Kindred Biosciences Announces Positive Results from Pivotal Study of KIND-010 for the Management of Weight Loss in Cats

Conference call and webcast scheduled for 4:30 p.m. ET / 1:30 p.m. PT today

San Francisco, CA (May 16, 2016) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced positive topline results from its pivotal field study of KIND-010, mirtazapine transdermal gel, for the management of weight loss in cats.

This study, KB105, was a multicenter, randomized, double-blind, placebo-controlled pivotal field study that enrolled 231 cats to assess the effectiveness of KIND-010 in stimulating weight gain in cats. The primary endpoint was 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 4.07% in the KIND-010 group (n=90), versus 0.29% in the placebo group (n=97) (p<0.0001). Based on a preliminary review of the safety data, the drug appears to be well tolerated.

“I would like to thank the KindredBio team and our investigators. Inappetence in cats is a serious disease, and is one of the leading causes of veterinary visits among cat owners. We are very pleased to advance this drug closer to approval. The pivotal study was completed on budget and ahead of schedule, underscoring our ability to develop therapeutics that improve the lives of companion animals quickly and in a cost-efficient manner,” said Richard Chin, M.D., President and Chief Executive Officer. “We look forward to continuing to build on our successes.”

The Company plans to file the Effectiveness Technical Section with the data from the KB105 pivotal field study with the Food and Drug Administration (FDA) in the third quarter of 2016. KindredBio has already filed the Chemistry, Manufacturing, and Controls technical section of the New Animal Drug Application with the FDA and completed the in-life portion of the Target Animal Safety Study successfully.

Conference Call and Webcast

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 12596310.

About Inappetence in Cats

Inappetence is a serious unmet medical need in cats, and may be caused by multiple factors, including chronic illness or infection. If untreated, it may lead to hepatic failure, which can be a life-threatening condition. Inappetence is common in cats, especially in older cats. On average, a small animal veterinarian may see up to 7 cats per week with the condition.

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.  www.kindredbio.com

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 Announces First Quarter 2016 Financial Results

San Francisco, CA (May 5, 2016) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced financial results for the first quarter ended March 31, 2016 and provided updates on its programs.

“We successfully advanced our lead product candidates in the first quarter. We look forward to reporting topline results for KIND-010, a transdermal gel for the management of weight loss in cats, by mid-year, as planned. Additionally, preparations for the commercial launch of Zimeta for fever in horses are on track, positioning KindredBio for the expected revenue generation by the end of 2016 or early 2017,” stated Richard Chin, M.D., President and CEO of KindredBio. “Backed by a strong cash position and deep pipeline, we continue to advance our strategy of quickly and efficiently developing therapeutics that improve the lives of companion animals.”

Development and Corporate Milestones

  • Launch preparations for Zimeta™ (dipyrone injection) are underway. All major technical sections of the New Animal Drug Application (NADA) have been submitted to the Food and Drug Administration and the Company anticipates approval of Zimeta for the treatment of pyrexia (fever) in horses by the end of 2016, or early 2017. With launch planned shortly after the anticipated approval, KindredBio Equine, a subsidiary for the equine business, has been created.
  • Enrollment in the pivotal study for KIND-010, a transdermal gel for the management of weight loss in cats, has been completed ahead of schedule. The Company is preparing for database lock and reporting of topline results by the middle of this year, as planned. The Target Animal Safety Study has been completed successfully. The Company has submitted the Chemical, Manufacturing and Controls technical section of the NADA.
  • A pilot laboratory study has been completed for Epocat™ (feline erythropoietin, KIND-510) for the control of non-regenerative anemia in cats. The pilot field efficacy study is underway.
  • A pilot laboratory study was conducted to demonstrate the effectiveness and safety of two formulations of KIND-014, a development candidate for the treatment of equine gastric ulcers in horses. The results were positive. Both formulations showed efficacy, as measured by gastric pH, and were well-tolerated. A pilot field study has been initiated.
  • Formulation for KIND-015, a development candidate for metabolic syndrome in horses, a disease similar to Type II diabetes in humans, is being optimized. The Company plans to initiate a pilot field efficacy study in the second half of 2016.
  • Other biologics: Antibodies against cytokines and immune checkpoints are progressing on track, and initial pilot studies for some of the antibodies are anticipated in 2016. KIND-Bodies, a novel biologics scaffold that has certain advantages over antibodies, including bispecific binding, is proceeding on track.
  • A GMP biologics manufacturing plant has been constructed and is undergoing commissioning. This state-of-art plant is one of the first in the world dedicated to veterinary biologics.

First Quarter 2016 Financial Results

For the quarter ended March 31, 2016, KindredBio reported a net loss of $6.1 million or $0.31 per share, as compared to a net loss of $6.7 million or $0.34 per share for the same period in 2015.

