On August 7, 2025 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported a business update and announced financial results for the second quarter ended June 30, 2025 (Press release, Corvus Pharmaceuticals, AUG 7, 2025, View Source [SID1234654969]).

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"We are excited by the data reported from our Phase 1 trial of soquelitinib for atopic dermatitis and are advancing its development for this indication on multiple fronts," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "This includes patient enrollment in the extension cohort 4 of the Phase 1 trial, which is exploring an 8-week treatment period and is on track to report data in the fourth quarter 2025, along with near-final plans for a Phase 2 trial that we expect to initiate before year-end. In China, our partner Angel Pharmaceuticals plans to initiate a separate Phase 1b/2 trial, which will further expand the clinical experience with soquelitinib, including a 12-week treatment period and a 400 mg once-daily dose. In addition, enrollment continues in our Phase 3 registration clinical trial in PTCL and the Phase 2 trial in autoimmune lymphoproliferative syndrome (ALPS), reflecting the broader opportunity for ITK inhibition across a range of immune diseases."

Business Update and Strategy

Soquelitinib (Corvus’ selective ITK inhibitor) for Immune Diseases

On June 4, 2025, Corvus reported interim results (data cutoff date of May 28, 2025) from the first three cohorts of its randomized, placebo-controlled Phase 1 clinical trial of soquelitinib in patients with moderate to severe atopic dermatitis that continued to demonstrate a favorable safety profile and efficacy profile. Patients in cohort 3 had more advanced disease with a higher mean baseline EASI (Eczema Area and Severity Index) score compared to patients in cohorts 1 and 2. At 28 days, the mean reduction in EASI for cohort 3 (n=12) was 64.8%, compared to 54.6% for cohort 1 and 2 combined (n=24) and 34.4% for placebo (n=12). Cohort 3 patients experienced earlier responses and deeper separation from placebo compared to cohorts 1 and 2 starting by day 8. EASI scores continue to improve further in treated patients from all cohorts out to day 58.
In cohort 3, of the patients for whom adequate PP-NRS (Peak Pruritus Numerical Rating Scale) data was available, 4 of 8 (50%) had a ≥4 point reduction in PP-NRS score from baseline at day 28, with a reduction in itch seen as early as day 8. Of the remaining patients, two had baseline PP-NRS of less than 4 and two had incomplete PP-NRS data. One of 10 evaluable placebo patients (10%) experienced a ≥4 point reduction in PP-NRS score at Day 28.
As of the data cutoff, soquelitinib was well tolerated in the Phase 1 clinical trial, with no dose limiting toxicities (DLTs) and no clinically significant laboratory abnormalities observed in any of the cohorts.
Corvus initiated enrollment in extension cohort 4 of the Phase 1 clinical trial, which is planned to study 24 patients randomized 1:1 between active (soquelitinib 200 mg twice per day, the same dose as cohort 3) and placebo. The treatment period for this group is 8 weeks, compared to 4 weeks in cohorts 1-3, with the same additional 30-day follow-up period with no treatment.
Angel Pharmaceuticals, Corvus’ partner in China, has been approved by the Center for Drug Evaluation of the China National Medical Products Administration to initiate a Phase 1b/2 clinical trial of soquelitinib for the treatment of patients with moderate-to-severe atopic dermatitis in China. The trial, which is planned to enroll 48 patients and will study four soquelitinib doses and placebo, will further expand the clinical experience with soquelitinib in atopic dermatitis, including a 12-week treatment period and a 400 mg once-daily dose.
Preclinical data highlighting the potential of soquelitinib to treat systemic sclerosis was presented in a poster session at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress, where it was selected as a top 10 abstract by the Emerging EULAR Network (EMEUNET), a network of young rheumatologists and researchers in the field of rheumatology in Europe and beyond.
Corvus also continues to advance its next-generation ITK inhibitor preclinical product candidates, which are designed to deliver precise T-cell modulation that is optimized for specific immunology indications.
Collaboration with National Institute of Allergy and Infectious Diseases (NIAID)

