On July 17, 2024 Johnson & Johnson (NYSE: JNJ) reported results for second-quarter 2024 (Press release, Johnson & Johnson, JUL 17, 2024, View Source [SID1234644933]). "Johnson & Johnson’s second quarter performance reflects our relentless focus on advancing the next wave of medical innovation and resulted in strong sales and adjusted operational earnings per share growth," said Joaquin Duato, Chairman and Chief Executive Officer. "With a robust pipeline, upcoming regulatory milestones for RYBREVANT and TREMFYA, the integration of Shockwave, and continued expansion of newly launched products, including ACUVUE OASYS MAX 1-Day contact lenses and our VARIPULSE platform, we have a strong foundation for near and long-term growth."
Unless otherwise noted, the financial results and earnings guidance included below reflect the continuing operations of Johnson & Johnson.

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Overall financial results
Q2
($ in Millions, except EPS) 2024 2023 % Change
Reported Sales $22,447
$ 21,519
4.3%
Net Earnings $4,686 $5,376 (12.8)%
EPS (diluted) $1.93 $2.05 (5.9)%

Q2
Non-GAAP* ($ in Millions, except EPS) 2024 2023 % Change
Operational Sales1,2
6.6%
Adjusted Operational Sales1,3
6.5%
Adjusted Operational Sales ex. COVID-19 Vaccine1,3
7.1%
Adjusted Net Earnings1,4
$6,840 $6,730 1.6%
Adjusted EPS (diluted)1,4
$2.82 $2.56 10.2%

1Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2Excludes the impact of translational currency
3Excludes the net impact of acquisitions and divestitures and translational currency
4Excludes intangible amortization expense and special items
5Excludes COVID-19 Vaccine
Note: values may have been rounded

Regional sales results
Q2 % Change
($ in Millions) 2024 2023 Reported
Operational1,2
Currency
Adjusted
Operational1,3
U.S. $12,569 $11,657 7.8% 7.8 — 7.6
International 9,878 9,862 0.2 5.1 (4.9) 5.3
Worldwide $22,447 $21,519 4.3% 6.6 (2.3) 6.5

1Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2Excludes the impact of translational currency
3Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

Segment sales results
Q2 % Change
($ in Millions) 2024 2023 Reported
Operational1,2
Currency
Adjusted
Operational1,3
Innovative Medicine $14,490 $13,731 5.5% 7.8 (2.3) 8.0
MedTech 7,957 7,788 2.2 4.4 (2.2) 4.0
Worldwide $22,447 $21,519 4.3% 6.6 (2.3) 6.5

1Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2Excludes the impact of translational currency
3Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

Second Quarter 2024 segment commentary:
Operational sales* reflected below excludes the impact of translational currency.
Innovative Medicine
Innovative Medicine worldwide operational sales, excluding the COVID-19 Vaccine, grew 8.8%*. Growth was driven by DARZALEX (daratumumab), ERLEADA (apalutamide), and Other Oncology in Oncology, TREMFYA (guselkumab) and STELARA (ustekinumab) in Immunology, and SPRAVATO (esketamine) in Neuroscience. Growth was partially offset by Other Neuroscience. Including the COVID-19 Vaccine, Innovative Medicine worldwide operational sales grew 7.8%*.

MedTech
MedTech worldwide operational sales grew 4.4%*, with acquisitions and divestitures positively impacting growth by 0.4%. Operational sales growth was driven primarily by electrophysiology products and Abiomed in Cardiovascular, previously referred to as Interventional Solutions, and wound closure products in General Surgery.
Full-year 2024 guidance:
Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.
Johnson & Johnson is updating its 2024 guidance, including adjusted operational EPS guidance, to reflect improved performance and the impact for the recent acquisitions of Shockwave Medical, Proteologix, and NM26 Bispecific Antibody.

