On August 13, 2025 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported corporate updates and announced financial results for the quarter ended June 30, 2025 (Press release, Allogene, AUG 13, 2025, View Source [SID1234655190]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This quarter marked a significant inflection point for Allogene as we advance the streamlined ALPHA3 trial toward its next key milestone, initiate clinical enrollment in our first autoimmune indications with ALLO-329, and aligned with the FDA on a pivotal path forward for ALLO-316 in solid tumors," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "Our progress reflects a focused and disciplined execution strategy, and a clear path to value creation as we advance the next wave of scalable and accessible cell therapies with potentially durable results."

Program Updates
Cema-Cel: Pivotal Phase 2 ALPHA3 1L Consolidation Trial in LBCL
The Company has selected standard fludarabine and cyclophosphamide (FC) as the lymphodepletion regimen to be used in its ALPHA3 study. The amended ALPHA3 trial now proceeds as a randomized study with two arms, comparing cema-cel after standard FC lymphodepletion to observation, the current standard of care.

The selection of FC as the lymphodepletion regimen in the ALPHA3 trial reflects strategic advantages supported by preliminary safety and biomarker data. Early observations indicate an encouraging minimal residual disease (MRD) conversion rate and a favorable safety profile when cema-cel is administered following standard FC. The regimen also offers operational benefits, including ease of administration and the potential for broader adoption within community cancer centers, and is enthusiastically supported by study investigators. In contrast to the relapsed/refractory setting, where a higher disease burden may necessitate more intensive lymphodepletion, standard FC may be sufficient to support the eradication of microscopic disease in earlier lines of treatment.

The next milestone will be the futility analysis comparing MRD conversion between the two arms and is expected to occur 1H 2026. The Company expects to provide the rates of MRD conversion between the two arms at the time of this announcement. To date, over 50 clinical sites are activated across the United States and Canada, including community cancer centers and major academic institutions.

ALLO-329: CD19/CD70 Dual CAR with Dagger Technology in AID
The Phase 1 RESOLUTION basket trial in rheumatology launched in Q2 2025 and represents a significant step in evaluating CAR T therapy across multiple autoimmune conditions, including systemic lupus erythematosus (with or without lupus nephritis), idiopathic inflammatory myopathies, and systemic sclerosis. The trial features two lymphodepletion arms: one with cyclophosphamide alone and one with no lymphodepletion. The first clinical update, expected in 1H 2026, will include biomarker data and clinical proof-of-concept data.

ALLO-329 is a first-in-class allogeneic CD19/CD70 dual CAR T product designed to target both CD19+ B cells and CD70+ activated T cells, which are key drivers of autoimmune disease. It leverages CRISPR-based site-specific integration and incorporates the Company’s clinically validated Dagger technology, which aims to reduce or eliminate the need for lymphodepletion to facilitate broader CAR T adoption in autoimmune indications.

ALLO-316: TRAVERSE Trial in RCC
ALLO-316 is the only allogeneic CAR T therapy to show potential in solid tumors. Enrollment has been completed in the Phase 1b cohort, which evaluated the safety and efficacy of ALLO-316 at DL2 (80M CAR T cells) in patients with heavily pretreated advanced or metastatic RCC. The Company presented updated Phase 1b cohort data in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and has since met with the FDA to align on the design of a pivotal trial, laying the groundwork for potential partnership discussions to advance the program.

2025 Second Quarter Financial Results

Research and development expenses were $40.2 million for the second quarter of 2025, which includes $2.6 million of non-cash stock-based compensation expense.
General and administrative expenses were $14.3 million for the second quarter of 2025, which includes $6.1 million of non-cash stock-based compensation expense.
Net loss for the second quarter of 2025 was $50.9 million, or $0.23 per share, including non-cash stock-based compensation expense of $8.7 million and non-cash impairment of long-lived asset expense of $2.4 million.
The Company had $302.6 million in cash, cash equivalents, and investments as of June 30, 2025.
The Company’s cash runway is expected to extend into the second half of 2027. Guidance for 2025 is an expected decrease in cash, cash equivalents, and investments of approximately $150 million. GAAP Operating Expenses are expected to be approximately $230 million, including estimated non-cash stock-based compensation expense of approximately $45 million. These estimates exclude any impact from potential business development activities.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 p.m. PT/5:00 p.m. ET to discuss financial results and provide a business update. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

