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Selecta Biosciences Announces Third Quarter 2016 Financial Results and Provides Corporate Update
- Phase 2 Trial of SEL-212 for Treatment of Gout Initiated
- SEL-212 Phase 1 Clinical Data to be Presented
December 7-8, 2016 - Preclinical Data Presented for SVP’s Potential in Gene Therapy and Oncology
- Exclusive Rights Obtained to Peanut Allergy and Celiac Disease Programs
$79.9 Million in Cash, Cash Equivalents, Investments and Restricted Cash as ofSeptember 30, 2016
“We have recently reported a series of scientific and clinical advances demonstrating the breadth of our Synthetic Vaccine Particles (SVP™) platform and culminating with the dosing of the first gout patients in our Phase 2 clinical trial of SEL-212,” said
Recent Business Highlights
- Initiated Phase 2 Trial of SEL-212 in Gout:
Selecta recently began dosing the first patients in its Phase 2 clinical trial of SEL-212 (SVP-Rapamycin in combination with pegsiticase). This Phase 2 trial is being conducted at 15 centers inthe United States and is expected to enroll more than 36 symptomatic gout patients with elevated uric acid levels. The primary and secondary endpoints include safety and tolerability of multiple doses of SEL-212, reduction of serum uric acid levels and mitigation of anti-drug antibodies (ADAs) against the enzyme product. Exploratory endpoints include measurement of uric acid deposits by Dual Energy Computed Tomography (DECT) imaging. Multiple dose treatment with SEL-212 has the potential to significantly lower total uric acid crystal burden in joints and tissues, which cannot be effectively or rapidly achieved by oral gout therapy. The removal of the uric acid crystal deposits is expected to reduce overall inflammation and the frequency of debilitating gout flares. Initial results from this trial are expected in the first half of 2017.
- SEL-212 Phase 1a/b Data to be Presented December 7/8: Data from Selecta’s SEL-212 Phase 1 program, including its ongoing Phase 1b trial, will be presented on
December 7, 2016 at the 11th Annual Immunization and Vaccine Summit (IMVACS) inBoston, MA. At8:30 a.m. ET onThursday, December 8, 2016 , this data will be discussed on a conference call. Investors and the public can access a live and archived webcast of this call via the Investors & Media section of the company’s website, http://selectabio.com. Individuals may also participate in the live call via telephone by dialing (844) 309-6574 (domestic) or (484) 747-6923 (international) and may access a teleconference replay for one week by dialing (855) 859-2056 (domestic) or (404) 537-3406 (international) and using confirmation code 14490302.
- Reported Gene Therapy Data: Preclinical data were recently presented at the Annual Congress of the
European Society of Gene and Cell Therapy inFlorence, Italy that demonstrate the benefits of applying Selecta’s immune tolerance SVP technology to an AAV8 gene therapy vector expressing Factor IX, a coagulation protein deficient in patients with Hemophilia B. These studies elucidate the mechanism by which SVP-Rapamycin demonstrated successful mitigation of both humoral (antibody) and cellular immune responses that are associated with gene therapy using adeno-associated viral (AAV) vectors. Cellular immune responses observed in clinical trials of gene therapies have been associated with an increase in liver enzymes and a loss of transgene expression in patients. Antibodies against AAV develop with the first dose of gene therapy and can prevent re-administration of therapy, which may be important in pediatric applications and diseases where sufficient protein expression cannot be achieved with a single dose. Selecta’s technology has the potential to overcome these limitations and enable repeat administrations.
- Announced Oncology Cancer Data: Results from preclinical studies applying Selecta’s immune tolerance SVP technology to LMB-100, an anti-cancer therapeutic, were recently presented at the Immunogenicity and Bioassay Summit 2016 in
Baltimore, Maryland . LMB-100 is a targeted immunotoxin that is currently undergoing Phase 1 clinical trials in patients with mesothelioma and pancreatic cancer. In a collaboration between theNational Cancer Institute andSelecta , SVP-Rapamycin prevented the formation of anti-LMB-100 antibodies in mice, allowing for a significant increase in the number of treatment cycles and restoring the beneficial effect of LMB-100 on controlling tumor growth.
- Received Exclusive Rights to Peanut Allergy, Celiac Disease Programs:
Selecta announced today that it is receiving worldwide rights to intellectual property, data and materials generated through a discovery collaboration initiated and funded bySanofi for the development of product candidates to treat peanut allergy and celiac disease. This follows Sanofi’s strategic review of its R&D portfolio, which resulted in its decision to exit this collaboration withSelecta . The transition of these discovery programs is not expected to have a material impact on Selecta’s cash runway.Selecta plans to evaluate strategic opportunities to continue advancing these non-core programs.
