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Recursion and Exscientia, two leaders in the AI drug discovery space, have officially combined to advance the industrialization of drug discovery

  • Recursion unveils post–combination technology–enabled portfolio with more than 10 clinical and preclinical programs, 10 advanced discovery programs, and more than 10 partnered programs
  • Platform will focus on first and best–in–class drug discovery and development, demonstrating the ability to find novel insights and dramatically reduce the time and cost of discovery
  • Recursion will host an update call today, November 20, 2024 at 7:30 a.m. ET / 5:30 a.m. MT / 12:30 p.m. GMT on LinkedIn, X and Youtube

SALT LAKE CITY, Nov. 20, 2024 (GLOBE NEWSWIRE) — The business combination of two AI–powered drug discovery and development companies, Recursion (Nasdaq: RXRX) and Exscientia has been completed, with Exscientia becoming a wholly owned subsidiary of Recursion creating a vertically–integrated and technology–enabled drug discovery platform. Exscientia ADSs (Nasdaq: EXAI) ceased trading and will be delisted from Nasdaq.

“I believe the combination of the incredible teams and platforms at Exscientia and Recursion position us as the leader of the AI–enabled drug discovery and development space,” said Chris Gibson, Ph.D., Co–Founder and CEO of Recursion. “With more than 10 clinical and preclinical programs in the internal pipeline, more than 10 partnered programs and over $450M in upfront and realized milestone payments received from partners to date out of more than $20B possible, we are advancing a flywheel of discovery and creating value in our pipeline through technology.”

“The combination of our platforms and people make us the company to beat,” said David Hallett, Ph.D., former CSO and Interim CEO of Exscientia and newly appointed Chief Scientific Officer at Recursion. “With our combined strength of real–world proprietary data and the models we’ve created – hypothesizing, testing and learning in a continuous loop – we're redefining the space by shrinking timelines and costs, identifying and optimizing lead candidates faster than traditional methods.”

The Company is pleased to share updates on the combined entity’s pipeline, partnerships, and platform below:

Pipeline

The combined pipeline represents more than 10 clinical and preclinical programs. In addition there are approximately 10 advanced discovery programs in the current pipeline.

Updated guidance is bulleted below as well as a snapshot of our pipeline:

  • REC–617 (CDK7 inhibitor; Advanced Solid Tumors): Initial Phase 1 monotherapy safety and PK/PD data expected at the AACR Special Conference on December 9th 2024, and a webinar to follow on December 10th 2024.
  • REV102 (ENPP1 inhibitor; Hypophosphatasia): Development candidate nomination expected in Q4 2024
  • REC–4881 (MEK1/2 inhibitor, Familial Adenomatous Polyposis): Phase 1b/2 safety and early efficacy data expected in H1 2025
  • REC–2282 (pan–HDAC inhibitor; Neurofibromatosis Type 2): PFS6 futility analysis expected by H1 2025
  • REC–3565 (MALT1 inhibitor, B–Cell Malignancies): Phase 1 first patient dosed (FPD) expected in Q1 2025
  • REC–4539 (LSD1 inhibitor, Small–Cell Lung Cancer): Phase 1 first patient dosed (FPD) expected in H1 2025
  • REC–994 (Superoxide scavenger, Cerebral Cavernous Malformation): Further data to be shared at an upcoming medical conference / publication / webinar in H1 2025; regulatory update expected by H2 2025
  • REC–394 (C. difficile Toxin B selective inhibitor, C. difficile): Phase 2 update expected in Q1 2026
  • REC–1245 (RBM39 degrader; Solid Tumors and Lymphoma): Phase 1 dose–escalation data update expected in H1 2026
  • REC–4209 (undisclosed target; Idiopathic Pulmonary Fibrosis): IND–enabling studies are ongoing
  • REC–4881 in APC/AXIN1 indications have been deprioritized as part of a disciplined strategic prioritization of the portfolio. Study status will be updated on clinicaltrials.gov

Partnerships

The combined company’s therapeutic partnerships represent more than 10 partnered programs in areas such as oncology and immunology. The combined company has received approximately $450M in upfront and milestone payments from partnerships to date. Through these partnerships, we have the potential to receive more than approximately $20B in additional milestone payments before royalties.

