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 announces
second quarter 2021 financial results and provides a corporate
update.
The Company today announces an expanded clinical development
strategy for FS118, F-star’s first-in-class bispecific antibody
targeting LAG-3 and PD-L1, into checkpoint inhibitor naïve
patients. This new study with FS118 is in biomarker enriched
subsets of patients with non-small cell lung cancer (NSCLC) and
diffuse large B-cell lymphoma (DLBCL). By moving into earlier lines
of therapy, FS118 has the potential not only to delay, but also to
prevent checkpoint resistance, which could provide an alternative
treatment for patients who do not see a durable benefit from
currently approved immunotherapies.
In addition to the expanded FS118 clinical strategy, F-star has
three other ongoing clinical stage programs. These programs are
combined with a strong balance sheet, having closed an underwritten
public offering of stock and its “at the market” facility during
Q2, which will enable the company to deliver multiple clinical data
milestones. At the end of the second quarter the company had over
$80 million in cash and cash equivalents. In the past quarter,
F-star has also delivered on clinical and business development
objectives, specifically the recent interim Phase 1 update on SB
11285 and the announcement of two major collaborations, a licensing
agreement with AstraZeneca Plc for STING inhibitors and a supply
agreement with MSD (Merck & Co., Inc., Kenilworth, NJ,
USA) to evaluate the combination of FS120, F-star’s first-in-class
dual-agonist, tetravalent, bispecific antibody targeting CD137 and
OX40, with KEYTRUDA® (pembrolizumab), MSD’s
anti-PD-1 therapy.
Eliot Forster, CEO of F-star Therapeutics, Inc., said, “I’m
happy to share today the expansion of the FS118 clinical
development program into checkpoint naïve patients. By targeting
LAG-3, which was recently externally validated in the clinic as an
important target, and PD-L1 simultaneously, we believe FS118 has
the opportunity to improve patient outcomes over those seen with
first generation immunotherapies. We also continue to focus on the
checkpoint inhibitor refractory patient population in our ongoing
FS118 proof-of-concept study in head and neck cancers. We are also
pleased to have concluded two new collaborations, with AstraZeneca
and MSD for STING antagonists and combining Keytruda with FS120,
respectively.
“We believe that our strong balance sheet, expanded strategy for
FS118, continuing and beneficial partnerships, along with our
dedicated staff and investors, position F-star for a promising 2021
and beyond. We look forward to sharing data with you at upcoming
medical conferences, including at ESMO next month.”
SECOND QUARTER 2021 AND RECENT HIGHLIGHTS
FS118 development expansion plans following recent
external clinical validation of LAG-3: Phase 3 data with
LAG-3 at ASCO 2021, further supported F-star’s expansion of the
FS118 clinical development plan into checkpoint naïve, biomarker
enriched NSCLC and DLBCL patients. This study is anticipated to
begin in the second half of 2021.
Strong financial position: In Q2 2021, the
Company received $82.6 million in gross proceeds through the
combination of an underwritten public offering of stock and use of
its “at the market” facility.
FS222 Poster presented at the American Association for
Cancer Research (AACR) Annual Meeting in 2021: In April,
F-star presented a poster at AACR 2021 entitled ‘FS222, a
Tetravalent Bispecific Antibody Targeting CD137 and PD-L1, is
Designed for Optimal CD137 Interactions Resulting in Potent T cell
Activation Without Toxicity’. This poster and the associated data
showcased the differentiation of FS222 from competitor molecules
and highlighted the importance of ‘tuning’ for both the affinity
and avidity of bispecific antibodies.
Combination of FS120 with KEYTRUDA: Last week,
F-star announced a clinical trial collaboration and supply
agreement with MSD (Merck & Co., Inc., Kenilworth, NJ,
USA), to evaluate the combination of FS120, F-star’s first-in-class
dual-agonist tetravalent bispecific antibody targeting CD137 and
OX40, with KEYTRUDA® (pembrolizumab), MSD’s
anti-PD-1 therapy.
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 contingent value rights
(CVR) agreement entered into in connection with the transaction
with Spring Bank Pharmaceuticals, Inc., has been completed. Based
on the positive emerging clinical data, further dose escalations
are ongoing and a further clinical update is planned for 2022.
SB 11285 in Nature
publication and composition of matter patent granted in the
US: F-star published on its second-generation STING
agonist, SB 11285, in the April 2021 issue of Nature
Communications. The study, entitled ‘STING enhances cell death
through regulation of reactive oxygen species and DNA damage’
demonstrated that systemic administration of a STING agonist in
combination with radiation in a preclinical model enhances local
control in Head and Neck Squamous Cell Carcinoma (HNSCC) and
suggests that STING expression in the tumor is required for maximal
therapeutic benefit. The US Patent Office granted a patent during
the quarter with claims protecting the composition of matter of
F-star’s SB 11285 molecule giving protection until 2037.
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 Stimulator of
Interferon Genes (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.
F-star retains rights to all STING agonists, currently in clinical
development for patients with cancer. This agreement is subject to
the second CVR with the former shareholders of Spring Bank
Pharmaceuticals.
