On February 25, 2025 Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) reported that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for its breakthrough investigational kidney cancer PET[1] imaging agent TLX250-CDx (Zircaix[2], 89Zr-DFO-girentuximab), granted a Priority Review and provided a PDUFA[3] date of 27 August 2025, paving the way for a U.S. commercial launch in 2025 (Press release, Telix Pharmaceuticals, FEB 25, 2025, View Source [SID1234650553]).

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If approved, TLX250-CDx will become the first commercially available imaging agent to accurately and non-invasively diagnose and characterize clear cell renal cell carcinoma (ccRCC), the most common and one of the most aggressive sub-types of kidney cancer. It works by specifically binding to carbonic anhydrase IX (CAIX), a validated target protein expressed on 95% of ccRCC cells to produce images with high tumor-to-background ratio and high intra- and inter-reader consistency.

The BLA is based on Telix’s successful global Phase 3 ZIRCON[4] study, which demonstrated a sensitivity of 86%, specificity of 87% and a positive predictive value (PPV) of 93% for ccRCC, including in very small, difficult-to-detect lesions[5]. The results of this study were published in The Lancet Oncology in September 2024, in a peer-reviewed manuscript by Professor Brian Shuch (University of California, Los Angeles, UCLA) and colleagues[6]. The paper outlines the critical unmet need for a new, non-invasive technique that can accurately detect and differentiate ccRCC from other renal masses in patients and concluded that TLX250-CDx meets this need and ‘has the potential to be practice changing.’

Kevin Richardson, Chief Executive Officer, Precision Medicine, said, "We are delighted that the FDA has accepted this BLA as it moves us one step closer to bringing our breakthrough product to patients. We are aiming to revolutionize the management of kidney cancer, just as PSMA-PET/CT[7] scanning has changed the management of prostate cancer. By providing a more definitive clinical diagnosis for renal masses, we believe that Zircaix[2] will help physicians make more timely and confident patient management decisions and more quickly provide patients with a clear understanding of their disease and treatment options. Building further on Telix’s successful urology franchise, we are preparing to bring this powerful precision medicine product to market in 2025[8]."

About TLX250-CDx

TLX250-CDx (Zircaix[2]) is an investigational PET agent that is under development for the diagnosis and characterization of ccRCC. Telix’s pivotal Phase 3 ZIRCON trial evaluating TLX250-CDx in 300 patients, of whom 284 were evaluable, met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% PPV for ccRCC across three independent radiology readers[5]. Telix believes this demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing and characterizing ccRCC. Confidence intervals exceeded expectations amongst all three readers, showing evidence of high accuracy and consistency of interpretation.

As part of Telix’s commitment to access to medicine, the Company operates an expanded access program (EAP) in the U.S.[9], named patient programs (NPPs) in Europe, and a special access scheme (SAS) in Australia to allow continued access to TLX250-CDx outside of a clinical trial, to patients for whom there are no comparable or satisfactory alternate options. TLX250-CDx has not received a marketing authorization in any jurisdiction and is for investigational use only.

On February 25, 2025 Astrazeneca reported positive high-level results from a planned interim analysis of the SERENA-6 Phase III trial showed that AstraZeneca’s camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) demonstrated a highly statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) (Press release, AstraZeneca, FEB 25, 2025, View Source [SID1234650552]). The trial evaluated switching to the camizestrant combination versus continuing standard-of-care treatment with an aromatase inhibitor (AI) (anastrozole or letrozole) in combination with a CDK4/6 inhibitor in the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumours have an emergent ESR1 mutation.

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The key secondary endpoints of time to second disease progression (PFS2) and overall survival (OS) were immature at the time of this interim analysis. However, the camizestrant combination demonstrated a trend toward improvement in PFS2. The trial will continue as planned to further assess key secondary endpoints.

SERENA-6 is the first global, double-blind, registrational Phase III trial to use a circulating tumour DNA (ctDNA)-guided approach to detect the emergence of endocrine resistance and inform a switch in therapy before disease progression. The novel trial design used ctDNA monitoring at the time of routine tumour scan visits to identify patients for early signs of endocrine resistance and the emergence of ESR1 mutations. Following detection of an ESR1 mutation without disease progression, the endocrine therapy of patients was switched to camizestrant from ongoing treatment with an AI, while continuing combination with the same CDK4/6 inhibitor.

