On August 7, 2025 Cidara Therapeutics, Inc. (Nasdaq: CDTX) (the Company or Cidara), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) therapeutics, reported financial results for the second quarter ended June 30, 2025, and provided recent business updates (Press release, Cidara Therapeutics, AUG 7, 2025, View Source [SID1234654966]).

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"The highly compelling results of our Phase 2b NAVIGATE trial for CD388 and subsequent financing puts us in a position of strength to execute on our Phase 3 plan to examine the potential of CD388, a non-vaccine solution, to provide single-dose per season, universal protection against influenza in individuals at greatest risk from influenza," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "Our planned Phase 3 development program focuses initially on individuals with compromised immune systems or those at a heightened risk of severe illness due to underlying health conditions. We have submitted an End-of-Phase 2 meeting request to the FDA to discuss our planned Phase 3 study design and start timing."

Recent and Expected Corporate Highlights

Phase 2b NAVIGATE trial evaluating CD388 for the prevention of seasonal influenza generated positive top-line results in June 2025. The study met its primary and all secondary efficacy endpoints for all dose groups. Single doses of 450mg, 300mg and 150mg of CD388 conferred 76.1%, 61.3% and 57.7% protection, respectively, from symptomatic influenza over 24 weeks compared to placebo. The placebo attack rate was 2.8% for the primary endpoint, and a clear dose response for efficacy was observed. CD388 was well-tolerated with no safety signals observed, and there were no meaningful changes in safety across the dose groups and placebo. Loss to follow-up rates were low and similar in all arms. Full primary analysis details from the Phase 2b NAVIGATE trial are expected to be submitted to upcoming scientific conferences in 2025.
End of Phase 2 meeting request submitted to the FDA in June 2025. Based on the robust data from the Phase 2b NAVIGATE trial, Cidara has submitted an End of Phase 2 meeting request to the FDA to review the data and discuss the details of a proposed Phase 3 study focusing on large populations with the highest unmet need, which includes high-risk/co-morbid and immune-compromised patients. We plan to initiate the Phase 3 study no later than in the spring of 2026 during the Southern Hemisphere influenza season, subject to FDA consultation on our study design.
Closed an upsized public offering for gross proceeds of $402.5 million in June 2025. Cidara closed an underwritten public offering of 9,147,727 shares of its common stock, including the exercise in full by the underwriters of their option to purchase an additional 1,193,181 shares, at a price to the public of $44.00 per share. The gross proceeds to Cidara from the offering, before deducting underwriting discounts and commissions and offering expenses, were $402.5 million.
Company announces inclusion in the Russell 2000 and Russell 3000 Indexes in June 2025. In June 2025, Cidara was added to the Russell 2000 and Russell 3000 Indexes, further enhancing the Company’s visibility with the institutional investment community.
Hosted virtual research and development (R&D) Day to discuss CD388 as a potential universal, once-per-flu season preventative of seasonal and pandemic influenza in May 2025. The event featured key opinion leaders Fred Hayden, MD, FACP (University of Virginia School of Medicine) and Rick Bright, PhD (Pandemic Prevention Institute, The Rockefeller Foundation), who joined company management to discuss CD388.
Second Quarter 2025 Financial Results