Patient enrollment continues in the ALPS Phase 2 clinical trial, which is being conducted under a clinical research and development agreement with NIAID. The Phase 2 clinical trial (NCT06730126) is anticipated to enroll up to 30 patients aged 16 or older with confirmed ALPS based on genetic testing.
Soquelitinib for T Cell Lymphoma

Corvus continues to enroll patients in a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed/refractory PTCL at multiple clinical sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed/refractory PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate. The primary endpoint of the trial is progression free survival. There are no FDA fully approved agents for the treatment of relapsed/refractory PTCL, and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory PTCL after at least 2 lines of systemic therapy.
Collaboration with Kidney Cancer Research Consortium: Ciforadenant (adenosine A2a receptor inhibitor)

Corvus is collaborating with the Kidney Cancer Research Consortium (KCRC) in a Phase 1b/2 clinical trial evaluating ciforadenant as a potential first line therapy for metastatic renal cell cancer (RCC) in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The trial is fully enrolled and patients are being followed.
Partner Led Program: Mupadolimab (anti-CD73)

Angel Pharmaceuticals continues to evaluate data from its Phase 1/1b clinical trial of mupadolimab in patients with relapsed non-small cell lung cancer (NSCLC).
Financial Results
As of June 30, 2025, Corvus had cash, cash equivalents and marketable securities of $74.4 million as compared to $52.0 million as of December 31, 2024. During the three months ended June 30, 2025, all of the remaining outstanding common stock warrants were exercised, resulting in proceeds of $35.7 million which included $2.0 million from warrants exercised by Corvus’ CEO, Dr. Miller. Based on its current plans, Corvus expects its cash to fund operations into the fourth quarter of 2026.

Research and development expenses for the three months ended June 30, 2025 totaled $7.9 million compared to $4.1 million for the same period in 2024. The increase of approximately $3.8 million was primarily due to higher clinical trial and manufacturing costs associated with the development of soquelitinib as well as an increase in personnel related costs.

Net loss for the three months ended June 30, 2025 was $8.0 million compared to a net loss of $4.3 million for the same period in 2024. Included in net loss for the three months ended June 30, 2024 and 2025 was a gain of $2.0 million and $1.8 million, respectively, associated with a change in fair value of the Company’s warrant liability. Total stock compensation expense for the three months ended June 30, 2025 was $1.3 million compared to $0.8 million for the same period in 2024, and the non-cash loss from Corvus’ equity method investment in Angel Pharmaceuticals was $0.4 million for the three months ended June 30, 2025 compared to non-cash income of $0.6 million for the same period in 2024.

Conference Call Details
Corvus will host a conference call and webcast today, Thursday, August 7, 2025, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the second quarter 2025 financial results. The conference call can be accessed by dialing 1-800-717-1738 (toll-free domestic) or 1-646-307-1865 (international) or by clicking on this link for instant telephone access to the event. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.

On August 7, 2025 CorMedix Inc. (Nasdaq: CRMD) reported financial results for the second quarter and six months ended June 30, 2025 and provided an update on its business announcing the acquisition of Melinta Therapeutics LLC, with a target closing date as early as September 1, 2025 (Press release, CorMedix, AUG 7, 2025, View Source [SID1234654968]).

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Second Quarter and Six Months 2025 Financial Highlights

For the second quarter of 2025, CorMedix recorded $39.7 million in net revenue from sales of DefenCath, compared to $0.8 million for the same period last year, and recorded net income of $19.8 million, or $0.29 per share, compared with a net loss of $14.2 million, or $0.25 per share, in the second quarter of 2024, driven primarily by net sales of DefenCath during the period.

Operating expenses in the second quarter of 2025 were $18.3 million, compared with $15.6 million in the second quarter of 2024, an increase of approximately 18%. The increase was driven primarily by an increase in G&A expense and R&D expense for the period. R&D expense in the second quarter of 2025 was $2.4 million, compared with $0.7 million for the same period in 2024, due to an increase in personnel and clinical trial services in support of the ongoing clinical programs. Selling and Marketing expense for the second quarter of 2025 amounted to $6.4 million, compared with $7.4 million in the second quarter of 2024, a decrease of 14% which was primarily due to increased marketing costs in the prior period related to the launch of DefenCath. General and administrative expense in the second quarter of 2025 amounted to $9.5 million, compared with $7.6 million in the second quarter of 2024, an increase of 25%. The increase was primarily driven by non-cash charges for stock-based compensation and costs related to business development.

