Kindred Biosciences Announces the Termination of Its At-The-Market Equity Offering Program

San Francisco, California. (June 20, 2018) – Kindred Biosciences, Inc. (NASDAQ: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, today announced the termination of its “at-the-market” equity offering program (the “ATM Facility”) with B. Riley FBR, Inc. and Oppenheimer & Co. Inc. as sales agents.

“With the recent successful offering, KindredBio is now well capitalized and we do not anticipate requiring additional funding to achieve our current corporate and development objectives,” stated Richard Chin, CEO of KindredBio.

Although the official termination of the ATM Facility will be effective as of June 30, 2018, KindredBio will make no further sales of shares under the ATM Facility between June 20, 2018 and the effective date.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may there be any sale of the common stock in the public offering described above in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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

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

 

Contact

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

Kindred Biosciences Announces Pricing of Public Offering

SAN FRANCISCO, California. (June 20, 2018) – Kindred Biosciences, Inc. (NASDAQ: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, today announced the pricing of an underwritten public offering of 4,631,578 shares of its common stock at a public offering price of $9.50 per share, for a total offering amount of $44 million before deducting underwriting discounts and commissions and estimated offering expenses payable by KindredBio.  KindredBio has granted to the underwriters a 30-day option to purchase up to an additional 694,736 shares of its common stock. All of the shares are being offered by KindredBio.

The offering is expected to close on June 22, 2018, subject to satisfaction of customary closing conditions.

Cantor Fitzgerald & Co. is acting as the sole book-running manager for the offering and B. Riley FBR is acting as the co-manager.  A.G.P. / Alliance Global Partners and H.C. Wainwright & Co. provided financial advisory services.

KindredBio intends to use the net proceeds from the offering, if completed, for the expansion of its commercial infrastructure in anticipation of future product approvals and launches, for expansion of its manufacturing capacity, the development of its therapeutic candidates, and for other general corporate and working capital purposes.

The shares are being offered pursuant to an effective shelf registration statement on Form S-3, as amended (File No. 333-222597), that was previously filed with the Securities and Exchange Commission (SEC) and declared effective on February 7, 2018.  A preliminary prospectus supplement and accompanying prospectus related to the offering was filed with the SEC on June 19, 2018 and is available on the SEC’s website located at www.sec.gov.  A final prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC. When available, the final prospectus supplement and accompanying prospectus may also be obtained by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by e-mail at prospectus@cantor.com.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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

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

 

Contact

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

Kindred Biosciences Announces Proposed Public Offering of Common Stock

SAN FRANCISCO, California. (June 19, 2018) – Kindred Biosciences, Inc. (NASDAQ: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, today announced a proposed public offering of its common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Cantor Fitzgerald & Co. is acting as the sole book-running manager for the offering and B. Riley is acting as the co-manager.

KindredBio intends to use the net proceeds from the offering, if completed, for the expansion of its commercial infrastructure in anticipation of future product approvals and launches, for expansion of its manufacturing capacity, the development of its therapeutic candidates, and for other general corporate and working capital purposes.

The shares are being offered pursuant to an effective shelf registration statement on Form S-3, as amended (File No. 333-222597), that was previously filed with the Securities and Exchange Commission (SEC) and declared effective on February 7, 2018. The securities may be offered only by means of a prospectus. A preliminary prospectus supplement and accompanying base prospectus related to the offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Copies of the preliminary prospectus supplement, when available, and accompanying base prospectus may also be obtained by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by e-mail at prospectus@cantor.com.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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

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

 

Contact

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

KindredBio Announces Positive Results from Pilot Effectiveness Study of KIND-014 for the Treatment of Gastric Ulcers in Horses

SAN FRANCISCO, May 30, 2018 /PRNewswire/ — Kindred Biosciences, Inc. (NASDAQ: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, today announced positive results from its pilot field effectiveness study of KIND-014 for the treatment of gastric ulcers in horses.

This study was a randomized, single-blind, placebo-controlled, dose-ranging study that enrolled 53 horses (40 horses in three KIND-014 groups with different doses and dosing schedules, 13 horses in the placebo group). The objective was to determine the effective dose of KIND-014 for the treatment of gastric ulcers in horses. At Week 3, the gastric ulcer resolution (gastric ulcer score=0) rates in all three KIND-014 groups were statistically significantly higher than the placebo group (p-values < 0.05).

“We are very pleased with the positive results from this study and believe that KIND-014 has the potential to improve the treatment of horses with this important medical need. We look forward to advancing KIND-014 into the next phase of development, ” stated Richard Chin, M.D., President and Chief Executive Officer of KindredBio.

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.

