On July 25, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer, reported that pathologic results are available for four of the five patients treated in the fourth cohort (Press release, Agenus, JUL 25, 2025, View Source [SID1234654551]). A complete pathologic response (100% tumor clearance) has been reported for one patient with cutaneous squamous cell carcinoma (cSCC). One patient with metastatic Merkel cell carcinoma was reported as a partial response (> 50% clearance). Two patients with cSCC were reported as having a pathologic non-response (<50% tumor clearance). Pathologic results for the remaining patient with cSCC are still pending.

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Phio’s ongoing Phase 1b dose escalation clinical trial (NCT 06014086) is designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in Stages 1, 2 and 4 cSCC, Stage 4 melanoma, and Stage 4 Merkel cell carcinoma. To date, a total of 15 patients with cutaneous carcinomas have been treated across the four cohorts. There were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in the patients receiving intratumoral PH-762 in this trial. Moreover, PH-762 has been well tolerated in all enrolled patients in each escalating dose cohort. No patients exhibited clinical progression of disease.

The cumulative pathologic response in 13 patients with cSCC include five complete response (100% clearance), one patient with a near complete response (>90% clearance) and one with a partial response (>50% clearance) and six patients with a pathologic non-response (< 50% clearance).

The one Merkel cell carcinoma patient with stage 4 metastatic disease had a partial response (>50% clearance). The melanoma patient was a non-responder (<50% clearance).

Phio is now enrolling what is expected to be the 5th and final cohort in the Phase 1b study.

"The positive safety and efficacy outcomes through the fourth cohort continue to indicate that PH-762 may present a viable non-surgical alternative in this large and continually expanding skin cancer market," said Robert Bitterman, CEO and Chairman of Phio Pharmaceuticals.

On July 25, 2025 Portage Biotech Inc. ("Portage" or the "Company") (NASDAQ: PRTG), a clinical-stage immuno-oncology company formed under the laws of the British Virgin Islands, with a portfolio of novel multi-targeted therapies for use as monotherapy and in combination, reported its financial results for the fiscal year ended March 31, 2025 (Press release, Portage Biotech, JUL 25, 2025, View Source [SID1234654534]).

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Financial Results from Year Ended March 31, 2025

The Company incurred a net loss of approximately $6.8 million during the fiscal year ended March 31, 2025 ("Fiscal 2025"), which includes approximately $0.2 million of net non-cash expenses. This compares to a net loss of approximately $75.4 million during the fiscal year ended March 31, 2024 ("Fiscal 2024"), which included approximately $60.9 million of net non-cash expenses. Net loss decreased by approximately $68.6 million year-over-year, which is primarily due to lower non-cash losses attributable to full impairment of the Company’s identifiable intangible assets, goodwill, and certain investments as of March 31, 2024.

Operating expenses, including research and development ("R&D") costs and general and administrative ("G&A") expenses, were $7.4 million in the Fiscal 2025, down from $18.2 million in the Fiscal 2024, a decrease of $10.8 million, as detailed below.

R&D expenses decreased by approximately $9.4 million, or approximately 75%, from approximately $12.5 million in Fiscal 2024, to approximately $3.1 million in Fiscal 2025. The decrease was primarily attributable to clinical trial costs (principally CRO-related), which decreased by approximately $3.4 million, from $5.2 million in Fiscal 2024 to $1.8 million in Fiscal 2025, due to the decision to pause enrollment in our sponsored clinical trials in the third and fourth quarters of Fiscal 2024. Manufacturing-related costs decreased by $1.6 million from $1.8 million in Fiscal 2024, compared to $0.2 million in Fiscal 2025, related to the iNKT and adenosine clinical trials. During Fiscal 2024, we deprioritized development of the iNKT program and closed the related clinical trial. In August 2024, we temporarily paused enrollment in the PORT-6 arm of the study. Enrollment resumed in March 2025 with the initiation of the final dose escalation cohort. Non-cash share-based compensation expense allocable to R&D decreased by $1.4 million, from $1.4 million in Fiscal 2024, compared to nil in Fiscal 2025, as the relevant share options fully vested by Fiscal 2024 and no new share option awards were allocable to R&D during Fiscal 2025. Payroll-related expenses decreased by $0.9 million from $1.6 million in Fiscal 2024 to $0.7 million in Fiscal 2025; the decrease in salaries is primarily due to reduced headcount. R&D services decreased by $0.5 million due to the pause of medical writing, analysis, and clinical studies at the beginning of Fiscal 2025. Scientific consulting fees decreased by approximately $0.6 million from $0.8 million in Fiscal 2024 to $0.2 million in Fiscal 2025 to reflect the decrease in activity year-over-year. Additionally, in Fiscal 2024, we incurred a one-time milestone payment of $0.5 million for dosing our first adenosine patients, and finally, $0.5 million in fees paid with respect to the transition of the iNKT study prior to discontinuing the study in Fiscal 2024.

