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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
|
|
Press Release dated March 15, 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.
|
||
By:
|
/s/ Nima Farzan
|
|
Nima Farzan
|
||
President and Chief Executive Officer
|
||
Date: March 15, 2023
|
• |
Announced Phase 1 monotherapy dose escalation data for investigational pan-RAF inhibitor exarafenib (KIN-2787) was selected for an oral presentation at the American Association
for Cancer Research 2023 Annual Meeting
|
• |
Announced the company has initiated enrollment of patients into the monotherapy expansion cohorts evaluating exarafenib
|
• |
Announced the U.S. Food and Drug Administration granted Fast Track designation for KIN-3248, our investigational pan-FGFR inhibitor
|
• |
Cash, cash equivalents and investments of $266.3 million as of December 31, 2022
|
• |
Announced Kinnate will present monotherapy dose escalation data from KN-8701, a global Phase 1
clinical trial evaluating exarafenib, in an oral presentation at the American Association for Cancer Research (AACR) 2023 Annual Meeting. Also announced it has initiated enrollment of patients into the monotherapy expansion cohorts of
KN-8701 and will discuss the expansion strategy, along with the AACR results and additional pipeline updates, at a virtual investor event following the AACR presentation. (View Release)
|
• |
Announced initiation of KN-8701 in the People’s Republic of China (PRC), with trial sites open in
PRC and Taiwan. (View Release)
|
• |
Announced that the U.S. Food and Drug Administration granted Fast Track designation for KIN-3248
for the treatment of patients with unresectable, locally advanced or metastatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 gene fusions or other alterations, who have received at least one prior systemic therapy. (View Release)
|
• |
Presented the structure and discovery of exarafenib at the 2023 Winter Conference on Medicinal & Bioorganic Chemistry. (View Presentation)
|
• |
Presented trials in progress poster for KIN-3248 at the 2023 American Society of Clinical Oncology
(ASCO) Gastrointestinal Cancers Symposium and the ASCO Genitourinary Cancers Symposium. (View Release)
|
• |
Announced in February 2023 that Kinnate acquired ownership stake of Kinnjiu Biopharma Inc. (Kinnjiu), the China joint venture established in May 2021, previously held by the Series A investors (funds affiliated with OrbiMed and Foresite Capital Management) for $24 million, using a combination of $9.1 million in cash and 2.2 million shares of common
stock of Kinnate. Kinnate retains Kinnjiu’s cash, intellectual property and other assets, including key personnel and its legal entity structure. (View Release)
|
• |
Appointed a new independent director, Jill DeSimone, effective March 1, 2023. (View Release)
|
• |
As of December 31, 2022, the total of cash and cash equivalents and investments was $266.3 million, inclusive of cash from Kinnjiu Biopharma Inc., and is expected to fund current operations into
mid-2024.
|
• |
Research and development expenses for 2022 were $88.2 million, compared to $67.2 million in 2021.
|
• |
General and administrative expenses for 2022 were $30.4 million, compared to $22.9 million in 2021.
|
• |
Net loss for 2022 was $116.3 million, compared to $89.8 million in 2021.
|
|
December 31,
|
|||||||
|
2022
|
2021
|
||||||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
29,261
|
$
|
116,096
|
||||
Cash at consolidated joint venture
|
25,725
|
33,593
|
||||||
Short-term investments
|
172,214
|
103,362
|
||||||
Prepaid expenses and other current assets
|
3,637
|
5,639
|
||||||
Total current assets
|
230,837
|
258,690
|
||||||
Property and equipment, net
|
3,071
|
956
|
||||||
Right-of-use lease assets
|
3,377
|
-
|
||||||
Long-term investments
|
39,139
|
105,449
|
||||||
Restricted cash
|
371
|
371
|
||||||
Deferred offering costs
|
-
|
641
|
||||||
Other non-current assets
|
2,031
|
757
|
||||||
Total assets
|
$
|
278,826
|
$
|
366,864
|
||||
Liabilities, Redeemable Convertible Noncontrolling Interests and
Stockholders' Equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
2,970
|
$
|
3,148
|
||||
Accrued expenses
|
13,206
|
9,239
|
||||||
Current portion of operating lease liabilities
|
991
|
-
|
||||||
Total current liabilities
|
17,167
|
12,387
|
||||||
Operating lease liabilities, long-term
|
3,191
|
-
|
||||||
Total liabilities
|
20,358
|
12,387
|
||||||
Redeemable convertible noncontrolling interests
|
35,000
|
35,000
|
||||||
Stockholders’ equity:
|
||||||||
Preferred stock, $0.0001 par value; 200,000,000 shares authorized at
December 31, 2022 and 2021; 0 shares outstanding at December 31, 2022 and 2021
|
-
|
-
|
||||||
Common stock, $0.0001 par value; 1,000,000,000 shares authorized at
December 31, 2022 and 2021; 44,342,292 and 43,855,944 shares issued
and outstanding at December 31, 2022 and 2021, respectively
|
4
|
4
|
||||||
Additional paid-in capital
|
484,237
|
463,089
|
||||||
Accumulated other comprehensive loss
|
(1,410
|
)
|
(524
|
)
|
||||
Accumulated deficit
|
(259,363
|
)
|
(143,092
|
)
|
||||
Total stockholders’ equity
|
223,468
|
319,477
|
||||||
Total liabilities, redeemable convertible noncontrolling interests and stockholders' equity
|
$
|
278,826
|
$
|
366,864
|
Years Ended December 31,
|
||||||||
2022
|
2021
|
|||||||
Operating expenses:
|
||||||||
Research and development
|
$
|
88,150
|
$
|
67,166
|
||||
General and administrative
|
30,371
|
22,945
|
||||||
Total operating expenses
|
118,521
|
90,111
|
||||||
Loss from operations
|
(118,521
|
)
|
(90,111
|
)
|
||||
Other income, net
|
2,250
|
348
|
||||||
Net loss
|
(116,271
|
)
|
(89,763
|
)
|
||||
Net loss attributable to redeemable convertible noncontrolling interests
|
-
|
-
|
||||||
Net loss attributable to Kinnate
|
$
|
(116,271
|
)
|
$
|
(89,763
|
)
|
||
Weighted-average shares outstanding, basic and diluted
|
44,065,749
|
43,601,162
|
||||||
Net loss per share, basic and diluted
|
$
|
(2.64
|
)
|
$
|
(2.06
|
)
|
||
Comprehensive loss:
|
||||||||
Net loss
|
$
|
(116,271
|
)
|
$
|
(89,763
|
)
|
||
Other comprehensive loss:
|
||||||||
Currency translation adjsutments
|
1
|
-
|
||||||
Unrealized loss on investments
|
(887
|
)
|
(515
|
)
|
||||
Total comprehensive loss
|
(117,157
|
)
|
(90,278
|
)
|
||||
Comprehensive loss attributable to redeemable convertible noncontrolling interests
|
-
|
-
|
||||||
Comprehensive loss attributable to Kinnate
|
$
|
(117,157
|
)
|
$
|
(90,278
|
)
|