Unaudited Third Quarter Financial Results:
- Revenue: For the third quarter of 2016, the company’s total revenue was
$1.0 million , which compares with$1.6 million for the same period in the prior year. The decline is primarily the result of lower collaboration revenue.
- Research and Development Expenses: Research and development expenses for the third quarter of 2016 were
$6.0 million , which compares with$5.5 million for the same period in the prior year. The increase is primarily the result of incremental headcount and consulting to support the development of SEL-212 as well as increased stock compensation and insurance expense.
- General and Administrative Expenses: General and administrative expenses for the third quarter of 2016 were
$2.5 million , which compares with$2.2 million for the same period in the prior year. The increase is primarily the result of additional costs related to market research as well as increased consulting and insurance fees associated with being a public company.
- Net Loss: For the third quarter of 2016,
Selecta reported a net loss attributable to common stockholders of$(7.7) million , or$(0.43) per share, compared to a net loss of$(7.6) million , or$(3.50) per share, for the same period in 2015.
- Cash Position:
Selecta had$79.9 million in cash, cash equivalents, investments and restricted cash as ofSeptember 30, 2016 , which compared with a balance of$85.3 million atJune 30, 2016 . The decline is primarily a result of the company’s operating expenditures, partially offset by cash received from collaborations and grants as well as the partial exercise by underwriters of the company’s initial public offering (IPO) overallotment option.
- Financial Guidance: Based on the company’s current operating plan,
Selecta expects that its cash, cash equivalents, investments and restricted cash are sufficient to fund the company’s operating expenses and capital expenditure requirements into the first quarter of 2018.
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Forward-Looking Statements
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| Selecta Biosciences, Inc. and Subsidiaries Consolidated Balance Sheets (In thousands, except for shares and par value) |
||||||||
| September 30, 2016 | December 31, 2015 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 59,488 | $ | 32,337 | ||||
| Short term deposits and investments | 19,788 | 4,125 | ||||||
| Restricted cash | 335 | 133 | ||||||
| Accounts receivable | 483 | 824 | ||||||
| Prepaid expenses and other current assets | 3,303 | 1,494 | ||||||
| Total current assets | 83,397 | 38,913 | ||||||
| Property and equipment, net | 2,066 | 2,029 | ||||||
| Restricted cash and other deposits | 316 | 316 | ||||||
| Other assets | — | 1,566 | ||||||
| Total assets | $ | 85,779 | $ | 42,824 | ||||
| Liabilities, redeemable convertible preferred stock, and stockholders’ equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,040 | $ | 2,179 | ||||
| Accrued expenses | 2,434 | 3,378 | ||||||
| Loans payable, current portion | 2,913 | — | ||||||
| Deferred revenue, current portion | 1,041 | 1,313 | ||||||
| Contingently repayable grant funding | 262 | 420 | ||||||
| Total current liabilities | 7,690 | 7,290 | ||||||
| Non‑current liabilities: | ||||||||
| Deferred rent and lease incentive | 234 | 105 | ||||||
| Loans payable, net of current portion | 9,064 | 11,855 | ||||||
| Deferred revenue, net of current portion | 3,348 | 2,295 | ||||||
| Other long‑term liabilities | — | 290 | ||||||
| Total liabilities | 20,336 | 21,835 | ||||||
| Commitments and contingencies (Notes 8 and 13) | ||||||||
| Redeemable Convertible Preferred Stock: | ||||||||
| Series A redeemable convertible preferred stock, $0.0001 par value; 0 and 2,589,868 shares authorized; 0 and 2,589,868 shares issued and outstanding; as of September 30, 2016 and December 31, 2015 respectively. | — | 3,644 | ||||||
| Series B redeemable convertible preferred stock, $0.0001 par value; 0 and 7,437,325 shares authorized; 0 and 7,437,325 shares issued and outstanding; as of September 30, 2016 and December 31, 2015 respectively. | — | 21,448 | ||||||
