Kindred Biosciences to Present at 9th Annual LD Micro Investor Conference

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

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

An archived version of the webcast and presentation will be available for 30 days on the Company’s website: http://kindredbio.com/investor-relations/events.

About Kindred Biosciences, Inc.

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

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

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

Kindred Biosciences Announces Third Quarter 2016 Financial Results

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

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

Development and Corporate Updates

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

  • KindredBio is preparing for the commercial launch of Zimeta for the treatment of pyrexia (fever) in horses. All major technical sections of the New Animal Drug Application (NADA) have been submitted to the Food and Drug Administration (FDA). The Company received the technical section complete letter for effectiveness from the FDA in early October. The basis for this complete letter was a multicenter, randomized, blinded, placebo-controlled pivotal study that enrolled 138 horses to assess the effectiveness of Zimeta. The results of the field study demonstrated that Zimeta administered at 30 mg/kg intravenously was effective for the control of pyrexia 6 hours following treatment administration. Approval of Zimeta is anticipated in the first half of 2017, assuming FDA review proceeds as expected. Zimeta is expected to be the first FDA-approved product for fever in horses, a significant and widely prevalent unmet medical condition that affects millions of horses each year.
  • The Company has completed its formulation development of the oral gel form of Zimeta for the treatment of fever in horses. The pivotal trial for Zimeta (dipyrone oral gel) is expected to start in the first half of 2017. The oral gel form of dipyrone is expected to be an additional, valuable tool for equine veterinarians by providing an easy-to-administer fever reducing agent for the horse and horse owner.
  • KindredBio is also preparing for the commercial launch of Mirataz transdermal ointment for the management of weight loss in cats. Weight loss in cats is a serious and potentially fatal condition for which there is no FDA-approved drug. The Company submitted the final major NADA technical section during the quarter. In the target animal safety study, Mirataz was generally well-tolerated. At the proposed label dose, topical administration of mirtazapine ointment was associated with mild, reversible skin changes at the site of dose application (ear). The Company expects approval of Mirataz in mid-2017, assuming FDA review proceeds as expected.KindredBio is in discussions with several potential commercialization partners regarding Mirataz.
  • KindredBio continues to enroll the pilot field study of epoCat™, feline erythropoietin, for the control of non-regenerative anemia in cats.
  • KindredBio has completed a pilot field study of KIND-014 for the treatment of equine gastric ulcers. Based on the study results, the Company is optimizing its formulation.
  • The Company continues to optimize the formulation for KIND-015, a development candidate for metabolic syndrome in horses; following which, it expects to initiate a pilot field efficacy study by the first quarter of 2017.
  • The Company has completed the first stage of a pilot field study in sick or septic foals to assess safety and efficacy of anti-TNF. All five foals enrolled survived to day 7, the primary endpoint of the study. The second stage of the study is planned early 2017, during the next foaling season.
  • KindredBio continues to enroll a pilot field study of atopic dermatitis in dogs, the purpose of which is to assess safety and efficacy of several molecules, including anti-cytokine antibodies. Based on the results, the Company will select certain product candidate(s) for further development.
  • The Company’s antibodies against cytokines and immune checkpoints continue to progress on track, with initial pilot studies for some expected in 2016. KIND-Bodies, a novel biologics scaffold with certain advantages over antibodies, including bispecific binding, is also proceeding on track.
  • The Company has completed construction and is undergoing commissioning of a state-of-the-art GMP biologics manufacturing plant. This facility is believed to be one of the first in the world dedicated to veterinary biologics.

 

Third Quarter and Nine Months 2016 Financial Results

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

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

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

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

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

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

Webcast and Conference Call

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

Forward-Looking Statements

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

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

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

Contact

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

 

Kindred Biosciences to Announce Third Quarter 2016 Financial Results

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

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

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

 

About Kindred Biosciences

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

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

Contact

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

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

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

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

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

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

About Kindred Biosciences

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

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

Forward-Looking Statements

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

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

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

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

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

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

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

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

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

About Kindred Biosciences

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

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

Forward-Looking Statements

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

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

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

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

Kindred Biosciences to Present at 2016 Ladenburg Thalmann Healthcare Conference

San Francisco, CA (September 20, 2016) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced Dr. Richard Chin, President and CEO, will be presenting at the Ladenburg Thalmann Healthcare Conference in New York City on Tuesday, September 27, 2016 at 11:00 AM EDT. The conference is being held at the Sofitel Hotel.

