Significant progress achieved on three clinical
stage programs focused on rare hematologic diseases and cancers
Etavopivat Phase 1 open label extension
enrollment in sickle cell disease (SCD) complete, updated results
to be presented at American Society of Hematology (ASH) Annual
Meeting December 11-14
Initial Phase 1 results presented in men with
metastatic castration-resistant prostate cancer (mCRPC ) showed
FT-7051 well-tolerated with evidence of clinical activity
Olutasidenib combination data in
relapsed/refractory acute myeloid leukemia (R/R/ AML) to be
presented at ASH Annual Meeting December 11-14
Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a
clinical-stage biopharmaceutical company focused on sickle cell
disease, prostate cancer and other rare hematologic diseases and
cancers, today reported financial results for the third quarter
ended Sept. 30, 2021. The company also highlighted recent progress
and upcoming milestones for its pipeline programs.
“During the third quarter, we made significant progress pursuing
our commitment not only to serving the needs of people living with
sickle cell disease with our lead program, etavopivat, but also
targeting prostate cancer with initial FT-7051 results, in addition
to new olutasidenib clinical data accepted for presentation at ASH
next month,” said Frank Lee, president and chief executive officer
of Forma.
Key Business and Clinical
Highlights
PKR Program in Sickle Cell Disease (SCD):
- Enrollment in etavopivat open label extension completed.
Full enrollment of 15 patients in the open label extension (OLE)
was completed during the quarter. Patients in the OLE are being
administered etavopivat 400 mg once daily for up to 12 weeks and
assessed for hematologic and hemolytic response, and improvement in
markers of red blood cell (RBC) health, including oxygenation and
deformability, as well as systemic biomarkers of SCD.
CPB/p300 Program in Prostate Cancer:
- Initial FT-7051 Phase 1 clinical trial results presented at
NCI/AACR/EORTC Virtual International Conference on Molecular
Targets and Cancer Therapeutics. Preliminary results included
data as of Sept. 1, 2021, from eight men enrolled in the trial.
FT-7051 was administered in 28-day cycles, with 21 days of dosing
followed by seven days of no dosing. The initial pharmacokinetic
(PK) analysis of FT-7051 documented rapid absorption, with drug
concentrations that approached the predicted efficacious dose based
on estimates from preclinical animal models. Skin biopsies of the
men participating in the study demonstrated a reduction in H3K27AC,
a marker of activity in the CBP/p300 pathway. The majority of the
treatment-emergent adverse events (TEAEs) were mild or moderate, at
Grade 2 or lower, with no events leading to treatment
discontinuation. The first evaluable patient completing more than
90 days of treatment demonstrated an ongoing response of
>80% decline in prostate-specific antigen (PSA80) from
baseline with stable disease.
Corporate
- Upcoming investor conference participation. Forma will
participate in the Jefferies London Healthcare Conference taking
place Nov. 16-19. The pre-recorded presentation will be available
Nov. 18 at 8:00am Greenwich Mean Time (GMT) in the “News &
Investors” section of Forma’s website at
www.FormaTherapeutics.com.
- Investor briefing to discuss results presented at ASH.
Forma will hold an investor briefing Dec. 13 at 8:00 am Eastern
Time (ET). The live webcast will be available in the “News &
Investors” section of Forma’s website
www.FormaTherapeutics.com.
Upcoming Milestones
- Updated Phase 1 OLE trial results for etavopivat in SCD to
be presented at ASH Dec. 11-14. Results to be presented will
include 15 patients being administered etavopivat 400mg once daily
for up to 12 weeks and assessed for hematologic and hemolytic
response, and improvements in markers of RBC health including
oxygenation and deformability, and systemic markers of SCD.
- Patient enrollment continues in Phase 2/3 registrational
trial, the Hibiscus Study. The Hibiscus study includes two
co-primary end points (hemoglobin and vaso-occlusive crises) that
support the traditional approval pathway. Based on ongoing feedback
from the FDA, although accelerated approval is still an available
regulatory pathway, Forma will need to provide additional
information to support hemoglobin response as a surrogate endpoint
eligible for accelerated approval for etavopivat. The company plans
to continue to seek accelerated approval for etavopivat utilizing
hemoglobin response rates as a surrogate endpoint by providing
additional data to support that hemoglobin response rates predict
for a clinical benefit.
- Additional etavopivat trials to begin late 2021/1H:22.
