$SELB Beats Earnings by .10/Phase 2 Results/Cash into 2020
Aktualisiert
Phase 2 head-to-head (COMPARE) clinical trial of SEL-212 vs. KRYSTEXXA® to begin in 1Q19,
interim six-month data expected in 4Q19
Collaboration with CureCN projected to dose first patient with combination of ImmTOR + AAV
gene therapy candidate in 2H19
Company raises 33M in gross offering proceeds and 31.3M in net proceeds in 1Q19, cash
runway into 1Q20
“During 2018 we laid a strong groundwork for a year of execution in 2019. We kicked off the year by
streamlining the company through a corporate restructuring, which is projected to cut our cash burn rate
by 19%. We then completed an equity fundraise of approximately $33 million in gross proceeds and
$31.3 million in net proceeds, and anticipate reporting key milestones for both our chronic refractory
gout and gene therapy programs. We continue to believe that our lead program, SEL-212, has the
potential to address several unmet needs in chronic refractory gout patients, including sustained serum
uric acid reduction, reduced painful flares and once monthly dosing, and we look forward to initiating
the planned six-month head-to-head (COMPARE) clinical trial against Krystexxa this month,” said Carsten
Brunn, Ph.D., President and CEO of Selecta. “We also look forward to further advancing our ImmTOR +
AAV gene therapy combination product candidate in Crigler-Najjar Syndrome in collaboration with
CureCN in the second half of the year and identifying other ways to advance our ImmTOR platform and
grow our strategic partnerships.”
Effective December 1, 2018, Carsten Brunn, Ph.D., assumed
the role of President and CEO of Selecta, following his previous position as President of
Pharmaceuticals for the Americas Region and member of the Global Pharmaceutical Executive
Committee at Bayer.
Reported Phase 2 Data: Selecta has reported data from its Phase 2 trial showing that 66% of
evaluable patients (21/32), maintained serum uric acid (sUA) levels of <6mg/dL after five oncemonthly treatments of SEL-212 at doses of 0.1 or 0.15 mg/kg of ImmTOR in combination with
0.2mg/kg of pegadricase. Furthermore, reduced total urate burden and lowered flare rates and
severity were observed in the Phase 2 clinical trial, and SEL-212 continued to be generally well
tolerated.
Collaboration with CureCN Consortium Projected to Dose First Patient in 2H19: In September
2018, Selecta announced a collaboration with CureCN, a European consortium, for an
ImmTOR+AAV gene therapy combination product candidate in Crigler-Najjar Syndrome, building
upon preclinical work that was published together with Genethon in Nature Communications in
October 2018. Selecta expects CureCN to initiate preclinical toxicology studies in the first half of
2019 and for the combination product candidate to enter the clinic in the second half of 2019.
Selecta expects to initiate a Phase 2 head-to-head (COMPARE) clinical trial of SEL-212,
compared to the current FDA-approved uricase therapy, Krystexxa, in the first quarter of 2019.
An interim six-month data readout is projected for the fourth quarter of 2019, with a full statistical data analysis expected in the first quarter of 2020. The results of the COMPARE trial are expected to inform the design of the planned Phase 3 clinical trial of SEL-212, which the company plans to initiate in the fourth quarter of 2019.
Cash Position: Selecta had $37.7 million in cash, cash equivalents and restricted cash as of December
31, 2018, which compares to cash, cash equivalents and short-term investments of $50.5 million at
September 30, 2018. The company currently has a cash runway into the first quarter of 2020, which
includes proceeds net of underwriting discounts and commissions of $31.3 million from the
company’s recent follow-on offering in January 2019.
Corporate Restructuring Completed in January 2019: Selecta completed a corporate
restructuring that reduced the company’s workforce by 36 percent as of January 3, 2019. This
reduction, coupled with a reprioritization of the company’s pipeline programs, is projected to
reduce the yearly cash burn by 19 percent.
