F-star Therapeutics,
Inc. (NASDAQ: FSTX), a
clinical-stage biopharmaceutical company dedicated to developing
next generation bispecific immunotherapies to transform the lives
of patients with cancer, today announced third quarter 2021
financial results and a corporate update.
Eliot Forster, CEO of F-star Therapeutics, Inc.,
said, “A year on from listing on NASDAQ, we have delivered on our
planned milestones, and through them value for patients, partners
and our investors. Our agile, tenacious approach, working with
world-leading investigators, continues to further F-star’s mission
to bring our unique bispecific antibodies to patients who need them
most. We continue to advance four clinical programs, initiate
validating partnerships and execute our financial plan. This past
quarter included a number of clinical updates and significant new
partnerships with AstraZeneca and Janssen Biotech. I’m proud of the
team paving the way with huge passion and dedication to make real
the promise of next generation immunotherapies.”
The Company continues to advance FS118, F-star’s
first-in-class bispecific antibody targeting LAG-3 and PD-L1, in
checkpoint inhibitor relapsed head and neck cancer and in
checkpoint inhibitor naïve patients with non-small cell lung cancer
(NSCLC) and diffuse large B cell lymphoma (DLBCL), with a clinical
trial in the latter two populations currently being initiated.
FS120, F-star’s first-in-class dual-agonist, bispecific antibody
targeting CD137 and OX40, remains on track in the clinic, having
completed the accelerated dose titration phase, with presentations
at ESMO 2021 and SITC 2021. SB 11285, a second-generation
STimulator of INterferon Gene (STING) agonist, continues to advance
well in the clinic, further to the update provided in the second
quarter of 2021. FS222, the potentially best-in-class bispecific
targeting PD-L1 and CD137, is also progressing well in the
clinic.
The Company also announced during the third
quarter significant new partnerships with both AstraZeneca PLC and
Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies
of Johnson & Johnson, leveraging our platform technology. With
four clinical-stage programs in progress, F-star is focused on the
further development of its wholly-owned pipeline of tetravalent
bispecific antibodies, as well as collaborations that have the
potential to bring value to shareholders and patients alike.
THIRD QUARTER 2021 AND RECENT
HIGHLIGHTS
FS118 development expanded following
external clinical validation of the LAG-3 target: The
expansion of the FS118 clinical development into checkpoint naïve,
biomarker enriched NSCLC and DLBCL patients will broaden the
clinical reach of this exciting LAG-3 & PD-L1 targeting
bispecific antibody. This adds to the already ongoing checkpoint
inhibitor relapsed head and neck cancer study that is anticipated
to report data in mid-2022.
Combination of FS120 with
KEYTRUDA: In August, F-star announced a clinical
trial collaboration and supply agreement with Merck & Co.,
Inc., Kenilworth, NJ, USA (MSD) to evaluate the combination of
FS120, F-star’s first-in-class dual-agonist bispecific antibody
targeting CD137 and OX40, with KEYTRUDA®
(pembrolizumab), MSD’s anti-PD-1 therapy. FS120 has completed
the accelerated dose titration phase in monotherapy with no safety
concerns identified, and the pharmacokinetics were in line with
expectations. The Company continues dose escalation to determine an
optimal dosing regimen to initiate the KEYTRUDA combination.
AstraZeneca licenses STING
inhibitors: In July, F-star entered into an exclusive
licensing agreement with AstraZeneca plc under which AstraZeneca
received global rights to research, develop and commercialize next
generation STING inhibitor compounds. AstraZeneca was granted
exclusive access to F-star’s novel preclinical STING inhibitors and
will be responsible for all future research, development and
commercialization of the STING inhibitor compounds. This forms part
of the second CVR agreement with the former shareholders of Spring
Bank Pharmaceuticals, Inc. (Spring Bank). F-star retains rights to
all STING agonists currently in clinical development for patients
with cancer.
SB 11285 Phase 1 interim
update: In July, F-star
provided an interim update on the safety, tolerability and
pharmacokinetics of its intravenously administered novel STING
agonist, alone and in combination with atezolizumab. SB 11285
appeared to be well tolerated both alone and in combination across
all dose levels tested to-date, including five dose levels as
monotherapy and three dose levels as a combination. The Part 1a/1b
study database lock (as defined in the first CVR agreement with
Spring Bank’s former shareholders) has been completed. Based on the
positive emerging clinical data, further dose escalations are
ongoing, and a further clinical update is planned for the second
half of 2022.
Johnson and Johnson licenses five new
programs, based on platform technology: Under the terms of
the license and collaboration agreement, F-star will grant Janssen
Biotech a worldwide, exclusive royalty-bearing license to research,
develop, and commercialize up to five novel bispecific antibodies
directed to Janssen therapeutic targets using F-star’s proprietary
Fcab™ and mAb2™ platforms. Janssen will be responsible for all
research, development, and commercialization activities under the
agreement.