Forma plans to initiate a Phase 2 trial in transfusion dependent
SCD and both transfusion dependent and independent thalassemia
prior to the end of the year, and a pediatric SCD trial beginning
in the first half of 2022.
- Olutasidenib results in R/R AML to be presented at ASH Dec.
11-14. Results from the Phase 2 trial will show the impact of
the combination of olutasidenib and azacitidine on rates of
remission and transfusion independence in patients with mutant
isocitrate dehydrogenase 1 (mIDH1) AML. Analyses of safety and
efficacy will be presented at the ASH annual meeting.
- Additional FT-7051 clinical results in mCRPC to be presented
in 2022. Men with mCRPC continue to be enrolled in the dose
escalation portion of the Phase 1 trial. Forma plans to present
updated results from the trial at a scientific conference in
mid-2022.
- Possibility of COVID-19 impact remains. The COVID-19
pandemic remains a factor in the successful completion of these
milestones and ongoing clinical trials. Many clinical trials across
the biopharma industry, including Forma’s, have been impacted by
the COVID-19 pandemic. Clinical trial sites implementing new
policies in response to COVID-19 have impacted enrollment of
clinical trials or and the ability to access sites participating in
clinical trials.
Financial Results
- Cash Position: Cash, cash equivalents and marketable
securities were $531.8 million as of Sept. 30, 2021, as compared to
$645.6 million as of Dec. 31, 2020. Current cash runway is
projected through the third quarter of 2024.
- Research and Development (R&D) Expenses: R&D
expenses were $30.7 million for the quarter ended Sept. 30, 2021,
compared to $24.8 million for the quarter ended Sept. 30, 2020. The
increase was primarily attributable to an increase in research and
development staff to support advancement of etavopivat and other
programs, an increase in equity-based compensation, and increases
in external predevelopment and preclinical programs, conduct of the
Phase II/III etavopivat trial in SCD patients and study start-up
costs related to a trial in thalassemia/transfusion
dependence.
- General and Administrative (G&A) Expenses: G&A
expenses were $12.7 million for the quarter ended Sept. 30, 2021,
compared to $7.5 million for the quarter ended Sept. 30, 2020. The
increase was primarily attributable to equity-based compensation,
costs due to executive and staff hiring, legal, consulting, and
other professional fee expenses, and other related general and
administrative costs.
- Net Loss: Net loss was $43.3 million for the quarter
ended Sept. 30, 2021, compared to net loss of $27.6 million for the
quarter ended Sept. 30, 2020.
Forma will conduct a conference call and webcast Nov. 12 at 8:00
a.m. Eastern Daylight Time (EDT) to discuss third quarter 2021
results and business updates. The call can be accessed by dialing
(833) 301-1146 in the U.S., and (914) 987-7386 internationally,
with conference ID 6662686.
The live webcast will be available in the “News & Investors”
section of Forma’s website www.formatherapeutics.com.
About Forma Therapeutics
Forma Therapeutics is a clinical-stage biopharmaceutical company
focused on the research, development and commercialization of novel
therapeutics to transform the lives of patients with rare
hematologic diseases and cancers. Our R&D engine combines deep
biology insight, chemistry expertise and clinical development
capabilities to create drug candidates with differentiated
mechanisms of action focused on indications with high unmet need.
Our work has generated a broad proprietary portfolio of programs
with the potential to provide profound patient benefit. For more
information, please visit www.FormaTherapeutics.com or follow us on
Twitter @FORMAInc and LinkedIn.