François-Clément Bidard, MD, PhD, Professor of Medical Oncology at Institut Curie & UVSQ/Université Paris-Saclay, France, and co-principal investigator for the trial, said: "Patients have an urgent need for new treatments that delay disease progression on 1st-line endocrine-based therapies. The results from SERENA-6 show that switching from an aromatase inhibitor to camizestrant in combination with any of the three CDK4/6 inhibitors after emergence of an ESR1 mutation delays progression of disease and extends the benefit of 1st-line treatment, representing an important step forward for patients, and a potential shift in clinical practice."

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "These impressive results demonstrate the versatility of camizestrant in combination with all the widely approved CDK4/6 inhibitors to provide a well-tolerated new potential treatment option in the first-line setting for the one in three patients with HR-positive, HER2-negative advanced breast cancer whose tumours develop ESR1 mutations during treatment with an aromatase inhibitor in combination with a CDK4/6 inhibitor. This critical read-out moves us one step closer to realising the potential of camizestrant to become a new standard-of-care as we look to shift the treatment paradigm and establish this new endocrine therapy backbone in HR-positive breast cancer."

The safety profile of camizestrant in combination with palbociclib, ribociclib or abemaciclib in SERENA-6 was consistent with the known safety profile of each medicine. No new safety concerns were identified and discontinuations were very low and similar in both arms.

Globally, approximately 200,000 patients with HR-positive breast cancer are treated with a medicine in the 1st-line setting; most frequently with endocrine therapies that target estrogen receptor (ER)-driven disease, which are often paired with CDK4/6 inhibitors.1-3 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease.3

Mutations in the ESR1 gene are a key driver of endocrine resistance and are widely tested for in clinical practice.4,5 These mutations develop during treatment of the disease, becoming more prevalent as the disease progresses and are associated with poor outcomes.4,5 Approximately 30% of patients with endocrine sensitive HR-positive disease develop ESR1 mutations during 1st-line treatment without disease progression.1

Data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.

Notes

HR-positive breast cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.6 More than two million patients were diagnosed with breast cancer in 2022, with more than 665,000 deaths globally.6 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.7

HR-positive breast cancer, characterised by the expression of estrogen or progesterone receptors, or both, is the most common subtype of breast cancer with 70% of tumours considered HR-positive and HER2-negative.7 ERs often drive the growth of HR-positive breast cancer cells.8

Once resistance to the treatment of HR-positive breast cancer with CDK4/6 inhibitors and current endocrine therapies occurs, treatment options are limited and survival rates are low with 35% of patients anticipated to live beyond five years after diagnosis.3,7,9 The optimisation of endocrine therapy and overcoming resistance to enable patients to continue benefiting from these treatments, as well as identifying new therapies for those who are less likely to benefit, are active areas of focus for breast cancer research.

SERENA-6
SERENA-6 is a Phase III, double-blind, randomised trial evaluating the efficacy and safety of camizestrant in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib ) versus treatment with an AI (anastrozole or letrozole) in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) in patients with HR-positive, HER2-negative advanced breast cancer (patients with either locally advanced disease, or metastatic disease) whose tumours have an emergent ESR1 mutation.

The global trial enrolled 315 adult patients with histologically confirmed HR-positive, HER2-negative advanced breast cancer, undergoing treatment with an AI in combination with a CDK4/6 inhibitor as 1st-line treatment. The primary endpoint of the SERENA-6 trial is PFS as assessed by investigator, with secondary endpoints including OS, and PFS2 by investigator assessment.

Camizestrant
Camizestrant is an investigational, potent, next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist that is currently in Phase III trials for the treatment of HR-positive breast cancer.

AstraZeneca’s broad, robust and innovative clinical development programme, including the SERENA-6, SERENA-4, CAMBRIA-1 and CAMBRIA-2 trials, is evaluating the safety and efficacy of camizestrant when used as a monotherapy or in combination with other agents to address a number of areas of unmet need in this specific type of breast cancer.