G&A expenses decreased by approximately $1.4 million, or approximately 24.9%, from approximately $5.7 million in Fiscal 2024, to approximately $4.3 million in Fiscal 2025. The decreases are attributable to decreases in: non-cash share-based compensation expense allocable to G&A expenses by $0.9 million, from $1.2 million in Fiscal 2024 to $0.3 million in Fiscal 2025, primarily due to the vesting of certain share options granted in prior years fully vesting by Fiscal 2024 and lower fair value associated with more recent grants; professional fees by $0.7 million, from $2.3 million in Fiscal 2024, compared to $1.6 million in Fiscal 2025, primarily due to decline in public relations and accounting services related expenses; directors’ fees by $0.1 million, from $0.3 million in Fiscal 2024, compared to $0.2 million Fiscal 2025 due to the adoption of a new director compensation policy in March 2025; and general office related supplies and expenses by $0.1 million, from $0.2 million in Fiscal 2024, compared to $0.1 million in Fiscal 2025. These decreases were offset to some extent by an increase in payroll-related and consulting expenses by $0.4 million from $0.9 million in Fiscal 2024 to $1.3 million in Fiscal 2025 primarily attributable to $0.2 million in retention payments to an employee and a consultant included in payroll expenses allocable to general and administrative expenses.

The primary reasons for the year-over-year differences in the Company’s pre-tax items of income and expense were substantially non-cash in nature, aggregating approximately $0.6 million net gain in Fiscal 2025 compared to approximately $67.7 million net loss in Fiscal 2024. The net gain in year over year were attributable to $0.9 million net gain from the settlement and release of obligations and liabilities under the Master Services Agreement between iOx and Parexel partially offset to some extent by the $0.4 million non-cash loss from the change in the fair value of certain warrants accounted for as liabilities, issued in connection with a private placement offering in October 2023 in Fiscal 2025. In Fiscal 2024, the recognized full impairment of the carrying value of in-process research and development of $57.9 million for iOx and $23.6 million for Tarus, as well as a $1.0 million loss on the impairment of the Company’s investment in Stimunity and the Stimunity convertible note. These expenses were partially offset by the non-cash gains from the decrease in the fair value of the deferred purchase price payable to the former Tarus shareholders and the deferred obligation for the iOx milestone, totaling $11.3 million. These losses were offset to some extent by a $0.7 million gain on the sale of Intensity shares, accounted for under fair value through other comprehensive income (FVOCI), which had a carrying value of $2.1 million and a $2.4 million loss during Fiscal 2024 from the Company’s equity financing in October 2023, representing the excess of the fair value of certain warrants over the net proceeds. Additionally, a $6.9 million non-cash gain was recognized from the change in the fair value of certain warrants accounted for as liabilities issued in connection with this equity offering.

Additionally, the Company recognized a non-cash net deferred income tax benefit of $10.5 million in Fiscal 2024, compared to a non-cash net deferred income tax benefit of $3 thousand in Fiscal 2025. The benefit in Fiscal 2024 was primarily attributable to the tax effect of the non-cash impairment loss on IPR&D for iOx, partially offset by the derecognition of previously recognized losses.

As of March 31, 2025, the Company had cash and cash equivalents of approximately $1.7 million and total current liabilities of approximately $1.1 million.