Forward-looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, express or implied
statements regarding the company’s beliefs and expectations
regarding its: business plans and objectives; future plans for
etavopivat, FT-7051 and olutasidenib, including expectations
regarding timing, success and data announcements of our current
ongoing clinical trials; initial results for the etavopivat open
label extension cohort of our Phase 1 clinical trial and for the
FT-7051 Phase 1 clinical trial; therapeutic potential, clinical
benefits, mechanisms of action and safety of our product
candidates; planned regulatory submissions; upcoming milestones and
planned additional trials for the company’s product candidates;
growth as a company; presentation of additional data at upcoming
scientific conferences, and other preclinical data and potential
data publications in 2021 and 2022; uses and need of capital,
expenses and other 2021 financial results currently or in the
future; and the potential impact of COVID-19 on patient retention
and enrollment, future operations, clinical trials or
investigational new drug (IND) applications. The words “may,”
“will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,”
“intend,” “believe,” “estimate,” “predict,” “project,” “potential,”
“continue,” “target” and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
Any forward-looking statements in this press release are based
on management’s current expectations and beliefs and are subject to
a number of risks, uncertainties and important factors that may
cause actual events or results to differ materially from those
expressed or implied by any forward-looking statements contained in
this press release, including, without limitation, those risks and
uncertainties associated with the following: the impact of the
COVID-19 pandemic on the company’s business, operations, patient
enrollment and retention, strategy, goals and anticipated
milestones; the therapeutic potential of etavopivat, FT-7051, and
olutasidenib; the timing and completion of our Phase 1 clinical
study in etavopivat and our Phase 1 clinical study in FT-7051 and
final audit and quality controlled verification of initial data and
related analyses; the timing associated with the initiation or
continuation of any trials and success of ongoing clinical trials
of etavopivat and FT-7051; our ability to execute on our strategy;
positive results from a clinical study may not necessarily be
predictive of the results of future or ongoing clinical studies;
any one or more of our product candidates may not be successfully
developed and commercialized; regulatory developments in the United
States and foreign countries; our ability to protect and maintain
our intellectual property position; the impact of COVID-19 our
supply chain and production as well as global economies and
financial markets; and our ability to fund operations; as well as
those risks and uncertainties set forth more fully under the
caption "Risk Factors" in our Quarterly Report on Form 10-Q for the
quarter ended September 30, 2021, to be filed with the United
States Securities and Exchange Commission (SEC) and subsequent
filings with the SEC. We disclaim any obligation to publicly update
or revise any such statements to reflect any change in expectations
or in events, conditions or circumstances on which any such
statements may be based, or that may affect the likelihood that
actual results will differ from those set forth in the
forward-looking statements. Any forward-looking statements
contained in this press release represent our views only as of the
date hereof and should not be relied upon as representing our views
as of any subsequent date.
Selected Financial
Information
(in thousands except share and
per share data)
(unaudited)
Statement of Operations Items:
For the Three Months
Ended
September 30,
For the Nine Months
Ended
September 30,
2021
2020
2021
2020
Collaboration revenue
$
—
$
—
$
—
$
—
Operating expenses:
Research and development
30,684
24,780
88,614
68,501
General and administrative
12,749
7,460
35,087
22,841
Restructuring charges
—
—
—
63
Total operating expenses
43,433
32,240
123,701
91,405
Loss from operations
(43,433
)
(32,240
)
(123,701
)
(91,405
)
Other income:
Gain on Hit Discovery divestiture
—
—
—
23,312
Interest income
216
870
770
2,406
Other (expense) income, net
(70
)
(52
)
215
(2,668
)
Total other income, net
146
818
985
23,050
Loss before taxes
(43,287
)
(31,422
)
(122,716
)
(68,355
)
Income tax expense (benefit)
7
(3,806
)
123
(26,529
)
Net loss and comprehensive loss
$
(43,294
)
$
(27,616
)
$
(122,839
)
$
(41,826
)
Accretion of cumulative dividends on
Series D redeemable convertible preferred stock
—
—
—
(3,736
)
Net loss allocable to shares of common
stock, basic
$
(43,294
)
$
(27,616
)
$
(122,839
)
$
(45,562
)
Change in fair value attributable to
warrants to purchase common stock
—
(8
)
—
—
Net loss allocable to shares of common
stock, diluted
$
(43,294
)
$
(27,624
)
$
(122,839
)
$
(45,562
)
Net loss per share of common stock:
Basic
$
(0.91
)
$
(0.67
)
$
(2.60
)
$
(2.74
)
Diluted
$
(0.91
)
$
(0.67
)
$
(2.60
)
$
(2.74
)
Weighted-average shares of common stock
outstanding:
Basic
47,365,704
41,088,261
47,333,652
16,616,143
Diluted
47,365,704
41,088,924
47,333,652
16,616,143
Selected Balance Sheet Items:
September 30, 2021
December 31, 2020
Cash, cash equivalents, and marketable
securities
$
531,769
$
645,588
Total assets
$
602,225
$
680,971
Accounts payable, accrued expenses, and
other current liabilities
$
28,048
$
31,399
Total stockholders’ equity
$
542,831
$
648,244
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211112005262/en/
Media Contact: Adam Silverstein, +1 917-697-9313 Porter
Novelli adam.silverstein@porternovelli.com
Investor Contact: Mario Corso, +1 781-366-5726 Forma
Therapeutics mcorso@formatherapeutics.com
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