Announced strategic reprioritization, with plans to advance mucopolysaccharidosis type I (MPS-1) and diabetes as lead indications as well as continued platform optimization
Strengthened leadership team with appointment of new Chief Technical Operations Officer and other key leadership changes
Current cash position expected to fund operating plans into 2024
CAMBRIDGE, Mass., March 14, 2022 (GLOBE NEWSWIRE) -- Sigilon Therapeutics, Inc. (NASDAQ:SGTX), a biotechnology company that seeks to develop functional cures for chronic diseases through its Shielded Living Therapeutics™ platform, today reported financial results for the fourth quarter and full year ended December 31, 2021 as well as certain other business highlights.
"In 2021, we made important adjustments to our overall corporate and clinical strategy as well as our leadership team to best position us for sustained future growth and success," said Rogerio Vivaldi, M.D., President and CEO of Sigilon. "Based on key learnings from our first-in-human trial in hemophilia A, we have shifted our clinical focus and plan to prioritize MPS-1, in addition to our diabetes program in partnership with Eli Lilly, as we continue to optimize our novel platform. Looking ahead, we remain dedicated to taking the necessary steps to advance our differentiated, non-viral engineered cell-based therapies with the goal of delivering functional cures to patients with a broad range of chronic diseases."
Recent Program Highlights
Corporate Updates
Strategic Priorities and Anticipated Milestones
The Company is focusing its development efforts in three strategic areas:
MPS-1: SIG-005 is the Company's product candidate that contains a cell line genetically modified with a non-viral vector to express human α L iduronidase, or IDUA, encapsulated within Sigilon's spheres. SIG-005 is being developed to treat the non-neurological manifestations of mucopolysaccharidosis type 1, or MPS-1, in patients with the disease. The Company believes its product candidates for lysosomal diseases can leverage the well understood mechanism of enzyme replacement therapies, or ERTs, by using engineered cells to express functional human enzyme or other protein that more closely resemble normal physiology in a continuous manner. Sigilon is also working to develop next-generation product candidates to address the neurological manifestations of lysosomal diseases, starting with MPS-1, using transporter molecules designed to penetrate the blood brain barrier and molecules designed to extend plasma half-life.
Diabetes: SIG-002 is the Company's product candidate designed to replace islet cells for the treatment of type 1 diabetes, or T1D. In T1D, the immune system attacks and destroys the insulin-producing beta cells within the endocrine islets of the pancreas. Insulin deficiency results in dysregulation of glucose metabolism. In April 2018, the Company partnered with Eli Lilly and Company, a global leader in diabetes, to develop cell therapies for the treatment of T1D, including SIG-002. Under the terms of the partnership, Sigilon is leading execution of the program through an IND and Lilly will develop and commercialize the program worldwide.
Platform optimization: Sigilon is continuing to optimize its Shielded Living Therapeutics, or SLTx, platform, which combines advanced cell engineering with cutting-edge innovations in biocompatible materials to pioneer a new class of therapeutics. In November 2021, the Company reported that spheres covered with pericapsular fibrotic overgrowth, or PFO, were observed during a retrieval procedure in its Phase 1/2 study of SIG-001 in severe or moderately severe hemophilia A. With the modularity of the SLTx platform, the Company is evaluating changes designed to further modulate or otherwise reduce the potential for a patient's immune response to its product candidates.
In these prioritized areas, Sigilon expects to achieve the following milestones:
Financial Results
About Sigilon Therapeutics
Sigilon Therapeutics seeks to develop functional cures for patients with a broad range of chronic diseases by harnessing the power of the human cell through its Shielded Living Therapeutics™ platform. Sigilon's product candidates are non-viral engineered cell-based therapies designed to produce the crucial proteins, enzymes or other therapeutic molecules needed by patients living with chronic diseases such as lysosomal diseases and diabetes. The engineered cells are encapsulated by Sigilon's Afibromer™ biomaterials matrix, which is designed to shield them from immune rejection. Sigilon was founded by Flagship Pioneering in conjunction with Daniel Anderson, Ph.D., and Robert Langer, Sc.D., of the Massachusetts Institute of Technology.
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 timing and results of our preclinical studies and clinical development of our current product candidates and next generation product candidates, our ability to evaluate PFO and mitigation strategies related thereto, the timing of our IND submission and CTA amendments for SIG-005, the timing for the initiation of our Phase 1/2 clinical trial of SIG-005 in MPS-1, the initiation and timing of IND-enabling studies for SIG-002, 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 we fail to achieve the expected financial and operational benefits of our corporate restructuring, our business and financial results may be harmed; the results of our investigation of the preliminary results of our Phase 1/2 clinical trial of SIG-001 in Hemophilia A or failure of SIG-005 in clinical development 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 quarterly period ended September 30, 2021, and filed with the Securities and Exchange Commission (the "SEC"), as well as the other information we file with the SEC.
