Clinical stage programs focused on rare
hematologic diseases and cancers
Comprehensive etavopivat Phase I SCD trial
completed with results supporting tolerability and benefits in
hematologic biomarkers and red blood cell health; pivotal Phase
II/III trial enrolling
Initial FT-7051 Phase I results in mCRPC showed
tolerability/safety and signs of pharmacodynamic and clinical
activity; escalating dose results expected mid-2022
Well-capitalized with nearly $500 million in
cash providing runway through the third quarter of 2024
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 year ended
December 31, 2021. The company also highlighted recent progress and
upcoming milestones for its pipeline programs.
“2021 was a year of continued growth for Forma as we completed
our comprehensive Phase 1 etavopivat trial, and further advanced
the importance of assessing red blood cell health,” said Frank Lee,
president and chief executive officer of Forma. “2022 represents a
year of expansion for Forma, expanding the breadth of the
etavopivat development plan into new indications, proof of concept
readout for FT-7051 in metastatic prostate cancer and a new
development candidate emerging from our research pipeline.”
Key Business and Clinical
Highlights
Pyruvate Kinase-R (PKR) Program in Sickle Cell Disease
(SCD):
- Comprehensive etavopivat Phase I trial completed. Open
label extension (OLE) results for 15 patients administered
etavopivat 400 mg once daily for up to 12 weeks with a data cutoff
as of November 23, 2021 were presented at the American Society of
Hematology (ASH) annual meeting in December 2021. Improvements were
observed in measures of hematologic and hemolytic response, and
biomarkers of red blood cell (RBC) health, including oxygenation
and deformability, as well as systemic biomarkers of SCD.
Etavopivat administered for up to 12 weeks reduced anemia by
significantly raising and sustaining hemoglobin levels and also
significantly increased the lifespan of RBCs with decreased
hemolysis. In addition, an analysis of all patients in the 12-week
open label cohort showed a decreasing trend in vaso-occlusive
crises (VOCs) requiring hospitalization when compared to the rate
12 months prior to trial entry. Etavopivat was well tolerated in
the trial and safety was consistent with underlying SCD.
CBP/p300 Program in metastatic Castration- Resistant Prostate
Cancer (mCRPC):
- FT-7051 well tolerated with signs of clinical activity in
initial Phase I clinical trial results. Initial results from
eight men in the trial were presented at the NCI/AACR/EORTC Virtual
International Conference on Molecular Targets and Cancer
Therapeutics in October 2021. Pharmacokinetic (PK) analysis of
FT-7051 documented rapid absorption, with drug concentrations that
approached the predicted efficacious dose based on estimates from
preclinical models. In addition, skin biopsies demonstrated a
reduction in a marker of activity in the CBP/p300 pathway. The
majority of treatment-emergent adverse events (TEAEs) observed were
mild or moderate with no events leading to treatment
discontinuation. The first evaluable patient completing 12 weeks of
treatment demonstrated a >80% decline in
prostate-specific antigen (PSA80) from baseline at 16 weeks with
stable disease.
IDH1 Program in Acute Myeloid Leukemia (AML)
- First Phase II results of olutasidenib used in combination
with a chemotherapy were presented at the ASH annual meeting in
December 2021. The trial included patients who had not
yet received therapy and were candidates for azacitidine as a
first-line treatment, and also patients with relapsed/refractory
(R/R) AML that had prior therapy with a hypomethylating agent (HMA)
or an IDH1 inhibitor. The results support the potential of
olutasidenib as the basis of combination therapy in patients with
AML who have not achieved a durable response from prior therapy.
Olutasidenib was well tolerated in the trial in combination with
azacitidine and the combination had a safety profile largely
consistent with that of olutasidenib alone. Forma is progressing a
new drug application (NDA) for the treatment of R/R AML.
Corporate
- Appointed Ifeyinwa (Ify) Osunkwo, MD, MPH, as the company’s
inaugural chief patient officer and senior vice president. Dr.
Osunkwo will be responsible for realizing Forma’s vision to
transform the lives of patients, including improving access and
care through partnerships with global patient and community
stakeholders.
- Launched formabridge and grants program. Through
formabridge grants, Forma has committed $1 million in funding for
promising and innovative initiatives that address unmet needs in
transition from pediatric to adult care in SCD.
- Upcoming investor conference participation. Forma will
participate in the Oppenheimer Healthcare Conference taking place
March 15-16, 2022. The presentation webcast will be available in
the “News & Investors” section of Forma’s website at
www.FormaTherapeutics.com.
- Virtual Research and Development (R&D) review to be held
in May, 2022. The company will provide an overview of its
internal research pipeline strategy and review compounds in
clinical and pre-clinical development. The live webcast will be
available in the “News & Investors” section of Forma’s website
www.FormaTherapeutics.com.
