Advancing IND-enabling activities for lead program in diabetes, SIG-002, with plans to conduct non-human primate studies in second half of 2023
SIG-002 demonstrated efficacy and durability in in vivo mouse models for up to 17 weeks
Extended anticipated cash runway into 2025
“Reflecting on 2022, we made many important strategic decisions that will help shape the future of our Company, including conducting research that informed the optimization of our SLTx platform, as well as refocusing our pipeline to prioritize our diabetes candidate, SIG-002, in a fiscally disciplined manner,” said
Recent Program Highlights and Anticipated Milestones
- Sigilon has prioritized its product candidates based on their potential to provide meaningful clinical benefits to patients, rapid time to proof of concept, clear regulatory path, and validated biology and clinical endpoints. Based on these criteria, the Company is focusing its efforts on its product candidate for type 1 diabetes, SIG-002, which is being developed in collaboration with Eli Lilly and Company. Sigilon expects to initiate Investigational New Drug (IND)-enabling activities for SIG-002 in 2023.
- At the Cell and Gene Therapy Meeting on the Mesa in
October 2022 , the Company presented encouraging data showing its proprietary iPS cell differentiation protocol for SIG-002. The Company’s protocol has generated stem cell-derived human islets that are similar to human cadaveric islets with a high percentage of beta cells, high levels of insulin content and glucose-regulated insulin secretion. In addition, the Company has demonstrated that SIG-002 is efficacious in an STZ-induced diabetes mouse model for up to 17 weeks. - The Company has incorporated several changes into its SLTx platform intended to avoid immune responses to its product candidates, including changes to the cross-linking chemistry designed to strengthen the integrity and stability of the spheres. The Company’s current programs, including SIG-002, have incorporated a number of these platform optimizations. Furthermore, Sigilon continues to utilize its innovative predictive preclinical models of pericapsular fibrotic overgrowth, including in vitro macrophage attachment assays and in vivo humanized mouse models, to support the continued development of its current and future product candidates.
- In the first quarter of 2023, Sigilon decreased its external spend relating to the mucopolysaccharidosis type 1 (MPS-1) program to preserve capital. For MPS-1 and other lysosomal disorders, Sigilon is continuing to advance engineering techniques and other cell line strategies designed to minimize or otherwise avoid a patient’s immune response to the Company’s product candidates, as well as optimize blood-brain-barrier penetration and product half-life.
Financial Results
- Cash Position: Cash, cash equivalents and marketable securities were
$69.6 million as ofDecember 31, 2022 compared to$123.4 million as ofDecember 31, 2021 . The decrease was primarily driven by$51.5 million used in operating activities and$1.7 million of debt principal repayments. The Company expects that its cash, cash equivalents and marketable securities as ofDecember 31, 2022 will be sufficient to support its currently anticipated operating expenses and capital expenditure requirements into 2025. - R&D Expenses: Research and development expenses were
$5.9 million for the fourth quarter of 2022 compared to$14.7 million for the fourth quarter of 2021. The decrease in research and development expenses was primarily related to decreased activity in ongoing platform and other early-stage program development, personnel expenses, facility-related expenses, which were offset by increased expenses related to the Company’s diabetes program. The decrease in platform and other early-stage program activity and personnel expenses was primarily due to the Company’s reprioritization of the development of the MPS-1 program, diabetes program and platform optimization following the Company’s restructuring activities inDecember 2021 . The decrease in facility-related expenses was primarily due to the sublease of a portion of the Company’s facility. - G&A Expenses: General and administrative expenses were
$4.5 million for the fourth quarter of 2022 compared to$4.6 million for the fourth quarter of 2021. - Net Loss: Net loss was
$6.7 million for the fourth quarter of 2022 compared to$17.7 million for the fourth quarter of 2021, primarily due to the decrease in R&D expenses discussed above.
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 initiation and timing of IND-enabling activities and non-human primate studies for SIG-002, our ability to complete process development and scale up activities for SIG-002 and advance our diabetes program into the clinic, and our expected cash runway. 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 if negative results of preclinical or clinical studies of any of our product candidates could adversely affect our business and may require us to discontinue or delay development of other product candidates, which are all based on the same SLTx platform; the SLTx platform consists of novel technologies that are not yet clinically validated for human therapeutic use and the approaches we are taking to discover and develop novel therapeutics are unproven; we may not be successful in our efforts to identify and develop product candidates; if clinical trials of our current and future product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do not otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of such product candidates; if we are unable to obtain and maintain patent and other intellectual property protection our product candidates, our SLTx platform may be adversely affected, and the risks identified under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended
SIGILON THERAPEUTICS, INC.
