Kindred Biosciences Announces European Commission Approval of Mirataz® 20 mg/g Transdermal Ointment for Cats Experiencing Poor Appetite and Weight Loss

  • Mirataz is the first and only medication approved in the European Union to treat cats experiencing poor appetite and weight loss resulting from chronic medical conditions.

San Francisco, California (December 12, 2019) – Kindred Biosciences, Inc. (Nasdaq: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, today announced that the European Commission has granted marketing authorization of Mirataz for bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions.

“We are excited to gain approval in the European Union for Mirataz, our second product approval in 2019,” said Kindred Biosciences Chief Executive Officer, Richard Chin, M.D. “We are pleased to continue to build on our track record of successes, as we bring this innovative product to new geographies.”

Mirataz is the first and only medication approved in the EU to induce bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions. Europe represents the second largest market for veterinary therapeutics internationally. Regulations restrict use of human medicine once an approved therapeutic is available. The authorization is valid in all 28-member states of the European Union, together with Iceland, Liechtenstein, and Norway.

The approval of Mirataz in the European Union is based on results from both clinical and non-clinical studies. Mirataz is a serotonin (5HT2A, 5HT2C, and 5HT3) and histamine (H1) receptor antagonist, which has demonstrated body weight gain in cats experiencing poor appetite and weight loss from chronic medical conditions. In clinical studies, Mirataz resulted in significant weight gain in cats in as little as 14 days following topical application of 2 mg per day [1]. Mirataz, which is formulated with KindredBio’s proprietary Accusorb™ technology, is applied topically to the cat’s inner ear (pinna) once a day, providing a different application route compared to oral administration.

Aniserve GmbH is the marketing authorization holder acting on behalf of Kindred Biosciences in Europe.

Mirataz® (mirtazapine transdermal ointment) was approved for use in cats by the U.S. Food & Drug Administration in May 2018.

[1] Summary of Product Characteristics for Mirataz® 20 mg/g transdermal ointment for cats, Aniserve GmbH (Munich, Germany) on behalf of Kindred Biosciences, Inc. (Burlingame, CA). EU/2/19/247/001

Rev. 12/2019.

About Kindred Biosciences

Kindred Biosciences is a commercial-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. KindredBio has a deep pipeline of novel drugs and biologics in development across many therapeutic classes. The company has two approved drugs, namely Mirataz® (mirtazapine transdermal ointment) and Zimeta™ (dipyrone injection).

About Aniserve

Aniserve offers business support services to the animal health and nutrition industry, start-ups, small and medium enterprises and established players. We support our clients to register their company and products in Europe and abroad. Our services include acting as representatives towards regulatory authorities including acting as applicant for submissions of dossiers to register veterinary medicinal products and feed additives and marketing authorization holder. We support our clients in establishing subsidiaries in Europe complying with veterinary pharmaceutical legislation to establish their business activities. With our network of partners, we can support our clients in most regions of the world.

Forward-Looking Statements 

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

These forward-looking statements are based on our current expectations. These statements are not promises or guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results to be materially different from any future results expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: our limited operating history and expectations of losses for the foreseeable future; the absence of significant revenue from our products and our product candidates for the foreseeable future; the likelihood that our revenue will vary from quarter to quarter; our potential inability to obtain any necessary additional financing; our substantial dependence on the success of our products and 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 products and 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 and maintain patent protection and other intellectual property protection for our products and 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.

Contacts
Katja Buhrer
Katja.buhrer@kindredbio.com 
(917) 969-3438

Kindred Biosciences Receives FDA Approval of Zimeta™ (dipyrone injection) for the Control of Pyrexia in Horses

San Francisco, California (November 25, 2019) – Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced that the U.S. Food and Drug Administration’s Center for Veterinary Medicine has approved Zimeta™ (dipyrone injection) for the control of pyrexia in horses.

Pyrexia, or fever, is associated with a number of underlying diseases and can result in significant negative outcomes, including dehydration, laminitis, muscle wasting, weight loss, and in some cases death. Among performance horses, fever can also lead to loss of training and competition days. There are more than eight million horses in the United States, and over one million are seen by a veterinarian for fever annually.

Zimeta is the first and only FDA-approved medication for the control of pyrexia (fever) in horses.

“The equine community has been eagerly anticipating an FDA-approved safe and effective product to control fever in horses,” said Denise Bevers, President and COO of KindredBio. “Equine pyrexia is an attractive market for KindredBio, with high unmet medical need and a commitment to treat. This second KindredBio commercial product was developed in five years and at a cost of $5 million, consistent with our business model. It positions KindredBio as a key player in the equine community as we advance a pipeline of promising drug candidates for horses.”

Zimeta, which is classified as a nonsteroidal anti-inflammatory drug, targets fever centrally in the brain, where it originates. In a clinical study, Zimeta demonstrated rapid and effective fever reduction in horses with naturally occurring fever. The most common cause of fever in horses is respiratory disease, both viral and bacterial, but fever also can occur with other infections or inflammation of any body system. Zimeta is administered intravenously at 30 mg/kg once or twice daily, at 12-hour intervals, for up to three days. The overall number of doses and duration of treatment is dependent on the response observed (fever reduction). Zimeta may be re-administered based on recurrence of fever for up to three days.

KindredBio is proud to be a member of the American Association of Equine Practitioners (AAEP) Educational and Media Partners Program. The program represents industry-leading corporations, media outlets, and industry organizations dedicated to providing resources and education through AAEP to equine veterinarians and horse owners to improve the health and welfare of the horse. Nearly 9,300 veterinarians and veterinary students across more than 60 countries are members of the AAEP.

