Kinnate Biopharma Inc. Reports Second Quarter 2023 Financial Results and Recent Corporate Updates
08 Agosto 2023 - 5:05PM
Kinnate Biopharma Inc. (Nasdaq: KNTE) (“Kinnate” or the “Company”),
a clinical-stage precision oncology company, today announced
financial results for the second quarter of 2023 and recent
corporate updates.
Nima Farzan, chief executive officer of Kinnate Biopharma Inc.,
stated, “We are pleased to receive FDA clearance of the IND
application for our internally developed brain-penetrant MEK
inhibitor, KIN-7136. This achievement underscores the rapid
progress of Kinnate's in-house research efforts, which have
effectively generated multiple clinical programs within only five
years of our founding. In the balance of the year, we look forward
to providing initial dose escalation data for KIN-3248, our
investigational FGFR inhibitor, as well as additional data for the
combination of exarafenib and binimetinib in NRAS-mutant melanoma.
With an exciting array of catalysts on the horizon, we are
confident in Kinnate’s pipeline growth.”
Pipeline Updates
- 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.
- 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)
- 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).
Financial Results
- 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.
- Second quarter research and development expenses for 2023 were
$26.3 million, compared to $19.8 million for the same period in
2022.
- Second quarter general and administrative expenses for 2023
were $7.8 million, compared to $7.6 million for the same period in
2022.
- Second quarter net loss for 2023 was $31.9 million, compared to
$27.1 million for the same period in 2022.
About Kinnate Biopharma Inc.
Kinnate Biopharma Inc. is a clinical-stage precision oncology
company founded with a mission to inspire hope in those battling
cancer by expanding on the promise of targeted therapies. The
Company concentrates its efforts on addressing known oncogenic
drivers for which there are currently no approved targeted
therapies and to overcome the limitations associated with existing
cancer therapies, such as non-responsiveness or the development of
acquired and intrinsic resistance.
The Company’s lead product candidates are investigational
pan-RAF inhibitor, exarafenib, which targets cancers with BRAF and
NRAS-driven alterations, and investigational FGFR inhibitor,
KIN-3248, which is designed for cancers with FGFR2 and FGFR3
alterations. The Company also has early-stage programs, including a
potentially brain-penetrant MEK inhibitor and a cMET inhibitor that
targets resistant variants. The Kinnate Discovery Engine drives the
Company’s pipeline of small molecule candidates, prioritizing high
selectivity, optimized pharmaceutical properties, broad genetic
alteration coverage, overcoming resistance, and brain penetration.
The Company is driven by the urgency and knowledge that patients
are waiting for new, effective cancer medicines. For more
information, visit Kinnate.com and follow the company on LinkedIn
to learn about its most recent initiatives.
Forward Looking Statements
This press release contains forward-looking statements that
involve substantial risks and uncertainties. These forward-looking
statements include, without limitation, the timing and presentation
of initial clinical data for dose escalation of KIN-3248; the
timing and presentation of additional dose escalation of exarafenib
plus binimetinib combination; the planned initiation and conduct of
a Phase 1 clinical trial evaluating KIN-7136 as monotherapy and in
combination with exarafenib; statements regarding the potential
benefits and properties of the Company’s product candidates; the
Company’s planned presentation on the structure and discovery of
KIN-3248 at a scientific conference; the period over which we
estimate our existing cash, cash equivalents and investments will
be sufficient to fund our operations; and statements by our chief
executive officer. Words such as “believes,” “anticipates,”
“plans,” “expects,” “will,” “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, among other things: operating as a clinical-stage
biopharmaceutical company with a limited operating history; the
timing, progress and results of ongoing and planned preclinical
studies and clinical trials for our current product candidates;
that continued dose escalation in our clinical trials could
increase the risk of the occurrence of adverse events; the
potential for future clinical trial results to differ from initial
results or from our preclinical studies; our ability to timely
enroll a sufficient number of patients in our clinical trials; 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; negative impacts of pandemics or other widespread
public health concerns on our business, including ongoing and
planned clinical trials and preclinical studies; competition in our
industry; regulatory and legal 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 quarter ended
June 30, 2023 that we are concurrently filing with the Securities
and Exchange Commission (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.
