Delaware | 001-36225 | 46-1160142 | ||
(State or other jurisdiction of incorporation or organization) | (Commission File Number) | (I.R.S. Employer Identification No.) |
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Title of each class | Trading Symbol | Name of each exchange on which registered | ||
Common Stock, $0.0001 par value | KIN | The NASDAQ Stock Market LLC | ||
Preferred Stock Purchase Rights | KIN | The NASDAQ Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933(§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). | ||||
Emerging growth company ¨ | ||||
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨ |
Exhibit No. | Description | |
99.1 |
KINDRED BIOSCIENCES, INC. | |
Date: August 1, 2019 | By: /s/ Wendy Wee |
Wendy Wee | |
Chief Financial Officer | |
– | Mortality benefit seen in both prophylaxis and treatment of parvovirus infection |
• | 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. |
• | 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 |
• | 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 |
• | 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. |
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