On May 9, 2024 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported financial results for the first quarter ended March 31, 2024, and provided corporate updates (Press release, Sensei Biotherapeutics, MAY 9, 2024, View Source [SID1234643017]).

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"Building upon our initial data for SNS-101, which we believe support a favorable and potentially best-in-class clinical safety and PK profile, we now look forward to sharing topline dose escalation data at ASCO (Free ASCO Whitepaper) in June and initial dose expansion data in the fourth quarter of this year," said John Celebi, President and Chief Executive Officer. "Looking ahead, we are squarely focused on advancing patient enrollment in the dose expansion cohorts, which are intended to generate additional supportive data and optimize the Phase 2 trial design for SNS-101. With cash runway into the fourth quarter of 2025, we believe we are in a strong position to build on both our clinical momentum on behalf of the patients we aim to serve and our scientific advances, as illustrated by our recent publication in Nature Communications."

Highlights and Milestones

SNS-101

SNS-101 is a conditionally active antibody harnessing the acidic tumor microenvironment to selectively target the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation). VISTA is implicated in numerous cancer indications and its expression correlates with low survival rates. Sensei is conducting a multi-center Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SNS-101 as both a monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced solid tumors. Recent updates include:

Sensei has completed enrollment in the dose escalation portion of the Phase 1/2 clinical trial of SNS-101, enrolling 16 patients in the monotherapy arm and 18 patients in the combination arm.
In the monotherapy dose escalation arm, patients have cleared all planned dosing cohorts of 0.3, 1, 3, 10, and 15 mg/kg.
In the combination dose escalation arm, patients have cleared all planned dosing cohorts of 3, 10, and 15 mg/kg of SNS-101 plus Libtayo.
There have been no dose limiting toxicities (DLT) observed across both the monotherapy and the combination arms.
Sensei will present topline clinical data from the monotherapy and combination dose escalation portion of its Phase 1/2 trial of SNS-101 in a poster presentation at the upcoming 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago, IL, from May 31 – June 4, 2024.
Title: Initial results from a first-in-human phase 1 study of SNS-101 (pH-selective anti-VISTA antibody) alone or in combination with cemiplimab in patients with advanced solid tumors
Presenter: Dr. Shiraj Sen
Session Type: Poster Session
Session Title: Developmental Therapeutics—Immunotherapy
Date and Time: Saturday, June 1, 2024, at 9:00 a.m. – 12:00 p.m. CDT
Abstract Number: 2600
Patient enrollment is ongoing for both the monotherapy and combination dose expansion arms.
In the monotherapy dose expansion arm, Sensei is enrolling patients with microsatellite stable (MSS) colorectal cancer (CRC) at a dose level of 15 mg/kg.
In the combination dose expansion arm, Sensei is enrolling patients with MSS CRC, Head and Neck (H&N) cancer, non-small cell lung cancer (NSCLC), and melanoma at a dose level of 15 mg/kg plus Libtayo.
The solid tumor types were selected to focus the cancer indications on a basket of more commonly occurring histologies, including both "hot" (NSCLC, H&N, Melanoma) and "cold" (CRC) tumors where the company believes SNS-101 has potential to provide clinical benefit based on VISTA biology and supporting preclinical data. Additional tumor types and doses may be considered for both the monotherapy and combination expansion arms.
The Company expects to report initial data from the dose expansion cohorts and hold an end-of-Phase 1 meeting with the FDA by the end of 2024.
In April 2024, Sensei published a peer-reviewed research paper in Nature Communications describing the mechanism of action of SNS-101 selectively targeting the active form of VISTA within the tumor microenvironment.
In March 2024, the company presented SNS-101 data at Keystone Symposia’s Cancer Immunotherapy: Beyond Immune Checkpoint Blockade and Overcoming Resistance.
In February, Sensei presented at the 10th Annual Immuno-Oncology 360 Conference (IO360).
Corporate Updates

In January 2024, Sensei announced the appointment of Ron Weitzman, M.D., F.A.C.P., as part-time Chief Medical Officer.
In January 2024, Sensei announced a realignment of its resources to fully support the Phase 1/2 clinical trial of SNS-101. As a result, Sensei has paused IND-enabling work on its preclinical-stage TMAb programs, including SNS-102 (VSIG4), SNS-103 (CD39) and SNS-201 (VISTAxCD28). Preclinical work to characterize selected lead antibodies, including their mechanisms of action, and target biology is expected to continue throughout 2024.
As a result of this realignment of resources Sensei’s cash runway now extends into the fourth quarter of 2025.
First Quarter 2024 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $58.1 million as of March 31, 2024, as compared to $65.8 million as of December 31, 2023. The decrease is due to cash used to fund operations. Sensei expects its current cash balance to fund operations into the fourth quarter of 2025.