Total research and development expenses for the quarter ended March 31, 2016 were $3.4 million, compared to $4.8 million for the same period in 2015. The $1.4 million year-over-year decrease in research and development expenses was primarily due to reduced payroll and related expenses as a result of the Company’s corporate restructuring in January, lower clinical trial expenses due to the earlier than expected completion of the pivotal study for KIND-010, as well as lower stock-based compensation expense and consulting costs. 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 for the 2016 and 2015 first quarters were stable at $2.0 million. Expenditures in the first quarter of 2016 included a mix of higher payroll and related expenses due to increased headcount and higher facility and marketing expenses, offset by lower consulting, professional services and stock-based compensation expenses.

The Company recorded a restructuring charge of $655,000 in the first quarter of 2016 in order to streamline its development programs and extend its cash runway. The total number of employees impacted by the restructuring was 18.

As of March 31, 2016, KindredBio had $70.5 million in cash, cash equivalents and investments, compared with $77.6 million as of December 31, 2015. The decrease was primarily due to cash used in operating activities of approximately $6.5 million.

For the 2016 calendar year the Company reiterates its previous guidance for operating expenses to be in the range of $24 million to $26 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 regulatory costs associated with the filing of registration of KIND-010, preparing for the commercial launch of Zimeta, 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 98352561.

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.  www.KindredBio.com

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-010 New Animal Drug Application Technical Section for Chemistry, Manufacturing, and Controls to FDA

San Francisco, CA (May 4, 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 Chemistry, Manufacturing, and Controls (CMC) technical section of the New Animal Drug Application for KIND-010.

Richard Chin, M.D., President and CEO of KindredBio, stated, “We have been very pleased with the progress of the KIND-010 program for the management of weight loss in cats.  Submitting the CMC technical section to FDA is a major milestone.”

The Company will host its first quarter 2016 financial results conference call at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time on May 5, 2016.

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 98352561.

 

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. www.kindredbio.com

Contact

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

 

Kindred Biosciences to Announce First 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 Thursday, May 5, 2016

San Francisco, CA (April 25, 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 first quarter 2016 financial results on May 5, 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 98352561.

 

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.

Contact

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

 

 

Kindred Biosciences Elects Herbert D. Montgomery to Join Its Board of Directors

Highly Experienced Finance Executive to Join KindredBio’s Board

San Francisco, CA (April 15, 2016) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced that Mr. Herbert Montgomery will be joining the Company’s Board of Directors.  Mr. Montgomery will serve as the Chairman of the Company’s Audit Committee.

Mr. Montgomery has extensive experience in finance, including having served as CFO of several public companies, and having taken three companies public.  Most recently, he was Vice Chairman of the Board and Executive Officer of Lightpost Holdings, LLC. Prior to that, Mr. Montgomery was Executive Vice President, Chief Financial Officer, and Treasurer of Standard Media International; Senior Vice President, Chief Financial Officer and Treasurer of Cotelligent, Inc.; and Senior Vice President, Chief Financial Officer and Treasurer of Guy F. Atkinson. He holds a Master of Science degree in Management and a Bachelor of Science degree in Finance from California State University, Northridge. Mr. Montgomery was also previously Chairman of the Board of Institute for OneWorld Health.

“We are very pleased to welcome Herbert Montgomery to our Board of Directors,” stated Richard Chin, CEO of KindredBio. “I had the pleasure of serving with Herb previously and know, firsthand, the value he will bring to KindredBio.”

Mr. Montgomery stated, “I am delighted to be a part of the highly talented team of professionals who are developing innovative medications that will make a difference in our pets’ quality of life.”

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 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 Announces Fourth Quarter and Year-End 2015 Financial Results

San Francisco, CA (March 2, 2016) Kindred Biosciences, Inc. (NASDAQ: KIN), 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, 2015.

“We are very pleased with the progress on Zimeta™, our lead product candidate, and look forward to our first product approval and launch,” stated Richard Chin, M.D., President and CEO of KindredBio. “We are also pleased to report that the strong pipeline of additional products, including KIND-010 for management of weight in cats and feline epo for anemia in cats, are also advancing rapidly. With the rich pipeline and a strong cash position, we are well-positioned for success.”

Development and Corporate Milestones

  • Positive topline results were reported in 2015 for Zimeta (dipyrone injection), for the treatment of pyrexia (fever) in horses, in a multicenter, randomized, blinded, placebo-controlled pivotal study that enrolled 138 horses. The Company has submitted the Chemical, Manufacturing and Controls (CMC) and Effectiveness technical sections of the New Animal Drug Application (NADA) to the Food and Drug Administration (FDA) and successfully completed the Target Animal Safety Study (TASS).  All other technical sections of the NADA for Zimeta are planned for submission by the end of the first quarter of 2016 and the Company anticipates the approval of Zimeta by the end of 2016 or early 2017.  Zimeta was previously known as KIND-012.
  • Pivotal study is underway for KIND-010 for the management of weight loss in cats, following the successful completion of pilot studies. Enrollment in the pivotal study is over halfway complete and topline results are expected mid-year 2016.  The Company is currently conducting the TASS and preparing the CMC technical section of the NADA for submission.
  • Pilot laboratory study has been completed for KIND-510 (feline erythropoietin), for the control of non-regenerative anemia in cats. The pilot field efficacy study has been initiated. The Company is completing a GMP manufacturing plant and anticipates proceeding to GMP manufacturing in 2016.
  • Formulation for KIND-014, a development candidate for equine gastric ulcer syndrome in horses, is being optimized, following the completion of dose ranging and palatability studies. The Company plans to initiate a pilot field efficacy study in the second quarter of 2016.
  • Formulation for KIND-015, a development candidate for metabolic syndrome in horses, is being optimized. The Company plans to initiate a pilot field efficacy study in the second half of 2016.
  • Other biologics: Antibodies against cytokines and immune checkpoint are progressing on track, and initial pilot studies for some of the antibodies are anticipated in 2016.
  • KIND-Bodies, a novel biologics scaffold that has certain advantages over antibodies, including bispecific binding, has been invented and is being further developed.

