Event: Kindred Biosciences to Present Zimeta Pivotal Data at the 62nd Annual American Association of Equine Practitioners Convention

Tuesday, December 6, 2016 

Time of Event: 8:25 a.m. Eastern Time

Location: Orlando, FL

Slides:  Click here to view the sides from the presentation 

For more information about this event, please see the press release or the official page for the American Association of Equine Practitioners annual convention

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Kindred Biosciences to Present Zimeta Pivotal Data at the 62nd Annual American Association of Equine Practitioners Convention

San Francisco, CA (November 29, 2016) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced that Emily Sundman, DVM, Clinical Development Scientist for KindredBio, will present pivotal effectiveness data for Zimeta™ (dipyrone injection) at the American Association of Equine Practitioners (AAEP) Convention in Orlando, FL on Tuesday, December 6, 2016 at 8:25 AM ET as part of the Internal Medicine track. The presentation will be available at http://kindredbio.com/investor-relations/events/ following the AAEP presentation.

Zimeta is a pyrazolone anti-inflammatory drug with a unique mechanism of action that is under development for the control of pyrexia (fever) in horses. The application for Zimeta is currently under review at the FDA Center for Veterinary Medicine (CVM).  Approval and launch of the drug is expected in 2017.

 

About Kindred Biosciences

Kindred Biosciences is a development-stage biopharmaceutical company focused on saving and improving the lives of pets.  Its mission is to bring to pets the same kinds of safe and effective medicines that human family members enjoy.  The Company’s strategy is to identify compounds and targets that have already demonstrated safety and efficacy in humans and to develop therapeutics based on these validated compounds and targets for dogs, cats and horses.  The Company has a deep pipeline of novel drugs and biologics in development across many therapeutic classes.

For more information or to download the corporate presentation, visit www.KindredBio.com/LearnMore. Stay connected with KindredBio on Facebook at www.Facebook.com/KindredBio.

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our expectations about the trials, regulatory approval, manufacturing, distribution and commercialization of our current and future product candidates, and statements regarding our anticipated revenues, expenses, margins, profits and use of cash.

These forward-looking statements are based on our current expectations. These statements are not promises or guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results to be materially different from any future results expressed or implied by the forward-looking statements.  These risks include, but are not limited to, the following:  our limited operating history and expectations of losses for the foreseeable future; the absence of revenue from our product candidates for the foreseeable future; our potential inability to obtain any necessary additional financing; our substantial dependence on the success of our lead product candidates, which may not be successfully commercialized even if they are approved for marketing; the effect of competition; our potential inability to obtain regulatory approval for our existing or future product candidates; our dependence on third parties to conduct some of our development activities; our dependence upon third-party manufacturers for supplies of our product candidates; uncertainties regarding the outcomes of trials regarding our product candidates; our potential failure to attract and retain senior management and key scientific personnel; uncertainty about our ability to develop a satisfactory sales organization; our significant costs of operating as a public company; our potential inability to obtain patent protection and other intellectual property protection for our product candidates; potential claims by third parties alleging our infringement of their patents and other intellectual property rights; our potential failure to comply with regulatory requirements, which are subject to change on an ongoing basis; the potential volatility of our stock price; and the significant control over our business by our principal stockholders and management.

For a further description of these risks and other risks that we face, please see the risk factors described in our filings with the U.S. Securities and Exchange Commission (the SEC), including the risk factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K and any subsequent updates that may be contained in our Quarterly Reports on Form 10-Q filed with the SEC.  As a result of the risks described above and in our filings with the SEC, actual results may differ materially from those indicated by the forward-looking statements made in this press release.   Forward-looking statements contained in this press release speak only as of the date of this press release and we undertake no obligation to update or revise these statements, except as may be required by law.

Contact
Russell Radefeld
KindredBio
russell.radefeld@kindredbio.com
(650) 701-7904

Kindred Biosciences Receives Approval of Effectiveness Technical Section from FDA for Zimeta New Animal Drug Application

San Francisco, CA (October 4, 2016) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced it has received a technical section complete letter for effectiveness from the U.S. Food and Drug Administration’s Center for Veterinary Medicine for Zimeta™ (dipyrone injection) approving the technical section.