Platform

With chemical design and synthesis methods from Exscientia and over 60 petabytes of proprietary data generated in house or licensed from partners like Helix and Tempus, the combined entity will strengthen the Recursion OS to be a first–in–class and best–in–class drug discovery and development platform.

The platform will continue to drive iterative loops of hypotheses and active learning all the way from research to development, with the goal of eventually creating virtual cells that will allow the company to execute clinical trials at scale.

Company, Board, and Leadership Updates

The combined company will have approximately 800 employees with the headquarters remaining in Salt Lake City, and primary offices in Toronto, Montreal, Milpitas, New York, the Oxford area, and London.

Individual board and executive leadership changes of Recursion, effective as of November 20, 2024, are summarized below:

  • Franziska Michor, a former member of the Board of Directors of Exscientia, was appointed as a Class II Director of the Board of Directors of Recursion, with her initial term to extend until the 2026 Annual Meeting of Stockholders of Recursion.
  • Ben Taylor, former Chief Financial and Strategy Officer of Exscientia, was appointed as the Chief Financial Officer of the Company and President of Recursion UK.
  • Dave Hallett, former Interim Chief Executive Officer of Exscientia, was appointed as Chief Scientific Officer of the Company.
  • Kristen Rushton, Chief Business Operations Officer of the Company, was promoted to Chief Operating Officer of the Company.
  • Matthew Kinn, Senior Vice President, Business Development and Corporate Initiatives of the Company was promoted to serve as Chief Business Officer of the Company.
  • Lina Nilsson, Senior Vice President, Emerging Technologies of the Company, was promoted to serve on the executive team as Senior Vice President, Head of Platform of the Company.
  • Michael Secora, Tina Marriott, and Laura Schaevitz will transition from their executive roles into advisor roles for the combined company. All three have provided many years of dedicated service to the Company and we wish to express our heartfelt gratitude for each of them. Recursion would not be where it is today without their dedication and efforts.

Update Call Information

Recursion will host an update call today at 7:30 a.m. ET / 5:30 a.m. MT / 12:30 p.m. GMT. The Company will broadcast the live stream from Recursion’s X (formerly Twitter), LinkedIn and YouTube accounts, and on Exscientia’s LinkedIn account. Questions can be submitted via this link ahead of time or during the livestream.

About Recursion
Recursion is a leading, clinical–stage TechBio company decoding biology to industrialize drug discovery. Central to its mission is the Recursion Operating System (OS), a platform built across diverse technologies that continuously expands one of the world’s largest proprietary biological, chemical and patient–centric datasets. Recursion leverages sophisticated machine–learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale—up to millions of wet lab experiments weekly—and massive computational scale—owning and operating one of the most powerful supercomputers in the world—Recursion is uniting technology, biology, chemistry and patient–centric data to advance the future of medicine.

Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has other primary offices in Toronto, Montreal, the San Francisco Bay Area, New York, the Oxford area, and London.

