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- Positive Data from Ongoing Phase 2 Study of SEL-212 Reported at Clinical Meetings in
- Further Preclinical Data Confirm Immune Tolerance Platform’s Broad Potential
- Recent Financing Extends Cash Runway Into 2019
- Company to Host Conference Call Today at
8:30 a.m. ET
“The second quarter of 2017 was a time of significant accomplishment for the
“Most importantly, we presented positive clinical data from our ongoing Phase 2 trial for our lead product candidate, SEL-212, indicating that we have identified a minimum effective dose that mitigates the formation of anti-drug antibodies (ADAs), allowing for a significant lowering and durable control of serum uric acid for gout patients over multiple monthly doses,” Dr. Cautreels continued. “We believe such a treatment would enable the resolution of crystallized uric acid deposits, or tophi, that are increasingly being cited as sources of morbidity and mortality in chronic severe gout patients. The clinical data also suggest that the incidence of gout flares in patients treated with SEL-212 was reduced as compared to the control cohorts.”
Recent Business Highlights and Activities
- Presented SEL-212 Phase 2 Trial Data: In
June 2017, Selectapresented clinical data from its ongoing open-label, multiple ascending dose Phase 2 trial of SEL-212 (SVP-Rapamycin in combination with pegsiticase) at the Annual European Congress of Rheumatology(EULAR 2017) and the Federation of Clinical Immunology Societies(FOCIS 2017). As of August 1, 2017, a total of 63 patients had been dosed in eight cohorts. No additional serious adverse events or new notable safety trends have been observed in the trial since the presentations in June. The company plans to report further data from this trial at a medical meeting in late 2017 and to initiate its Phase 3 program in 2018.
- Added a Clinical-Stage Oncology Asset: In
May 2017, Selectaannounced that it had licensed LMB-100, a clinical-stage, next-generation recombinant immunotoxin, from the Center for Cancer Researchat the National Cancer Institute(NCI), part of National Institutes of Health. LMB-100 contains a potent toxin that is derived from Pseudomonas exotoxin A fused to an antibody fragment targeting mesothelin, which is overexpressed in virtually all mesotheliomas and pancreatic adenocarcinomas and a high percentage of other malignancies, including ovarian, lung and breast cancers. A precursor to LMB-100 was shown to induce marked tumor reduction and prolonged survival in mesothelioma patients in which an ADA response was inhibited by immunosuppressants; however, ADAs limited the number of cycles that could be administered in the vast majority of patients. Additionally, a July 2017publication entitled “Combining Local Immunotoxins Targeting Mesothelin with CTLA-4 Blockade Synergistically Eradicates Murine Cancer by Promoting Anti-Cancer Immunity” (Leshem Y et al) in Cancer Immunology Researchdescribed a preclinical study showing that a combination of LMB-100 and a checkpoint inhibitor induced complete mesothelioma regression in most mice. NCI is currently conducting two Phase 1 trials of LMB-100 in mesothelioma and pancreatic cancer, and Selectaand NCI are currently planning a Phase 1b clinical trial to evaluate multiple cycles of a combination treatment consisting of LMB-100 and SVP-Rapamycin.
- Announced New Gene Therapy Data: Additional preclinical data regarding non-immunogenic gene therapies were presented at the
American Society of Gene & Cell Therapy(ASGCT) 2017 Annual Meeting in Washington, D.C.in May 2017. Selecta’s collaborators at the National Human Genome Research Instituteand Massachusetts Eye and Ear presented preclinical proof-of-concept data showing the efficacy of the company’s methymalonic acidemia (MMA) gene therapy candidate and SVP-Rapamycin’s ability to mitigate immune responses to an Anc80 capsid. A team led by Federico Mingozzi, Ph.D., Head of Immunology and Liver Gene Therapy at Genethon, also presented preclinical data in mice and non-human primates indicating that co-administration of SVP-Rapamycin completely blocked anti-AAV immune responses and allowed for vector re-administration and gene therapy dose titration.
- Published Preclinical Data in Pompe Disease: Molecular Genetics and Metabolism Reports published a paper in
July 2017from collaborators at Duke Universityled by Dr. Priya Kishnanientitled “A pilot study on using rapamycin-carrying synthetic vaccine particles (SVP) in conjunction with enzyme replacement therapy to induce immune tolerance in Pompe disease.” These investigators utilized a mouse model of Pompe disease to show that the co-administration of SVP-Rapamycin with the enzyme replacement therapy alglucosidase alfa (marketed as Myozyme® and Lumizyme®) inhibited the formation of ADAs, reduced glycogen storage, and improved weight and motor skills compared to co-administration of the enzyme with the immunosuppressive methotrexate.
- Added a New Board Member: At Selecta’s 2017 Annual Meeting of Stockholders in
June 2017, Patrick J. Zennerwas elected to the company’s Board of Directors. Mr. Zenner previously served as President and Chief Executive Officer of Hoffmann-La Roche Inc., North America, the prescription drug unit of Roche.
$50 Millionin Financing: Selectacompleted a private placement with new and existing investors during the second quarter that resulted in gross proceeds to the company of $50 million, before deducting placement agent and other offering expenses.