The basis for this complete letter was a multicenter, randomized, blinded, placebo-controlled pivotal study that enrolled 138 horses to assess the effectiveness of Zimeta. The primary endpoint was improvement (a 2°F or greater decrease in temperature from baseline) or resolution of fever (a return to normothermia (≤101.0°F)) at hour 6 following treatment. One hundred and thirty-seven horses (103 Zimeta and 34 control product) were included in the statistical analysis for effectiveness. At 6 hours post-treatment, the success rate was 74.8% (77/103) of Zimeta-treated horses and 20.6% (7/34) of control horses. The results of the field study demonstrate that Zimeta administered at 30 mg/kg intravenously was effective for the control of pyrexia 6 hours following treatment administration.

Richard Chin, CEO of KindredBio, stated, “This is a major milestone for KindredBio, and it is a testament to the strength of the data that it was reviewed by the FDA so rapidly. The entire clinical program, from initiation of enrollment in the pivotal field study to the receipt of the complete letter, was only 18 months, highlighting the quality of our team and investigators. We look forward to the launch of the first FDA-approved drug for fever in horses, a condition that affects millions of horses every year.”

KindredBio has responded to the first round of review by the FDA for the CMC technical section. KindredBio is in the process of responding to the first round of review by the FDA on the safety technical section. KindredBio expects the approval of Zimeta in the first half of 2017 if the FDA review process is rapid.

About Kindred Biosciences

Kindred Biosciences is a development-stage biopharmaceutical company focused on saving and improving the lives of pets.  Its mission is to bring to pets the same kinds of safe and effective medicines that human family members enjoy.  The Company’s strategy is to identify compounds and targets that have already demonstrated safety and efficacy in humans and to develop therapeutics based on these validated compounds and targets for dogs, cats and horses.  The Company has a deep pipeline of novel drugs and biologics in development across many therapeutic classes.

For more information or to download the corporate presentation, visit www.KindredBio.com/LearnMore. Stay connected with KindredBio on Facebook at www.Facebook.com/KindredBio.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our expectations about the trials, regulatory approval, manufacturing, distribution and commercialization of our current and future product candidates, and statements regarding our anticipated revenues, expenses, margins, profits and use of cash.

These forward-looking statements are based on our current expectations. These statements are not promises or guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results to be materially different from any future results expressed or implied by the forward-looking statements.  These risks include, but are not limited to, the following:  our limited operating history and expectations of losses for the foreseeable future; the absence of revenue from our product candidates for the foreseeable future; our potential inability to obtain any necessary additional financing; our substantial dependence on the success of our lead product candidates, which may not be successfully commercialized even if they are approved for marketing; the effect of competition; our potential inability to obtain regulatory approval for our existing or future product candidates; our dependence on third parties to conduct some of our development activities; our dependence upon third-party manufacturers for supplies of our product candidates; uncertainties regarding the outcomes of trials regarding our product candidates; our potential failure to attract and retain senior management and key scientific personnel; uncertainty about our ability to develop a satisfactory sales organization; our significant costs of operating as a public company; our potential inability to obtain patent protection and other intellectual property protection for our product candidates; potential claims by third parties alleging our infringement of their patents and other intellectual property rights; our potential failure to comply with regulatory requirements, which are subject to change on an ongoing basis; the potential volatility of our stock price; and the significant control over our business by our principal stockholders and management.

For a further description of these risks and other risks that we face, please see the risk factors described in our filings with the U.S. Securities and Exchange Commission (the SEC), including the risk factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K and any subsequent updates that may be contained in our Quarterly Reports on Form 10-Q filed with the SEC.  As a result of the risks described above and in our filings with the SEC, actual results may differ materially from those indicated by the forward-looking statements made in this press release.   Forward-looking statements contained in this press release speak only as of the date of this press release and we undertake no obligation to update or revise these statements, except as may be required by law.

