On August 13, 2026 Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, reported financial results for the second quarter ended June 30, 2026 and other recent business developments.

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"Celcuity made monumental progress these past few months, achieving critical clinical and regulatory milestones related to gedatolisib. With the FDA approval of REVTORPYK, positive results from the PIK3CA MT cohort of the pivotal VIKTORIA-1 study, and a preferred Category 1 recommendation in the NCCN Guidelines, we are well positioned to address a significant unmet need for the tens of thousands of patients affected each year by HR+/HER2-, locally advanced or metastatic breast cancer whose disease has progressed after endocrine therapy," said Brian Sullivan, CEO and co-founder of Celcuity. "We are on track to begin shipping REVTORPYK late in the third quarter of 2026, and we look forward to making this important therapy available to patients with locally advanced or metastatic breast cancer."

Mr. Sullivan added, "Based on the positive data from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 study, we plan to submit an sNDA to FDA in the third quarter of 2026. Additionally, our VIKTORIA-2 study was expanded to enable evaluation of treatment-naive patients who have endocrine-sensitive breast cancer, positioning gedatolisib regimens to potentially be available for nearly all patients in the first- and second-line setting, irrespective of their endocrine sensitivity or PIK3CA mutation status."

Clinical Highlights

HR+/HER2- Advanced Breast Cancer

2nd Line Setting – PIK3CA Wild-Type

Following the unprecedented results from the PIK3CA WT cohort of the VIKTORIA-1 Phase 3 clinical trial, on July 14, 2026 Celcuity announced that the U.S. Food and Drug Administration ("FDA") had approved REVTORPYK, the company’s pan-PI3K, mTORC1/2 inhibitor, for the treatment of patients with hormone receptor positive ("HR+"), human epidermal growth factor 2 receptor negative ("HER2-"), locally advanced or metastatic breast cancer ("ABC") without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.

Celcuity subsequently announced that REVTORPYK in combination with fulvestrant, with or without palbociclib, was recommended by the National Comprehensive Cancer Network ("NCCN") as a preferred Category 1 second-line and/or subsequent-line therapy for the treatment of patients with HR+/HER2- breast cancer without a PIK3CA mutation following progression on or after treatment with at least one line of endocrine therapy.

The build-out of the commercialization infrastructure needed to support a successful launch of REVTORPYK is complete and commercial launch activities for REVTORPYK commenced immediately after approval. Shipments of REVTORPYK are expected to begin late in the third quarter of 2026.

To make gedatolisib available to patients prior to commercial availability of REVTORPYK, last week Celcuity opened an Expanded Access Program (EAP) to participating physicians on behalf of eligible patients, and we have begun to distribute gedatolisib to those physicians.

2nd Line Setting – PIK3CA Mutant-Type

Gedatolisib continued to demonstrate a differentiated clinical profile across different patient populations when combined with fulvestrant, with or without palbociclib. At the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting, detailed results from the PIK3CA MT cohort of the global VIKTORIA-1 Phase 3 study were presented at a late-breaking abstract Oral Session. The study demonstrated statistically significant and clinically meaningful improvements in the primary endpoint of progression-free survival ("PFS") compared with alpelisib plus fulvestrant, with a manageable safety profile.

Gedatolisib plus fulvestrant and palbociclib (the "gedatolisib-triplet") reduced the risk of disease progression or death by 50% vs. alpelisib plus fulvestrant (HR=0.50; 95% CI: 0.37–0.68; p<0.0001). Median PFS was 11.1 months with the gedatolisib triplet versus 5.6 months with alpelisib plus fulvestrant. Gedatolisib plus fulvestrant (the "gedatolisib-doublet") reduced the risk of disease progression or death by 49% vs. alpelisib plus fulvestrant (HR=0.51; 95% CI: 0.33–0.79; descriptive p=0.0013). Median PFS was 11.3 months with the gedatolisib-doublet versus 5.6 months with alpelisib plus fulvestrant. Gedatolisib regimens demonstrated robust and durable responses: 49% objective response rate ("ORR") and median duration of response ("DoR") of 15.7 months for the gedatolisib-triplet and 36% ORR and median DoR of 24.2 months for the gedatolisib-doublet.