Research and Development (R&D) Expenses: R&D expenses were $4.9 million for the quarter ended March 31, 2024, compared to $5.2 million for the quarter ended March 31, 2023. The decrease in R&D expenses was primarily attributable to lower manufacturing-related expenses and lower costs related to preclinical research, primarily offset by higher expenses associated with clinical trials.

General and Administrative (G&A) Expenses: G&A expenses were $3.8 million for the quarter ended March 31, 2024, compared to $5.8 million for the quarter ended March 31, 2023. The decrease in G&A expense was primarily attributable to decreased cost for external professional services.

Net Loss: Net loss was $8.0 million for the quarter ended March 31, 2024, compared to $10.2 million for the quarter ended March 31, 2023.

On May 9, 2024 Royalty Pharma plc (Nasdaq: RPRX) reported financial results for the first quarter of 2024 and confirmed full year 2024 guidance for Portfolio Receipts (Press release, Royalty Pharma , MAY 9, 2024, View Source [SID1234643016]).

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"We continued to execute on our strategy in the first quarter of 2024 and are on track to deliver our full year guidance" said Pablo Legorreta, Royalty Pharma’s founder and Chief Executive Officer. "We achieved double-digit growth in Royalty Receipts driven by the strength of our diversified portfolio. With today’s transaction to acquire royalties on Sanofi’s frexalimab, a therapy with multi-blockbuster potential, we’ve increased our development-stage portfolio by five-fold to 15 medicines since our IPO. Looking ahead, 2024 is expected to be an event-rich year for our expanding development-stage pipeline with multiple potential regulatory and clinical events. Furthermore, we continue to be highly active in assessing attractive new royalty opportunities, reflecting the strong demand for capital to fund the ongoing wave of healthcare innovation. Based on the powerful fundamental tailwinds underpinning our business, we remain highly confident in our ability to deliver attractive, long-term compounding growth."

Strong Royalty Receipts growth; Portfolio Receipts growth impacted by a high base of comparison

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Royalty Receipts grew 14% to $705 million, driven by strong portfolio performance, including royalties on Evrysdi, Trelegy and the cystic fibrosis franchise.

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Portfolio Receipts declined to $717 million from $1,131 million, reflecting a $475 million Biohaven-related milestone payment received in the first quarter of 2023.

Capital Deployment of approximately $670 million, including cash expected to be paid for frexalimab

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Announced transaction to acquire royalties on Sanofi’s frexalimab, a potential multi-blockbuster in Phase 3 development for multiple sclerosis, for approximately $525 million including estimated transaction costs.

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Financial capacity of >$3.5 billion (including cash and leverage capacity) to execute on value-creating transactions.

Development-stage portfolio growing to 15 therapies with potential significantly >$1 billion in peak royalties

•
11 of 15 therapies are in Phase 3 development or undergoing regulatory review.

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Key events expected over next year: FDA filings for aficamten (cardiovascular), pelabresib (myelofibrosis); pivotal study results for seltorexant (depression), Tremfya (Crohn’s disease); FDA action date for KarXT (schizophrenia).

Financial guidance for full year 2024 (excludes contribution from future transactions)

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Royalty Pharma expects 2024 Portfolio Receipts to be between $2,600 million and $2,700 million.

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2024 Portfolio Receipts guidance includes expected growth in Royalty Receipts of 5% to 9%.Financial & Liquidity Summary

Three Months Ended March 31,
(unaudited)
($ and shares in millions) 2024 2023 Change
Portfolio Receipts

717 1,131 (37 )%
Net cash provided by operating activities

665 1,034 (36 )%
Adjusted EBITDA (non-GAAP)*

656 1,044 (37 )%
Portfolio Cash Flow (non-GAAP)*

584 977 (40 )%
Weighted average Class A ordinary shares outstanding – diluted

597 607 (2 )%

*
See "Liquidity and Capital Resources" section. Adjusted EBITDA and Portfolio Cash Flow are non-GAAP liquidity measures calculated in accordance with the credit agreement.

