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 New York City.

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:
H.C. Wainwright Global Investment Conference
Date: Tuesday, September 10, 2019
KindredBio participant: CEO Richard Chin
Presentation time: 8:20-8:45a.m. ET in Adams, 4th Fl
Location: Lotte New York Palace Hotel
Webcast URL: Click here
Lake Street Best Ideas Growth Conference
Date: Thursday, September 12, 2019
KindredBio participant: CEO Richard Chin
Location: Parker New York
Cantor Global Healthcare Conference
Date: Wednesday, October 2, 2019
KindredBio participant: President and COO Denise Bevers
Presentation time: 9:30-10:00a.m ET in Track 5 – Empire Ballroom 2
Location: InterContinental New York Barclay
Webcast URL: Click here

An archived version of the above webcasts 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 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

Kindred Biosciences Announces Positive Results from Pilot Field Effectiveness Study of its Interleukin-31 Monoclonal Antibody for the Treatment of Atopic Dermatitis in Dogs

– Achieved rapid and dramatic reduction in pruritus (itch) and CADESI score versus placebo.
– Call to discuss study results at 8:30 a.m. Eastern time today.

San Francisco, California (July 29, 2019) – Kindred Biosciences, Inc. (NASDAQ: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, today announced positive topline results from its pilot effectiveness study of KIND-016, a fully caninized, high-affinity monoclonal antibody targeting interleukin-31 (IL-31), for the treatment of atopic dermatitis in dogs. Atopic dermatitis is the most common reason owners take their dog to the veterinarian, and is estimated to affect 10 – 15% of dogs worldwide. [1] The current market size is over $600 million annually and growing rapidly.  

The study was a randomized, blinded, placebo-controlled, pilot field study that enrolled 62 client-owned dogs with atopic dermatitis to assess the effectiveness of KIND-016. A single dose of KIND-016 or placebo was administered on day 0, and the severity of pruritus (Pruritic Visual Analog Scale [PVAS score]) and atopic dermatitis severity (Canine Atopic Dermatitis Extent and Severity Index-4 [CADESI-4 score]) were assessed at day 0 and weeks 1, 2, 3, 4, 6, and 8. Additionally, PVAS scores were assessed at 4 hours and days 1, 2 and 3 post-administration of KIND-016 or placebo. Treatment success for individual dogs at each visit was defined as a 50% or higher reduction from baseline in either the PVAS or CADESI-4 scores. The primary efficacy endpoint was proportion of treatment successes at week 4 in the per-protocol population. The primary effectiveness analysis was the 95% confidence interval (CI) for the treatment effect.

At week 4, 60.7% of the KIND-016 group met treatment success criteria, vs. 33.3% of the placebo group (p=0.0420, 95% CI -0.0033, 0.6539). 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. The CADESI response was also very rapid, with treatment success rate reaching 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.

“We are delighted by the positive results of this study. Atopic dermatitis, allergic dermatitis, and other pruritic diseases constitute an enormous market, now at $600 million annually and growing. We believe we have an excellent product candidate which has the potential to be a blockbuster, especially given its rapid onset of action and robust efficacy. According to our market research, there are approximately 14 million dogs and 4.5 million cats that suffer from pruritus each year in the U.S. alone. Our market research also found that more than 70% of veterinarians, and a higher percentage of dermatologists, express a need for a new biological treatment option for pruritic dogs,” stated Richard Chin, CEO of KindredBio. “This is our fifth positive pilot efficacy study in a row, three of which were de novo biologics. Our Kansas biologics plant that has been designed at maximal capacity to meet demand of over a billion dollars of product per year will soon be fully commissioned. We look forward to initiating the pivotal study for KIND-016 this year as we continue to execute on our rapid, capital-efficient business model.”

KindredBio will hold a call to discuss and answer questions on the results of the pilot field effectiveness study at 8:30 a.m. Eastern time/5:30 a.m. Pacific time today. 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 9162039. The call will 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.

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 United States Department of Agriculture Center for Veterinary Biologics.