The safety data for the gedatolisib-triplet and -doublet were consistent with previously reported data from the PIK3CA wild-type cohort of VIKTORIA-1. Analyses of the treatment discontinuation rate due to an adverse event for gedatolisib and alpelisib in the PIK3CA MT cohort were updated using the same methodology that determined the discontinuation rate due to an adverse event for the PIK3CA WT cohort presented in the REVTORPYK label. For patients who received the gedatolisib triplet and gedatolisib doublet, 5.2% and 3.8% of patients discontinued gedatolisib due to an adverse event, respectively. For patients who received alpelisib, 19.1% discontinued treatment with alpelisib due to an adverse event.

Celcuity intends to submit these data to the FDA in the third quarter as an sNDA and to submit VIKTORIA-1 data to other regulatory authorities outside the U.S. following the sNDA submission.

Analyses of the mean number of gedatolisib treatment cycles patients received in the PIK3CA WT and MT cohorts of the VIKTORIA-1 Phase 3 trial were also updated as of August 2, 2026, with a median follow-up period of approximately 21 months and 17 months for the PIK3CA WT and MT cohorts, respectively. For patients who received the gedatolisib-triplet, the mean number of treatment cycles on gedatolisib was 9.0 and 10.0 cycles in the PIK3CA WT and MT cohorts, respectively, with 12% (16) and 22% (34) of patients still receiving gedatolisib therapy in each cohort, respectively. For patients who received the gedatolisib-doublet, the mean number of treatment cycles on gedatolisib was 9.7 and 11.3 cycles in the PIK3CA WT and MT cohorts, respectively, with 12% (15) and 19% (10) of patients still receiving gedatolisib therapy in each cohort, respectively.

Celcuity expects to provide further updates to results from both the PIK3CA MT and WT cohorts of VIKTORIA-1 at medical conferences in the fourth quarter.

1st Line Setting

Celcuity continues to advance gedatolisib combined with palbociclib and endocrine therapy in the first-line setting for patients with HR+/HER2- ABC through its ongoing Phase 3 VIKTORIA-2 clinical trial. The VIKTORIA-2 trial was expanded in the second quarter 2026 to include a second study (Study 2) evaluating the efficacy and safety of gedatolisib in combination with palbociclib and letrozole in patients with treatment-naive endocrine-sensitive HR+/HER2- ABC. Study 1 of the VIKTORIA-2 trial is evaluating gedatolisib in combination with palbociclib and fulvestrant in patients with treatment-naive endocrine-resistant HR+/HER2- ABC.

Metastatic Castration-Resistant Prostate Cancer ("mCRPC")

Development of gedatolisib in combination with darolutamide continues to advance. In the dose finding portion of Celcuity’s Phase 1b study, evaluation of a 240 mg dose of gedatolisib was completed. No adverse events led to treatment discontinuation of gedatolisib and dose limiting toxicity criteria for dose reduction were not met. Evaluation of a 300 mg dose is ongoing. Once the Phase 1/1b portion of the study is completed, Celcuity expects to select the recommended phase 2 dose level(s) and control arm options for the randomized Phase 2 portion of the study. The company expects to provide updated clinical data and additional visibility into its mCRPC development strategy during the fourth quarter of 2026.

Other Recent Developments

In June 2026, the Company conducted a public offering of 0.250% convertible senior notes due 2032. The net proceeds from the offering were $557.2 million, after deducting underwriting discounts and commissions and the Company’s estimated offering expenses. The Company utilized $137.0 million of the net proceeds to prepay term loan debt.

Celcuity’s advancement of a subcutaneous gedatolisib formulation is ongoing with the goal of demonstrating clinical equivalence to the current intravenous formulation of gedatolisib. The subcutaneous formulation is aimed to support potential future indications for gedatolisib regimens that may result in duration of treatment periods greater than several years.

Second Quarter 2026 Financial Results

Unless otherwise stated, all comparisons are for the second quarter ended June 30, 2026, compared to the second quarter ended June 30, 2025.

Net loss for the second quarter of 2026 was $78.9 million, or $1.44 per share, compared to a net loss of $45.3 million, or $1.04 per share, for the prior year period. Non-GAAP adjusted net loss for the second quarter of 2026 was $58.7 million, or $1.07 per share, compared to non-GAAP adjusted net loss of $40.5 million, or $0.93 per share, for the prior year period. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, non-cash investment (income) expense and loss on debt extinguishment. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States ("GAAP") to non-GAAP financial measures, please see the financial tables at the end of this press release.