Non-GAAP* 2024
April 2024 Adjusted Operational EPS1,2
$10.68
Improved performance outlook $0.05
July 2024 Adjusted Operational EPS1,2 pre-M&A
$10.73
M&A impact ($0.68)
July 2024 Adjusted Operational EPS1,2
$10.05

1Non-GAAP financial measure; excludes the impact of translational currency
2Non-GAAP financial measure; excludes intangible amortization expense and special items
Note: Adjusted operational EPS figures reflect midpoint of issued guidance

($ in Billions, except EPS) July 2024 April 2024
Adjusted Operational Sales1,2,5
Change vs. Prior Year / Mid-point
5.5% – 6.0% / 5.8% 5.5% – 6.0% / 5.8%
Operational Sales2,5/ Mid-point
Change vs. Prior Year / Mid-point
$89.2B – $89.6B / $89.4B
6.1% – 6.6% / 6.4%
$88.7B – $89.1B / $88.9B
5.5% – 6.0% / 5.8%
Estimated Reported Sales3,5/ Mid-point
Change vs. Prior Year / Mid-point
$88.0B – $88.4B / $88.2B
4.7% – 5.2% / 5.0%
$88.0B – $88.4B / $88.2B
4.7% – 5.2% / 5.0%
Adjusted Operational EPS (Diluted)2,4/ Mid-point
Change vs. Prior Year / Mid-point
$10.00 – $10.10 / $10.05
0.8% – 1.8% / 1.3%
$10.60 – $10.75 / $10.68
6.9% – 8.4% / 7.7%
Adjusted EPS (Diluted)3,4 / Mid-point
Change vs. Prior Year / Mid-point
$9.97 – $10.07 / $10.02
0.5% – 1.5% / 1.0%
$10.57 – $10.72 / $10.65
6.6% – 8.1% / 7.4%

1Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures
2Non-GAAP financial measure; excludes the impact of translational currency
3Calculated using Euro Average Rate: July 2024 = $1.08 and April 2024 = $1.08 (Illustrative purposes only)
4Non-GAAP financial measure; excludes intangible amortization expense and special items
5Excludes COVID-19 Vaccine
Note: percentages may have been rounded
Other modeling considerations will be provided on the webcast.
Notable announcements in the quarter:
The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investor Relations section of the company’s website at News Releases, as well as Innovative Medicine News Center, MedTech News & Events, www.factsabouttalc.com, and www.LLTManagementInformation.com.
Regulatory CHMP adopts positive opinion for BALVERSA (erdafitinib) for the treatment of adult patients with unresectable or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations
Press Release
RYBREVANT (amivantamab) in combination with chemotherapy is the first therapy approved by the European Commission for the first-line treatment of patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations
Press Release
Johnson & Johnson submits application to U.S. FDA seeking approval of TREMFYA (guselkumab) for the treatment of moderately to severely active Crohn’s disease
Press Release
Subcutaneous amivantamab Biologics License Application submitted to U.S. FDA for patients with EGFR-mutated non-small cell lung cancer
Press Release
DePuy Synthes Receives 510(k) FDA Clearance of the VELYS Robotic-Assisted Solution for Use in Unicompartmental Knee Arthroplasty Procedures
Press Release
Johnson & Johnson submits regulatory applications to European Medicines Agency for TREMFYA (guselkumab) for treatment of patients with ulcerative colitis and Crohn’s disease
Press Release
CARVYKTI (ciltacabtagene autoleucel; cilta-cel) is the first BCMA-targeted treatment approved by the European Commission for patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy
Press Release