On August 12, 2025 Adaptimmune Therapeutics plc (NASDAQ: ADAP) reported financial results and provided a business update for the second quarter ended June 30, 2025 (Press release, Adaptimmune, AUG 13, 2025, View Source [SID1234655189]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer: "The launch of TECELRA continued to accelerate through Q2 with an increase of over 150% in patients invoiced and in revenue. The full network of ATCs is close to completion with 30 now accepting referrals. Our manufacturing organization continues to deliver with a 100% commercial manufacturing success rate through to the end of Q2. The transaction with US WorldMeds will ensure that patient access to TECLRA continues and also places lete-cel in capable hands leading up to its planned launch in 2026. As we noted when we announced the transaction on July 28, this deal follows an extensive review of strategic alternatives and represents the best path forward for Adaptimmune, our patients and stakeholders. Since closing the transaction on July 31, we have repaid our debt facility with Hercules Capital and are restructuring to support the assets transferred to US WorldMeds, and to maximize value from our remaining assets including programs targeting PRAME and CD70."

Financial Results for the six months ended June 30, 2025

● Cash / liquidity position: As of June 30, 2025, Adaptimmune had cash and cash equivalents of $26.1 million and Total Liquidity1 of $26.1 million, compared to $91.1 million and $151.6 million respectively, as of December 31, 2024.
● Revenue: Revenue for the three and six months ended June 30, 2025, was $13.7 million and $21.0 million respectively, compared to $128.2 million and$133.9 million for the same periods in 2024. Revenue from development activities decreased by 96% for the six months ended June 30, 2025, compared to the same period in 2024. This decline was primarily due to the termination of the Genentech collaboration in April 2024 which resulted in the recognition of a cumulative catch-up adjustment of $101.3 million for the six months ended June 30, 2024. The product revenue has increased due to product sales commencing following the FDA approval of TECELRA on August 1, 2024.
● Research and development (R&D) expenses: R&D expenses for the three and six months ended June 30, 2025, were $23.0 million and $51.8 million respectively, compared to $40.4 million and $75.7 million for the same periods in 2024. R&D expenses decreased due to a decrease in the average number of employees engaged in R&D following the restructuring and reprioritization of activities that was announced in November 2024 and a decrease in subcontracted expenditure and manufacturing facilities expenses , offset by a decrease in offsetting reimbursements receivable for R&D tax and expenditure credits.

● Selling, general and administrative (SG&A) expenses: SG&A expenses for the three months and six months ended June 30, 2025, were $18.5 million and $41.8 million respectively, compared to $19.1 million and $38.8 million for the equivalent periods in 2024. SG&A expenses increased due to restructuring charges for the restructuring program initiated in the fourth quarter of 2024 for which there was no equivalent in the same periods of 2024 which was partially offset by a decrease in share-based compensation expense due to forfeitures arising as a result of this restructuring program. Also, there was an increase in accounting, legal and professional fees due to fees relating to business development work.
● Net loss: Net loss attributable to holders of the Company’s ordinary shareholders for the three months and six months ended June 30, 2025, were $30.3 million and $77.9 million respectively ($(0.02) and $(0.05) per ordinary share), compared to profits of $69.5 million and $21.0 million ($0.05 and $0.01 per ordinary share), for the equivalent periods in 2024.

As a result of the transaction with US WorldMeds and repayment of all sums under the loan agreement with Hercules Capital Inc, we consider that the cash and cash equivalents of the Company will be sufficient to meet our planned operating requirements through the 12 months following the filing of our Quarterly Report for the second quarter of 2025.