Portfolio Receipts Highlights

Three Months Ended March 31,
(unaudited)
($ in millions) 2024 2023 Change
Products:

Marketers: Therapeutic Area:
Cystic fibrosis franchise

Vertex Rare disease 218 197 11 %
Trelegy

GSK Respiratory 71 48 46 %
Tysabri

Biogen Neuroscience 69 71 (2 )%
Imbruvica

AbbVie, J&J Cancer 50 57 (12 )%
Evrysdi

Roche Rare disease 45 18 156 %
Promacta

Novartis Hematology 43 41 4 %
Xtandi

Pfizer, Astellas Cancer 41 36 14 %
Tremfya

Johnson & Johnson Immunology 36 32 15 %
Cabometyx/Cometriq

Exelixis, Ipsen, Takeda Cancer 18 16 14 %
Trodelvy

Gilead Cancer 10 7 57 %
Erleada

Johnson & Johnson Cancer 9 6 57 %
Orladeyo

BioCryst Rare disease 9 7 28 %
Spinraza

Biogen Rare disease 7 —  n/a
Nurtec ODT/Zavzpret

Pfizer Neuroscience 6 4 40 %
Other products(5)

73 78 (6 )%

Royalty Receipts

705 616 14 %
Milestones and other contractual receipts

12 515 (98 )%

Portfolio Receipts

717 1,131 (37 )%

Amounts shown in the table may not add due to rounding.

Portfolio Receipts were $717 million in the first quarter of 2024, a decrease of 37% compared to $1,131 million in the same period of 2023. The decrease was attributable to a high base of comparison in the first quarter of 2023 in milestones and other contractual receipts, which reflected a $475 million Zavzpret milestone payment and a $29 million Airsupra payment.

Royalty Receipts increased 14% to $705 million, primarily driven by strong growth in Trelegy and the cystic fibrosis franchise, and incremental royalties acquired on Evrysdi in October 2023.

Liquidity and Capital Resources

Royalty Pharma’s liquidity and capital resources are summarized below:

As of March 31, 2024, Royalty Pharma had cash and cash equivalents of $843 million and total debt with principal value of $6.3 billion.

Liquidity Summary

Three Months Ended March 31,
(unaudited)
($ in millions) 2024 2023
Portfolio Receipts

717 1,131
Payments for operating and professional costs

(61 ) (87 )

Adjusted EBITDA (non-GAAP)

656 1,044
Interest paid, net

(73 ) (67 )

Portfolio Cash Flow (non-GAAP)

584 977
 Amounts shown in the table may not add due to rounding.

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Adjusted EBITDA (non-GAAP) was $656 million in the first quarter of 2024. Adjusted EBITDA is calculated in accordance with the credit agreement as Portfolio Receipts minus payments for operating and professional costs.

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Portfolio Cash Flow (non-GAAP) was $584 million in the first quarter of 2024. Portfolio Cash Flow is calculated in accordance with the credit agreement as Adjusted EBITDA minus interest paid or received, net. This measure reflects the cash generated by Royalty Pharma’s business that can be redeployed into value-enhancing royalty acquisitions, used to repay debt, returned to shareholders through dividends or share purchases, or utilized for other discretionary investments.

Royalty Pharma has provided a reconciliation of each non-GAAP measure to the most directly comparable GAAP financial measure, net cash provided by operating activities, in Table 4.

Royalty Pharma announced new transactions of up to $94 million in the first quarter of 2024, which include upfront payments and potential future milestones. Royalty Pharma is also providing an aggregate amount for Capital Deployment, which reflects cash payments during the period for new and previously announced transactions. Capital Deployment was $93 million in the first quarter of 2024, consisting primarily of the $49 million upfront payment for ecopipam and $36 million in research and development funding support for TEV-’749. Additionally, in April 2024, Royalty Pharma made a $50 million milestone payment to Arrowhead related to olpasiran. In May 2024, Royalty Pharma announced a transaction to acquire royalties and milestones on frexalimab owned by ImmuNext for approximately $525 million in cash including estimated transaction costs.

