FHTX 4/28/2023 Shareholder/Stockholder Letter Transcript:
2022 Annual Report
UNITED STA
TATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
R PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
ANNUAL REPORT
For the fi
f scal year ended December 31, 2022
OR
TRA
R NSITION REPORT
R PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period fr
f om
to
Commission fi
f le number: 001-39634
Foghorn Therapeutics Inc.
(Exact name of registrant as specifi
f ed in its charter)
Delaware
47-5271393
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identifi
f cation Number)
500 Technology Square, Ste 700
Cambridge, Massachusetts
02139
(Address of principal executive off
ffices)
(Zip Code)
Registrant s telephone number, including area code: 617-586-3100
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, $0.0001 Par Va
V lue
FHTX
The Nasdaq Global Market
Securities registered pursuant to Section 12(g) of the Act:
None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defi
f ned in Rul
R e 405 of the Securities Act.
Indicate by check mark if the registrant is not required to fi
f le report
r s pursuant to Section 13 or Section 15(d) of the Act.
Yes No
Yes
No
Indicate by check mark whether the registrant (1) has fi
f led all report
r s required to be fi
f led by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or fo
f r such short
r er period that the registrant was required to fi
f le such report
r s), and (2) has been subject to such fi
f ling requirements fo
f r the past
90 days. Yes No
Indicate by check mark whether the registrant has submitted electronically every
r Interactive Data File required to be submitted pursuant to Rul
R e 405 of Regulation S-T
( 232.405 of this chapter) during the preceding 12 months (or for
f such short
r er period that the registrant was required to sub
u mit such fi
f les). Yes No
Indicate by check mark whether the registrant is a large accelerated fi
f ler, an accelerated fi
f ler, a non-accelerated fi
f ler, a smaller report
r ing company or an emerging growth
company. See the defi
f nitions of large accelerated fi
f ler, accelerated fi
f ler, smaller report
r ing company, and emerging growth company in Rul
R e 12b-2 of the Exchange Act.
Large accelerated fi
f ler
Accelerated fi
f ler
Non-accelerated fi
f ler
Smaller report
r ing company
Emerging growth company
If an emerging growth company, indicate by check mark
r if the registrant has elected not to use the extended transition period fo
f r complying with any new or revised
f nancial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
fi
Indicate by check mark whether the registrant has fi
f led a report
r on and attestation to its management s assessment of the eff
ff ectiveness of its interna
r l control over fi
f nancial
report
r ing under Section 404(b) of the Sarba
r nes-Oxley Act (15 U.S.C. 7262(b)) by the registered pub
u lic accounting fi
f rm that prepared or issued its audit report
r.
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the
correction of an error to previously issued financial statements.
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the
registrant s executive o cers during the relevant recovery period pursuant to 240.10D-1(b).
Indicate by check mark whether the registrant is a shell company (as defi
f ned in Rule 12b-2 of the Exchange Act). Yes No
The aggregate market value of common stock held by non-aff
ffiliates of the registrant computed by refe
f rence to the price of the registrant s common stock as of June 30,
2022, the last business day of the registrant's most recently completed second fi
f scal quart
r er, was approximately (based on the last report
r ed sale price on the NASDAQ Global Marke
r t
as of such date) $334.9 million.
As of Februa
r ry
r 28, 2023 there were 41,804,112 shares of the registrant s common stock, par value $0.0001 per share, outstanding.
DOCUMENTS INCORPORA
RATED BY RE
R FERE
R NCE
Port
r ions of the registrant s Proxy Statement fo
f r its 2023 Annual Meeting of Stockholders, which the registrant intends to fi
f le with the Securities and Exchange
Commission not later than 120 days aft
f er the registrant s fi
f scal year ended December 31, 2022, are incorpor
r ated by refe
f rence into Part
r III of this Annual Report on Form
r 10-K.
1
Foghorn Therapeutics Inc.
Index
Page
P RT
PA
R I
Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.
Business
Risk Factors
Unresolved Staff
f Comments
Properties
Legal Proceedings
Mine Safe
f ty Disclosures
5
44
68
69
69
69
P RT
PA
R II
Item 5.
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
Item 9C.
