UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
(Exact name of registrant as specified in its charter)
|
|
|
|
|
(State or other jurisdiction
of incorporation)
|
(Commission
File Number)
|
(IRS Employer
Identification No.)
|
The Presidio of San Francisco
(Address, including zip code, of Registrant’s principal executive offices)
(858 ) 299-4699
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions
(see General Instruction A.2. below):
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
|
Securities registered pursuant to Section 12(b) of the Act:
|
Title of each class
|
Trading
Symbol(s)
|
Name of each exchange
on which registered
|
||
|
|
|
|
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. ☐
| Item 2.02 |
Results of Operations and Financial Condition.
|
On May 12, 2022, Kinnate Biopharma Inc. issued a press release announcing its financial results for the quarter ended
March 31, 2022. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
All of the information furnished in this Item 2.02 and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of
the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended (the
“Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
| Item 9.01 |
Financial Statements and Exhibits.
|
| (d) |
Exhibits
|
|
Exhibit No.
|
Description
|
||
|
Press Release dated May 12, 2022.
|
|||
|
104
|
Cover page interactive data file (embedded within the inline XBRL document).
|
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly
authorized.
|
KINNATE BIOPHARMA INC.
|
||
|
By:
|
/s/ Nima Farzan
|
|
|
Nima Farzan
|
||
|
President and Chief Executive Officer
|
||
|
Date: May 12, 2022
|
||
Exhibit 99.1
Kinnate Biopharma Inc. Reports First Quarter 2022 Financial Results and Provides Operational Updates
Initial monotherapy data from ongoing Phase 1 KN-8701 clinical trial expected in the fourth quarter of 2022
Announces initiation of the combination portion of Phase 1 KN-8701 clinical trial to evaluate its pan-RAF inhibitor, KIN-2787, with binimetinib in
NRAS-mutant melanoma
First patient dosed in ongoing Phase 1 KN-4802 clinical trial of lead FGFR inhibitor product candidate, KIN-3248; initial data expected in the second
half of 2023
Cash runway extended into early 2024, with budget reallocation; Cash, cash equivalents and investments of approximately $302.4
million as of March 31, 2022 (excluding cash from its China joint venture)
SAN FRANCISCO and SAN DIEGO, Calif. – May 12, 2022 – Kinnate Biopharma Inc. (Nasdaq: KNTE) (“Kinnate”), a biopharmaceutical company focused on
the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, today announced financial results for the quarter ended March 31, 2022.
“The company continues to make meaningful progress with our pipeline candidates, inclusive of our pan-RAF inhibitor, KIN-2787, and our FGFR
inhibitor, KIN-3248, both in the clinic, and with initial data from the Phase 1 KN-8701 clinical trial forthcoming later this year for KIN-2787,” said Nima Farzan, Chief Executive Officer of Kinnate. “We remain focused on developing a new generation
of small molecule kinase inhibitors that target a wide range of cancers, including those that resist current treatment, and we are incredibly proud that in just four years we have advanced two compounds into clinical trials, with several more
compounds in the pipeline. Our consistent, disciplined use of capital and updated cash runway guidance is expected to enable Kinnate to fund scientific innovation and operations into early 2024.”
Recent Business Highlights and Corporate Update:
KIN-2787, pan-RAF inhibitor
| • |
Initial monotherapy data from the ongoing Phase 1 KN-8701 clinical trial expected in the fourth quarter of 2022.
|
| • |
Upon meeting a combination of pre-specified milestones in the ongoing Phase 1 KN-8701 clinical trial, initiated combination
portion of KN-8701 to study KIN-2787 with binimetinib in NRAS-mutant melanoma; initial data expected in the first half of 2023.
|
| • |
Abstract highlighting the company's KIN-2787 program was accepted for publication at the American Society of Clinical Oncology (“ASCO”) Annual Meeting taking place June 3-7, 2022, in Chicago, Illinois. The
abstract is titled: Antitumor activity of KIN-2787, a next-generation pan-RAF inhibitor, in combination with MEK inhibition in preclinical models of human NRAS mutant melanoma.
|
| • |
Presented three separate poster presentations highlighting (1) preclinical activity of
KIN-2787 in BRAF alteration positive and NRAS-mutant melanoma models, (2) an overview of the KN-8701 clinical trial design and (3) a clinico-genomics study and outcome analysis that documented the common occurrence of BRAF Class II and
Class III alterations across solid tumors, at the 2022 American Association for Cancer Research (AACR) Annual Meeting. (View release)
|
KIN-3248, FGFR Inhibitor
| • |
Abstract highlighting KIN-3248 was accepted for poster presentation during the ASCO 2022 Annual Meeting. The abstract is titled: Design and rationale of a first-in-human (FIH)
phase 1/1b study evaluating KIN-3248, a next-generation, irreversible (irrev), pan-FGFR inhibitor (FGFRi), in adult patients with solid tumors harboring FGFR2 and/or FGFR3 gene alterations (NCT05242822).