The table below details Capital Deployment by category:

Capital Deployment

Three Months Ended March 31,
($ in millions) 2024 2023
Acquisitions of financial royalty assets

(86 ) (602 )
Development-stage funding payments – ongoing

(1 ) (1 )
Milestone payments

—  (12 )
Investments in equity method investees

(7 ) (4 )
Contributions from legacy non-controlling interests – R&D

0 0

Capital Deployment

(93 ) (618 )
 Amounts may not add due to rounding.

Recent Transactions

During 2024, Royalty Pharma announced new transactions of up to $619 million. Announced transactions amount reflects the entire amount of capital committed for new transactions during the year, including potential future milestones.

Recent transactions include:

•
In January 2024, Royalty Pharma acquired a royalty interest in ecopipam for an upfront payment of $49 million and up to $44 million in milestone payments contingent on the achievement of certain regulatory milestones. Ecopipam is in Phase 3 development by Emalex Biosciences for the treatment of Tourette Syndrome.

•
In May 2024, Royalty Pharma announced a transaction to acquire royalties and milestones on frexalimab owned by ImmuNext for approximately $525 million in cash including estimated transaction costs. ImmuNext is entitled to royalties on frexalimab, which is a first-in-class, second generation anti-CD40 ligand monoclonal antibody in development by Sanofi. Frexalimab is being evaluated in Phase 3 clinical studies for the treatment of multiple sclerosis and is in Phase 2 clinical studies for systemic lupus erythematosus and Type 1 Diabetes.

The information in this section should be read together with Royalty Pharma’s reports and documents filed with the SEC at www.sec.gov and the reader is also encouraged to review all other press releases and information available in the Investors section of Royalty Pharma’s website at www.royaltypharma.com.

Key Developments Relating to the Portfolio

The key developments related to Royalty Pharma’s royalty interests are discussed below based on disclosures from the marketers of the products.

TEV-‘749 In May 2024, Teva Pharmaceuticals announced positive efficacy results from its Phase 3 trial evaluating TEV-‘749, a once-monthly subcutaneous long-acting injection of olanzapine, in adult patients with schizophrenia. Results demonstrated that TEV-‘749 met its primary endpoint as measured by a change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline after eight weeks compared to placebo. Additionally, no cases of Post-injection Delirium/Sedation Syndrome (PDSS) have been reported to date, after administration of approximately 80% of the minimal target injection number.
Cystic fibrosis franchise
In May 2024, Vertex announced that it submitted a New Drug Application and Marketing Authorization Application for the new triple combination therapy to the Food & Drug Administration and the European Medicines Agency, respectively, for approval. This follows positive Phase 3 results for the new triple combination therapy in February 2024.

In April 2024, Vertex announced that the European Commission had granted approval for the label expansion of Kalydeco for the treatment of infants down to one month of age with cystic fibrosis (CF) who have certain mutations in the CF transmembrane conductance regulator gene.

Tremfya In May 2024, Johnson and Johnson announced positive Phase 3 results for Tremfya in patients with moderately to severely active Crohn’s disease with inadequate response/intolerance to conventional therapies and/or biologics. Johnson and Johnson submitted applications to the European Medicines Agency seeking to expand the Marketing Authorization Application for Tremfya to include ulcerative colitis and Crohn’s disease.
Xtandi
In April 2024, Astellas Pharma announced the European Commission approved a label extension for Xtandi as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer who are unsuitable for salvage-radiotherapy.

In January 2024, Pfizer announced that the European Commission had approved Talzenna (talazoparib), an oral poly ADP-ribose polymerase inhibitor, in combination with Xtandi, for the treatment of adult patients with metastatic castration-resistant prostate cancer in whom chemotherapy is not clinically indicated.

KarXT In March 2024, Bristol Myers Squibb announced that it completed its acquisition of Karuna. Bristol Myers acquired Karuna for $330 per share, for a total equity value of $14 billion. The New Drug Application for KarXT for the treatment of schizophrenia in adults was accepted for review by the FDA, with a Prescription Drug User Fee Act date of September 26, 2024.
Trontinemab In March 2024, Roche held a neurology update event in which it announced that in people with Alzheimer’s Disease, trontinemab demonstrated rapid and robust amyloid plaque reduction at relatively low doses compared with standard anti-Aß monoclonal antibodies. The sustained low Amyloid Related Imaging Abnormalities incidence and overall favorable safety and tolerability profile support further investigation.

