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

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

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

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

About Kindred Biosciences

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

Forward-Looking Statements

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

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

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

Kindred Biosciences Announces Positive Results from Pivotal Study of KIND-012 for Pyrexia in Horses, and Provides Other Product Updates

KIND-012 study meets primary endpoint with p<0.0001. Data to be filed with the FDA for approval. SentiKind study misses primary endpoint.

Conference call and webcast scheduled for 5:00 p.m. Eastern Time today.

San Francisco, CA (November 16, 2015) 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 (KB0120) of KIND-012 for the control of pyrexia (fever) in horses. Read more

Kindred Biosciences Announces Third Quarter 2015 Financial Results

San Francisco, CA (November 9, 2015) Kindred Biosciences, Inc. (NASDAQ: KIN) today announced financial results for the third quarter ended September 30, 2015 and provided updates on its programs.

Development and Corporate Updates

KindredBio continues to advance a diversified portfolio of molecules in a capital efficient manner. Some of the recent highlights include:

  • SentiKind™, or KIND-090, pivotal study. The pivotal field study of SentiKind, a KCNQ potassium channel agonist for post-operative pain in dogs, completed enrollment and the Company plans to report topline results in the coming weeks. The Chemical, Manufacturing, and Controls (CMC) and Target Animal Safety Study (TASS) technical sections of the New Animal Drug Application (NADA) have been submitted for this product candidate.
  • Completion of enrollment in KIND-012 pivotal study. The pivotal study is fully enrolled and topline results are expected in the coming weeks. KindredBio announced positive results from a randomized, placebo-controlled pilot study investigating KIND-012 for fever in horses in March of this year. The Company has completed the in-life portion of the TASS and is currently preparing the CMC technical section of the NADA.
  • Initiation of a randomized, placebo-controlled, pivotal field study for KIND-010 for the management of weight loss in cats. A randomized pilot study of KIND-010 has been completed and the Company initiated the pivotal field study for KIND-010 in October 2015. Topline results for the pivotal field study are expected in the fourth quarter of 2016.
  • Completion of pilot study of KIND-011. The initial pilot study of KIND-011 for metabolic syndrome in horses has been completed. Based on the results, KindredBio is advancing formulation development for an analog, KIND-015, of this novel equine product candidate. KIND-015 is expected to have a similar safety and efficacy profile to KIND-011 but a lower cost of goods.
  • KIND-014 development program for equine gastric ulcer syndrome in horses. KindredBio has completed pilot studies and has initiated formulation development for KIND-014.
  • Completion of pilot laboratory studies of feline erythropoietin. The feline erythropoietin program is advancing rapidly. The initial laboratory studies have been completed, with a positive efficacy signal, as evidenced by increased reticulocyte formation. The Company is preparing for GMP manufacturing activities and anticipates proceeding to GMP manufacturing in early 2016.
  • Completion of PK study of canine TNF antibody. The PK study for the anti-TNF antibody has been completed with favorable pharmacokinetics, and KindredBio expects to initiate GMP manufacturing activities shortly.
  • Progress in checkpoint inhibitor and multiple biologics programs. The checkpoint inhibitor programs are making strong progress, as are multiple other biologics programs that are in early-stage development.

Richard Chin, M.D., President and CEO of KindredBio, stated, “We are very pleased with the progress we’re making across our programs. In particular, we want to highlight the completion of enrollment in the SentiKind pivotal study and the KIND-012 pivotal study. The Company continues to expect top-line results prior to year-end. We also met milestones in a number of other areas, including the filing of the CMC and TASS sections of the NADA for SentiKind, and rapid initiation of the KIND-010 pivotal study. We have made significant progress on our feline erythropoietin and other biologics programs, and have initiated activities toward GMP manufacturing for the biologics portfolio. We continue to be highly capital efficient.”