|
| • |
Announced that the first patient has commenced treatment in KN-4802 (NCT05242822), a
Phase 1 clinical trial evaluating KIN-3248. KIN-3248 is a next-generation pan-FGFR inhibitor being developed for the treatment of intrahepatic cholangiocarcinoma (ICC) and urothelial carcinoma (UC), as well as other solid tumors. KN-4802
will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-cancer activity of KIN-3248 in FGFR inhibitor naïve and pretreated cancer patients with FGFR2 and/or FGFR3 gene alterations. (View release)
|
Corporate Update
| • |
Expanded the organization to 68 full-time employees as of March 31, 2022, of which 52 were engaged in research and development activities, and subsequently appointed the following senior leaders:
|
| o |
Ben Powell, Vice President, Discovery Biology
|
| o |
Priyanka Shah, Vice President, IR & Communications
|
First Quarter 2022 Financial Results
| • |
Cash and Cash Equivalents and Investments Position: As of March 31, 2022, the total of cash and cash equivalents and investments was $302.4 million, exclusive of Kinnjiu’s cash. Existing cash and cash equivalents and investments as
of March 31, 2022 with budget reallocation is expected to fund current operations, including initiation of multiple registrational studies, into early 2024.
|
| • |
Research and Development Expenses: First quarter research and development expenses for 2022 were $19.6 million, compared to $12.7 million for the same period in 2021.
|
| • |
General and Administrative Expenses: First quarter general and administrative expenses for 2022 were $7.4 million, compared to $4.8 million for the same period in 2021.
|
| • |
Net Loss: First quarter net loss for 2022 was $26.9 million, compared to $17.5 million for the same period in 2021.
|
About Kinnate Biopharma Inc.
Kinnate is focused on the discovery and development of small molecule
kinase inhibitors for difficult-to-treat, genomically defined cancers. Kinnate’s mission is to expand the reach of targeted therapeutics by developing products that are designed to address significant unmet need. Kinnate utilizes its deep expertise
in structure-based drug discovery, translational research, and patient-driven precision medicine, which it refers to as the Kinnate Discovery Engine, to develop targeted therapies. Based in San Francisco and San Diego, California, the Kinnate team
is composed of drug discovery experts supported by a distinguished group of scientific advisors. For more information, visit Kinnate.com.
Forward Looking Statements
This press release contains forward-looking statements that involve
substantial risks and uncertainties. These forward-looking statements include, without limitation, statements regarding the expected timing of clinical data from KN-8701 for both monotherapy and in combination with binimetinib; the potential
benefits of our product candidates; the expected timing of clinical data from, and the conduct of, KN-4802; the period over which we estimate our existing cash, cash equivalents and investments will be sufficient to fund our operations; statements regarding Kinnate’s development plans and timelines; and
statements by our Chief Executive Officer. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are also intended to identify forward-looking statements. We have based these
forward-looking statements largely on our current expectations and projections about future events and trends. Such expectations and projections may never materialize or may prove to be incorrect. These forward-looking statements are subject to a
number of risks, uncertainties, assumptions and other factors, including risks related to recently transitioning to operating as a clinical-stage biopharmaceutical company with a limited operating history; our ability to raise additional capital to
finance our operations; our ability to discover, advance through the preclinical and clinical development of, obtain regulatory approval for and commercialize our product candidates; the novel approach we are taking to discover and develop drugs;
our ability to timely file and obtain approval of investigational new drug applications for our planned clinical trials; the potential for any clinical trial results to differ from our preclinical study results; negative impacts of the COVID-19
pandemic on our business, including ongoing and planned clinical trials and preclinical studies; competition in our industry; regulatory developments in the United States and other countries; our ability to attract, hire and retain highly skilled
executive officers and employees; difficulties in managing our growth; our ability to protect our intellectual property; reliance on third parties to conduct our ongoing and planned preclinical studies and clinical trials, and to manufacture our
product candidates; general economic and market conditions; and other risks. These and other risks, uncertainties, assumptions and other factors are further described under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the
quarterly period ended March 31, 2022 that we have filed with the Securities and Exchange Commission (the “SEC”), as well as in our subsequent filings we make with the SEC. New risk factors emerge from time to time and it is not possible for our
management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by,
any forward-looking statements. Investors should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee
future results, levels of activity, performance or achievements. Our forward-looking statements speak only as of the date of this release, and except as required by law, we undertake no obligation to update publicly any forward-looking statements
for any reason in the future.