Pelabresib In February 2024, Novartis announced that it had entered into an agreement to make a voluntary public takeover offer to acquire MorphoSys for €68 per share, for a total equity value of €2.7 billion. The closing is expected in the first half of 2024.
Trodelvy In January 2024, Gilead announced that the Phase 3 EVOKE-01 study evaluating Trodelvy compared to docetaxel did not meet its primary endpoint of overall survival in patients with previously treated metastatic non-small cell lung cancer.
2024 Financial Outlook

Royalty Pharma has provided guidance for full year 2024, excluding transactions and borrowings announced after the date of this release, as follows:

Provided May 9, 2024 Previous
Portfolio Receipts

$2,600 million to $2,700 million $2,600 million to $2,700 million
Payments for operating and professional costs

8% to 9% of Portfolio Receipts 8% to 9% of Portfolio Receipts
Interest paid

$160 million $160 million
The above Portfolio Receipts guidance includes expected Royalty Receipts growth of 5% to 9% in 2024.

Royalty Pharma’s full year 2024 guidance reflects a negligible estimated foreign exchange impact to Portfolio Receipts, assuming current foreign exchange rates prevail for 2024.

Total interest paid is based on the semi-annual interest payment schedule of Royalty Pharma’s existing notes and is anticipated to be approximately $160 million in 2024. Interest paid is anticipated to be approximately $79 million in the third quarter of 2024 with de minimis amounts being recorded in the second and fourth quarters of 2024. The projection assumes no additional debt financing in 2024, including no drawdown on the revolving credit facility. In the first quarter of 2024, Royalty Pharma collected interest of $6 million on its cash and cash equivalents, which partially offset interest paid.

Royalty Pharma today provides this guidance based on its most up-to-date view of its prospects. This guidance assumes no major unforeseen adverse events and excludes the contributions from transactions announced subsequent to the date of this press release. Furthermore, Royalty Pharma may amend its guidance in the event it engages in new royalty transactions which have a material near-term financial impact on the company.

Financial Results Call

Royalty Pharma will host a conference call and simultaneous webcast to discuss its first quarter 2024 results today at 8:00 a.m., Eastern Time. Please visit the "Investors" page of the company’s website at View Source to obtain conference call information and to view the live webcast. A replay of the conference call and webcast will be archived on the company’s website for at least 30 days.

On May 9, 2024 Recursion (Nasdaq: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, reported business updates and financial results for its first quarter ending March 31, 2024 (Press release, Recursion Pharmaceuticals, MAY 9, 2024, View Source [SID1234643015]).

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"We are excited about the multiple upcoming value catalysts that could potentially occur in the near-term, including clinical trial readouts, partnership option exercises, new partnerships, and interest in Recursion’s data and technology solutions," said Chris Gibson, Ph.D., Co-founder and CEO of Recursion. "It is great to see individuals from both the biopharma and technology industries demonstrating an understanding and appetite for the power of combining large-scale computing resources with the ability to generate a proprietary source of large-scale data. To that end, we are thrilled to welcome Dr. Najat Khan to Recursion who will help lead our R&D and commercialization efforts."

Summary of Business Highlights
•Pipeline
◦Cerebral Cavernous Malformation (CCM) (REC-994): Our Phase 2 SYCAMORE clinical trial is a randomized, double-blind, placebo-controlled study of two doses of REC-994 in participants with CCM. The primary endpoint of the study is safety and tolerability. Secondary and exploratory endpoints, including clinician measured outcomes, imaging of CCM lesions, patient reported outcomes, and selected biomarkers, will be evaluated. This trial was fully enrolled in June 2023 with 62 participants, where the vast majority of participants who completed 12 months of treatment have entered the long-term extension study. We expect to share Phase 2 data in Q3 2024.

◦Neurofibromatosis Type 2 (NF2) (REC-2282): Our adaptive Phase 2/3 POPLAR clinical trial is a randomized, two part study of REC-2282 in participants with progressive NF2-mutated meningiomas. Part 1 of the study is ongoing and is exploring two doses of REC-2282 in approximately 23 adults and 9 adolescents, with enrollment in adults expected to complete in Q2 2024. We expect to share Phase 2 safety and preliminary efficacy data in Q4 2024.
◦Familial Adenomatous Polyposis (FAP) (REC-4881): Our Phase 1b/2 TUPELO clinical trial is an open label, multicenter, two part study of REC-4881 in participants with FAP. Part 1 is complete and enrollment in Part 2 has commenced. We expect to share Phase 2 safety and preliminary efficacy data in H1 2025.

