.7 million in general and administrative expenses. Other income of $0.2 million comprised research and development income of $0.4 million offset by an exchange loss of $0.2 million. For the nine months ended March 31, 2017, Nexvet reported a net loss of $16.5 million which reflected one off items, namely $1.0 million to Pfizer for a patent license and $0.8 million in cost reduction costs, compared to $15.4 million for the nine months ended March 31, 2016. Net loss per share attributable to ordinary shareholders (basic and diluted) for the nine months ended March 31, 2017 was $1.41, compared to $1.34 for the nine months ended March 31, 2016. The net loss of $16.5 million for the nine months ended March 31, 2017 included operating expenses of $18.0 million, reflecting $12.8 million in research and development expenses and $5.2 million in general and administrative expenses. Other income of $1.5 million comprised research and development income of $1.6 million, government grant income of $0.8 million and interest income of $0.1 million, offset by an exchange loss of $1.0 million. The net loss of $15.4 million for the nine months ended March 31, 2016 included operating expenses of $17.1 million, reflecting $11.8 million in research and development expenses and $5.3 million in general and administrative expenses. Other income of $1.7 million comprised research and development income of $1.4 million, interest income $0.1 million and an exchange gain of $0.2 million. Nexvet is a clinical-stage biopharmaceutical company focused on transforming the therapeutic market for companion animals, such as dogs and cats, by developing and commercializing novel, species-specific biologics. Nexvet’s proprietary PETization platform is designed to rapidly design monoclonal antibodies (mAbs) that are recognized as “self” or “native” by an animal’s immune system, a property Nexvet refers to as “100% species-specificity.” Nexvet’s product candidates build upon the safety and efficacy data from clinically tested human therapies, thereby reducing clinical risk and development cost. Nexvet is leveraging diverse global expertise and incentives to build a vertically integrated biopharmaceutical company, which conducts drug discovery in Australia, conducts clinical development in the United States and Europe and conducts manufacturing in Ireland. This press release contains 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 (the “Exchange Act”). Forward looking statements consist of all statements other than statements of historical fact, including statements regarding our future results of operations and financial position, potential acquisition by Zoetis, ability to access financing on acceptable terms or at all, results of any current or future pivotal study, future expenditures relating to our lead product candidates, time for completion of any of our studies or facilities upgrades, ability to develop our pipeline of product candidates, business strategy, prospective products, ability to successfully manufacture our own product candidates, ability to meet conditions for the receipt of government grants, time for regulatory submissions or ability to qualify for conditional licensure or obtain product approvals, research and development costs, timing and likelihood of success, plans and objectives of management for future operations, and future results of current and anticipated products.  These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward looking statements.  The words “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “plan,” “potential,” “predict,” “project,” “position,” “seek,” “should,” “target,” “will,” “would,” or the negative of these terms or other similar expressions are intended to identify forward looking statements, although not all forward looking statements contain these identifying words.  These forward looking statements are based on current expectations, estimates, forecasts and projections about our business and the industry in which we operate, and management’s beliefs and assumptions are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors. Factors that could cause actual results to differ materially from our expectations expressed in this report include those summarized under Risk Factors in our reports on Forms 10-Q and 10-K and the other documents we file from time to time with the Securities and Exchange Commission.  Given these risks and uncertainties, you should not place undue reliance on these forward looking statements.  Also, forward looking statements represent management’s beliefs and assumptions only as of the date of this press release.  Except as required by law, we do not intend, and undertake no obligation, to revise or update these forward looking statements or to update the reasons actual results could differ materially from those anticipated in these forward looking statements, even if new information becomes available in the future.