Contact

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

Kindred Biosciences to Present at Jefferies 2018 Global Healthcare Conference and 8th Annual LD Micro Invitational Conference

SAN FRANCISCO, May 29, 2018 /PRNewswire/ — Kindred Biosciences, Inc. (NASDAQ: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, will present at the 8th Annual LD Micro Invitational Conference taking place June 4th-6th in Bel Air, CA and at the Jefferies 2018 Global Healthcare Conference taking place June 5th-8th in New York.

Richard Chin, M.D., President and 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 approval of KindredBio’s first product, key therapeutic programs in development, and upcoming milestones.

Presentation Details:

8th Annual LD Micro Invitational Conference

Date: Tuesday, June 5, 2018

Time: 7:30 – 8 AM PDT

Location: Luxe Sunset Boulevard Hotel, Track 2

Webcast URL: Click here

Jefferies 2018 Global Healthcare Conference

Date: Friday, June 8, 2018

Time: 2 – 2.25 PM EDT

Location: Grand Hyatt, NY, Ballroom IV

Webcast URL: Click here

An archived version 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.

Contact

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

Kindred Biosciences to Present at Stifel 2018 Dental & Veterinary Conference

SAN FRANCISCO, May 24, 2018 /PRNewswire/ — Kindred Biosciences, Inc. (NASDAQ: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, will present at the Stifel 2018 Dental & Veterinary Conference on May 30, 2018 in New York City.

Denise Bevers, Co-Founder and Chief Operating Officer, will present and be available for one-on-one meetings along with KindredBio’s Chief Financial Officer, Wendy Wee. During this time, investors will have the opportunity to discuss recent developments, including the approval of KindredBio’s first product, key therapeutic programs in development, and upcoming milestones.

Presentation Details:

Date: Wednesday, May 30, 2018

Time: 8:35 – 9:05am EDT

Location: The Peninsula Hotel, NY, Gramercy Room

Webcast URL: Click here

An archived version of the above webcast 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.

Contact

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

Kindred Biosciences Announces First Quarter 2018 Financial Results

San Francisco, CA (May 8, 2018) 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 first quarter ended March 31, 2018 and provided updates on its programs.

“We are excited about the recent approval of our first product, Mirataz™, for the management of weight loss in cats. This first-in-class medicine, which is the only FDA-approved treatment for this indication, and the first transdermal product ever approved for cats by FDA, will help millions of cats with a serious and potentially fatal unmet medical need,” stated Richard Chin, CEO of KindredBio. “In less than five years and at a cost of under $5 million, we have brought to market our first product, thereby validating our strategy of quickly and cost-efficiently developing therapeutics that improve the lives of pets. We are also very pleased with the progress across our rich pipeline, including epoCat™ and our monoclonal antibodies for atopic dermatitis, which represent large market opportunities.”

Development and Corporate Milestones

  • On May 4, KindredBio received approval of Mirataz™ (mirtazapine transdermal ointment).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. The Company’s research estimates that U.S. veterinarians see as many as 9 million cats each year with unintended weight loss, making this condition the leading cause of visits to the veterinarian for cats. 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 Company will commence taking Mirataz orders within the next two weeks via distributors and KindredBio’s team of sales specialists. The product will then ship within the next two to three months, once packaging has been updated based with the final FDA-approved label.