Cash, cash equivalents and restricted cash totaled $516.9 million as of June 30, 2025, compared with $196.2 million as of December 31, 2024.
Collaboration revenue was zero for the three and six months ended June 30, 2025, compared to $0.3 million and $1.3 million for the same periods in 2024, respectively. Collaboration revenue related to R&D and clinical supply services provided to J&J Innovative Medicine, previously Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), under our license and collaboration agreement with Janssen (the Janssen Collaboration Agreement) which was terminated upon the effectiveness of our license and technology transfer agreement with Janssen (the Janssen License Agreement) on April 24, 2024.
Acquired in-process research and development (IPR&D) expenses were zero for the three and six months ended June 30, 2025, compared to $84.9 million for the same periods in 2024. Acquired IPR&D related to an upfront payment of $85.0 million paid to Janssen under the Janssen License Agreement on April 24, 2024, plus $0.4 million in direct transaction costs, offset by a gain of $0.5 million to settle the preexisting Janssen Collaboration Agreement relationship.
R&D expenses were $24.8 million and $49.4 million for the three and six months ended June 30, 2025, respectively, compared to $6.7 million and $12.6 million for the same periods in 2024, respectively. The increase in R&D expenses is primarily due to higher expenses associated with our CD388 Phase 2b NAVIGATE study as well as CD388 development costs relating to our planned Phase 3 study, offset by lower nonclinical expenses associated with our Cloudbreak platform.
General and administrative (G&A) expenses were $6.5 million and $12.7 million for the three and six months ended June 30, 2025, respectively, compared to $4.7 million and $8.3 million for the same periods in 2024, respectively. The increase in G&A expenses is primarily due to higher personnel costs relating to stock-based compensation, offset by lower audit fees and legal costs.
During the three and six months ended June 30, 2025, the Company determined that accrued indirect taxes relating to shipments of our former rezafungin assets totaling $3.9 million and $9.4 million, respectively, were not due and payable upon voluntary disclosure and full compliance in certain jurisdictions and the associated liabilities and operating expenses were reversed as part of continuing operations. No indirect tax reversals were recorded during the same periods in 2024.
Income from discontinued operations for the three and six months ended June 30, 2025 was zero, compared to $3.0 million and $0.9 million for the same periods in 2024, respectively. On April 24, 2024, the Company entered into an asset purchase agreement with Napp Pharmaceutical Group Limited (Napp), an affiliate of Mundipharma Medical Company, pursuant to which all rezafungin assets and related contracts were sold to Napp. All conditions of the sale were completed on April 24, 2024, and the financial results of rezafungin have been reported separately as discontinued operations.
Net loss for the three and six months ended June 30, 2025 was $25.7 million and $49.2 million, respectively, compared to a net loss of $91.2 million and $101.5 million for the same periods in 2024, respectively.
Second Quarter 2025 Conference Call and Webcast Details

Cidara Therapeutics management will host a conference call and webcast beginning at 5:00 pm ET / 2:00 pm PT today, August 7, 2025. A live webcast may be accessed here. The conference call can be accessed by dialing toll-free (844) 825-9789 or (412) 317-5180 (international). The passcode for the conference call is 10200740.

A replay of the webcast will be archived on www.cidara.com for one year under the "Events & Presentations" tab in the Investors section of the company’s website.

On August 7, 2025 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer and autoimmune diseases, reported financial results and business highlights for the second quarter ended June 30, 2025 (Press release, In8bio, AUG 7, 2025, View Source [SID1234654982]).

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Key Highlights:

Durable Four-Year PFS Milestone in Glioblastoma:

A patient in IN8bio’s INB-200 clinical trial has now surpassed four years without progression, a significant clinical milestone in front-line, grade IV glioblastoma (GBM), demonstrating the potential for extended overall survival and the durability of IN8bio’s therapy.
Positive Clinical Data Presented at ASCO (Free ASCO Whitepaper) 2025:

IN8bio presented positive new data showing that GBM patients receiving multiple doses of INB-200 achieved mPFS of 16.1 months as of May 31, 2025, more than double the 6.9 months typically observed with the standard-of-care Stupp protocol.
40% of patients receiving multiple doses remain progression-free for over 18 months with no significant toxicities observed as of May 31, 2025.
Award for Innovative Cell Therapy Manufacturing:

The Company was recognized with the Host Region USA East Abstract Award at the ISCT 2025 Annual Meeting for its DeltEx platform. IN8bio showcased its robust manufacturing processes and scalable technology platform, essential for advancing cell therapy treatments with consistency and operational efficiency.
New Preclinical Data in Autoimmune Diseases:

IN8bio presented exciting new preclinical results at ASGCT (Free ASGCT Whitepaper) 2025 for its innovative gamma-delta T cell engager (INB-619). INB-619 demonstrated complete, targeted depletion of harmful B cells in lupus samples without significant inflammatory cytokines, representing a potentially safer immunotherapy alternative with the ability to drive deeper B cell depletion.
William Ho, CEO and co-founder, IN8bio, commented, "We believe this quarter clearly demonstrates our ability to deliver transformative outcomes in cancer and autoimmune disease. We had an oral presentation at ASCO (Free ASCO Whitepaper), reached a remarkable four-year PFS milestone in a grade IV glioblastoma patient, demonstrated the potential of our T cell engager platform to treat autoimmune diseases, and highlighted our robust cell therapy manufacturing capabilities. We’re proud of these continued accomplishments, which demonstrate our ability to be a leader in gamma-delta T cell therapies and highlight our potential to help transform the treatment of cancer and autoimmune disease. We’ve also extended our runway into June 2026."

