Kindred Biosciences to Present at 2017 Jefferies Animal Health Summit

San Francisco, CA (March 16, 2017) – Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced that Dr. Richard Chin, Chief Executive Officer, will be presenting at the 2017 Jefferies Animal Health Summit in New York, NY on Thursday, March 30, 2017 at 10:45 AM EDT.

This conference will not be webcast.  Investors and other interested parties may access the corporate presentation following this meeting at http://kindredbio.com/jefferies2017.

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.

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

Kindred Biosciences Announces Global Sponsorship of International Society of Equine Locomotion Pathology

San Francisco, CA (March 7, 2017) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, is proud to announce its partnership with the International Society of Equine Locomotion Pathology (ISELP) by joining their team of Global Sponsors starting in 2017. The partnership with ISELP is part of an initiative by KindredBio to support the education of veterinarians and veterinary students, and to promote the growth and advancement of the equine industry. ISELP is an advanced education program for equine veterinarians to learn the most advanced techniques in diagnostics and treatments for the performance horse.

Kent Allen, DVM, Vice President & Executive Director of ISELP said, “It is a great pleasure to welcome KindredBio to the ISELP family of Global Sponsors. I am thrilled that we have this opportunity. KindredBio fits into our ISELP model because of their leading-edge technology and commitment to excellence in equine healthcare. We look forward to many productive years of collaboration and networking.”

KindredBio looks forward to announcing its global sponsorship of the ISELP Student Education Program starting in 2017, which will be made to ISELP members attending the 3-Day meeting in Irving, Texas, March 7-11, 2017.

“The commitment to supporting continuing education of this caliber for equine veterinarians and students is at the core of our culture at KindredBio. We are honored to be partnered with ISELP, an organization at the apex of equine education,” said Denise Bevers, Co-Founder and Chief Operating Officer of KindredBio.

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.

About ISELP

“Continuing education of equine practitioners for a better management of patients”

Formed in the United States, under the direction of Dr. Jean-Marie Denoix, The International Society of Equine Locomotor Pathology (ISELP) will focus on the problem of lameness in the equine athlete. The goal of ISELP is to provide contemporary knowledge and techniques in the continually evolving field of equine locomotor analysis to better prepare the equine clinician to understand and manage lameness conditions in the equine athlete.  Founded in 2006, ISELP is rapidly growing and currently has members on all five continents.

 

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

Kindred Biosciences Announces Fourth Quarter and Year-End 2016 Financial Results

San Francisco, CA (March 1, 2017) Kindred Biosciences, Inc. (NASDAQ: KIN) (KindredBio), a biopharmaceutical company focused on saving and improving the lives of pets, today announced financial results for the fourth quarter and full year ended December 31, 2016.

“We are very pleased with the progress of Mirataz™ and Zimeta™, including the recently announced approval of the efficacy technical section for Mirataz,” stated Richard Chin, M.D., President and CEO of KindredBio. “We are looking forward to the transition to a commercial-stage company in 2017, with the anticipated approval and launch of two products in the second half of the year, assuming that the regulatory review proceeds as expected. Zimeta (for the control of fever in horses) and Mirataz (for the management of weight loss in cats) are expected to be the first products approved by the Food and Drug Administration for their respective indications. Our robust cash position supports our deep pipeline, with readouts from multiple pilot studies and the initiation of add  itional pivotal studies expected this year. In addition, our state-of-the art GMP biologics manufacturing plant is in the final stages of commissioning, which will mark an important milestone for our biologics program.”

Development and Corporate Milestones

With more than 20 programs in development, KindredBio continues to advance a diversified portfolio of validated molecules in a capital efficient manner. Recent highlights include:

  • KindredBio is preparing for the commercial launch of Mirataz (mirtazapine transdermal ointment) for the management of weight loss in cats.All three major technical sections of the New Drug Application (NADA) have been filed. KindredBio received approval of the technical section for effectiveness from the Food and Drug Administration (FDA) in February. The Company has responded to comments from the FDA regarding the Chemistry, Manufacturing and Controls (CMC) technical section, and is awaiting feedback from the FDA on its safety technical section. The Company expects approval of Mirataz in the second half of 2017, assuming the FDA finds the submissions acceptable, and the launch of the drug shortly after approval. The regulatory approval is expected, but is subject to the typical risks inherent in such a process.

    Mirataz is expected to be the first FDA-approved product for the management of weight loss in cats, a serious and potentially fatal condition that is the leading cause of visits to the veterinarian for cats.

  • KindredBio is preparing for the commercial launch the IV form of Zimeta (dipyrone injection) for the control of pyrexia (fever) in horses.All three major technical sections of the NADA have been submitted to the FDA. The Company received the technical section complete letter for effectiveness from the FDA in October and has also responded to comments from the FDA regarding the CMC and safety technical sections. Approval of Zimeta is anticipated in the second half of 2017, assuming the FDA finds the responses acceptable, with the launch of the drug shortly after approval. The regulatory approval is expected, but is subject to the typical risks inherent in such a process.