Important Safety Information

ZimetaTM (dipyrone injection) should not be used more frequently than every 12 hours. For use in horses only. Do not use in horses with a hypersensitivity to dipyrone, horses intended for human consumption or any food producing animals, including lactating dairy animals. Not for use in humans, avoid contact with skin and keep out of reach of children. Take care to avoid accidental self-injection and use routine precautions when handling and using loaded syringes.  Prior to use, horses should undergo a thorough history and physical examination by a veterinarian. Monitor for signs of abnormal bleeding and use caution in horses at risk for hemorrhage. Concurrent use with other NSAIDs, corticosteroids and drugs associated with kidney toxicity, should be avoided. As a class, NSAIDs may be associated with gastrointestinal, kidney, and liver toxicity. The most common adverse reactions observed during clinical trials were elevated glucose conversion enzymes, decreased blood protein, and gastric ulcers. Please see the full Prescribing Information.

Mirataz® (mirtazapine transdermal ointment) is for topical use in cats only under veterinary supervision. Do not use in cats with a known hypersensitivity to mirtazapine or any of the excipients or in cats treated with monoamine oxidase inhibitors (MAOIs). Not for human use. Keep out of reach of children. Wear gloves to apply and wash hands after. Avoid contact with treated cat for 2 hours following application.  The most common adverse reactions include application site reactions, behavioral abnormalities (vocalization and hyperactivity) and vomiting. Please see the full Prescribing Information.

About Kindred Biosciences 

Kindred Biosciences is a commercial-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. KindredBio has a deep pipeline of novel drugs and biologics in development across many therapeutic classes. The company has two approved drugs, namely Mirataz® (mirtazapine transdermal ointment) for the management of weight loss in cats and Zimeta™ (dipyrone injection) for the control of fever in horses.

Forward-Looking Statements 

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

These forward-looking statements are based on our current expectations. These statements are not promises or guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results to be materially different from any future results expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: our limited operating history and expectations of losses for the foreseeable future; the absence of significant revenue from our products and our product candidates for the foreseeable future; the likelihood that our revenue will vary from quarter to quarter; our potential inability to obtain any necessary additional financing; our substantial dependence on the success of our products and 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 products and 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 and maintain patent protection and other intellectual property protection for our products and 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.

Contacts

For investor inquiries:

Katja Buhrer

Katja.buhrer@kindredbio.com 

(917) 969-3438

Kindred Biosciences to Participate in Stifel Healthcare Conference and Jefferies London Healthcare Conference

San Francisco, California (November 14, 2019) – Kindred Biosciences, Inc. (NASDAQ: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, will participate in the Stifel Healthcare Conference on November 19 in New York City and Jefferies London Healthcare Conference on November 21.

Dr. Richard Chin, Chief Executive Officer, will present and be available for one-on-one meetings. During this time, investors will have the opportunity to discuss recent developments, including the launch of KindredBio’s first product, study results from key therapeutic programs in development, and upcoming milestones.

Conference Details:
Stifel Healthcare Conference
Date: Tuesday, November 19, 2019
Presentation time: 10:20-10:50a.m. ET in Kennedy
Location: Lotte New York Palace Hotel
Webcast URL: Click here
Jefferies London Healthcare Conference
Date: Thursday, November 21, 2019
Location: Waldorf Hilton, London

An archived version of the above webcast will be available for 30 days on the KindredBio  website.

About Kindred Biosciences 
Kindred Biosciences is a commercial-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. KindredBio’s first approved drug is Mirataz® (mirtazapine transdermal ointment) for the management of weight loss in cats.

Important Safety Information
Mirataz® (mirtazapine transdermal ointment) is for topical use in cats only under veterinary supervision. Do not use in cats with a known hypersensitivity to mirtazapine or any of the excipients or in cats treated with monoamine oxidase inhibitors (MAOIs). Not for human use. Keep out of reach of children. Wear gloves to apply and wash hands after. Avoid contact with treated cat for 2 hours following application.  The most common adverse reactions include application site reactions, behavioral abnormalities (vocalization and hyperactivity) and vomiting. Please see the full Prescribing Information.

Contact
Katja Buhrer 
katja.buhrer@kindredbio.com 
(917) 969-3438

Kindred Biosciences Announces Third Quarter 2019 Financial Results

San Francisco, California (November 12, 2019) – Kindred Biosciences, Inc. (NASDAQ: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, today announced financial results for the third quarter ended September 30, 2019 and provided updates on its programs. For the third quarter 2019, KindredBio reported net product revenues of $1.1 million and a net loss of $15.3 million, or $0.39 per share.

“We are excited about the positive opinion in the European Union regarding the Mirataz submission and expect approval of the product candidate this year. By year-end, we anticipate multiple additional catalysts, including approval of dipyrone IV in the US,” stated Richard Chin, Chief Executive Officer of KindredBio.

“Our quarterly revenues are still subject to fluctuations in distributor ordering patterns. As such, the third quarter result is not reflective of underlying demand as sales from distributors to veterinary clinics grew in the double-digits quarter-over-quarter.”

Development and Corporate Updates

  • KindredBio recorded Mirataz® (mirtazapine transdermal ointment) net product revenues of $1.1 million in the third quarter. Net product revenues were lower on a sequential basis due to several factors, including fluctuations in the ordering pattern by distributors. Sales from distributors to veterinary clinics grew 20% versus the second quarter and have increased consistently quarter-over-quarter since Mirataz’s launch. Market penetration reached approximately 51% in the third quarter, positioning Mirataz ahead of most key feline therapeutics at an equivalent stage of launch. Approximately 68% of all purchasing veterinary clinics placed re-orders, and average order size grew quarter-over-quarter.

    On October 10, 2019, KindredBio announced the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use adopted a positive opinion recommending marketing authorization of Mirataz® (mirtazapine transdermal ointment) for bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions. A marketing authorization decision from the European Commission is anticipated by mid-December.

