Exhibit 99.1
Forma Therapeutics Reports Fourth Quarter and Year-end 2021 Financial Results and Provides Business Update
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
WATERTOWN, Mass. – Mar. 1, 2022 – 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 I 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):
CBP/p300 Program in Metastatic Castrate Resistant Prostate Cancer (mCRPC):
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IDH1 Program in Acute Myeloid Leukemia (AML)
Corporate
Upcoming Milestones
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Financial Results
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,
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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.
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Selected Financial Information
(in thousands except share and per share data)
(unaudited)
Statement of Operations Items: |
|
For the Three Months |
|
|
For the Year |
|
||||||||||
|
|
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 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(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 |
|
|
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 |
|
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
SOURCE: Forma Therapeutics Holdings, Inc.
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