On August 13, 2025 XOMA Royalty Corporation (NASDAQ: XOMA), the biotech royalty aggregator, reported its 2025 second quarter and year to date financial results and highlighted recent actions that have the potential to deliver shareholder value (Press release, Xoma, AUG 13, 2025, View Source [SID1234655165]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continue to add to our diversified portfolio of both early- and late-stage assets through disciplined capital deployment and creative financial structures," stated Owen Hughes, Chief Executive Officer of XOMA Royalty. "Recently approved drugs are addressing key unmet patient needs, which is driving increased royalty receipts, and we await data from several key Phase 3 assets over the coming quarters."

Royalty and Milestone Acquisitions

Company

Asset and Transaction Detail

BioInvent XOMA Royalty deployed $20 million to purchase the future mezagitamab royalty and milestone interests held by BioInvent and will pay an additional $10 million as the asset achieves a certain regulatory milestone. With its existing entitlement, plus the newly acquired economics from BioInvent, XOMA Royalty will be entitled to milestones of up to $16.25 million from Takeda and mid-single digit royalties on future mezagitamab commercial sales.
LAVA Therapeutics XOMA Royalty will secure an economic interest in two partnered assets through the Company’s recently announced acquisition of LAVA. The partnered assets are PF-08046052, which is being developed by Pfizer, and JNJ-89853413, which is being developed by Johnson & Johnson.
Company Acquisitions

Company

Transaction Details

Turnstone Biologics XOMA Royalty and Turnstone Biologics entered into a definitive merger agreement, whereby XOMA Royalty will acquire Turnstone for $0.34 in cash per share of Turnstone common stock plus one non-transferable contingent value right (CVR). The transaction closed on August 11.
HilleVax XOMA Royalty and HilleVax have entered into a definitive merger agreement, whereby XOMA Royalty will acquire HilleVax for $1.95 per share upon closing. HilleVax stockholders also will receive a CVR that entitles them to receive certain potential payments following the closing of a pro rata portion of any remaining HilleVax cash in excess of $102.95 million; certain savings realized related to HilleVax’ office lease obligations, and should XOMA Royalty sell or out license the HilleVax norovirus programs within two years after the acquisition closes, 90% of any net proceeds received within five years by XOMA Royalty. The acquisition is expected to be completed in September.
LAVA Therapeutics XOMA Royalty and LAVA Therapeutics have entered into a definitive merger agreement, whereby XOMA Royalty will acquire LAVA for between $1.16 and $1.24 in cash per share of LAVA common stock plus one non-transferable CVR representing the right to receive 75% of the net proceeds related to LAVA’s two partnered assets and 75% of any proceeds related to the sale or out license of LAVA’s unpartnered programs. The acquisition is expected to close in the fourth quarter of 2025.
XenoTherapeutics Acquisition of ESSA Pharma XOMA Royalty acted as structuring agent and is providing short-term financing for XenoTherapeutics’ acquisition of ESSA Pharma.
Kinnate XOMA Royalty sold the remaining Kinnate pipeline assets for a total of up to $270 million in upfront and milestone payments, plus royalties on commercial sales at rates ranging from low-single digits to mid-teens. In July, the Kinnate CVRs holders received their 85% share of the modest upfront payments.
Pipeline Partner Updates through August 8, 2025

Partner

Event

Rezolute
In May, the company announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to its investigational therapy, ersodetug, for the treatment of hypoglycemia caused by tumor HI.1

In May, Rezolute announced the completion of enrollment in the Phase 3 sunRIZE study. Topline data are anticipated in December of 2025.2 As a result of Rezolute completing enrollment in the study, XOMA Royalty received a $5 million milestone payment.