Company on Track to File NDA with U.S. FDA in Early Q 3 2017 MALVERN, Pa., May 09, 2017 (GLOBE NEWSWIRE) -- Recro Pharma, Inc. (Nasdaq:REPH), a revenue generating specialty pharmaceutical company focused on therapeutics for hospital and other acute care settings, today announced successful top-line results from its Phase III safety study evaluating intravenous (IV) meloxicam (30mg bolus injection) following major surgery.  The primary objective of the study was to evaluate the safety and tolerability of IV meloxicam 30mg vs. placebo through Day 28 following treatment.  The study demonstrated that the adverse event profile of IV meloxicam 30mg was consistent with previously completed studies, and was similar to placebo.  Recro Pharma believes the results of this 722 patient Phase III safety study support the safety profile of IV meloxicam 30mg and completes the last clinical requirement of the full efficacy and safety program for a New Drug Application (NDA) for IV meloxicam 30mg as a novel, non-opioid for management of moderate to severe pain. This multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial, included patients who had undergone major elective surgical procedures which were expected to result in hospitalization for at least 24-48 hours. Major surgical procedures included total hip and knee replacements, spinal, GI, hernia repair, and gynecologic surgeries, as well as a range of other surgeries.  Patient demographics were balanced across treatment groups and included 40% male patients and about 23% of patients who were over age 65.  Unlike the pivotal efficacy trials, minimum pain scores were not required for treatment.  Sites were permitted to use opioids and other pain management modes according to their “standard of care” and meloxicam or placebo was added to this regimen.  Patients were randomized in a 3:1 ratio to receive either IV meloxicam 30mg or IV placebo daily for up to 7 doses.  A total of 721 patients received at least one dose of study medication. The most common (≥3%) adverse events (AEs) observed in the IV meloxicam 30mg treatment group (n=538) are listed in the table below: In patients age 65 and over, the percentage of patients reporting at least one AE was approximately 7% less in the IV meloxicam 30mg treatment arm compared to the placebo arm.  The total occurrence of patients with at least one serious adverse event (SAE) was observed to be lower in the IV meloxicam 30mg group, 2.6%, (14/538 meloxicam patients) than in the placebo group, 5.5%, (10/183 placebo patients).  In this safety study only two SAE events were listed as possibly related to study treatment.  Both of these SAEs occurred in one placebo treated patient. No deaths were reported in either treatment group.  Approximately 3% of patients in each study group discontinued. There were no meaningful differences between treatment groups in vital signs, ECGs, clinical lab assessments and surgeon satisfaction with wound healing.   Overall there was low incidence of clinically significant wound healing abnormalities, as scored by the primary investigator, in both treatment groups (~2%).  The meloxicam group had 4 patients with more than one attribute scored “clinically significant”, while other patients were scored “clinically significant” for only one attribute. In addition, overall opioid use was lower, and “time to first use” of opioids was significantly longer, in the IV meloxicam 30mg treatment arm, compared to placebo. “The positive data reported today from this Phase III safety trial demonstrate that the safety profile for IV meloxicam 30mg is in line with prior studies and similar to placebo in acute postoperative pain in patients following a wide range of major soft and hard tissue surgeries,” said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer for Recro Pharma.  “These data are also important because they continue to support the thesis that, if approved, IV meloxicam 30mg has the potential to be a novel, non-opioid alternative for management of patients with moderate to severe pain, such as pain following major surgery.” Gerri Henwood, President and Chief Executive Officer of Recro Pharma, commented, “We believe that these safety study results, together with the positive results from our two Phase III efficacy studies, as well as our positive Phase II trials and other safety studies complete the full development program for our planned NDA submission for IV meloxicam 30mg as a novel non-opioid product for management of moderate to severe pain.  We believe we remain on track to file the NDA with the U.S. Food and Drug Administration during early Q3 2017.” Meloxicam is a long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory, and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase (COX) and subsequent reduction in prostaglandin biosynthesis. IV meloxicam was designed using a NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. Recro is a specialty pharmaceutical company that operates through two business divisions, an Acute Care, hospital product division and a revenue-generating contract development and manufacturing, or CDMO division, located at the Company’s Gainesville facility. The Acute Care division is primarily focused on developing innovative products for hospital and other acute care settings. The Company’s lead product candidate is a proprietary injectable form of meloxicam, a long-acting preferential COX-2 inhibitor.  