Total operating expenses were $66.1 million for the second quarter of 2026, compared to $44.0 million for the prior year period.

Research and development ("R&D") expenses were $31.1 million for the second quarter of 2026, compared to $36.4 million for the prior year period. The $5.3 million decrease in R&D expenses was primarily due to a $7.0 million decrease in clinical trial costs, which was primarily driven by decreased costs for the VIKTORIA-1 Phase 3 clinical trial, and a $5.0 million decrease in license milestone costs. These decreases were partially offset by a $3.8 million increase in employee-related and consulting expenses, of which $0.9 million related to stock-based compensation, and a $2.9 million increase in manufacturing and other costs.

Selling, general and administrative ("SG&A") expenses were $35.0 million for the second quarter of 2026, compared to $7.6 million for the prior year period. The $27.4 million increase in SG&A expenses was primarily due to a $14.5 million increase in employee-related expenses, of which $3.3 million related to stock-based compensation. The increase in employee-related expenses was primarily driven by the hiring of additional personnel within our commercial function to support the anticipated launch of REVTORPYK. The remaining $12.9 million increase was primarily due to a $10.8 million increase in costs to support pre-commercial launch activities, including consulting expenses, professional fees and expanding infrastructure costs, and a $2.1 million increase in other administrative expenses. In the aggregate, $23.4 million of the $27.4 million SG&A increase related to commercial headcount additions and other launch-related activities.

Net cash used in operating activities for the second quarter of 2026 was $55.4 million, compared to $36.2 million for the prior year period. Cash, cash equivalents and short-term investments were $754.0 million at the end of the second quarter of 2026. We expect that our current cash, cash equivalents and short-term investments will finance our operations at least into 2029.

Webcast and Conference Call Information

To participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865.

A live webcast presentation can also be accessed using this weblink: View Source;tp_key=7e57f2ab18. A replay of the webcast will be available on the Celcuity website following the live event.

About REVTORPYK (gedatolisib)

REVTORPYK (gedatolisib) is a kinase inhibitor indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.

Please click here for Important Safety Information and Full Prescribing Information for REVTORPYK.

(Press release, Celcuity, AUG 13, 2026, View Source [SID1234670094])

On August 13, 2026 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported financial results for the second quarter of 2026 and provided an update on commercial execution for ZEVASKYN (prademagene zamikeracel).

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Commercial Update

Steady launch-year growth for ZEVASKYN. Commercial execution continued to strengthen during the second quarter of 2026 with five patients treated with ZEVASKYN. In the third quarter of 2026 to-date, three patients have completed treatments. Since launch, 12 patient treatments have been completed. Revenue was not recognized for two patients due to low manufacturing yield or not meeting lot release specifications.

Expanded qualified treatment center (QTC) network and increased patient onboarding. Abeona continues to expand the ZEVASKYN QTC network, and the number of QTCs that have treated patients with ZEVASKYN has increased. Key recent milestones include:

NewYork-Presbyterian/Columbia University Irving Medical Center and Children’s Hospital of Philadelphia (CHOP) were activated as QTCs during the second quarter of 2026.
CHOP and University of Texas Medical Branch (UTMB) have commenced collection of patient biopsies, and CHOP has treated its first patient with ZEVASKYN.
In the third quarter of 2026, Abeona announced the activation of Cincinnati Children’s as the newest ZEVASKYN QTC. Cincinnati Children’s is one of the largest epidermolysis bullosa treatment centers in the U.S.
Secured CMS New Technology Add-On Payment (NTAP) status for ZEVASKYN. Effective October 1, 2026, ZEVASKYN will have NTAP status under the fiscal year 2027 Hospital Inpatient Prospective Payment System Final Rule from the Centers for Medicare & Medicaid Services (CMS). NTAP provides a pathway for eligible hospitals to receive a supplemental payment from CMS, in addition to the base diagnosis-related group (DRG) payment, when treating Medicare beneficiaries with ZEVASKYN. This designation is expected to support hospital adoption and help facilitate access for Medicare patients, who represent approximately 10 percent of RDEB patients.

Continued engagement raising RDEB community awareness. The Company presented 5-year long-term follow-up data after ZEVASKYN application from the VIITAL Phase 3 clinical study and a case report from the longest follow-up of 12 years from the Phase 1/2a study. Presentations were made at key medical congresses, including the Society for Investigative Dermatology (SID) and Society for Pediatric Dermatology (SPD) annual meetings, as well as the debra Care Conference, to drive physician awareness, patient identification, and enable patient referral to the expanding QTC network.

