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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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(d)
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Exhibits.
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Exhibit No.
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Description
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Press Release dated August 8, 2023.
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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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Date: August 8, 2023
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By:
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/s/ Nima Farzan
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Nima Farzan
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Chief Executive Officer and President
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• |
Received FDA clearance of IND application for brain-penetrant MEK inhibitor, KIN-7136; expect to enter the clinic with Phase 1 trial in the second half of 2023
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• |
Cash, cash equivalents and investments of $204.3 million as of June 30, 2023 anticipated to fund operations into early 2025
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• |
Received clearance from the U.S. Food and Drug Administration (FDA) for the Investigational New Drug (IND) application of KIN-7136, a potentially brain-penetrant mitogen-activated protein kinase
(MEK) inhibitor. The Company expects to enter the clinic in the second half of 2023 with KN-3603, a Phase 1 trial, to evaluate KIN-7136 in adult participants with advanced solid tumors that are driven by the mitogen-activated protein kinase
pathway, primarily non-small cell lung cancer, including in participants with brain metastases. KIN-7136 will be evaluated as monotherapy and in combination with Kinnate’s investigational pan-RAF inhibitor, exarafenib.
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• |
First presentation on the structure and discovery of FGFR inhibitor, KIN-3248, upcoming at the 2023 American Chemical Society on August 16. (View
Presentation Details)
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• |
Presented a poster at the 2023 American Society of Clinical Oncology Annual Meeting on circulating tumor DNA-based genomic landscape analysis for evaluating molecular brake and gatekeeper mutations
in FGFR2. (View Poster).
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• |
As of June 30, 2023, total cash, cash equivalents and investments were $204.3 million, which is expected to fund current operations into early 2025.
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• |
Second quarter research and development expenses for 2023 were $26.3 million, compared to $19.8 million for the same period in 2022.
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• |
Second quarter general and administrative expenses for 2023 were $7.8 million, compared to $7.6 million for the same period in 2022.
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• |
Second quarter net loss for 2023 was $31.9 million, compared to $27.1 million for the same period in 2022.
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June 30, 2023
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December 31, 2022
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||||||
Assets
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||||||||
Current assets:
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||||||||
Cash and cash equivalents
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$
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34,507
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$
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29,261
|
||||
Cash at consolidated joint venture
|
-
|
25,725
|
||||||
Short-term investments
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150,196
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172,214
|
||||||
Prepaid expenses and other current assets
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3,897
|
3,637
|
||||||
Total current assets
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188,600
|
230,837
|
||||||
Property and equipment, net
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2,667
|
3,071
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||||||
Right-of-use lease assets
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2,958
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3,377
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||||||
Long-term investments
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19,579
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39,139
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||||||
Restricted cash
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371
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371
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||||||
Other non-current assets
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1,960
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2,031
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||||||
Total assets
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$
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216,135
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$
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278,826
|
||||
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||||||||
Liabilities, Redeemable Convertible Noncontrolling Interests and Stockholders' Equity
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||||||||
Current liabilities:
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||||||||
Accounts payable
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$
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2,696
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$
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2,970
|
||||
Accrued expenses
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12,118
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13,206
|
||||||
Current portion of operating lease liabilities
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959
|
991
|
||||||
Total current liabilities
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15,773
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17,167
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||||||
Operating lease liabilities, long-term
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2,742
|
3,191
|
||||||
Total liabilities
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18,515
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20,358
|
||||||
Redeemable convertible noncontrolling interests
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-
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35,000
|
||||||
Stockholders’ equity:
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||||||||
Preferred stock, $0.0001 par value; 200,000,000 shares authorized at June 30, 2023 and December 31, 2022; 0 shares outstanding at June 30,
2023 and December 31, 2022
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-
|
-
|
||||||
Common stock, $0.0001 par value; 1,000,000,000 shares authorized at June 30, 2023 and December 31, 2022; 47,051,450 and 44,342,292 shares
issued and outstanding at June 30, 2023 and December 31, 2022 , respectively
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5
|
4
|
||||||
Additional paid-in capital
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522,178
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484,237
|
||||||
Accumulated other comprehensive loss
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(342
|
)
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(1,410
|
)
|
||||
Accumulated deficit
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(324,221
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)
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(259,363
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)
|
||||
Total stockholders’ equity
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197,620
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223,468
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||||||
Total liabilities, redeemable convertible noncontrolling interests and stockholders' equity
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$
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216,135
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$
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278,826
|
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Three Months Ended June 30,
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Six Months Ended June 30
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||||||||||||||
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2023
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2022
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2023
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2022
|
||||||||||||
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||||||||||||||||
Operating expenses:
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||||||||||||||||
Research and development
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$
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26,327
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$
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19,767
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$
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52,886
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$
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39,414
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||||||||
General and administrative
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7,808
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7,639
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15,902
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15,051
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||||||||||||
Total operating expenses
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34,135
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27,406
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68,788
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54,465
|
||||||||||||
Loss from operations
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(34,135
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)
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(27,406
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)
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(68,788
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)
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(54,465
|
)
|
||||||||
Other income, net
|
2,217
|
337
|
3,930
|
494
|
||||||||||||
Net loss
|
$
|
(31,918
|
)
|
$
|
(27,069
|
)
|
$
|
(64,858
|
)
|
$
|
(53,971
|
)
|
||||
|
||||||||||||||||
Weighted-average shares outstanding, basic and diluted
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46,655,966
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44,002,391
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46,036,212
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43,942,986
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||||||||||||
Net loss per share, basic and diluted
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$
|
(0.68
|
)
|
$
|
(0.62
|
)
|
$
|
(1.41
|
)
|
$
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(1.23
|
)
|
||||
|
||||||||||||||||
Comprehensive loss:
|
||||||||||||||||
Net loss
|
$
|
(31,918
|
)
|
$
|
(27,069
|
)
|
$
|
(64,858
|
)
|
$
|
(53,971
|
)
|
||||
Other comprehensive loss:
|
||||||||||||||||
Unrealized gain (loss) on investments
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122
|
(557
|
)
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1,068
|
(2,213
|
)
|
||||||||||
Total comprehensive loss
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$
|
(31,796
|
)
|
$
|
(27,626
|
)
|
$
|
(63,790
|
)
|
$
|
(56,184
|
)
|