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

About Kindred Biosciences, Inc.

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

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

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

Kindred Biosciences to Participate in a BIO Animal Biotech Summit Panel

San Francisco, CA (September 14, 2016) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced that Stephen Sundlof, DVM, PhD, Chief Scientific Officer and Executive Vice President, Regulatory Affairs and Quality, will be serving on a panel at the BIO Animal Biotech Summit in Bethesda, Maryland on Thursday, September 22, 2016 at 3.30pm EDT. The panel discussion, titled “Barriers to Innovation: Regulation and Politics,” will discuss the role of regulation in facilitating or impeding technological innovation. The conference is being held in the Grand Ballroom of the Bethesda Marriott.

About Kindred Biosciences, Inc.

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

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

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

Kindred Biosciences Submits New Animal Drug Application Technical Section for Effectiveness for Mirataz to FDA

San Francisco, CA (August 22, 2016) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced the submission of the Effectiveness Technical Section of the New Animal Drug Application for Mirataz™ (mirtazapine transdermal ointment) to the Food and Drug Administration (FDA) for the management of weight loss in cats. The Chemistry, Manufacturing, and Controls Technical Section was submitted in May 2016 and the Company plans to submit the Safety Technical Section in the third quarter of 2016.

The multicenter, randomized, double-blind, placebo-controlled pivotal field study enrolled 231 cats to assess the effectiveness of Mirataz 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 review of the safety data, the drug appears to be well tolerated.

“We are excited about the market potential for Mirataz and are pleased to bring this program one step closer to approval. Managing weight loss in cats is a serious unmet medical need, with an estimated 9 million cats in the U.S. suffering from inappetence. As a transdermal product, Mirataz is an attractive alternative for veterinarians and owners to administering a drug orally to cats. I want to thank the KindredBio team and our investigators for their hard work as we advance our plan to launch Mirataz,” stated Richard Chin, M.D., President and CEO of KindredBio.

Weight loss is one of the leading causes of veterinary visits among cat owners, and a veterinarian will see on average 7 cats per week with this condition. In many cases, significant weight loss can lead to liver failure and ultimately death. Currently, there are limited options for the management of weight loss in cats, none of which include an FDA-approved transdermal option. As a transdermal product, it is formulated using KindredBio’s Accusorb™ technology, which results in high and predictable absorption. About 80% of veterinarians surveyed have indicated their intent to use the product, based on the Company’s market research.

About Kindred Biosciences

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

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

Forward-Looking Statements

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

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

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

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

Kindred Biosciences Announces Second Quarter 2016 Financial Results

San Francisco, CA (August 8, 2016) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced financial results for the second quarter ended June 30, 2016 and provided updates on its programs.

“We are on track to launch our two lead product candidates by the first half of next year, and transition to revenue generation less than five years after KindredBio was founded. During the quarter we advanced Mirataz™, mirtazapine transdermal gel (formerly known as KIND-010), for the management of weight loss in cats, reporting positive results from a pivotal study. In addition, preparations are progressing as planned for the commercial launch of Zimeta™, dipyrone injection, for fever in horses. Our deep pipeline is supported by our strong cash position, and features an industry-leading biologics program with substantial revenue potential. Our most promising biologics candidates include treatments for anemia in cats and atopic dermatitis in dogs, both of which are currently undergoing pilot filed studies,” stated Richard Chin, M.D., President and CEO of KindredBio. “I am pleased with our rapid progress as we deliver on our strategy of quickly and cost-efficiently developing animal health therapeutics.”