"Our confidence in ZEVASKYN’s substantial opportunity is reinforced by our launch progress and experience to date as we engage with a growing number of patients and expand our QTC network," said Vish Seshadri, Ph.D., Chief Executive Officer of Abeona Therapeutics. "As early real-world experience with ZEVASKYN matures across activated sites, we expect to drive broader adoption and long-term growth."

Second Quarter 2026 Financial Results

Net ZEVASKYN revenue for the quarter ended June 30, 2026 increased 31% quarter-over-quarter to $11.4 million, compared to $8.7 million in the first quarter of 2026. While five patients were treated with ZEVASKYN during the second quarter of 2026, revenue was recognized for four treatments as one batch yielded fewer than the threshold number of sheets for revenue recognition.

Research and development (R&D) expenses were $5.0 million for the second quarter of 2026 compared to $9.6 million in the first quarter of 2026, which included the one-time, up-front cost of $7.0 million for in-licensing ABO-701.

Selling, general and administrative expenses were $15.8 million for the second quarter of 2026, compared to $19.5 million for the first quarter of 2026. The decrease primarily reflects fewer engineering runs and less manufacturing training costs in the second quarter of 2026.

Net loss was $(20.2) million, or $(0.35) per basic and diluted common share, for the quarter ended June 30, 2026. Net loss for the first quarter of 2026 was $(17.1) million, or $(0.30) per basic and diluted common share.

Cash, cash equivalents and short-term investments totaled $146.8 million as of June 30, 2026, compared to $191.4 million as of December 31, 2025.

Conference Call Details

The Company will host a conference call and webcast on August 13, 2026, at 8:30 a.m. ET to discuss its financial results and corporate progress. To access the call, dial 888-506-0062 (U.S. toll-free) or 973-528-0011 (international) and Entry Code: 245916 five minutes prior to the start of the call. A live, listen-only webcast can be accessed on the Investors & Media section of Abeona’s website at View Source An archived webcast replay will be available for 30 days following the call.

(Press release, Abeona Therapeutics, AUG 13, 2026, View Source [SID1234670058])

On August 13, 2026 Beyond Air, Inc. (NASDAQ: XAIR) ("Beyond Air" or the "Company"), a commercial-stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve patients’ lives, reported financial results for the quarter ended June 30, 2026, and provided a corporate update.

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"Over the past several months, we have been focused on strengthening every aspect of the business in advance of our next phase of commercial growth," said Robert Goodman, Chief Executive Officer of Beyond Air. "We strengthened our balance sheet with an up to $30 million financing, and continued to build our commercial infrastructure, customer relationships and sales pipeline. We believe these efforts position us well for the anticipated launch of our second-generation LungFit PH system, pending FDA approval, and support our objective of expanding adoption of LungFit PH over the long term."

Recent Financial and Operating Highlights

Entered into a national group purchasing agreement with a leading U.S. group purchasing organization (GPO), marking the third major U.S. GPO to engage Beyond Air and expanding the Company’s reach by nearly 2,000 U.S. hospitals and health systems.
Regained compliance with Nasdaq’s minimum bid price requirement.
Continued to expand the Company’s global distribution network for LungFit PH, which now covers more than 45 countries positioning the Company for continued international commercial expansion, subject to applicable regulatory approvals.

Pending Regulatory Milestones

Awaiting FDA review of the PMA supplement for the second-generation LungFit PH system, submitted in June 2025.
International submissions for LungFit PH remain on track with local partners.

Financial Results for the Quarter Ended June 30, 2026

Revenues for the quarters ended June 30, 2026 and 2025 were $1.8 million.

Gross margins for the quarter ended June 30, 2026 were 13%, compared to 9% for the same period last year.

Research and development expenses for the quarter ended June 30, 2026 were $2.0 million, compared with $3.1 million for the same period last year.

Selling, general and administrative expenses for the quarter ended June 30, 2026 were $4.9 million, compared with $4.7 million for the same period last year.

Other expense for the quarter ended June 30, 2026 was $1.5 million, compared with $0.5 million for the same period last year.

Net loss attributable to common stockholders of Beyond Air, Inc. for the quarter ended June 30, 2026 was $7.9 million, or a loss of $11.00 per basic and diluted share, compared with a net loss of $7.7 million, or $30.67 per share, for the same period last year.