IV meloxicam has successfully completed four Phase II clinical trials in the management of moderate to severe post-operative pain and two pivotal Phase III clinical efficacy trials in patients following bunionectomy and abdominoplasty surgeries, as well as a large double blind Phase III safety trial and other safety studies.  As injectable meloxicam is in the non-opioid class of drugs, the Company believes it will overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well having no addictive potential while maintaining meaningful analgesic effects for relief of pain. The Company’s CDMO division leverages its formulation expertise to develop and manufacture pharmaceutical products using its proprietary delivery technologies and other manufacturing services for commercial partners who commercialize or plan to commercialize these products. These collaborations can result in revenue streams including royalties, profit sharing, research and development and manufacturing fees, which support continued operations for its CDMO division and it contributes non-dilutive funding for the development and pre-commercialization activities of its Acute Care division. This press release contains forward-looking statements that involve risks and uncertainties. Such forward looking statements reflect Recro's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "upcoming," "plan," "target", "intend" and "expect" and similar expressions, as they relate to Recro or its management, are intended to identify such forward-looking statements. These forward looking statements are based on information available to Recro as of the date of this press release and are subject to a number of risks, uncertainties, and other factors that could cause Recro’s performance to differ materially from those expressed in, or implied by, these forward looking statements. Recro assumes no obligation to update any such forward-looking statements. Factors that could cause Recro’s actual performance to materially differ from those expressed in the forward-looking statements set forth in this press release include, without limitation: results and timing of the clinical trials of injectable meloxicam, the preparation and filing of other portions of the drug application, including CMC, the ability to obtain and maintain regulatory approval of injectable meloxicam and, and the labeling under any such approval, regulatory developments in the United States and foreign countries; the Company’s ability to achieve its financial goals, including financial guidance: the Company’s ability to raise future financing for continued development and the payment of milestones; the Company’s ability to pay its debt; customer product performance and ordering patterns, the performance of third-party suppliers and manufacturers; the Company’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection; and the successful commercialization of injectable meloxicam. In addition, the forward looking statements in this press release should be considered together with the risks and uncertainties that may affect Recro’s business and future results included in Recro’s filings with the Securities and Exchange Commission at www.sec.gov. Recro assumes no obligation to update any such forward looking statements.


News Article | May 12, 2017
Site: globenewswire.com

Expands ADAPTIR Portfolio and Announces New Bispecific Candidate; Presents Data at the 2016 PEPTALK Conference Showcasing Advantages of the ADAPTIR™ Platform SEATTLE, May 12, 2017 (GLOBE NEWSWIRE) -- Aptevo Therapeutics Inc. (Nasdaq:APVO), a biotechnology company focused on developing novel oncology and hematology therapeutics, today provided a business review and reported its financial results for the first quarter ended March 31, 2017. “Aptevo made important strides in early 2017 in both our development and commercial portfolios,” said Marvin L. White, President and Chief Executive Officer.  “Most notably, we expanded our ADAPTIR™ portfolio with the advancement of a new immuno-oncology bispecific antibody candidate, APVO436, engineered to simultaneously target the cell surface receptors CD123 and CD3 to promote redirected T-cell cytotoxicity (RTCC).  New preclinical data highlight the antibody-like half-life, stability and potent activity of this molecule.  The team has made exceptional progress advancing APVO436 and other ADAPTIR candidates and we are on track to provide additional information around our investigational new drug (IND) strategy for these candidates later this year.” “Also during the first quarter, we were pleased to announce that Aptevo had resumed commercial production of IXINITY,” continued Mr. White.  “As a result, we did not experience a supply interruption of IXINITY as originally anticipated.  Our proactive and transparent communications with the Hemophilia B community, and the tremendous support of people taking IXINITY enabled us to retain over 90% of patients.  