Development and Corporate Updates

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

  • The Company is preparing for the commercial launch of Zimeta, for the treatment of pyrexia (fever) in horses. All major technical sections of the New Animal Drug Application (NADA) have been submitted to the Food and Drug Administration (FDA). The Company anticipates approval of Zimeta in the first half of 2017. Zimeta is expected to be the first FDA-approved product for fever in horses, a significant and widely prevalent unmet medical need.
  • In May 2016, KindredBio announced positive topline results from the pivotal field study of Mirataz, for the management of weight loss in cats. Inappetence is a serious unmet medical need in cats, and can lead to hepatic failure. It is one of the leading causes for veterinary visits among cat owners.    The Company expects to file the Effectiveness and Safety technical sections of the NADA with the FDA in the third quarter of 2016, having filed the Chemical, Manufacturing, and Controls technical section earlier this year.
  • The Company has initiated a pilot field study of epoCat™, feline erythropoietin, for the control of non-regenerative anemia in cats. This study is underway with several clinical sites.
  • KindredBio conducted a pilot laboratory study to demonstrate the effectiveness and safety of two formulations of KIND-014, a development candidate for the treatment of equine gastric ulcers. Both formulations were well-tolerated and showed positive results for efficacy, as measured by gastric pH.
    The Company initiated a pilot field study earlier this year, which has completed enrollment and is expected to be completed in the third quarter of 2016.
  • The Company is finalizing the formulation for KIND-015, a development candidate for metabolic syndrome in horses, following which it expects to initiate a pilot field efficacy study by the end of 2016.
  • In June 2016, KindredBio announced the initiation of a pilot field study of atopic dermatitis in dogs, the purpose of which is to assess safety and efficacy of several molecules, including anti-cytokine antibodies. Based on the results, the Company will select certain product candidate(s) for further development.
  • The Company has completed the first stage of a pilot field study in sick or septic foals to assess safety and efficacy of anti-TNF. All five foals enrolled survived to day 7, the primary endpoint of the study. The second stage of the study is planned for early 2017, during the next foaling season.
  • The Company’s antibodies against cytokines and immune checkpoints continue to progress on track, with initial pilot studies for some expected in 2016. KIND-Bodies, a novel biologics scaffold with certain advantages over antibodies, including bispecific binding, is also proceeding on track.
  • The Company has completed construction and is undergoing commissioning of a state-of-the-art GMP biologics manufacturing plant. This facility is believed to be one of the first in the world dedicated to veterinary biologics.

Second Quarter and Six Month 2016 Financial Results

For the quarter ended June 30, 2016, KindredBio reported a net loss of $4.9 million or $0.25 per share, as compared to a net loss of $6.9 million or $0.35 per share for the same period in 2015. For the six months ended June 30, 2016, net loss was $11.0 million or $0.55 per share, as compared to a net loss of $13.6 million or $0.69 per share for the same period in 2015.

Total research and development expenses for the three and six months ended June 30, 2016 were $3.2 million and $6.6 million, respectively, compared to $5.0 million and $9.8 million for the same periods in 2015.  Stock-based compensation expense was $0.4 million and $0.7 million for the three and six months ended June 30, 2016 as compared to $0.5 million and $0.9 million for the same periods in 2015.  The decrease in research and development expenses in 2016 compared to 2015 was primarily due to lower field trial and material costs including consulting expenses, lower payroll and related expenses as a result of the Company’s restructuring in January and lower stock based compensation expense.  The prior year’s expenses also included costs related to pivotal studies for programs that have been completed or discontinued.

Total general and administrative expenses of $1.9 million and $3.9 million for the three and six months ended June 30, 2016 remained unchanged compared to the same periods in 2015. Higher payroll, corporate and marketing expenses were offset by lower consulting, legal and professional fees, as well as lower stock-based compensation expense. Stock-based compensation expense was $0.5 million and $1.0 million for the three and six months ended June 30, 2016 as compared to $0.6 million and $1.2 million for the same periods in 2015.

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

As of June 30, 2016, KindredBio had $66.3 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 $10.6 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 Mirataz, 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 54160476.

About Kindred Biosciences

Kindred Biosciences is a development-stage biopharmaceutical company focused on saving and improving the lives of pets.  Its mission is to bring to pets the same kinds of safe and effective medicines that human family members enjoy.  The Company’s strategy is to identify compounds and targets that have already demonstrated safety and efficacy in humans and to develop therapeutics based on these validated compounds and targets for dogs, cats and horses.  The Company has a deep pipeline of novel drugs and biologics in development across many therapeutic classes. For more information or to download the corporate presentation, visit www.KindredBio.com/LearnMore. Stay connected with KindredBio on Facebook at www.Facebook.com/KindredBio.

Forward-Looking Statements

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

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

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

Contact

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

 

Kindred Biosciences to Announce Second Quarter 2016 Financial Results

Company to Hold Conference Call and Webcast at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time on Monday, August 8, 2016

San Francisco, CA (July 26, 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 second quarter 2016 financial results on August 8, 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 54160476.

 

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