Simple Summary / Theme
Investment evaluation for the Fund (the VDP-7 proposed investment fund that VitaDAO will be acting as an analyst for, assuming the proposal passes)
VitaDAO is sending a recommendation to the Fund to invest in Turn.bio or not, based on the on-chain vote result. You, the tokenholders, will decide.
After multiple meetings and careful analysis with access to the Turn Bio Dataroom under NDA, the Longevity WG recommends an “Agree” vote.
Lead/Investigator(s)
Laurence Ion, Tim Peterson, Todd White
Resource(s)
Niklas Rindtorff, Jesse Hudson, Savva Kerdemelidis, Alev Basaran, Morten Scheibye-Knudsen
Abstract
Turn.Bio is developing therapeutics to correct aging-related conditions using mRNA-lipid nanoparticle (LNP)-based cellular reprogramming.
- Scientific and market validation: Cellular reprogramming has emerged over the past half-decade as one of the most promising approaches for aging and aging-related disease. The most recent validation of this was a $270M investment to create Altos Labs funded by Yuri Milner, Jeff Bezos, amongst other high-profile investors.
- Out in front in both core technologies: reprogramming and mRNA-lipid nanoparticle (LNP)-based gene therapy. The reprogramming approach the field has gravitated towards is conceptually based on the 2012 Nobel Prize work of Shinya Yamanaka. The LNP approach has similarities to that used in the COVID-19 vaccines as well as gene therapy applications already tested in humans, e.g., by Alnylam - a MIT-founded $20B+ market cap biotech.
- Strategic lead indications: skin and eye indications have strong market demand. Additionally, Turn.Bio has novel payload delivery approaches for both.
- Elite management (CEO, Anja Krammer, has IPO’d biotech companies before) and scientific team (Stanford Univ. IP, peer-reviewed science in leading outlets, such as Nature journals).
- Already supported by top tech and longevity investors such as Khosla Ventures and Methuselah Fund.
- Fits the fund’s thesis of relatively lesser-risk, already patented technology (vs. VitaDAO, which funds relatively higher-risk, pre-startup technology, e.g., VDP-5).
- Provides a potential buyer of reprogramming, mRNA, and LNP technology being developed by others that VitaDAO is considering.
Details
Turn Biotechnologies, Inc. (“Turn.Bio”, mailing address: 548 Market St. Pmb 23131, San Francisco, Ca 94104) is a pre-clinical start-up based on Stanford University Intellectual Property (IP) developed from 2016 onwards based on the work of Vittorio Sebastiano, Ph.D. and Jay Shakar, Ph.D. (Institute of Stem Cell Biology and Regenerative Medicine, Stanford Univ.) (ERA™) and Marco Quarta, Ph.D. (Center for Tissue Regeneration, Repair, and Restoration, Stanford School of Medicine) (AN™) .
Turn.Bio’s focus is a translational program based on the Sebastiano, Shakar, and Quarta research into mRNA and epigenomic reprogramming to restore aging-related loss of function. The developments have evolved into both an mRNA payload development system (ERA™ / AN ™) and a delivery system based on lipid nanoparticles. Both payload and delivery IP are licensed exclusively by Turn.Bio through a combined royalty license agreement with Stanford.
Turn.Bio is moving to the next stage in their corporate development – preclinical efficacy testing. The experiments for the ultimate dermatology and ophthalmology indications will lead their pre-clinical efficacy data generation efforts in Q4 '2021, with data available in Q1’2022.
The new round of funding Turn is raising, a relatively small (up to $10M USD) convertible note (non-priced, with a valuation cap) is positioned as ensuring the ability to fully execute, with contingencies, further developing pre-clinical efficacy data important to the Series A negotiations anticipated in Q1/Q2’2022.
Recommendations / Next Steps:
That the Fund invest in Turn.Bio in the form of a convertible note with the Fund being the beneficiary of record.
Background
From various discussions, it has become apparent that VitaDAO’s credibility with both the investment community and Researcher / Universities will be driven in large part by a track record of biopharma IP evaluated by VitaDAO becoming successful, and it is important to establish some “quick wins”.
To that end, VitaDAO Longevity Working Group has been engaging with a wide cross section of existing companies, researchers and universities as part of their outreach.
In July 2021, VitaDAO Working Group members met with the Methuselah Foundation to discuss how VitaDAO might best balance its goals for early stage research and also to participate in deal flow with high credibility and possibility of success.
Subsequently, VitaDAO was introduced to Turn.Bio for analysis. After initial discussions, a due diligence team drawn from the Longevity Working Group entered into an NDA with Turn.Bio and began evaluation of Turn.Bio’s intellectual property and business features.
Analysis
The Company
Turn.Bio is a start-up that is preparing its first lead payload candidates to enter in vivo safety and efficacy trials prior to proceeding to an FDA IND application.
As is common in university IP, which is transferred to a spin-off company, the first couple years are a continuation of the work done in the university lab; but due to capital demands, the company requires funding beyond that available within the university/grant funding environment. In the case of Turn Bio, this additional capital came in the form of approximately $4.6M in convertible debt and $3.5M in SAFE Notes – totaling $8.1M since 2018.
Though Turn.Bio was founded in 2018, it was not until 2020 that the company began to transition from what was, essentially, an externally funded laboratory into a biopharma company.