Upcoming Milestones
- Patient enrollment in global pivotal Phase II/III trial of
etavopivat for the treatment of SCD, the Hibiscus Study. The
first interim analysis (IA1) in the Hibiscus Study is expected to
be reached by the end of 2022, with dose selection for the Phase
III portion of the trial.
- Etavopivat development plans expanding. Forma began a
Phase 2 trial in transfusion dependent SCD and both transfusion
dependent and non-transfusion dependent thalassemia in late 2021,
with initial results expected in late 2022. During 2022, Forma
plans to begin clinical trials in pediatric SCD and low-risk
myelodysplastic syndrome (MDS).
- Additional FT-7051 clinical trial results in mCRPC. Men
with mCRPC continue to be enrolled in the dose escalation portion
of the Phase I trial. Forma plans to present updated results from
the trial 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 $490.3 million as of December 31, 2021, as compared
to $645.6 million as of December 31, 2020. Current cash runway is
projected through the third quarter of 2024.
- R&D Expenses: R&D expenses were $37.0 million
and $125.7 million for the quarter and year ended December 31,
2021, compared to $24.9 million and $93.4 million for the quarter
and year ended December 31, 2020. The increase was primarily
attributable to the conduct of etavopivat Phase II/III and Phase I
trials in SCD patients, as well as start-up costs related to the
thalassemia trial, manufacturing activities, and increases in
research and development staff, equity-based compensation and
investment in preclinical programs.
- General and Administrative (G&A) Expenses: G&A
expenses were $13.2 million and $48.3 million for the quarter and
year ended December 31, 2021, compared to $7.9 million and $30.8
million for the quarter and year ended December 31, 2020. The
increase was primarily attributable to increases in an equity-based
compensation, personnel-related costs related to executive and
staff hiring, professional fees, and insurance related
expenses.
- Net Loss: Net loss was $50.1 million and $173.0 million
for the quarter and year ended December 31, 2021, compared to net
loss of $28.6 million and $70.4 million for the quarter and year
ended December 31, 2020.
Forma will conduct a conference call and webcast March 1, 2022
at 8:00 a.m. Eastern Daylight Time (EDT) to discuss year end 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 3322907.
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 potential development expansion plans as well as the
timing, success and data announcements of planned and ongoing
clinical trials; 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 2022;
uses and need of capital, expenses and other financial results
currently or in the future; and the potential impact of COVID-19 on
patient retention and enrollment, future operations or clinical
trials. 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, supply
chain patient enrollment and retention, strategy, goals and
anticipated milestones, as well as global economies and financial
markets; the therapeutic potential of our product candidates and
the timing and completion of our clinical trials and related data
analyses; 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;
and our ability to fund operations; as well as those risks and
uncertainties set forth more fully under the caption "Risk Factors"
in our most recent annual report on Form 10-K 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
December 31,
For the Year Ended December
31,
2021
2020
2021
2020
Collaboration revenue
$
—
$
—
$
—
$
—
Operating expenses:
Research and development
37,047
24,866
125,661
93,367
General and administrative
13,238
7,941
48,325
30,782
Restructuring charges
—
—
—
63
Total operating expenses
50,285
32,807
173,986
124,212
Loss from operations
(50,285
)
(32,807
)
(173,986
)
(124,212
)
Other income:
Gain on Hit Discovery divestiture
—
—
—
23,312
Interest income
284
1,022
1,054
3,428
Other income (expense), net
(93
)
7
122
(2,661
)
Total other income, net
191
1,029
1,176
24,079
Loss before taxes
(50,094
)
(31,778
)
(172,810
)
(100,133
)
Income tax expense (benefit)
31
(3,190
)
154
(29,719
)
Net loss and comprehensive loss
$
(50,125
)
$
(28,588
)
$
(172,964
)
$
(70,414
)
Accretion of cumulative dividends and
issuance costs on Series D redeemable convertible preferred
stock
—
—
—
(3,736
)
Net loss allocable to shares of common
stock, basic and diluted
$
(50,125
)
$
(28,588
)
$
(172,964
)
$
(74,150
)
Net loss per share of common stock, basic
and diluted
$
(1.06
)
$
(0.68
)
$
(3.65
)
$
(3.22
)
Weighted-average shares of common stock
outstanding, basic and diluted
47,387,969
42,239,451
47,347,343
23,056,975
Selected Balance Sheet Items:
December 31, 2021
December 31, 2020
Cash, cash equivalents, and marketable
securities
$
490,273
$
645,588
Total assets
$
561,061
$
680,971
Accounts payable, accrued expenses, and
other current liabilities
$
35,018
$
31,399
Total stockholders’ equity
$
498,356
$
648,244
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220301005392/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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