Investor & Media Contact:
Priyanka Shah | Priyanka.Shah@kinnate.com | +1-908-447-6134
Kinnate
Biopharma Inc. |
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|
Condensed
Consolidated Balance Sheets |
|
|
(Unaudited) |
|
|
(in
thousands, except share and par value amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2023 |
|
December 31, 2022 |
|
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
34,507 |
|
|
$ |
29,261 |
|
|
|
Cash at consolidated joint venture |
|
|
- |
|
|
|
25,725 |
|
|
|
Short-term investments |
|
|
150,196 |
|
|
|
172,214 |
|
|
|
Prepaid expenses and other current assets |
|
|
3,897 |
|
|
|
3,637 |
|
|
|
Total current assets |
|
|
188,600 |
|
|
|
230,837 |
|
|
|
Property and
equipment, net |
|
|
2,667 |
|
|
|
3,071 |
|
|
|
Right-of-use
lease assets |
|
|
2,958 |
|
|
|
3,377 |
|
|
|
Long-term
investments |
|
|
19,579 |
|
|
|
39,139 |
|
|
|
Restricted
cash |
|
|
371 |
|
|
|
371 |
|
|
|
Other
non-current assets |
|
|
1,960 |
|
|
|
2,031 |
|
|
|
Total assets |
|
$ |
216,135 |
|
|
$ |
278,826 |
|
|
|
|
|
|
|
|
|
|
Liabilities, Redeemable Convertible Noncontrolling
Interests and Stockholders' Equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,696 |
|
|
$ |
2,970 |
|
|
|
Accrued expenses |
|
|
12,118 |
|
|
|
13,206 |
|
|
|
Current portion of operating lease liabilities |
|
|
959 |
|
|
|
991 |
|
|
|
Total current liabilities |
|
|
15,773 |
|
|
|
17,167 |
|
|
|
Operating
lease liabilities, long-term |
|
|
2,742 |
|
|
|
3,191 |
|
|
|
Total liabilities |
|
|
18,515 |
|
|
|
20,358 |
|
|
|
Commitments
and contingencies (See Note 12) |
|
|
|
|
|
|
Redeemable
convertible noncontrolling interests |
|
|
- |
|
|
|
35,000 |
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
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 |
|
|
- |
|
|
|
- |
|
|
|
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 |
|
|
5 |
|
|
|
4 |
|
|
|
Additional paid-in capital |
|
|
522,178 |
|
|
|
484,237 |
|
|
|
Accumulated other comprehensive loss |
|
|
(342 |
) |
|
|
(1,410 |
) |
|
|
Accumulated deficit |
|
|
(324,221 |
) |
|
|
(259,363 |
) |
|
|
Total stockholders’ equity |
|
|
197,620 |
|
|
|
223,468 |
|
|
|
Total
liabilities, redeemable convertible noncontrolling interests and
stockholders' equity |
|
$ |
216,135 |
|
|
$ |
278,826 |
|
|
|
|
|
|
|
|
|
|
Kinnate
Biopharma Inc. |
|
Condensed
Consolidated Statements of Operations and Comprehensive
Loss |
|
(Unaudited) |
|
(in
thousands, except share and per share amounts) |
|
|
|
|
|
|
|
|
|
|
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Three Months Ended June 30, |
|
Six Months Ended June 30 |
|
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
$ |
26,327 |
|
|
$ |
19,767 |
|
|
$ |
52,886 |
|
|
$ |
39,414 |
|
|
General and administrative |
|
|
|
7,808 |
|
|
|
7,639 |
|
|
|
15,902 |
|
|
|
15,051 |
|
|
Total operating expenses |
|
|
|
34,135 |
|
|
|
27,406 |
|
|
|
68,788 |
|
|
|
54,465 |
|
|
Loss from
operations |
|
|
|
(34,135 |
) |
|
|
(27,406 |
) |
|
|
(68,788 |
) |
|
|
(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 |
|
|
|
46,655,966 |
|
|
|
44,002,391 |
|
|
|
46,036,212 |
|
|
|
43,942,986 |
|
|
Net loss per
share, basic and diluted |
|
|
$ |
(0.68 |
) |
|
$ |
(0.62 |
) |
|
$ |
(1.41 |
) |
|
$ |
(1.23 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
|
$ |
(31,918 |
) |
|
$ |
(27,069 |
) |
|
$ |
(64,858 |
) |
|
$ |
(53,971 |
) |
|
Other
comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on investments |
|
|
|
122 |
|
|
|
(557 |
) |
|
|
1,068 |
|
|
|
(2,213 |
) |
|
Total
comprehensive loss |
|
|
$ |
(31,796 |
) |
|
$ |
(27,626 |
) |
|
$ |
(63,790 |
) |
|
$ |
(56,184 |
) |
|
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