Contact
Russell Radefeld
KindredBio
russell.radefeld@kindredbio.com
(650) 701-7904

Kindred Biosciences Submits Final Major New Animal Drug Application Technical Section for Safety for Mirataz to FDA and Launches KindredBio Equine Website

San Francisco, CA (September 30, 2016) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced the submission to FDA of the Safety technical section of the New Animal Drug Application (NADA) for Mirataz™ (mirtazapine 2% transdermal ointment, KIND-010).  This is the final major technical section to be submitted for Mirataz. The Chemistry, Manufacturing, and Controls technical section was submitted in May 2016 and the Effectiveness technical section was submitted in August 2016.

In the target animal safety study, Mirataz was generally well-tolerated and no significant safety concerns were identified at 1X, 3X, or 5X the proposed label dose (2 mg/cat applied once daily to the inner pinna of the ear) for 42 consecutive days of transdermal application. At the proposed label dose, topical administration of mirtazapine ointment was associated with mild, reversible skin changes at the site of dose application (ear).

Richard Chin, CEO of KindredBio, stated, “We are pleased to bring Mirataz one step closer to approval. Weight loss in cats is a serious and potentially fatal problem, and there is currently no drug approved for the treatment of this unmet medical need. We believe that, with its excellent efficacy and safety profile, Mirataz will be an important new drug for feline patients. Like our other programs, the Mirataz program was completed ahead of time and on budget. I want to congratulate the KindredBio team and our investigators for their dedication and hard work.”

KindredBio also announced the launch of the KindredBio Equine website (www.kindredbioequine.com).  This website may also be accessed via KindredBio’s homepage (www.kindredbio.com).

About Kindred Biosciences

Kindred Biosciences is a development-stage biopharmaceutical company focused on saving and improving the lives of pets.  Its mission is to bring to pets the same kinds of safe and effective medicines that human family members enjoy.  The Company’s strategy is to identify compounds and targets that have already demonstrated safety and efficacy in humans and to develop therapeutics based on these validated compounds and targets for dogs, cats and horses.  The Company has a deep pipeline of novel drugs and biologics in development across many therapeutic classes.

For more information or to download the corporate presentation, visit www.KindredBio.com/LearnMore. Stay connected with KindredBio on Facebook at www.Facebook.com/KindredBio.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our expectations about the trials, regulatory approval, manufacturing, distribution and commercialization of our current and future product candidates, and statements regarding our anticipated revenues, expenses, margins, profits and use of cash.

These forward-looking statements are based on our current expectations. These statements are not promises or guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results to be materially different from any future results expressed or implied by the forward-looking statements.  These risks include, but are not limited to, the following:  our limited operating history and expectations of losses for the foreseeable future; the absence of revenue from our product candidates for the foreseeable future; our potential inability to obtain any necessary additional financing; our substantial dependence on the success of our lead product candidates, which may not be successfully commercialized even if they are approved for marketing; the effect of competition; our potential inability to obtain regulatory approval for our existing or future product candidates; our dependence on third parties to conduct some of our development activities; our dependence upon third-party manufacturers for supplies of our product candidates; uncertainties regarding the outcomes of trials regarding our product candidates; our potential failure to attract and retain senior management and key scientific personnel; uncertainty about our ability to develop a satisfactory sales organization; our significant costs of operating as a public company; our potential inability to obtain patent protection and other intellectual property protection for our product candidates; potential claims by third parties alleging our infringement of their patents and other intellectual property rights; our potential failure to comply with regulatory requirements, which are subject to change on an ongoing basis; the potential volatility of our stock price; and the significant control over our business by our principal stockholders and management.

For a further description of these risks and other risks that we face, please see the risk factors described in our filings with the U.S. Securities and Exchange Commission (the SEC), including the risk factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K and any subsequent updates that may be contained in our Quarterly Reports on Form 10-Q filed with the SEC.  As a result of the risks described above and in our filings with the SEC, actual results may differ materially from those indicated by the forward-looking statements made in this press release.   Forward-looking statements contained in this press release speak only as of the date of this press release and we undertake no obligation to update or revise these statements, except as may be required by law.