◦AXIN1 or APC Mutant Cancers (REC-4881): Our Phase 2 LILAC clinical trial is an open label, multicenter study of REC-4881 in participants with unresectable, locally advanced or metastatic cancer with AXIN1 or APC mutations. This study was initiated at the end of 2023 with the first participant dosed in Q1 2024. Since that time, multiple participants are now enrolled. We expect to share Phase 2 safety and preliminary efficacy data in H1 2025.
◦Clostridioides difficile Infection (REC-3964): REC-3964 is a first-in-class C. difficile toxin inhibitor and the first new chemical entity developed by Recursion, with promising preclinical efficacy data seen in relevant models (superiority versus bezlotoxumab). Full Phase 1 data from our healthy volunteers study will be presented at the World Congress on Infectious Diseases in Paris in June 2024. We expect to initiate a randomized Phase 2 study in patients at high risk for C. difficile infection recurrence in 2024.

◦Advanced HR-Proficient Cancers (RBM39): RBM39 is a novel CDK12-adjacent target identified by the Recursion OS. We intend to position our lead candidate as a single agent for the potential treatment of advanced HR-proficient cancers including ovarian and other solid tumors. We expect to submit an IND in H2 2024 and anticipate initiating a Phase 1 open label study of our lead candidate in participants with relapsed/refractory cancer. The primary endpoint of the study will be safety and tolerability. Secondary endpoints will explore pharmacokinetics and preliminary signs of anti-tumor activity.

◦Undisclosed Indication in Fibrosis (Target Epsilon): This program originated under our initial fibrosis collaboration with Bayer and we have since in-licensed from Bayer all rights to this program. We are advancing our lead candidate through IND-enabling studies with IND submission expected in the near-term.

•Platform

◦Supercomputer Expansion: We worked with our partner NVIDIA to design and build BioHive-2, our next generation supercomputer with over 500 H100 GPUs. We have nearly completed the build out of BioHive-2 and began performance benchmarking tests. We believe that the performance of our supercomputer may place BioHive-2 in the top 50 of the next TOP500 list, making it one of the most powerful supercomputers in the world across any industry and the most powerful supercomputer owned and operated by any biopharma company. These computational resources, paired with Recursion’s vast datasets and data generation capabilities, enable the construction of Recursion’s large foundation models for biology, chemistry and causal patient outcomes.
◦Whole-Genome Transcriptomics Map: We continue to focus on key technologies that enhance our ability to generate, extract and validate novel insights for therapeutic advancements. Over the past year, we have scaled our transcriptomics technology in order to validate phenotypic-insights and relate to patient-derived RNA sequencing data. In April, we announced sequencing our 1 millionth transcriptome. We believe that we are one of the largest transcriptomics sequencers in the world and are advancing the development of a whole-genome knockout transcriptomics map, which we expect to complete in the coming quarters. Such platform capabilities are important for curating scaled datasets that are relatable and provide a more complete understanding of biology, chemistry, and patient outcomes.

◦Active Learning: We have been applying active learning approaches to predict where our OS should generate and enrich biological and chemical datasets via phenotypic and ADME compound profiling across existing and new cellular contexts. These capabilities enable Recursion to rapidly construct multiomics maps that are enriched for areas of biology and chemistry that may be of high value for translating insights into therapeutic programs. We believe that such approaches enable Recursion to more rapidly expand its data moat and see active learning capabilities as an important step towards autonomous drug discovery.

•Partnerships

◦Helix Collaboration: Recursion entered into a multi-year agreement with Helix to access hundreds of thousands of de-identified records including Helix’s Exome+(R) genomic data and data from longitudinal health records. Recursion plans to use this data to train causal AI models and design biomarker and patient stratification strategies across broad disease areas. The Helix dataset expands Recursion’s integration of real-world patient data and complements Recursion’s access to Tempus’ oncology data.
◦Transformational Collaborations: We continue to advance efforts to discover potential new therapeutics with our strategic partners in the areas of undruggable oncology (Bayer) as well as neuroscience and a single indication in gastrointestinal oncology (Roche-Genentech). In the near-term, there is the potential for option exercises associated with partnership programs, option exercises associated with map building initiatives or data sharing and additional partnerships in large, intractable areas of biology or technological innovation.