On July 25, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer, reported the entry into definitive agreements to exercise certain outstanding warrants to purchase up to an aggregate of 928,596 shares of common stock of the Company originally issued in December 2024 and January 2025, having exercise prices between $2.00 and $3.00 per share (Press release, Phio Pharmaceuticals, JUL 25, 2025, View Source [SID1234654552]). Warrants to purchase 100,000 shares of common stock at the existing exercise price of $2.00 per share will be exercised at their existing exercise price of $2.00 per share and warrants to purchase 828,596 shares of common stock will be exercised at a reduced exercise price of $2.485 per share. The shares of common stock issuable upon exercise of the warrants are registered pursuant to effective registration statement on Form S-1 (No. 333-284381). The gross proceeds to the Company from the exercise of the warrants are expected to be approximately $2.5 million, prior to deducting placement agent fees and offering expenses.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

In consideration for the immediate exercise of the warrants for cash and the payment of additional $0.125 per new unregistered warrant (additional $232,149 in the aggregate, which are included in the gross proceeds to the Company), the exercising holders will receive new unregistered warrants to purchase shares of common stock in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act"). The new warrants will be exercisable for an aggregate of up to 1,857,192 shares of common stock, at an exercise price of $2.485 per share and will be immediately exercisable upon issuance and (i) will have a term of twenty-four months with respect to new warrants to purchase up to 1,538,596 shares of common stock and (ii) will have a term of five years with respect to new warrants to purchase up to 318,596 shares of common stock, in each case, following the effective date of the resale registration statement registering the shares of common stock issuable upon exercise of the new warrants.

The offering is expected to close on or about July 28, 2025, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering for working capital and other general corporate purposes.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the 1933 Act and, along with the shares of common stock issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities 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 any such state or jurisdiction.

On July 24, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the second quarter of fiscal year 2025 (Press release, Chugai, JUL 24, 2025, View Source [SID1234654499]).

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Chugai reported increased revenue and operating profit year-on-year for the second quarter (Core-basis).

Regarding revenue, domestic sales increased by 2.8%. In the oncology field, sales decreased by 1.9%. While new products Phesgo performed well and Lunsumio steadily penetrated the market, this was offset by the decline in Perjeta and Herceptin along with the market penetration of Phesgo which includes the same active pharmaceutical ingredients. Additionally, products including our mainstay product Avastin were affected by NHI drug price revisions and biosimilars. In the specialty field, sales increased by 8.4%, driven by significant growth of the mainstay product Vabysmo and successful market penetration of the new product PiaSky. Overseas sales increased by 7.3%, driven by a substantial increase in exports of Actemra to Roche. Other revenue decreased by 0.4%, despite the increase in royalty income related to Hemlibra, mainly due to a decrease in one-time income.

Cost to sales ratio increased by 1.3 percentage points year-on-year to 34.3%, mainly due to changes in the product mix. Research and development expenses increased by 2.7% due to investments into drug discovery and early development, and increase associated with the progress of development projects, while selling, general and administrative expenses decreased by 2.6% due to efficient management of various expenses. Other operating income (expense) resulted in income of ¥0.4 billion. As a result, Core operating profit was ¥272.0 billion (+3.5%).

Chugai made good progress in both early and late-stage development activities.

In early-stage development of in-house projects that will drive mid to long-term growth, GYM329 (for obesity) and Hemlibra (for von Willebrand disease) have initiated Phase II and Phase III clinical trials, respectively. Additionally, AUBE00 (for solid tumors), the second clinical-stage project following LUNA18 in our mid-size molecule pipeline, has initiated Phase I clinical trials. In late-stage development, Alecensa has been filed for approval for additional tumor agnostic indication in ALK fusion / rearrangement gene-positive solid tumors, including pediatric patients. In-house projects out-licensed to third parties excluding Roche also progressed steadily, with AVMAPKI, out-licensed to Verastem Oncology, receiving approval from the U.S. Food and Drug Administration (FDA) for use in combination with FAKZYNJA for KRAS-mutated recurrent low-grade serous ovarian cancer, under the accelerated approval pathway* based on overall response rate and duration of response.