Turn.Bio, in late 2019 moved to bring in additional operational expertise in the form of Anja Kramer as CEO, who started in January 2020. Former interim CEO Gary Hudson, who guided the company during the ongoing research refinement of 2018/2019, remains an executive advisor – he is Oisin Biotechnologies’ co-founder and Executive Chairman (Oisin is a Methuselah Fund portfolio company). Methuselah Fund (“M.Fund”) Managing Director Sergio Ruiz moved from a consulting role to COO, given his increasing involvement in the company’s operations. Turn.Bio is one of the Methuselah Fund portfolio companies, and as such David Gobel, CEO of Methuselah Foundation, is on the Board of Turn.Bio.
Anja Kramer’s expertise is well-suited in restructuring biotech start-ups into clinical trial-ready companies. Her background includes pharma executive experience, taking companies public, enhancing operational capabilities, and serving as a board member in several companies, some of which have either been acquired or are public companies, including BioPharamX [NYSE: BPMX] and Vivos Therapeutics [NASDAQ: VVOS].
Co-founders Marco Quarta and Vittorio Sebastiano remain engaged with the company part-time as part of the scientific advisory board. As part of the migration from a research-focused to a clinical-ready company, co-founder Jay Shakar, Ph.D. has assumed the lead role as VP Research, supported by Mouhannad Jumaa, Ph.D., who acts as SVP Pharma, and Chemistry, Manufacturing and Controls (CMC) – his expertise is specifically in the delivery of biologics and mRNA payloads. Mouhannad is helping Turn.Bio in the equivalent of a full-time consulting role on CMC via his consulting companies Perception Neuroscience, and Astura Therapeutics.
Why Turn.Bio matters?
Reprogramming is about to get it’s “close-up” within the biotech community. The recent announcement of the formation of Altos Labs with funding from Jeff Bezos and Yuri Milner, having been advised by some of the biggest names in the longevity field, signals a serious commitment to advancing this particular technology.
Turn.Bio seems already ahead of Altos Labs, with an intellectual property portfolio and platform well under development. Turn.Bio is now moving towards a value creation inflection point by producing safety and efficacy data leading to FDA IND applications.
Re-orientation of staff, the completion of IP licensing and protection work, and efficiencies around pipeline development all focus on aligning the company around the clinical program.
The parallel development of both mRNA payloads and developing and retaining the delivery mechanism IP in-house versus contracting to CDO/CMO partners was a strategic decision both from a valuation perspective and a cost-management solution for Turn.Bio; in part, this is due to removing long-term royalty payments to CMO partners in the medium to long term and more immediately, there are no CDO/CMO partners with readily available plug-and-play deliver systems that can be used to selectively deliver Turn’s mRNA payloads. The platform approach (ERA™ and AN™) is intended to allow Turn.Bio to pivot quickly towards any new payloads with promising target implications and secures its IP options.
Turn.Bio’s current burn rate will increase as part of the company’s preparations for a clinical trial program. This additional spending will guarantee adequate resources to execute the clinical program with the initial targets in dermatology and ophthalmology being the most immediate commercially exciting options. Several other payloads have been assessed and can join the pipeline in relatively rapid succession due to commonalities in cell types.
Management believes that co-development agreements with one or more Pharma companies will be executed by early 2022. These partnerships will demonstrate an upstream market interest in Turn. Bio’s platforms.
Risk Analysis
Management has considered a reasonable range of contingencies to regulatory, clinical trial, and other market developments.
Given the considerable efforts by the FDA to develop protocols for mRNA payloads during the SAR-CoV-2 pandemic, the regulatory risks associated with trial design and approval are deemed to be low given that the process is now well developed and supported.
Risks associated with deficiencies in efficacy have been considered. The amount of funding sought will allow for refinement of payload/delivery and contingencies for delays. These contingencies will not materially affect Turn.Bio as a going concern at its projected burn rate.
One of the largest outlays of funds is for the production of GLP quality materials for trials – which management estimates the materials cost at $4.5M. In the event that management is not comfortable with efficacy data results in Q1’2022, they can delay the contracting of GLP materials and retain the extra funding for operational needs while efficacy is sorted and improved.
However, management has acknowledged that the capacity to obtain GLP quality materials is at a premium due to the supply chain disruptions caused by the COVID-19 pandemic and the limited production capacity currently on the market for mRNA payloads. This is a timing risk that is outside of Turn. Bio’s control, and should delays occur it may have a material impact on cash reserves depending on the severity of the delay. However, there would be a precedent for current funding partners to bridge such a cash flow gap while the company pursues its Series A and awaits capacity issues to be addressed.
Financial Sensitivity Analysis
Turn.Bio has sufficient funds to continue operating at the current burn rate until the end of the year, assuming no other funds. However, existing investors have indicated their intent to participate in this funding round.
In that case, should no other external parties, including the Fund, participate in the convertible note round, Turn.Bio could continue to operate and complete their efficacy studies on schedule. At that point, the company would need to either proceed to a Series A, and defer Phase 2 GLP material orders until the Series A was closed (with a 6-month window available for this process if necessary) or seek other funding arrangements.
Additionally, there is no reason to suggest that Turn.Bio will not also complete their co-development agreements with Pharma partners, which will add more capital to available funds. At which point, current partners and new Pharma partners could effectively fund Turn.Bio through to Series A even if they face some delays during the efficacy trials or protracted Series A negotiations.
In summary, management has the necessary flexibility to achieve targets relying only on existing partners if needed, though at the expense of time and potential lost opportunity on valuation due to any loss of interest in biotech/pharma by VCs
- Agree (recommendation to invest)
- Agree with revisions (please comment)
- Disagree (recommendation against investing)
0 voters