Additional Corporate Updates
•L(earnings) Call: Recursion will host a L(earnings) Call on May 9, 2024 at 5:00 pm Eastern Time / 3:00 pm Mountain Time. Recursion will broadcast the live stream from Recursion’s X (formerly Twitter), LinkedIn and YouTube accounts and there will be opportunities to ask questions of the company.
•Chief R&D Officer and Chief Commercialization Officer: In April 2024, Recursion named Najat Khan, Ph.D. as Chief R&D Officer and Chief Commercialization Officer. Previous to joining Recursion, Dr. Khan worked at Johnson & Johnson for over 6 years, serving most recently as Chief Data Science Officer and Global Head of Strategy & Portfolio Organization for Innovative Medicine R&D. Dr. Khan has also been appointed to Recursion’s Board of Directors.
•London Office: In March 2024, Recursion announced plans to open a new office in London in order to recruit top TechBio talent within the areas of computational biology, machine learning and data science. Additionally, Recursion announced that Prof. Michael Bronstein, DeepMind Professor of Artificial Intelligence at Oxford University, will join Recursion as a Scientific Advisor.
•Annual Shareholder Meeting: Recursion’s Annual Shareholder Meeting will be held on June 3, 2024 at 10:00 am Eastern Time / 8:00 am Mountain Time.

First Quarter 2024 Financial Results

•Cash Position: Cash and cash equivalents were $296.3 million as of March 31, 2024.

•Revenue: Total revenue was $13.8 million for the first quarter of 2024, compared to $12.1 million for the first quarter of 2023. The increase was due to revenue recognized from our partnership with Roche, as our mix of work on the three performance obligations shifted towards higher cost processes including the progression of work related to one of our neuroscience performance obligations.

•Research and Development Expenses: Research and development expenses were $67.6 million for the first quarter of 2024, compared to $46.7 million for the first quarter of 2023. The increase in research and development expenses was across all development phases as we continue to expand and upgrade our platform, including our chemical technology, machine learning and transcriptomics platform. Our discovery costs increased as we advanced our preclinical pipeline including our work on Target Epsilon. Our clinical costs grew as we continued to progress through our various clinical trials.

•General and Administrative Expenses: General and administrative expenses were $31.4 million for the first quarter of 2024, compared to $22.9 million for the first quarter of 2023. The increase in general and administrative expenses was due to an increase in salaries and wages of $3.9 million and increases in software and depreciation expenses.
•Net Loss: Net loss was $91.4 million for the first quarter of 2024, compared to a net loss of $65.3 million for the first quarter of 2023.

•Net Cash: Net cash used in operating activities was $102.3 million for the first quarter of 2024, compared to net cash used in operating activities of $73.3 million for the first quarter of 2023. The increase in net cash used in operating activities compared to the same period last year was due to higher operating costs incurred for research and development and general and administrative due to Recursion’s expansion and upgraded capabilities. Net cash used in operating activities was $74.1 million for the fourth quarter of 2023. The increase in net cash used compared to the fourth quarter of 2023 was due to paying our annual cash bonuses to employees of $18.0 million, timing of accrual payments of $6.4 million and a lease deposit prepayment for our BioHive-2 supercomputer of $1.6 million.

On May 9, 2024 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, reported financial results for the first quarter ended March 31, 2024 (Press release, RAPT Therapeutics, MAY 9, 2024, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-reports-first-quarter-2024-financial-results [SID1234643014]).

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The Company also announced today that it has decided to close and unblind both its Phase 2b clinical trial of zelnecirnon (RPT193) in atopic dermatitis ("AD") and its Phase 2a trial of zelnecirnon in asthma. Both clinical trials were placed on clinical hold by the FDA in February 2024 based on a serious adverse event of liver failure requiring transplant in one patient in the AD trial. Prior to the imposition of the clinical hold, a total of 229 patients had been enrolled in the Phase 2b AD trial, of which approximately 110 had completed the 16-week dosing period.