Third Quarter and Nine Month 2015 Financial Results

For the quarter ended September 30, 2015, KindredBio reported a net loss of $7.1 million or $0.36 per share, as compared to a net loss of $6.1 million or $0.31 per share for the same period in 2014. For the nine months ended September 30, 2015, net loss was $20.7 million or $1.05 per share, as compared to a net loss of $20.3 million or $1.10 per share for the same period in 2014.

Total research and development expenses for the three and nine months ended September 30, 2015 were $5.0 million and $14.8 million, respectively, compared to $3.8 million and $13.9 million for the same periods in 2014. Stock-based compensation expense was $0.4 million and $1.4 million for the three and nine months ended September 30, 2015 as compared to $0.4 million and $1.1 million for the same periods in 2014. The increase in research and development expenses in 2015 compared to 2014 was primarily due to higher payroll and related expenses as a result of increased headcount including costs associated with advancing biologics programs and stock-based compensation expense offset, in part, by lower field trial and material costs including consulting expenses. The 2014 expenses included costs of the Company’s CereKin and AtoKin pivotal trials.

Total general and administrative expenses for the three and nine months ended September 30, 2015 were $2.1 million and $6.0 million, respectively, compared to $2.3 million and $6.5 million for the same periods in 2014. Stock-based compensation expense was $0.6 million and $1.7 million for the three and nine months ended September 30, 2015 as compared to $0.9 million and $2.5 million for the same periods in 2014. The decrease in general and administrative expenses in 2015 was due primarily to lower consulting fees, professional services, and corporate and stock-based compensation expenses, offset by increased headcount expenses as the Company continues to build its corporate infrastructure and other general business expenses.

As of September 30, 2015, KindredBio had $83.6 million in cash, cash equivalents and short term investments. Net cash used in operating activities for the nine months ended September 30, 2015 was approximately $17.2 million. For the full year 2015, the Company expects operating expenses to be in the range of $25 million to $30 million, excluding the impact of stock-based compensation expense.

About Kindred Biosciences

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

Forward-Looking Statements

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

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

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

Q3_Press_release_table_750

Kindred Biosciences Announces Second Quarter 2015 Financial Results

San Francisco, CA (August 10, 2015) Kindred Biosciences, Inc. (NASDAQ: KIN) today announced financial results for the second quarter ended June 30, 2015 and provided updates on its programs.

Development and Corporate Updates

KindredBio continues to advance a diversified portfolio of validated molecules in a capital efficient manner and has over 20 programs in development. Some of the recent highlights include:

  • Completion of enrollment in SentiKind™ pivotal study. The pivotal field trial of SentiKind, a KCNQ potassium channel agonist for post-operative pain in dogs, recently completed enrollment and the Company plans to report topline results before the end of this year.
  • Continued rolling submission of SentiKind New Animal Drug Application (NADA) sections. The Chemical, Manufacturing, and Controls technical section of the NADA was filed at the end of the second quarter of this year and the Company is continuing the rolling submission of the NADA technical sections. A Target Animal Safety Study of SentiKind has been completed and filing of the data is anticipated shortly.
  • Continued progress on additional indications for SentiKind. The Company continues to conduct pilot studies of the active ingredient in SentiKind in several other indications across multiple species.
  • Initiation of KIND-012 pivotal study. In April 2015, the Company received a protocol concurrence from the FDA on the pivotal field study for KIND-012 and has since initiated multiple clinical sites across the U.S. The study is halfway enrolled. Topline results for the pivotal trial are expected at the end of 2015 or early 2016. KindredBio announced positive results from a randomized, placebo-controlled, pilot study investigating KIND-012 for fever in horses in March of this year. The Company recently received a protocol concurrence from the FDA for the Target Animal Safety Study for KIND-012 and will be initiating this study in the third quarter of this year.
  • Completion of PK study of KIND-010 for management of weight loss in cats. The PK study of KIND-010 for management of weight loss in cats has been completed, with a positive efficacy signal, as evidenced by increase in weight.
  • Initiation of a randomized, placebo-controlled pilot study for KIND-010. A pilot study of KIND-010 is currently in the enrollment phase. If the pilot study is positive, the pivotal field study will be initiated this year. Topline results for the pivotal trial are expected in 2016.
  • Completion of pilot study of KIND-011. The initial pilot study of KIND-011 for metabolic syndrome in horses has been completed. Based on the results, KindredBio anticipates advancing the program.
  • Completion of pilot laboratory studies of feline erythropoietin. The feline erythropoietin program is advancing rapidly. The initial laboratory studies have been completed, with a positive efficacy signal, as evidenced by increased reticulocyte formation. KindredBio expects to initiate GMP manufacturing activities shortly.
  • Completion of PK study of canine TNF antibody. The PK study for the anti-TNF antibody has been completed with favorable pharmacokinetics, and KindredBio expects to initiate GMP manufacturing activities shortly.
  • Progress in checkpoint inhibitor and multiple biologics programs. The checkpoint inhibitor programs are making strong progress, as are multiple other biologics programs that are in early-stage development.
  • Continued progress on business development. KindredBio is in active discussions with multiple potential partners regarding late-stage opportunities.