  • The U.S. Food and Drug Administration has approved the safety and effectiveness technical sections for dipyrone injection for the control of pyrexia (fever) in horses. KindredBio expects approval of the product candidate by the end of November, dependent on satisfactory responses to outstanding Chemistry, Manufacturing, and Controls questions. Regulatory approval is subject to the typical risks inherent in such a process. Preparations for the commercial launch remain on track.

    Dipyrone injection is expected to be the first FDA-approved product for the control of fever in horses. There are eight to nine million horses in the U.S. and currently more than one million are seen by a veterinarian for fever annually. Existing off-label treatments can have serious side effects.

  • In July 2019, KindredBio reported positive topline results from its pilot field effectiveness study of KIND-016, a fully caninized, high-affinity monoclonal antibody targeting interleukin-31, for the treatment of atopic dermatitis in dogs. Due to changes and enhancements to the manufacturing process during scale-up, the pivotal effectiveness study is now expected to start in 2020.

    Almost all patients have been enrolled in the pilot effectiveness study for the company’s canine anti-IL-4/IL-13 SINK molecule, with results expected in the first quarter of 2020.

    KindredBio is pursuing a multi-pronged approach toward atopic dermatitis, with a portfolio of promising biologics. Atopic dermatitis is an immune-mediated inflammatory skin condition in dogs. It is the leading reason owners take their dog to the veterinarian, and the current market size is more than $600 million annually and growing.  

  • cGMP fill & finish for KindredBio’s feline recombinant erythropoietin was completed at the Elwood, Kansas biologics manufacturing facility in the third quarter of 2019, and the pivotal efficacy study has since been initiated. The product candidate is being developed for the management of non-regenerative anemia in cats. It has been engineered by the company to have a prolonged half-life compared to endogenous erythropoietin, a protein that regulates and stimulates production of red blood cells.

    Anemia is a common condition that is estimated to afflict millions of older cats. It is often associated with chronic kidney disease, because kidneys produce erythropoietin and chronic kidney disease leads to decreased levels of endogenous erythropoietin. Chronic kidney disease affects approximately half of older cats, making it a leading cause of feline mortality. Human erythropoietins, which are multi-billion dollar products in the human market, have been shown to be immunogenic in many cats.

  • On August 1, 2019, KindredBio announced positive results from its pilot efficacy study of KIND-030, a monoclonal antibody targeting canine parvovirus (CPV). Pivotal studies for this molecule are expected to be completed in 2020. Approval is anticipated by late 2020 or early 2021.

    CPV is the most significant cause of viral enteritis in dogs, especially puppies, with over 90% mortality rate if untreated. There are currently no approved or unapproved treatments for CPV. Currently, owners spend up to thousands of dollars for supportive care for dogs infected with CPV.

  • The pilot field effectiveness study for KindredBio’s anti-TNF antibody for canine inflammatory bowel disease (IBD) has been initiated with completion now expected in the first half of 2020, due to competing priorities for drug supply manufacturing.

    The majority of canine IBD cases involve chronic states of diarrhea, vomiting, gastroenteritis, inappetence, and other symptoms, certain of which are cited as among the most frequent disorders impacting dogs. For certain dog breeds, the prevalence of diarrhea exceeds 5%. Existing treatments can have significant drawbacks, including limited diets and excessive antibiotic use, which can lead to owner frustration, lapses in treatment adherence, or poor quality of life for the affected animal.

  • The pivotal field efficacy study for KIND-014 for the treatment of gastric ulcers in horses is scheduled to start in the fourth quarter of 2019.

Third Quarter 2019 Financial Results

For the quarter ended September 30, 2019, KindredBio reported a net loss of $15.3 million or $0.39 per share, as compared to a net loss of $13.0 million or $0.39 per share for the same period in 2018. For the nine months ended September 30, 2019, the net loss was $45.7 million or $1.18 per share, as compared to a net loss of $34.2 million or $1.14 per share for the same period in 2018.

The company recorded $1.1 million in net product revenues for Mirataz for the third quarter and $2.9 million for the first nine months of 2019. Net product revenues for the same period in 2018 were $0.6 million. Mirataz became commercially available in July 2018.

The cost of product sales totaled $0.1 million in the third quarter and $0.4 million for the first nine months in 2019, resulting in a gross margin of 87% and 86%, respectively.

Total research and development expenses for the three and nine months ended September 30, 2019 were $7.3 million and $21.2 million, respectively, compared to $7.5 million and $18.6 million for the same periods in 2018. Stock-based compensation expense included in research and development expense was $0.5 million and $1.4 million for the three and nine months ended September 30, 2019 compared to $0.4 million and $1.3 million for the same periods in 2018. The $2.5 million year-over-year increase in research and development expenses was primarily due to higher headcount and related expenses as the company focuses on advancing its biologics programs, higher consulting expenses for quality assurance programs and increased capital equipment depreciation expense.  

Selling, general and administrative expenses totaled $9.4 million and $28.3 million for the three and nine months ended September 30, 2019, compared to $6.6 million and $17.3 million for the same periods in 2018. The $11.1 million year-over-year increase is the result of being a commercial company, as well as increased expenses incurred by the Elwood, Kansas plant in the lead up to its commissioning. In addition, higher corporate infrastructure costs and stock-based compensation expense also contributed to the increase in expenses. Stock-based compensation expense included in selling, general and administrative expense was $1.4 million and $4.2 million for the three and nine months ended September 30, 2019, as compared to $1.2 million and $3.3 million for the same periods in 2018.

As of September 30, 2019, KindredBio had $87.6 million in cash, cash equivalents and investments, compared with $73.9 million as of December 31, 2018. Net cash used in operating activities for the first nine months of 2019 was approximately $42.6 million, offset by $43.1 million of net cash proceeds from an underwritten public offering of common stock in the first quarter of 2019 and $19.2 million from a debt financing in the third quarter of 2019, net of closing fees and expenses. The company also invested approximately $7.3 million in capital expenditures for the remaining portion of the build-out of its Elwood, Kansas manufacturing facility and the purchase of associated lab and manufacturing equipment for the facility.