Takeda The first patient was dosed in Takeda’s Phase 3 clinical trial investigating mezagitamab as a treatment for adults with chronic primary immune thrombocytopenia (ITP). This achievement resulted in XOMA Royalty receiving a $3.0 million milestone payment, net, during the second quarter.
Day One Biopharmaceuticals Ipsen, Day One’s partner outside of the U.S., announced its Marketing Authorization Application (MAA) for tovorafenib as a treatment for pediatric low-grade glioma (pLGG) had been accepted for review by the European Medicines Agency (EMA)3.
Zevra Therapeutics On July 28, Zevra announced it had submitted an MAA to EMA for the evaluation of arimoclomol for the treatment of Niemann-Pick Disease Type C (NPC)4.
Gossamer Bio On June 16, Gossamer announced it had completed enrollment in the ongoing Phase 3 PROSERA Study that is evaluating seralutinib in Functional Class II and III pulmonary atrial hypertension (PAH) patients 5. Topline results continue to be anticipated in February 20266.
Daré Biosciences Announced positive interim safety and efficacy results from its ongoing Phase 3 clinical trial evaluating the contraceptive effectiveness, safety, and acceptability of Ovaprene, an investigational monthly, hormone-free intravaginal contraceptive.

Anticipated 2025 Partner Events of Note

Partner

Event

Rezolute
Topline data from sunRIZE Phase 3 clinical trial, which is investigating ersodetug in infants and children with congenital hyperinsulinism (cHI). Topline data are expected in December 20252.

First patient dosed in the Phase 3 registrational study for ersodetug for the treatment of hypoglycemia due to tumor hyperinsulinism8.

Takeda First patient dosed in Takeda’s Phase 3 clinical trial investigating mezagitamab as a treatment for adults with IgA Nephropathy.
Gossamer Bio Activates first clinical sites for the global, registrational Phase 3 SERANATA Study examining seralutinib in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) in the fourth quarter5.
Daré Bioscience
Makes Sildenafil Cream, 3.6% available commercially via prescription in the fourth quarter of 2025 as a compounded drug under Section 503B of the Federal Food, Drug, and Cosmetic Act.9

Commencement of one of two registrational Phase 3 clinical trials investigating Sildenafil Cream, 3.6%, for the treatment of female sexual arousal disorder10.

Second Quarter and Year to Date 2025 Financial Results

Tom Burns, Chief Financial Officer of XOMA Royalty, commented, "In the first six months of 2025, we have received $29.6 million in cash from partners, of which $16.0 million were royalty payments related to commercial sales and $13.6 million in milestone payments and fees. In the second quarter, we received $11.7 million in cash, $2.6 million from our partners’ commercial sales and $9.0 million from milestones and fees. Our partners’ product marketing activities continue to be well executed and as new commercial opportunities within our portfolio emerge, our line of sight to becoming cash flow positive on a consistent basis exclusively from the cash payments received from royalties grows clearer. With this outlook, we deployed $1.8 million to repurchase 81,682 shares of our common stock in the second quarter, bringing the total number of shares repurchased in 2025 to over 107,500 shares."

8
View Source
of-rz358-for-treatment-of-hypoglycemia-due-to-tumor-hyperinsulinism

9
View Source

10
View Source

Income and Revenue: Income and revenue for the three and six months ended June 30, 2025, were $13.1 million and $29.0 million, respectively, as compared with $11.1 million and $12.6 million for the corresponding periods of 2024. The increase in both periods presented was primarily driven by increased income related to VABYSMO and OJEMDA.

Research and Development (R&D) Expenses: R&D expenses for the three and six months ended June 30, 2025, were $0.1 million and $1.4 million, respectively, compared with $1.2 million for each of the corresponding periods of 2024. The R&D expenses in the first quarter of 2025 and the three- and six-month periods of 2024 were related to the clinical trial costs incurred subsequent to XOMA Royalty’s acquisition of Kinnate in April 2024 related to KIN-3248 and the associated wind-down activities.

General and Administrative (G&A) Expenses: G&A expenses for the three and six months ended June 30, 2025, were $7.8 million and $15.9 million, respectively, as compared with $11.0 million and $19.5 million for the corresponding periods of 2024. The decrease in the second quarter of 2025 compared to the second quarter of 2024 was primarily due to the $3.6 million in exit packages paid to Kinnate senior leadership in the second quarter of 2024.

