Development pipeline progressing to key
upcoming clinical milestones
Multiple-ascending dose (MAD) cohorts of
FT-4202 Phase 1 trial in sickle cell disease completed; hemoglobin
increased ≥ 1 g/dL in approximately 71% of patients and improved
hematologic and hemolytic markers consistent with improved red
blood cell (RBC) health
Updated MAD results and initial open-label
extension trial (OLE) results to date to be presented at European
Hematology Association (EHA) Virtual Congress in June
Phase 1 trial of FT-7051 in metastatic
castration-resistant prostate cancer (mCRPC) ongoing, initial
results expected fourth quarter of 2021
Olutasidenib relapsed/refractory acute myeloid
leukemia (R/R AML) results presentation in June at American Society
of Clinical Oncology (ASCO), new drug application (NDA) preparation
ongoing
Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a
clinical-stage biopharmaceutical company focused on rare
hematologic diseases and cancers, today reported financial results
for the first quarter ended March 31, 2021. The company also
highlighted recent progress and upcoming milestones for its
pipeline programs.
“During the first quarter, we successfully completed the
multiple ascending dose portion of our Phase 1 trial in sickle cell
disease, and despite challenges from the COVID-19 pandemic also
began enrolling patients in the Phase 2/3 trial of FT-4202, called
The Hibiscus Study, as well as in the Phase 1 trial of FT-7051 for
metastatic castration resistant prostate cancer,” said Frank Lee,
President and Chief Executive Officer of Forma. “We look forward to
sharing additional pipeline results over the course of 2021 in our
mission to transform the lives of people living with rare
hematologic diseases and cancers.“
Key Business and Clinical
Highlights
PKR Program in Sickle Cell Disease (SCD):
- MAD cohorts completed with approximately 71% of participants
achieving hemoglobin increase ≥ 1 g/dL from baseline, and
improvement across markers of RBC health. Doubling the dose of
FT-4202 to 600 mg daily for 14 days compared to the previous 300 mg
cohort was well-tolerated with no dose-limiting toxicities or
treatment-related adverse events observed. Improvements in
hematologic (hemoglobin and reticulocytes) and hemolytic (bilirubin
and lactate dehydrogenase) parameters were comparable to that
observed with the 300 mg dose, with best response typically
observed at the end of the 14-day treatment period. In the combined
cohorts, 10 of 14 (71%) patients on FT-4202 achieved a hemoglobin
increase ≥ 1 g/dL from baseline to Day 14. Improvement in RBC
health was evidenced by increased sickle RBC survival and reduced
intravascular hemolysis in patients with SCD based on a reduction
in reticulocytes, bilirubin and LDH levels.
- Patient enrollment began in Phase 2/3 registrational trial,
the Hibiscus Study. The Phase 2/3 Hibiscus Study is currently
enrolling people living with SCD. This adaptive, randomized,
placebo-controlled, double-blind, multi-center trial is expected to
enroll approximately 344 adults and adolescents with SCD. FT-4202
doses of 200mg and 400mg administered once-daily are being
evaluated in the Phase 2 portion of the trial. Primary endpoints in
the Phase 3 portion of the trial are hemoglobin response rate at
week 24 (increase of > 1 g/dL from baseline), intended to
support accelerated approval, and annualized vaso-occlusive crisis
rate during the 52-week blinded treatment period, which if positive
is expected to support full approval.
CPB/p300 Program in Prostate Cancer:
- FT-7051 Phase 1 clinical trial initiated for the treatment
of mCRPC. In January 2021, Forma announced that the first
patient was dosed in the ongoing Phase 1 clinical trial evaluating
FT-7051 for the treatment of mCRPC. The trial is a multicenter,
open-label evaluation of the safety and tolerability, preliminary
anti-tumor activity (prostate specific antigen (PSA) and
radiographic responses), and pharmacokinetics/pharmacodynamics
(PK/PD) of FT-7051 in men with mCRPC who have progressed despite
prior therapy with at least one anti-androgen therapy. The trial
will include genetic mutation analysis to identify the basis of
resistance to standard-of-care and will also evaluate expression of
the AR-v7 splice variant, for which there are no approved
therapies. The trial utilizes an adaptive trial design, intended to
accelerate the escalation to potentially therapeutic doses and
yield important safety information, as well as to identify
biomarkers of clinical benefit such as PSA response.
IDH1 Program in AML and Glioma:
- Olutasidenib NDA preparation for R/R AML. With the
conclusion of the Phase 2 R/R AML trial, Forma has begun preparing
an NDA for submission to the U.S. Food and Drug Administration
(FDA).
Upcoming Milestones
- Presentation of updated Phase 1 FT-4202 results in SCD.
A poster presentation on FT-4202 in SCD is scheduled for the EHA
Virtual Congress taking place June 9-17, 2021. The presentation
will include combined unblinded data from the two-week MAD cohorts
as well as initial OLE results to date. In addition, full results
from the MAD dose cohorts and the OLE are expected to be presented
at a scientific congress in late 2021.
- Initial Phase 1 clinical results from FT-7051 in mCRPC
anticipated later this year. This adaptive trial is assessing
multiple doses of FT-7051 with dose escalation dependent upon
safety and tolerability. Initial results anticipated in the fourth
quarter of 2021 may include safety/tolerability, PK/PD results and
preliminary biomarker data.
- Olutasidenib results presentation in R/R AML. Phase 2
registrational results of olutasidenib in R/R AML will be presented
at the 2021 ASCO Annual Meeting taking place from June 4-8, 2021,
and the EHA Virtual Congress taking place June 9-17, 2021.