Recursion Investor Relations
investor@recursion.com

Recursion Media
media@recursion.com

Forward Looking Statements

Statements contained herein which are not historical facts may be considered forward–looking statements under federal securities laws and may be identified by words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “plans,” “potential,” “predicts,” “projects,” “seeks,” “should,” “will,” or words of similar meaning and include, but are not limited to, statements regarding the leadership position of the combined company and its impact on the industry; the ability for the combined business to accelerate the discovery of better solutions for patients; the timing of IND submissions and IND enabling studies; the potential to receive upfront, milestone, and royalty payments and work on over 60 therapeutic programs; the strengthening of the Recursion OS through the combined company; the continued learning of Recursion’s platform and the creation of virtual cells to enable execution of clinical trials at scale; Recursion’s achievement of efficiencies; the continuous expansion of the Recursion OS datasets; and advancing the future of medicine; the outlook for Recursion’s future business and financial performance; and others. Such forward–looking statements are based on the current beliefs of Recursion’s management as well as assumptions made by and information currently available to them, which are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Actual outcomes and results may vary materially from these forward–looking statements based on a variety of risks and uncertainties including: the ability of the combined company to retain key personnel; the ability to realize the benefits of the combination, including cost synergies; the ability to successfully integrate Exscientia's business with Recursion’s business, at all or in a timely manner; the amount of the costs, fees, expenses and charges related to the combination; the effect of economic, market or business conditions, including competition, regulatory approvals and commercializing drug candidates, or changes in such conditions, have on the combined company’s operations, revenue, cash flow, operating expenses, employee hiring and retention, relationships with business partners, the development or launch of technology enabled drug discovery, and commercializing drug candidates; the risks of conducting business internationally; the impact of changes in interest rates by the Federal Reserve and other central banks; the impact of potential inflation, volatility in foreign currency exchange rates and supply chain disruptions; the ability to maintain technology–enabled drug discovery in the biopharma industry; and risks relating to the market value of Recursion’s Class A common stock.

Other important factors and information are contained in Recursion’s most recent Annual Report on Form 10–K, including the risks summarized in the section entitled “Risk Factors,” Recursion’s subsequent Quarterly Reports on Form 10–Q, the joint definitive proxy statement filed by Recursion and Exscientia on October 10, 2024, as amended by the supplemental disclosures filed by Recursion on November 6, 2024, and each of Recursion’s other filings with the U.S. Securities and Exchange Commission (the “SEC”), which can be accessed at https://ir.recursion.com, or www.sec.gov. All forward–looking statements are qualified by these cautionary statements and apply only as of the date they are made. Recursion undertakes no obligation to update any forward–looking statement, whether as a result of new information, future events or otherwise.

Photos accompanying this announcement are available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/359d7cd4–0ccf–4210–938d–f585a9b073ee
https://www.globenewswire.com/NewsRoom/AttachmentNg/a94dc301–518d–48a8–b8d3–430cd726d651
https://www.globenewswire.com/NewsRoom/AttachmentNg/57cb9454–a7a7–4abf–a76f–82356a3682ac


GLOBENEWSWIRE (Distribution ID 9277015)

Entera Bio Reports Q3 2024 Financial Results and Provides Business Updates

JERUSALEM, Nov. 08, 2024 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of oral peptides and small therapeutic proteins, today reported financial results and key business updates for the quarter ended September 30, 2024.

“The third quarter of 2024 drew consistent attention to our pivotal–staged clinical asset, EB613, the first oral PTH(1–34) tablet treatment dedicated to post–menopausal women with high risk osteoporosis. Entera’s proprietary N–Tab™ platform consistently delivered across our oral GLP–2 tablet, oral GLP–1/Glucagon tablet and confidential hypoparathyroidism tablet program. Finally, we are humbled by key additions from around the world to our clinical and scientific advisory board which we view as testament to what we are aspiring to build at Entera,” said Miranda Toledano, Chief Executive Officer of Entera.

Ms. Toledano continued, “We are headed into a busy year end across all programs and keenly anticipating FDA’s potential landmark ruling on the ASBMR–FNIH SABRE regulatory endpoint for osteoporosis drugs, expected in January 2025. Current regulatory guidelines requiring fracture outcomes have curtailed innovation in the treatment of this significant disease due to ethical, time and sizing of studies required to evaluate new treatments. The SABRE work is based on a statistical meta–analysis of over 170,000 patients across 53 randomized clinical studies and 7 osteoporosis drug classes correlating total hip Bone Mineral Density (BMD) to fracture outcomes. We believe that our pivotal program for EB613 is first in line to leverage this pathway. Our recent discussions with patients, regulatory agencies, clinicians and fellow industry colleagues acknowledge the need for new treatments for osteoporosis and, especially, oral anabolic therapy. Osteoporosis is one of the foremost underserved women’s health issues globally, where fracture rates continue to rise and where, despite medical guidelines, efficacious injectable anabolics are used in a minority of patients worldwide. We are developing EB613 to help close this treatment gap.”