Contact
Russell Radefeld
KindredBio
russell.radefeld@kindredbio.com
(650) 701-7904

KindredBio supports New Horizon Ranch – both working to strengthen the bond between horses and humans

KindredBio is a veterinary biopharmaceutical company based in Burlingame, CA that is focused on a strong development pipeline serving the horse with the motto “best medicines for our best friends.” KindredBio’s co-founder and many employees are horse people and advocates for the bond between horses and people with an understanding of how these animals change people’s lives. The value of the horse goes way beyond high end athletes such as our Olympic horses or Kentucky Derby winners.  Even retired or back yard horses touch human lives in unimaginable ways.

New Horizon ranch is a therapeutic riding center located in Rantoul, KS.  When you think “therapeutic riding,” most people imagine physically disabled children riding a horse.  That is partly true, but there is so much more to the purpose of the horses at New Horizon Ranch.  New Horizon Ranch serves children, teens, adults and seniors in need through various programs such as Giddy up and Read, Silver Spurs, Hippotherapy, Mending Fences, and summer day camps.  New Horizon also partners with local facilities and programs to support the underprivileged and elderly communities through equine assisted activities.

Dr. Valentine Williams, the Director of Veterinary Affairs at KindredBio, explains how she, KindredBio, and New Horizon all share their feverish desire to serve the horse and the people alongside them. “I sit on the board at New Horizon Ranch and, as they celebrate 10 years in the making, I have watched them profoundly influence the lives of so many people through the horse. Not only the riders and receivers of the service, but the families and the horses themselves.  The riding center’s horses, many of which are no longer able to serve in their traditional use, become these kid’s best friends and often the high point of their week.  Parents who would never be able to afford equine assisted activities are able to watch their kids grow and be transformed by the relationship with these horses through the amazing people that volunteer and support this community.  There are endless numbers of volunteer hours and financial supporters that make this happen for this community.  It all starts here.  The ways in which we can get involved in our communities changing lives is how we impact the world in our own way.  KindredBio’s founders and employees support communities changing lives through horses such as New Horizon Ranch.  It is the people within the company that allow this to happen at this level. We can all partner to promote wellness and health in horses that transcends animals to wellness and health (mental and physical) in people.”

Please visit the websites for both KindredBio and New Horizon Ranch to see how they are developing, serving, and building on the bond between horse and human.

http://KindredBio.com/

http://newhorizonranch.org/

World’s Top Show Jumper, McLain Ward, wins the $15,000 KindredBio Jumper Prix

Saugerties, NY (June 12, 2016) The HITS-on-the-Hudson III at the Grand Prix Stadium saw some excellent competition on Saturday and we were excited to see the action around the $15,000 KindredBio 1.40M Jumper Prix.

McLain Ward, a two-time Olympic gold medalist and currently ranked the #1 show jumper in the world, aboard Best Buy, a nine-year-old Holsteiner mare owned by Double H Farm, topped the competition. The team was clean in the first round along with 8 other horse and rider combinations.  Ward and Best Buy had a fast and clean jump-off round, navigating the tough track in a fast 31.774 seconds.

“It’s great to have their support in our sport,” said Ward of KindredBio’s sponsorship in the equine industry. “A lot of care goes into these horses, and companies that provide a veterinary service to keep these animals competing and healthy are important.”

Denise Bevers, Co-Founder and Chief Operating Officer, said, “Congratulations to McLain Ward and Best Buy for winning the KindredBio Jumper Prix at HITS Saugerties!  I had the pleasure of watching McLain and Rothchild win the AIG $1 Million Grand Prix at HITS Thermal this year and find it very exciting to watch McLain develop horses like Best Buy in a class such as the 1.40M that KindredBio is sponsoring.”

Read more about McLain’s win and the event details at the HITS website.