We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of these statements, except as required by law. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
SIGILON THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
(Unaudited)
| December 31, | ||||||||
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 107,143 | $ | 202,229 | ||||
| Marketable securities | 16,213 | — | ||||||
| Accounts receivable | 59 | 177 | ||||||
| Prepaid expenses and other current assets | 2,729 | 1,729 | ||||||
| Restricted cash—current | 250 | 75 | ||||||
| Total current assets | 126,394 | 204,210 | ||||||
| Property and equipment, net | 3,994 | 2,991 | ||||||
| Right-of-use assets | 12,863 | 16,731 | ||||||
| Restricted cash | 1,118 | 1,118 | ||||||
| Total assets | $ | 144,369 | $ | 225,050 | ||||
| Liabilities and stockholders' equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,344 | $ | 1,988 | ||||
| Accrued expenses and other current liabilities | 8,998 | 7,892 | ||||||
| Lease liabilities, current portion | 4,845 | 5,361 | ||||||
| Current portion of long-term debt | 1,667 | — | ||||||
| Deferred revenue from related party, current portion | 17,034 | 31,777 | ||||||
| Total current liabilities | 34,888 | 47,018 | ||||||
| Deferred revenue from related party, net of current portion | 5,333 | — | ||||||
| Lease liability, net of current portion | 8,577 | 11,893 | ||||||
| Long-term debt, net of discount | 18,411 | 19,807 | ||||||
| Other liabilities | — | 176 | ||||||
| Total liabilities | $ | 67,209 | $ | 78,894 | ||||
| Stockholders' equity | ||||||||
| Common stock, par value $0.001 per share; 175,000,000 shares authorized at December 31, 2021 and 2020; 32,359,895 and 31,464,989 shares issued and outstanding at December 31, 2021 and 2020, respectively | 32 | 31 | ||||||
| Preferred stock, par value $0.001 per share; 25,000,000 shares authorized at December 31, 2021 and 2020; no shares issued and outstanding at December 31, 2021 and 2020 | — | — | ||||||
| Additional paid-in capital | 290,377 | 282,053 | ||||||
| Accumulated other comprehensive income | (10 | ) | — | |||||
| Accumulated deficit | (213,239 | ) | (135,928 | ) | ||||
| Total stockholders' equity | 77,160 | 146,156 | ||||||
| Total liabilities and stockholders' equity | $ | 144,369 | $ | 225,050 | ||||
SIGILON THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share data)
(Unaudited)
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue | ||||||||||||||||
| Collaboration revenue | $ | 1,990 | $ | 3,756 | $ | 9,599 | $ | 13,374 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 14,689 | 14,337 | 65,069 | 53,488 | ||||||||||||
| General and administrative | 4,594 | 3,505 | 20,166 | 12,528 | ||||||||||||
| Total operating expenses | 19,283 | 17,842 | 85,235 | 66,016 | ||||||||||||
| Loss from operations | (17,293 | ) | (14,086 | ) | (75,636 | ) | (52,642 | ) | ||||||||
| Other income (expense), net: | ||||||||||||||||
| Interest income | 46 | 44 | 258 | 312 | ||||||||||||
| Interest expense | (507 | ) | (505 | ) | (1,988 | ) | (1,202 | ) | ||||||||
| Other income (expense) | 8 | (42 | ) | 55 | (89 | ) | ||||||||||
| Change in fair value of preferred stock warrant liability | — | (600 | ) | — | (644 | ) | ||||||||||
| Loss on extinguishment of debt | — | — | — | (343 | ) | |||||||||||
| Total other expense, net | (453 | ) | (1,103 | ) | (1,675 | ) | (1,966 | ) | ||||||||
| Net loss attributable to ordinary shareholders | $ | (17,746 | ) | $ | (15,189 | ) | $ | (77,311 | ) | $ | (54,608 | ) | ||||
| Net loss per share attributable to common stockholders—basic and diluted | $ | (0.55 | ) | $ | (1.15 | ) | $ | (2.43 | ) | $ | (7.55 | ) | ||||
| Weighted average common stock outstanding—basic and diluted | 32,314,854 | 13,230,224 | 31,860,264 | 7,229,626 | ||||||||||||
SOURCE: Sigilon Therapeutics, Inc.
Investor Contact
Robert Windsor, Jr., J.D.
VP, Head of Investor Relations
Sigilon Therapeutics
robert.windsor@sigilon.com
617-586-3837
Media Contacts
Amy Bonanno
Solebury Trout
abonanno@soleburytrout.com
914-450-0349