Contacts

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

[1] Hillier, A. and C.E. Griffin, The ACVD task force on canine atopic dermatitis (I): incidence and prevalence. Vet Immunol Immunopathol, 2001. 81(3-4): p. 147-51.
[1] Website, N.P.I. Top 10 Medical Conditions of 2016. Available from: https://www.prnewswire.com/news-releases/most-common-medical-conditions-for-dogs-and-cats-300418097.html

Kindred Biosciences Announces First Quarter 2019 Financial Results

San Francisco, CA (May 9, 2019) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced financial results for the first quarter ended March 31, 2019 and provided updates on its programs. For the first quarter 2019, KindredBio reported net product revenues of $0.5 million and a net loss of $16.1 million, or $0.42 per share.

“We are confident that Mirataz is on track to be a successful feline drug. We have seen strong growth in penetration and continued positive customer feedback, and expect the commencement of planned commercial initiatives to meaningfully expand sales this year,” said Richard Chin, CEO of KindredBio. “We believe 2019 will be a banner year for KindredBio. Already, we have successfully completed our first cGMP drug substance manufacturing runs at our plant in Burlingame, CA, representing a major accomplishment for KindredBio. With one of the deepest pipelines in animal health, we expect FDA approval of dipyrone IV, the commencement of three pivotal studies, readouts on several pilot studies, and the commissioning of our Kansas biologics manufacturing facility to further enhance our position as a leader in companion animal therapeutics in 2019.”

Development and Corporate Updates

  • KindredBio recorded Mirataz® (mirtazapine transdermal ointment) net product revenues of $0.5 million in the first quarter. While net product revenues were lower versus the fourth quarter, sales of Mirataz from distributors to veterinary clinics increased quarter-over-quarter. Market penetration reached approximately 40%, positioning Mirataz ahead of most key feline therapeutics at an equivalent stage of launch, with approximately 61% of all purchasing veterinary clinics placing re-orders. KindredBio has seen a positive relationship between the number of veterinarian interactions (promotion by the Company’s sales specialists, professional service veterinarians, and educational events) and Mirataz sales. Accordingly, the Company expects a higher volume of promotional and educational events in the second quarter, alongside the commencement of a direct-to-consumer campaign, to further drive uptake.

    In April 2019, KindredBio received a request for further information from the European Medicines Agency (EMA) following their review of the Company’s responses to the first round of queries. The EMA’s response included a request to discuss the submission at an oral hearing, which has been scheduled for September 2019. The outcome of the oral hearing will determine the extent to which additional data may need to be generated to obtain European approval of Mirataz. 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 Food and Drug Administration (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 research estimates 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.

  • The FDA has approved the safety and effectiveness technical sections for dipyrone injection for the control of pyrexia (fever) in horses. The Company has filed a New Animal Drug Application for dipyrone injection with the FDA. The FDA inspection of the contract manufacturer of the active pharmaceutical ingredient dipyrone took place in March 2019. Pending a positive outcome from the manufacturer’s response to the findings, FDA approval of dipyrone injection is expected in mid-2019. 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 United States 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.

  • The Company is currently conducting a pilot field effectiveness study of KIND-016, a fully caninized, high-affinity monoclonal antibody targeting interleukin-31 (IL-31), for the treatment of atopic dermatitis in dogs. Results from the study are expected in the third quarter, with a pivotal study expected to commence by year-end. In October 2018, KindredBio reported positive topline results from its pilot efficacy study of KIND-016.

    The Company also expects pilot effectiveness results for its canine anti-IL-4/IL-13 SINK molecule in 2H 2019 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.

  • cGMP manufacturing has been completed at the Company’s Burlingame facility for KindredBio’s feline recombinant erythropoietin that is being developed for the management of non-regenerative anemia in cats. cGMP fill & finish will be undertaken at the Company’s biologics manufacturing facility in Elwood, Kansas, which is expected to be completed by mid-2019. Thereafter, a pivotal effectiveness study will commence before year-end. KindredBio announced positive topline results from a pilot field effectiveness study of its feline recombinant erythropoietin in January 2019. The product candidate has been engineered by KindredBio 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.

  • 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.

    IBD can affect dogs at any age, but is more common in middle-aged and older dogs.

  • 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 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 expected to be completed by mid-2019. 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.

First Quarter 2019 Financial Results

For the quarter ended March 31, 2019, KindredBio reported a net loss of $16.1 million or $0.42 per share, as compared to a net loss of $10.0 million or $0.36 per share, for the same period in 2018.

The Company recorded $0.5 million in net product revenues for Mirataz for the quarter ended March 31, 2019. There were no net product revenues for the same period in 2018 as Mirataz became commercially available in July 2018.

