UNITED STATES
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FORM
CURRENT REPORT
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| Item 7.01 | Regulation FD Disclosure. |
On January 10, 2022, Recursion Pharmaceuticals, Inc. released an updated investor presentation. The investor presentation will be used at the JP Morgan Healthcare meeting and from time to time in meetings with investors. A copy of the presentation is attached hereto as Exhibit 99.1.
The information furnished pursuant to Item 7.01 on this Form 8-K, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Investor presentation of Recursion Pharmaceuticals, Inc. dated January 10, 2022. | |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| RECURSION PHARMACEUTICALS, INC. | ||||
| Date: January 10, 2022 | By: | /S/ Christopher Gibson | ||
| Name: Christopher Gibson Title: Chief Executive Officer | ||||
Exhibit 99.1 th January 10 , 2022
2 This presentation and any accompanying discussion or documents may contain information that includes or is based upon forward‐ looking statements within the meaning of the Securities Litigation Reform Act of 1995. These forward‐looking statements are based on our current expectations, estimates and projections about our industry, management's beliefs and certain assumptions we have made. They are neither historical facts nor assurances of future performance, are subject to significant risks and uncertainties, and may turn out to be wrong. For a discussion of factors that could affect our business, please refer to the Risk Factors sections in our Prospectus filed with the SEC on April 16, 2021 and in our periodic filings with the SEC. This presentation does not purport to contain all the information that may be required to make a full analysis of the subject matter. We undertake no obligation to correct or update any forward‐looking statements.
3 3 Recursion is a clinical stage Pharmatech company Mapping and Navigating biology designed to bring better medicines to patients faster and at lower cost via an Internal Pipeline and Partnerships The Leading Pharmatech Mapping & Navigating Internal Pipeline Partnerships 13 Petabytes of proprietary biological 4 Programs entering Ph2 or >$230M in upfront payments and >150+ Biologists, chemists and and chemical data generated in‐house Ph2/3 in 1H 2022 and 1 investment to date from partners drug developers program entering Ph1 in 2H 2022 >$500M in performance/data‐sharing >200B inferred biological relationships >150+ Data scientists, software to mine using our maps of biology milestones possible in intermediate term programmers, and engineers >10 programs in late discovery or preclinical >$13B in project milestones across up to 50+ programs possible Dozens of programs in early discovery Royalties on all partnered programs
4 Political sentiment the world over, The number of new drug approvals is up and increasingly in the U.S., against only 47% over the last 25 years and first in high drug prices will create class drug approvals have fallen 17% over 2 additional pressure the past decade 60% of sales growth of the top selling $2.4B of R&D per new drug is 3 drugs is accounted for by price increases 2.1 times more than a decade 1 ago 1 Deloitte, Measuring the Return from Pharmaceutical innovation (2020 and 2015 editions). 2 3 Mullard, A. Nature Reviews Drug Discovery 2021. Biopharma Dive, 2018 (leerink) and Brown, D and Wobst H J Med Chem 2021 (FIC)
5 All primary relationships found by the Recursion Well‐known primary relationships found by the OS between key members of five pathways: Recursion OS between key members of five pathways: JAK/STAT | SWI/SNF | TGFβ | RAS | Proteasome JAK/STAT | SWI/SNF | TGFβ | RAS | Proteasome
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7 1 Profile real systems 1 2 Aggregate and analyze Capture high‐dimensional Aggregate data to create data to create a digital record Real (atoms) digital maps of reality of reality (things, places, behaviors, preferences, etc) Digital (bits) 3 2 Algorithmic Inference 3 Navigate digital maps to predict or suggest novel relationships and routes ‐ then try them in reality
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How we build maps of biology 9 Digitization of Complex Biology Automated Execution at Scale Up to Proprietary High‐Dimensional Biological Data Experiments per week Biological and Chemical Diversity ML/AI‐Based Analysis Human cell types Small Molecules Supercomputer on Earth Arrayed Cytokines CRISPR guides & soluble factors Enables quality, reliability, repeatability and scale Novel Efficacy and Insights At Scale High‐Dimensional Validation ML/AI‐Based Exploration Up to Near whole exomes per week ML‐enabled hypotheses Proteomics panels in 2021