Upcoming Anticipated Pipeline Milestones and Events

Update on enrollment in INB-100 expansion cohort in leukemia patients
Glioblastoma clinical update from INB-200 and INB-400 clinical trials
Additional preclinical data from INB-619 T cell engager program for cancer and autoimmune diseases in 4Q25
Second Quarter 2025 Financial Highlights

Research and Development (R&D) expenses: R&D expenses were $2.5 million for the three months ended June 30, 2025, compared with $5.2 million in the prior year. These amounts include non-cash items such as stock-based compensation (SBC) and depreciation of $0.5 million. The change was primarily due to a strategic pause on clinical trial-related activities for the INB-400 program and reduced personnel-related costs, which followed the Company’s pipeline prioritization announcement in September 2024.
General and administrative (G&A) expenses: G&A expenses were $2.7 million for the three months ended June 30, 2025, compared with $3.5 million for the comparable prior year period. These amounts include non-cash items such as SBC and depreciation of $0.7 million. The change was primarily due to cost savings related to personnel-related costs, director and officer insurance premiums and professional services.
Net loss: The company reported a net loss of $5.1 million, or $1.24 per basic and diluted common share, for the three months ended June 30, 2025, compared with a net loss of $8.6 million, or $5.51 per basic and diluted common share, for the comparable prior year period. This amount includes non-cash items such as SBC and depreciation of $1.2 million, along with one-time charges related to the Company’s pipeline prioritization announcement in September 2024.
Cash position: As of June 30, 2025, the Company had cash of $13.2 million, compared with $10.2 million for the comparable prior year.

On August 7, 2025 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported financial results for the fiscal first quarter ended June 30, 2025 and provided a business update (Press release, Replimune, AUG 7, 2025, View Source [SID1234654998]).

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The Company announced on July 22, 2025 that the U.S. Food and Drug Administration (FDA) had issued a Complete Response Letter (CRL) for the RP1 BLA in advanced melanoma.

"Based on the compelling clinical data and safety profile generated to date with RP1 in the IGNYTE study, the melanoma community, including clinical experts and patients, strongly believe RP1 should be made available to patients that have few remaining treatment options as soon as possible. We are committed to finding an expeditious path forward with the FDA," said Sushil Patel, Ph.D., CEO of Replimune.

Program Highlights & Milestones

RP1 (vusolimogene oderparepvec)

The global Phase 3 trial, IGNYTE-3 assessing RP1 in combination with nivolumab is ongoing. The trial is expected to enroll approximately 400 patients across 100 sites globally and is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment. The primary endpoint of this trial is overall survival and key secondary endpoints are progression free survival and overall response rate. Following the CRL, the Company anticipates discussing the design of this trial with the FDA.

RP1 (vusolimogene oderparepvec)

RP1 + nivolumab in non-melanoma skin cancers
The Company continues to evaluate the potential of RP1 in merkel cell carcinoma, basal cell carcinoma and angiosarcoma, and locally advanced cutaneous squamous cell carcinoma, including anti-PD1-failed patients, in the ongoing IGNYTE trial cohort.
RP1 in skin cancer organ transplant patients
The Company continues to evaluate RP1 as monotherapy in cutaneous squamous cell carcinoma patients with organ transplants in its Phase 2 ARTACUS trial. Data to-date has shown RP1 to be well tolerated with no cases of RP1-related allograft rejection observed. The overall response rate was 34.6% with a duration of response of 24 months in 61% of patients in the intent-to-treat population. ARTACUS continues to enroll patients.
RP2

