Clinical programs advancing in rare hematologic
diseases and cancers
May 26 R&D Day to focus on research
pipeline strategy and expanded development programs
Cash balance of $441.3 million positions
company with 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 first quarter
ended March 31, 2022. The company also highlighted recent progress
and upcoming milestones for its pipeline programs.
“The first quarter of 2022 was one of continued progress in
enrolling ongoing trials of etavopivat and FT-7051, and also
expansion into other areas where red blood cell health may play an
important role,” said Frank Lee, president and chief executive
officer of Forma. “We also continue to strengthen our capabilities
and focus on the patients we serve with the addition of talented
leaders.”
Key Business Updates
- Ifeyinwa (Ify) Osunkwo, M.D., MPH, joined Forma as the
company’s inaugural chief patient officer and senior vice
president. Dr. Osunkwo leads Forma’s efforts to be a trusted
partner, collaborating with patients, advocates and healthcare
providers who share a dedication to changing the care and treatment
paradigm.
- Arturo Molina, M.D., elected to Board of Directors and
R&D Committee. Dr. Molina is an internationally acclaimed
clinician, hematology and oncology researcher, practicing physician
and pioneer addressing healthcare inequities. He has over 25 years
of experience in biopharma, hematology and oncology and currently
serves as chief medical officer at Sutro Biopharma, Inc., where he
is responsible for the clinical development of oncology and
hematology therapeutics.
- Virtual Research and Development (R&D) Day to be held
May 26, 2022. The company will provide an overview of its
clinical development programs and research pipeline strategy,
including the introduction of a new molecule currently undergoing
investigational new drug application enabling studies. The live
webcast will be available in the “News & Investors” section of
Forma’s website.
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. IA1 is designed to select the dose
for the Phase III portion of the trial.
- Additional etavopivat development programs. Forma has
initiated a Phase II trial in patients with either transfusion
dependent SCD, transfusion dependent thalassemia, or
non-transfusion dependent thalassemia, with initial results
expected in late 2022. During 2022, Forma plans to begin clinical
trials in pediatric SCD and lower-risk myelodysplastic syndrome
(MDS).
- Update on FT-7051 clinical trial in mCRPC. Men with
metastatic castration-resistant prostate cancer (mCRPC) continue to
be enrolled in the Phase I trial. Forma plans to provide an update
at its May R&D Day and further results later in 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 and/or the ability to access sites participating in
clinical trials.
Financial Results
- Cash Position: Cash, cash equivalents and marketable
securities were $441.3 million as of March 31, 2022, as compared to
$490.3 million as of December 31, 2021. Current cash runway is
projected through the third quarter of 2024.
- R&D Expenses: R&D expenses were $31.3 million
for the quarter ended March 31, 2022, as compared to $26.3 million
for the quarter ended March 31, 2021. 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, the conduct of our Phase II/III trial
in SCD patients, and study start-up costs related to our Phase II
trial of etavopivat in thalassemia patients.
- General and Administrative (G&A) Expenses: G&A
expenses were $13.1 million for the quarter ended March 31, 2022,
as compared to $9.9 million for the quarter ended March 31, 2021.
The increase was primarily attributable to equity-based
compensation, costs due to executive and staff hiring, and other
related general and administrative costs.
- Net Loss: Net loss was $44.1 million for the quarter
ended March 31, 2022, as compared to net loss of $36.0 million for
the quarter ended March 31, 2021.
Forma will conduct a conference call and webcast May 6, 2022 at
8:00 a.m. Eastern Daylight Time (EDT) to discuss first quarter 2022
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 1879297.
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 and FT-7051, including expectations regarding potential
development expansion plans as well as the enrollment, timing,
success and data announcements of planned and ongoing clinical
trials; therapeutic potential, clinical benefits, mechanisms of
action and safety of our product candidates; upcoming milestones
and planned additional trials for the company’s product candidates;
growth as a company; upcoming presentations of our R&D
programs, including the introduction of a new molecule and related
studies; 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, clinical trials, 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
March 31,
2022
2021
Collaboration revenue $
—
$
—
Operating expenses: Research and development
31,273
26,343
General and administrative
13,136
9,867
Total operating expenses
44,409
36,210
Loss from operations
(44,409
)
(36,210
)
Other income: Interest income
289
262
Other expense, net
(35
)
(4
)
Total other income, net
254
258
Loss before taxes
(44,155
)
(35,952
)
Income tax expense
3
8
Net loss and comprehensive loss $
(44,158
)
$
(35,960
)
Net loss allocable to shares of common stock, basic and diluted
$
(44,158
)
$
(35,960
)
Net loss per share of common stock, basic and diluted $
(0.93
)
$
(0.76
)
Weighted-average shares of common stock outstanding, basic and
diluted
47,561,631
47,295,013
Selected Balance Sheet Items:
March 31, 2022 December 31, 2021 Cash, cash
equivalents, and marketable securities $
441,343
$
490,273
Total assets $
514,497
$
561,061
Accounts payable, accrued expenses, and other current liabilities
$
26,247
$
35,018
Total stockholders’ equity $
461,193
$
498,356
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220506005072/en/
Media: Caitlin Hunt, +1 781-985-5967 Porter Novelli
caitlin.hunt@porternovelli.com
Investors: Mario Corso, +1 781-366-5726 Forma
Therapeutics mcorso@formatherapeutics.com
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