Market fo
f r Registrant s Common Equ
q ity, Related Stockholder Matters and Issuer Purchases of Equity
Securities
Reserved
Management s Discussion and Analysis of Financial Condition and Results of Operations
Quantitative and Qualitative Disclosures About Market Risk
Consolidated Financial Statements and Supplementary Data
Changes in and Disagreements Wi
W th Accountants on Accounting and Financial Disclosure
Controls and Procedu
d res
Other Info
f rmation
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
70
70
70
78
79
101
101
102
102
P RT
PA
R III
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
Directors, Executive Off
fficers and Corp
r orate Govern
r ance
Executive Compensation
Security Ownership of Certain Benefi
f cial Owners and Management and Related Stockholder Matters
Certain Relationships and Related Tr
T ansactions, and Director Independence
Principal Accountant Fees and Services
103
103
103
103
103
P RT
PA
R IV
Item 15. Exhibit and Financial Statement Schedules
Item 16. Form 10-K Summary
Signatu
t res
104
104
107
2
SPECIAL NOTE REGARDING FORW
RWARD-LOOKING STA
TATEMENTS
This Annual Report on Form 10-K contains fo
f rward-looking statements that are based on management s beliefs
f and
assumptions and on info
f rmation curr
r ently availab
a le to management. All statements other than statements of historical fa
f cts
contained in this Annual Report on Form 10-K are fo
f rward-looking statements. In some cases, you can identify
f fo
f rward-looking
statements by terms such as may, will, should, expect, plan, anticipate, could, intend, target, proj
o ect,
contemplate, believe, estimate, predict, potential or continu
n e or the negative of these terms or other similar
expressions, although not all fo
f rward-looking statements contain these words. Forward-looking statements include, but are not
limited to, statements concerning:
the initiation, timing, progress and results of our research and development programs and our preclinical and
clinical stu
t dies, including the potential resolution of the fu
f ll clinical hold and anticipated timing of release of
clinical data;
our ab
a ility
t to advan
a ce any product candidates that we may develop and to successfu
f lly complete preclinical and
clinical stu
t dies;
our ab
a ility
t to leverage our initial programs to develop additional product candidates using our Gene Tr
T aff
f f ic
Control platfo
f rm;
developments related to our competitors and our industry;
our ab
a ility
t to expan
a d the target populations of our programs and the availab
a ility
t of patients fo
f r clinical testing;
our ab
a ility
t to obtain regulatory ap
a proval fo
f r FHD-286, FHD-609, an
a d any fu
f tu
t re produ
d ct candidates fr
f om the
U.S. Food and Dru
r g Administration (the FDA ) and other regulatory au
a thorities;
our ab
a ility
t to identify
f and enter into fu
f tu
t re license agreements and collab
a orations;
our ab
a ility
t to continu
n e to rely on our contract development and manufa
f ctu
t ring organ
a izations ( CDMOs ) or
contract research organizations ( CROs ) fo
f r our manufa
f ctu
t ring and research needs;
regulatory
r developments in the United States and fo
f reign countries;
general economic conditions, including recessionary conditions, interest rates, monetary fl
f uctu
t ations and supply
chain constraints;
our ab
a ility
t to attract and retain key scientifi
f c and management personnel;
the scope of protection we are ab
a le to estab
a lish, maintain and enfo
f rce fo
f r intellectu
t al propert
r y rights covering
FHD-286, FHD-609, our fu
f tu
t re produ
d cts and our Gene Tr
T aff
ffic Control platfo
f rm
r ; and
the impact of th
t e COVID-19 pandemic on our and our collab
a orators business operations, including our research
and development programs and preclinical and clinical stu
t dies, as well as geopolitical instab
a ility
t and oth
t er
developments that may negatively impact the ab
a ility
t to utilize CDMOs and CROs that are located outside of the
United States.
The fo
f rward-looking statements in this Annual Report on Form 10-K ar
a e only predictions and are based largely on our current
expectations and proj
o ections ab
a out fu
f tu
t re events and fi
f nancial trends that we believe may
a aff
ffect our business, fi
f nancial
condition an
a d results of operations. These fo
f rward-looking statements speak only as of the date of this Annual Report on Form
10-K and are subj
b ect to a numb
m er of known and unknown risks, uncertainties and assumptions, including those described under
the section entitled Item 1A. Risk Factors in this Annual Report on Form 10-K. Because fo
f rward-looking statements are
inherently sub
ubject to risks and uncertainties, some of which cannot be predicted or quantifi
f ed and some of which are beyond our
control, you should not rely on these fo
f rward-looking statements as predictions of fu
f tu
t re events. Moreover, we operate in an
evolving environment. New risks and uncertainties may emerge fr
f om time to time, and it is not possible fo
f r management to
predict all risks and uncertainties. Except as required by ap
a plicab
a le law, we do not plan
a to publicly update or revise any
f rward-looking statements contained herein, whether as a result of any new info
fo
f rmation, fu
f tu
t re events, changed circumstances
or otherwise.
3
4/28/2023 Letter Continued (Full PDF)