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Structuring Biotech & Pharma Startup
Portfolios for Global Impact, Value,
and PartneringJuly 30, 2020
Life Sciences Webinar Series
Case Study on Common Issues for Early Stage/Startup BioPharma
• Small teams, possibly working remotely, moving
and pivoting quickly
• Relying on CROs and Universities to prepare
and test compounds
• Using sophisticated screening assays / in silico
assays
• Laser focused on one or two programs
• Expect major partnering or exit by acquisition
fr.com | 2
Case Study
Case Study
• Davy Biosciences, an early stage US pharmaceutical company, is developing novel
small molecules for the treatment of cancer
– Current focus on two new targets: BMT1 and EBMT2
• Working on developing a number of pipeline programs, some are at the discovery stage
while others have progressed to preclinical development
• No clinical development has started for any program to date
– Targets have shown to have high potential – and, if successful, could have applications in a
number of cancers or different subpopulations in a particular cancer
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Davy Biosciences
Case Study
• Davy Biosciences is a virtual company with a small
team of employees working across the US and the
world; founder has hired a number of former
colleagues from Goliath Pharma, where they
were working on NAMMT1 for treatment of cancer,
to work at Davy Biosciences
• Collaborations with multiple prestigious US
Universities – Haughty University and Stupendous
University – have facilitated access to proprietary
assays for validation of biological activity
• A CRO in China has been synthesizing new
compounds under the direction of Davy Biosciences
scientists
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Case Study
• Davy Biosciences’ financing to date has come
through a successful seed round, a Series A round,
and SBIR grants
• The company has formed two subsidiaries:
Daydream Biopharma (BMT1) and Believer
Biopharma (EBMT2)
• Davy Biosciences has recently entered into
partnering deals with two big pharma partners –
Sisyphus Pharma licensed BMT1 and Achilles
Therapeutics licensed EBMT2, each having the
option to license up to four more targets – that
have delivered upfront payments, together with the
potential for substantial milestone payments and
royalties
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Case Study
• In terms of strategy going forward, Davy
Biosciences’ investors are looking to achieve an
exit in the near term and are looking to proceed
with an IPO or, alternatively, to be acquired by a
large pharma company – potentially one of its
current license partners
• You’ve been hired as either the GC or the head of IP
for Davy Biosciences
– How do you wrap your head around the potential
issues?
– While also preparing the company for either one of
the two exit strategies?
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Hypotheticals
Hypothetical #1 – Parents and Subs
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• Davy Biosciences, an early stage US pharmaceutical company, is developing novel small molecules for the
treatment of cancer
– Current focus on two new targets: BMT1 and EBMT2
• Working on developing a number of pipeline products, some are at the discovery stage while some have progressed to
preclinical development
• None have entered the clinic
– Targets have shown some really exciting results – such that if successful, could have wide sweeping applications in a variety of
cancers and other indications
• The company has formed two subsidiaries, one for each of the two targets: Daydream Biopharma (BMT1) and
Believer Biopharma (EBMT2)
Daydream Biopharma
BMT1
Believer Biopharma
EBMT2
Davy Biosciences
Hypothetical #1 – Parents and Subs
fr.com | 10
• Davy Biosciences has formed two subsidiaries, one for each of the two targets: Daydream Biopharma (BMT1)
and Believer Biopharma (EBMT2)
Daydream Biopharma
BMT1
Believer Biopharma
EBMT2
Davy Biosciences
Davy Biosciences
formed
Provisional #1 BMT1
Applicant: Davy Biosciences
Daydream Biopharma
formed
Provisional #1 EBMT2
Applicant: Davy Biosciences
Believer Biopharma
formed
Hypothetical #2 – Clear Division Between Targets
fr.com | 11
• Davy Biosciences, an early stage US pharmaceutical company, is developing novel small
molecules for the treatment of cancer
– Current focus on two new targets: BMT1 and EBMT2
• Working on developing a number of pipeline products, some are at the discovery stage while
some have progressed to preclinical development
• None have entered the clinic
– Targets have shown some really exciting results – such that if successful, could have wide
sweeping applications in a variety of cancers and other indications
• Davy Biosciences has recently entered into partnering deals with two big pharma
partners – Sisyphus Pharma licensed BMT1 and Achilles Therapeutics licensed
EBMT2, each having the option to license up to four more targets
Hypothetical #2 – Clear Division Between Targets
fr.com | 12
• Davy Biosciences, an early stage US pharmaceutical company, is developing novel small molecules for the treatment of cancer
– Current focus on two new targets: BMT1 and EBMT2
• Working on developing a number of pipeline products, some are at the discovery stage while some have progressed to preclinical development
• None have entered the clinic
– Targets have shown some really exciting results – such that if successful, could have wide sweeping applications in a variety of cancers and other
indications
• Davy Biosciences has recently entered into partnering deals with two big pharma partners – Sisyphus Pharma licensed BMT1
and Achilles Therapeutics licensed EBMT2, each having the option to license up to four more targets
BMT1 EBMT2
BMT1 EBMT2
BMT1 EBMT2
Early IP
Hypothetical #2 – Clear Division Between Targets
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BMT1 EBMT2
Early IP
Family #2 BMT1
Applicant: Daydream Biopharma
Family #3 EBMT2
Applicant: Believer Biopharma
Family #1
Generic coverage for compounds
targeting BMT1 and/or EBMT2
Applicant: Davy Biosciences
Hypothetical #3 – Right to Claim Priority
fr.com | 14
• Davy Biosciences, an early stage US pharmaceutical company, is developing novel small
molecules for the treatment of cancer
• The company has formed two subsidiaries, one for each of the two targets: Daydream
Biopharma (BMT1) and Believer Biopharma (EBMT2)
Hypothetical #3 – Right to Claim Priority
fr.com | 15
• Davy Biosciences, an early stage US pharmaceutical company, is developing novel small
molecules for the treatment of cancer
• The company has formed two subsidiaries, one for each of the two targets: Daydream
Biopharma (BMT1) and Believer Biopharma (EBMT2)
Provisional #1
Applicant: Davy Biosciences
Provisional #2
Applicant: Believer Biopharma
PCT
Applicant: Believer Biopharma
Believer Biopharma
formed
Hypothetical #3 – Right to Claim Priority
fr.com | 16
• Intervening publication
Provisional #1
Applicant: Davy Biosciences
Provisional #2
Applicant: Believer Biopharma
PCT
Applicant: Believer Biopharma
Believer Biopharma
formed
Poster publication
based on select
Prov#1 compounds
Hypothetical #3 – Right to Claim Priority
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• Intervening Prior Art
• Services agreement between Davy Biosciences and Believer Biopharma requires
Applicant to be Believer Biopharma
Provisional #1
Applicant: Davy Biosciences
Claims compounds with X=H
Provisional #2
Applicant: Davy Biosciences
Claims compounds with X=H, F, etc.