Richard Chin, M.D., President and CEO of KindredBio, stated, “We are very pleased with the progress we’re making across our programs. In particular, we want to highlight the completion of enrollment in the SentiKind pivotal study. The Company continues to expect top-line results prior to year-end. We also met milestones in a number of other areas, including the filing of the CMC section of the NADA for SentiKind, rapid initiation of the KIND-012 pivotal study on the heels of the statistically significant results of the placebo-controlled, blinded, randomized pilot study, and the preliminary efficacy signal from the feline erythropoietin study. We are also pleased with progress on our biologics programs. Of note, our progress is coupled with our continued exercise of financial discipline, allowing us to advance our programs in a highly capital-efficient manner.”

Second Quarter and Six Month 2015 Financial Results

For the quarter ended June 30, 2015, KindredBio reported a net loss of $6.9 million or $0.35 per share, as compared to a net loss of $8.1 million or $0.42 per share for the same period in 2014. For the six months ended June 30, 2015, net loss was $13.6 million or $0.69 per share, as compared to a net loss of $14.3 million or $0.80 per share for the same period in 2014.

Total research and development expenses for the three and six months ended June 30, 2015 were $5.0 million and $9.8 million, respectively, compared to $5.6 million and $10.1 million for the same periods in 2014. Stock-based compensation expense was $0.5 million and $0.9 million for the three and six months ended June 30, 2015 as compared to $0.4 million and $0.7 million for the same periods in 2014. The decrease in research and development expenses in 2015 compared to 2014 was primarily due to lower field trial and material costs including consulting expenses, offset in part by higher payroll and related expenses as a result of increased headcount and costs associated with advancing biologics programs. The 2014 expenses included costs of the Company’s CereKin and AtoKin pivotal.

Total general and administrative expenses for the three and six months ended June 30, 2015 were $1.9 million and $3.9 million, respectively, compared to $2.5 million and $4.2 million for the same periods in 2014. Stock-based compensation expense was $0.6 million and $1.2 million for the three and six months ended June 30, 2015 as compared to $0.8 million and $1.6 million for the same periods in 2014. The decrease in general and administrative expenses in 2015 was due primarily to lower consulting, professional services and stock-based compensation expenses offset by increased headcount expenses as the company continues to build its corporate infrastructure.

As of June 30, 2015, KindredBio had $89.7 million in cash, cash equivalents, and short term investments. Net cash used in operating activities for the six months ended June 30, 2015 was approximately $11.4 million. The Company is revising its previous guidance for operating expenses and now expects it to be in the range of $30 million to $35 million for the 2015 calendar year, as compared to its previous guidance for annual operating expenses that were expected to be $35 to $40 million.

About Kindred Biosciences

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

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

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

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

Contact
Denise Bevers
KindredBio
denise.bevers@kindredbio.com
(650) 701-79042015Q2Statement of Operations

KindredBio Announces Appointment of Jennifer Elliott as Vice President of Legal Affairs and Intellectual Property

 

San Francisco, CA (May 28, 2015) Kindred Biosciences, Inc. (NASDAQ: KIN) today announced the appointment of Jennifer Elliott as Vice President of Legal Affairs and Intellectual Property.