The cost of product sales totaled $92,000 in the first quarter of 2019, resulting in a gross margin of 82%.

Research and development expenses for the quarter ended March 31, 2019 were $7.2 million, compared to $5.3 million for the same period in 2018. The $1.8 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. Stock based compensation expense for the first quarter of 2019 was $0.4 million, as compared to $0.5 million for the same period in 2018.

Selling, general and administrative expenses for the 2019 and 2018 first quarters were $9.9 million and $4.9 million, respectively. The $5.0 million year-over-year increase included higher payroll and related expenses, marketing, travel and conference expenses related to Mirataz, as well as increased expenses incurred by the 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 for the 2019 first quarter, versus $1.0 million in the year-ago period.

As of March 31, 2019, KindredBio had $96.0 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 quarter of 2019 was approximately $18.7 million. The Company also invested approximately $2.7 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.

On January 23, 2019, KindredBio closed its public offering of 4,847,250 shares of common stock at $9.50 per share. The gross proceeds are approximately $46 million before deducting underwriting discounts and commissions and offering expenses payable by KindredBio. The net proceeds will be used for the development of KindredBio’s therapeutic candidates, the expansion of its commercial infrastructure, and for other general corporate and working capital purposes.

With respect to spending in 2019, the Company remains focused on advancing its core pipeline and programs, including the commencement of multiple pivotal studies, increasing adoption of Mirataz and preparing for the commercial launch of dipyrone injection. Given approval of Mirataz EU is no longer expected in 2019, the Company is revising its expectations for 2019 operating expenses. KindredBio now anticipates operating expenses of between $57 million and $59 million, excluding the impact of stock-based compensation expense and the impact of acquisitions, if any. The Company continues to plan to invest $8.0 million to $10.0 million in capital expenditures on lab and manufacturing equipment for its biologics programs and the remaining portion of the build-out of its Elwood, Kansas facility. KindredBio believes its existing cash, cash equivalents, restricted cash and short-term investments will be sufficient to fund the current operating plan through early 2021.

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 5176808. 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. 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.

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 Mirataz® (mirtazapine transdermal ointment) 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 Mirataz 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 Mirataz 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 Mirataz 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 Announce Second 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 Thursday, August 1, 2019.

San Francisco, California (July 16, 2019) — Kindred Biosciences, Inc. (NASDAQ: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, will release its second quarter 2019 financial results on August 1, 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 3784614.

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

Source: Kindred Biosciences, Inc.

Kindred Biosciences to Participate in the B. Riley FBR Institutional Investor Conference, Stifel 2019 Dental & Veterinary Conference and 9th Annual LD Micro Invitational

SAN FRANCISCO (May 13, 2019) Kindred Biosciences, Inc. (NASDAQ: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, will participate in the B. Riley FBR Institutional Investor Conference taking place May 22nd in Beverly Hills, the Stifel 2019 Dental & Veterinary Conference taking place May 29th in New York, and the 9th Annual LD Micro Invitational taking place June 4th in Bel-Air, CA.

During this time, investors will have the opportunity to discuss recent developments, including the launch of KindredBio’s first product, key therapeutic programs in development, and upcoming milestones.

Conference Details:
B. Riley FBR Institutional Investor Conference
Date: Wednesday, May 22, 2019
KindredBio participant: Richard Chin, Chief Executive Officer
Presentation time: 1:00 – 1:25 PM PT
Location: The Beverly Hilton, Beverly Hills, Room 4
Webcast URL: Click here
Stifel 2019 Dental & Veterinary Conference
Date: Wednesday, May 29, 2019
KindredBio participant: Denise Bevers, President and Chief Operating Officer
Presentation time: 10:00 – 10:25 AM ET
Location: The Pierre Hotel, Grand Ballroom
Webcast URL: Click here
9th Annual LD Micro Invitational
Date: Tuesday, June 4, 2019
KindredBio participant: Richard Chin, Chief Executive Officer
Presentation time: 10:20 – 10:40 AM PT
Location: Luxe Sunset Boulevard Hotel, Bel-Air, Track 1
Webcast URL: Click here

Archived versions of the above webcasts will be available for 30 days on the Company’s 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.

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.

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

Source:  Kindred Biosciences, Inc.

Kindred Biosciences to Announce First 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 Thursday, May 9, 2019

San Francisco, CA (April 25, 2019) — Kindred Biosciences, Inc. (NASDAQ: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, today announced that it will release its first quarter 2019 financial results on May 9, 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.

