FORMA THERAPEUTICS HOLDINGS, INC. Item 7.01. Regulation FD Disclosure.
On
In addition, the Company has made available on its website the Company's
presentation from the 2021
The information in this Item 7.01, including Exhibits 99.1 and 99.2 attached hereto, is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
Item 8.01. Other Events.
On
Clinical Data Results
In the combined (300 mg QD) and MAD2 (600 mg QD) cohorts, 73% (11 of 15) of patients achieved a hemoglobin increase of greater than 1g/dL over baseline; significant improvement in hematologic and hemolytic markers also include decreased absolute reticulocytes (100%, or 15 of 15), decreased LDH levels (73%, or 11 of 15) and decreased indirect bilirubin levels (93%, or 14 of 15). The osmoscan and oxygenscan results from 14 patients showed a statistically significant improvement.
Initial results as of
The safety profile in the OLE cohort was consistent with underlying disease. Of note, two patients reported serious adverse events, including one vaso-occlusive crisis and acute chest syndrome, which was not considered related to treatment by the trial investigator. A deep-vein thrombosis (DVT) report was described as possibly related.
The disclosure under this Item 8.01 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: initial results to date for the
etavopivat open label extension cohort of the Company's Phase 1 clinical trial;
the therapeutic potential, clinical benefits and safety related to etavopivat;
whether initial results from the Company's clinical trials are predictive of
final trial results or future clinical studies; and the Company's planned
presentation of data at 2021
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
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limitation, those risks and uncertainties related the Company's ability to
execute on its strategy; the therapeutic potential and safety of etavopivat; the
timing and completion of the Company's Phase 1 study of etavopivat and final
audit and quality controlled verification of initial data and related analyses;
the timing and success of the Company's Phase 2/3 Hibiscus Study of etavopivat
in SCD patients; positive results from initial data analyses may not be
predictive of final results; risks related to the Company's planned regulatory
submissions and developments; and other risks identified in the Company's
Item 9.01. Exhibits
(d) Exhibits
Press release issued by Forma Therapeutics Holdings, Inc. on June 11 ,
99.1 2021, furnished herewith.
99.2 Forma Therapeutics Holdings, Inc. Corporate Presentation, dated June 11,
2021 , furnished herewith.
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