| Series C redeemable convertible preferred stock, $0.0001 par value; 0 and 5,000,002 shares authorized; 0 and 5,000,002 shares issued and outstanding; as of September 30, 2016 and December 31, 2015 respectively. | — | 20,178 | ||||||
| Series D redeemable convertible preferred stock, $0.0001 par value; 0 and 8,166,662 shares authorized; 0 and 8,099,994 shares issued and outstanding; as of September 30, 2016 and December 31, 2015 respectively. | — | 42,902 | ||||||
| Series SRN redeemable convertible preferred stock, $0.0001 par value; 0 and 5,611,112 shares authorized; 0 and 2,111,109 shares issued and outstanding; as of September 30, 2016 and December 31, 2015 respectively. | — | 12,082 | ||||||
| Series E redeemable convertible preferred stock, $0.0001 par value; 0 and 9,030,654 shares authorized; 0 and 8,888,888 shares issued and outstanding; as of September 30, 2016 and December 31, 2015 respectively. | — | 37,228 | ||||||
| Total redeemable convertible preferred stock | — | 137,482 | ||||||
| Stockholders’ equity (deficit): | ||||||||
| Preferred stock, $0.0001 par value; 10,000,000 and 0 shares authorized; 0 shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively. | — | — | ||||||
| Common stock, $0.0001 par value; 200,000,000 and 62,164,377 shares authorized at September 30, 2016 and December 31, 2015 respectively; 18,190,180 and 2,180,976 shares issued, 18,188,313 and 2,173,399 shares outstanding as of September 30, 2016 and December 31, 2015, respectively. | 1 | — | ||||||
| Additional paid-in capital | 207,489 | 1 | ||||||
| Accumulated deficit | (137,493 | ) | (111,508 | ) | ||||
| Accumulated other comprehensive loss | (4,554 | ) | (4,986 | ) | ||||
| Total stockholders’ equity (deficit) | 65,443 | (116,493 | ) | |||||
| Total liabilities, redeemable convertible preferred stock and stockholders’ equity | $ | 85,779 | $ | 42,824 | ||||
| Selecta Biosciences, Inc. and Subsidiaries Consolidated Statements of Operations and Comprehensive Loss (Unaudited, amounts in thousands, except share and per share data) |
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| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Grant and collaboration revenue | $ | 1,048 | $ | 1,607 | $ | 5,153 | $ | 3,877 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 6,021 | 5,483 | 18,669 | 15,769 | ||||||||||||
| General and administrative | 2,495 | 2,195 | 7,294 | 6,305 | ||||||||||||
| Total operating expenses | 8,516 | 7,678 | 25,963 | 22,074 | ||||||||||||
| Loss from operations | (7,468 | ) | (6,071 | ) | (20,810 | ) | (18,197 | ) | ||||||||
| Investment income | 98 | 25 | 121 | 149 | ||||||||||||
| Foreign currency transaction gain (loss), net | (51 | ) | 668 | (429 | ) | 616 | ||||||||||
| Interest expense | (311 | ) | (334 | ) | (931 | ) | (843 | ) | ||||||||
| Other expense, net | 4 | (13 | ) | (78 | ) | (50 | ) | |||||||||
| Net loss | (7,728 | ) | (5,725 | ) | (22,127 | ) | (18,325 | ) | ||||||||
| Other comprehensive loss: | ||||||||||||||||
| Foreign currency translation adjustment | 15 | (800 | ) | 416 | (763 | ) | ||||||||||
| Unrealized gain (loss) on securities | 16 | — | 16 | — | ||||||||||||
| Comprehensive loss | $ | (7,697 | ) | $ | (6,525 | ) | $ | (21,695 | ) | $ | (19,088 | ) | ||||
| Net loss | (7,728 | ) | (5,725 | ) | (22,127 | ) | (18,325 | ) | ||||||||
| Accretion of redeemable convertible preferred stock | — | (1,836 | ) | (4,566 | ) | (4,959 | ) | |||||||||
| Net loss attributable to common stockholders | $ | (7,728 | ) | $ | (7,561 | ) | $ | (26,693 | ) | $ | (23,284 | ) | ||||
| Net loss per share attributable to common stockholders | ||||||||||||||||
| Basic and diluted | $ | (0.43 | ) | $ | (3.50 | ) | $ | (3.39 | ) | $ | (10.86 | ) | ||||
| Weighted average common shares outstanding | ||||||||||||||||
| Basic and diluted | 18,108,014 | 2,159,658 | 7,881,625 | 2,144,731 | ||||||||||||
Contact Information:Jason Fredette Selecta Biosciences, Inc. 617-231-8078 jfredette@selectabio.com
Follow @SelectaBio