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Recursion visualizes its Maps in different ways. Below is a Map of thousands of new chemical entities, clustered by chemical similarity and colored by potency, which demonstrated a strong anti‐inflammatory response on the Recursion OS To the left, shared for the first time ever, is whole‐ genome arrayed CRISPR KO Map generated in 11 primary human endothelial cells
Many known mitochondrial‐related genes cluster together along with a few less well‐known genes 12
JAK1 Many known JAK/STAT genes cluster together along with a few less well‐known genes 13
JAK1 JAK1 JAK1 The JAK/STAT pathway now clustered by strength of interaction, including both similar genes (red) and ‘opposite’ genes (blue) – note both expected and less well‐known genes that could serve as novel hypotheses 14
20S Subunit 26S Subunit The 20S and 26S proteosomes are another of hundreds of expected clusters that give confidence in this Map, one of many we have built – however the most exciting elements of each map are the tens of thousands of unknown and unexplored high‐confidence relationships 15
16 Traditional Approach Recursion Approach MAP OF BIOLOGY LIMITATIONS BENEFITS World’s literature reviewed >200B predicted relationships from 1. Millions of disparate journal 1. Massive, relatable >100M highly reproducible experiments articles and publications proprietary map of searchable biology 2. Many data cannot be People navigate machine‐generated independently replicated 2. Data highly replicable People generate hypotheses with unmet need and and scalable hypotheses scientific intuition in mind 3. Human‐selected low dimensional assays prone to 3. High‐dimensional confirmation bias orthogonal validation minimizes ‘leak’ of poor Chosen hypotheses automatically Hypotheses validated in 4. Humans prone to hypotheses to later validated using orthogonal high‐ low dimensional assays confirmation bias stages dimensional assays 4. Minimization of human bias Increased efficiency of translation: Translation 5. Maximization of more scale, more speed, less cost biological systems relevance This approach is designed to achieve <10% higher clinical success rates clinical success rate
17 Preliminary data shown is the average of all our programs since late 2017. All industry data adapted from Paul, et al. Nature Reviews Drug Discovery. (2010) 9, 203–214
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19 Pipeline strategy • Advance programs where we Oncology have a data arbitrage • Focus on capital efficient Asset Sales / therapeutic areas Internal Pipeline Commercialization, Inflammation & Licenses / ‐ licensing and asset Immunology Commercialization Internal Pipeline Rare Genetic sales Diseases Rare Diseases • Exclusive multi‐year discovery deal signed in ‘20 and expanded in ‘21 • $30M upfront and $50M equity investment Fibrosis • Up to or exceeding $1.2B in milestones for up to or exceeding 12 programs • Mid single‐digit royalties on net sales Other large, intractable areas of Discovery Partnership strategy • Exclusive multi‐year discovery deal signed in biology Partnerships • Partner in large, difficult and/or ‘21 competitive therapeutic areas • $150M upfront and up to or exceeding $500M • Add knowledge to and improve in performance‐based research milestones and Neuroscience our growing atlas of biology data usage options *and a single oncology indication • Up to or exceeding $300M in milestones possible for up to 40 programs • Mid to high single‐digit tiered royalties on net sales
20 PREVALENCE CAUSE LOF mutations in genes CCM1, CCM2 & CCM3, key for maintaining the structural integrity of the vasculature due to US + EU5 unknown mechanisms PATHOPHYSIOLOGY OUR REASON TO BELIEVE Vascular malformations of the CNS leading Efficacy in Recursion OS as well as functional to focal neurological deficits, hemorrhage validation via scavenging of massive superoxide and other symptoms accumulation in cellular models; reduction in lesion number with chronic administration in mice KEY ELEMENTS • Targeting both sporadic and familial symptomatic • Once daily oral dosing CCM • Patients with CCM1, CCM2, and CCM3 mutations • US and EU Orphan Drug Designation granted High Dose 1° - Safety and Tolerability CCM Confirmed 52‐Week Open Label 1:1:1 Low Dose 2° - Imaging, assessments with MRI Treatment Extension Julia – living with CCM Placebo and PROs