Q3 2024 Updates:

EB613: First Oral PTH(1–34) Anabolic Tablet Treatment for Women with Osteoporosis

  • In September 2024, new comparative pharmacological data for EB613 was presented at the American Society for Bone Mineral Research September 2024 (ASBMR 2024) Annual Meeting in Toronto. The abstract was previewed by Dr. Serge Ferrari of Geneva University Hospital in Switzerland in his sneak–peak highlights of cutting–edge clinical abstracts on osteoporosis therapy at ASBMR2024.

First GLP–1/Glucagon Agonist (Oxyntomodulin) Peptide Tablets for Obesity

  • In September 2024, Entera and OPKO Health, Inc. (“OPKO”; Nasdaq: OPK), jointly announced topline pharmacokinetic/ pharmacodynamic (PK/PD) results for the oral oxyntomodulin (OXM) tablet program. The program is focused on developing the first oral dual agonist GLP–1/glucagon peptide as a potential once–daily treatment for patients with obesity and metabolic disorders using Entera’s proprietary N–Tab™ platform. Oral OXM exhibited significant systemic exposure across two in vivo models, a favorable PK profile and bioavailability. The high plasma concentrations with prolonged systemic exposure were consistent with the reported half–life for semaglutide (Rybelsus®), the only approved oral GLP–1 analog. Oral OXM showed a statistically significant reduction in plasma glucose levels compared with placebo. Entera plans to present this data together with OPKO at an upcoming clinical conference.

First GLP–2 Peptide Tablets for Short Bowel Syndrome

  • Entera continues pre–IND validation of its oral GLP–2 tablet in partnership with OPKO. Final in vivo PK/PD data is expected in the second half of 2024. This program is being developed as the first potential tablet GLP–2 replacement therapy for patients suffering with Short Bowel Syndrome, a rare and devastating intestinal failure condition. The program may also provide value to other critical conditions of GI inflammation, which is being explored with external parties. 

EB612: First Oral PTH(1–34) Peptide Replacement Therapy Tablets for Hypoparathyroidism

  • Entera continues to collaborate productively with a third party on the oral tablet development of another PTH replacement treatment for hypoparathyroidism.

Financial Results for the Quarter Ended September 30, 2024

As of September 30,2024, Entera had cash and cash equivalents of $6.9 million. The Company expects that its existing cash resources are sufficient to meet its projected operating requirements into the third quarter of 2025.

Research and development expenses for the three months ended September 30, 2024 were $1.5 million, as compared to $1.4 million for the three months ended September 30, 2023. The increase of $0.1 million was primarily due to an increase of $0.5 million in materials required in connection with the optimization processes related to the preparation of the EB613 phase 3 study. The increase was partially offset by a decrease of $0.4 million related to a completed Phase 1 PK, which occurred in 2023.

General and administrative expenses for the three months ended September 30, 2024 were $1.5 million, as compared to $1.0 million for the three months ended September 30, 2023. The increase of $0.5 million was mainly attributable to increases in intellectual property expenses, consultancy fees and share–based compensation.

Operating expenses for the period ended September 30, 2024 were $3.0 million, as compared to $2.4 million for the quarter ended September 30, 2023.

Net loss was $3.0 million, or $0.08 per ordinary share (basic and diluted), for the quarter ended September 30, 2024, as compared to $2.4 million, or $0.08 per ordinary share (basic and diluted), for the quarter ended September 30, 2023.