Dr. Elliott joins KindredBio from Genentech, where she most recently served as Associate General Counsel and Director of Patent Law. She had increasing levels of responsibility in her nearly 10 year tenure with Genentech, and most recently oversaw Genentech’s oncology intellectual property group. She has had an extensive intellectual property practice throughout her career, with a particular focus on biologics and antibodies. Prior to her role her at Genentech, Dr. Elliott was an Associate at Finnegan, Henderson, Farabow, Garrett and Dunner, LLP and a Technical Expert at Lahive & Cockfield LLP. She holds a Ph.D. in Microbiology and Molecular Genetics from Harvard University and a J.D. from Stanford Law School.

Richard Chin, Chief Executive Officer of KindredBio, stated, “We are extremely pleased to welcome Jennifer onto KindredBio’s team as we build one of the world’s leading portfolios of veterinary intellectual property.”

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

Kindred Biosciences Announces First Quarter 2015 Financial Results

San Francisco, CA (May 8, 2015) Kindred Biosciences, Inc. (NASDAQ: KIN) today announced financial results for the first quarter ended March 31, 2015 and provided updates on its programs.

Development Updates

KindredBio continues to advance a diversified portfolio of validated molecules in a capital efficient manner and has over 20 programs in development. Some of the highlights include:

The pivotal field trial of SentiKind, a KCNQ potassium channel agonist for post-operative pain in dogs, continues to enroll well and the Company expects to report topline results on this program in the second half of this year. The Company has completed a Target Animal Safety Study and is continuing the rolling submission of the NADA technical sections for SentiKind. The Company is also investigating the active ingredient in SentiKind in several other indications across multiple species.

KindredBio announced a positive pilot study investigating KIND-012 for fever in horses in March of this year. KindredBio has received a protocol concurrence from the FDA on the pivotal field study for KIND-012. The pivotal study has been initiated at multiple clinical sites across the U.S. The topline results for the pivotal trial are expected at the end of 2015 or early 2016.

The PK study of KIND-010 for management of weight loss in cats has been completed and the pilot study is currently in the enrollment phase. If the pilot study is positive, the pivotal field study will be initiated this year. The topline results for the pivotal trial are expected in 2016.

The initial formulation work has been completed for KIND-011 for metabolic syndrome in horses, and KindredBio is initiating the pilot study.

The feline erythropoietin program is advancing as planned and an initial laboratory study has been completed. The initial preliminary results are positive, with evidence of new red blood cell production in treated cats.

The PK study for the anti-TNF antibody has been completed, and the results are favorable.

The checkpoint inhibitor programs are making strong progress, as well as multiple other biologics programs that are in early-stage development.

Richard Chin, M.D., President and CEO of KindredBio, stated, “We are very pleased with the progress we’re making across our programs. We are particularly pleased to announce the initiation of the pivotal study of KIND-012 under an FDA protocol concurrence, on the heels of the positive pilot study.”

First Quarter 2015 Financial Results

For the quarter ended March 31, 2015, KindredBio reported a net loss of $6.7 million or $0.34 per share, as compared to a net loss of $6.2 million or $0.38 per share for the same period in 2014.

Total research and development expenses for the quarter ended March 31, 2015 were $4.8 million, compared to $4.5 million for the same period in 2014. The increase of $0.3 million in research and development expenses in 2015 compared to 2014 was primarily due to payroll and related expenses as a result of increased headcount as well as stock-based compensation expense, offset in part by lower clinical trial and consulting costs. The 2014 expenses included costs of the Company’s CereKin and AtoKin pivotal studies.

Total general and administrative expenses for the quarter ended March 31, 2015 were $2.0 million, compared to $1.7 million for the same period in 2014. The increase of $0.3 million in general and administrative expenses in 2015 was due primarily to increased headcount, consulting and legal fees as well as other general business services as we operate as a public company.