Camizestrant has demonstrated anti-cancer activity across a range of preclinical models, including those with ER-activating mutations. In the SERENA-2 Phase II trial, camizestrant demonstrated PFS benefit versus Faslodex (fulvestrant) irrespective of ESR1 mutation status or prior treatment with CDK4/6 inhibitors in patients with ER-positive locally advanced or metastatic breast cancer, previously treated with endocrine therapy. The SERENA-1 Phase I trial demonstrated that camizestrant is well tolerated and has a promising anti-tumour profile when administered alone or in combination with palbociclib, ribociclib and abemaciclib; three widely used CDK4/6 inhibitors. Combinations with other agents are ongoing in SERENA-1.

On February 25, 2025 Oncotelic Therapeutics, Inc. (OTCQB:OTLC). Oncotelic Therapeutics Inc., a leader in RNA-based therapeutics, including its subsidiaries ("Oncotelic") and including Sapu Bioscience, LLC ("SAPU"), a wholly owned subsidiary of GMP Biotechnology Limited in which Oncotelic is a 45% owner, reported a strategic partnership with Shanghai Medicilon Inc. ("Medicilon") (stock code: 688202.SH) (Press release, Oncotelic, FEB 25, 2025, View Source [SID1234650551]). Through this collaboration, Oncotelic and SAPU will utilize Medicilon’s industry-leading rapid IND development platform to support up to 20 Investigational New Drug (IND) projects. Six of these INDs are ongoing and are focused on next-generation anticancer agents.

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Oncotelic and SAPU’s partnership with Medicilon is poised to significantly accelerate the development of our innovative oncology pipeline. This collaboration reflects our strategic move to strengthen our position as a leader in novel cancer therapies.

Enabling Rapid Growth: Medicilon’s integrated platform for drug discovery, pharmaceutical research, and preclinical development will expedite the regulatory pathways for Oncotelic’s and SAPU’s upcoming IND submissions.

Portfolio Expansion: This initiative will initially focus on the current six INDs but has the potential to extend up to 20 projects, reflecting the depth of Oncotelic’s and its affiliates’ R&D programs.

Dr. Vuong Trieu, Chairman and CEO of Oncotelic and SAPU, stated, "This partnership is poised to be a game-changer for our development programs. The ability to access a rapid IND-enabling platform is crucial for accelerating SAPU’s and Oncotelic’s development programs. We look forward to continued success working with Medicilon as we advance innovative anticancer agents to the clinic."

Dr. Chen Chunlin, Founder and CEO of Medicilon, remarked, "We are excited to partner with Oncotelic and SAPU and contribute our international experience in drug R&D. We are a comprehensive, one-stop services organization, from early discovery to IND registration, built to accelerate the translation of Oncotelic and SAPU’s pipeline into new therapeutic options for patients."

On February 25, 2025 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported financial results for fourth quarter and full year 2024 and associated Company developments (Press release, Supernus, FEB 25, 2025, View Source [SID1234650545]).

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"Our 2024 results reflect solid commercial execution across the company, including continued growth of our core products, and strong growth in operating earnings," said Jack Khattar, President and CEO of Supernus. "In 2025, we look forward to continued Qelbree growth; the launch of ONAPGO for the treatment of Parkinson’s disease, planned for the second quarter of 2025; and further advancement of our product pipeline."

Qelbree Highlights

The U.S. Food and Drug Administration (FDA) has approved an update for the label for Qelbree to include new pharmacodynamic data. The updated label highlights Qelbree’s partial agonist activity at the serotonin 5-HT2C receptor and inhibition of the norepinephrine transporter, reinforcing its multimodal pharmacodynamic profile. Additionally, the updated label now includes new lactation data for breastfeeding women with attention-deficit/hyperactivity disorder (ADHD), showing that the transfer of Qelbree into breastmilk is low.