Data Releases
CARVYKTI (ciltacabtagene autoleucel) achieved statistically significant and clinically meaningful improvement in overall survival in landmark CARTITUDE-4 study1
Press Release
Nipocalimab pivotal Phase 3 trial demonstrates longest sustained disease control in FcRn class for broadest population of myasthenia gravis patients
Press Release
TREMFYA (guselkumab) studies underscore its potential to be the only IL-23 inhibitor to offer both subcutaneous and intravenous induction
Press Release
Johnson & Johnson showcases innovation and leadership in rheumatology at EULAR 2024 Congress
Press Release
Johnson & Johnson pivotal study of seltorexant shows statistically significant and clinically meaningful improvement in depressive symptoms and sleep disturbance outcomes
Press Release
Johnson & Johnson advances leadership in oncology innovation with more than 75 clinical study and real-world presentations at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper)
Press Release
TREMFYA (guselkumab) demonstrates superiority versus STELARA (ustekinumab) in Phase 3 Crohn’s disease program
Press Release
TREMFYA (guselkumab) QUASAR Maintenance Study in UC met its primary endpoint and all major secondary endpoints, including highly statistically significant rates of endoscopic remission
Press Release
Biosense Webster Presents Late-Breaking Data from admIRE Clinical Trial at the Heart Rhythm Society Annual Meeting
Press Release
TAR-210 results show 90% recurrence-free survival and 90% complete response in patients with high-risk and intermediate-risk non–muscle-invasive bladder cancer, respectively
Press Release
Johnson & Johnson Highlights Commitment to Transform Treatment of Retinal Diseases at ARVO 2024
Press Release
Phase 2 data for ERLEADA (apalutamide) plus androgen deprivation therapy following radical prostatectomy in patients with high-risk localized prostate cancer show 100% biochemical free recurrence rate more than two years post-surgery
Press Release
TAR-200 monotherapy shows greater than 80% complete response rate in patients with high-risk non–muscle-invasive bladder cancer
Press Release
Product Launch Biosense Webster Launches New Version of CARTO 3 Electro-Anatomical Mapping System
Press Release
Other
Johnson & Johnson Strengthens Pipeline to Lead in Atopic Dermatitis With the Completion of the Acquisition of Yellow Jersey Therapeutics, Gaining Ownership of NM261
Press Release
Johnson & Johnson Completes Acquisition of Proteologix, Inc.
Press Release
Johnson & Johnson Completes Acquisition of Shockwave Medical
Press Release
Johnson & Johnson to Obtain Rights to a Clinical-Stage Bispecific Antibody to Address Distinct Patient Needs in Atopic Dermatitis
Press Release
Johnson & Johnson Announces Plan by its Subsidiary, LLT Management LLC, to Resolve All Current and Future Ovarian Cancer Talc Claims Through a Consensual "Prepackaged" Reorganization
Press Release

Webcast information:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investor Relations section of the company’s website at events-and-presentations.

On July 16, 2024 Genomics plc (Genomics), a healthcare company transforming health through the power of genomics reported a three-year extension of the company’s collaboration with Vertex Pharmaceuticals Incorporated (Vertex) (Nasdaq: VRTX) to use human genetics and machine learning to improve the discovery and development of new precision medicines (Press release, Vertex Pharmaceuticals, JUL 16, 2024, View Source [SID1234644900]). The partnership, which began in 2018, was previously extended in 2021. The collaboration will now run until 2026.

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The companies have been working together to support Vertex’s efforts to develop transformative medicines for serious diseases. To date, Genomics’ work has focused on using improved understanding of human genetics to pinpoint causal disease pathways and processes, and to identify novel targets in known and newly identified pathways.

As part of the extension, Genomics will expand the range of genomic insights it uses to support this work and expand the number of therapeutic areas under study. The partnership will now also explore using Genomics’ proprietary genetic tools to improve identification of patient populations and to de-risk the selection of biomarkers for measuring early readout of drug efficacy.

Mark Bunnage, Senior Vice President and Head of Global Research, Vertex:

"Vertex’s leading-edge discovery teams and R&D capabilities, and Genomics’ world class scientists, are at the forefront of using insights into human genetics to identify the most promising targets and advance them into medicines for patients. This collaboration has been valuable and productive, and we’re excited to continue and expand our transformative work right across the drug development pathway."

Professor Sir Peter Donnelly FRS, FMedSci, Founder and Chief Executive Officer, Genomics plc:

"We are proud to extend our partnership with Vertex once again. Our unique genomic data platform has meant that together, we have discovered novel genetically-validated targets with the potential to address diseases of high unmet medical need. Vertex is rightly recognized for its innovative pipeline and track record in developing treatments for serious diseases, which benefit the patients, families, and healthcare systems coping with these often life-threatening conditions. We are delighted to continue working with them to drive precision medicine approaches where treatments are tailored and delivered to those most likely to benefit."

