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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 November 10, 2021
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KINNATE BIOPHARMA INC.
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||
Date: November 10, 2021
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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
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• |
Announced a collaboration with Guardant Health, a leading precision oncology company, focused on characterizing the prevalence of patients with advanced solid tumors bearing BRAF Class I, II and III alterations. The study will also
assess real-world clinical outcomes stratified by BRAF alteration class and by treatment line and type. Preliminary analyses conducted utilizing the GuardantINFORM™ platform suggest that the prevalence of Class II and III alterations across
patients with advanced and metastatic solid tumors screened via liquid biopsy-based comprehensive genomic profiling (CGP) is higher than previously understood. Among the nearly 6,000 patients who were identified as having BRAF
alteration-positive cancers, approximately 55% were found to be harboring Class II and III alterations across all tumor types. When looking across common tumor types – Non-Small Cell Lung Cancer (NSCLC), Melanoma and Colorectal Cancer (CRC)
– approximately 65%, 20% and 30% of oncogenic BRAF alterations, respectively, are BRAF Class II and III. In addition to NSCLC, Melanoma, and CRC, BRAF Class II and III alterations are also detected at substantial rates in other common and
rare tumor types such as prostate, breast, duodenal adenocarcinoma, renal pelvis urothelial carcinoma, and cholangiocarcinoma. These findings, as well as other studies that will assess real-world clinical outcomes stratified by BRAF Class
and by treatment, are planned for presentation at a future date.
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• |
Presented design and rationale details of a Phase 1 clinical trial (KN-8701: NCT04913285) evaluating KIN-2787 during the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics. KN-8701 is a
first-in-human, multicenter, non-randomized, open-label, Phase 1 clinical trial of KIN-2787 in adult patients with BRAF mutant advanced and metastatic solid tumors (AMST). KIN-2787 is given orally BID continuously in 28-day cycles until
drug intolerance or disease progression. Planned sample size is approximately 115 patients in two parts: Part A is a trial of dose-escalation to maximum tolerated dose open to patients with AMST driven by BRAF Class I, Class II or Class III
genomic alterations. Part B will evaluate a selected dose of KIN-2787 in three cohorts of patients with melanoma, NSCLC, or other AMST, each driven by BRAF Class II or Class III alterations. Standard Phase 1 enrollment criteria are
required, and key exclusion criteria include known clinically active brain metastases from non-brain tumors, and prior receipt of BRAF-, MEK-, or MAPK-directed inhibitor therapy (except for cases in which these inhibitors were used in
indications approved by the U.S. Food and Drug Administration (FDA)).
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• |
Announced results from preclinical studies evaluating Kinnate’s lead Fibroblast Growth Factor Receptor (FGFR) inhibitor candidate, KIN-3248 during a virtual poster session at the joint JCA-AACR Precision Cancer Medicine International
Conference. The poster presentation highlighted data which show that in biochemical and cellular assays, KIN-3248 exhibited nanomolar potency against all four wild-type FGFR family members but not against other non-FGFR kinases.
Importantly, KIN-3248 was active against mutations associated with resistance to FGFR inhibitors both in the clinic and in experimental models, including the FGFR2 and FGFR3 gatekeeper (V565X and V555M, respectively), molecular brake (N550X
and N540X, respectively), and activation loop (L618V and K650M, respectively) mutations with less than a five-fold difference in IC50 values relative to corresponding wild-type receptors. In addition, dose-dependent inhibition of FGFR2- and
FGFR3-driven human in vivo xenografts, including one with an acquired gatekeeper mutation, was attained with once-daily KIN-3248 treatment and was well tolerated. This efficacy was accompanied by both pharmacodynamic biomarker modulation
and downstream pathway inhibition. Kinnate anticipates filling an Investigational New Drug application for KIN-3248 with the FDA in the first half of 2022.
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• |
Announced that on December 3, 2021 Eric Murphy, Ph.D. will transition from the company’s Chief Scientific Officer to a member of its Scientific Advisory Board.
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• |
Third quarter net loss for 2021 was $24.7 million, compared to $10.5 million for the same period in 2020.
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• |
Third quarter research and development expenses for 2021 were $18.7 million, compared to $8.5 million for the same period in 2020.
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• |
Third quarter general and administrative expenses for 2021 were $6.1 million, compared to $2.0 million for the same period in 2020.
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• |
As of September 30, 2021, the total of cash and cash equivalents and investments was $347.9 million, exclusive of the China joint venture’s cash.
