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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Forma Therapeutics Holdings Inc | NASDAQ:FMTX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 20.01 | 19.98 | 19.40 | 0 | 01:00:00 |
Significant progress achieved with pipeline focused on rare hematologic diseases and cancers
Positive Phase 1 results in patients with sickle cell disease (SCD) presented at European Hematology Association (EHA) Virtual Congress supporting etavopivat’s potential to significantly impact RBC health and lifespan
Phase 1 trial of FT-7051 enrolling men with metastatic castration-resistant prostate cancer (mCRPC); initial results to be presented in October at the NCI/AACR/EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics
Olutasidenib data in relapsed/refractory acute myeloid leukemia (R/R AML) presented at the American Society of Clinical Oncology (ASCO) and EHA Virtual Congress; 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 second quarter ended June 30, 2021. The company also highlighted recent progress and upcoming milestones for its pipeline programs.
“During the second quarter, we presented positive results from our ongoing Phase 1 trial demonstrating etavopivat’s highly differentiated profile and multimodal mechanism of action to improve markers of sickle cell disease and red blood cell health that are associated with vaso-occlusion,” said Frank Lee, president and chief executive officer of Forma. “These results, in addition to the progress on our other clinical programs this quarter, position us well to deliver on our mission of transforming the lives of patients with rare hematologic diseases and cancers.”
Key Business and Clinical Highlights
PKR Program in Sickle Cell Disease (SCD):
CPB/p300 Program in Prostate Cancer:
IDH1 Program in AML and Glioma:
Corporate
Upcoming Milestones
Financial Results
Forma will conduct a conference call and webcast Aug.13 at 8:00 a.m. Eastern Daylight Time (EDT) to discuss second 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 9155938.
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; therapeutic potential, clinical benefits, mechanisms of action and safety of our product candidates, 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 etavopivat, FT-7051, and olutasidenib, the timing and completion of our Phase 1 clinical study in etavopivat and final audit and quality controlled verification of initial data and related analyses, and the timing associated with the initiation or continuation of any trials and success of ongoing clinical trials of etavopivat 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, 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 June 30,
For the Six Months Ended June 30,
2021
2020
2021
2020
Collaboration revenue$
—
$
—
$
—
$
—
Operating expenses: Research and development
31,587
20,511
57,930
43,721
General and administrative
12,471
6,448
22,338
15,381
Restructuring charges
—
(20
)
—
63
Total operating expenses
44,058
26,939
80,268
59,165
Loss from operations
(44,058
)
(26,939
)
(80,268
)
(59,165
)
Other income (expense): Gain on Hit Discovery divestiture
—
—
—
23,312
Interest income
309
895
571
1,536
Other income (expense), net
272
(2,634
)
268
(2,616
)
Total other income (expense), net
581
(1,739
)
839
22,232
Loss before taxes
(43,477
)
(28,678
)
(79,429
)
(36,933
)
Income tax expense (benefit)
108
(3,238
)
116
(22,723
)
Net loss and comprehensive loss$
(43,585
)
$
(25,440
)
$
(79,545
)
$
(14,210
)
Accretion of cumulative dividends on Series D redeemable convertible preferred stock
—
(1,800
)
—
(3,736
)
Net loss allocable to shares of common stock, basic and diluted$
(43,585
)
$
(27,240
)
$
(79,545
)
$
(17,946
)
Net loss per share of common stock, basic and diluted$
(0.92
)
$
(4.58
)
$
(1.68
)
$
(4.23
)
Weighted-average shares of common stock outstanding, basic and diluted
47,339,464
5,943,165
47,317,361
4,245,622
Selected Balance Sheet Items:
June 30, 2021
December 31, 2020
Cash, cash equivalents, and marketable securities$
570,793
$
645,588
Total assets$
613,369
$
680,971
Accounts payable, accrued expenses, and other current liabilities$
29,104
$
31,399
Total stockholders’ equity$
579,395
$
648,244
View source version on businesswire.com: https://www.businesswire.com/news/home/20210813005019/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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