 

Place Horse Owner Rider Prize Rd. 1 Faults JO Faults JO Time
1 Best Buy Double H Farm McLain Ward $4,350 0 0 31.774
2 Welfare Shalanno Farms LLC Fernando Lozinsky $3,150 0 0 32.579
3 Out Of Ireland The Edge Laura Chapot $2,100 0 0 33.134
4 Cecotto’s As Jennifer Rowland Kevin Mealiff $1,400 0 0 35.063
5 Caspar’s Lasino Market Street, Inc. Anne Kursinski $1,100 0 4 34.694
6 Doutzen Morgan Ward Morgan Ward $800 0 4 37.240
7 KM Whatever RV Beyaert Farm Inc. Mattias Tromp $650 0 8 33.314
8 Candori Rebecca Lewis Max Nieberg $550 0 8 47.701
9 Pretzel Logic Megan McDermott Kevin McCarthy $450 4
10 Shooting Star Mary Chapot Laura Chapot $450 4

 

The winner from Week II was Jeffery Welles and Calais and Week I was Laura Chapot and Out of Ireland.  Chapot won the $10,000 Brook Ledge Open Welcome, $25,000 SmartPak Grand Prix and then captured first, second and fifth place in the $15,000 KindredBio Open Jumper Prix.

“I’d like to thank Kindred Bio for sponsoring this class,” said Chapot. “It’s great to have them here at HITS and let’s hope we have them around for long time in the future.”

KindredBio is looking forward to 5 more weeks of the HITS on the Hudson Series that will start back up July 20th finishing on September 11th with the Saugerties $1 Million Dollar Grand Prix- FEI CSI-5* the final event in the HITS Triple Crown of Show Jumping.  As a proud platinum sponsor of the HITS Horse Shows Series sponsoring the KindredBio Open Jumper Prix, we congratulate all the horses and riders!

 

About Kindred Biosciences

Kindred Biosciences is a development-stage biopharmaceutical company focused on saving and improving the lives of pets.  Its mission is to bring to pets the same kinds of safe and effective medicines that human family members enjoy.  The Company’s strategy is to identify compounds and targets that have already demonstrated safety and efficacy in humans and to develop therapeutics based on these validated compounds and targets for dogs, cats, and horses.  The Company has a deep pipeline of novel drugs and biologics in development across many therapeutic classes.

For more information or to download the corporate presentation, visit www.KindredBio.com. Stay connected with KindredBio on Facebook at www.Facebook.com/KindredBio.

 

About HITS, Inc.

HITS, Inc. is a special events management company primarily focused on producing hunter/jumper horse shows. Based in upstate New York in the village of Saugerties, HITS produced its first horse show circuit in Gainesville, Florida in 1982. Since then, HITS has grown into a nationwide company with world-class hunter/jumper circuits in California, Florida, Arizona, New York and Virginia.

HITS produces three of the richest grand prix in the world with the AIG $1 Million Grand Prix in Thermal, California, Great American $1 Million Grand Prix in Ocala, Florida and Saugerties $1 Million Grand Prix FEI CSI-5* in Saugerties, New York – all forming the HITS Triple Crown of Show Jumping. The HITS Championship, held each September at HITS-on-the-Hudson, hosts the HITS $250,000 Junior/Amateur-Owner Jumper Prix, the Stal Hendrix Pre-Green Futurity, and the crown jewels of the hunter discipline: the Diamond Mills $500,000 Hunter Prix Final and the Platinum Performance $250,000 Hunter Prix Final.

For more information and a complete schedule of classes and events, visit www.HitsShows.com. Stay connected with HITS! Join us on Facebook and follow us on Twitter and Instagram. Media should contact the HITS Media Team at 845.246.8833 or e-mail media_info@HitsShows.com.

Kindred Biosciences Announces HITS Sponsorship

San Francisco, CA (May 25, 2016) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, is pleased to announce their Platinum Sponsorship of the HITS Horse Show series.  The sponsorship will start this week at the Saugerties, New York facility for the HITS-on-the-Hudson series and will extend through both the HITS Ocala Winter Circuit in Ocala, Florida, and the HITS Desert Circuit in Thermal, California.

Denise Bevers, Co-Founder and Chief Operating Officer, said, “As a company dedicated to developing innovative medications for our horse companions, we are very pleased to be partnering with HITS to sponsor the KindredBio Open Jumper Prix.  With members of the show jumping community on our very own KindredBio team, we look forward to supporting the veterinarians, trainers, and horse owners behind such talented horse and rider athletes.”

“We are honored that KindredBio selected HITS Horse Shows as its first sponsorship in the industry,” said HITS President and CEO Tom Struzzieri. “My team is looking forward to watching this new innovative company grow into something special right before our eyes.”

