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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
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Trading
Symbol(s)
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Name of each exchange
on which registered
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Item 2.02 |
Results of Operations and Financial Condition.
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Item 9.01 |
Financial Statements and Exhibits.
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Exhibit No.
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Description
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Press Release dated August 11, 2022.
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104
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Cover page interactive data file (embedded within the inline XBRL document).
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KINNATE BIOPHARMA INC.
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By:
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/s/ Nima Farzan
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Nima Farzan
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President and Chief Executive Officer | ||
Date: August 11, 2022
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![]() |
• |
Phase 1 clinical trial for KIN-2787, the company’s investigational pan-RAF inhibitor, was initiated in Taiwan by Kinnjiu Biopharma Inc., Kinnate’s China
joint venture
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• |
U.S. Food and Drug Administration granted Orphan Drug Designation for KIN-2787 for the treatment of stage IIb-IV melanoma
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• |
Continued to expand clinical trial sites for KIN-2787 in the U.S. and globally
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• |
Cash, cash equivalents and investments of approximately $279.6 million as of June 30, 2022 (excluding cash from China joint
venture)
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• |
Announced that KN-8701, a Phase 1 clinical trial to evaluate KIN-2787, was initiated in Taiwan by Kinnjiu Biopharma Inc., Kinnate’s China joint venture to develop and
commercialize its most advanced kinase inhibitors in the People's Republic of China, Hong Kong, Macau and Taiwan.
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• |
Granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration for KIN-2787 for the treatment of stage IIb-IV melanoma. An ODD is granted to investigational
therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the U.S.
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• |
Published online abstract as part of the 2022 Annual Meeting of the American Society of Clinical
Oncology (ASCO) meeting proceedings on the in vitro and in vivo
preclinical studies evaluating KIN-2787 in combination with binimetinib in NRAS-mutant melanoma models. (View release)
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• |
Enrolling patients in the ongoing Phase 1 dose escalation portion of KN-8701 evaluating KIN-2787 at approximately 18 active trial sites, including in the U.S., Spain, France and
Australia. Initial monotherapy data is expected in the fourth quarter of 2022, and data for the binimetinib combination in the first half of
2023.
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• |
Presented the design and rationale of KN-4802, a Phase 1 clinical trial evaluating KIN-3248, the
company’s investigational FGFR inhibitor, at the 2022 ASCO Annual Meeting. (View release)
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• |
Enrolling patients in the Phase 1 dose escalation portion of KN-4802, with initial clinical data for KIN-3248 expected in the second half of 2023.
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• |
Expanded the organization to 82 full-time employees as of June 30, 2022, of which 61 were engaged in research and development activities.
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• |
The following senior leaders joined the company in the second quarter:
|
o |
Robert Pelham, PhD, Vice President, Translational Medicine
|
o |
Cheng Quah, MBBS, Vice President, Clinical Development
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• |
Cash and Cash Equivalents and Investments Position: As of June
30, 2022, the total of cash and cash equivalents and investments was $279.6 million, exclusive of Kinnjiu’s cash.
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• |
Research and Development Expenses: Second quarter research
and development expenses for 2022 were $19.8 million, compared to $16.2 million for the same period in 2021.
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• |
General and Administrative Expenses: Second quarter general
and administrative expenses for 2022 were $7.6 million, compared to $5.3 million for the same period in 2021.
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• |
Net Loss: Second quarter net loss for 2022 was $27.1
million, compared to $21.4 million for the same period in 2021.