Consolidated Balance Sheets
(in thousands, except share and per share amounts)
(Unaudited)
2022 | 2021 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 42,066 | $ | 107,143 | |||
Marketable securities | 27,560 | 16,213 | |||||
Accounts receivable | 2,171 | 59 | |||||
Unbilled accounts receivable | 1,287 | — | |||||
Prepaid expenses and other current assets | 1,077 | 2,729 | |||||
Restricted cash—current | 250 | 250 | |||||
Total current assets | 74,411 | 126,394 | |||||
Property and equipment, net | 2,854 | 3,994 | |||||
Right‑of‑use assets | 8,979 | 12,863 | |||||
Restricted cash | 1,034 | 1,118 | |||||
Total assets | $ | 87,278 | $ | 144,369 | |||
Liabilities and stockholders’ equity (deficit) | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 936 | $ | 2,344 | |||
Accrued expenses and other current liabilities | 6,021 | 8,998 | |||||
Lease liabilities, current portion | 4,485 | 4,845 | |||||
Current portion of long‑term debt | 6,667 | 1,667 | |||||
Deferred revenue from related party, current portion | 12,885 | 17,034 | |||||
Total current liabilities | 30,994 | 34,888 | |||||
Deferred revenue from related party, net of current portion | — | 5,333 | |||||
Lease liability, net of current portion | 4,888 | 8,577 | |||||
Long‑term debt, net of discount and current portion | 12,021 | 18,411 | |||||
Other liabilities | 233 | — | |||||
Total liabilities | 48,136 | 67,209 | |||||
Stockholders’ equity | |||||||
Common stock, par value | 32 | 32 | |||||
Preferred stock, par value | — | — | |||||
Additional paid‑in capital | 296,339 | 290,377 | |||||
Accumulated other comprehensive loss | (429 | ) | (10 | ) | |||
Accumulated deficit | (256,800 | ) | (213,239 | ) | |||
Total stockholders’ equity | 39,142 | 77,160 | |||||
Total liabilities and stockholders’ equity | $ | 87,278 | $ | 144,369 | |||
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share data)
(Unaudited)
Three Months Ended | Year Ended | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Revenue | |||||||||||||||
Collaboration revenue | $ | 2,644 | $ | 1,990 | $ | 12,944 | $ | 9,599 | |||||||
Operating expenses: | |||||||||||||||
Research and development | 5,856 | 14,689 | 37,631 | 65,069 | |||||||||||
General and administrative | 4,518 | 4,594 | 18,979 | 20,166 | |||||||||||
Total operating expenses | 10,375 | 19,283 | 56,610 | 85,235 | |||||||||||
Loss from operations | (7,730 | ) | (17,293 | ) | (43,666 | ) | (75,636 | ) | |||||||
Other income (expense), net: | |||||||||||||||
Interest income | 404 | 46 | 946 | 258 | |||||||||||
Interest expense | (650 | ) | (507 | ) | (2,290 | ) | (1,988 | ) | |||||||
Other income, net | 1,291 | 8 | 1,449 | 55 | |||||||||||
Total other expense, net | 1,045 | (453 | ) | 105 | (1,675 | ) | |||||||||
Net loss attributable to ordinary shareholders | $ | (6,685 | ) | $ | (17,746 | ) | $ | (43,561 | ) | $ | (77,311 | ) | |||
Net loss per share attributable to common stockholders—basic and diluted | $ | (0.21 | ) | $ | (0.55 | ) | $ | (1.34 | ) | $ | (2.43 | ) | |||
Weighted average common stock outstanding—basic and diluted | 32,462,199 | 32,314,854 | 32,405,786 | 31,860,264 | |||||||||||
SOURCE:
Investor Contact
VP, Head of Investor Relations
robert.windsor@sigilon.com
617-586-3837
Media Contacts
abonanno@soleburystrat.com
914-450-0349
Source:
2023 GlobeNewswire, Inc., source