    Zimeta is expected to be the first FDA-approved product for the control of fever in horses, a significant unmet medical condition that affects millions of horses each year.

  • The pivotal trial for the oral form of Zimeta (dipyrone oral gel) is expected to start in the first half of this year. Zimeta Oral is expected to expand the use of the drug and build upon the success of Zimeta IV.
  • The pilot field study of epoCat™ (feline recombinant erythropoietin) for the control of non-regenerative anemia in cats continues to enroll patients. Anemia is a common condition in older cats which is often associated with chronic kidney disease, resulting in decreased levels of endogenous erythropoietin. epoCat is a recombinant protein that has been specially engineered by KindredBio with a prolonged half-life compared to endogenous feline erythropoietin.
  • The first pilot field study of KIND-014 for the treatment of equine gastric ulcers has been completed. Based on the study results, the Company is optimizing its formulation and expects to initiate the next pilot field study in the second quarter of this year.
  • A pilot field study with the new formulation of KIND-015 for the management of clinical signs associated with equine metabolic syndrome is expected to commence by the second quarter of this year.
  • The second stage of the pilot field study of KIND-011, an anti-TNF monoclonal antibody targeting sick or septic foals, is planned to commence in the first quarter of this year.
  • The pilot field study of atopic dermatitis in dogs, to assess safety and efficacy of several anti-cytokine antibodies continues to enroll patients. Based on the results, KindredBio will select certain product candidate(s) for further development.
  • KindredBio’s antibodies against cytokines and immune checkpoints continue to progress on track, with initial pilot studies for some expected in 2017. KIND-Bodies, a novel biologics scaffold with certain advantages over antibodies, including bispecific binding, is also proceeding on track.
  • Construction is now complete and commissioning is underway at the state-of-the-art GMP biologics manufacturing plant. The Company anticipates proceeding to cGMP manufacturing in mid-2017. This facility is believed to be one of the first in the world dedicated to veterinary biologics.

Fourth Quarter and Full Year 2016 Financial Results

For the quarter ended December 31, 2016, KindredBio reported a net loss of $5.8 million, or $0.29 per share, compared to a net loss of $6.4 million, or $0.32 per share, for the same period in 2015. Research and development expenses for the fourth quarter of 2016 totaled $3.5 million, compared to $4.6 million for the same period in 2015. General and administrative expenses for the fourth quarter of 2016 were $2.4 million, compared to $1.9 million for the same period in 2015.

For the year ended December 31, 2016, KindredBio reported a net loss of $22.5 million, or $1.13 per share, versus a net loss of $27.1 million, or $1.37 per share, for the same period in 2015.

Research and development expenses for the year ended December 31, 2016 were $13.9 million compared to $19.4 million in 2015. Stock-based compensation expense related to research and development was $1.5 million, versus $1.9 million in 2015. The $5.5 million year-over-year decrease in research and development expenses was primarily due to lower payroll and related expenses following a reduction in headcount along with lower clinical trial costs and stock-based compensation expense. 2015 expenses included pivotal field trial costs for SentiKind and Zimeta.

General and administrative expenses for the year ended December 31, 2016 were $8.3 million compared to $7.9 million in 2015. General and administrative stock-based compensation expense was $2.2 million in 2016, versus $2.3 million in 2015. The $0.4 million increase in general and administrative expenses was related to increased headcount including higher marketing and corporate expenses as the Company has initiated pre-launch activities and the build-out of a small commercial team. The increase was offset in part by lower consulting and professional fees, as well as reduced stock-based compensation expense.

The Company recorded a restructuring charge of $655,000 for payroll related costs, which was paid in the first quarter of 2016, in order to streamline its development programs and extend its cash runway.

As of December 31, 2016, KindredBio had $57.8 million in cash, cash equivalents and investments. Net cash used in operating activities for 2016 was approximately $18.8 million. The Company also invested approximately $1.6 million in capital expenditures for the build-out of its GMP biologics manufacturing facility.

With respect to spending in 2017, the Company is preparing for the commercial launches of Mirataz and Zimeta, and will continue to spend on its core pipeline and programs. Accordingly, for 2017 the Company expects expenses of between $30 million and $32 million, excluding the impact of stock-based compensation expense and the impact of acquisitions, if any. The Company’s anticipated expenditures for 2017 include the build-out of a small commercial team, and preparations for distribution, commercial scale-up and manufacturing for Mirataz and Zimeta. Additionally, KindredBio plans to focus on the development of epoCat, KIND-014, KIND-015 and KIND-011, as well as the necessary manufacturing requirements for its biologics program.