The Company recently presented interim results from an open-label Phase IV trial with Qelbree in 161 adults with ADHD and mood symptoms at the 30th Annual National Psychopharmacology Update conference. The improvements in clinician and patient-rated measures of ADHD, depression and anxiety symptoms in the interim data analysis, analyzed for the first 95 patients who completed the trial, are encouraging and suggest that Qelbree’s effects may extend to adults with complex ADHD. Efficacy and safety outcomes were consistent with the double-blind, pivotal trial of Qelbree in adult ADHD. Topline results from the full Phase IV trial (all 161 adults) are consistent with the interim results and will be presented at the American Psychiatric Association Annual Meeting in May 2025.

Total IQVIA prescriptions(2) for Qelbree were 214,613 and 767,791 for the fourth quarter and full year of 2024, respectively, an increase of 25% for both periods compared to the same periods in the prior year.

The Company received a two-plus year patent term extension from the US Patent and Trademark Office for US Patent number 9,662,338 that covers Qelbree. This extends the original expiration date of the patent to the year 2035.
Product Pipeline Update

ONAPGO (formerly, SPN-830) (apomorphine infusion device) for treatment of Parkinson’s disease (PD)

The Company announced in early February 2025 that the FDA approved ONAPGO (apomorphine hydrochloride), formerly known as SPN-830, as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced PD. The Company plans to launch ONAPGO in the second quarter of 2025 with a support team of experts, including a robust nurse education program, and access support.
SPN-817 – Novel first-in-class highly selective AChE inhibitor for epilepsy

In November 2024, the Company reported topline results from an open label Phase 2a study in patients with treatment-resistant seizures. The study suggested a differentiated profile, with strong efficacy in focal seizures at the 3mg to 4mg twice daily doses. SPN-817 was safe and had acceptable tolerability with two subjects discontinuing because of treatment related adverse events out of the 26 subjects who entered the maintenance period.

The Company has initiated a Phase 2b randomized, double-blind, placebo-controlled study of 3mg and 4mg twice daily doses with a targeted enrollment of approximately 258 adult patients with treatment resistant focal seizures.
SPN-820 – Novel first-in-class molecule that increases mTORC1 mediated synaptic function for depression

In February 2025, the Company reported topline results from a randomized double-blind placebo-controlled Phase 2b study of SPN-820 in adults with treatment-resistant depression (TRD). The study did not demonstrate a statistically significant improvement on the primary and secondary endpoints. The safety profile of SPN-820 was consistent with previous clinical trials, showing few adverse events. The Company will continue to analyze the data and decide on the future of the program.
SPN-443 – Novel stimulant for ADHD/CNS

Supernus completed a Phase 1 pharmacokinetic study of two oral formulations in healthy adults. Both formulations of SPN-443 showed adequate bioavailability and were well tolerated.
Financial Highlights

This section includes information on non-GAAP financial measures. See "Non-GAAP Financial Information" section for information on non-GAAP financial measures. In addition, a reconciliation of applicable GAAP to non-GAAP financial information is included at the end of this press release.

Revenues

The following table provides information regarding total revenues (dollars in millions):

Three Months Ended December 31, Year Ended
December 31,
2024 2023 Change % 2024 2023 Change %
Net product sales
Qelbree $ 74.4 $ 46.4 60% $ 241.3 $ 140.2 72%
GOCOVRI 36.9 32.0 15% 130.8 119.6 9%
Oxtellar XR 13.2 31.0 (57)% 99.5 113.4 (12)%
APOKYN 20.1 18.7 8% 73.9 75.1 (2)%
Trokendi XR 14.8 19.6 (24)% 63.2 94.3 (33)%
Other(3) 7.0 8.3 (16)% 29.0 31.3 (7)%
Total net product sales $ 166.4 $ 156.0 7% $ 637.7 $ 573.9 11%
Royalty, licensing and other revenues(4) 7.8 8.3 (6)% 24.1 33.6 (28)%
Total revenues $ 174.2 $ 164.3 6% $ 661.8 $ 607.5 9%

