“While we remain focused on patient safety and resolving the clinical hold on our Phase 1/2 trial in hemophilia A, we are also taking important steps to advance our broad pipeline of product candidates,” said
Recent Program Highlights
- In
July 2021 , the Phase 1/2 study of SIG-001 was placed on clinical hold by theU.S. Food and Drug Administration (FDA). The clinical hold was initiated following Sigilon’s submission of a serious adverse event (SAE) and temporary enrollment halt to the FDA and other regulatory agencies. To date, three patients have been dosed with SIG-001 and are continuing to be monitored by study protocol. The third patient, who received the highest dose of study drug, developed inhibitors to FVIII, which is a well-known complication of FVIII therapy. The patient responded well to medical treatment. Among other things, the FDA has requested additional information and data on factors potentially contributing to the development of inhibitors in this patient as well as follow-up data relating to FVIII inhibitor and activity levels. - Three scientific abstracts were selected for presentation—including an oral presentation on mucopolysaccharidosis type I (MPS-1)—at the 16th International Symposium on MPS and Related Diseases (MPS 2021), which took place
July 23 – 25, 2021. The Company also presented initial results from preclinical studies of expanded pipeline programs in immune-mediated and metabolic disorders at theAmerican Society of Gene andCell Therapy (ASGCT) 24th Annual Meeting in May. - In
June 2021 , the Company filed a Clinical Trial Application (CTA) in theUK for SIG-005 for the treatment of MPS-1. In addition, the Company filed a CTA inBrazil for SIG-005 inJuly 2021 . - The Company plans to cryopreserve the cell component for the manufacture of SIG-005 in the Phase 1/2 clinical trial of MPS-1, allowing these cells to be produced in advance of the manufacture of drug product. This planned manufacturing change is expected to reduce the manufacturing lead times for patient doses of SIG-005 by approximately 80 percent.
Corporate Updates
Deya Corzo , M.D., is stepping down as Chief Medical Officer. The Company entered into an agreement withDr. Corzo providing for transition services until her separation onAugust 13, 2021 . As Sigilon initiates a search for a CMO, the Board of Directors and management will work closely together on key clinical priorities.- Philip Ashton-Rickardt, Ph.D., joined Sigilon as Chief Scientific Officer. Dr. Ashton-Rickardt is a highly regarded scientific leader in the field of immunology with a successful track record of developing cell therapies and platform technologies.
Ajay Rai , M.B.A., joined the Company as Senior Vice President, Head of Business Development.Mr. Rai brings over two decades of business development, finance and partnering experience in the life sciences to Sigilon.- Sigilon has initiated a search for a full-time Chief Financial Officer and, in the meantime, has engaged
Michael Wyzga , M.B.A., former Chief Financial Officer ofGenzyme , to provide finance-related services on an interim basis. Brooke Story , M.B.A., was appointed to the Company’s Board of Directors.Ms. Story has more than 20 years of extensive commercial and operating experience in the healthcare industry.
Anticipated Milestones
- Sigilon expects to initiate a Phase 1/2 trial of SIG-005 in patients with MPS-1 in the second half of 2021.
- The Company expects to disclose up to 9 months of follow-up data for three patients from the Phase 1/2 safety and dose-ranging study of SIG-001 in severe to moderate-severe hemophilia in the third quarter of 2021.
Financial Results
- Cash Position: Cash was
$162.4 million as ofJune 30, 2021 compared to$202.2 million as ofDecember 31, 2020 . - R&D Expenses: Research and development expenses were
$17.8 million for the second quarter of 2021 compared to$12.5 million for the second quarter of 2020. The increase in research and development expenses was primarily related to ongoing platform, pipeline, and development activities related to Sigilon’s SIG-005 and SIG-007 programs, which received orphan drug designation inDecember 2020 andMarch 2021 , respectively. Personnel expenses increased primarily as a result of the increase in headcount in Sigilon’s research and development function and increases in stock-based compensation. Stock-based compensation expense increased to$0.9 million from$0.3 million for the three months endedJune 30, 2021 and 2020, respectively. These increases were partially offset by a reduction of$0.5 million and$0.6 million associated with Sigilon’s SIG-001 and SIG-002 programs, respectively. The decrease in SIG-001-related expenses was due to the timing of manufacturing activities in the second quarter of 2020 and the decrease in SIG-002-related expenses was due to changes in the timeline for preclinical activities. - G&A Expenses: General and administrative expenses were
$5.0 million for the second quarter of 2021 compared to$2.8 million for the second quarter of 2020. The increase in general and administrative expenses was primarily driven by a$0.8 million in increased costs from operating as a public company in the second quarter of 2021. In addition, personnel expenses increased by$1.0 million primarily as a result of the increase in headcount in Sigilon’s general and administrative function and increases in stock-based compensation. Stock-based compensation expense increased to$1.1 million from$0.4 million for the three months endedJune 30, 2021 and 2020, respectively. - Net Loss: Net loss was
$20.4 million for the second quarter endedJune 30, 2021 compared to$13.5 million for the same period of 2020.