PCT
Applicant: Davy Biosciences
Believer Biopharma
formed
Provisional #1
Applicant: Beatles Bio
Claims compounds with X=H
Hypothetical #4 – Academic Collaborations
fr.com | 18
• Collaborations with multiple prestigious US
Universities – Haughty University and Stupendous
University – that have facilitated access to
proprietary assays for validation of biological activity
Hypothetical #5 – CROs
fr.com | 19
• A CRO in China has been synthesizing new
compounds under the direction of Davy Biosciences
scientists
Hypothetical #5 – CROs
fr.com | 20
• A CRO in China has been synthesizing new compounds under the direction of Davy
Biosciences scientists
Scenario
1) List of compounds for synthesis provided to the CRO
2) Compounds provided with a general synthetic strategy
Hypothetical #5 – CROs
fr.com | 21
• A CRO in China has been synthesizing new compounds under the direction of Davy
Biosciences scientists
US Inventors CN Inventors
Hypothetical #5 – CROs
fr.com | 22
• A CRO in China has been synthesizing new compounds under the direction of Davy
Biosciences scientists
US Inventors CN Inventors
1) Request expedited Foreign Filing License (FFL) from the US
2) File a “priority” PCT application in China (withdraw designation of the US)
3) REPEAT (as needed/desired)
4) File a “standard” PCT application claiming priority to “priority” PCT applications
5) Proceed through National Stage filings
Hypothetical #6 – Employees
fr.com | 23
• Davy Biosciences is a virtual company with a small
team of employees working across the US and the
world; founder has hired a number of former
colleagues from Goliath Pharma, where they
were working on NAMMT1 for treatment of cancer,
to work at Davy Biosciences
Hypothetical #6 – Employees
fr.com | 24
• Davy Biosciences is a virtual company with a small team of employees working across the
US and the world; founder has hired a number of former colleagues from Goliath Pharma,
where they were working on NAMMT1 for treatment of cancer, to work at Davy Biosciences
Start discussions with Founder
Inventive Activity
Goliath Pharma Employee Davy Biosciences Employee
Hypothetical #7 – When to File
fr.com | 25
• Davy Biosciences, an early stage US pharmaceutical company, is developing novel small
molecules for the treatment of cancer
– Current focus on two new targets: BMT1 and EBMT2
• Working on developing a number of pipeline programs, some are at the discovery stage while
others have progressed to preclinical development
• No clinical development has started for any program to date
– Targets have shown to have high potential – and, if successful, could have wide sweeping
applications in a variety of cancers and other indications
Hypothetical #7 – When to File
fr.com | 26
Provisional #1
Generic
coverage of
lead compound
PCTProvisional #2
Specific
coverage of
lead compound
Scenario
1) File first provisional with limited compounds and no/limited data
2) Follow-up provisional with additional compounds and supporting data
Hypothetical #7 – When to File
fr.com | 27
Provisional #1
Generic
coverage of
lead compound
PCT
Beatles Bio Provisional #1
Species included which
anticipates genus of
DB Provisional #1
Provisional #2
Specific
coverage of
lead compound
Beatles Bio
PCT Publishes
Potential FTO and
patentability issue for DB lead
compound
Beatles Bio PCT filed
Genus expanded to cover
DB lead compound
Hypothetical #7 – When to File
fr.com | 28
Provisional #1
Generic
coverage of
lead compound
PCT
Beatles Bio Provisional #1
Species anticipating
DB Provisional #1
Provisional #2
Specific
coverage of
lead compound
Beatles Bio PCT filed
Genus expanded to cover
DB lead compound
Hypothetical #8 – Preparing for the Exit
• In terms of strategy going forward, Davy Biosciences’ investors are looking to achieve an
exit in the near term and are looking to proceed with an IPO or, alternatively, to be acquired
by a large pharma company – potentially one of its current license partners
fr.com | 29
Davy Biosciences
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Thank You!
Teresa Lavoie
Principal
Angela Follett
Principal
Please send your NY/NJ CLE forms or CLE
questions to [email protected].
Questions about the webinar should be sent
to Lauren McGovern at [email protected]
A replay of the webinar will be available for
viewing at http://www.fr.com/webinars