As of June 30, 2026, the Company reported cash, cash equivalents, restricted cash and marketable securities of $15.2 million. Subsequent to quarter-end, the Company strengthened its balance sheet with an up to $30.1 million financing, consisting of $10.2 million in upfront gross proceeds and up to an additional $20.0 million from the potential exercise of short- and long-term warrants, including $10.0 million tied to FDA approval of the second-generation LungFit PH system. The financing was led by certain institutional healthcare investors, with additional participation from certain of the Company’s directors and executive officers.

Financial Guidance

The Company reaffirms its previously issued revenue guidance of $8 million for calendar year 2026, which does not include any revenue from the second-generation LungFit PH system. The Company also reaffirms its previously issued 2027 revenue guidance of $16-$18 million, representing more than 110% year-over-year growth at the midpoint compared with 2026 guidance and includes anticipated revenue from the second-generation LungFit PH system, pending regulatory approval.

The Company believes it is entering an important new phase of commercial execution and a potential inflection point for revenue growth, supported by expanding market access, growing customer adoption, international expansion and a significantly larger addressable market pending the commercial launch of the second-generation LungFit PH.

Conference Call & Webcast

Thursday, August 13, 2026 @ 8 a.m. ET

Domestic: 1-877-407-0784
International: 1-201-689-8560
Conference ID: 13762077
Webcast: A webcast of the live conference call can be accessed by visiting the Events section of the Company’s website (click here) or directly (click here). An online replay will be available on the Company’s website or via the direct link an hour after the call.

(Press release, Beyond Air, AUG 13, 2026, View Source [SID1234670079])

On August 13, 2026 Eikon Therapeutics, Inc. (Nasdaq: EIKN) ("Eikon"), a late-stage clinical biopharmaceutical company dedicated to developing innovative medicines to address serious unmet medical needs, reported second quarter 2026 financial results and provided updates on its programs.

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"The second quarter saw meaningful acceleration of Eikon’s most important clinical programs, leading to acceptance of seven abstracts, related to all four of our current clinical candidates, for presentation at the upcoming ESMO (Free ESMO Whitepaper) conference in October in Madrid," said Roger M. Perlmutter, M.D., Ph.D., Chief Executive Officer and Board Chair of Eikon Therapeutics. "These new results expand what we reported at the ASCO (Free ASCO Whitepaper) conference in June and advance our ability to address important unmet needs in cancer therapy. Moreover, our clinical progress reinforces the conclusion that Eikon’s unique research platform can reproducibly elucidate novel approaches towards the treatment of grievous illness."

Clinical Development Highlights

EIK1001

EIK1001 is a systemically administered TLR 7/8 dual-agonist designed to stimulate both innate and adaptive immune responses to malignancy. Eikon believes that its data generated to date show that intravenous administration of EIK1001 has been generally well-tolerated, activates readily measured systemic immune responses, and can be combined with current standard-of-care for the treatment of malignant disease.

Eikon will present comprehensive updated data from TeLuRide-005 (NCT06246110), an ongoing open-label Phase 2 trial evaluating the safety and tolerability of EIK1001 in combination with both pembrolizumab and histology-appropriate chemotherapy for the treatment of patients with non–small cell lung cancer (NSCLC), on Monday, October 26 at the ESMO (Free ESMO Whitepaper) Congress 2026 in Madrid, Spain.
On August 11, 2026, Eikon reported that a first interim analysis of TeLuRide-006 (NCT06697301), an ongoing global Phase 2/3 registrational trial evaluating EIK1001 in combination with pembrolizumab in the first-line treatment of advanced melanoma, was completed by an independent Data Monitoring Committee (DMC). The DMC selected, per protocol, a single dosing regimen for expansion of the trial, and recommended that the study continue as planned.
On July 27, 2026, Eikon announced dosing of the first patient in TeLuRide-008 (NCT07365319), a Phase 2/3 registrational trial evaluating EIK1001 in combination with both pembrolizumab and histology-appropriate chemotherapy as first-line therapy for treatment-naive patients with stage 4 NSCLC.
On May 30, 2026, Eikon presented updated data at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting from TeLuRide-005 (NCT06246110), an ongoing open-label Phase 2 trial evaluating the safety and tolerability of EIK1001 in combination with both pembrolizumab and histology-appropriate chemotherapy for the treatment of patients with non-small cell lung cancer (NSCLC). Among other results, the presentation showed:
When combined with standard-of-care therapy, EIK1001 was observed to be associated with meaningful and consistent clinical activity across PD-(L)1 tumor proportion score subgroups
EIK1001 was observed to be generally well tolerated, permitting administration in the outpatient setting
Durable anti-tumor activity with median response duration of greater than 11 months for the non-squamous cohort was observed
A more complete characterization of these durable responses will be presented at the ESMO (Free ESMO Whitepaper) Congress 2026 in October.