For the six months ended June 30, 2025, the Company recorded $78.8 million in net revenue from the sales of DefenCath, compared to $0.8 million in net revenue for the same period last year, and recorded net income of $40.5 million, or $0.60 per share, during the first half of 2025, compared to a net loss of $28.6 million, or $0.50 per share, for the same period in 2024.

Operating expenses in the first half of 2025 were $35.7 million, compared to $31.5 million in the same period in 2024, an increase of approximately $4.2 million or 13%. This increase was primarily due to an increase in R&D expense and G&A expense, partially offset by a decrease in S&M expense related to the commercial launch activities of DefenCath.

The Company reported cash and short-term investments of $190.7 million as of June 30, 2025, excluding restricted cash. The Company believes that it has sufficient resources to fund operations for at least twelve months from the issuance of the Company’s Quarterly Report on Form 10-Q.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, August 7, 2025, at 8:30AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows:

Thursday, August 7th @ 8:30am ET
Domestic: 1-844-676-2922
International: 1-412-634-6840
Webcast: Webcast Link

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 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 Lisata Therapeutics, Inc. (Nasdaq: LSTA) ("Lisata" or the "Company"), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, reported a business update and announced financial results for the second quarter ended June 30, 2025 (Press release, Lisata Therapeutics, AUG 7, 2025, View Source [SID1234654965]).

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"We continued to advance our clinical development portfolio and partnering initiatives during the second quarter of 2025," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata. "All of our activities are to support our core mission of exploiting the broad applicability of certepetide across a variety of advanced solid tumors and other difficult-to-treat indications. To this end, we recently announced positive preliminary results from the ASCEND and iLSTA trials, and we anticipate a number of additional data events through the remainder of 2025 and into 2026."
Dr. Mazzo added, "Our continued rigorous financial management allows us to reaffirm our projection that available cash will fund current operations into the fourth quarter of 2026, including all active clinical studies through to their next data milestone."

Development Portfolio Highlights

Certepetide as a treatment for solid tumors in combination with other anti-cancer agents
Certepetide (formerly LSTA1), a proprietary, internalizing RGD (arginyl-glycyl-aspartic acid or iRGD), cyclic peptide product candidate, is an investigational drug designed to activate the C-end rule active transport mechanism in a tumor specific manner, resulting in systemically co-administered anti-cancer agents more efficiently penetrating and accumulating in the tumor. Additionally, certepetide has been shown to modify the tumor microenvironment ("TME"), diminishing its immunosuppressive nature, enhancing cytotoxic T cell concentration in the TME and inhibiting the metastatic cascade. Lisata and its collaborators have amassed significant non-clinical data demonstrating enhanced efficacy of various existing and emerging anti-cancer therapies, including chemotherapies, immunotherapies, and RNA-based therapeutics in solid tumor models.

In addition, to date, certepetide has also demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing clinical trials designed to demonstrate its ability to enhance the effectiveness of standard-of-care ("SoC") chemotherapy for pancreatic cancer as well as the combination of chemotherapy and immunotherapy in a variety of solid tumors. Certepetide has been awarded Fast Track designation (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.) as well as Orphan Drug Designation for glioma, osteosarcoma, and cholangiocarcinoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.). Currently, certepetide is the subject of multiple ongoing or planned clinical studies being conducted globally across several solid tumor types in combination with a variety of anti-cancer regimens, including:

•ASCEND: Phase 2b double-blind, randomized (2:1 ratio), placebo-controlled trial evaluating two dosing regimens of certepetide in combination with SoC chemotherapy (gemcitabine/nab-paclitaxel) in patients with previously untreated metastatic pancreatic ductal adenocarcinoma ("mPDAC"). The trial is being conducted across 25 sites in Australia and New Zealand led by the Australasian Gastro-Intestinal Trials Group ("AGITG") and coordinated by the National Health and Medical Research Council Clinical Trial Centre at the University of Sydney. Cohort A, with 95 patients receiving a single intravenous ("IV") dose of certepetide 3.2 mg/kg or placebo in combination with SoC, completed enrollment in the third quarter of 2023. Preliminary Cohort A data presented at the 2025 ASCO (Free ASCO Whitepaper)-GI Symposium showed a positive trend in overall survival, including four complete responses in the certepetide-treated group compared to none in the placebo treated group. As recently announced, preliminary data from Cohort B, with 63 patients receiving two IV doses of certepetide 3.2 mg/kg or placebo administered 4 hours apart in combination with SoC, was presented at the ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers ("ESMO-GI") Congress on July 2, 2025. The preliminary Cohort B data demonstrate a positive signal in progression-free survival and objective response rate observed in the certepetide-treated group compared to the placebo-treated group, indicating that the addition of two doses of certepetide (Cohort B regimen) to SoC resulted in a clinically meaningful treatment effect and an attractive safety profile. Final data and key findings from both cohorts of the ASCEND study are anticipated to be available later this year, with more information to follow as it becomes available.
•BOLSTER: Phase 2a double-blind, placebo-controlled, multi-center, randomized trial in the U.S. evaluating certepetide in combination with SoC chemotherapy in first- and second-line cholangiocarcinoma (CCA). The Company achieved complete enrollment in first-line CCA nearly six months ahead of plan, accelerating anticipated topline data readout to fourth quarter of 2025. Based on this rapid enrollment rate and the pressing need to improve treatment outcomes in patients that have progressed after first-line CCA treatment, a second cohort was added to the BOLSTER trial evaluating certepetide in combination with SoC in subjects with second-line CCA. In September 2024, Lisata announced first patient treated in the second-line CCA cohort and recently decided to stop enrollment at approximately 20 patients to accelerate data read out and optimize capital allocation.

•CENDIFOX: Phase 1b/2a open-label trial in the U.S. evaluating certepetide in combination with neoadjuvant FOLFIRINOX based therapies in pancreatic, colon and appendiceal cancers. In December 2024, the Company announced enrollment completion in all three cohorts. The single-center study, conducted solely at the University of Kansas Cancer Center, was designed with a 3-cycle run-in period to ensure patients met specific criteria before receiving treatment. Of the 66 patients enrolled, 50 patients met the criteria and were treated with certepetide across three cohorts, including 24 with resectable or borderline resectable pancreatic cancer, 15 with high-grade colon or appendiceal cancer and peritoneal metastasis, and 11 with oligometastatic colon cancer. The trial is expected to provide Lisata with valuable pre- and post-treatment tumor tissue data for immune profiling, along with long-term patient outcome information. CENDIFOX data are expected in the coming months; however, given that this is an investigator-initiated study, the exact timing is not in Lisata’s control. The trial is funded by the University of Kansas Cancer Center and Lisata is supplying certepetide.

•Qilu Pharmaceutical, the licensee of certepetide in the Greater China territory, is currently evaluating certepetide in combination with gemcitabine and nab-paclitaxel as a treatment for first-line mPDAC. During the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting, Qilu Pharmaceutical presented an abstract sharing preliminary data from the study which corroborated previously reported findings from the Phase 1b/2a trial of certepetide plus gemcitabine and nab-paclitaxel conducted in Australia in patients with first-line mPDAC. Qilu has completed enrollment in its Phase 2 trial and data are expected in the near future. Progression of Qilu’s certepetide development program into Phase 3 in China will trigger a $10 million milestone payment due to Lisata under the terms of the license agreement with Qilu.