About Entera Bio

Entera is a clinical–stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages a disruptive and proprietary technology platform (N–Tab™) and its pipeline includes five differentiated, first–in–class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH (1–34)), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n=161) met primary (PD/bone turnover biomarker) and secondary (BMD) endpoints. Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint, which is expected to occur by January 2025. The EB612 program is being developed as the first oral PTH (1–34) tablet peptide replacement therapy for hypoparathyroidism. In collaboration with OPKO Health, Entera is also developing the first oral oxyntomodulin, a dual targeted GLP–1/glucagon peptide, in tablet form for the treatment of obesity; and the first oral GLP–2 peptide tablet as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome. For more information, visit www.enterabio.com or follow us on LinkedIn, X (formerly Twitter), Facebook and Instagram.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are “forward–looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera’s forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s expectations regarding licensing, business transactions and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statements Regarding Forward–Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10–K filed with the SEC, as well as the company’s subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

 
ENTERA BIO LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
 
       
  September 30,   December 31,
  2024   2023
  (Unaudited)   (Audited)
   
Cash and cash equivalents 6,915   11,019
Accounts receivable and other current assets 425   238
Property and equipment, net 65   100
Other assets, net 336   408
Total assets 7,741   11,765
     
     
Accounts payable and other current liabilities 1,111   1,091
Total non–current liabilities 178   288
Total liabilities 1,289   1,379
Total shareholders' equity 6,452   10,386
       
Total liabilities and shareholders' equity 7,741   11,765

 
ENTERA BIO LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)

(Unaudited)
 
  Three Months Ended
September 30,
  2024   2023
REVENUES 42   –
COST OF REVENUES 42   –
GROSS PROFIT –   –
OPERATING EXPENSES:      
Research and development 1,477   1,370
General and administrative 1,544   1,028
Other income –   (12)
TOTAL OPERATING EXPENSES 3,021   2,386
OPERATING LOSS 3,021   2,386
FINANCIAL INCOME, NET –   (36)
INCOME TAX –   29
NET LOSS 3,021   2,379
       
LOSS PER SHARE BASIC AND DILUTED 0.08   0.08
       
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE 37,644,612   28,813,952
       


GLOBENEWSWIRE (Distribution ID 9270213)

Zenas BioPharma to Participate in Upcoming Healthcare Investor Conferences

WALTHAM, Mass, Nov. 07, 2024 (GLOBE NEWSWIRE) — Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical–stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative immunology–based therapies, today announced the Company’s participation at the following healthcare investor conferences:

  • Guggenheim’s Inaugural Healthcare Innovation Conference on November 12, 2024, in Boston, MA
  • Jefferies London Healthcare Conference on November 19, 2024 presentation at 4:00 p.m. to 4:25 p.m. GDT, in London
  • Citi’s 2024 Global Healthcare Conference on December 3, 2024 presentation at 9:30 a.m. to 10:10 a.m. ET, in Miami, FL
  • Evercore ISI HealthCONx Conference on December 4, 2024 presentation at 1:20 p.m. to 1:40 p.m. ET, in Coral Gables, FL

Live webcasts and archived replays of the Company’s presentations at the Jefferies, Citi and Evercore conferences can be accessed under “Events and Presentations” in the Investors and Media section of the Zenas BioPharma website.

About Zenas BioPharma, Inc.

Zenas is a clinical–stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative immunology–based therapies for patients in need. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas’ lead product candidate, obexelimab, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s mechanism of action and chronic dosing regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. For more information about Zenas BioPharma, please visit www.zenasbio.com and follow us on X at @ZenasBioPharma and LinkedIn.

The Zenas BioPharma word mark and logos are trademarks of Zenas BioPharma, Inc. or its affiliated companies.

Investor Contact:
Matthew Osborne
Investor Relations and Corporate Communications
Matt.osborne@zenasbio.com

Media Contact:
Argot Partners
Zenas@argotpartners.com


GLOBENEWSWIRE (Distribution ID 9268589)

Recursion announces first patient dosed in Phase 2 clinical study of REC-3964, a potential first-in-class, oral, non-antibiotic small molecule for recurrent Clostridioides difficile infection

  • REC–3964 is Recursion’s first new chemical entity developed using the RecursionOS.
  • REC–3964 represents a novel, non–antibiotic approach with a unique mechanism of action that binds and blocks catalytic activity of the toxin's innate glucosyltransferase in order to inhibit the toxin produced by C. diff. in the gastrointestinal tract.
  • There are up to 175,000 cases of recurrent C. diff. each year and more than 29,000 patients die in the U.S. from C. diff. annually. Rates of recurrent C. diff. have increased significantly in recent years, representing a major public health challenge.