About
Forward-Looking Statements
This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “plan,” “could,” “may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “project,” and other words of similar meaning. These forward-looking statements address various matters, including the modularity of our pipeline programs and the potential benefits of our platform, the timing for the initiation of our Phase 1/2 clinical trial of SIG-005 in MPS-1 as well as the filings related thereto, our ability to cryopreserve cell components of SIG-005 and other product candidates and the associated impact on manufacturing lead times, the timing for the submission of regulatory filings for MPS-1 and other product candidates, and the timing and scope of disclosure of initial data relating to our Phase 1/2 clinical study of SIG-001 in Hemophilia A. Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, that favorable preclinical results are not predictive of clinical trial results, our ability to resolve the clinical hold on SIG-001, the FDA or other regulators may request additional preclinical studies or clinical trials beyond those that we currently anticipate, manufacturing changes may not have the desired effect, and the risks identified under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended
Sigilon Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
(Unaudited)
2021 | 2020 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash | $ | 162,406 | $ | 202,229 | |||
Accounts receivable (inclusive of | 178 | 177 | |||||
Prepaid expenses and other current assets | 3,611 | 1,729 | |||||
Restricted cash—current | 75 | 75 | |||||
Total current assets | 166,270 | 204,210 | |||||
Property and equipment, net | 3,630 | 2,991 | |||||
Right-of-use assets | 14,928 | 16,731 | |||||
Restricted cash | 1,293 | 1,118 | |||||
Total assets | $ | 186,121 | $ | 225,050 | |||
Liabilities, convertible preferred stock and stockholders’ equity (deficit) | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 4,661 | $ | 1,988 | |||
Accrued expenses and other current liabilities | 8,693 | 7,892 | |||||
Lease liabilities, current portion | 5,075 | 5,361 | |||||
Deferred revenue from related party, current portion | 25,957 | 31,777 | |||||
Total current liabilities | 44,386 | 47,018 | |||||
Deferred revenue from related party, net of current portion | 272 | — | |||||
Lease liability, net of current portion | 10,279 | 11,893 | |||||
Long-term debt, net of discount | 19,941 | 19,807 | |||||
Other liabilities | 176 | 176 | |||||
Total liabilities | $ | 75,054 | $ | 78,894 | |||
Stockholders’ equity | |||||||
Common stock, par value | 32 | 31 | |||||
Preferred stock, par value | — | — | |||||
Additional paid-in capital | 286,373 | 282,053 | |||||
Accumulated deficit | (175,338 | ) | (135,928 | ) | |||
Total stockholders’ equity | 111,067 | 146,156 | |||||
Total liabilities, convertible preferred stock and stockholders’ equity | $ | 186,121 | $ | 225,050 |
Sigilon Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except per share data)
(Unaudited)
Three Months Ended | Six Months Ended | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
Revenue | |||||||||||||||
Collaboration revenue (inclusive of | $ | 2,704 | $ | 1,951 | $ | 5,662 | $ | 5,417 | |||||||
Operating expenses: | |||||||||||||||
Research and development | 17,751 | 12,452 | 33,736 | 25,726 | |||||||||||
General and administrative | 4,992 | 2,818 | 10,532 | 5,689 | |||||||||||
Total operating expenses | 22,743 | 15,270 | 44,268 | 31,415 | |||||||||||
Loss from operations | (20,039 | ) | (13,319 | ) | (38,606 | ) | (25,998 | ) | |||||||
Other income (expense), net: | |||||||||||||||
Interest income | 71 | 35 | 157 | 238 | |||||||||||
Interest expense | (494 | ) | (196 | ) | (982 | ) | (404 | ) | |||||||
Other expense | 25 | (11 | ) | 21 | (27 | ) | |||||||||
Change in fair value of preferred stock warrant liability | — | 1 | — | (34 | ) | ||||||||||
Total other expense, net | (398 | ) | (171 | ) | (804 | ) | (227 | ) | |||||||
Net loss and comprehensive loss | $ | (20,437 | ) | $ | (13,490 | ) | $ | (39,410 | ) | $ | (26,225 | ) | |||
Net loss per share attributable to common stockholders—basic and diluted | $ | (0.65 | ) | $ | (2.54 | ) | $ | (1.25 | ) | $ | (5.09 | ) | |||
Weighted average common stock outstanding—basic and diluted | 31,571,704 | 5,320,427 | 31,529,939 | 5,152,477 |
SOURCE:
Investor Contacts
robert.windsor@sigilon.com
617-586-3837
Media Contact
Solebury Trout
abonanno@soleburytrout.com
914-450-0349
Source:
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