RP2 in uveal melanoma
The registration-directed Phase 2/3 REVEAL trial of RP2 in metastatic uveal melanoma is currently enrolling. The clinical trial is expected to enroll approximately 280 patients with metastatic uveal melanoma who are immune checkpoint inhibitor-naïve and evaluate RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab. The primary endpoints of the trial are overall survival and progression free survival, and key secondary endpoints are overall response rate and disease control rate.
RP2 in hepatocellular carcinoma (HCC)
The Phase 2 clinical trial of RP2 combined with atezolizumab and bevacizumab in anti-PD1/PD-L1 progressed HCC is currently enrolling with data anticipated in the first half of 2026. This trial will evaluate RP2 combined with the second-line therapy of atezolizumab and bevacizumab and is expected to enroll 30 patients. The trial is being conducted under a collaboration and supply agreement with Roche.
RP2 in biliary tract cancer (BTC)
As previously reported, the Company expects to dose its first patient in the second half of 2025 in a cohort evaluating RP2 in patients with biliary tract cancer. This trial will evaluate RP2 combined with durvalumab and is expected to enroll 30 patients.
Financial Highlights

Cash Position: As of June 30, 2025, cash, cash equivalents and short-term investments were $403.3 million, as compared to $483.8 million as of fiscal year ended March 31, 2025. The decrease in cash balance was a result of cash burn related to operating activities in advancing the company’s clinical development plans.
Based on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments, as of June 30, 2025 will enable the Company to fund operations into the fourth quarter of 2026 which includes the potential commercialization of RP1 in skin cancers and for working capital and general corporate purposes and excludes any potential revenue.

R&D Expenses: Research and development expenses were $57.8 million for the fiscal first quarter and $43.0 million for the fiscal first quarter ended June 30, 2024. This increase was primarily due to an increase in personnel-related costs as we scaled operations in preparation for commercial launch of RP1, as well as medical affairs and consulting costs. Research and development expenses included $4.7 million in stock-based compensation expenses for the fiscal first quarter ended June 30, 2025.
S,G&A Expenses: Selling, general and administrative expenses were $32.6 million for the fiscal first quarter ended June 30, 2025, as compared to $14.4 million for the fiscal first quarter ended June 30, 2024. Selling, general and administrative expenses included $4.1 million in stock-based compensation expenses for the fiscal first quarter ended June 30, 2025.
Net Loss: Net loss was $86.7 million for the fiscal first quarter ended June 30, 2025 and $53.8 million for the fiscal first quarter ended June 30, 2024.
About RP1

RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About RP2

RP2 is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity.

On August 7, 2025 Coherus Oncology, Inc. (Nasdaq: CHRS), reported financial results for the second quarter ended June 30, 2025 and provided an overview of recent business highlights (Press release, Coherus Oncology, AUG 7, 2025, View Source [SID1234654967]).

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"Coherus Oncology is dedicated to significantly extending survival for people with cancer," said Denny Lanfear, Coherus Chairman and Chief Executive Officer. "We are executing well commercially, and our focus on maximizing LOQTORZI’s potential in nasopharyngeal carcinoma has resulted in a 36% net revenue increase over Q1 2025 to $10.0 million. With a cash runway through 2026, beyond key data readouts, continued strong clinical execution will derisk the pipeline, unlocking large U.S. market potential and creating Ex-U.S. licensing opportunities as the clinical data further evolve."

"Our pipeline clinical programs with CHS-114 and casdozkitug in solid tumors are progressing and on track for data readouts in 2026," said Theresa LaVallee, Ph.D., Coherus Chief Scientific and Development Officer. "Data on CHS-114, our cytolytic CCR8 antibody, in combination with toripalimab, provide compelling evidence of their potential in remodeling the tumor microenvironment by depleting immunosuppressive Treg cells with CHS-114 and boosting immune activation with toripalimab. We believe that in 2026, anti-CCR8s may start to realize their therapeutic promise and become a new treatment backbone, used broadly across solid tumor types."

