Exhibit 99.1
Fulcrum Therapeutics Announces Second Quarter 2022 Financial Results
and Business Update
– Presented initial data from Phase 1b trial in sickle cell disease (SCD), which demonstrate rapid and robust increases in hemoglobin F (HbF); supports proof-of-concept that FTX-6058 is a novel oral HbF inducer –
– Announced enrollment of first patient in Phase 3 REACH trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD); first ever Phase 3 trial in this disease –
– Announced strategic realignment to reduce operating expenses by $40-50M, prioritize clinical execution, and extend cash runway into mid-2024 –
– Conference call scheduled for 8:00 a.m. ET today –
CAMBRIDGE, Mass. – August 11, 2022 – Fulcrum Therapeutics, Inc.® (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today reported financial results for the second quarter of 2022 and announced a strategic plan to realign internal resources to support the two clinical programs that are expected to be the key drivers of near-term value and extend cash runway.
“In the second quarter, we achieved major milestones in both of our clinical programs,” said Bryan Stuart, Chief Executive Officer of Fulcrum Therapeutics. “We demonstrated compelling proof of concept data for 6058 and initiated the first registrational trial for FSHD. Our strategic refocus will better position us to continue to advance our exciting pipeline and deliver on our unwavering commitment to patients with genetically defined rare diseases.”
Key Business Updates
FTX-6058
Losmapimod
Preclinical Pipeline
Organizational Changes
Second Quarter 2022 Financial Results
Conference Call and Webcast
Fulcrum Therapeutics, Inc. will host a conference call and webcast today at 8:00 a.m. ET to discuss its second quarter 2022 recent business highlights and financial results. The webcast will be accessible through the Investor Relations section of Fulcrum’s website at www.fulcrumtx.com. Following the live webcast, an archived replay will also be available for 90 days.
Dial-in Number
U.S./Canada Dial-in Number: 1-833-634-2546
International Dial-in Number: 1-412-902-4190
Conference ID: 7096297
Replay Dial-in Number: 1-877-344-7529
Replay International Dial-in Number: 1-412-317-0088
Conference ID: 7096297
About Fulcrum Therapeutics
Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum’s two lead programs in clinical development are losmapimod, a small molecule for the treatment of facioscapulohumeral muscular dystrophy (FSHD), and FTX-6058, a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease and other hemoglobinopathies, including beta-thalassemia. Fulcrum’s proprietary product engine, FulcrumSeek™, identifies drug targets that can modulate gene expression to treat the known root cause of gene mis-expression. For more information, visit www.fulcrumtx.com and follow us on Twitter @FulcrumTx and LinkedIn.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements, including statements regarding the strategic operational realignment and impact on operating expenses, research and discovery efforts, cost savings, Fulcrum’s cash runway, and ability to achieve near term objectives and deliver on its long-term vision; completion of enrollment in the Phase 1b SCD trial of FTX-6058, as well as enrollment in three dose cohorts; timing of registration trial of FTX-6058 in SCD as well as timing for Phase 1b trial in other hemoglobinopathies; the REACH trial; timing of submission of next IND; among others. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with Fulcrum’s ability to continue to advance its product candidates in clinical trials; initiate and enroll clinical trials on the timeline expected or at all; obtain and maintain necessary approvals from the FDA and other regulatory authorities; replicate in clinical trials positive results found in preclinical studies and/or earlier-stage clinical trials of losmapimod, FTX-6058 and its other product candidates; obtain, maintain or protect intellectual property rights related to its product candidates; manage expenses; realize the anticipated benefits of the strategic realignment; and raise the substantial additional capital needed to achieve its business objectives. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Fulcrum’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties, and other important factors, in Fulcrum’s most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Fulcrum’s views as of the date hereof and should not be relied upon as representing Fulcrum’s views as of any date subsequent to the date hereof. Fulcrum anticipates that subsequent events and developments will cause Fulcrum’s views to change. However, while Fulcrum may elect to update these forward-looking statements at some point in the future, Fulcrum specifically disclaims any obligation to do so.
Fulcrum Therapeutics, Inc.
Selected Consolidated Balance Sheet Data
(In thousands)
(Unaudited)
|
| June 30, |
|
| December 31, |
| ||
Cash, cash equivalents, and marketable securities |
| $ | 168,973 |
|
| $ | 218,162 |
|
Working capital(1) |
|
| 152,126 |
|
|
| 206,799 |
|
Total assets |
|
| 195,233 |
|
|
| 235,000 |
|
Total stockholders’ equity |
|
| 160,755 |
|
|
| 211,539 |
|
(1) Fulcrum defines working capital as current assets minus current liabilities.
Fulcrum Therapeutics, Inc.
Consolidated Statements of Operations
(In thousands, except per share data)
(Unaudited)
|
| Three Months Ended |
|
| Six Months Ended |
| ||||||||||
|
| 2022 |
|
| 2021 |
|
| 2022 |
|
| 2021 |
| ||||
Collaboration revenue |
| $ | 1,882 |
|
| $ | 4,381 |
|
| $ | 4,474 |
|
| $ | 9,170 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Research and development |
|
| 25,019 |
|
|
| 17,378 |
|
|
| 42,850 |
|
|
| 33,712 |
|
General and administrative |
|
| 11,098 |
|
|
| 6,685 |
|
|
| 21,857 |
|
|
| 12,183 |
|
Total operating expenses |
|
| 36,117 |
|
|
| 24,063 |
|
|
| 64,707 |
|
|
| 45,895 |
|
Loss from operations |
|
| (34,235 | ) |
|
| (19,682 | ) |
|
| (60,233 | ) |
|
| (36,725 | ) |
Other income, net |
|
| 165 |
|
|
| 34 |
|
|
| 235 |
|
|
| 78 |
|
Net loss |
| $ | (34,070 | ) |
| $ | (19,648 | ) |
| $ | (59,998 | ) |
| $ | (36,647 | ) |
Net loss per share, basic and diluted |
| $ | (0.83 | ) |
| $ | (0.60 | ) |
| $ | (1.47 | ) |
| $ | (1.14 | ) |
Weighted-average common shares outstanding, basic and diluted |
|
| 40,890 |
|
|
| 32,636 |
|
|
| 40,768 |
|
|
| 32,076 |
|
Contact:
Investors:
Stephanie Ascher
Stern Investor Relations, Inc.
stephanie.ascher@sternir.com
212-362-1200
Media:
Dee Smith
Executive Director, Corporate Communications
Fulcrum Therapeutics, Inc.
dsmith@fulcrumtx.com
202-746-1324