Total revenues excluding Trokendi XR and Oxtellar XR net product sales (non-GAAP)(1) $ 146.2 $ 113.7 29% $ 499.1 $ 399.8 25%
Total revenues were $174.2 million and $661.8 million for the three and twelve months ended December 31, 2024, compared to $164.3 million and $607.5 million in the same periods in 2023, respectively.
Total net product sales were $166.4 million and $637.7 million for the three and twelve months ended December 31, 2024, compared to $156.0 million and $573.9 million in the same periods in 2023, respectively. The increase in both periods was primarily due to increases in net sales of Qelbree and GOCOVRI, partially offset by the decline in net product sales of Trokendi XR and Oxtellar XR due to generic erosion.
Total revenues excluding Trokendi XR and Oxtellar XR net product sales (non-GAAP) increased 29% and 25% for the three and twelve months ended December 31, 2024, compared to the same periods in 2023, respectively.
Other Financial Highlights

Operating earnings were $21.4 million and $81.7 million for the three and twelve months ended December 31, 2024, compared to operating loss of $(1.0) million and $(5.3) million for the same periods in 2023, respectively. The positive increase in both periods was primarily due to an increase in total net product sales. Furthermore, the fourth quarter of 2023 included $20.2 million in intangible asset impairment charges, mainly related to XADAGO.
Adjusted operating earnings (non-GAAP) were $48.3 million and $183.7 million for the three and twelve months ended December 31, 2024, compared to $47.1 million and $125.1 million for the same periods in 2023, respectively.
Net earnings and diluted earnings per share were $15.3 million and $0.27 for the three months and $73.9 million and $1.32 for the twelve months ended December 31, 2024, respectively, compared to net earnings and diluted earnings per share of $1.2 million and $0.02 for the three months and $1.3 million and $0.02 for the twelve months ended December 31, 2023, respectively.
At December 31, 2024, cash, cash equivalents, and current and long-term marketable securities were approximately $453.6 million compared to $271.5 million as of December 31, 2023. This increase was primarily due to cash generated from operations.
Full Year 2025 Financial Guidance

For the full year 2025, the Company is providing the financial guidance for total revenues and operating earnings (GAAP and Non-GAAP) as set forth below (dollars in millions):

Current Guidance
(as of February 25, 2025)
Total revenues (includes approximately $65 million – $75 million of Trokendi XR and Oxtellar XR)(5)(6) $600 – $630
Combined R&D and SG&A expenses $435 – $460
Operating earnings (loss) $(15) – $10
Adjusted operating earnings (non-GAAP)(1) $105 – $130
Non-GAAP Financial Information

This press release contains financial measures that present financial information which do not comply with United States generally accepted accounting principles (GAAP). The non-GAAP financial measures should be considered in addition to, not as a substitute for or in isolation from, or superior to measures prepared in accordance with GAAP. Non-GAAP adjusted operating earnings on a historical and projected basis adjusts for non-cash share-based compensation expense, depreciation and amortization, intangible asset impairment charges and changes to fair value of contingent consideration, and for factors that are unusual, non-recurring or unpredictable, and excludes those costs, expenses, and other specified items presented in the reconciliation tables in this press release. In addition to non-GAAP adjusted operating earnings, we also present total revenues excluding net product sales of Trokendi XR (GAAP) and Oxtellar XR (GAAP), which is a non-GAAP measure and is calculated as total revenues (GAAP) less net product sales of Trokendi XR (GAAP) and Oxtellar XR (GAAP). Beginning in the year a product loses exclusivity due to generic entrants we generally do not expect net product sales of such products to constitute a significant part of our revenue in the future. We believe that the use of non-GAAP financial measures provides useful supplemental information to management, investors, analysts and others regarding the Company’s revenue and results of operations and assist management, investors, analysts, and others in understanding and evaluating our revenue growth and the performance of the business.

There are limitations associated with the use of non-GAAP financial measures and therefore comparability may be limited. These limitations include: non-GAAP financial measures that may not be entirely comparable to similarly titled measures used by other companies; these may not reflect all items of income and expense, as applicable, that affect our operations; there may be potential differences among calculation methodologies; these may differ from the non-GAAP information used by other companies, including peer companies. We mitigate these limitations by reconciling the non-GAAP financial measure to the most comparable GAAP financial measure. Investors are encouraged to review the reconciliation. The Company’s 2024 financial guidance is also being provided on both a GAAP and a non-GAAP basis.