21 INCIDENCE CAUSE LOF mutations in NF2 tumor suppressor gene US + EU5 PATHOPHYSIOLOGY OUR REASON TO BELIEVE Efficacy in Recursion OS, cellular, & animal Inherited rare CNS tumor syndrome leading models; suppression of aberrant ERK, AKT, and to loss of hearing and mobility, other focal S6 pathway activation in a Phase 1 PD Study in neurologic deficits NF2 patient tumors KEY ELEMENTS • Targeting familial and sporadic NF2 meningioma • Oral bioavailability and CNS exposure together are patients unique among clinical‐stage HDAC inhibitors • Adult and adolescent patient populations• Potentially reduced cardiac toxicity compared to class Phase 2 Interim 20 x 1 Month 6 x 1 Month Progressive REC‐2282 40mg 1:1 Analysis Cycles Cycles NF2‐mutated meningioma REC‐2282 60mg Ricki – living with NF2 Progressive REC‐2282 26 x 1M 1° - PFS 2:1 NF2‐mutated meningioma Placebo Cycles 2° - TTR, DOR & ORR Phase 3
22 PREVALENCE CAUSE Inactivating mutations in the tumor suppressor gene APC US + EU5 PATHOPHYSIOLOGY OUR REASON TO BELIEVE Efficacy in the Recursion OS shows that Polyps throughout the GI tract with specific MEK 1/2 inhibitors had a specific extremely high risk of malignant effect in context of APC LOF. Subsequent transformation min mouse model APC showed potent reduction in polyps and dysplastic adenomas KEY ELEMENTS • Targeting Classical FAP patients (w/ APC mutation)• Oral Dosing & Gut‐Biased • Benign polyps and dysplastic adenomas• US Orphan Drug Designation granted FAP with APC High Dose 1° - Δ Polyp burden at 12M 2:2:1 Food 48 Week Open Label mutation Low Dose 2° - PL, Safety, polyp # Effect Treatment Extension Placebo confirmed and histological grade
23 PREVALENCE CAUSE LOF mutations in lysosomal beta‐hexosaminidase subunit genes leading to neuronal GM2 US + EU5 accumulation PATHOPHYSIOLOGY OUR REASON TO BELIEVE Efficacy on the Recursion OS of a unique GM2 + lipofuscin accumulation leads PKCß/GSK3ß dual inhibitor stimulating cellular to complete neurological disability autophagy and modulating lysosomal and death in the first few years of life biogenesis. Reduction of disease‐ specific activity in patient derived cells KEY ELEMENTS • Tay‐Sachs Disease (HEXA), Sandhoff Disease • Complementary MOA for potential combination (HEXB), and GM2 Activator Deficiency Patients with genetic therapies • Human safety database with established chronic dosing• Liquid formulation suitable for G‐tube dosing 1°-Survival Infants with Dose Up to 34 Open Label 2° - Safety, GM2 CSF GM2 Diagnosis Escalation Months TX Extension Amelie – lived with GM2 ganglioside, neuro development
24 INCIDENCE CAUSE Release of C. Difficile toxins by colonizing bacterium causes degradation of colon cell junction, toxin transit to bloodstream, and morbidity to host US + EU5 PATHOPHYSIOLOGY OUR REASON TO BELIEVE Highly recurrent infectious disease Efficacy on the Recursion OS identified a new with severe diarrhea, colitis, and risk of chemical entity for prophylaxis and recurrent C. toxic megacolon, sepsis, and death difficile infection via glycosyl transferase inhibition with potential to be both orally active and gut‐biased KEY TPP ELEMENTS • Orally active small molecule toxin inhibitor• Designed for gut‐biased pharmacology to target infection in the GI tract while reducing systemic exposure and potential • Non‐antibiotic approach with potential for combination systemic effects with SOC and other therapies for recurrent disease• Not expected to negatively impact the gut microbiome Colleen – overcame recurrent C diff.
Tumor‐intrinsic immune resistance STK11 Target Alpha Target Beta More... REC‐ Gene B 648918 BIRC2 Gene A • Goal: Identify novel compounds capable of re‐sensitizing tumors with tumor‐ intrinsic resistance factors to checkpoint therapy Gene A Similar • Phenomap insight: Novel compound (REC‐648918) identified with similarity to BIRC2 knockout of potential immunotherapy resistance gene targets (Gene A, Gene B) REC‐648918 • Result: Reduction in tumor growth vs. anti‐PD‐1 alone in both CT26 checkpoint Opposite resistance and EMT6 models (including 40% and 80% complete response in combination in each model respectively) Gene B Efficacy demonstrated in CT26 checkpoint resistance (left) mouse model; complete response (CR) mice show minimal tumor growth when rechallenged (right) Efficacy demonstrated in EMT6 mouse model CT26 CT26 CT26 rechallenge rechallenge EMT6 Vehicle Vehicle Naïve mice Anti‐PD‐1 Anti‐PD‐1 CR mice from previous study REC‐648918 REC‐648918 REC‐648918 REC‐648918 + aPD1 + aPD1 80% CR in combo 40% CR in combo 25 days days days 25 CT26: mouse colon carcinoma. REC‐648918 was dosed PO, QD for 5 weeks at 100mg/kg. Anti‐PD‐1 was dosed IP, BIW for 5 weeks at 10mg/kg. 10 mice per group, dosing initiated when tumors reached ~ 80 mm3; * p<0.05 ** p<0.01 **** p<0.0001; ^ Combination treatment in EMT6 resulted in 8 CR and 8 rejections on re‐challenge