Second Quarter Financial Results:
- Revenue: For the second quarter of 2017, the company’s total revenue was less than
$0.1 million, which compares with $2.0 millionfor the second quarter of 2016. The decline is primarily the result of reduced revenue recognized from the company’s nicotine vaccine candidate grant award from the National Institute on Drug Abuse, which is now winding down, as well as the previously announced termination of its collaboration with Sanofi.
- Research and Development Expenses: Research and development expenses for the second quarter of 2017 were
$11.0 million, which compares with $6.0 millionfor the second quarter of 2016. The increase is primarily the result of clinical costs related to the company's Phase 2 program for SEL-212, incremental headcount, and consulting, licensing, supplies and testing activities related to the company’s other pipeline programs.
- General and Administrative Expenses: General and administrative expenses for the second quarter of 2017 were
$4.9 million, which compares with $2.4 millionfor the second quarter of 2016. The increase is primarily the result of greater expenses related to patents as well as general expenses and incremental salaries from increased headcount to support a clinical-stage public company.
- Net Loss: For the second quarter of 2017,
Selectareported a net loss attributable to common stockholders of $(16.0) million, or $(0.85)per share, compared to a net loss of $(9.1) million, or $(2.75)per share, for the same period in 2016. The decrease in net loss per share in the most recent quarter is primarily the result of shares of common stock that were issued in the company’s June 2016initial public offering (IPO) and conversion of Selecta’s redeemable preferred stock into common stock in connection with the IPO, partially offset by an increase in net loss for the period.
- Cash Position:
Selectahad $113.0 millionin cash, cash equivalents, short-term deposits, investments and restricted cash as of June 30, 2017, which compares with a balance of $68.9 millionat March 31, 2017. The increase is primarily the result of net proceeds from the company’s aforementioned private placement as well as cash payments associated with the company’s license and stock purchase agreements with Spark Therapeutics. Selectaexpects that its cash, cash equivalents, short-term deposits, investments and restricted cash will be sufficient to fund the company’s operating expenses and capital expenditure requirements into 2019.
Conference Call Reminder
Any statements in this press release about the future expectations, plans and prospects of
|Selecta Biosciences, Inc. and Subsidiaries|
|Consolidated Balance Sheets|
|(In thousands, except for shares and par value)|
|December 31, 2016|
|Cash and cash equivalents||$||82,630||$||58,656|
|Short-term deposits and investments||30,025||25,485|
|Prepaid expenses and other current assets||1,848||2,382|
|Total current assets||114,578||86,816|
|Property and equipment, net||2,131||2,047|
|Restricted cash and other deposits||316||316|
|Liabilities and stockholders’ equity|
|Loans payable, current portion||4,612||4,067|
|Deferred revenue, current portion||2,566||1,836|
|Total current liabilities||20,053||13,706|
|Deferred rent and lease incentive||189||222|
|Loans payable, net of current portion||5,732||7,977|
|Deferred revenue, net of current portion||11,619||12,439|
|Other long‑term liabilities||1,250||—|
|Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively.||—||—|
|Common stock, $0.0001 par value; 200,000,000 shares authorized; 22,056,147 and 18,438,742 shares issued and outstanding as of June 30, 2017 and December 31, 2016, respectively.||1||1|
|Additional paid-in capital||265,297||211,125|
|Receivable from stock option exercises||(26||)||(75||)|
|Accumulated other comprehensive loss||(4,413||)||(4,518||)|
|Total stockholders’ equity||78,182||54,957|
|Total liabilities and stockholders’ equity||$||117,025||$||89,301|
|Selecta Biosciences, Inc. and Subsidiaries|
|Consolidated Statements of Operations and Comprehensive Loss|
|(In thousands, except share and per share data)|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Grant and collaboration revenue||$||26||$||2,017||$||163||$||4,105|
|Research and development||10,994||6,000||22,038||12,648|
|General and administrative||4,903||2,418||8,778||4,799|
|Total operating expenses||15,897||8,418||30,816||17,447|
|Loss from operations||(15,871||)||(6,401||)||(30,653||)||(13,342||)|
|Foreign currency transaction gain (loss), net||82||(158||)||(83||)||(378||)|
|Other expense, net||—||(64||)||—||(82||)|
|Other comprehensive loss:|
|Foreign currency translation adjustment||(43||)||170||80||401|
|Unrealized gain (loss) on securities||10||—||25||—|
|Accretion of redeemable convertible preferred stock||—||(2,210||)||—||(4,566||)|
|Net loss attributable to common stockholders||$||(15,967||)||$||(9,133||)||$||(31,101||)||$||(18,965||)|
|Net loss per share attributable to common stockholders|
|Basic and diluted||$||(0.85||)||$||(2.75||)||$||(1.67||)||$||(6.90||)|
|Weighted average common shares outstanding|
|Basic and diluted||18,814,570||3,322,546||18,645,339||2,749,105|
Jason Fredette Selecta Biosciences, Inc.617-231-8078 firstname.lastname@example.org