Dynavax (DVAX) began the presentation talking about its first commercialized product Heplisav-B,
which received FDA approval for adults with hepatitis B infection in November 2017 and was
launched in Q1 2018. The drug demonstrated higher seroprotection rates with its one-month,
two-dose regimen compared with GlaxoSmithKline’s Engerix-B with a six-month, three-dose
regimen. Heplisav-B is expected to be profitable by year end and is positioned to be the standard
of care hepatitis B adult vaccine in the US. Gross peak US sales could reach $500m. It is currently
available in all Sam’s Club pharmacy locations and Dynavax will work with pharmacy chains across
the US to make the drug more available. Other clients for Heplisav-B include department of
corrections facilities and the Department of Defense. CEO Eddie Gray pointed out that since there
is no cure for hepatitis B, effective vaccination is critical.
The company went on to talk about its lead clinical program SD-101/pembrolizumab combination
that consistently provides significantly higher and more durable responses than monotherapy.
The combo therapy is in Phase II trials for melanoma (resistant and refractory), head and neck
cancer (naïve), and breast cancer (naïve). In 47 patients who received 2 mg/lesion of SD-101 in
combination with pembrolizumab the overall response rate was 70%. Dynavax looks to explore
SD-101 in other tumor indications and find potential partners to allow the therapy to reach its
fullest potential.
Dynavax’s pipeline also includes DV281, currently being studied in Phase I for NSCLC in
combination with nivolumab (anti-PD-1). Upcoming 2019 catalysts are safety and biomarker data
from the Phase I study and initiation of a Phase II study, both anticipated in the first quarter. The
company is continuing to advance its preclinical programs. Dynavax closed the presentation by
announcing its strong financial position with cash and equivalents of $180.2m as of the end of
September 2018. It looks forward to a busy and exciting year ahead.
• Having been mired in legal issues concerning former company executives and opioid kickback
schemes in the last few years, Saeed Motahari, CEO of Insys Therapeutics (INYS) since 2017,
began his presentation by emphasizing the transformation of the company and the rebuilding of
its reputation. Key priorities included resolving government investigations, strengthening the
leadership team and board members, and establishing a new organizational culture of
compliance. Mr. Motahari highlighted that there was new leadership within the company and
that more than two-thirds of the Board is new since April 2017. The aim of new management is to
change the company’s focus to pharmaceutical cannabinoids and spray technology, and
strategically divest their opioid assets.
The Company provided updates on their pipeline activities focusing on pharmaceutical
cannabinoids and sprays. Oral Cannabidiol which is in Phase 2 for childhood absence epilepsy has
an expected first data readout in Q1 2019. Insys has also initiated a proof-of-concept study for
oral cannabidiol in Prader-Willi Syndrome and first data readouts are expected in the last quarter
of this year. The drug is also in Phase III development for infantile spasms, however, management
admitted that the Company was having difficulty enrolling the Phase III trial due to the nature of the infants being registered. They will therefore be revisiting the protocol and/or adding more
enrolment sites.
Having released positive data from a dose-finding pharmacokinetic study for epinephrine nasal
spray for the treatment of anaphylaxis on January 9, management touted their positive outlook in
this space. As epinephrine products are currently all injectables, the intranasal formulation
provides a convenient and attractive non-invasive alternative. Importantly, the PK data
demonstrated that the intranasal formulation provided a rapid drug absorption with similar
bioavailability as compared to intramuscular injection of EpiPen® (0.3mg). Planned pivotal
studies this year will include nasal allergen challenged patients with seasonal allergies, as well as
in healthy volunteers. Insys will be presenting further results at the AAAAI Annual Meeting in
February 2019, with a planned NDA filing date in Q4 2019.