Successfully Completed a $33.3 Million Public Offering; Providing Cash Runway into 1Q20: In
January 2019, Selecta completed an underwritten public offering of 22,188,706 shares of its
common stock, at a price to public of $1.50 per share, resulting in net proceeds to Selecta of
$31.3 million, after deducting underwriting discounts and commissions.
interim six-month data expected in 4Q19
Collaboration with CureCN projected to dose first patient with combination of ImmTOR + AAV
gene therapy candidate in 2H19
Company raises 33M in gross offering proceeds and 31.3M in net proceeds in 1Q19, cash
runway into 1Q20
“During 2018 we laid a strong groundwork for a year of execution in 2019. We kicked off the year by
streamlining the company through a corporate restructuring, which is projected to cut our cash burn rate
by 19%. We then completed an equity fundraise of approximately $33 million in gross proceeds and
$31.3 million in net proceeds, and anticipate reporting key milestones for both our chronic refractory
gout and gene therapy programs. We continue to believe that our lead program, SEL-212, has the
potential to address several unmet needs in chronic refractory gout patients, including sustained serum
uric acid reduction, reduced painful flares and once monthly dosing, and we look forward to initiating
the planned six-month head-to-head (COMPARE) clinical trial against Krystexxa this month,” said Carsten
Brunn, Ph.D., President and CEO of Selecta. “We also look forward to further advancing our ImmTOR +
AAV gene therapy combination product candidate in Crigler-Najjar Syndrome in collaboration with
CureCN in the second half of the year and identifying other ways to advance our ImmTOR platform and
grow our strategic partnerships.”
Effective December 1, 2018, Carsten Brunn, Ph.D., assumed
the role of President and CEO of Selecta, following his previous position as President of
Pharmaceuticals for the Americas Region and member of the Global Pharmaceutical Executive
Committee at Bayer.
Reported Phase 2 Data: Selecta has reported data from its Phase 2 trial showing that 66% of
evaluable patients (21/32), maintained serum uric acid (sUA) levels of <6mg/dL after five oncemonthly treatments of SEL-212 at doses of 0.1 or 0.15 mg/kg of ImmTOR in combination with
0.2mg/kg of pegadricase. Furthermore, reduced total urate burden and lowered flare rates and
severity were observed in the Phase 2 clinical trial, and SEL-212 continued to be generally well
tolerated.
Collaboration with CureCN Consortium Projected to Dose First Patient in 2H19: In September
2018, Selecta announced a collaboration with CureCN, a European consortium, for an
ImmTOR+AAV gene therapy combination product candidate in Crigler-Najjar Syndrome, building
upon preclinical work that was published together with Genethon in Nature Communications in
October 2018. Selecta expects CureCN to initiate preclinical toxicology studies in the first half of
2019 and for the combination product candidate to enter the clinic in the second half of 2019.
Selecta expects to initiate a Phase 2 head-to-head (COMPARE) clinical trial of SEL-212,
compared to the current FDA-approved uricase therapy, Krystexxa, in the first quarter of 2019.
An interim six-month data readout is projected for the fourth quarter of 2019, with a full statistical data analysis expected in the first quarter of 2020. The results of the COMPARE trial are expected to inform the design of the planned Phase 3 clinical trial of SEL-212, which the company plans to initiate in the fourth quarter of 2019.
Cash Position: Selecta had $37.7 million in cash, cash equivalents and restricted cash as of December
31, 2018, which compares to cash, cash equivalents and short-term investments of $50.5 million at
September 30, 2018. The company currently has a cash runway into the first quarter of 2020, which
includes proceeds net of underwriting discounts and commissions of $31.3 million from the
company’s recent follow-on offering in January 2019.
Corporate Restructuring Completed in January 2019: Selecta completed a corporate
restructuring that reduced the company’s workforce by 36 percent as of January 3, 2019. This
reduction, coupled with a reprioritization of the company’s pipeline programs, is projected to
reduce the yearly cash burn by 19 percent.
Successfully Completed a $33.3 Million Public Offering; Providing Cash Runway into 1Q20: In
January 2019, Selecta completed an underwritten public offering of 22,188,706 shares of its
common stock, at a price to public of $1.50 per share, resulting in net proceeds to Selecta of
$31.3 million, after deducting underwriting discounts and commissions.
Anmerkung
PPS Target based on 52Week Price range $16.00
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