  • The FDA has approved the safety and effectiveness technical sections for Zimeta™ (dipyrone injection) for the control of pyrexia (fever) in horses. The FDA has indicated it does not have any additional questions or requests from KindredBio regarding the CMC technical section. The approval is pending a pre-approval inspection, or PAI, at the contract manufacturer of Zimeta IV scheduled by the FDA in July 2018, and an acceptable resolution by the contract manufacturer of the active pharmaceutical ingredient (API) dipyrone of findings identified during an inspection last month. The Company believes that the findings at the API manufacturer are minor and addressable. Regulatory approval is subject to the typical risks inherent in such a process. Preparations for the commercial launch remain on track.Zimeta IV 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 Zimeta™ (dipyrone oral gel) has been completed with positive results. The target animal safety study is also complete, and the Zimeta Oral 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.Zimeta Oral, which is a proprietary oral gel, is expected to expand use of the drug and build upon the success of Zimeta IV.
  • KindredBio has initiated or is in the process of initiating pilot field effectiveness studies for several molecules for atopic dermatitis, including fully-caninized anti-IL31 antibody, fully-caninized anti-IL17 antibody, and canine anti-IL4/IL13 SINK molecule.Atopic dermatitis is an immune-mediated inflammatory skin condition in dogs. It is one of the most common skin diseases in dogs and represents a significant unmet medical need, with the two lead products in the market expected to reach combined sales of over $500 million this year. KindredBio is pursuing a multi-pronged approach toward atopic dermatitis, with a portfolio of promising biologics.
  • The pilot field effectiveness study of the enhanced version of epoCat™ (long-acting feline recombinant erythropoietin) for the control of non-regenerative anemia in cats has been initiated and enrollment is ongoing.Anemia is a common condition in older cats which is often associated with chronic kidney disease, resulting in decreased levels of endogenous erythropoietin. Chronic kidney disease can affect approximately half of older cats. epoCat is a recombinant protein that has been specially engineered by KindredBio with a prolonged half-life compared to endogenous feline erythropoietin. The PK data suggest that the molecule may have a sufficiently long half-life to allow for once-monthly dosing.
  • The pilot field safety study of KIND-014 for the treatment of equine gastric ulcers has been completed and KIND-014 was well-tolerated. KindredBio has completed dose range finding and palatability studies and, based on the study results, the Company has advanced two formulations into pilot field studies. The pilot studies have been initiated and enrollment for one of the formulation candidates has been completed. By the end of the second quarter, the Company expects to have completed the review of data to determine which formulation will move into a pivotal field study, assuming the data support further development.
  • The pilot field efficacy study of KIND-011, an anti-TNF monoclonal antibody targeting sick or septic foals, has been completed, with positive results.Sepsis in foals can cause up to 50% mortality and is an important unmet medical need. There is currently no FDA-approved therapy. KindredBio has optimized this fully-equinized anti-TNF monoclonal antibody and intends to continue field studies during the 2019 foaling season, following discussion with FDA regarding the development plan.
  • A pilot field study assessing oral tolerability and palatability of KIND-015 for the management of clinical signs associated with equine metabolic syndrome has been completed. The Company has optimized the formulation for KIND-015 and has initiated a pilot field effectiveness study.
  • The Company has started construction on the biologics manufacturing lines in the Elwood, Kansas facility it acquired in August 2017. The facility includes approximately 180,000 square feet with clean rooms, utility, equipment, and related quality documentation suitable for small molecule and biologics manufacturing. Construction to support KindredBio’s initial production lines is expected to be completed by mid-2019.

First Quarter 2018 Financial Results

For the quarter ended March 31, 2018, KindredBio reported a net loss of $10.0 million or $0.36 per share, as compared to a net loss of $6.5 million or $0.30 per share, for the same period in 2017.

Total research and development expenses for the quarter ended March 31, 2018 were $5.3 million, compared to $3.8 million for the same period in 2017. The $1.5 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, as well as increased biologics batch production and testing costs, including lab supplies.

Total general and administrative expenses for the 2018 and 2017 first quarters were $4.9 million and $2.8 million, respectively. Expenditures in the first quarter of 2018 increased across the board. The $2.1 million increase in the first quarter of 2018 over the same period in 2017 included a mix of higher payroll and related expenses, marketing, travel and conference expenses as a result of pre-launch activities and the build-out of a small commercial team.  In addition, higher corporate infrastructure costs and stock-based compensation expense also contributed to the increase in expenses.

As of March 31, 2018, KindredBio had $70.8 million in cash, cash equivalents and investments, compared with $82.5 million as of December 31, 2017. Net cash used in operating activities for the first quarter of 2018 was approximately $11.2 million. The Company also invested approximately $0.4 million in capital expenditures for the build-out of its Elwood, Kansas manufacturing facility.

For the 2018 calendar year, the Company reiterates its previous guidance for operating expenses to be in the range of $44 million to $48 million, excluding the impact of stock-based compensation expense and the impact of acquisitions, if any. The Company is preparing for the commercial launches of Mirataz and Zimeta including the scale up of a commercial team and will continue to focus on the development of its core pipeline candidates and programs. Additionally, KindredBio plans to invest $14.0 to $16.0 million in capital expenditures on the construction and build-out of its Elwood, Kansas facility for its biologics programs. Revenues for Mirataz and Zimeta are expected to have a substantial impact on cash utilization and expenses.

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 8967967. The call will be webcast live at https://edge.media-server.com/m6/p/nhw6xeop. A replay will also be 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.

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

MiratazTM (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.

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

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

Contact

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

 

Kindred Biosciences Receives FDA Approval of Mirataz™ (mirtazapine transdermal ointment) for the Management of Weight Loss in Cats

San Francisco, CA (May 7, 2018) 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 approved Mirataz (mirtazapine transdermal ointment) for the management of weight loss in cats.

“We are pleased to announce the FDA approval of Mirataz for cats experiencing unintended weight loss, a serious medical and potentially fatal condition,” said Richard Chin, M.D., President and Chief Executive Officer of KindredBio. “Based on our market research, we estimate that veterinarians in the U.S. see as many as 9 million cats each year with unintended weight loss due to various underlying conditions. We developed this first-in-class product in less than five years, which is a testament to the quality of our team and validates our strategy of quickly and cost-efficiently developing animal health therapeutics.”

