Decided to post a new cheat sheet without some outdated info. The old one can be found here: Old Cheat Sheet

Upcoming Events

  • Aug 14 - (not verified) Q2 2023 Earnings Report
  • Oct 3 - Presentation at European Association for the Study of Diabetes, Press Release

Financials

  • Outstanding shares - 12M as of Q1 2023
  • 2022 OPEX - $62.1M (vs est. of $60M)
    • Q1 - $20M ($18M excluding stock-based compensation expense)
    • Q2 - $14.3M ($12.9M excluding stock-based compensation expense)
    • Q3 - $14.1M
    • Q4 - $13.9M
  • 2023 OPEX
    • Q1 - $15.5M
  • Cash as of Dec 31, 2022 - $30.4M. Cash has been consistent for the past 3 quarters; I think it’s safe to assume Biora intends to keep at least $30M in cash, even if it means heavy dilution.
  • ATM Offering Left - ~$33M (used $5M in Q4 2021, $3.7M in Q1 2022, $1.1M in Q2 2022, $1.8M in Q3 2022, $12.9M in Q4 2022, $12.5M in Q1 2023). Initial offering was $90M but reduced to $70M in Q3 2022.
  • Estimated runway - “well into 2023”, w/ ATM Offering - mid-late 2024
  • Avero Diagnostics sold for $10.9M. Press Release
  • No revenue streams
  • Nov 2022, Sold patent to Roche Diagnostics for undisclosed amount. No mentions in ER and no info in filings

Enumera Molecular

  • Biora has a 25% minority ownership stake (6M shares) with potential financial upside and without committing any funds or resources from the company, Press Release
  • Website
  • Founded by Biora’s former CSO, Matthew Cooper. Cooper previously founded Carmenta Bioscience, which was later acquired by Progenity (along with what later became Preecludia)
  • Series A funded by Arboretum Ventures for $12.5M

Athyrium

Progenity/Biora’s major shareholder, who started investing in Progenity back in 2013.

BELOW INFO IS SLIGHTLY OUTDATED. Athyrium recently invested more to adjust their warrant strike price. It is unclear exactly how much they own right now.

  • Owns 3,669,578 shares based on latest 13D/F
  • Cost basis is last calculated to be between $50-75, but potentially less now due to warrants
  • Did not sell any shares during Nov 2021’s ramp up to $6
  • Part of their MO is to buy a company then turn them into a desirable target for acquisition
  • Jeffrey Ferrell, managing partner of Athyrium, is also one of Progenity/Biora’s Board of Directors. Related DD

Buyout Theory

This was a prominent theory during the initial ramp in late 2021, but not many talk about this anymore. A buyout is always possible, but there are not that many signs which points to one.

NaviCap (formerly Drug Delivery System (DDS))

BT-600 (formerly PGN-600)

  • Tofacitinib + Device
  • Highest priority.
  • Treats ulcerative colitis.
  • Target market is $7B.
  • Timeline:
    • Healthy patient studies (PM-601) - completed, Press Release
    • UC patient studies (PM-602) - completed, Topline Results. Full publication will likely become available after American College of Gastroenterology Annual Scientific Meeting (Oct 21-26)
    • Study effects of food on function of the device (PM-611) - completed, Press Release
    • Tox Studies - Completed, analysis in progress, should be done before Q3. Encouraging results that shows robust safety profiles
    • IND filing - Q3 2023
    • Phase 1 - Q4 2023 to Q1 2024.
    • There was timeline for Phase 2, but that’s now removed from presentation

BT-001 (formerly PGN-001)

  • Adalimumab variant + Device
  • Sidelined, possibly due to lawsuits by AbbVie to other companies who uses Adalimumab

Related Screenshot

  • Treats ulcerative colitis.
  • Target market is $7B.

BioJet (Formerly Oral Biotherapeutic Delivery System (OBDS))

  • 5 different programs
    • BT-002- Adalimumab variant + Device, avg bioavailability. of 51.3%
    • BT-200- Semaglutide (GLP-1) + Device, avg bioavailability of 37% (vs 1% of competitor).
    • IONIS collab - Antisense Therapy + Device. (During Q1 2023 ER) Preclinical testing performed, results still pending
    • Large Pharma 1 collab - undisclosed
    • Large Pharma 2 collab - undisclosed
  • Targets multiple markets, e.g. IBD $17B, GLP-1 $13B
  • Timeline:
    • 2022, continue generating preclinical data
    • Q3 2022, Data Readout of Preclinical PK Studies
    • Q4 2022, start clinical studies / trials. Announced a “next gen” device, which basically meant their old device wasn’t good enough
  • Biora looking to expand collaborations, hoping to gain non-dilutive capitol

Preecludia

  • Rule out Preeclampsia
  • Target market is $3B
  • Validation study results published. Journal
  • Progenity/Biora will not spend more resources developing Preecludia
  • Licensed to Avero Diagnostics with milestone payments and low double-digit royalties. Press Release

Risks

Note: the likelihood is my personal opinion and is subject to change.

  • Dilution - using ATM offering will dilute shares. Convertible notes (not sure how much) that can be converted to shares.
  • Reverse Split - already happened
  • Delisting - Biora does not meet the $50M asset / $50M revenue listing criteria. Notice was sent on April 4, 2023, and they had to submit a plan for compliance by May 19. It is unclear if Biora submitted the plan or if SEC accepted them. (Press Release)[https://investors.bioratherapeutics.com/static-files/e9c14c3a-8c35-44e3-8777-50107a742cb8]
  • Trial Delays - already happened to all their programs, multiple times. Can definitely happen again
  • Poor Results - all research thus far points to NaviCap/DDS and BioJet/OBDS being effective solutions. However, their “previous generation” OBDS definitely had problems; likely with deployment rate.
  • Unexpected Expenses (Unsure) - there are a few open lawsuits against Progenity, which could result in settlement payments or other forms of expense. This can decrease their cash reserve/runway. SEC Filing, see “Item 1. Legal Proceedings”

Additional Resources