THIRD QUARTER 2021 FINANCIAL
SUMMARY
Cash and cash equivalents as of September 30,
2021, were $71.1 million, compared to $18.5 million as of December
31, 2020. The up-front payment of $17.5 million in connection with
the license and collaboration agreement with Janssen Biotech is
expected to be received in the fourth quarter of 2021.
Research & Development (R&D) expenses
were $5.1 million for the quarter ended September 30, 2021,
compared to $5.3 million for the corresponding quarter in 2020,
which included non-cash stock-based compensation expense of $1.1
million and $1.1 million, respectively.
General & Administrative (G&A) expenses
were $5.2 million for the quarter ended September 30, 2021,
compared to $7.3 million for the third quarter of 2020, which
included non-cash stock-based compensation expense of $0.4 million
and $59,000, respectively.
Net loss was $10.8 million, or a loss per share
of $0.52 (basic and diluted), for the quarter ended September 30,
2021, compared to a net loss of $3.5 million, or a loss per share
of $1.88 (basic and diluted), for the quarter ended September 30,
2020.
CONFERENCE CALL AND
WEBCASTF-star will host a conference call today, November
10, 2021, beginning at 9:00 a.m. EST. To access the call,
participants may join via a live webcast on the Investors &
News section of the F-star Therapeutics website, under Events and
Presentations. To join by phone, participants may dial the
following numbers at least 10 minutes prior to the start of the
call:
US/Canada: |
|
1-833-471-0868 |
International: |
|
1-914-987-7751 |
United Kingdom: |
|
800 0288438 or 0203 1070289 |
A replay of the conference call will be
available for 90 days from the date of the call and may be accessed
in the Investors & News section of the F-star Therapeutics
website under Events and Presentations.
About F-star Therapeutics, Inc.
F-star Therapeutics, Inc. is a clinical-stage
biopharmaceutical company dedicated to developing next generation
immunotherapies to transform the lives of patients with cancer.
F-star is pioneering the use of tetravalent (2+2) bispecific
antibodies to create a paradigm shift in cancer therapy. The
Company has four second-generation immuno-oncology (IO)
therapeutics in the clinic, each directed against some of the most
promising IO targets. F-star’s proprietary antibody discovery
platform is protected by an extensive intellectual property estate.
F-star has over 500 granted patents and pending patent applications
relating to its platform technology and product pipeline. The
Company has attracted multiple partnerships with biopharma
companies targeting the significant unmet needs across several
disease areas, including oncology, immunology, and the central
nervous system. For more information
visit www.f-star.com and follow us
on LinkedIn and Twitter.
Forward Looking Statements
Certain statements contained in this
communication regarding matters that are not historical facts, are
forward-looking statements within the meaning of Section 21E of the
Securities Exchange Act of 1934, as amended, and the Private
Securities Litigation Reform Act of 1995, known as the PSLRA. These
include statements regarding management’s intentions, plans,
beliefs, expectations or forecasts for the future, and, therefore,
you are cautioned not to place undue reliance on them. No
forward-looking statement can be guaranteed, and actual results may
differ materially from those projected. F-star undertakes no
obligation to publicly update any forward-looking statement,
whether as a result of new information, future events or otherwise,
except to the extent required by law. In some cases, you can
identify forward-looking statements by terminology such as
“anticipates,” “believes,” “plans,” “expects,” “projects,”
“future,” “intends,” “may,” “will,” “should,” “could,” “estimates,”
“predicts,” “potential,” “continue,” “guidance,” or the negative of
these terms or other comparable terminology, which are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Such
forward-looking statements are based on our expectations and
involve risks and uncertainties; consequently, actual results may
differ materially from those expressed or implied in the statements
due to a number of factors, including, but not limited to, the cash
balances of F-star, the ability of F-star to remain listed on the
Nasdaq Capital Market, F-star’s status as a clinical-stage
immuno-oncology company and its need for substantial additional
funding in order to complete the development and commercialization
of its product candidates, the expected timing and potential
outcomes of the reporting by F-star of key clinical data from its
programs, that F-star may experience delays in completing, or
ultimately be unable to complete, the development and
commercialization of its product candidates, that F-star’s clinical
trials may fail to adequately demonstrate the safety and efficacy
of its product candidates, that preclinical drug development is
uncertain, that some of F-star’s product candidates may never
advance to clinical trials, that results of preclinical studies and
early-stage clinical trials may not be predictive of the results of
later-stage clinical trials, that F-star relies on patents and
other intellectual property rights to protect its product
candidates, that the anticipated benefits and potential of F-star’s
collaboration with AstraZeneca and Janssen Biotech may not be
achieved, and the enforcement, defense and maintenance of such
rights may be challenging and costly, and that F-star faces
significant competition in its drug discovery and development
efforts.