I continue to be grateful to our IXINITY family for their patience and encouragement during the last few months. With new IXINITY supply anticipated to be available soon, we have aggressively resumed our new patient acquisition efforts and look forward to returning IXINITY to its growth trajectory.” Cash Position:  Aptevo had cash, cash equivalents, and marketable securities as of March 31, 2017 totaling $61.3 million. Product Sales Revenue:  Total product sales revenue was $7.4 million for the first three months ended March 31, 2017, compared to $7.9 million for the same period in 2016.  The decrease in product sales revenue was primarily related to revenue associated with WinRho, which decreased by $0.9 million in the first quarter of 2017. Cost of Product Sales:  Cost of product sales decreased by $3.0 million, or 86%, to $0.5 million for the three months ended March 31, 2017 from $3.5 million for the three months ended March 31, 2016. This decrease was due to a one-time, non-cash adjustment in the first quarter of 2017 in the amount of $3.0 million relating to a settlement agreement executed between Aptevo and CMC ICOS Biologics, Inc., in relation to certain batches of IXINITY produced in 2015 that did not meet manufacturing specifications. The settlement is reflected as a reduction in Aptevo’s cost of product sales in the first quarter of 2017. Research and Development Expenses:  Research and development expenses decreased by $2.2 million, or 27%, to $5.9 million for the three months ended March 31, 2017, from $8.1 million for the corresponding period in 2016.  The decrease was primarily due to a decrease in manufacturing process development costs related to IXINITY and the timing of certain ADAPTIR clinical trial activities.  Our principal research and development expenses for the three months ended March 31, 2017 are summarized in the table below. Selling, General and Administrative Expenses:  Selling, general and administrative expenses for the three months ended March 31, 2017 were $10.6 million, compared to $9.4 million for the same period in 2016.  The increase in SG&A expenses in the first quarter of 2017 was primarily due to increased marketing expenses, personnel costs due to the spin-off, and consulting expenses. Net Loss:  Aptevo’s net loss for the three months ended March 31, 2017 was $9.9 million or ($0.48) per share, compared to $12.9 million or ($0.64) per share for the corresponding period in 2016. Credit Agreement Amendment:  Aptevo and MidCap Financial Trust agreed to amend a credit agreement initially executed in August 2016.  The amendment (1) modifies the minimum net commercial product revenue requirements which Aptevo is required to achieve on a rolling twelve-month basis; (2) extends the time period through which the Company can draw the second tranche from August 2017 to March 2018; (3) increases the exit fee from 5.75% for repayment or prepayment to 6.75% and; (4) permits MidCap to obtain an affirmative lien on Aptevo’s intellectual property, upon the earlier of (i) the Company’s draw down of the second tranche or (ii) the Company’s cash balance descending below a minimum cash threshold of $25 million. Aptevo Therapeutics Inc. is a biotechnology company focused on novel oncology and hematology therapeutics to meaningfully improve patients’ lives. Aptevo’s core technology is the ADAPTIR™ (modular protein technology) platform. Aptevo has four commercial products in the areas of hematology and infectious diseases, as well as various investigational stage product candidates in immuno-oncology. This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including, without limitation, statements regarding Aptevo’s outlook, financial performance or financial condition, our technology and related pipeline, collaboration and partnership opportunities, commercial portfolio, Aptevo’s future growth rates, Aptevo’s ability to timely manufacture its products, and any other statements containing the words “believes,” “expects,” “anticipates,” “intends,” “plans,” “forecasts,” “estimates,” “will” and similar expressions are forward-looking statements. These forward-looking statements are based on Aptevo’s current intentions, beliefs and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo’s expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not undertake to update any forward-looking statement to reflect new information, events or circumstances. There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements, including possible negative effects on our business operations, assets or financial results as a result of the separation; a deterioration in our business or prospects; the ability of our contractors and suppliers to supply product and materials; our ability and the ability of our contractors and suppliers to maintain compliance with cGMP and other regulatory obligations; the results of regulatory inspections; adverse developments in our customer-base or markets and our ability to retain patients; adverse developments in the U.S. or global capital markets, credit markets or economies generally; and changes in regulatory, social and political conditions. Additional risks and factors that may affect results are set forth in our filings with the Securities and Exchange Commission, including Aptevo’s most recent Annual Report on Form 10-K, as filed on March 15, 2017, and our subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement.