SALT LAKE CITY, Oct. 22, 2024 (GLOBE NEWSWIRE) — Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to radically improve lives, today announced that the first patient has been dosed in its Phase 2 clinical trial of REC–3964, a potential first–in–class, oral small molecule and new chemical entity for the treatment of recurrent Clostridioides difficile infection. C. diff is a toxin producing bacteria that causes diarrhea and colitis, and can be life threatening. Up to 730,000 cases are estimated to occur in the U.S. and EU5 annually, and the infection is responsible for an estimated 29,000 deaths in the U.S. each year. Recursion’s study will initially address the recurrent C. diff. (up to 175,000 cases in the United States per year) population, which costs the healthcare system approximately two billion dollars per year.

Increasing cases of recurrent C. diff. infections pose significant public health challenges. Antibiotics, the standard treatment for C. diff. infections, disturb the gut microbiome due to their non–selective nature. Despite initial success, antibiotics fail to prevent recurrence in 20–30% of primary cases. Further, the risk of subsequent recurrence rises to 40% after the first and 45–65% after two or more.

REC–3964 is the first novel small molecule developed through Recursion’s Operating System, and selectively inhibits the glucosyltransferase activity of toxin B produced by C. diff in the gastrointestinal tract, offering a unique mechanism of action. Unlike antibiotics, which disrupt the gut microbiome, REC–3964 precisely targets the bacterial toxin while sparing healthy tissue, potentially minimizing adverse events. It is being studied as part of a treatment regimen to prevent recurrent C. diff infections, a leading cause of antibiotic–associated diarrhea that can lead to significant morbidity and mortality.

Presented at the 6th Edition of World Congress on Infectious Diseases, preclinical studies demonstrated its superiority over bezlotoxumab in a human disease–relevant C. diff. hamster model. Additionally, Phase 1 studies in healthy volunteers showed REC–3964 was well tolerated with no serious adverse events (SAEs), underscoring its potential safety and tolerability.

“There’s a significant unmet need for new treatment options for patients with C. diff. infection that are easier to use and more cost effective,” said Chris Gibson, Ph.D., Co–Founder and CEO of Recursion. “We are encouraged by the progress of REC–3964, the first new chemical entity from our platform to advance to Phase 2 clinical trials, and now, to the first patient dosed. We look forward to continuing to advance this trial to help patients in need and drive down billions in costs to the healthcare system for treatment.”

Christian John Lillie, Co–Founder and CEO of the Peggy Lillis Foundation, shared: “We are so pleased to learn that our partner Recursion has initiated its ALDER trial. All new therapies that can be added to the known standard of care have the potential to decrease the physical and emotional suffering of recurrent C. diff. on patients and the significant burden to the health care system.”

“Patients with C. diff face significant challenges, with 20–30% of initial infections recurring after standard treatment and a 40% chance of further recurrence, often leading to severe complications and a diminished quality of life,” said Najat Khan, Ph.D., Chief Commercial Officer and Chief R&D Officer at Recursion. “For these patients and their families, the need for safe, effective, non–antibiotic treatment options is critical. REC–3964 offers a novel, targeted approach by selectively inhibiting the bacterial toxin while sparing the host. With encouraging preclinical data and strong tolerability demonstrated in Phase 1 studies, it’s particularly rewarding to see the first drug developed using the RecursionOS and advancing to Phase 2 trials.”

The Phase 2 ALDER clinical trial is a multi–center randomized study to investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of REC–3964 at doses of either 250 mg or 500 mg for the reduction of C. diff. and will include an observation only arm. Approximately 80 individuals will ultimately be enrolled in the study across the U.S. and Europe.