- Possibility of COVID-19 impact remains. The COVID-19
pandemic remains a factor in the successful completion of these
milestones. Many clinical trials across the biopharma industry,
including ours, have been impacted by the COVID-19 pandemic, with
clinical trial sites implementing new policies in response to
COVID-19, resulting in potential delays to enrollment of clinical
trials or changes in the ability to access sites participating in
clinical trials.
Financial Results
- Cash Position: Cash, cash equivalents and marketable
securities were $603.7 million as of March 31, 2021, as compared to
$645.6 million as of December 31, 2020. Current cash runway is
projected through the third quarter of 2024.
- Research and Development (R&D) Expenses: R&D
expenses were $26.3 million for the quarter ended March 31, 2021,
compared to $23.2 million for the quarter ended March 31, 2020. The
increase was primarily attributable to increases in FT-4202
development expenses, partially offset by reduced spending on
olutasidenib development.
- General and Administrative (G&A) Expenses: G&A
expenses were $9.9 million for the quarter ended March 31, 2021,
compared to $8.9 million for the quarter ended March 31, 2020. The
increase in general and administrative expense was primarily
attributable to stock compensation expense and insurance, partially
offset by a reduction in professional fees.
- Net Income/Loss: Net loss was $36.0 million for the
quarter ended March 31, 2021, compared to net income of $11.2
million for the quarter ended March 31, 2020.
Forma will conduct a conference call and webcast May 14th at 8
a.m. Eastern Daylight Time (EDT) to discuss first quarter 2021
results and business update. The call can be accessed by dialing
(833) 301-1146 in the U.S., and (914) 987-7386 internationally,
with conference ID 8597396.
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
FT-4202, FT-7051 and olutasidenib, including expectations regarding
timing and success of the current ongoing clinical trials,
therapeutic potential, clinical benefits and safety thereof,
planned regulatory submissions, including an NDA for olutasidenib,
and upcoming milestones for the company’s other product candidates;
growth as a company; presentation of additional data at upcoming
scientific conferences, and other preclinical data and potential
data publications in 2021; the potential commercial and
collaboration opportunities, including potential future
collaborators and parties, as well as value and market, for our
product candidates; 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 FT-4202, FT-7051, and
olutasidenib, and the timing associated with the initiation or
continuation of any trials and success of ongoing clinical trials
of FT-4202 and FT-7051; Forma’s ability to execute on its strategy;
the submission and acceptance of a new drug application (NDA) for
submission to the U.S. Food and Drug Administration (FDA) for
olutasidenib; 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 Forma’s product candidates may
not be successfully developed and commercialized; regulatory
developments in the United States and foreign countries; Forma’s
ability to protect and maintain our intellectual property position;
the impact of COVID-19 affecting countries or regions in which we
have operations or do business, including potential negative
impacts on our employees, customers, supply chain and production as
well as global economies and financial markets; Forma’s ability to
fund operations; Forma’s ability to identify satisfactory
collaboration opportunities, as well as those risks and
uncertainties set forth more fully under the caption "Risk Factors"
in our Annual Report on Form 10-K for the year ended December 31,
2020, filed with the United States Securities and Exchange
Commission (SEC) and subsequent filings with the SEC.. Forma
disclaims 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 Forma’s views only as of the date hereof and should not
be relied upon as representing its views as of any subsequent date.
Forma explicitly disclaims any obligation to update any
forward-looking statements.
Selected Financial
Information
(in thousands except share and
per share data)
(unaudited)
Statement of Operations Items:
For the Three Months
Ended March 31,
2021
2020
Collaboration revenue
$
—
$
—
Operating expenses: Research and development
26,343
23,210
General and administrative
9,867
8,933
Restructuring charges
—
83
Total operating expenses
36,210
32,226
Loss from operations
(36,210
)
(32,226
)
Other income, net
258
23,971
Loss before taxes
(35,952
)
(8,255
)
Income tax expense (benefit)
8
(19,485
)
Net (loss) income
$
(35,960
)
$
11,230
Accretion of cumulative dividends on Series D redeemable
convertible preferred stock
—
(1,936
)
Undistributed earnings allocable to participating securities
—
(3,456
)
Net (loss) income allocable to shares of common stock, basic
$
(35,960
)
$
5,838
Change in fair value attributable to warrants to purchase Series
B-3 convertible preferred shares
—
(20
)
Accretion of cumulative dividends on Series D redeemable
convertible preferred stock
—
1,936
Net (loss) income allocable to shares of common stock, diluted
$
(35,960
)
$
7,754
Net (loss) income per share of common stock: Basic
$
(0.76
)
$
2.29
Diluted
$
(0.76
)
$
0.36
Weighted-average shares of common stock outstanding: Basic
47,295,013
2,548,079
Diluted
47,295,013
21,392,760
Selected Balance Sheet Items: March 31, 2021
December 31, 2020 Cash, cash equivalents, and marketable
securities
$
603,724
$
645,588
Total assets
$
650,236
$
680,971
Accounts payable, accrued expenses, and other current liabilities
$
25,142
$
31,399
Total stockholders’ equity
$
(93,370
)
$
(57,410
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210514005072/en/
Investor Contact: Mario Corso, +1 781-366-5726 Forma
Therapeutics mcorso@formatherapeutics.com
Forma Therapeutics (NASDAQ:FMTX)
Historical Stock Chart
From Jul 2024 to Aug 2024
Forma Therapeutics (NASDAQ:FMTX)
Historical Stock Chart
From Aug 2023 to Aug 2024