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 5176808.

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. 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.

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

Source:  Kindred Biosciences, Inc.

Kindred Biosciences Announces Fourth Quarter and Full Year 2018 Financial Results

San Francisco, CA (March 6, 2019) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced financial results for the fourth quarter and full year ended December 31, 2018 and provided updates on its programs. For the fourth quarter 2018, KindredBio reported net product revenues of $1.3 million and a net loss of $15.4 million, or $0.46 per share. For the full year 2018, net product revenues were $2.0 million and the net loss was $49.7 million, or $1.60 per share.

“2018 was a transformational year for KindredBio marked by the approval of our first product, our transition to a commercial-stage company and the announcement of positive data validating our industry leading biologics pipeline. We are pleased to have doubled fourth quarter Mirataz® revenues quarter-over-quarter, reflecting broad-based customer demand and increased re-order size. We also achieved our goal of having Mirataz stocked in one-third of all veterinary clinics in the United States within six months of launch. Year-to-date, the rollout of Mirataz remains on track, with sales responding favorably to our participation at key industry conferences and broader marketing efforts. We also reported positive topline results from our pilot field effectiveness study of our feline recombinant erythropoietin in January, representing our third consecutive positive efficacy study in our biologics pipeline,” said Richard Chin, KindredBio CEO. “Looking to the year ahead, we expect the expansion of Mirataz sales, study results across key pipeline candidates, additional approvals and the commissioning of our Kansas biologics manufacturing facility to drive continued positive momentum.”

Development and Corporate Updates

  • KindredBio recorded Mirataz® (mirtazapine transdermal ointment) net product revenues of $1.3 million in the fourth quarter, which is more than double third quarter net product revenues of $0.6 million. The product became commercially available to U.S. veterinarians on July 9, 2018. During the second half of 2018, market penetration reached approximately 33%, with approximately 56% of participating veterinary clinics placing re-orders in that period.

    In December 2017, the European Medicines Agency (EMA) accepted KindredBio’s Mirataz submission for review. The Company has responded to the EMA’s list of questions and expects that Mirataz will be approved by the EMA in 2019. Regulatory approval is subject to the typical risks inherent in such a process.

    Mirataz is the first and only transdermal medication specifically developed, and Food and Drug Administration (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 research estimates 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 January 14, 2019, KindredBio announced positive topline results from its pilot field effectiveness study of its feline recombinant erythropoietin that is being developed for the management of non-regenerative anemia in cats. The product candidate has been engineered by KindredBio 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.

  • The FDA has approved the safety and effectiveness technical sections for dipyrone injection for the control of pyrexia (fever) in horses. The Company has filed a New Animal Drug Application for dipyrone injection with the FDA. Pending a positive inspection of the contract manufacturer of the active pharmaceutical ingredient dipyrone, FDA approval of dipyrone injection is expected in mid-2019. 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, a significant unmet medical condition that affects millions of horses each year.

  • 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 is in discussions with the FDA regarding the data required for submission and is in the process of transferring the product to the commercial manufacturer.

    Dipyrone oral gel, which is a proprietary oral gel, is expected to expand use of the drug and build upon the success of dipyrone injection.

  • In October 2018, KindredBio reported positive topline results from its pilot effectiveness study of KIND-016, a fully caninized, high-affinity monoclonal antibody targeting interleukin-31 (IL-31), for the treatment of atopic dermatitis in dogs.

    KindredBio is currently conducting a pilot field effectiveness study for its IL-31 antibody, with a pivotal study expected to commence in 2019. The Company continues to expect pilot efficacy results for its canine anti-IL-4/IL-13 SINK molecule in 2019 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 almost $600 million annually and growing rapidly.

  • The pilot field efficacy study for KindredBio’s anti-TNF antibody for canine inflammatory bowel disease (IBD) has been initiated and is currently enrolling.

    IBD can affect dogs at any age, but is more common in middle-aged and older dogs.

  • 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 anticipates moving into a pivotal field study in 2019.

    Equine gastric ulcer syndrome (EGUS) is a common condition in horses which affects approximately half of all horses. A variety of clinical signs are associated with EGUS, including poor appetite, poor condition, colic, and behavioral issues.