Tumor‐targeted precision therapeutics Hepatocellular Carcinoma MYC CDK12 More... REC‐65029 • Goal: Identify novel compounds capable of sensitizing HRD‐negative ovarian and 2.5μM other tumors to PARP inhibition Similar 1.0μM • Phenomap insight: Inhibition of target Gene A (for example, with REC‐65029) REC‐65029 may mimic inhibition of CDK12 while mitigating toxicity due to CDK13 inhibition 0.25μM 0.1μM • Result: Single agent and combo activity with olaparib in an HRD‐negative ovarian Opposite cancer CDX and PDX models with durable response Gene A CDK12 Single agent activity in olaparib‐resistant CDX mouse model Single agent and combination (with olaparib) in an HRD‐negative ovarian cancer PDX model with durable response OVCAR‐3 CDX OV0273 PDX OV0273 PDX (Survival) Vehicle Vehicle Olaparib Olaparib REC‐65029 REC‐65029 REC‐65029 REC‐65029 +olaparib +olaparib 80% CR by day 14 in combo Treatment stopped on Day 28 100% CR 26 days days days 26 OVCAR‐3 CDX – animals dosed with REC‐65029 for 5 days at 100 mg/kg BID, a holiday from days 6‐9 (due to body weight loss) and dosing resumed at 85 mg/kg BID; OV0273 PDX – REC‐65029 dosed at 85 mg/kg PO, BID, olalparib dosed at 90mg/kg PO QD; ** p<0.01 **** p<0.0001
Team Credentials Gender: % Women 45% 400+ Employees today Below VP VP and above 41% Advanced degrees 45% Life Sciences ‐ biology, chemistry, development, etc. Tech ‐ Data science, software engineering, automation, etc. Strategic Operations 27
28 Today Intermediate‐Term Near‐Term Recursion OS Continued digital chemistry and Clinical Predictions Enables quality, reliability, repeatability predictive ADMET OS build and scale
29 Near‐Term Milestones Medium‐term milestones • Rec‐994 for CCM Ph2a clinical start in Q1• Multiple POC readout(s) for AI‐discovered programs • Rec‐2882 for NF2 Ph2/3 clinical start in Q1• Potential additional partnership in large, intractable area of biology • Rec‐4881 for FAP Ph2 clinical start in Q2• Additional option exercises for partnership programs • Rec‐3599 for GM2 clinical start in Q2• Recursion OS Begins to move to Autonomous Map Building and Navigation with Automated Chemical Synthesis, Digital Chemistry • Rec‐3964 for C diff. IND and Phase 1 start in 2H and Predictive ADMET Tools • Additional INDs and Clinical Starts • In‐House Small Molecule Manufacturing Capabilities come On‐Line • Option Exercises for Partnership Programs Strong Financials • $579M in cash, equivalents & investments with no substantial debt at end Q3, 2021 • Does not include $150M upfront from Roche/Genentech deal • Recognition of partnership upfronts over 2‐3 years suggests possible annual revenue of $60‐$80M Clinical Programs
IMPACT
Board of Directors DEAN LI, MD/PHD CHRIS GIBSON, PHD BLAKE BORGESON, PHD ZAVAIN DAR Recursion Co‐founder, Co‐founder & CEO Recursion Co‐founder, Board Partner, Lux Capital President of Merck Research member Machine Intelligence Labs Research Institute ZACHARY BOGUE, JD ROBERT HERSHBERG, TERRY‐ANN BURRELL, MBA R. MARTIN CHAVEZ th Partner, Data Collective CFO & Treasurer Vice‐Chair of 6 Street MD/PHD Beam Therapeutics Financial. Former CFO/CIO Former EVP CSO & at GS BD, Celgene Executive Team RAMONA DOYLE, MD TINA LARSON SHAFIQUE VIRANI, MD FRCS MASON VICTORS CHRIS GIBSON, PHD Chief Medical Officer President & COO Chief Corp Dev Officer Chief Product Officer Co‐Founder & CEO MICHAEL SECORA, PHD BEN MABEY RON ALFA, MD/PHD LOUISA DANIELS, JD HEATHER KIRKBY Chief Financial Officer Chief Legal Officer & General Chief Technology Officer SVP of Research Chief People Officer Counsel Trademarks are the property of their respective owners and used for informational purposes only.
Forward program growth Significant program growth • Growing economic opportunity • Reduction of binary risks (1) ‘Unique Perturbations’ refers to the number of gene, soluble factor, cell and/or compound combinations physically explored. (2) Includes approximately 500,000 compounds from Bayer’s proprietary library. (3) ‘Inferential Relationships’ refers to the number of Unique Perturbations that have been predicted using our Recursion Map. (4) ‘Cost Per Experiment’ refers to the average adjusted direct cost to perform one phenomic experiment (defined as one well per perturbation) and is inclusive of consumable, compound and labor costs.
Company Early Discovery – Preclinical Clinical / Commercial Assets 1318 1018 113 712 7 (multiple through collaboration) 12 >504 Pipeline data from company websites as of 11/08/2021. Trademarks are the property of their respective owners and used for informational and educational purposes only.
Trademarks are the property of their respective owners and used for informational purposes only. Analysis as of April 2021.