As of March 31, 2015, KindredBio had $94.6 million in cash, cash equivalents and short term investments, compared with $101.0 million as of December 31, 2014. The decrease was primarily due to cash used in operating activities of approximately $6.4 million. For the 2015 calendar year the Company reiterated its previous guidance for operating expenses to be in the range of $35 million to $40 million as the Company ramps up its clinical programs and the development of necessary regulatory and quality processes as KindredBio nears the filing of registration for its product candidates.

About Kindred Biosciences

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

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

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

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

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

 

2015Q1Statement of Operations

 

Kindred Biosciences to Present at 2015 Jefferies Animal Health Summit

San Francisco, CA (March 19, 2015) – Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced that Denise Bevers, Co-Founder and Chief Operating Officer, will be presenting at the 2015 Jefferies Animal Health Summit in New York, NY on Thursday, March 26, 2015 at 1:30 PM EDT.

Read more

Kindred Biosciences Announces Positive Results of Pilot Field Study of KIND-012 for the Control of Fever in Horses

Randomized, Blinded, Placebo-Controlled Phase 2 Study Meets Its Primary Endpoint.

San Francisco, CA (March 16, 2015) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced positive results from its pilot field study of KIND-012 for the control of pyrexia (fever) in horses.

This study, which is the equivalent of a Phase 2 study, was a randomized, blinded, placebo-controlled, crossover study that enrolled 31 adult horses. The primary endpoint was improvement or resolution of fever. In the first treatment period, the response rate was 66.7% in the KIND-012 group vs. 12.5% in the placebo group (p=0.0032). In the second treatment period, the response rate was 57.1% in the KIND-012 group vs. 0% in the placebo group (p=0.0019).

KindredBio is planning to start a pivotal field study required for FDA approval of KIND-012 for the control of fever in horses.

Richard Chin, M.D., President and Chief Executive Officer, stated, “We are very pleased with the results of this study. As we mentioned on our recent earnings call, we are making excellent progress across our programs and we look forward to continuing to build value for our patients and investors.”

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

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

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

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

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

Kindred Biosciences Announces Fourth Quarter and Year-End 2014 Financial Results

San Francisco, CA (March 12, 2015) Kindred Biosciences, Inc. (NASDAQ: KIN) today announced financial results for the quarter ended December 31, 2014.

Conference Call and Webcast at 4:30 p.m. Eastern / 1:30 p.m. Pacific

KindredBio today announced its fourth quarter financial results and provided updates on its programs.

Development Updates
KindredBio continues to build and advance its pipeline, including biologics, and now has over 20 programs across multiple product candidates and indications. Some of the key programs are highlighted below.

The pivotal field trial of SentiKind, a KCNQ potassium channel agonist, for post-operative pain in dogs is currently enrolling patients and the Company expects to report topline results on this program in the second half of this year. The Company has completed Target Animal Safety Study and has started the rolling submission of the NADA technical sections for SentiKind. The Company is also testing the active ingredient in SentiKind in several other indications in multiple species.

The PK study of KIND-010 for management of weight loss in cats has been completed and the pilot study has been initiated. If the pilot study is positive, the pivotal field study will be initiated this year. The topline results for the pivotal trial are expected in 2016.

The PK study of KIND-012 for fever in horses has been completed and the pilot study has been initiated. If the pilot study is positive, the pivotal field study will be initiated this year. The topline results for the pivotal trial are expected at the end of 2015 or early 2016.

The feline erythropoietin program is advancing as planned and initial laboratory studies have been initiated. The anti-TNF and checkpoint inhibitor programs are also on track, as well as multiple other biologics programs that are in early-stage development.

Management Updates
KindredBio also announced additions to its team, including Wendy Wee, Vice President of Finance and Alan Weingarten, Head of Clinical Development. In addition, it announced the promotion of Stephen Sundlof to Chief Scientific Officer and Executive Vice President of Regulatory Affairs and Quality.