•iLSTA: Phase 1b/2a randomized, single-blind, single-center, safety and pharmacodynamic trial in Australia, funded by WARPNINE Inc., evaluating certepetide in combination with SoC chemotherapy (nab-paclitaxel and gemcitabine) plus SoC immunotherapy (durvalumab) versus SoC alone in patients with locally advanced non-resectable PDAC. As recently announced, enrollment in this study has been completed. Updated interim analyses from the iLSTA trial, presented at the ESMO (Free ESMO Whitepaper)-GI Congress on July 3, 2025, show compelling new preliminary data for certepetide. Consistent with earlier preliminary findings from the 2025 ASCO (Free ASCO Whitepaper)-GI meeting, the data reinforce certepetide’s potential to enhance immunotherapy effectiveness by provoking significant RECIST responses and improving overall response and disease control rates. Final data and key findings from this study are anticipated in the first quarter of 2026.
•A Lisata-funded Phase 2a, double-blind, placebo-controlled, randomized, proof-of-concept study evaluating certepetide in combination with SoC temozolomide versus temozolomide alone in patients with newly diagnosed glioblastoma multiforme ("GBM") is being conducted across multiple sites in Estonia and Latvia and is planned to also include a site in Lithuania. The study is targeted to enroll 30 patients with a randomization of 2:1 in favor of the certepetide treatment group. Enrollment completion is expected in 2026.

Lisata entered into a research license with Catalent, Inc. ("Catalent"), to preclinically evaluate the efficacy of certepetide in combination with Catalent’s SMARTag ADC dual payload technology platform for the treatment of various difficult-to-treat diseases. Additionally, Lisata has expanded its strategic collaboration with GATC Health Corp ("GATC") to combine Lisata’s drug development expertise with GATC’s AI-powered Multiomics Advanced Technology platform to optimize and accelerate drug discovery and development, including analyzing certepetide for new indications and identifying combination therapies.

Lisata recently announced that the United States Patent and Trademark Office ("USPTO") issued the Company a new composition of matter patent for certepetide (U.S. Patent No. 12,351,653), which extends its patent protection until March 2040, with potential for further extensions. The patent grants Lisata exclusive rights to the drug itself, preventing others from manufacturing or selling certepetide. The patent’s claims cover certepetide’s chemical structure, pharmacokinetic properties, methods of manufacturing, and applications for treating solid tumors.

Second Quarter 2025 Financial Highlights

Revenue

For the three months ended June 30, 2025, revenue totaled $70 thousand in connection with an upfront license fee related to the Research License Agreement with Catalent, Inc. We did not have any revenue for the three months ended June 30, 2024.

Operating Expenses

For the three months ended June 30, 2025, operating expenses totaled $4.9 million, compared to $5.5 million for the three months ended June 30, 2024, representing a decrease of $0.6 million or 10.6%.
Research and development expenses were approximately $2.3 million for the three months ended June 30, 2025, compared to $2.6 million for the three months ended June 30, 2024, representing a decrease of $0.3 million or 13.4%. This was primarily due to a reduction in patient treatment costs and clinical research organization expenses associated with our Phase 2a BOLSTER trial and lower spend on chemistry, manufacturing and controls.
General and administrative expenses were approximately $2.7 million for the three months ended June 30, 2025, compared to $2.9 million for the three months ended June 30, 2024, representing a decrease of $0.2 million or 8.1%. This was primarily due to savings resulting from the elimination of an employee position and lower spend on consulting and travel and entertainment expenses.

Overall, net losses were $4.7 million for the three months ended June 30, 2025, compared to $5.0 million for the three months ended June 30, 2024.

Balance Sheet Highlights

As of June 30, 2025, we had cash, cash equivalents and marketable securities of approximately $22.0 million. Based on its existing and planned activities, the Company believes available funds will support current operations into the fourth quarter of 2026.

Conference Call Information
Lisata will hold a live conference call today, August 7, 2025, at 4:30 p.m. Eastern Time to discuss financial results, provide a business update and answer questions.

Those wishing to participate must register for the conference call by way of the following link: CLICK HERE TO REGISTER. Registered participants will receive an email containing conference call details with dial-in options. To avoid delays, we encourage participants to dial into the conference call 15 minutes ahead of the scheduled start time.
A live webcast of the call will also be accessible under the Investors & News section of Lisata’s website and will be available for replay beginning two hours after the conclusion of the call for 12 months.