About Kindred Biosciences

Kindred Biosciences is a development-stage biopharmaceutical company focused on saving and improving the lives of pets.  Its mission is to bring to pets the same kinds of safe and effective medicines that human family members enjoy.  The Company’s strategy is to identify compounds and targets that have already demonstrated safety and efficacy in humans and to develop therapeutics based on these validated compounds and targets for dogs, cats, and horses.  The Company has a deep pipeline of novel drugs and biologics in development across many therapeutic classes.

For more information or to download the corporate presentation, visit www.KindredBio.com. Stay connected with KindredBio on Facebook at www.Facebook.com/KindredBio.

About HITS, Inc.

HITS, Inc. is a special events management company primarily focused on producing hunter/jumper horse shows. Based in upstate New York in the village of Saugerties, HITS produced its first horse show circuit in Gainesville, Florida in 1982. Since then, HITS has grown into a nationwide company with world-class hunter/jumper circuits in California, Florida, Arizona, New York and Virginia.

HITS produces three of the richest grand prix in the world with the AIG $1 Million Grand Prix in Thermal, California, Great American $1 Million Grand Prix in Ocala, Florida and Saugerties $1 Million Grand Prix FEI CSI-5* in Saugerties, New York – all forming the HITS Triple Crown of Show Jumping. The HITS Championship, held each September at HITS-on-the-Hudson, hosts the HITS $250,000 Junior/Amateur-Owner Jumper Prix, the Stal Hendrix Pre-Green Futurity, and the crown jewels of the hunter discipline: the Diamond Mills $500,000 Hunter Prix Final and the Platinum Performance $250,000 Hunter Prix Final.

For more information and a complete schedule of classes and events, visit www.HitsShows.com. Stay connected with HITS! Join us on Facebook and follow us on Twitter and Instagram. Media should contact the HITS Media Team at 845.246.8833 or e-mail media_info@HitsShows.com.

Contact

Russell Radefeld
KindredBio
russell.radefeld@kindredbio.com
(650) 701-7904

Kindred Biosciences Submits Final Major New Animal Drug Application Technical Section for Safety for Zimeta to FDA

San Francisco, CA (March 15, 2016) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced the submission to FDA of the Safety technical section of the New Animal Drug Application (NADA) for Zimeta™ (dipyrone injection, KIND-012).  This is the final major technical section to be submitted for Zimeta. The Chemistry, Manufacturing, and Controls technical section was submitted in December 2015 and the Effectiveness technical section was submitted in February 2016.

In the target animal safety study, Zimeta, was well tolerated with no clinically-significant changes when compared to control horses (placebo group). There were no Zimeta‑related macroscopic or microscopic changes identified during evaluation of tissues for pathology (including the GI tract) at the proposed labeled dose of 30 mg/kg.

Richard Chin, CEO of KindredBio, stated, “We are pleased to bring Zimeta one step closer to approval. We believe that with its favorable safety profile in horses, Zimeta will offer an attractive first-in-class therapy for an important unmet medical need. The Zimeta program was completed ahead of time and on budget, further validating our development model. I want to congratulate the KindredBio team and our investigators for their dedication and hard work.”

 

About Kindred Biosciences

Kindred Biosciences is a development-stage biopharmaceutical company focused on saving and improving the lives of pets.  Its mission is to bring to pets the same kinds of safe and effective medicines that human family members enjoy.  The Company’s strategy is to identify compounds and targets that have already demonstrated safety and efficacy in humans and to develop therapeutics based on these validated compounds and targets for dogs, cats and horses.  The Company has a deep pipeline of novel drugs and biologics in development across many therapeutic classes.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our expectations about the trials, regulatory approval, manufacturing, distribution and commercialization of our current and future product candidates, and statements regarding our anticipated revenues, expenses, margins, profits and use of cash.