On July 16, 2024 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, reported that it has received written approval from the GW University Hospital, UC Irvine and Northwell Health to proceed with its First-in-Human (FIH) Phase 2a clinical trial of HT-001 for the treatment of skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi) (Press release, Hoth Therapeutics, JUL 16, 2024, View Source [SID1234644901]).

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"We are very pleased to have received approval from these three world class medical centers for our FIH clinical trial," said Hoth Therapeutics Chief Executive Officer, Robb Knie. "We are hopeful that this trial will demonstrate successful delivery of our lead therapeutic candidate HT-001 and bring hope to cancer patients suffering from skin toxicities associated with EGFRi treatments."

This Phase 2a dose- ranging study to investigate the efficacy, safety, and tolerability of topical HT-001 for the treatment of skin toxicities associated with EGFRi. More information can be found at clinicaltrials.gov.

On July 16, 2024 Oncodesign Precision Medicine (OPM) (ISIN: FR001400CM63; Mnemonic: ALOPM), a biopharmaceutical company specializing in precision medicine for the treatment of resistant and metastatic cancers, reported positive results of phase 1 trial testing the drug candidate OPM-101, administered orally in single ascending doses (SAD) and multiple ascending doses (MAD), in healthy volunteers (HV) (Press release, Oncodesign, JUL 16, 2024, View Source [SID1234644902]).

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OPM-101 is an experimental, powerful and selective small molecule inhibitor of the RIPK2 kinase. OPM-101 is designed to modulate the pro-inflammatory signal transmission pathway of this kinase, which is responsible for the development of inflammatory diseases, and has the potential to treat diseases in the fields of IBD (Chronic Inflammatory Bowel Disease) and immuno-oncology. RIPK2 is a key protein in the regulation of immune responses and inflammatory processes. Recent research highlighted its potential as a therapeutic target, both in chronic inflammatory disorders and in several types of cancer.

This randomized, double-blind, placebo-controlled phase 1 study was designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of OPM-101 (EudraCT: 2022-003122-50) in 104 healthy volunteers (78 HV with OPM-101 and 26 with placebo):

In the SAD part of the trial, 72 HV (mean age = 34 years) received a single oral dose of placebo or 5, 20, 60, 150, 300, 600 or 1,000 mg of OPM-101, with one cohort dedicated to the high-fat meal effect and another to the gender effect.
In the MAD part of the trial, 32 HV (mean age = 36 years) received an oral dose of 75, 150 or 300 mg of OPM-101 or placebo twice daily for 14 consecutive days, including a cohort dedicated to the gender effect.
This phase 1 trial, which began in February 2023, was completed on schedule in June 2024.

The results of the SAD and MAD administrations in the clinical trial demonstrated that OPM-101 is well tolerated and significantly inhibits the RIPK2 pathway at doses as low as 60 mg single administration and 75 mg b.i.d. (bis in die – Twice daily). Target engagement kinetics and pharmacodynamic results showed a fast development of inhibitory effect, already observed 2 to 4 hours after the first administration, and inhibition maintained for 14 days of administration. The mean level of target engagement was 65% (75 mg b.i.d), 75% (150 mg b.i.d) and 85% (300 mg b.i.d) over the 14 days of treatment.

Safety evaluations (vital signs, blood tests, ECG, holters) were carried out regularly throughout the trial. The trial also collects secondary pharmacokinetic measures, including half-life assessments. Exploratory measures to assess OPM-101 target engagement were calculated by tracking changes from baseline in L18-MDP-stimulated TNFα production ex-vivo in whole blood samples.

The results of the MAD cohorts demonstrated maximum target engagement by OPM-101, demonstrated by a 90 to 100% reduction in TNFα production, leading to complete inhibition of stimulated production and a return to basal levels of TNFα, thus showing immunomodulation rather than total suppression of immunity as observed with other IBD treatments. This maximum engagement of the target was observed, depending on the dose, between 2 and 6 hours after the first administration of the treatment. Residual target engagement prior to the next dose was maintained over the 14 days of administration at mean levels of 65%, 75% and 85% with the 3 dose levels tested in MAD, respectively.