RECENT BUSINESS HIGHLIGHTS

LOQTORZI (toripalimab-tpzi) COMMERCIAL UPDATES

LOQTORZI is the only FDA-approved and available treatment in the U.S. for recurrent, locally advanced or metastatic nasopharyngeal carcinoma (NPC), in all patient subsets and across all lines of therapy.
LOQTORZI net revenue for Q2 2025 was $10.0 million, a 36% growth over LOQTORZI net revenue of $7.3 million in Q1 2025. This growth was driven largely by higher patient demand and some inventory restocking. LOQTORZI net revenue was $3.8 million in Q2 2024.
Following a recent revision in the National Comprehensive Cancer Network (NCCN) guidelines granting LOQTORZI preferred status for NPC indication, the Company has seen strong demand growth among Head & Neck cancer specialists. The Company’s focus remains on deepening adoption within the community oncologist setting.
ADVANCEMENT OF INNOVATIVE, NEXT-GENERATION ONCOLOGY PIPELINE

LOQTORZI is a next-generation, differentiated PD-1 marketed in the U.S. in two indications.

Coherus plans to maximize the value of this medicine by combining LOQTORZI with internal pipeline candidates, CHS-114 and casdozokitug, for additional solid tumor indications and entering into capital-efficient external partnerships for label expansions.
CHS-114 is a highly selective cytolytic CCR8 antibody that specifically binds and preferentially depletes CCR8+ tumor regulatory T cells (Tregs) with no off-target binding.

Phase 1b CHS-114/toripalimab combination dose optimization studies in 2L head and neck (HNSCC) and 2L gastric cancers are underway, with initial data readouts expected in 1H 2026.
A Phase 1b study evaluating the CHS-114/toripalimab combination, with and without chemotherapy, in 1L and 2L esophageal squamous cell carcinoma (ESCC), respectively, is underway with a first data readout expected in 1H 2026.
Casdozokitug is a first-in-class, clinical-stage IL-27 antagonist, with demonstrated monotherapy activity in treatment-refractory non-small cell lung cancer (NSCLC) and clear cell renal cell carcinoma (ccRCC) and combination activity in hepatocellular carcinoma (HCC).

Enrollment is ongoing in the Phase 2 randomized trial of casdozokitug/toripalimab/bevacizumab in 1L HCC, with the first data readout expected in 1H 2026.
UDENYCA DIVESTITURE COMPLETED AND CERTAIN FINANCIAL OBLIGATIONS PAID OFF

On April 11, 2025, Coherus completed the UDENYCA divestiture and received $483.4 million in cash, inclusive of $118.4 million for UDENYCA product inventory. In addition, the Company is eligible to receive potential milestone payments of up to $75 million.

During Q2 2025, the Company used a portion of the proceeds from the UDENYCA sale to: (1) repay substantially all of the $230 million aggregate principal amount of the outstanding 2026 Convertible Notes, and (2) buy out the royalty rights on the net revenues of UDENYCA, in accordance with the Revenue Purchase and Sale Agreement, resulting in a $47.7 million payment.

SECOND QUARTER 2025 FINANCIAL RESULTS

Net revenue from continuing operations was approximately $10.3 million for each of the quarters ended June 30, 2025 and 2024. LOQTORZI net product revenue increased $6.2 million compared to Q2 in the prior year primarily due to volume growth, offset by a $6.2 million decrease in other revenue primarily due to the upfront fee recognized in the prior year period for the outlicense of rights to commercialize toripalimab within Canada. Net revenue was $17.9 million and $12.6 million for the six months ended June 30, 2025 and 2024, respectively, with the increase primarily driven by volume growth of LOQTORZI, which launched in December 2023.

Cost of goods sold (COGS) from continuing operations was $3.4 million and $1.8 million during the three months ended June 30, 2025 and 2024, respectively, and $6.0 million and $3.2 million during the six months ended June 30, 2025 and 2024, respectively. The increases were primarily due to volume growth of LOQTORZI.

Research and development (R&D) expenses from continuing operations were $26.3 million and $20.6 million for the three months ended June 30, 2025 and 2024, respectively, and $50.7 million and $49.0 million during the six months ended June 30, 2025 and 2024, respectively. The increases were primarily due to increased costs for development of casdozokitug and CHS-114, partially offset by reductions in co-development costs for toripalimab, termination of the TIGIT Program, savings from reduced headcount, and lower infrastructure costs.

Selling, general and administrative (SG&A) expenses from continuing operations were $26.0 million and $27.5 million during the three months ended June 30, 2025 and 2024, respectively, and $52.1 million and $67.7 million during the six months ended June 30, 2025 and 2024, respectively. The decreases were driven primarily by lower headcount and decreased operating costs following Coherus’ recent divestitures. The decrease in the six-month period was also due to a net $6.8 million charge in the first quarter of 2024 for the write-off of an intangible asset and associated contingent value right liability related to NZV930, which was acquired in the Surface Oncology, Inc. acquisition.