On October 2, 2019, KindredBio announced the closing of a $50 million senior secured debt facility with investment affiliates managed by Solar Capital Partners, LLC. The non-dilutive financing agreement provides KindredBio with up to $50 million of borrowing capacity available in three tranches, each bearing interest at 1-Month LIBOR + 6.75% with a floor of 2.17%. The entire debt facility will mature on September 30, 2024.

With respect to spending in 2019, the company continues to expect operating expenses of between $57 million and $59 million, excluding the impact of stock-based compensation expense and the impact of acquisitions, if any. In addition, the company is on track with its $8.0 million to $10.0 million investment in capital expenditures for the year. KindredBio believes its existing cash, cash equivalents, restricted cash, short-term investments and additional draw down of $30 million from its debt facility, contingent on the achievement of certain milestones, will be sufficient to fund the current operating plan through 2021. Furthermore, the company plans to reduce both operating expenses and capital expenditures in 2020.

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 8153966. The call will be webcast live here, with a replay available at that link for 30 days. 

Important Safety Information

Mirataz® (mirtazapine transdermal ointment) is for topical use in cats only under veterinary supervision. Do not use in cats with a known hypersensitivity to mirtazapine or any of the excipients or in cats treated with monoamine oxidase inhibitors (MAOIs). Not for human use. Keep out of reach of children. Wear gloves to apply and wash hands after. Avoid contact with treated cat for 2 hours following application.  The most common adverse reactions include application site reactions, behavioral abnormalities (vocalization and hyperactivity) and vomiting. Please see the full Prescribing Information.

About Kindred Biosciences

Kindred Biosciences is a commercial-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. KindredBio has a deep pipeline of novel drugs and biologics in development across many therapeutic classes. Its first approved drug is Mirataz® (mirtazapine transdermal ointment) for the management of weight loss in cats.

Forward-Looking Statements 

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

These forward-looking statements are based on our current expectations. These statements are not promises or guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results to be materially different from any future results expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: our limited operating history and expectations of losses for the foreseeable future; the absence of significant revenue from our products and our product candidates for the foreseeable future; the likelihood that our revenue will vary from quarter to quarter; our potential inability to obtain any necessary additional financing; our substantial dependence on the success of our products and 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 products and 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 and maintain patent protection and other intellectual property protection for our products and 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.

The results stated in this press release have not been reviewed by the Food and Drug Administration or the United States Department of Agriculture Center for Veterinary Biologics, as applicable.

Contacts
For investor inquiries: 
Katja Buhrer
Katja.buhrer@kindredbio.com 
(917) 969-3438

Kindred Biosciences to Announce Third Quarter 2019 Financial Results

Company to Hold Conference Call and Webcast at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time on Tuesday, November 12, 2019.

San Francisco, California (October 28, 2019) — Kindred Biosciences, Inc. (NASDAQ: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, will release its third quarter 2019 financial results on November 12, 2019, 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.

Access the call by dialing toll-free (855) 433-0927 from the U.S., or (484) 756-4262 internationally, and using conference ID 8153966.

The call will also be webcast live here, with a replay available at that link for 30 days.

About Kindred Biosciences

Kindred Biosciences is a commercial-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. KindredBio has a deep pipeline of novel drugs and biologics in development across many therapeutic classes. Its first approved drug is Mirataz® (mirtazapine transdermal ointment) for the management of weight loss in cats.

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.

Important Safety Information

Mirataz® (mirtazapine transdermal ointment) is for topical use in cats only under veterinary supervision. Do not use in cats with a known hypersensitivity to mirtazapine or any of the excipients or in cats treated with monoamine oxidase inhibitors (MAOIs). Not for human use. Keep out of reach of children. Wear gloves to apply and wash hands after. Avoid contact with treated cat for 2 hours following application. The most common adverse reactions include application site reactions, behavioral abnormalities (vocalization and hyperactivity), and vomiting. Please see the full Prescribing Information.

Contacts
For investor inquiries:
Katja Buhrer
katja.buhrer@kindredbio.com
(917) 969-3438

Kindred Biosciences Announces Positive Opinion from CVMP in the European Union for Mirataz® (mirtazapine transdermal ointment) for Cats Experiencing Poor Appetite and Weight Loss

  • Mirataz would be the first and only medication approved in the EU to treat cats experiencing poor appetite and weight loss resulting from chronic medical conditions.

San Francisco, California (October 10, 2019) – Kindred Biosciences, Inc. (Nasdaq: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, today announced that the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) has adopted a positive opinion recommending marketing authorization of Mirataz® (mirtazapine transdermal ointment) for bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions. Furthermore, KindredBio announced that it recently filed for regulatory approval of Mirataz in Canada.

“Today’s positive CVMP opinion marks a key achievement for KindredBio. Europe is the second largest market for veterinary therapeutics globally. As the first medication expected to be approved for poor appetite and weight loss in cats in the EU, we are once again at the forefront of addressing unmet needs in veterinary medicine. This anticipated approval provides further validation of our rapid and cost-efficient development model,” said Richard Chin, Chief Executive Officer of KindredBio. “We expect European uptake of Mirataz to benefit from regulations prohibiting use of human medicine once an approved veterinary therapeutic is available.”

If approved in the European Union, Mirataz would be the first and only medication approved to induce bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions. Weight loss is a leading cause of visits to the veterinarian for cats in Europe.

A marketing authorization decision from the European Commission is anticipated within approximately two months. Regulatory approval is subject to the typical risks inherent in such a process. If approved, the authorization will be valid in all 28-member states of the European Union, as well as Iceland, Liechtenstein, and Norway. In Canada, the validation of the Canadian submission will be complete in the next 30 to 45 days and once accepted for review, the review timeline is approximately one year.