Management addressed the declining financials for Insys since 2015 and reinforced that they had
no debt but had financial obligations regarding DOJ settlements and other legal spending. In
addition, their goals are to manage operational costs without compromising their clinical
development program. More details surrounding financials will be delivered in the Company’s
upcoming investor call.
which received FDA approval for adults with hepatitis B infection in November 2017 and was
launched in Q1 2018. The drug demonstrated higher seroprotection rates with its one-month,
two-dose regimen compared with GlaxoSmithKline’s Engerix-B with a six-month, three-dose
regimen. Heplisav-B is expected to be profitable by year end and is positioned to be the standard
of care hepatitis B adult vaccine in the US. Gross peak US sales could reach $500m. It is currently
available in all Sam’s Club pharmacy locations and Dynavax will work with pharmacy chains across
the US to make the drug more available. Other clients for Heplisav-B include department of
corrections facilities and the Department of Defense. CEO Eddie Gray pointed out that since there
is no cure for hepatitis B, effective vaccination is critical.
The company went on to talk about its lead clinical program SD-101/pembrolizumab combination
that consistently provides significantly higher and more durable responses than monotherapy.
The combo therapy is in Phase II trials for melanoma (resistant and refractory), head and neck
cancer (naïve), and breast cancer (naïve). In 47 patients who received 2 mg/lesion of SD-101 in
combination with pembrolizumab the overall response rate was 70%. Dynavax looks to explore
SD-101 in other tumor indications and find potential partners to allow the therapy to reach its
fullest potential.
Dynavax’s pipeline also includes DV281, currently being studied in Phase I for NSCLC in
combination with nivolumab (anti-PD-1). Upcoming 2019 catalysts are safety and biomarker data
from the Phase I study and initiation of a Phase II study, both anticipated in the first quarter. The
company is continuing to advance its preclinical programs. Dynavax closed the presentation by
announcing its strong financial position with cash and equivalents of $180.2m as of the end of
September 2018. It looks forward to a busy and exciting year ahead.
• Having been mired in legal issues concerning former company executives and opioid kickback
schemes in the last few years, Saeed Motahari, CEO of Insys Therapeutics (INYS) since 2017,
began his presentation by emphasizing the transformation of the company and the rebuilding of
its reputation. Key priorities included resolving government investigations, strengthening the
leadership team and board members, and establishing a new organizational culture of
compliance. Mr. Motahari highlighted that there was new leadership within the company and
that more than two-thirds of the Board is new since April 2017. The aim of new management is to
change the company’s focus to pharmaceutical cannabinoids and spray technology, and
strategically divest their opioid assets.
The Company provided updates on their pipeline activities focusing on pharmaceutical
cannabinoids and sprays. Oral Cannabidiol which is in Phase 2 for childhood absence epilepsy has
an expected first data readout in Q1 2019. Insys has also initiated a proof-of-concept study for
oral cannabidiol in Prader-Willi Syndrome and first data readouts are expected in the last quarter
of this year. The drug is also in Phase III development for infantile spasms, however, management
admitted that the Company was having difficulty enrolling the Phase III trial due to the nature of the infants being registered. They will therefore be revisiting the protocol and/or adding more
enrolment sites.
Having released positive data from a dose-finding pharmacokinetic study for epinephrine nasal
spray for the treatment of anaphylaxis on January 9, management touted their positive outlook in
this space. As epinephrine products are currently all injectables, the intranasal formulation
provides a convenient and attractive non-invasive alternative. Importantly, the PK data
demonstrated that the intranasal formulation provided a rapid drug absorption with similar
bioavailability as compared to intramuscular injection of EpiPen® (0.3mg). Planned pivotal
studies this year will include nasal allergen challenged patients with seasonal allergies, as well as
in healthy volunteers. Insys will be presenting further results at the AAAAI Annual Meeting in
February 2019, with a planned NDA filing date in Q4 2019.
Management addressed the declining financials for Insys since 2015 and reinforced that they had
no debt but had financial obligations regarding DOJ settlements and other legal spending. In
addition, their goals are to manage operational costs without compromising their clinical
development program. More details surrounding financials will be delivered in the Company’s
upcoming investor call.
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