Interest expense from continuing operations was $2.3 million and $4.1 million during the three months ended June 30, 2025 and 2024, respectively, and $4.4 million and $7.2 million during the six months ended June 30, 2025 and 2024, respectively. The decreases were primarily due to the prepayment of the remaining $75.0 million of the principal amount due under the 2027 Term Loans on May 8, 2024, partially offset by interest on the $38.7 million senior secured term loan facility and the LOQTORZI portion of the Revenue Participation Right Purchase and Sale Agreement, each commencing May 8, 2024.

Net loss from continuing operations for the second quarter of 2025 was $44.9 million, or $(0.39) per share on a diluted basis, compared to a net loss of $54.9 million, or $(0.48) per share on a diluted basis, for the same period in 2024. Net loss for the first half of 2025 was $92.3 million, or $(0.80) per share on a diluted basis, compared to a net loss of $122.9 million, or $(1.08) per share on a diluted basis for the first half of 2024.

Non-GAAP net loss from continuing operations for the second quarter of 2025 was $39.0 million, or $(0.34) per share on a diluted basis, compared to $34.7 million, or $(0.30) per share for the same period in 2024. Non-GAAP net loss for the first half of 2025 was $79.9 million, or $(0.69) per share on a diluted basis, compared to $88.3 million, or $(0.78) per share for the first half of 2024. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net loss from continuing operations and a reconciliation to the most directly comparable GAAP measures.

Net income from discontinued operations, net of tax was $342.6 million, or $2.95 per share on a diluted basis, for the second quarter of 2025 compared to $41.9 million, or $0.37 per share on a diluted basis, for the same period in 2024. Net income from discontinued operations, net of tax for the first half of 2025 was $333.5 million, or $2.88 per share on a diluted basis, compared to $212.8 million, or $1.87 per share on a diluted basis for the same period in 2024.

The increases compared to the prior year periods were primarily due to the $339.1 million net gain on the UDENYCA divestiture in April 2025, partially offset by the $22.9 million net gain on the YUSIMRY Sale in June 2024, the $10.3 million charge for loss on debt extinguishment, and lower net revenue driven by the 2024 divestitures. Total net revenues attributable to the Company’s divested products, UDENYCA, CIMERLI and YUSIMRY, which are reflected in discontinued operations, were $23.1 million and $54.7 million for the three months ended June 30, 2025 and 2024, respectively, and $55.2 million and $129.4 million during the six months ended June 30, 2025 and 2024, respectively.

The increase in the six-month period was partially offset by $153.6 million gain on sale of the CIMERLI divestiture in the first quarter of 2024 and an $11.8 million charge in the first quarter of 2025 for the change in fair value of the Royalty Fee Derivative Liability related to UDENYCA.

Cash, cash equivalents and marketable securities totaled $237.6 million as of June 30, 2025, compared to $126.0 million as of December 31, 2024. A majority of the $96.8 million in accrued rebates, fees and reserves reflected on the June 30, 2025 balance sheet were UDENYCA-related obligations that did not transfer in the divestiture and are expected to be settled in a front-loaded fashion over the remainder of the year and into 2026.

Conference Call Information
When: Thursday, August 7, 2025, starting at 5:00 p.m. Eastern Daylight Time

To access the conference call:

TOLL-FREE DIAL-IN: (800) 715-9871
INTERNATIONAL DIAL-IN: (646) 307-1963
Conference ID 8712736
Webcast: View Source

A live and archived webcast will be available on the "Investors" section of the Coherus website at View Source

Please dial in 15 minutes early to ensure a timely connection to the call.

On August 7, 2025 INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported its financial results for the quarter ended June 30, 2025 and provides a business update (Press release, INmune Bio, AUG 7, 2025, View Source [SID1234654983]).

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Q2 2025 and Recent Corporate Highlights

DN-TNF Platform Highlights (XPro):

● Released top-line data from the MINDFuL phase 2 trial in 208 patients with MCI and early Alzheimer’s.