Fourth Quarter and Full Year 2015 Financial Results

For the quarter ended December 31, 2015, KindredBio reported a net loss of $6.4 million, or $0.32 per share, compared to a net loss of $6.8 million, or $0.34 per share, for the same period in 2014.  Research and development expenses for the fourth quarter of 2015 totaled $4.6 million, compared to $4.8 million for the same period in 2014.  General and administrative expenses for the fourth quarter of 2015 were $1.9 million, compared to $2.0 million for the same period in 2014.

For the year ended December 31, 2015, KindredBio reported a net loss of $27.1 million, or $1.37 per share, versus a net loss of $27.1 million, or $1.44 per share, for the same period in 2014.

Research and development expenses for the year ended December 31, 2015 were $19.4 million compared to $18.7 million in 2014.  Stock-based compensation expense related to research and development was $1.9 million, versus $1.5 million in 2014.  The $0.7 million year-over-year increase in research and development expenses was primarily due to higher payroll and related expenses as a result of increased headcount, additional expense associated with advancing biologics programs and higher stock-based compensation expense.  The increase in expense was offset, in part, by lower field trial and material costs as the development of CereKin and AtoKin were discontinued and enrollment for the SentiKind program was completed in the second quarter of 2015.  Consulting expenses were also lower.

General and administrative expenses for the year ended December 31, 2015 were $7.9 million compared to $8.5 million in 2014.  General and administrative stock-based compensation expense was $2.3 million in 2015, versus $3.0 million in 2014.  The $0.6 million decrease in general and administrative expenses was related to lower stock-based compensation expense, consulting and professional fees, marketing and corporate expenses.  The decrease was offset in part by higher payroll and related expenses due to increased headcount as the Company continues to build its corporate infrastructure and other general business expenses.

At December 31, 2015, KindredBio had $77.6 million in cash, cash equivalents and investments.  Net cash used in operating activities for 2015 was approximately $22.8 million.  The Company also invested approximately $1.0 million in capital expenditures for the build-out of its GMP biologics manufacturing facility.

With respect to spending in 2016, the Company plans to focus on its core pipeline and programs.  Accordingly, for 2016 the Company expects to spend between $24 million and $26 million, excluding the impact of stock-based compensation expense and the impact of acquisitions, if any.  The Company’s anticipated expenditures for 2016 include the development of the necessary regulatory and quality processes as KindredBio nears the filing of registration for its second lead product candidate, KIND-010, and preparing for the commercial launch of Zimeta.  Additionally, the Company is addressing the necessary manufacturing requirements for possible commercialization in the following years.

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 56547791.

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

 

Press-release-4Q15-data-03022016

Kindred Biosciences to Announce Fourth Quarter and Year-End 2015 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 2, 2016

San Francisco, CA (February 25, 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 fourth quarter and year-end 2015 financial results on March 2, 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 56547791.

 

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.

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 Releases Positive Results of Pilot Field Study of KIND-010 for the Management of Weight in Cats

San Francisco, CA (January 26, 2016) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today released positive results from its pilot field study (KB104P) of KIND-010 for the management of weight in cats. It also announced successful completion of the sample size reassessment of the ongoing pivotal study.

This study was a randomized, single-blind, placebo-controlled study that enrolled 32 cats (16 in the KIND-010 group, 16 in the placebo group). The objective was to demonstrate the effectiveness and safety of KIND-010 for the stimulation of weight gain in cats under clinical conditions.  At Week 2, mean weight of cats in the KIND-010 group was 4.32 kg (percent increase from Day 1 was 3.25%) versus 3.98 kg (percent increase from Day 1 was -1.65%) in the placebo group (p=0.0042).

KindredBio also announced that the pivotal effectiveness study (KB105) for KIND-010 for the management of weight loss in cats is over halfway enrolled, ahead of schedule.  This randomized, double-blind, placebo-controlled study was concurred upon by FDA and will enroll a minimum of 200 cats (100 KIND-010/100 placebo) to assess the mean percent change in body weight from Day 1 to Week 2.  The Company conducted a pre-specified, interim sample-size reassessment once over 100 cats were enrolled and determined that the original sample size does not need to be increased.

Richard Chin, M.D., President and Chief Executive Officer, stated, “We are very pleased to release the positive results from the pilot KIND-010 study and the interim sample-size reassessment.  Weight loss in cats is a major unmet medical need, and we look forward to further progress.”

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