Contacts:
Investors:
Patti Bank
ICR Westwicke
415-513-1284
investors@kinnate.com
Media:
Colin Sanford
colin@bioscribe.com
Kinnate Biopharma Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands, except share and par value amounts)
|
March 31, 2022
|
December 31, 2021
|
||||||
|
Assets
|
|||||||
|
Current assets:
|
|||||||
|
Cash and cash equivalents
|
$
|
33,099
|
$
|
116,096
|
|||
|
Cash at consolidated joint venture
|
30,998
|
33,593
|
|||||
|
Short-term investments
|
206,164
|
103,362
|
|||||
|
Prepaid expenses and other current assets
|
4,935
|
5,639
|
|||||
|
Total current assets
|
275,196
|
258,690
|
|||||
|
Property and equipment, net
|
3,213
|
956
|
|||||
|
Right-of-use lease assets
|
3,979
|
-
|
|||||
|
Long-term investments
|
63,131
|
105,449
|
|||||
|
Restricted cash
|
371
|
371
|
|||||
|
Deferred offering costs
|
641
|
641
|
|||||
|
Other non-current assets
|
2,089
|
757
|
|||||
|
Total assets
|
$
|
348,620
|
$
|
366,864
|
|||
|
Liabilities, Redeemable Convertible Noncontrolling Interests and Stockholders' Equity
|
|||||||
|
Current liabilities:
|
|||||||
|
Accounts payable
|
$
|
4,419
|
$
|
3,148
|
|||
|
Accrued expenses
|
8,783
|
9,239
|
|||||
|
Current portion of operating lease liabilities
|
454
|
-
|
|||||
|
Total current liabilities
|
13,656
|
12,387
|
|||||
|
Operating lease liabilities, long-term
|
4,143
|
-
|
|||||
|
Total liabilities
|
17,799
|
12,387
|
|||||
|
Redeemable convertible noncontrolling interests
|
35,000
|
35,000
|
|||||
|
Stockholders’ equity:
|
|||||||
|
Preferred stock, $0.0001 par value; 200,000,000 shares authorized at March 31, 2022 and December 31, 2021; 0 shares outstanding at March 31, 2022 and December 31, 2021
|
- | - |
|||||
|
Common stock, $0.0001 par value; 1,000,000,000 shares authorized at March 31, 2022 and December 31, 2021; 43,956,049 and 43,855,944 shares issued and outstanding at March 31,
2022 and December 31, 2021, respectively
|
4
|
4
|
|||||
|
Additional paid-in capital
|
467,991
|
463,089
|
|||||
|
Accumulated other comprehensive loss
|
(2,180)
|
|
(524)
|
|
|||
|
Accumulated deficit
|
(169,994)
|
|
(143,092)
|
|
|||
|
Total stockholders’ equity
|
295,821
|
319,477
|
|||||
|
Total liabilities, redeemable convertible noncontrolling interests and stockholders' equity
|
$
|
348,620
|
$
|
366,864
|
|||
Kinnate Biopharma Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except share and per share amounts)
|
Three Months Ended March 31,
|
||||||||
|
2022
|
2021
|
|||||||
|
Operating expenses:
|
||||||||
|
Research and development
|
$
|
19,647
|
$
|
12,666
|
||||
|
General and administrative
|
7,412
|
4,815
|
||||||
|
Total operating expenses
|
27,059
|
17,481
|
||||||
|
Loss from operations
|
(27,059
|
)
|
(17,481
|
)
|
||||
|
Other income, net
|
157
|
24
|
||||||
|
Net loss
|
(26,902
|
)
|
(17,457
|
)
|
||||
|
Net loss attributable to redeemable convertible noncontrolling interests
|
-
|
-
|
||||||
|
Net loss attributable to Kinnate
|
$
|
(26,902
|
)
|
$
|
(17,457
|
)
|
||
|
Weighted-average shares outstanding, basic and diluted
|
43,882,920
|
43,477,439
|
||||||
|
Net loss per share, basic and diluted
|
$
|
(0.61
|
)
|
$
|
(0.40
|
)
|
||
|
Comprehensive loss:
|
||||||||
|
Net loss
|
$
|
(26,902
|
)
|
$
|
(17,457
|
)
|
||
|
Other comprehensive loss:
|
||||||||
|
Unrealized loss on investments
|
(1,656
|
)
|
(31
|
)
|
||||
|
Total comprehensive loss
|
(28,558
|
)
|
(17,488
|
)
|
||||
|
Comprehensive loss attributable to redeemable convertible noncontrolling interests
|
-
|
-
|
||||||
|
Comprehensive loss attributable to Kinnate
|
$
|
(28,558
|
)
|
$
|
(17,488
|
)
|
||