The CVMP’s positive opinion is based on results from both clinical and non-clinical studies. Mirataz is a serotonin (5HT2A, 5HT2C, and 5HT3) and histamine (H1) receptor antagonist, which has demonstrated body weight gain in cats experiencing poor appetite and weight loss from chronic medical conditions. In clinical studies, Mirataz resulted in significant weight gain in cats in as little as 14 days following topical application of 2 mg per day [1]. Mirataz, which is formulated with KindredBio’s proprietary Accusorb™ technology, is applied topically to the cat’s inner ear (pinna) once a day, providing a different application route compared to oral administration.

Mirataz was approved by the U.S. Food & Drug Administration in May 2018 for the management of weight loss in cats.

[1] Mirataz® (mirtazapine transdermal ointment) [package insert], Kindred Biosciences, Inc. (Burlingame, CA). Rev. 5/2018.

Important Safety Information

Mirataz® (mirtazapine transdermal ointment) is for topical use in cats only under veterinary supervision. Do not use in cats with a known hypersensitivity to mirtazapine or any of the excipients or in cats treated with monoamine oxidase inhibitors (MAOIs). Not for human use. Keep out of reach of children. Wear gloves to apply and wash hands after. Avoid contact with treated cat for 2 hours following application.  The most common adverse reactions include application site reactions, behavioral abnormalities (vocalization and hyperactivity) and vomiting. Please see the full Prescribing Information.

About Kindred Biosciences

Kindred Biosciences is a commercial-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. KindredBio has a deep pipeline of novel drugs and biologics in development across many therapeutic classes. Its first approved drug is Mirataz® (mirtazapine transdermal ointment) for the management of weight loss in cats.

Forward-Looking Statements

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

These forward-looking statements are based on our current expectations. These statements are not promises or guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results to be materially different from any future results expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: our limited operating history and expectations of losses for the foreseeable future; the absence of significant revenue from our products and our product candidates for the foreseeable future; the likelihood that our revenue will vary from quarter to quarter; our potential inability to obtain any necessary additional financing; our substantial dependence on the success of our products and 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 products and 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 and maintain patent protection and other intellectual property protection for our products and 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.

Contacts
Katja Buhrer
Katja.buhrer@kindredbio.com
(917) 969-3438

Kindred Biosciences Secures $50 Million Debt Facility with Solar Capital Partners

San Francisco, California (October 2, 2019) – Kindred Biosciences, Inc. (Nasdaq: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, today announced the closing of a $50 million senior secured debt facility with investment affiliates managed by Solar Capital Partners, LLC.

“We are pleased to have further strengthened our balance sheet and extended our operating cash runway with this non-dilutive financing. The strong credit market and high demand among lenders enabled us to achieve attractive terms on this facility. This gives us the potential to fund the current operating plan at least through the end of 2021, by which time we expect approval and launch of multiple additional products with substantial revenue potential. Assuming typical refinancing, we expect to pay the principal of the loan after we achieve positive cash flow,” said Richard Chin, Chief Executive Officer of KindredBio. “We continue to make substantial progress on our deep pipeline, with six positive pilot efficacy studies and three positive pivotal studies in a row. We look forward to a number of important catalysts through year-end as we execute on our capital-efficient business model.”

The non-dilutive financing agreement provides KindredBio with up to $50 million of borrowing capacity available in three tranches, each bearing interest at 1-Month LIBOR + 6.75% with a floor of 2.17%. Under the terms of the agreement, an initial tranche of $20 million was funded at closing. KindredBio is required to make interest only payments on a monthly basis through October 2021. An additional $30 million will be available in two tranches at the company’s option, subject to certain conditions. The entire debt facility will mature on September 30, 2024. Further information with respect to the credit facility is set forth in a Form 8-K filed by KindredBio with the Securities and Exchange Commission on October 2, 2019.

Cantor Fitzgerald & Co acted as Sole Lead Arranger and financial advisor to KindredBio on this transaction.

KindredBio’s President and Chief Operating Officer, Denise Bevers, will present today at the Cantor Global Healthcare Conference in New York City. The presentation will take place at 8:20-8:50a.m ET in Grand Ballroom 2, and will be webcast here.

About Kindred Biosciences

Kindred Biosciences is a commercial-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. KindredBio has a deep pipeline of novel drugs and biologics in development across many therapeutic classes.

About Solar Capital Partners, LLC.

Solar Capital Partners, LLC (“Solar Capital Partners”) is an SEC-registered investment adviser that primarily invests directly in leveraged, U.S. middle market companies in the form of cash flow and asset-based senior secured investments. Solar Capital Partners manages approximately $5.5 billion of investable capital, including serving as the investment adviser to two publicly-traded business development companies, Solar Capital Ltd. and Solar Senior Capital Ltd. Solar Capital Partners’ life science lending business provides financing solutions for later-stage bio-pharma, medical device, healthcare IT and healthcare services companies, both venture-backed private and public, and from pre-revenue clinical to early commercial stage. For more information, please visit http://www.solarcapltd.com/Life-Science-Lending.

Forward-Looking Statements

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

These forward-looking statements are based on our current expectations. These statements are not promises or guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results to be materially different from any future results expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: our limited operating history and expectations of losses for the foreseeable future; the absence of significant revenue from our products and our product candidates for the foreseeable future; the likelihood that our revenue will vary from quarter to quarter; our potential inability to obtain any necessary additional financing; our substantial dependence on the success of our products and 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 products and 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 and maintain patent protection and other intellectual property protection for our products and 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.

