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 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 Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, reported financial results for the second quarter of 2026 and provided general business updates.

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"During the second quarter, the Company continued to make meaningful clinical and operational progress. We look forward to reporting the upcoming topline data of our Phase 3 OnPrime/GOG-3076 registrational trial, as well as dose-finding updates from our systemic administration studies in lung cancer," said Thomas Zindrick, President, CEO and Chairman of Genelux. "Recent translational findings further support Olvi-Vec’s tumor-priming immunotherapy mechanism and its potential to promote tumor sensitization to platinum-based chemotherapy, as well as strengthening the scientific foundation of our ongoing clinical development programs."

"Alongside our clinical progress, we continue advancing our manufacturing and operational capabilities in preparation for the next stage of Olvi-Vec’s development. As our registration-directed programs mature, we remain focused on strengthening our organization, investing in our capabilities, and preparing for potential commercialization and future pipeline expansion," concluded Mr. Zindrick.

Clinical Program Highlights

Olvi-Vec in Platinum-Resistant/Refractory Ovarian Cancer:
Genelux continues to advance Olvi-Vec toward potential registration for platinum-resistant/refractory ovarian cancer (PRROC), a setting defined by limited treatment options. Ovarian cancer is the 5th leading cause of cancer-related death among women, and more than 70% of patients diagnosed with ovarian cancer in the United States will not respond to or will relapse after frontline platinum-based therapy (NIH Ovarian Cancer Fact Sheet 2022), underscoring the significant unmet medical need Olvi-Vec seeks to address.

Olvi-Vec’s intraperitoneal administration is designed to deliver high, localized dosing within the peritoneal cavity to drive anti-tumor activity and resensitize tumors to platinum-based chemotherapy.

OnPrime/GOG-3076 (NCT05281471) is an ongoing multi-center, randomized, open-label Phase 3 registrational trial being conducted at sites across the United States, with topline data anticipated in the second half of 2026.
The trial is evaluating Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab against an active comparator arm of physician’s choice of chemotherapy and bevacizumab in women with PRROC (including fallopian tube and primary peritoneal cancers).
In June 2026, Genelux announced the publication of translational analyses from the Phase 1b/2 VIRO-15 trial demonstrating immune activation, remodeling of tumor microenvironment, and gene expression changes consistent with platinum sensitization following treatment with Olvi-Vec. These data were presented in Gynecologic Oncology Reports, a peer-reviewed journal published by Elsevier, available here.

Olvi-Vec in Lung Cancer:
Genelux continues to advance two ongoing systemic Olvi-Vec lung cancer trials, expanding the platform beyond intraperitoneal delivery into a broader range of solid tumor types. Together, data from dose-escalation cohorts in these studies are designed to generate the clinical evidence to guide selection of a recommended systemic dose for subsequent development in lung cancer and for future development in additional systemic indications.

The Phase 1b/2 study (OLVI-VEC-SCLC-202) in small-cell lung cancer (SCLC) (NCT07136285) is evaluating Olvi-Vec in combination with platinum and etoposide chemotherapy in SCLC patients with platinum-resistant or relapsed disease after failing previous treatment, including frontline platinum and etoposide chemotherapy. The trial is being conducted by the Company’s licensing partner, Newsoara HYK Biopharmaceuticals Co., Ltd., in China.
The Phase 2 VIRO-25 study (NCT06463665) is assessing Olvi-Vec in combination with platinum-based chemotherapy and an immune checkpoint inhibitor (ICI) in patients with advanced or metastatic recurrent non-small-cell lung cancer (NSCLC) who failed standard frontline treatment of platinum chemotherapy and an ICI. The trial is being conducted in the United States and is designed to extend Olvi-Vec’s tumor-priming approach into NSCLC.

Additional dose‑finding updates from both the SCLC Phase 1b/2 and NSCLC Phase 2 VIRO‑25 trials are expected in 2026, aligning with the Company’s strategy to optimize a systemic dosing regimen and inform future registrational development.

Second Quarter 2026 Financial Results

Cash, cash equivalents, marketable securities and restricted cash were $18.7 million as of June 30, 2026. The Company expects that combined cash, cash equivalents, marketable securities and restricted cash will fund operations into the first quarter of 2027.

Research and development (R&D) expenses were $6.5 million and $4.8 million for the three months ended June 30, 2026 and 2025, respectively, an increase of $1.8 million. The increase was primarily driven by clinical and regulatory expenses relating to increased clinical trial costs associated with our Phase 3 OnPrime/GOG-3076 registration trial.

General and administrative (G&A) expenses were $3.1 million and $3.0 million for the three months ended June 30, 2026 and 2025, respectively, an increase of $0.1 million. The increase was primarily driven by an increase in stock compensation, partially offset by a reduction in professional services and other expenses.

Net loss was $9.5 million or $0.21 per share for the three months ended June 30, 2026, as compared to $7.5 million or $0.20 per share over the same period in 2025.

(Press release, Genelux, AUG 13, 2026, View Source [SID1234670093])

On August 13, 2026 Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported financial and operating results for the three months ended June 30, 2026, and reviewed recent business highlights.