News Article | May 12, 2017
Site: globenewswire.com

Expands ADAPTIR Portfolio and Announces New Bispecific Candidate; Presents Data at the 2016 PEPTALK Conference Showcasing Advantages of the ADAPTIR™ Platform SEATTLE, May 12, 2017 (GLOBE NEWSWIRE) -- Aptevo Therapeutics Inc. (Nasdaq:APVO), a biotechnology company focused on developing novel oncology and hematology therapeutics, today provided a business review and reported its financial results for the first quarter ended March 31, 2017. “Aptevo made important strides in early 2017 in both our development and commercial portfolios,” said Marvin L. White, President and Chief Executive Officer.  “Most notably, we expanded our ADAPTIR™ portfolio with the advancement of a new immuno-oncology bispecific antibody candidate, APVO436, engineered to simultaneously target the cell surface receptors CD123 and CD3 to promote redirected T-cell cytotoxicity (RTCC).  New preclinical data highlight the antibody-like half-life, stability and potent activity of this molecule.  The team has made exceptional progress advancing APVO436 and other ADAPTIR candidates and we are on track to provide additional information around our investigational new drug (IND) strategy for these candidates later this year.” “Also during the first quarter, we were pleased to announce that Aptevo had resumed commercial production of IXINITY,” continued Mr. White.  “As a result, we did not experience a supply interruption of IXINITY as originally anticipated.  Our proactive and transparent communications with the Hemophilia B community, and the tremendous support of people taking IXINITY enabled us to retain over 90% of patients.  I continue to be grateful to our IXINITY family for their patience and encouragement during the last few months. With new IXINITY supply anticipated to be available soon, we have aggressively resumed our new patient acquisition efforts and look forward to returning IXINITY to its growth trajectory.” Cash Position:  Aptevo had cash, cash equivalents, and marketable securities as of March 31, 2017 totaling $61.3 million. Product Sales Revenue:  Total product sales revenue was $7.4 million for the first three months ended March 31, 2017, compared to $7.9 million for the same period in 2016.  The decrease in product sales revenue was primarily related to revenue associated with WinRho, which decreased by $0.9 million in the first quarter of 2017. Cost of Product Sales:  Cost of product sales decreased by $3.0 million, or 86%, to $0.5 million for the three months ended March 31, 2017 from $3.5 million for the three months ended March 31, 2016. This decrease was due to a one-time, non-cash adjustment in the first quarter of 2017 in the amount of $3.0 million relating to a settlement agreement executed between Aptevo and CMC ICOS Biologics, Inc., in relation to certain batches of IXINITY produced in 2015 that did not meet manufacturing specifications. The settlement is reflected as a reduction in Aptevo’s cost of product sales in the first quarter of 2017. Research and Development Expenses:  Research and development expenses decreased by $2.2 million, or 27%, to $5.9 million for the three months ended March 31, 2017, from $8.1 million for the corresponding period in 2016.  The decrease was primarily due to a decrease in manufacturing process development costs related to IXINITY and the timing of certain ADAPTIR clinical trial activities.  Our principal research and development expenses for the three months ended March 31, 2017 are summarized in the table below. Selling, General and Administrative Expenses:  Selling, general and administrative expenses for the three months ended March 31, 2017 were $10.6 million, compared to $9.4 million for the same period in 2016.  The increase in SG&A expenses in the first quarter of 2017 was primarily due to increased marketing expenses, personnel costs due to the spin-off, and consulting expenses. Net Loss:  Aptevo’s net loss for the three months ended March 31, 2017 was $9.9 million or ($0.48) per share, compared to $12.9 million or ($0.64) per share for the corresponding period in 2016. Credit Agreement Amendment:  Aptevo and MidCap Financial Trust agreed to amend a credit agreement initially executed in August 2016.  The amendment (1) modifies the minimum net commercial product revenue requirements which Aptevo is required to achieve on a rolling twelve-month basis; (2) extends the time period through which the Company can draw the second tranche from August 2017 to March 2018; (3) increases the exit fee from 5.75% for repayment or prepayment to 6.75% and; (4) permits MidCap to obtain an affirmative lien on Aptevo’s intellectual property, upon the earlier of (i) the Company’s draw down of the second tranche or (ii) the Company’s cash balance descending below a minimum cash threshold of $25 million. Aptevo Therapeutics Inc. is a biotechnology company focused on novel oncology and hematology therapeutics to meaningfully improve patients’ lives. Aptevo’s core technology is the ADAPTIR™ (modular protein technology) platform. Aptevo has four commercial products in the areas of hematology and infectious diseases, as well as various investigational stage product candidates in immuno-oncology. This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including, without limitation, statements regarding Aptevo’s outlook, financial performance or financial condition, our technology and related pipeline, collaboration and partnership opportunities, commercial portfolio, Aptevo’s future growth rates, Aptevo’s ability to timely manufacture its products, and any other statements containing the words “believes,” “expects,” “anticipates,” “intends,” “plans,” “forecasts,” “estimates,” “will” and similar expressions are forward-looking statements. These forward-looking statements are based on Aptevo’s current intentions, beliefs and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo’s expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not undertake to update any forward-looking statement to reflect new information, events or circumstances. There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements, including possible negative effects on our business operations, assets or financial results as a result of the separation; a deterioration in our business or prospects; the ability of our contractors and suppliers to supply product and materials; our ability and the ability of our contractors and suppliers to maintain compliance with cGMP and other regulatory obligations; the results of regulatory inspections; adverse developments in our customer-base or markets and our ability to retain patients; adverse developments in the U.S. or global capital markets, credit markets or economies generally; and changes in regulatory, social and political conditions. Additional risks and factors that may affect results are set forth in our filings with the Securities and Exchange Commission, including Aptevo’s most recent Annual Report on Form 10-K, as filed on March 15, 2017, and our subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement.