  • The pilot field efficacy study of KindredBio’s anti-TNF monoclonal antibody targeting sick or septic foals has been completed, with positive results. KindredBio intends to continue field studies during the 2020 foaling season, following discussion with the FDA regarding the development plan.

    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 expected to be completed by mid-2019. 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.

Fourth Quarter and Year-End 2018 Financial Results

For the quarter ended December 31, 2018, KindredBio reported a net loss of $15.4 million, or $0.46 per share, compared to a net loss of $9.7 million, or $0.35 per share, for the same period in 2017. For the year ended December 31, 2018, the net loss was $49.7 million or $1.60 per share as compared to a net loss of $30.9 million, or $1.23 per share in 2017.

The Company recorded $1.3 million and $2.0 million in net product revenues for Mirataz for the quarter and year ended December 31, 2018, respectively. Mirataz became commercially available in July 2018.

The cost of product sales totaled $0.2 million in the fourth quarter of 2018 and $0.3 million for the year, resulting in a gross margin of 84% for both periods.

Research and development expenses totaled $7.8 million for the fourth quarter ended December 31, 2018 compared to $5.1 million for the same period in 2017. For the full year 2018, research and development expenses were $26.4 million, compared to $17.7 million in 2017. Stock-based compensation expense related to research and development was $1.7 million for both years. The $8.7 million increase in full year research and development expenses was primarily due to higher headcount and related expenses as the Company advances its biologics programs. In addition, increased clinical trial costs and expanded biologics manufacturing, as well as lab supplies expenses (including other operations expenses), drove research and development expenses higher.

Selling, general and administrative expenses totaled $9.2 million for the fourth quarter ended December 31, 2018 compared to $4.8 million for the same period in 2017. For the full year 2018, selling, general and administrative expenses were $26.5 million, compared to $14.0 million for 2017. The $12.5 million increase in full year selling, general and administrative expenses was due to higher headcount and related expenses as KindredBio transitioned to a commercial stage Company, as well as higher corporate and administrative, and stock-based compensation expenses. Stock-based compensation expense included in selling, general and administrative was $4.5 million in 2018, versus $3.6 million in 2017.

As of December 31, 2018, KindredBio had $73.9 million in cash, cash equivalents and investments, compared to $82.5 million at December 31, 2017. Net cash used in operating activities in 2018 was approximately $45.0 million, offset by a total of $49.2 million of net cash proceeds from an underwritten public offering of the Company’s common stock and an At-the-Market equity offering program. The Company also invested approximately $13.9 million in capital expenditures for the build-out of its Elwood, Kansas manufacturing facility, including equipment purchases.

On January 23, 2019, KindredBio closed its public offering of 4,847,250 shares of common stock at $9.50 per share. The gross proceeds are approximately $46 million before deducting underwriting discounts and commissions and offering expenses payable by KindredBio. The net proceeds will be used for the development of KindredBio’s therapeutic candidates, the expansion of its commercial infrastructure, and for other general corporate and working capital purposes.

With respect to spending in 2019, the Company will focus on advancing its core pipeline and programs, including the commencement of multiple pivotal studies, increasing adoption of Mirataz and preparing for the commercial launch of dipyrone injection. Accordingly, for 2019 the Company expects operating expenses of between $64.0 million and $68.0 million, excluding the impact of stock-based compensation expense and the impact of acquisitions, if any. Additionally, KindredBio plans to invest $8.0 million to $10.0 million in capital expenditures on lab and manufacturing equipment for its biologics programs and the remaining portion of the build-out of its Elwood, Kansas facility.

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 6089328. 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. 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.

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 Mirataz® (mirtazapine transdermal ointment) and our product candidates for the foreseeable future; our potential inability to obtain any necessary additional financing; our substantial dependence on the success of Mirataz 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 Mirataz 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 Mirataz 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

For media inquiries:
Jeanene Timberlake
jtimberlake@rooneyco.com
(646) 770-8858

 

Kindred Biosciences to Announce Fourth Quarter and Year-End 2018 Financial Results

Company to Hold Conference Call and Webcast at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time on Wednesday, March 6, 2019

San Francisco, CA (February 19, 2019) — Kindred Biosciences, Inc. (NASDAQ: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, today announced that it will release its fourth quarter and year-end 2018 financial results on March 6, 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.

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 6089328.

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. 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.

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

For media inquiries:
Jeanene Timberlake
jtimberlake@rooneyco.com
(646) 770-8858