● The trial missed its primary cognitive endpoints in the 200 modified mITT patients enrolled, however;

● XPro demonstrated a positive impact on the primary cognitive endpoint EMACC in a pre-defined subset of 100 patients (50%) with two or more biomarkers of inflammation, defined as the enriched population.

● Additional data from the MINDFuL trial was presented by a Key Opinion Leader, Dr. Sharon Cohen of the Toronto Memory Program, at the Alzheimer’s Association International Conference (AAIC) on July 29th. This data is summarized in the forest plot below.

Figure Legend: With the enriched population underpowered for detecting statistically significant changes, the Company and third-party statisticians relied on Cohen’s d effect sizes to evaluate the meaningfulness of observed changes. These effect sizes, though small, consistently favored XPro over placebo on the primary endpoint and multiple secondary and exploratory endpoints (see figure). Across most endpoints, XPro showed favorable trends, with effect sizes approaching the 0.2 threshold for clinical relevance.

The clinical endpoints shown in the forest plot include:

● EMACC (Early Mild Alzheimer’s Cognitive Composite)-Performance-based measure of Cognition: empirically derived composite of neuropsychological tests that are widely used in clinics.

● ISRL (International Shopping List Test, delayed recall) – Performance-based measure of Memory. Delayed recall component of widely used word-list learning test.

● CDR-SB (Clinical Dementia Rating Scale – Sum of Boxes) – Clinician-rated measure that combines Cognition and Function: interview with study partner and patient as well as some performance-based items completed by patient.

● NPI (Neuropsychiatric Interview) – Caregiver-reported measure of the patient’s psychiatric symptoms.

● ECog (Everyday Cognition) – Caregiver reported questionnaire: caregiver rates the patient’s change in cognition (skills now as compared to 10 years ago – prior to cognitive decline)

● GAS (Goal Attainment Scale) Personalized Patient and caregiver-rated scale where the specific goals and items are chosen by patient and caregiver and they rate change on the goals over the course of the study.

● Presented a poster at the Keystone Symposia that showed that XPro significantly reduces amyloid formation and improves clinical measures of brain function in patients with TBI (tTaumatic Brain Injury).

CORDStrom Platform:

● Received a favorable written opinion from The United States Patent and Trademark Office (USPTO), acting as the International Search Authority, on all claims in INmune Bio’s international patent application PCT/US25/17028, titled "THERAPEUTIC COMPOSITIONS COMPRISING POOLED, CULTURE-EXPANDED HUMAN UMBILICAL CORD DERIVED MESENCHYMAL STROMAL CELLS."

● Partnered with the Cell and Gene Therapy Catapult (CGT Catapult) to establish large-scale, commercial-ready manufacturing for CORDStrom and the Company’s other cell therapy platforms. This is an essential part of our ambitious timeline to transfer the manufacturing site, validate the large-scale manufacturing process and all of the analytical assays in time for MAA and BLA submissions next year. Much of this work continues to provide data to strengthen our existing IP position portfolio.

● The complete database of clinical data from the randomized, double-blind trial of CORDStrom in Recessive Dystrophic Epidermolysis Bullosa (RDEB) has now been delivered from the trial sponsor to an independent statistical analysis company which is applying a statistical analysis plan devised by INmuneBio. We believe this will enrich the data presented by the Sponsor previously and we anticipate the data being available in Q4.

INKmune Platform:

● Following success in meeting the primary endpoint at completion of the phase I aspect of the CARE-PC trial we opened the phase II in Q1 this year and quickly enrolled the first three patients. Early analysis of blood samples for the biomarkers of interest demonstrated that both secondary endpoints of NK activation and NK cell proliferation in vivo had been met.

● Determined that patients with low NK cell function responded better to treatment, with substantial increases in NK cell potency. This allows us to screen patients in future trials to direct treatment only to those with the ability to respond, in the same way that patients have been screened for suitability for treatment with checkpoint inhibitor drugs.

● We await receipt of results of PSMA-PET scans for most of the trial subjects, although initial results from the phase I patients showed reduction or control of individual lesions in a background of worsening disease.