JERSEY CITY, N.J., May 08, 2017 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company delivering innovative anti-infective therapies for difficult-to-treat and often life-threatening infections, today reported financial results for the quarter ended March 31, 2017, and provided an update on recent operational and clinical developments. Clinical Development Program with Oral Formulation of SCY-078 On Track "In the first quarter of 2017, we continued to advance the development program for the oral formulation of SCY-078, our lead development program and the first representative of a novel triterpenoid antifungal family," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “Although the recent regulatory action is causing some delay in the development of our intravenous formulation, we are progressing our oral development program as planned while we address the clinical hold on the IV formulation. We remain committed to advancing SCY-078 as a treatment for increasingly urgent global health threats. As recently presented at ECCMID, there is a growing body of SCY-078 clinical and nonclinical research highlighting the potential versatility of this compound against multiple invasive, drug-resistant and difficult-to-treat fungal infections, including Candida auris.” First Quarter 2017 Financial Results Cash and cash equivalents and short-term investments totaled $54.9 million as of March 31, 2017, with net working capital of $52.2 million. Research and development, net expenses decreased to $4.0 million in the first quarter of 2017, compared to $4.7 million in the first quarter of 2016. The decrease of $0.7 million, or 15%, for the three months ended March 31, 2017 was primarily driven by a decrease of $0.6 million in clinical development expenses and a decrease of $0.7 million in chemistry, manufacturing and controls (CMC) expenses, offset in part by a $0.3 million increase in preclinical development and a $0.3 million increase in professional services. Selling, general and administrative expenses decreased to $2.1 million in the first quarter of 2017, compared to $2.5 million in the first quarter of 2016. The decrease of $0.5 million, or 19%, was primarily the result of a decrease of $0.6 million in consulting and professional services. Total other income increased to $1.1 million in the first quarter of 2017 due to a $1.5 million non-cash gain recorded on the adjustment in the fair value of the warrant liability, offset in part by a $0.3 million increase in interest expense. Net loss for the first quarter of 2017 was $4.9 million, or $0.19 per share.  This compares to a net loss for the first quarter of 2016 of $7.2 million, or $0.52 per share. About SCYNEXIS, Inc. SCYNEXIS, Inc. is a biotechnology company committed to positively impacting the lives of patients suffering from difficult-to-treat and often life-threatening infections by delivering innovative anti-infective therapies. The SCYNEXIS team has extensive experience in the life sciences industry, discovering and developing more than 30 innovative medicines over a broad range of therapeutic areas. The Company's lead product candidate, SCY-078, is the first representative of a novel intravenous and oral triterpenoid antifungal family and is in Phase 2 clinical development for the treatment of several fungal infections, including serious and life-threatening invasive fungal infections.  For more information, visit www.scynexis.com. Forward Looking Statement Statements contained in this press release maybe, "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited, to: risks inherent in SCYNEXIS' ability to successfully develop SCY-078, including SCYNEXIS' ability to resolve the FDA's concerns to lift the clinical hold on the IV formulation of SCY-078 on a timely basis, if at all, and obtain FDA approval for SCY-078; the expected costs of studies and when they might begin or be concluded; and SCYNEXIS' reliance on third parties to conduct SCYNEXIS' clinical studies. These and other risks are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K under the caption "Risk Factors" and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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