Foghorn Therapeutics Provides Second Quarter 2023 Financial and Corporate Update
04 Agosto 2023 - 8:00AM
Foghorn® Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage
biotechnology company pioneering a new class of medicines that
treat serious diseases by correcting abnormal gene expression,
today provided a financial and corporate update in conjunction with
the Company’s 10-Q filing for the quarter ended June 30, 2023. With
an initial focus in oncology, Foghorn’s Gene Traffic Control®
Platform and resulting broad pipeline have the potential to
transform the lives of people suffering from a wide spectrum of
diseases.
“Foghorn made important progress across both our
clinical and preclinical pipeline in the second quarter. We
successfully resolved the clinical hold for FHD-286 in AML and
disclosed the clinical data from the Phase 1 study which suggested
that FHD-286 is a potent, broad-based differentiation agent. We are
on track to initiate dosing in a combination study of FHD-286 in
AML in the third quarter. We continue to advance our selective BRM,
selective CBP, selective EP300, and selective ARID1B programs,
demonstrating our ability to repeatedly drug important targets in
oncology,” said Adrian Gottschalk, President and Chief Executive
Officer of Foghorn.
Key Recent Updates and Upcoming
Milestones
- FHD-286. FHD-286
is a potent, selective inhibitor of the BRG1 and BRM subunits of
the BAF chromatin remodeling complex where dependency on BRG1/BRM
is well-established preclinically with multiple tumor types,
including acute myelogenous leukemia (AML)/myelodysplastic syndrome
(MDS), non–small cell lung cancer (NSCLC) and prostate cancer.
- AML/MDS Update.
Foghorn plans to commence a Phase 1 study of FHD-286 in combination
with decitabine or low-dose cytarabine (LDAC) in relapsed and/or
refractory AML patients. The decision to advance to the Phase 1
combination study is based on clinical data demonstrating FHD-286’s
effect as a broad-based differentiation agent, its safety profile,
as well as supportive preclinical combination data, including
robust efficacy data in multiple CDX and PDX models.
- mUM Update. On
June 28, 2023, Foghorn announced data from the Phase 1 dose
escalation safety study of FHD-286 in metastatic uveal melanoma
(mUM). These data reinforced the safety and tolerability profile of
FHD-286. At this time, the company does not plan to advance FHD-286
in uveal melanoma independently.
- Differentiated Pipeline
Advancement. Foghorn continues to expand its platform and
pipeline. The Company anticipates the potential for six new
investigational new drug (IND) applications in the next four years.
The Company continues to progress programs for multiple targets
which include chromatin remodeling complexes, transcription
factors, helicases and other chromatin related factors. These
targets include Selective BRM* and wholly owned programs including
CBP, EP300, and ARID1B, as well as other undisclosed targets, which
combined could address more than 20 tumor types impacting more than
500,000 new patients annually.
- Strategic
Collaborations. Foghorn continued to progress its
strategic collaborations with world-leading pharmaceutical
companies, which validate the rigor of our science, highlight the
importance of the targets we are tackling, and confirm the
relevance of the biology on which Foghorn is focused.
- In December 2021, Foghorn entered
into a strategic collaboration with Loxo@Lilly. In 2023, Foghorn
anticipates continued progress across the collaboration including a
co-development and co-commercialization agreement on the Selective
BRM program*, an additional undisclosed oncology target and three
additional discovery programs. The Selective BRM program is on
track to transition to Loxo@Lilly in the second half of 2023.
- In July 2020, Foghorn entered into
a strategic collaboration with Merck Sharp & Dohme. Through the
first two quarters of 2023, Foghorn continued to utilize its Gene
Traffic Control platform to discover and develop novel therapeutics
under the collaboration based on disruptors of a specified
transcription factor target.
*In December 2021, Foghorn announced a strategic
collaboration with Loxo@Lilly to create novel oncology medicines.
The collaboration includes a co-development and
co-commercialization agreement for Foghorn’s Selective BRM oncology
program and an additional undisclosed oncology target. In addition,
the collaboration includes three discovery programs using Foghorn’s
proprietary Gene Traffic Control platform.
Second Quarter 2023 Financial
Highlights
- Strong Balance Sheet and
Cash Runway. As of June 30, 2023, the Company had
$284.3 million in cash, cash equivalents and marketable securities,
which provides a cash runway into the second half of 2025.
- Collaboration
Revenues. Collaboration revenue was $5.6 million for the
three months ended June 30, 2023, compared to $4.5 million for
the three months ended June 30, 2022. The increase
year-over-year was primarily driven by revenue recognized under the
Lilly collaboration agreement.
- Research and Development
Expenses. Research and development expenses were $29.2
million for the three months ended June 30, 2023, compared to
$26.0 million for the three months ended June 30, 2022. This
increase was primarily due to costs associated with continued
investment in R&D personnel and platform and early-stage
research investments, modestly offset by a decline in clinical
trial spend
- General and Administrative
Expenses. General and administrative expenses were $8.4
million for the three months ended June 30, 2023, compared to
$7.7 million for the three months ended June 30, 2022. This
increase was primarily due to an increase in investments to support
the growing business which included increases in personnel-related
costs and stock-based compensation expense.