Involvement of the target in the MAD part of the study (inhibition of TNFα production induced by L18-MDP, in % of predose)

In the MAD part of the study, on Day 15, i.e., 24 hours after the last administration, 50%, 55% and 80% of target engagement were still observed in the three doses of MAD tested. At 48 hours after the last administration, target engagement levels gradually decreased as expected. These results demonstrate time- and dose-dependent target engagement. These proof-of-concept results for the immunomodulatory mechanism were obtained with oral administration of OPM-101 for 14 consecutive days, which was also generally well tolerated in all SAD and MAD cohorts.

No serious adverse event was reported. All treatment-emergent adverse events considered to be at least possibly related to the drug and the study were mild to moderate in both the SAD and MAD cohorts. Twelve healthy volunteers (15%) reported a total of 15 adverse events considered to be related to OPM-101. 80% of these events were mild and 20% moderate. There was no clinically significant change in safety-related laboratory tests reported during the treatment periods for all dose cohorts of OPM-101 included in the analysis, except for one volunteer who experienced a moderate (3N) increase in ALT (liver enzyme) during MAD, resulting in discontinuation of treatment after 12 days.

The pharmacokinetic results in the MAD part are consistent with those observed in the SAD part of the study. The main pharmacokinetic characteristics of OPM-101 are: fast absorption with a Tmax observed between 2-4h, a terminal half-life estimated at 12-13h, a steady state reached after 3-4 days and a dose-dependent exposure.

On the basis of the PK/PD correlation determined from the results of the SAD part of the study, we anticipate that a very significant target engagement (≥80%) can be achieved and maintained with a plasma concentration of OPM-101 remaining above 150 ng/mL in the interval between 2 treatment administrations. This threshold was achieved with the 2nd and 3rd dose levels in the MAD part of the study.

OPM plans to present additional results from the phase 1 cohorts at a future medical meeting in Q4 2024, subject to acceptance of the abstract by the United European Gastroenterology Week (UEGW) organizing committee.

Based on the results presented today, OPM plans to initiate enrolment in a phase 1b/2a clinical trial in the fourth quarter of 2024.

"We are very pleased with the progress and results of this clinical trial with OPM-101, which provided convincing results for all primary, secondary and exploratory endpoints included in this study," said Philippe Genne, Chief Executive Officer of OPM. "We are pleased to demonstrate the safety of our candidate and the strong PK/PD correlation that exists. High target engagement is demonstrated at tolerated doses of OPM-101 throughout the treatment period. The modulation of TNFα production ex vivo can be considered as a key biomarker of target engagement for future clinical trials. The clinical results reported today not only highlight the consistency with the immunomodulatory effect of OPM-101 observed in preclinical studies, but also validate OPM-101 as a safe and effective inhibitor of the RIPK2 pathway. We are currently in the process of identifying with our clinical experts the first clinical indication that we will explore in a phase 1b/2a study before the end of the year in order to provide a first clinical proof of concept in a patient population capable of generating significant added value for our asset".

"These results validate OPM-101 as a highly specific, effective and well-tolerated inhibitor of the RIPK2 immune pathway," added Jan Hoflack, Deputy CEO and Chief Scientific Officer of OPM. "The field related to this therapeutic approach is currently booming with new high quality preclinical and clinical scientific publications mentioning a potential role for an inhibitor like OPM-101 in multiple immuno-oncology indications, in addition to the already well-established rational for the treatment of IBD and other inflammatory diseases. Our team is currently working to validate the different therapeutic options available for OPM-101, with the aim of launching a proof-of-concept clinical trial in relevant patients rapidly and efficiently before the end of the year. The current idea of a safe and effective RIPK2 inhibitor like OPM-101 suggests significant potential in both IBD and immuno-oncology, two of today’s largest pharmaceutical markets with significant unmet needs".