Chugai has made the management decision to discontinue our development of five projects from early-stage in-house clinical development pipeline; LUNA18, SAIL66, SOF10, STA551, and AMY109. Since the launch of TOP I 2030 in 2021, we have continuously generated new projects and built technological foundations through enhanced RED functions. The number of early-stage projects has been increasing, with nine in-house projects entering clinical development over the four-year period. For early-stage clinical development pipeline, we have prioritized in-house projects after considering obtained data and the current portfolio situation, resulting in the decision to discontinue these five projects. Through this decision, we aim to maximize the success rate of achieving TOP I 2030 goals through dynamic and strategic allocation of resources to priority projects.

*Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

For products in-licensed from Roche, Elevidys has obtained regulatory approval as a regenerative medicine product for the treatment of Duchenne muscular dystrophy under the conditional and time-limited approval pathway in Japan. Vabysmo has received approval for an additional indication for angioid streaks, and Evrysdi has launched a new formulation in Japan. Lunsumio has been filed for an additional indication in combination with Polivy for relapsed or refractory aggressive B-cell non-Hodgkin lymphoma, and Tecentriq has been filed for an additional indication for unresectable thymic cancer. Additionally, Vabysmo (for non-proliferative diabetic retinopathy) and inavolisib (for PIK3CA mutated breast cancer) have initiated new clinical trials.

[2025 second quarter results]

Billion JPY 2025
Jan – Jun 2024
Jan – Jun % change
Core results
Revenue 578.5 552.9 +4.6%
　Sales 511.4 485.5 +5.3%
　Other revenue 67.0 67.3 -0.4%
Operating profit 272.0 262.8 +3.5%
Net income 193.5 189.5 +2.1%
IFRS results
Revenue 578.5 552.9 +4.6%
Operating profit 273.3 258.2 +5.8%
Net income 194.4 186.3 +4.3%
[Sales breakdown]

Billion JPY 2025
Jan – Jun 2024
Jan – Jun % change
Sales 511.4 485.5 +5.3%
Domestic sales 223.3 217.2 +2.8%
　Oncology 116.6 118.8 -1.9%
　Specialty 106.7 98.4 +8.4%
Overseas sales 288.1 268.4 +7.3%
[Oncology field (Domestic) Top5-selling medicines]

Billion JPY 2025
Jan – Jun 2024
Jan – Jun % change
Tecentriq 29.9 31.1 -3.9%
Polivy 17.0 15.7 +8.3%
Alecensa 15.8 14.9 +6.0%
Phesgo 15.4 8.6 +79.1%
Avastin 13.0 17.4 -25.3%
[Specialty field (Domestic) Top5-selling medicines]

Billion JPY 2025
Jan – Jun 2024
Jan – Jun % change
Hemlibra 29.1 27.4 +6.2%
Actemra 23.8 22.4 +6.3%
Enspryng 13.3 11.6 +14.7%
Vabysmo 12.0 9.1 +31.9%
Evrysdi 7.9 7.5 +5.3%
[Progress in R&D activities from Apr 25th, 2025 to Jul 24th, 2025]

2025 Q2 R&D Progress
About Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting Non-Core items to IFRS results. Chugai’s recognition of non-recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and as the basis for payment-by-results such as a return to shareholders.

Trademarks used or mentioned in this release are protected by law.

On July 24, 2025 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technologies to its Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms, reported it will host its virtual R&D Day today at 1:30 PM PT (Press release, Janux Therapeutics, JUL 24, 2025, View Source [SID1234654515]). The event will highlight the company’s continued momentum in advancing its novel immunotherapy platforms—TRACTr and TRACIr, as well as ARM—designed to address significant unmet needs in oncology and autoimmune diseases.

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"At Janux, we are guided by a deep commitment to scientific excellence and a belief that innovation should translate into meaningful outcomes for patients," said David Campbell, Ph.D., President and CEO of Janux Therapeutics. "The progress we’ve shared today across our TRACTr, TRACIr, and ARM platforms reflects our disciplined strategy to focus first on maximizing the benefit and value of our clinical program JANX007, second to harness the value of our clinical experience by bringing forward TRACTrs where we can potentially be first- and/or best-in-class, and third to utilize our T cell engager development expertise to enable platform technologies that address other clear gaps in the treatment landscape."