● Having reviewed the current data, we concluded that the CARE-PC trial has provided all the data needed to design a future randomized trial and we have closed the trial to further recruitment to ensure completion of follow-up by end of Q4 of 2025 as planned.

Corporate:

● Dr. RJ Tesi retires as CEO.

● David Moss appointed President & CEO and to the Board of Directors.

● Cory Ellspermann appointed as Interim CFO.

● Kelly Ganjei appointed as Chairman of the Board.

● Closed a $19 million registered direct offering.

Upcoming Events and Milestones:

● End of phase 2 meeting regarding the MINDFuL trial with the FDA expected to take place in the fourth quarter.

● The Company will file a publication on the MINDFuL trial results expected to be available this month.

● The Company remains on track to file a Marketing Authorization Application (MAA) in the UK and Biologic License Application (BLA) for CORDStrom in RDEB by mid-2026.

● We have ambitious plans to develop a pipeline of additional indications for CORDStrom which we will pursue with non-dilutive funding or partnerships.

● Additional data from Greater Orman Street Hospital on RDEB patients treated with CORDStrom expected in the fourth quarter.

● More patient data from the INKmune ongoing phase 2 trial in metastatic castration-resistant prostate cancer will be released as it becomes available.

Financial Results for the Second Quarter Ended June 30, 2025:

● Net loss attributable to common stockholders for the quarter ended June 30, 2025 was approximately $24.5 million, compared to approximately $9.7 million during the quarter ended June 30, 2024.

● Research and development expenses totaled approximately $5.9 million for the quarter ended June 30, 2025, compared to approximately $7.1 million during the quarter ended June 30, 2024.

● General and administrative expenses were approximately $2.3 million for the quarter ended June 30, 2025, compared to approximately $2.8 million during the quarter ended June 30, 2024.

● Impairment of acquired in-process research and development intangible assets was $16.5 million during the quarter ended June 30, 2025 compared to none recorded during the quarter ended June 30, 2024.

● Other income, net was approximately $0.1 million for the quarter ended June 30, 2025, compared to approximately $0.1 million during the quarter ended June 30, 2024.

● As of June 30, 2025, the Company had cash and cash equivalents of approximately $33.4 million.

● As of August 7, 2025, the Company had approximately 26.6 million common shares outstanding.

Earnings Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio First Quarter Conference Call when reaching the operator.

Date: August 7th, 2025

Time: 4:30 PM Eastern Time

Participant Dial-in: 1-800-225-9448 Participant Dial-in (international): +1-203-518-9783

Conference ID: INMUNE

A live audio webcast of the call can be accessed by clicking here or using this link:

View Source;tp_key=2300519883

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through August 21, 2025 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering pin no. 11159128.

About XPro

XPro is a next-generation inhibitor of tumor necrosis factor (TNF) that acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.

About CORDStrom

CORDStrom is a patent-pending cell medicine comprising aseptic, allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs) in suspension for injection or infusion. The CORDStrom platform leverages, among other things, proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled hucMSCs as medicines to treat complex inflammatory diseases. CORDStrom products are designed to provide high-quality, off-the-shelf, batch-to-batch consistent, scalable, cGMP manufactured, potent cellular medicines that can be produced at low cost and with repeatable specification independent of donor characteristics. The CORDStrom product platform shares many similarities, including reagents, equipment, and procedures, with the Company’s INKmune oncology product, enabling the Company to leverage economies of scale, experienced staff, and other resources to strategically manufacture both products in a rotational campaign with resource and environmental efficiencies.

Initially developed at the INKmune manufacturing facilities utilizing UK academic grant funding, CORDStrom is an MSC product platform that shows promise as a first systemic therapy for potentially treating RDEB and many other debilitating conditions. While the first generation CORDStrom product is agnostic to disease indication, the platform enables creation of indication-specific products, which can be tuned for optimization of anti-inflammatory, immunomodulatory, wound healing, and other characteristics.

About INKmune

INKmune is a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals to convert the cancer patient’s resting NK cells into tumor killing memory-like NK cells (mlNK cells). INKmune treatment converts the patient’s own NK cells into mlNK cells. In patients, INKmune primed tumor killing NK cells have persisted for more than 100 days. These cells function in the hypoxic TME because due to upregulated nutrient receptors and mitochondrial survival proteins.