New factors emerge from time to time, and it is
not possible for us to predict all such factors, nor can we assess
the impact of each such factor on the business or the extent to
which any factor, or combination of factors, may cause actual
results to differ materially from those contained in any
forward-looking statements. These risks are more fully discussed in
F-star’s most recent Annual Report on Form 10-K, subsequent
Quarterly Reports on Form 10-Q and other documents filed from time
to time with the SEC. Forward-looking statements included in this
communication are based on information available to F-star as of
the date of this communication. F-star does not assume any
obligation to update such forward-looking statements, whether as a
result of new information, future events or otherwise, except as
required by law.
|
|
|
|
F-star Therapeutics, Inc. |
Condensed Consolidated Balance Sheets |
(in thousands) |
|
|
September 30, |
|
December 31, |
|
2021 |
|
2020 |
|
Unaudited |
|
|
Cash and cash equivalents |
$ |
71,050 |
|
$ |
18,526 |
Prepaid and other current assets |
5,111 |
|
7,539 |
Other assets |
38,637 |
|
37,544 |
Total assets |
$ |
114,798 |
|
$ |
63,609 |
|
|
|
|
Term debt |
$ |
9,535 |
|
$ |
- |
Accounts payable and other current liabilities |
8,835 |
|
16,977 |
Other liabilities |
6,350 |
|
3,638 |
Total liabilities |
24,720 |
|
20,615 |
Total stockholders’ equity |
90,078 |
|
42,994 |
Total liabilities and stockholders' equity |
$ |
114,798 |
|
$ |
63,609 |
|
|
|
|
F-star Therapeutics,
Inc.Condensed Consolidated Statement of Operations
and Comprehensive Loss(in thousands, except share
and per share data)Unaudited
|
For the Three Months EndedSeptember 30, |
|
For the Nine Months EndedSeptember 30, |
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License revenue |
$ |
751 |
|
|
$ |
9,195 |
|
|
$ |
3,668 |
|
|
$ |
11,093 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
5,113 |
|
|
|
5,321 |
|
|
|
20,536 |
|
|
|
10,695 |
|
General and administrative |
|
5,239 |
|
|
|
7,261 |
|
|
|
18,169 |
|
|
|
13,805 |
|
Total operating expenses |
|
10,352 |
|
|
|
12,582 |
|
|
|
38,705 |
|
|
|
24,500 |
|
Loss from operations |
|
(9,601 |
) |
|
|
(3,387 |
) |
|
|
(35,037 |
) |
|
|
(13,407 |
) |
Other non-operating (expense)
income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
(746 |
) |
|
|
506 |
|
|
|
230 |
|
|
|
(1,164 |
) |
Change in fair value of
convertible debt |
|
- |
|
|
|
(446 |
) |
|
|
- |
|
|
|
(2,330 |
) |
Change in fair value of
contingent value rights |
|
(444 |
) |
|
|
- |
|
|
|
(1,027 |
) |
|
|
- |
|
Loss before income taxes |
|
(10,791 |
) |
|
|
(3,327 |
) |
|
|
(35,834 |
) |
|
|
(16,901 |
) |
Income tax expense |
|
- |
|
|
|
(124 |
) |
|
|
(190 |
) |
|
|
(171 |
) |
Net loss |
$ |
(10,791 |
) |
|
$ |
(3,451 |
) |
|
$ |
(36,024 |
) |
|
$ |
(17,072 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to common shareholders |
$ |
(10,791 |
) |
|
$ |
(3,451 |
) |
|
$ |
(36,024 |
) |
|
$ |
(17,072 |
) |
Basic and diluted adjusted net
loss per common shares |
$ |
(0.52 |
) |
|
$ |
(1.88 |
) |
|
$ |
(2.35 |
) |
|
$ |
(9.34 |
) |
Weighted-average number of shares outstanding, basic and
diluted |
|
20,617,822 |
|
|
|
1,832,194 |
|
|
|
15,300,433 |
|
|
|
1,828,597 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For further information, please contact:
For investor inquiriesLindsey
TrickettVP Investor Relations & Communications+1 240
543 7970lindsey.trickett@f-star.com
For media inquiriesHelen
ShikShik Communications LLC+1 617 510
4373Shik.Helen10@gmail.com
F star Therapeutics (NASDAQ:FSTX)
과거 데이터 주식 차트
부터 10월(10) 2024 으로 11월(11) 2024
F star Therapeutics (NASDAQ:FSTX)
과거 데이터 주식 차트
부터 11월(11) 2023 으로 11월(11) 2024