About Clostridioides difficile infection
Clostridioides difficile (C. diff.) infection is a bacterial disease that impacts more than 730,000 people in the U.S. and EU5 every year. Rates of recurrent C. diff. have increased significantly in recent years, representing a major public health challenge, with people 7 to 10 times more likely to get C. diff. infection while taking an antibiotic and the subsequent month. About 20–30% patients who have C. diff. infection will have it again in the subsequent 2 to 8 weeks. After the first recurrence, there’s a 40% likelihood of a second recurrence, and a 45–65% likelihood of recurrence among patients who have recurred more than twice. In total C. diff. infection is estimated to cause 29,300 deaths in the U.S. each year. More than 80% of C. diff. infection deaths occur in people aged 65 and older. On average, one in 11 patients older than 65 years diagnosed with healthcare–associated C. diff. infection will die within a month. Extended stays in healthcare settings, such as hospitals and nursing homes, also increase risk.

About REC–3964
REC–3964 is a potential first–in–class, orally bioavailable non–antibiotic small molecule that is being investigated for the potential treatment of recurrent Clostridioides difficile (C. diff.) infection. This selective inhibitor is Recursion’s first new chemical entity to reach the clinic, and binds and blocks catalytic activity of the toxin's innate glucosyltransferase. In preclinical studies, REC–3964 was found to be superior to bezlotoxumab in a human disease relevant C. diff. hamster model, with significant difference in probability of survival versus bezlotoxumab alone at the end of treatment. REC–3964 was also well tolerated in Phase 1 healthy volunteer studies, demonstrating potential safety and tolerability with no serious adverse events (SAEs).

About the Trial
Our Phase 2 ALDER clinical trial is a multi–center, open–label study to investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of REC–3964 (doses of either 250 mg or 500 mg PO every 12 hours) for the reduction of Clostridioides Difficile infection (C. diff.). Approximately 80 individuals will be enrolled in this open–label Phase 2 study, randomized 1:2:1 to receive oral doses of REC–3964, 250 mg, 500 mg or observation. The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of REC–3964 for the reduction of recurrent Clostridioides difficile infection (rCDI) after initial cure with vancomycin. Participants will receive treatment with REC–3964 for 28 days.

About Recursion
Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world’s largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine–learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.

Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, London, and the San Francisco Bay Area. Learn more at www.Recursion.com, or connect on X (formerly Twitter) and LinkedIn.

Media Contact
Media@Recursion.com

Investor Contact
Investor@Recursion.com

Forward–Looking Statements

This document contains information that includes or is based upon “forward–looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including, without limitation, those regarding the potential efficacy of REC–3964; timing of the Phase 2 clinical trial of REC–3964; early and late stage discovery, preclinical, and clinical programs; licenses and collaborations; prospective products and their potential future indications and market opportunities; Recursion OS and other technologies; business and financial plans and performance; and all other statements that are not historical facts. Forward–looking statements may or may not include identifying words such as “plan,” “will,” “expect,” “anticipate,” “intend,” “believe,” “potential,” “continue,” and similar terms. These statements are subject to known or unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, including but not limited to: challenges inherent in pharmaceutical research and development, including the timing and results of preclinical and clinical programs, where the risk of failure is high and failure can occur at any stage prior to or after regulatory approval due to lack of sufficient efficacy, safety considerations, or other factors; our ability to leverage and enhance our drug discovery platform; our ability to obtain financing for development activities and other corporate purposes; the success of our collaboration activities; our ability to obtain regulatory approval of, and ultimately commercialize, drug candidates; our ability to obtain, maintain, and enforce intellectual property protections; cyberattacks or other disruptions to our technology systems; our ability to attract, motivate, and retain key employees and manage our growth; inflation and other macroeconomic issues; and other risks and uncertainties such as those described under the heading “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10–K and Quarterly Reports on Form 10–Q. All forward–looking statements are based on management’s current estimates, projections, and assumptions, and Recursion undertakes no obligation to correct or update any such statements, whether as a result of new information, future developments, or otherwise, except to the extent required by applicable law.


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