Webcast and Conference Call

KindredBio will host a conference call and webcast today at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time. Interested parties may access the call by dialing toll-free (855) 433-0927 from the US, or (484) 756-4262 internationally, and using conference ID 64461689. The call will also be webcast live at http://edge.media-server.com/m/p/oxntfqa9. A replay will also be available at that link for 30 days.

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 significant 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 to Announce Fourth Quarter and Year-End 2016 Financial Results

Company to Hold Conference Call and Webcast at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time on Wednesday, March 1, 2017

San Francisco, CA (February 21, 2017) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced that it will release its fourth quarter and year-end 2016 financial results on March 1, 2017 after the market close. The Company will host a conference call at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time that day.

Interested parties may access the call by dialing toll-free (855) 433-0927 from the US, or (484) 756-4262 internationally, and using conference ID 64461689.

The call will also be webcast live at http://edge.media-server.com/m/p/oxntfqa9.

A replay will also be available at that link for 30 days.

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.

Contact

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

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

San Francisco, CA (February 6, 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 Mirataz™ (mirtazapine transdermal ointment) approving the technical section.

The basis for this complete letter was a multicenter, randomized, double-blind, placebo-controlled pivotal field study that enrolled 230 cats to assess the effectiveness of Mirataz in managing weight loss in cats. The primary endpoint was mean percentage change in body weight from Day 1 to Week 2. At Week 2, the mean percent increase in body weight from Day 1 was 3.94% in the Mirataz group (n=83), versus 0.41% in the placebo group (n=94) (p<0.0001). Based on a preliminary review of the safety data, the drug appears to be well tolerated.

Richard Chin, CEO of KindredBio, stated, “This is a major milestone for KindredBio, and it is a testament to the quality of the submission and the significant unmet medical need that it was reviewed by the FDA in a single cycle and ahead of the standard (ADUFA) timelines. We look forward to the launch of the first FDA-approved drug for the management of weight loss in cats, the most common reason for feline veterinary visits in United States. We expect the approval of Mirataz in the second half of 2017 assuming no unforeseen delays in the review process.”

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 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 to Present at 9th Annual LD Micro Investor Conference

San Francisco, CA (November 18, 2016) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced that Dr. Richard Chin, President and CEO, will be presenting at the 9th Annual LD Micro Investor Conference in Los Angeles, CA on Wednesday, December 7, 2016 at 1:30 PM PT. The conference is being held at the Luxe Sunset Boulevard Hotel.

The presentation will be available via a live webcast at the following URL: http://wsw.com/webcast/ldmicro11/kin.

An archived version of the webcast and presentation will be available for 30 days on the Company’s website: http://kindredbio.com/investor-relations/events.

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.

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.

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

Kindred Biosciences Announces Third Quarter 2016 Financial Results

San Francisco, CA (November 7, 2016) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced financial results for the third quarter ended September 30, 2016 and provided updates on its programs.

“We are pleased with the progress across our programs as we execute our strategy of quickly and cost-effectively developing therapeutics for our animal family members. In support of the anticipated launch of Zimeta™ (dipyrone injection) and Mirataz™ (mirtazapine 2% ointment), we have been hiring key personnel, building our veterinary technical services and establishing distribution channels. The advances of our lead candidates are complemented by promising preliminary data from pilot studies on our industry-leading biologics pipeline. As we prepare to transition to a revenue generating company next year, our deep product pipeline of more than 20 programs is supported by our strong cash position,” stated Richard Chin, M.D., President and CEO of KindredBio.

Development and Corporate Updates

With more than 20 programs in development, KindredBio continues to advance a diversified portfolio of validated molecules in a capital efficient manner. Recent highlights include:

  • KindredBio is preparing for the commercial launch of Zimeta for the treatment of pyrexia (fever) in horses. All major technical sections of the New Animal Drug Application (NADA) have been submitted to the Food and Drug Administration (FDA). The Company received the technical section complete letter for effectiveness from the FDA in early October. 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 results of the field study demonstrated that Zimeta administered at 30 mg/kg intravenously was effective for the control of pyrexia 6 hours following treatment administration. Approval of Zimeta is anticipated in the first half of 2017, assuming FDA review proceeds as expected. Zimeta is expected to be the first FDA-approved product for fever in horses, a significant and widely prevalent unmet medical condition that affects millions of horses each year.
  • The Company has completed its formulation development of the oral gel form of Zimeta for the treatment of fever in horses. The pivotal trial for Zimeta (dipyrone oral gel) is expected to start in the first half of 2017. The oral gel form of dipyrone is expected to be an additional, valuable tool for equine veterinarians by providing an easy-to-administer fever reducing agent for the horse and horse owner.
  • KindredBio is also preparing for the commercial launch of Mirataz transdermal ointment for the management of weight loss in cats. Weight loss in cats is a serious and potentially fatal condition for which there is no FDA-approved drug. The Company submitted the final major NADA technical section during the quarter. In the target animal safety study, Mirataz was generally well-tolerated. At the proposed label dose, topical administration of mirtazapine ointment was associated with mild, reversible skin changes at the site of dose application (ear). The Company expects approval of Mirataz in mid-2017, assuming FDA review proceeds as expected.KindredBio is in discussions with several potential commercialization partners regarding Mirataz.
  • KindredBio continues to enroll the pilot field study of epoCat™, feline erythropoietin, for the control of non-regenerative anemia in cats.
  • KindredBio has completed a pilot field study of KIND-014 for the treatment of equine gastric ulcers. Based on the study results, the Company is optimizing its formulation.
  • The Company continues to optimize the formulation for KIND-015, a development candidate for metabolic syndrome in horses; following which, it expects to initiate a pilot field efficacy study by the first quarter of 2017.
  • The Company has completed the first stage of a pilot field study in sick or septic foals to assess safety and efficacy of anti-TNF. All five foals enrolled survived to day 7, the primary endpoint of the study. The second stage of the study is planned early 2017, during the next foaling season.
  • KindredBio continues to enroll a pilot field study of atopic dermatitis in dogs, the purpose of which is to assess safety and efficacy of several molecules, including anti-cytokine antibodies. Based on the results, the Company will select certain product candidate(s) for further development.
  • The Company’s antibodies against cytokines and immune checkpoints continue to progress on track, with initial pilot studies for some expected in 2016. KIND-Bodies, a novel biologics scaffold with certain advantages over antibodies, including bispecific binding, is also proceeding on track.
  • The Company has completed construction and is undergoing commissioning of a state-of-the-art GMP biologics manufacturing plant. This facility is believed to be one of the first in the world dedicated to veterinary biologics.

 

Third Quarter and Nine Months 2016 Financial Results

For the quarter ended September 30, 2016, KindredBio reported a net loss of $5.7 million or $0.29 per share, as compared to a net loss of $7.1 million or $0.36 per share for the same period in 2015. For the nine months ended September 30, 2016, the net loss was $16.7 million or $0.84 per share, as compared to a net loss of $20.7 million or $1.05 per share for the same period in 2015.

Total research and development expenses for the three and nine months ended September 30, 2016 were $3.8 million and $10.4 million, respectively, compared to $5.0 million and $14.8 million for the same periods in 2015. Stock-based compensation expense was $0.4 million and $1.1 million for the three and nine months ended September 30, 2016 as compared to $0.4 million and $1.4 million for the same periods in 2015. The decrease in research and development expenses in 2016 compared to 2015 was primarily due to lower field trial and material costs including consulting expenses, lower payroll and related expenses as a result of the Company’s restructuring in January and lower stock-based compensation expense. The prior year’s expenses also included costs related to pivotal studies for programs that have been completed or discontinued.

Total general and administrative expenses were $2.0 million and $5.9 million for the three and nine months ended September 30, 2016, respectively, compared to $2.1 million and $6.0 million for the same periods in 2015. General and administrative expenses year over year remain relatively flat with higher payroll, corporate and marketing expenses being offset by lower consulting, legal and professional fees. Stock-based compensation expense was $0.6 million and $1.6 million for the three and nine months ended September 30, 2016 as compared to $0.6 million and $1.7 million for the same periods in 2015.

The Company recorded a restructuring charge of $655,000 for payroll related costs, which was paid in the first quarter of 2016, in order to streamline its development programs and extend its cash runway.

As of September 30, 2016, KindredBio had $62.5 million in cash, cash equivalents and investments, compared to $77.6 million as of December 31, 2015. The decrease was primarily due to cash used in operating activities of $14.3 million and capital expenditures of $0.8 million.

For the full year 2016, the Company lowers its guidance for total operating expenses to between $21 million and $22 million, excluding the impact of stock-based compensation expense and the impact of acquisitions, if any. The Company’s anticipated expenditures for the remainder of the year include preparing for the commercial launches of Zimeta and Mirataz, as well as the continued development of its pipeline candidates.

Webcast and Conference Call

KindredBio will host a conference call and webcast today at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time. Interested parties may access the call by dialing toll-free (855) 433-0927 from the US, or (484) 756-4262 internationally, and using conference ID 99990229.

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 to Announce Third Quarter 2016 Financial Results

Company to Hold Conference Call and Webcast at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time on Monday, November 7, 2016

San Francisco, CA (October 24, 2016) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced that it will release its third quarter 2016 financial results on November 7, 2016 after the market close. The Company will host a conference call at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time that day.

Interested parties may access the call by dialing toll-free (855) 433-0927 from the US, or (484) 756-4262 internationally, and using conference ID 99990229.

 

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.

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