Creating an Opportunity to Further Differentiate JANX007 with TRACIr Combination

Janux is advancing its CD28-based TRACIr platform designed to enhance T cell activation and durability of its CD3-based TRACTr platform. TRACIr was built on the same technology with the same tumor-activation and PK design features as TRACTr and combines tumor targeting with immune costimulation. The TRACIr platform represents a strategic extension of Janux’s tumor-activated approach, designed to complement and enhance the clinical potential of its TRACTr portfolio, beginning with PSMA-TRACTr JANX007.

While JANX007 has already demonstrated differentiated clinical activity in late-stage metastatic castration-resistant prostate cancer (mCRPC) patients, the addition of a PSMAxCD28-TRACIr introduces a costimulatory signal that may further enhance durability of response within the tumor microenvironment. This combination has the potential to drive more prolonged anti-tumor effects without increasing systemic toxicity, positioning Janux to further differentiate JANX007 in the mCRPC treatment landscape. IND-enabling studies are underway for the PSMA-TRACIr, with clinical trials in combination with JANX007 expected to begin in the second half of 2026.

Expanding the TRACTr Platform into High-Value Oncology Indications

Building upon learnings from the JANX007 and JANX008 clinical programs, Janux introduced its latest trophoblast cell surface antigen 2 (TROP2) TRACTr program. This next-generation TROP2-TRACTr was engineered for potential best-in-class safety and efficacy across a broad range of TROP2-expressing tumors, including breast, lung and bladder cancers. Janux’s TROP2-TRACTr exemplifies the TRACTr technology’s ability to create high-value T cell engager (TCE) product candidates directed at tumor targets that contemporary TCE technologies have been unable to access due to broad healthy tissue expression.

Janux’s TROP2-TRACTr product candidate demonstrated strong potency across multiple tumor types, activity at low TROP2 expression levels, and was well tolerated in non-human primates with no signs of cytokine release syndrome (CRS) or healthy tissue toxicity. This preclinical data also displayed the ability to overcome limitations of existing TROP2-targeted therapies, including antibody drug conjugates. These findings support a wide therapeutic window and the potential for best-in-class performance in TROP2-expressing solid tumors. IND-enabling activities are planned in the second half of 2025.

ARM Platform Redefines T-Cell Engagers for Autoimmune Disease and Oncology

Janux also introduced its Adaptive Immune Response Modulator (ARM) bispecific platform, designed to overcome the limitations of conventional TCEs in autoimmune diseases and oncology.

Builds upon Janux’s expertise to redesign bispecific TCEs.
Differentiated non-clinical profile provides best-in-class opportunity in autoimmune diseases.
Potential broad applicability across multiple disease areas.
Large safety window and off-the-shelf format position it for higher dosing, rapid development and potential best-in-class performance.
The lead program, a CD19-ARM, has displayed rapid, deep and durable B-cell depletion in periphery and tissues with a prolonged memory B cell reset while maintaining a large safety window in non-human primates, supporting a potential best-in-class profile.

ARMs exhibit differentiated durable T cell activity with reduced T cell exhaustion preclinically.
The program demonstrated prolonged memory B-cell depletion and immune reset from a single subcutaneous dose, reflecting the durability seen with CD19 CAR-T therapies but with greater safety and convenience.
ARMs displayed potential to dose to maximum efficacy while enabling safer, outpatient-friendly dosing.
In non-human primates, CD19-ARM achieved deep and durable B-cell depletion in both blood and lymphoid tissues with a >100x CRS safety window.
The CD19-ARM is on track for first-in-human studies to begin in the first half of 2026.

Event Information

To join the webcast, please visit this link, or the Events & Presentations page of the Investors section on the Company’s website View Source A replay of the webcast will be archived and available following the event.

Participant Dial-In Numbers:
USA / International Toll +1 (646) 307-1963
USA – Toll-Free (800) 715-9871
Conference ID 9235403

Janux’s TRACTr, TRACIr and ARM Pipeline

Janux’s first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with mCRPC. Janux’s second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. Janux is also advancing additional CD3-based TRACTr and CD28-based TRACIr programs for future clinical development, including a PSMA-TRACIr for use in combination with our PSMA-TRACTr JANX007, and a TROP2-TRACTr for the treatment of TROP2+ solid tumors. Janux is also advancing its first ARM platform program candidate, a CD19-ARM for the potential treatment of autoimmune diseases toward clinical trials.