Mirataz is the first and only transdermal medication specifically developed, and FDA approved, for cats. Weight loss is the leading cause of visits to the veterinarian for cats. 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. Mirataz is a serotonin (5HT2A, 5HT2C, and 5HT3) and histamine (H1) receptor antagonist, which has demonstrated body weight gain in cats experiencing weight loss. The product is classified as a weight gain drug and can be used in cats with various underlying diseases associated with unintended weight loss.

KindredBio will provide additional updates regarding commercialization and pipeline during its first quarter 2018 financial call on Tuesday, May 8, 2018 at 4:30 PM Eastern Time / 1:30 PM 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 8967967. The call will also be webcast live at https://edge.media-server.com/m6/p/nhw6xeop.

About Kindred Biosciences

Kindred Biosciences is a 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 effectiveness 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

MiratazTM (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.

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

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

Contact

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

Kindred Biosciences Announces the Appointment of Dr. Ernest Mario and Dr. Joseph McCracken to its Board of Directors

San Francisco, CA (April 25, 2018) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced the appointment of Ernest Mario, Ph.D. and Joseph McCracken, D.V.M. to its Board of Directors.

Dr. Mario brings to KindredBio 50 years of experience in the pharmaceutical industry. He was previously Chief Executive and Deputy Chairman of Glaxo Holdings from 1989 to 1993, then the second-largest drug company in the world. Subsequently, Dr. Mario served as CEO and Chairman of ALZA Corporation and as CEO and Chairman of Reliant Pharmaceuticals. He is currently Chairman of Soleno Therapeutics, a Venture Partner with Pappas Ventures and serves on a number of corporate boards, including Celgene. Dr. Mario earned a B.S. in Pharmacy at Rutgers and his M.S. and Ph.D. in Physical Sciences at the University of Rhode Island. He holds honorary doctorates from URI and Rutgers, the latter of which in 2001 renamed its pharmacy school the Ernest Mario School of Pharmacy. In 2007, he was awarded pharmacy’s highest honor, the Remington Medal by the American Pharmacists’ Association.

Dr. McCracken was previously Vice President and Global Head of Business Development & Licensing for Roche Pharma where he was responsible for Roche Pharma’s global in-licensing and out-licensing activities. Prior to joining Roche Pharma, Dr. McCracken held the position of Vice President, Business Development at Genentech for more than 10 years, and previously held similar positions at Aventis Pharma and Rhone-Poulenc Rorer. He currently serves on the boards of Alkahest, Inc., Savara Pharmaceuticals, and Regimmune Inc. Dr. McCracken holds a B.S. in Microbiology, an M.S. in Pharmacology, and a Doctor of Veterinary Medicine from Ohio State University.

“I am very pleased to welcome Dr. Mario and Dr. McCracken to KindredBio’s Board of Directors,” said Richard Chin, M.D., CEO of KindredBio. “They are both highly respected in the pharmaceutical industry and their experience and insights will be instrumental as KindredBio transitions to a commercial-stage company and continues to advance its pipeline.”

About Kindred Biosciences

Kindred Biosciences is a 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 effectiveness in humans and to develop therapeutics based on these validated compounds and targets for dogs, cats and horses. The Company has a deep pipeline of novel drugs and biologics in development across many therapeutic classes.

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

Contact

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

Kindred Biosciences Provides Updates on Pending Drug Approvals

San Francisco, CA (April 25, 2018) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced that it has received a response from the Food and Drug Administration (FDA) for the Chemistry, Manufacturing, and Controls technical section for Zimeta IV for the control of fever in horses. The FDA has no additional questions or requests for KindredBio regarding this submission. The FDA stated that the approval is pending the pre-approval inspection, or PAI, at the contract manufacturer of Zimeta IV scheduled for July 2018, and an acceptable resolution by the contract manufacturer of the active pharmaceutical ingredient (API) dipyrone of findings identified during an inspection conducted this month. KindredBio believes that the findings at the API manufacturer are minor and addressable.

KindredBio continues to anticipate approval of its first product, Mirataz™ (mirtazapine transdermal ointment), for the management of weight loss in cats on or before the May 6, 2018 action date. The FDA does not have any additional questions or requests from KindredBio, final label negotiations have been completed, and all of the required inspections have been completed successfully at the contract manufacturers.

The Company will provide further program and corporate updates during its first quarter 2018 financial call on Tuesday, May 8, 2018 at 4:30 PM Eastern Time / 1:30 PM 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 8967967. The call will also be webcast live at https://edge.media-server.com/m6/p/nhw6xeop.

About Kindred Biosciences

Kindred Biosciences is a 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 effectiveness in humans and to develop therapeutics based on these validated compounds and targets for dogs, cats and horses. The Company has a deep pipeline of novel drugs and biologics in development across many therapeutic classes.

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

Forward-Looking Statements

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

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

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

Contact

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