SECOND QUARTER 2021 FINANCIAL SUMMARY
Cash and cash equivalents as of June 30, 2021, were $81.6
million, compared to $18.5 million at December 31, 2020.
Research & Development (R&D) expenses were $8.4 million
for the quarter ended June 30, 2021, compared to $2.1 million for
the corresponding quarter in 2020. The $6.3 million increase was
primarily related to manufacturing costs and clinical costs with
four programs now in the clinic versus one clinical program in Q2
2020.
General & Administrative (G&A) expenses were $6.5
million for the quarter ended June 30, 2021, compared to $3.2
million for the second quarter of 2020. This $3.3 million increase
in G&A expense was primarily due to increased non-cash
stock-based compensation expense, legal and professional fees and
costs associated with operating as a public company.
Net loss was $15.6 million or a loss per share of $0.92 (basic
and diluted), for the quarter ended June 30, 2021, compared to a
net loss of $6.5 million or a loss per share of $3.53 (basic and
diluted) for the quarter ended June 30, 2020.
CONFERENCE CALL AND WEBCAST
F-star will host a conference call today, August 12, 2021,
beginning at 9:00 AM EDT. To join the webcast, go to
our website. To join by phone, participants may dial
1-833-471-0868 in the US/Canada or 1-914-987-7751 for International
calls or 0800 0288438 or 0203 1070289 for the United Kingdom, at
least 10 minutes prior to the start of the call.
A recording of the conference call will be available on the
‘Events & Presentations’ section of the Company’s website at
www.f-star.com from August 13, 2021.
About F-star Therapeutics, Inc.
F-star is a clinical-stage biopharmaceutical company developing
tetravalent bispecific antibodies for a transformation in cancer
therapy. By developing medicines that seek to block tumor immune
evasion, the Company’s goal is to offer patients greater and more
durable benefits than current immuno-oncology treatments. Through
its proprietary tetravalent, bispecific natural antibody (mAb²™)
format, F-star’s mission is to generate highly differentiated
best-in-class drug candidates with monoclonal antibody-like
manufacturability. 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, 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, and 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, 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 Annual Report on
Form 10-K, 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) |
(Unaudited) |
|
|
|
|
|
June 30, |
|
December 31, |
|
2021 |
|
2020 |
|
|
|
|
Cash and
cash equivalents |
$ |
81,648 |
|
$ |
18,526 |
Prepaid and
other current assets |
|
3,671 |
|
|
7,539 |
Other
assets |
|
39,655 |
|
|
37,544 |
Total assets |
$ |
124,974 |
|
$ |
63,609 |
|
|
|
|
Term
debt |
$ |
9,466 |
|
$ |
— |
Accounts
payable and other current liabilities |
|
9,953 |
|
|
16,977 |
Other
liabilities |
|
6,562 |
|
|
3,638 |
Total liabilities |
|
25,981 |
|
|
20,615 |
Total
stockholders’ equity |
|
98,993 |
|
|
42,994 |
Total liabilities and stockholders' equity |
$ |
124,974 |
|
$ |
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 Ended June 30, |
|
For the Six Months Ended June 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
License revenue |
$ |
- |
|
|
$ |
543 |
|
|
$ |
2,917 |
|
|
$ |
1,898 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
8,437 |
|
|
|
2,093 |
|
|
|
15,704 |
|
|
|
5,493 |
|
General and administrative |
|
6,501 |
|
|
|
3,236 |
|
|
|
12,930 |
|
|
|
6,425 |
|
Total operating expenses |
|
14,938 |
|
|
|
5,329 |
|
|
|
28,634 |
|
|
|
11,918 |
|
Loss from
operations |
|
(14,938 |
) |
|
|
(4,786 |
) |
|
|
(25,717 |
) |
|
|
(10,020 |
) |
Other
non-operating (expense) income: |
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
(46 |
) |
|
|
(143 |
) |
|
|
972 |
|
|
|
(1,670 |
) |
Change in fair value of convertible debt |
|
- |
|
|
|
(1,498 |
) |
|
|
- |
|
|
|
(1,884 |
) |
Change in fair value of contingent value rights |
|
(583 |
) |
|
|
- |
|
|
|
(583 |
) |
|
|
- |
|
Loss before income taxes |
|
(15,567 |
) |
|
|
(6,427 |
) |
|
|
(25,328 |
) |
|
|
(13,574 |
) |
Income tax
provision |
|
(82 |
) |
|
|
(35 |
) |
|
|
(190 |
) |
|
|
(47 |
) |
Net
loss |
$ |
(15,649 |
) |
|
$ |
(6,462 |
) |
|
$ |
(25,518 |
) |
|
$ |
(13,621 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
attributable to common shareholders |
$ |
(15,649 |
) |
|
$ |
(6,462 |
) |
|
$ |
(25,518 |
) |
|
$ |
(13,621 |
) |
Basic and
diluted adjusted net loss per common shares |
$ |
(0.92 |
) |
|
$ |
(3.53 |
) |
|
$ |
(1.95 |
) |
|
$ |
(7.44 |
) |
Weighted-average number of shares outstanding-basic and
diluted |
|
17,022,417 |
|
|
|
1,830,075 |
|
|
|
13,083,230 |
|
|
|
1,829,993 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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
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