EIK1003 & EIK1004

EIK1003 and EIK1004 are highly selective PARP1 inhibitors designed to inhibit PARP1 while sparing PARP2, thereby promoting tumor regression by targeting the DNA damage response of cancer cells. EIK1004 was specifically engineered to penetrate the central nervous system (CNS), potentially expanding the utility of selective PARP1 inhibition to tumors involving the brain and CNS. Eikon believes the selectivity of EIK1003 and EIK1004 may enable the development of near full-dose combination regimens with chemotherapy, antibody-drug conjugates, or radionuclides, in earlier lines of therapy than currently possible with non-selective PARP inhibitors, and will potentially allow for more sustained therapeutic dosing during maintenance treatment.

Eikon will present clinical data from its ongoing Phase 1/2 trial of EIK1003 on Friday, October 23 at the ESMO (Free ESMO Whitepaper) Congress 2026 in Madrid, Spain. Various trial components evaluate the safety and efficacy of EIK1003 as monotherapy or in combination with anti-cancer agents in participants with advanced solid tumors (NCT06253130). The presentations will include updated data from Cohorts 1A and 1C, as well as initial data from Cohort 1B, which is specifically evaluating the safety and preliminary efficacy of EIK1003 in combination with abiraterone and prednisone for the treatment of patients with advanced prostate cancer.
Eikon is also currently enrolling an additional Cohort 1D, evaluating EIK1003 in combination with paclitaxel and platinum-based chemotherapeutic regimens in patients with ovarian cancer. Site selection for Cohort 1D is completed and enrollment is ongoing.
Eikon is currently evaluating two dose levels of EIK1003 monotherapy, 20 mg and 60 mg, to determine the optimal Phase 2 dose for EIK1003. Approximately 30 PARPi-naïve, HER2-negative breast cancer patients are expected to be enrolled at each dose level. Enrollment for the Part 2 dose optimization portion of the Phase 1/2 trial is ongoing.
On Friday, October 23 at the ESMO (Free ESMO Whitepaper) Congress 2026 in Madrid, Spain, Eikon will also present, for the first time, data from an ongoing Phase 1/2 trial evaluating the safety and efficacy of EIK1004, a selective PARP1 inhibitor designed to penetrate the CNS, for the treatment of patients with ovarian, breast, prostate, and pancreatic cancers (NCT06907043). Eikon believes that these results, together with data from its studies of EIK1003, will provide mutually reinforcing insights into the behavior of highly-selective PARP1 inhibitors.
On May 30, 2026, Eikon presented data at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting from its ongoing Phase 1/2 trial evaluating the safety and efficacy of EIK1003 as monotherapy or in combination with anti-cancer agents in participants with advanced solid tumors (NCT06253130), including:
Updated clinical safety, tolerability and preliminary efficacy data from Cohort 1A, evaluating EIK1003 as a monotherapy for the treatment of patients with ovarian, breast, prostate, and pancreatic cancers
Initial clinical safety, tolerability and preliminary efficacy data from Cohort 1C, evaluating EIK1003 in combination with paclitaxel for the treatment of patients with platinum-resistant ovarian, or breast cancer patients who are either HER2-negative, ER-positive, and hormonal therapy-experienced, or ER-negative and chemotherapy-experienced.

EIK1005

EIK1005 is a novel molecular entity, designed to inhibit the Werner ("WRN") helicase, that emerged from original research conducted in Eikon’s laboratories. Eikon believes that EIK1005 has the potential to be an effective anti-tumor agent for microsatellite instability-high (MSI-high) tumors, by producing synthetic lethality in MSI-high cells that depend upon the WRN helicase salvage pathway to maintain genome integrity.