End Notes
(1) See the section titled "Non-GAAP Financial Information" for information about this non-GAAP financial measure. A reconciliation of each non-GAAP financial measure to the most directly comparable GAAP financial measure is included at the end of this press release.
(2) IQVIA data restatement July 1, 2024.
(3) Includes net product sales of MYOBLOC, XADAGO and Osmolex ER.
(4) Royalty, licensing, and other revenues include royalties on generic Trokendi XR, other licensed products and intellectual property.
(5) Includes net product sales and royalty, licensing, and other revenue.
(6) Reflects continued generic erosion of Trokendi XR and generic erosion of Oxtellar XR beginning in September 2024.

Conference Call Details

Supernus will host a conference call and webcast today, February 25, 2025, at 4:30 p.m. Eastern Time to discuss these results.
A live webcast will be available in the Events & Presentations section of the Company’s Investor Relations website www.supernus.com/investors.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company’s Investor Relations website www.supernus.com/investors. The webcast will be available on the Company’s website for 60 days following the live call.

On February 25, 2025 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported focused registrational clinical development plans for its two lead programs, an extension of projected cash runway into 2027 (from previous guidance of late 2026), and accelerated/augmented corporate milestones (Press release, ORIC Pharmaceuticals, FEB 25, 2025, View Source [SID1234650544]).

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"Based on the initial data we have generated with ORIC-944 and ORIC-114 and recent clinical data reported with other programs in mCRPC and NSCLC, we have refined our registrational plans to focus on the most promising opportunities for both programs," stated Jacob M. Chacko, M.D., president and chief executive officer. "For ORIC-944, based on both internal and external data that validate the combination of PRC2 inhibitors with AR inhibitors in mCRPC, we intend to initiate our first Phase 3 trial in 1H 2026. For ORIC-114, we intend to initiate registrational trial(s) in 2026 with a focus on areas of highest unmet need in first-line NSCLC settings. With these focused registrational plans, we have extended our projected cash runway into 2027."

Registrational Clinical Development Plans and Updated Corporate Milestones:

ORIC-944: a potent and selective allosteric inhibitor of PRC2

Given the recently reported encouraging early safety and efficacy data from an ongoing dose escalation trial for ORIC-944 in combination with apalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) and favorable enrollment trends, ORIC now expects to report dose escalation data of ORIC-944 both in combination with apalutamide and in combination with darolutamide in 1H 2025, followed by an additional update in 2H 2025.
Expected timing for the previously communicated milestone of ORIC-944 dose optimization data in combination with AR inhibitor(s) has been accelerated/narrowed to 4Q25 or 1Q26 (previously 4Q25 or 1H 2026).
ORIC expects to initiate its first Phase 3 trial for ORIC-944 in mCRPC in 1H 2026.
ORIC-114: a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor

Given favorable enrollment for ORIC-114 in the 1L EGFR exon 20 monotherapy cohort and the 2L+ atypical EGFR cohort, ORIC now expects to provide a comprehensive data update during 2H 2025 that will include these two cohorts along with cohorts for 2L EGFR exon 20 and 2L+ HER2 exon 20.
ORIC-114 in combination with subcutaneous (SC) amivantamab in patients with 1L EGFR exon 20 has recently been initiated. Initial data from this trial in addition to ORIC-114 data as a monotherapy in 1L EGFR atypical mutations are expected in mid-2026.
ORIC expects to initiate Phase 3 trial(s) for ORIC-114 in 1L NSCLC in 2026, in EGFR exon 20, HER2 exon 20, and/or atypical EGFR mutations. ORIC does not currently plan to pursue registrational trials of ORIC-114 in 2L EGFR and 2L+ HER2 exon 20 NSCLC given the more significant commercial opportunity in first-line settings and the current state of capital markets.
Corporate Highlights:

Cash, cash equivalents and investments totaled $256 million as of December 31, 2024; based on the refined operating plan, projected cash runway has been extended into 2027.