Contacts

Katja Buhrer
Katja.buhrer@kindredbio.com
(917) 969-3438

Kindred Biosciences Awarded a Contract by the National Cancer Institute in Support of the PREVENT Cancer Program

San Francisco, (September 10, 2019) – Kindred Biosciences, Inc. (NASDAQ: KIN), a commercial-stage biopharmaceutical company developing novel drugs and biologics, today announced that it has been selected by the National Cancer Institute (NCI) as one of three contractors in response to the solicitation for the PREVENT Cancer Preclinical Drug Development Program (PREVENT): Current Good Manufacturing Practice (cGMP) Production of Vaccines and Biologicals for Cancer Prevention (cGMP Pool). As a cGMP pool contractor, KindredBio is eligible to provide manufacturing, formulation and analytical services to meet the needs of the PREVENT pipeline.

PREVENT is an NCI-supported venture to advance preclinical development of innovative cancer prevention interventions and biomarkers towards clinical applications. A maximum amount of $49.95 million will be shared across three contract pools, one of which is the cGMP manufacturing pool. Within the cGMP pool, KindredBio is one of three contractors selected for award. The contract term is four years, with specific amounts based on individual task order awards yet to be determined.

“This selection is a validation of our manufacturing and project management expertise, and we look forward to working with the NCI on this important program,” said Richard Chin, CEO of KindredBio.

KindredBio operates a state-of-the-art biological development and cGMP manufacturing facility in Burlingame, CA, and recently completed construction on a 180,000 square foot large scale cGMP manufacturing facility in Elwood, KS.

The company’s core expertise includes protein engineering, cell line development, master cell banking, process development, assay development, stability testing, and cGMP clinical and commercial manufacturing. KindredBio’s biologics team comprises experts in product development, manufacturing, quality control and quality assurance personnel, and is supported by a strong project management organization.

For additional information on PREVENT, please click here. Task orders awarded to KindredBio are expected to be conducted at the company’s cGMP manufacturing facility in Burlingame, CA.

This project has been funded in whole or in part with Federal funds from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N91019D00027.

About Kindred Biosciences

Kindred Biosciences is a commercial-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. KindredBio has a deep pipeline of novel drugs and biologics in development across many therapeutic classes.

Forward-Looking Statements

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

These forward-looking statements are based on our current expectations. These statements are not promises or guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results to be materially different from any future results expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: our limited operating history and expectations of losses for the foreseeable future; the absence of significant revenue from our products and our product candidates for the foreseeable future; the likelihood that our revenue will vary from quarter to quarter; our potential inability to obtain any necessary additional financing; our substantial dependence on the success of our products and 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 products and 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 and maintain patent protection and other intellectual property protection for our products and 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.

Contacts
Katja Buhrer
Katja.buhrer@kindredbio.com
(917) 969-3438

Kindred Biosciences to Participate in H.C. Wainwright Global Investment Conference, Lake Street Best Ideas Growth Conference, and Cantor Global Healthcare Conference

San Francisco, California (August 28, 2019) – Kindred Biosciences, Inc. (NASDAQ: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, will participate in the H.C. Wainwright Global Investment Conference on September 10, the Lake Street Best Ideas Growth Conference on September 12, and the Cantor Global Healthcare Conference on October 2, in […]

Kindred Biosciences Announces Second Quarter 2019 Financial Results and Unveils Positive Results from Pilot Efficacy Study of Parvovirus Monoclonal Antibody

  • Mortality benefit seen in both prophylaxis and treatment of parvovirus infection

San Francisco, California (August 1, 2019) – Kindred Biosciences, Inc. (NASDAQ: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, today announced financial results for the second quarter ended June 30, 2019 and provided updates on its programs, including positive results from a pilot efficacy study of its previously undisclosed parvovirus monoclonal antibody. For the second quarter 2019, KindredBio reported net product revenues of $1.2 million and a net loss of $14.3 million, or $0.37 per share. For the first six months of 2019, net product revenues were $1.8 million and the net loss was $30.4 million, or $0.79 per share.

“The increase in second quarter Mirataz revenues reflects broad-based customer adoption as expanded commercial activities drive continued growth in market penetration and re-order size,” said Richard Chin, CEO of KindredBio. “We are excited to announce our parvovirus antibody program, which targets a significant unmet medical need that results in very high mortality. We are pleased with the positive study results and are targeting approval of this product candidate by late 2020, or early 2021.”

“The second half of 2019 represents a catalyst rich period, and we are on track for key milestones. Earlier this week, we announced positive pilot field effectiveness study results for our lead canine atopic dermatitis biologic candidate, positioning it to become a key therapeutic in this large and growing market. We are also pleased to report that our first cGMP drug manufacturing campaigns at our plant in Burlingame have been successful, and that construction on our state-of-the-art Kansas biologics manufacturing facility has been completed on time and on budget. With end-to-end capabilities and a highly experienced biologics team that has worked on some of the most successful human drugs, we are well-positioned to be a leader in companion animal biologics. By year-end, we also anticipate announcement of results from additional pilot studies and the initiation of three pivotal studies. These catalysts have the potential to make 2019 a landmark year for KindredBio.”

Development and Corporate Updates

  • KindredBio today announced positive results from its pilot efficacy study of KIND-030, a chimeric, high-affinity monoclonal antibody targeting canine parvovirus. This was a 12-dog study, of which 4 dogs were treated prophylactically and 2 dogs were treated after establishment of the infection. All treated dogs survived, compared to none in the applicable placebo group. The effect was seen in both prophylaxis setting, as well as in a treatment setting after establishment of infection. Pivotal studies are expected to be conducted in 2020.

    Canine parvovirus (CPV) is the most significant contagious viral cause of enteritis in dogs, especially puppies, with mortality rates reportedly as high as 91%. There are currently no Food and Drug Administration (FDA) or United States Department of Agriculture (USDA) approved treatments for CPV, nor any other available treatment. Currently, owners spend thousands of dollars per puppy in supportive care for CPV. 