“We’re pleased with the progress we’re making across our programs and in building a strong team. We are excited about our pipeline, and believe that we’re well-positioned to deliver value to both our patients and shareholders,” stated Richard Chin, CEO of KindredBio.

Fourth Quarter and Full Year 2014 Financial Results
For the quarter ended December 31, 2014, KindredBio reported a net loss of $6.8 million or $0.34 per share, as compared to a net loss of $2.4 million or $0.40 per share for the same period in 2013. Research and development expenses for the fourth quarter of 2014 increased to $4.8 million, as compared to $1.7 million for the same period in 2013. General and administrative expenses for the fourth quarter of 2014 increased to $2.0 million as compared to $641,000 for the same period in 2013.

For the year ended December 31, 2014, KindredBio reported a net loss of $27.1 million or $1.44 per share as compared to a net loss of $4.2 million or $1.13 per share for the same period in 2013.

Research and development expenses for the year ended December 31, 2014 were $18.7 million compared to $3.1 million in 2013, while general and administrative expenses were $8.5 million compared to $1.1 million in 2013. The increase of $15.6 million in research and development expenses in 2014 compared to 2013 was primarily driven by the increase in outsourced development expense for SentiKind, AtoKin, CereKin and the Company’s other product development programs, a total of approximately $8.0 million. In addition, research and development expenses also increased by $6.4 million due to payroll and related expenses as KindredBio increased its headcount, as well as consulting and stock-based compensation expenses. The increase of $7.5 million in general and administrative expenses in 2014 over 2013 was due primarily to stock-based compensation expense, professional and consulting fees for legal, accounting and tax services, headcount related expenses and other general business services as we operate as a public company.

As of December 31, 2014, KindredBio had $101.0 million in cash, cash equivalents and short term investments, a net increase of $35.7 million from December 31, 2013. This increase was due to the net cash proceeds of $58.1 million from KindredBio’s follow-on offering in April, 2014, offset in part by cash used in operating activities of approximately $21.9 million.

With respect to spending in 2015, the Company plans to aggressively expand its pipeline and accelerate its programs. As a result, expenditures are expected to increase from the annualized fourth quarter 2014 level of approximately $27.2 million. Accordingly, for 2015 the Company expects to spend $35 to $40 million, excluding the impact of stock-based compensation expense and the impact of acquisitions, if any. These costs include the development of the necessary regulatory and quality processes as KindredBio nears the filing of registration for its product candidates. 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 today at 4:30 p.m. Eastern 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 98449349. The call will also be webcast live at http://edge.media-server.com/m/p/q6r6vhoj.

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 revenue from our product candidates for the foreseeable future; our potential inability to obtain any necessary additional financing; our substantial dependence on the success of our lead product candidates, which may not be successfully commercialized even if they are approved for marketing; the effect of competition; our potential inability to obtain regulatory approval for our existing or future product candidates; our dependence on third parties to conduct some of our development activities; our dependence upon third-party manufacturers for supplies of our product candidates; uncertainties regarding the outcomes of trials regarding our product candidates; our potential failure to attract and retain senior management and key scientific personnel; uncertainty about our ability to develop a satisfactory sales organization; our significant costs of operating as a public company; our potential inability to obtain patent protection and other intellectual property protection for our product candidates; potential claims by third parties alleging our infringement of their patents and other intellectual property rights; our potential failure to comply with regulatory requirements, which are subject to change on an ongoing basis; the potential volatility of our stock price; and the significant control over our business by our principal stockholders and management.

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

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

 

 

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KindredBio to Announce Fourth Quarter and Year-End 2014 Financial Results

Company to Hold Conference Call and Webcast at 4:30 p.m. Eastern Time on Thursday, March 12, 2015

SAN FRANCISCO, California. (March 3, 2015) – Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, announced today that it will release its fourth quarter and year-end 2014 financial results on March 12, 2015 after the market close. The Company will host a conference call at 4:30 p.m. Eastern Time that day. Read more