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June 30, 2022
|
December 31, 2021
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|||||||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
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$
|
35,065
|
$
|
116,096
|
||||
Cash at consolidated joint venture
|
29,420
|
33,593
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||||||
Short-term investments
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197,930
|
103,362
|
||||||
Prepaid expenses and other current assets
|
4,718
|
5,639
|
||||||
Total current assets
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267,133
|
258,690
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||||||
Property and equipment, net
|
3,292
|
956
|
||||||
Right-of-use lease assets
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3,781
|
-
|
||||||
Long-term investments
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46,604
|
105,449
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||||||
Restricted cash
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371
|
371
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||||||
Deferred offering costs
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641
|
641
|
||||||
Other non-current assets
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2,074
|
757
|
||||||
Total assets
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$
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323,896
|
$
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366,864
|
||||
Liabilities, Redeemable Convertible Noncontrolling Interests and Stockholders' Equity
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||||||||
Current liabilities:
|
||||||||
Accounts payable
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$
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2,016
|
$
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3,148
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||||
Accrued expenses
|
8,612
|
9,239
|
||||||
Current portion of operating lease liabilities
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836
|
-
|
||||||
Total current liabilities
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11,464
|
12,387
|
||||||
Operating lease liabilities, long-term
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3,703
|
-
|
||||||
Total liabilities
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15,167
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12,387
|
||||||
Redeemable convertible noncontrolling interests
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35,000
|
35,000
|
||||||
Stockholders’ equity:
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||||||||
Preferred stock, $0.0001 par value; 200,000,000 shares authorized at June 30, 2022 and December 31, 2021; 0 shares
outstanding at June 30, 2022 and December 31, 2021
|
-
|
-
|
||||||
Common stock, $0.0001 par value; 1,000,000,000 shares authorized at June 30, 2022 and December 31, 2021; 44,096,921 and
43,855,944 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively
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4
|
4
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||||||
Additional paid-in capital
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473,525
|
463,089
|
||||||
Accumulated other comprehensive loss
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(2,737
|
)
|
(524
|
)
|
||||
Accumulated deficit
|
(197,063
|
)
|
(143,092
|
)
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||||
Total stockholders’ equity
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273,729
|
319,477
|
||||||
Total liabilities, redeemable convertible noncontrolling interests and stockholders' equity
|
$
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323,896
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$
|
366,864
|
Three Months Ended June 30,
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Six Months Ended June 30,
|
|||||||||||||||
2022
|
2021
|
2022
|
2021
|
|||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
$
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19,767
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$
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16,242
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$
|
39,414
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$
|
28,908
|
||||||||
General and administrative
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7,639
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5,327
|
15,051
|
10,142
|
||||||||||||
Total operating expenses
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27,406
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21,569
|
54,465
|
39,050
|
||||||||||||
Loss from operations
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(27,406
|
)
|
(21,569
|
)
|
(54,465
|
)
|
(39,050
|
)
|
||||||||
Other income, net
|
337
|
124
|
494
|
148
|
||||||||||||
Net loss
|
(27,069
|
)
|
(21,445
|
)
|
(53,971
|
)
|
(38,902
|
)
|
||||||||
Net loss attributable to redeemable convertible noncontrolling interests
|
-
|
-
|
-
|
-
|
||||||||||||
Net loss attributable to Kinnate
|
$
|
(27,069
|
)
|
$
|
(21,445
|
)
|
$
|
(53,971
|
)
|
$
|
(38,902
|
)
|
||||
Weighted-average shares outstanding, basic and diluted
|
44,002,391
|
43,535,887
|
43,942,986
|
43,506,825
|
||||||||||||
Net loss per share, basic and diluted
|
$
|
(0.62
|
)
|
$
|
(0.49
|
)
|
$
|
(1.23
|
)
|
$
|
(0.89
|
)
|
||||
Comprehensive loss:
|
||||||||||||||||
Net loss
|
$
|
(27,069
|
)
|
$
|
(21,445
|
)
|
$
|
(53,971
|
)
|
$
|
(38,902
|
)
|
||||
Other comprehensive loss:
|
||||||||||||||||
Unrealized loss on investments
|
(557
|
)
|
(34
|
)
|
(2,213
|
)
|
(65
|
)
|
||||||||
Total comprehensive loss
|
(27,626
|
)
|
(21,479
|
)
|
(56,184
|
)
|
(38,967
|
)
|
||||||||
Comprehensive loss attributable to redeemable convertible noncontrolling interests
|
-
|
-
|
-
|
-
|
||||||||||||
Comprehensive loss attributable to Kinnate
|
$
|
(27,626
|
)
|
$
|
(21,479
|
)
|
$
|
(56,184
|
)
|
$
|
(38,967
|
)
|