  • The company recorded Mirataz®(mirtazapine transdermal ointment) net product revenues of $1.2 million in the second quarter, compared with net revenues of $0.5 million in the first quarter. Approximately 46% of veterinary clinics in the United States have purchased Mirataz since the product’s launch, and the reorder rate among participating clinics grew to approximately 65% in the quarter. The company expects ongoing commercial initiatives, the introduction of new marketing strategies and establishment of direct-to-consumer agreements to drive continued positive second-half momentum. KindredBio recently finalized agreements to stock Mirataz at leading eRetailers, such as Chewy.

    The outcome of an oral hearing requested by the European Medicines Agency (EMA) and scheduled for September 2019 will determine the extent to which additional data may be needed to obtain approval in Europe. KindredBio will update the market on the path forward for Mirataz EU pending communication from the EMA post the hearing. Regulatory approval is subject to the typical risks inherent in such a process. 

    Mirataz is the first and only transdermal medication specifically developed, and FDA-approved, for the management of weight loss in cats. Weight loss in cats is a serious and potentially fatal condition that represents a leading cause of visits to the veterinarian for cats. The company’s market research indicates that U.S. veterinarians see as many as nine million cats each year with unintended weight loss caused by varying underlying conditions, such as chronic kidney disease, cancer or diabetes. Mirataz, which is formulated with KindredBio’s proprietary Accusorb™ technology, is applied topically to the cat’s inner ear (pinna) once a day, providing a more attractive application route compared to oral administration. The product is classified as a weight gain drug and can be used in cats with various underlying diseases associated with unintended weight loss. 

  • On July 29, 2019, KindredBio reported positive topline results from its pilot field effectiveness study of KIND-016, a fully caninized, high-affinity monoclonal antibody targeting interleukin-31, for the treatment of atopic dermatitis in dogs. At week 4, 60.7% of the KIND-016 group met treatment success criteria, vs. 33.3% of the placebo group. The reduction in itching, as measured by the PVAS score, peaked rapidly, showing significant efficacy as early as 24 hours with a trend as early as 4 hours, and the CADESI response was also very rapid. Treatment success rate reached 70% as early as week 1 in the KIND-016 group. While the study was not powered to demonstrate efficacy beyond week 4, the majority of dogs who were treatment successes at week 4 maintained response through week 8. In October 2018, KindredBio previously reported positive topline results from its laboratory pilot efficacy study of KIND-016. A pivotal study is expected to commence by year-end.

    The company also expects pilot effectiveness results for its canine anti-IL-4/IL-13 SINK molecule by year-end and is advancing other programs for atopic dermatitis.  

    KindredBio is pursuing a multi-pronged approach toward atopic dermatitis, with a portfolio of promising biologics. Atopic dermatitis is an immune-mediated inflammatory skin condition in dogs. It is the leading reason owners take their dog to the veterinarian, and the current market size is more than $600 million annually and growing.  

  • The FDA has approved the safety and effectiveness technical sections for dipyrone injection for the control of pyrexia (fever) in horses. On May 16, 2019, KindredBio announced that it had been notified by its contract manufacturer of the active pharmaceutical ingredient (API) dipyrone that the FDA Center for Veterinary Medicine (CVM) had follow up questions, following an inspection in March 2019. Responses have since been submitted to the FDA by the API manufacturer, and the FDA has issued an Establishment Inspection Report indicating that the facility was compliant with good manufacturing practices. KindredBio has reactivated the New Animal Drug Application (NADA). The FDA granted a shortened timeline of 135 days for review of the NADA. Approval is expected in the fourth quarter of 2019 and is dependent on a product- and application-specific facility assessment of the API manufacturer by the CVM review office. Regulatory approval is subject to the typical risks inherent in such a process. Preparations for the commercial launch remain on track.

    Dipyrone injection is expected to be the first FDA-approved product for the control of fever in horses. There are eight to nine million horses in the U.S. and currently more than one million are seen by a veterinarian for fever annually. Existing off-label treatments can have serious side effects.  

  • The pivotal field effectiveness study for dipyrone oral gel has been completed with positive results. The target animal safety study is also complete, and dipyrone oral gel was found to be well-tolerated. KindredBio has agreed on a path forward with the FDA and bridging studies will likely commence in 2020.

    Dipyrone oral gel, which is a proprietary oral gel, is intended as a leave behind for owners to administer to their horse for continued care following dipyrone injection. Accordingly, it is expected to expand use of the drug and build upon the success of dipyrone injection.  

  • KindredBio’s feline recombinant erythropoietin cGMP drug substance met release criteria at the company’s plant in Burlingame, CA, and cGMP fill & finish will be undertaken at the Elwood, Kansas biologics manufacturing facility in the third quarter of 2019. Thereafter, a pivotal effectiveness study will commence before year-end. The product candidate is being developed for the management of non-regenerative anemia in cats. It has been engineered by the company to have a prolonged half-life compared to endogenous erythropoietin, a protein that regulates and stimulates production of red blood cells. KindredBio announced positive topline results from a pilot field effectiveness study of its feline recombinant erythropoietin in January 2019.

    Anemia is a common condition that is estimated to afflict millions of older cats. It is often associated with chronic kidney disease, because kidneys produce erythropoietin and chronic kidney disease leads to decreased levels of endogenous erythropoietin. Chronic kidney disease affects approximately half of older cats, making it a leading cause of feline mortality. Human erythropoietins, which are multi-billion dollar products in the human market, have been shown to be immunogenic in many cats.   

  • The pilot field effectiveness study for KindredBio’s anti-TNF antibody for canine inflammatory bowel disease (IBD) has been initiated and is underway. Study results are expected by the end of 2019.

    The majority of canine IBD cases involve chronic states of diarrhea, vomiting, gastroenteritis, inappetence, and other symptoms, certain of which are cited as among the most frequent disorders impacting dogs. For certain dog breeds, the prevalence of diarrhea exceeds 5%. Alongside a high frequency of canine IBD, the duration of impact is also significant, as IBD is most commonly diagnosed in middle aged dogs yet can impact the animal for life. Existing treatments can have significant drawbacks, including limited diets and excessive antibiotic use, which can lead to owner frustration, lapses in treatment adherence, or poor quality of life for the affected animal.  