On July 16, 2024 Scorpion Therapeutics, Inc. ("Scorpion"), a pioneering clinical-stage oncology company dedicated to transforming the lives of cancer patients by redefining the frontier of precision oncology, reported the closing of a $150 million Series C financing (Press release, Scorpion Therapeutics, JUL 16, 2024, View Source [SID1234644903]). The financing was co-led by Frazier Life Sciences and Lightspeed Venture Partners, and included additional new support from Willett Advisors and leading healthcare institutional investors, along with existing investors Omega Funds, Vida Ventures, Atlas Venture, Abingworth, Fidelity Management & Research Company, Boxer Capital, EcoR1 Capital, LLC, Surveyor Capital (a Citadel company), Invus, Wellington Management, Nextech Invest Ltd. (on behalf of one or more funds managed by it), OrbiMed, Logos Capital, Woodline Partners LP, and Casdin Capital, LLC. In connection with the financing, Shelley Chu, M.D., Ph.D., Partner at Lightspeed Venture Partners, will transition to an investor board member and Albert Cha, M.D., Ph.D., Managing Partner at Frazier Life Sciences, will join Scorpion’s board as an observer.

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"The robust demand for this capital raise is a testament to Scorpion’s continued clinical execution, the strength of our emerging clinical data, and the quality of our rapidly advancing pipeline," said Adam Friedman, M.D., Ph.D., Chief Executive Officer of Scorpion. "We are pleased to strengthen the Company’s financial position and expand Scorpion’s existing blue-chip investor syndicate with these additional leaders in life sciences who share our commitment to improving outcomes for people living with cancer by broadening the reach and impact of precision medicines."

"At Frazier Life Sciences, our goal is to invest in and develop transformational therapeutics companies. Scorpion continues to display an impressive track record of developing potentially best-in-class and first-in-class selective small molecule compounds for cancer," said Dr. Albert Cha. "With the combination of Scorpion’s clinical progress, advancing pipeline, validating partnerships and veteran leadership team, we believe the Company is well-positioned to rapidly develop therapeutics that will make a meaningful difference in patients’ lives."

"Lightspeed is pleased to support Scorpion through this important next phase of growth," said Dr. Shelley Chu. "The team has made remarkable progress since inception, and we believe Scorpion’s targeted approach may be able to overcome the selectivity challenges that plague existing treatment options, ultimately providing better outcomes to patients by offering improvements in both efficacy and safety. In particular, Scorpion’s mutant-selective PI3Kα inhibitor, STX-478, has the potential to become a best-in-class treatment for patients with PI3Kα-mutated breast cancer and other solid tumors, and we look forward to partnering with management to further explore STX-478 in mid-stage clinical trials."

Scorpion plans to use the proceeds from this financing to advance its pipeline of differentiated small molecule oncology programs, in particular, to expand clinical development of its allosteric, differentiated, mutant-selective PI3Kα inhibitor, STX-478. Further, the Company will continue to advance its clinical-stage EGFR inhibitor franchise, including STX-721 and STX-241, and its discovery pipeline of next-generation precision oncology therapies.

About STX-478

STX-478 was designed to improve outcomes in patients harboring PI3Kα mutations, one of the most prevalent drivers of cancer, occurring in over 166,000 patients per year with breast, gynecological and other solid tumors in the United States alone. In preclinical models, STX-478 demonstrated robust activity across a range of PI3Kα mutations while sparing wild-type PI3Kα inhibition in normal tissues; previous generations of non-selective PI3Kα inhibitors have limited patient benefit due to these on-target toxicities. Scorpion’s Phase 1/2 clinical trial is a multi-center, global, open-label study designed to evaluate the safety and tolerability of STX-478 in multiple ascending doses for patients with locally advanced or metastatic HR+/HER2- breast cancer and other solid tumors driven by PI3Kα mutations. The program entered the clinic in 2023 and has rapidly advanced, now in multiple expansion cohorts across a range of solid tumors and in breast cancer as monotherapy and in combinations with fulvestrant and CDK4/6 inhibitors. The Company remains on-track to disclose initial safety, pharmacokinetic and pharmacodynamic data, and preliminary efficacy data at a future academic conference. To learn more about the first-in-human trial of STX-478, please visit this page.