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"Throughout the second quarter, Calidi continued to advance its RedTail platform and redefine the potential of oncolytic viruses and genetic medicine," said Eric Poma, Ph.D., Calidi Biotherapeutics CEO. "We anticipate CLD-401, the lead drug candidate from our RedTail platform, entering the clinic during the first quarter of 2027. In addition, we have expanded what the RedTail platform can do with our new approach of in situ T-cell engagers."

Second Quarter 2026 and Recent Business Developments

In the pre-IND meeting, the FDA and Calidi agreed on key aspects of the CMC and non-clinical programs, and the FDA provided feedback on the overall design for the proposed first-in-human clinical study. This pre-IND (Type B) interaction builds upon the engagement and alignment achieved through early scientific advice as part of a Type D interaction with the FDA.
Presented preclinical data at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on CLD-501, the lead compound from Calidi’s in situ TCE approach. CLD-501 is a systemically delivered virotherapy designed to selectively target tumors and simultaneously enable the high-level in situ expression of a TROP-2 TCE and IL-15 superagonist (IL-15 SA). The Company also presented preclinical data on CLD-401, its lead program. CLD-401 is a systemically delivered virotherapy designed to selectively target tumors and enable high-level expression of IL-15 SA, a known T- and NK-cell activator, driving profound immune changes in the tumor microenvironment, including the recruitment and activation of NK, NK-T, and gamma delta (γδ) T-cells that lead to a robust therapeutic response in immunocompetent animal models.
Strengthened its Board of Directors with the addition of Corsee Sanders, Ph.D. Dr. Sanders served as strategic advisor to Celgene’s Chief Medical Officer following Celgene’s acquisition of Juno, where she was Executive Vice President of Development Operations. She also served as Transition Advisor to Bristol Myers Squibb following its acquisition of Celgene. Dr. Sanders held numerous leadership positions over the course of 23 years at Genentech/Roche, including Senior Vice President, Global Head of Clinical Operations and Industry Collaboration.
Reduced general and administrative expenses by $1.5 million, or 48%, in the second quarter of 2026 compared with the same period in 2025. The Company will continue its tight focus on expense management to ensure sufficient capital to advance its pipeline.
Second Quarter 2026 Financial Results

Calidi reported a net loss attributable to common stockholders of $4.2 million, or $2.94 per share, for the second quarter of 2026, compared with a net loss attributable to common stockholders of $5.7 million, or $31.75 per share, for the same period in 2025. Prior-period share and per-share amounts have been adjusted to reflect the Company’s 1-for-16 reverse stock split completed in July 2026.

Research and development expenses were $2.6 million for the second quarter of 2026, unchanged from the second quarter of 2025.

General and administrative expenses were $1.6 million for the second quarter of 2026, compared with $3.1 million for the comparable period in 2025.

The Company had $4.1 million in cash and $0.2 million in restricted cash as of June 30, 2026, compared with $5.6 million in cash and $0.2 million in restricted cash as of December 31, 2025.

(Press release, Calidi Biotherapeutics, AUG 13, 2026, View Source [SID1234670092])

On August 13, 2026 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL) ("Zentalis" or the "Company"), a clinical oncology innovator advancing late-stage development of an investigational, potentially first-in-class WEE1 inhibitor, azenosertib, as a biomarker-driven treatment approach for ovarian cancer, reported the pricing of an underwritten public offering of 23,000,000 shares of its common stock at a public offering price of $3.50 per share. The total gross proceeds to the Company from the offering are expected to be approximately $80.5 million, before deducting underwriting discounts and commissions and offering expenses payable by the Company. All of the common stock is being offered by the Company. The offering is expected to close on August 17, 2026, subject to customary closing conditions. In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 3,450,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

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The Company intends to use the net proceeds from the offering, together with the Company’s existing cash, cash equivalents and marketable securities, to fund clinical trials, preclinical studies, regulatory filings, manufacturing and the Company’s companion diagnostic in support of its programs, as well as for pre-commercial activities, capital expenditures, working capital and other general corporate purposes.

TD Cowen, Guggenheim Securities and Oppenheimer & Co. are acting as joint bookrunners for the offering. H.C. Wainwright & Co. is acting as a passive bookrunner for the offering. Rodman & Renshaw LLC is acting as a manager for the offering.

The securities described above are being offered pursuant to an effective shelf registration statement that was filed with the U.S. Securities and Exchange Commission (SEC) on March 26, 2025, and became effective on April 4, 2025. This offering is being made only by means of a prospectus supplement and the accompanying prospectus which forms a part of the effective shelf registration statement.

A final prospectus supplement related to the offering (including the accompanying prospectus) will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement related to the offering and the accompanying prospectus may be obtained, when available, by visiting the SEC’s website or by contacting: TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected]; or Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, by telephone at (212) 667-8055, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, the securities in this offering in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

(Press release, Zentalis Pharmaceuticals, AUG 13, 2026, View Source [SID1234670091])