  • The pilot field effectiveness study of KIND-014 for the treatment of gastric ulcers in horses has been completed with positive results. The company has selected a formulation for development and both the pivotal field and pivotal safety studies will begin in the second half of 2019.

    Equine gastric ulcer syndrome (EGUS) is a common condition in horses. Prevalence estimates have been reported to range from 60% to 90% in adult horses, depending on age, performance, and evaluated populations. A variety of clinical signs are associated with EGUS, including poor appetite, poor condition, colic, and behavioral issues.   

  • The pilot field effectiveness study of KindredBio’s anti-TNF monoclonal antibody targeting sick or septic foals has been completed, with positive results. KindredBio will initiate the next field study in 2020.

    Sepsis in foals can cause up to 50% mortality and is an important unmet medical need. There is currently no FDA-approved therapy.   

  • Construction to support initial production lines on KindredBio’s biologics manufacturing facility in Elwood, Kansas is complete. The fill & finish equipment is installed and fully commissioned. The bioreactors are being used for production of IL-31 antibodies offsite and will be installed and commissioned in Kansas on or before the first quarter of 2020, once current production activities are complete. The facility includes approximately 180,000 square feet with clean rooms, utility, equipment, and related quality documentation suitable for small molecule and biologics manufacturing. KindredBio acquired the facility in August 2017.

 Second Quarter 2019 Financial Results

For the quarter ended June 30, 2019, KindredBio reported a net loss of $14.3 million or $0.37 per share, as compared to a net loss of $11.2 million or $0.39 per share, for the same period in 2018. For the six months ended June 30, 2019, the net loss was $30.4 million or $0.79 per share, as compared to a net loss of $21.2 million or $0.75 per share for the same period in 2018.

The company recorded $1.2 million in net product revenues for Mirataz for the second quarter and $1.8 million for the first six months of 2019. There were no net product revenues for the same periods in 2018 as Mirataz became commercially available in July 2018.

The cost of product sales totaled $0.2 million in the second quarter and $0.3 million for the six months in 2019, resulting in a gross margin of 86% and 85%, respectively.

Research and development expenses for the three and six months ended June 30, 2019 were $6.7 million and $13.9 million, respectively, compared to $5.8 million and $11.2 million for the same periods in 2018. Stock-based compensation expense included in research and development expense was $0.5 million and $0.9 million for the three and six months ended June 30, 2019, as compared to $0.4 million and $0.9 million for the same periods in 2018. The $2.7 million year-over-year increase in research and development expenses was primarily due to higher headcount and related expenses as the company focuses on advancing its biologics programs, and higher consulting expenses for quality assurance programs.

Selling, general and administrative expenses were $9.1 million and $19.0 million for the three and six months ended June 30, 2019, compared to $5.8 million and $10.7 million for the same periods in 2018. The $8.3 million year-over-year increase is the result of being a commercial company, as well as increased expenses incurred by the Elwood, Kansas plant in the lead up to its commissioning. In addition, higher corporate infrastructure costs and stock-based compensation expense also contributed to the increase in expenses. Stock based compensation expense was $1.4 million and $2.8 million for the three and six months in the first half of 2019, versus $1.0 million and $2.0 million in the year-ago period.

As of June 30, 2019, KindredBio had $79.6 million in cash, cash equivalents and investments, compared with $73.9 million as of December 31, 2018. Net cash used in operating activities for the first six months of 2019 was approximately $31.8 million, offset by $43.1 million of net cash proceeds from an underwritten public offering of its common stock in the first quarter of 2019. The company also invested approximately $6.7 million in capital expenditures for the remaining portion of the build-out of its Elwood, Kansas manufacturing facility and the purchase of associated lab and manufacturing equipment for the facility.

With respect to spending in 2019, the company continues to expect operating expenses of between $57 million and $59 million, excluding the impact of stock-based compensation expense and the impact of acquisitions, if any. In addition, the company is on track with its $8.0 million to $10.0 million investment in capital expenditures for the year. KindredBio believes its existing cash, cash equivalents, restricted cash and short-term investments will be sufficient to fund the current operating plan at least through the end of 2020.

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 3784614. The call will be webcast live here, with a replay available at that link for 30 days. 

Important Safety Information

Mirataz® (mirtazapine transdermal ointment) is for topical use in cats only under veterinary supervision. Do not use in cats with a known hypersensitivity to mirtazapine or any of the excipients or in cats treated with monoamine oxidase inhibitors (MAOIs). Not for human use. Keep out of reach of children. Wear gloves to apply and wash hands after. Avoid contact with treated cat for 2 hours following application.  The most common adverse reactions include application site reactions, behavioral abnormalities (vocalization and hyperactivity) and vomiting. Please see the full Prescribing Information.

About Kindred Biosciences

Kindred Biosciences is a commercial-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. KindredBio has a deep pipeline of novel drugs and biologics in development across many therapeutic classes. Its first approved drug is Mirataz® (mirtazapine transdermal ointment) for the management of weight loss in cats.

Forward-Looking Statements 

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

These forward-looking statements are based on our current expectations. These statements are not promises or guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results to be materially different from any future results expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: our limited operating history and expectations of losses for the foreseeable future; the absence of significant revenue from our products and our product candidates for the foreseeable future; the likelihood that our revenue will vary from quarter to quarter; our potential inability to obtain any necessary additional financing; our substantial dependence on the success of our products and 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 products and 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 and maintain patent protection and other intellectual property protection for our products and 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.

The results stated in this press release have not been reviewed by the Food and Drug Administration or the United States Department of Agriculture Center for Veterinary Biologics, as applicable.

Contacts
For investor inquiries: 
Katja Buhrer
Katja.buhrer@kindredbio.com 
(917) 969-3438