"Although there were a significant number of patients who were unable to complete the AD trial due to the hold, we believe we will have sufficient data, even if not statistically significant, to inform our path forward and support our discussions with the FDA," said Brian Wong, President and CEO. "We are working with the clinical trial sites to clean the data and we anticipate that our analysis of the data will be completed in the third quarter of this year. Concurrently, we are continuing our investigation and analysis of the serious adverse event that triggered the clinical hold."

Financial Results for the First Quarter March 31, 2024

First Quarter Ended March 31, 2024

Net loss for the first quarter of 2024 was $30.5 million, compared to $29.3 million for the first quarter of 2023.

Research and development expenses for the first quarter of 2024 were $24.8 million, compared to $25.6 million for the same period in 2023. The decrease in research and development expenses was primarily due to lower development costs related to zelnecirnon, tivumecirnon and early-stage programs as well as decreased expenses for lab supplies partially offset by increased expenses for personnel, consultants, facilities and non-cash stock-based compensation.

General and administrative expenses for the first quarter of 2024 were $7.7 million, compared to $6.0 million for the same period in 2023. The increase in general and administrative expenses was primarily due to increased expenses for personnel, non-cash stock-based compensation, consulting and facilities.

As of March 31, 2024, the Company had cash and cash equivalents and marketable securities of $141.6 million.

On May 9, 2024 PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, reported financial results for the first quarter ended March 31, 2024, and provided a corporate update (Press release, PMV Pharma, MAY 9, 2024, View Source [SID1234643013]).

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"Dosing the first patient in the registrational, tumor-agnostic Phase 2 portion of the PYNNACLE trial is an important milestone for PMV. Our team has worked diligently to initiate this global trial and I would like to thank them for their efforts," said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. "Rezatapopt offers the potential to provide a new treatment option for patients with a TP53 Y220C mutation and KRAS wild-type advanced solid tumors."

Corporate Highlights:

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First patient dosed in Phase 2 portion of the PYNNACLE trial. The multi-center, single-arm, registrational, tumor-agnostic Phase 2 trial will assess rezatapopt as monotherapy at a dose of 2000 mg once-daily in patients with TP53 Y220C and KRAS wild-type advanced solid tumors. The primary endpoint of the trial is overall response rate per blinded independent central review. The trial is designed to enroll 114 patients across five cohorts at approximately 60 sites across the U.S., Europe, and Asia-Pacific.
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Phase 1 data of rezatapopt in advanced ovarian cancer was featured in a late-breaking oral presentation at the 2024 SGO Annual Meeting on Women’s Cancer. Of the 15 heavily pre-treated patients with advanced ovarian cancer harboring a TP53 Y220C mutation, seven patients achieved a confirmed partial response with a seven-month median duration of response and a favorable safety profile.

First Quarter 2024 Financial Results

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PMV Pharma ended the first quarter with $213.1 million in cash, cash equivalents, and marketable securities, compared to $228.6 million as of December 31, 2023. Net cash used in operations was $16.2 million for the three months ended March 31, 2024, compared to $15.0 million for the three months ended March 31, 2023.
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Net loss for the quarter ended March 31, 2024, was $15.3 million compared to $19.1 million for the quarter ended March 31, 2023.
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Research and development (R&D) expenses were $13.2 million for the quarter ended March 31, 2024, compared to $15.1 million for the quarter ended March 31, 2023. The decrease in R&D expenses was primarily related to decreased contractual research organization costs, offset by increased personnel related costs and stock-based compensation.
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General and administrative (G&A) expenses were $5.0 million for the quarter ended March 31, 2024, compared to $6.4 million for the quarter ended March 31, 2023. The decrease in G&A expenses was primarily due to reduced spend for facility and operational expenses.

About Rezatapopt

Rezatapopt (PC14586) is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein, restoring the wild-type tumor-suppressor function. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation.

About the PYNNACLE Clinical Trial

The ongoing Phase 1/2 PYNNACLE clinical trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation. The primary objective of the Phase 1 portion of the trial was to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of rezatapopt when administered orally to patients. Safety, tolerability, pharmacokinetics and effects on biomarkers were also assessed. The Phase 2 portion is a registrational, single arm, expansion basket clinical trial comprising five cohorts (ovarian, lung, breast, and endometrial cancers, and other solid tumors) with the primary objective of evaluating the efficacy of rezatapopt at the RP2D in patients with TP53 Y220C and KRAS wild-type advanced solid tumors. For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750).