Eikon is currently evaluating EIK1005 in a Phase 1/2 trial as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors (NCT07262619). The first patient in this Phase 1/2 dose-escalation trial was dosed in January 2026.
Preliminary safety, tolerability and pharmacokinetic data for EIK1005 will be presented on Friday, October 23 at the ESMO (Free ESMO Whitepaper) Congress 2026 in Madrid, Spain.

EIK1006

EIK1006 is another internally-derived clinical candidate and is being investigated as a potential next-generation androgen receptor ("AR") antagonist with activity against multiple clinically important genetic variants of AR that emerge during treatment with conventional AR blockers. Preclinically, Eikon scientists have shown that EIK1006 binds to the ligand binding domain of AR and blocks its nuclear translocation, thereby inhibiting AR transcriptional activity and downstream signaling.

Eikon expects to submit an investigational new drug application (IND) for EIK1006 by the end of 2026.

Key Upcoming Milestones

EIK1001: Presenting full combination data from the TeLuRide-005 trial in NSCLC on Monday, October 26 at ESMO (Free ESMO Whitepaper).
EIK1003: Presenting updated Phase 1/2 monotherapy and combination data in patients with advanced solid tumors across Cohorts 1A, 1B and 1C on Friday, October 23 at the ESMO (Free ESMO Whitepaper) Congress 2026.
EIK1004: Presenting initial Phase 1/2 data in patients with advanced solid tumors on Friday, October 23 at ESMO (Free ESMO Whitepaper).
EIK1005: Presenting initial Phase 1/2 data in patients with advanced solid tumors on Friday, October 23 at the ESMO (Free ESMO Whitepaper) Congress 2026.
EIK1006: Expects to submit an IND by the end of 2026.

Second Quarter 2026 Corporate Highlights

Appointment of Ma. Fatima D. Francisco to Board of Directors

Eikon appointed Ma. Fatima ("Fama") D. Francisco as an independent director to its Board of Directors, where Ms. Francisco will also serve on the Board’s Compensation Committee.

Ms. Francisco most recently served as Chief Executive Officer, Baby, Feminine and Family Care at The Procter & Gamble Company, where she led one of the company’s largest global business units. During her more than 35-year career at Procter & Gamble, she has held numerous leadership positions across marketing, innovation, commercial operations, and general management. She also serves on the Board of Directors of HP Inc. and Nestlé S.A., and previously served on the Board of Directors of Organon & Co.

Second Quarter 2026 Financial Results

Cash Position: As of June 30, 2026, Eikon had cash, cash equivalents, and marketable securities of $531.2 million. Eikon expects its current cash, cash equivalents, and marketable securities to fund operations into the second half of 2027.

Research and Development ("R&D") Expenses: R&D expenses were $75.5 million for the three months ended June 30, 2026, compared to $69.2 million for the three months ended June 30, 2025, an increase of $6.3 million, or 9%. Direct research and development expenses increased by $12.8 million as we advanced our clinical trial activity, and compensation costs increased by $1.7 million. These increases were partially offset by restructuring expenses and milestone payments in the prior year period and by lower occupancy costs.

General and Administrative ("G&A") Expenses: G&A expenses were $17.9 million for the three months ended June 30, 2026, compared to $40.5 million for the three months ended June 30, 2025, a decrease of $22.5 million, or 56%. The decrease was primarily due to the impairment in the year-ago period of $10.7 million of property and equipment and $10.3 million of operating lease right-of-use assets relating to properties in Hayward, California that Eikon vacated in April 2025 when the Company moved into its current corporate headquarters in Millbrae, California.

Net Loss: Net loss attributable to common stockholders was $88.4 million for the second quarter of 2026, compared to $105.2 million for the prior-year period.

"Our strong balance sheet enables us to continue to support an increasingly mature pipeline, including ongoing registrational studies of EIK1001 in both advanced melanoma and non-small cell lung cancer," said Freddie Bowie, Ph.D., Chief Financial Officer. "Additional development programs to be reviewed at ESMO (Free ESMO Whitepaper) demonstrate our ability to execute global clinical trials across multiple indications. We remain focused on deploying capital toward opportunities that we believe have the potential to significantly enhance shareholder value over the next few years."

(Press release, Eikon Therapeutics, AUG 13, 2026, View Source [SID1234670095])

On August 13, 2026 Evotec reported Half-Year Interim Report 2026.

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(Presentation, Evotec, AUG 13, 2026, View Source [SID1234670282])