- Net Loss. Net loss
was $29.5 million for the three months ended June 30, 2023,
compared to a net loss of $27.3 million for the three months ended
June 30, 2022.
About FHD-286FHD-286 is a
highly potent, selective, allosteric and orally available,
small-molecule, enzymatic inhibitor of BRG1 (SMARCA4) and BRM
(SMARCA2), two highly similar proteins that are the ATPases, or the
catalytic engines of the BAF complex, one of the key regulators
within the chromatin regulatory system. In preclinical studies,
FHD-286 has shown anti-tumor activity across a broad range of
malignancies including both hematologic and solid tumors. FHD-286
is being developed for relapsed and/or refractory AML, and the
company plans to commence a Phase 1 study, in combination with
decitabine or cytarabine, in the third quarter of 2023.
About AMLAdult acute myeloid
leukemia (AML) is a cancer of the blood and bone marrow and the
most common type of acute leukemia in adults. AML is a diverse
disease associated with multiple genetic mutations. It is diagnosed
in about 20,000 people every year in the United States.
About Foghorn
TherapeuticsFoghorn® Therapeutics is discovering and
developing a novel class of medicines targeting genetically
determined dependencies within the chromatin regulatory system.
Through its proprietary scalable Gene Traffic Control® platform,
Foghorn is systematically studying, identifying and validating
potential drug targets within the chromatin regulatory system. The
Company is developing multiple product candidates in oncology.
Visit our website at www.foghorntx.com for more information on the
company, and follow us on Twitter and LinkedIn.
Forward-Looking StatementsThis
press release contains “forward-looking statements” regarding the
Company’s clinical programs for FHD-286, including its initiation
of a Phase 1 study of FHD-286 in combination with decitabine or
low-dose cytarabine (LDAC) in relapsed and/or refractory AML
patients, its collaborations with Lilly and Merck and its research
pipeline, including the status of its Selective BRM program, the
filing of INDs, and its protein degrader efforts. Forward-looking
statements include statements regarding the Company’s clinical
trials, product candidates and research efforts and other
statements identified by words such as “could,” “may,” “might,”
“will,” “likely,” “anticipates,” “intends,” “plans,” “seeks,”
“believes,” “estimates,” “expects,” “continues,” “projects” and
similar references to future periods. Forward-looking statements
are based on our current expectations and assumptions regarding
capital market conditions, our business, the economy and other
future conditions. Because forward-looking statements relate to the
future, by their nature, they are subject to inherent
uncertainties, risks and changes in circumstances that are
difficult to predict. As a result, actual results may differ
materially from those contemplated by the forward-looking
statements. Important factors that could cause actual results to
differ materially from those in the forward-looking statements
include regional, national or global political, economic, business,
competitive, market and regulatory conditions, including risks
relating to our clinical trials and other factors set forth under
the heading “Risk Factors” in the Company’s Annual Report on Form
10-K for the year ended December 31, 2022, as filed with the
Securities and Exchange Commission. Any forward-looking statement
made in this press release speaks only as of the date on which it
is made.
Condensed Consolidated Balance Sheets |
(In thousands) |
|
|
June 30, |
|
|
|
2023 |
|
Dec. 31, 2022 |
Cash, cash equivalents and marketable securities |
$ |
284,311 |
|
|
$ |
345,798 |
|
All other assets |
|
55,265 |
|
|
|
59,085 |
|
Total
assets |
$ |
339,576 |
|
|
$ |
404,883 |
|
Deferred revenue, total |
$ |
325,912 |
|
|
$ |
336,820 |
|
All other liabilities |
|
63,014 |
|
|
|
67,951 |
|
Total
liabilities |
|
388,926 |
|
|
|
404,771 |
|
Total stockholders’
equity (deficit) |
|
(49,350 |
) |
|
|
112 |
|
Total liabilities and
stockholders’ equity |
$ |
339,576 |
|
|
$ |
404,883 |
|
Condensed Consolidated Statements of
Operations |
(In thousands, except share and per share
amounts) |
|
|
Three Months Ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
Collaboration revenue |
$ |
5,599 |
|
|
$ |
4,490 |
|
Operating expenses: |
|
|
|
Research and development |
|
29,248 |
|
|
|
25,974 |
|
General and administrative |
|
8,401 |
|
|
|
7,704 |
|
Total operating
expenses |
|
37,649 |
|
|
|
33,678 |
|
Loss from
operations |
|
(32,050 |
) |
|
|
(29,188 |
) |
Total other income,
net |
|
3,505 |
|
|
|
1,875 |
|
Provision for income
taxes |
|
(942 |
) |
|
|
— |
|
Net loss |
$ |
(29,487 |
) |
|
$ |
(27,313 |
) |
Net loss per share
attributable to common stockholders—basic and diluted |
$ |
(0.70 |
) |
|
$ |
(0.66 |
) |
Weighted average
common shares outstanding—basic and diluted |
|
41,825,555 |
|
|
|
41,515,305 |
|
Contact:Ben Strain, Foghorn Therapeutics Inc.
(Media and Investors) bstrain@foghorntx.com
Karin Hellsvik, Foghorn Therapeutics Inc. (Media)
khellsvik@foghorntx.com
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