These forward-looking statements are based on our current expectations. These statements are not promises or guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results to be materially different from any future results expressed or implied by the forward-looking statements.  These risks include, but are not limited to, the following:  our limited operating history and expectations of losses for the foreseeable future; the absence of revenue from our product candidates for the foreseeable future; our potential inability to obtain any necessary additional financing; our substantial dependence on the success of our lead product candidates, which may not be successfully commercialized even if they are approved for marketing; the effect of competition; our potential inability to obtain regulatory approval for our existing or future product candidates; our dependence on third parties to conduct some of our development activities; our dependence upon third-party manufacturers for supplies of our product candidates; uncertainties regarding the outcomes of trials regarding our product candidates; our potential failure to attract and retain senior management and key scientific personnel; uncertainty about our ability to develop a satisfactory sales organization; our significant costs of operating as a public company; our potential inability to obtain patent protection and other intellectual property protection for our product candidates; potential claims by third parties alleging our infringement of their patents and other intellectual property rights; our potential failure to comply with regulatory requirements, which are subject to change on an ongoing basis; the potential volatility of our stock price; and the significant control over our business by our principal stockholders and management.

For a further description of these risks and other risks that we face, please see the risk factors described in our filings with the U.S. Securities and Exchange Commission (the SEC), including the risk factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K and any subsequent updates that may be contained in our Quarterly Reports on Form 10-Q filed with the SEC.  As a result of the risks described above and in our filings with the SEC, actual results may differ materially from those indicated by the forward-looking statements made in this press release.   Forward-looking statements contained in this press release speak only as of the date of this press release and we undertake no obligation to update or revise these statements, except as may be required by law.

Contact

Russell Radefeld
KindredBio
russell.radefeld@kindredbio.com 
(650) 701-7904

 

 

Kindred Biosciences Submits Zimeta (KIND-012) New Animal Drug Application Technical Section for Effectiveness to FDA

San Francisco, CA (February 11, 2016) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced the submission to FDA of the Effectiveness Technical Section of the New Animal Drug Application (NADA) for Zimeta™ (dipyrone injection, KIND-012). Positive topline results from the pivotal field study (KB0120) of Zimeta for the control of pyrexia (fever) in horses were recently reported by the Company.

The Chemistry, Manufacturing, and Controls technical section for Zimeta was submitted in December 2015 and all remaining technical sections of the NADA are planned for submission by the end of the first quarter of 2016.

Richard Chin, CEO of KindredBio, stated, “We are pleased to bring Zimeta one step closer to approval. We believe that with its favorable safety profile in horses, Zimeta will offer an attractive first-in-class therapy for an important unmet medical need.”

Peter R. Morresey, BVSc, MACVSc, Dipl. ACVIM, Dipl. ACT of Rood and Riddle Equine Hospital in Lexington, KY stated, “Dipyrone will be very familiar to seasoned veterinarians. While never approved in the United States, dipyrone enjoyed widespread usage for control of fever and pain before withdrawal from the market in 1995. Since that time, it has continued to be widely used successfully in other countries. If approved, it will be available again in the United States, in an FDA-approved formulation, a new generation of veterinarians and horses can benefit from dipyrone’s proven fever-controlling properties.”

About Kindred Biosciences, Inc.

Kindred Biosciences is a development-stage biopharmaceutical company focused on saving and improving the lives of pets. Its mission is to bring to pets the same kinds of safe and effective medicines that human family members enjoy. The Company’s strategy is to identify compounds and targets that have already demonstrated safety and efficacy in humans and to develop therapeutics based on these validated compounds and targets for dogs, cats, and horses. The Company has a deep pipeline of novel drugs and biologics in development across many therapeutic classes.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our expectations about the trials, regulatory approval, manufacturing, distribution and commercialization of our current and future product candidates, and statements regarding our anticipated revenues, expenses, margins, profits and use of cash.

These forward-looking statements are based on our current expectations. These statements are not promises or guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results to be materially different from any future results expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: our limited operating history and expectations of losses for the foreseeable future; the absence of revenue from our product candidates for the foreseeable future; our potential inability to obtain any necessary additional financing; our substantial dependence on the success of our lead product candidates, which may not be successfully commercialized even if they are approved for marketing; the effect of competition; our potential inability to obtain regulatory approval for our existing or future product candidates; our dependence on third parties to conduct some of our development activities; our dependence upon third-party manufacturers for supplies of our product candidates; uncertainties regarding the outcomes of trials regarding our product candidates; our potential failure to attract and retain senior management and key scientific personnel; uncertainty about our ability to develop a satisfactory sales organization; our significant costs of operating as a public company; our potential inability to obtain patent protection and other intellectual property protection for our product candidates; potential claims by third parties alleging our infringement of their patents and other intellectual property rights; our potential failure to comply with regulatory requirements, which are subject to change on an ongoing basis; the potential volatility of our stock price; and the significant control over our business by our principal stockholders and management.