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Contacts:
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Investors:
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Patti Bank
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Westwicke, an ICR Company
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415-513-1284
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investors@kinnate.com
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Media:
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Colin Sanford
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colin@bioscribe.com
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September 30, 2021
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December 31, 2020
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|||||||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
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$
|
135,009
|
$
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365,462
|
||||
Cash at consolidated joint venture
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34,308
|
-
|
||||||
Short-term investments
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88,219
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31,398
|
||||||
Prepaid expenses and other current assets
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3,176
|
3,343
|
||||||
Total current assets
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260,712
|
400,203
|
||||||
Property and equipment, net
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291
|
368
|
||||||
Long-term investments
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124,636
|
-
|
||||||
Restricted cash
|
371
|
-
|
||||||
Other non-current assets
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319
|
-
|
||||||
Total assets
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$
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386,329
|
$
|
400,571
|
||||
Liabilities and Stockholders’ Equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
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$
|
2,724
|
$
|
3,940
|
||||
Accrued expenses
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7,575
|
3,364
|
||||||
Total current liabilities
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10,299
|
7,304
|
||||||
Commitments and contingencies (See Note 12)
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||||||||
Redeemable convertible noncontrolling interests
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35,000
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-
|
||||||
Stockholders’ equity:
|
||||||||
Preferred stock, $0.0001 par value; 200,000,000 shares authorized
at September 30, 2021 and December 31, 2020; 0 shares outstanding
at September 30, 2021 and December 31, 2020
|
-
|
-
|
||||||
Common stock, $0.0001 par value; 1,000,000,000 shares authorized
at September 30, 2021 and December 31, 2020; 43,682,671 and 43,477,439
shares issued and outstanding at September 30, 2021 and December 31, 2020,
respectively
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4
|
4
|
||||||
Additional paid-in capital
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457,995
|
446,601
|
||||||
Accumulated other comprehensive loss
|
(36
|
)
|
(9
|
)
|
||||
Accumulated deficit
|
(116,933
|
)
|
(53,329
|
)
|
||||
Total stockholders’ equity
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341,030
|
393,267
|
||||||
Total liabilities and equity
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$
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386,329
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$
|
400,571
|
Three Months Ended September 30,
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Nine Months Ended September 30,
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|||||||||||||||
2021
|
2020
|
2021
|
2020
|
|||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development
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$
|
18,729
|
$
|
8,484
|
$
|
47,637
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$
|
17,261
|
||||||||
General and administrative (includes related party amounts
of $0 and $92 for the three and nine months ended September 30, 2020)
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6,073
|
2,019
|
16,215
|
5,021
|
||||||||||||
Total operating expenses
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24,802
|
10,503
|
63,852
|
22,282
|
||||||||||||
Loss from operations
|
(24,802
|
)
|
(10,503
|
)
|
(63,852
|
)
|
(22,282
|
)
|
||||||||
Other income:
|
||||||||||||||||
Interest income
|
640
|
4
|
1,715
|
228
|
||||||||||||
Other expense, net
|
(540
|
)
|
-
|
(1,467
|
)
|
-
|
||||||||||
Total other income, net
|
100
|
4
|
248
|
228
|
||||||||||||
Net loss
|
(24,702
|
)
|
(10,499
|
)
|
(63,604
|
)
|
(22,054
|
)
|
||||||||
Net loss attributable to redeemable convertible noncontrolling interests
|
-
|
-
|
-
|
-
|
||||||||||||
Net loss attributable to Kinnate
|
$
|
(24,702
|
)
|
$
|
(10,499
|
)
|
$
|
(63,604
|
)
|
$
|
(22,054
|
)
|
||||
Weighted-average shares outstanding, basic and diluted
|
43,663,985
|
3,748,324
|
43,559,787
|
3,709,020
|
||||||||||||
Net loss per share, basic and diluted
|
$
|
(0.57
|
)
|
$
|
(2.80
|
)
|
$
|
(1.46
|
)
|
$
|
(5.95
|
)
|
||||
Comprehensive loss:
|
||||||||||||||||
Net loss
|
$
|
(24,702
|
)
|
$
|
(10,499
|
)
|
$
|
(63,604
|
)
|
$
|
(22,054
|
)
|
||||
Other comprehensive loss:
|
||||||||||||||||
Unrealized income (loss) on investments
|
38
|
-
|
(27
|
)
|
-
|
|||||||||||
Total comprehensive loss
|
(24,664
|
)
|
(10,499
|
)
|
(63,631
|
)
|
(22,054
|
)
|
||||||||
Comprehensive loss attributable to redeemable
convertible noncontrolling interests
|
-
|
-
|
-
|
-
|
||||||||||||
Comprehensive loss attributable to Kinnate
|
$
|
(24,664
|
)
|
$
|
(10,499
|
)
|
$
|
(63,631
|
)
|
$
|
(22,054
|
)
|