For a further description of these risks and other risks that we face, please see the risk factors described in our filings with the U.S. Securities and Exchange Commission (the SEC), including the risk factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K and any subsequent updates that may be contained in our Quarterly Reports on Form 10-Q filed with the SEC. As a result of the risks described above and in our filings with the SEC, actual results may differ materially from those indicated by the forward-looking statements made in this press release. Forward-looking statements contained in this press release speak only as of the date of this press release and we undertake no obligation to update or revise these statements, except as may be required by law.

Contact
Russell Radefeld
KindredBio
Russell.radefeld@kindredbio.com
(650) 701-7904

Kindred Biosciences Submits KIND-012 New Animal Drug Application Technical Section for Chemistry, Manufacturing, and Controls to FDA

San Francisco, CA (December 17, 2015) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced the submission to FDA of the Chemistry, Manufacturing, and Controls (CMC) technical section of the New Animal Drug Application (NADA) for KIND-012. Positive topline results from the pivotal field study (KB0120) of KIND-012 for the control of pyrexia (fever) in horses were recently reported by the Company.

All technical sections of the NADA for KIND-012 are planned for submission by the end of the first quarter of 2016.

Richard Chin, M.D., President and CEO of KindredBio, stated, “The submission of the CMC technical section is an important milestone and we are pleased with the continuing progress toward the anticipated approval of KIND-012.”

About Kindred Biosciences

Kindred Biosciences is a development-stage biopharmaceutical company focused on saving and improving the lives of pets. Its mission is to bring to pets the same kinds of safe and effective medicines that human family members enjoy. The Company’s strategy is to identify compounds and targets that have already demonstrated safety and efficacy in humans and to develop therapeutics based on these validated compounds and targets for dogs, cats and horses. The Company has a deep pipeline of novel drugs and biologics in development across many therapeutic classes.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our expectations about the trials, regulatory approval, manufacturing, distribution and commercialization of our current and future product candidates, and statements regarding our anticipated revenues, expenses, margins, profits and use of cash.
These forward-looking statements are based on our current expectations. These statements are not promises or guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results to be materially different from any future results expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: our limited operating history and expectations of losses for the foreseeable future; the absence of revenue from our product candidates for the foreseeable future; our potential inability to obtain any necessary additional financing; our substantial dependence on the success of our lead product candidates, which may not be successfully commercialized even if they are approved for marketing; the effect of competition; our potential inability to obtain regulatory approval for our existing or future product candidates; our dependence on third parties to conduct some of our development activities; our dependence upon third-party manufacturers for supplies of our product candidates; uncertainties regarding the outcomes of trials regarding our product candidates; our potential failure to attract and retain senior management and key scientific personnel; uncertainty about our ability to develop a satisfactory sales organization; our significant costs of operating as a public company; our potential inability to obtain patent protection and other intellectual property protection for our product candidates; potential claims by third parties alleging our infringement of their patents and other intellectual property rights; our potential failure to comply with regulatory requirements, which are subject to change on an ongoing basis; the potential volatility of our stock price; and the significant control over our business by our principal stockholders and management.

For a further description of these risks and other risks that we face, please see the risk factors described in our filings with the U.S. Securities and Exchange Commission (the SEC), including the risk factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K and any subsequent updates that may be contained in our Quarterly Reports on Form 10-Q filed with the SEC. As a result of the risks described above and in our filings with the SEC, actual results may differ materially from those indicated by the forward-looking statements made in this press release. Forward-looking statements contained in this press release speak only as of the date of this press release and we undertake no obligation to update or revise these statements, except as may be required by law.

Contact
Denise Bevers
KindredBio
denise.bevers@kindredbio.com
(650) 701-7904