In 2025, XOMA Royalty’s G&A expenses included non-cash stock-based compensation expenses during the three and six months ended June 30, 2025, of $1.6 million and $3.6 million, respectively, as compared to $2.7 million and $5.5 million for the corresponding periods of 2024. The 2024 periods reflect non-cash stock-based compensation related to the appointment of Mr. Hughes to full-time Chief Executive Officer and issuance of performance stock units.

Credit Losses on Purchased Receivables: In the second quarter of 2024, XOMA Royalty recorded a one-time, non-cash credit loss on purchased receivables of $9.0 million and a corresponding reduction of royalty receivables of $9.0 million associated with the Aronora assets. To date there have been no credit losses in 2025.

Amortization of Intangible Assets: Amortization of intangible assets relates to the IP acquired in the Company’s acquisitions of Pulmokine in November 2024 and the mezagitamab economics from the BioInvent transaction in May 2025. Amortization of non-cash intangible assets were $0.7 million and $1.2 million for the three and six months ended June 30, 2025.

Gain on Acquisition of Kinnate: In the second quarter of 2024, XOMA Royalty recorded a $19.3 million gain on the acquisition of Kinnate due to the fair value of net assets that exceeded total purchase consideration.

Interest Expense: For the three and six months ended June 30, 2025, interest expense was $3.2 million and $6.7 million, respectively, as compared with $3.4 million and $7.0 million for the corresponding periods of 2024. Interest expense relates to the Blue Owl Loan established in December 2023.

Other Income, net: For the three and six months ended June 30, 2025, other income, net was $7.8 million and $7.7 million, respectively, as compared with $2.1 million and $4.0 million for the corresponding periods of 2024. The increases for the periods presented were primarily driven by increases in the fair value of XOMA Royalty’s investments in equity securities.

Net Income: XOMA Royalty reported net income of $9.2 million and $11.6 million for the three and six months ended June 30, 2025, as compared to $16.0 and $7.4 million in the corresponding periods of 2025.

Cash Position: On June 30, 2025, XOMA Royalty had cash and cash equivalents of $78.5 million (including $3.4 million in restricted cash), compared with cash and cash equivalents of $106.4 million (including $4.8 million in restricted cash) on December 31, 2024.

In the second quarter of 2025, XOMA Royalty received $11.7 million in cash receipts including $2.6 million in royalties and commercial payments and $9.0 million in milestones and fees. During the second quarter of 2025, XOMA Royalty deployed $20 million to acquire additional economics in mezagitamab, repurchased approximately 81,700 shares of XOMA Royalty common stock for a cost of $1.8 million, and paid $1.4 million in dividends on the XOMA Royalty Perpetual Preferred stocks. In the first six months of 2025, XOMA Royalty received $29.6 million in cash receipts, including $16.0 million in royalties and commercial payments and $13.6 million in milestone payments and fees. During the first half of 2025, XOMA Royalty deployed $25.0 million to acquire additional assets for its royalty and milestone portfolio, repurchased approximately 107,500 shares of its common stock for a cost of $2.4 million, and paid $2.7 million in dividends on the XOMA Royalty Perpetual Preferred stocks.

On August 13, 2025 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported its financial results for the second quarter 2025 (Press release, Xenetic Biosciences, AUG 13, 2025, View Source [SID1234655164]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Recent Highlights

Expanded its collaboration with The Scripps Research Institute ("TSRI") to advance the development of the Company’s development program evaluating the combination of systemic DNase I and CAR T-cell therapies;

Announced advancements from its collaboration partner, PeriNess Ltd. ("PeriNess") including:

Entered into a Clinical Study Agreement to support an exploratory clinical study of DNase I in combination with anti-CD19 CAR T cells in patients with large B cell lymphoma;

Commenced patient dosing in an exploratory clinical study of systemic DNase I in combination with FOLFIRINOX for the first line treatment of unresectable, locally advanced or metastatic pancreatic cancer at Bnei Zion Medical Center; and

Continued pursuit of other strategic collaborations to advance the Company’s technology.

"We continue to set a strong foundation that we believe positions us for success as we advance our systemic DNase I in combination with immunotherapy, chemotherapy, and radiotherapy across various oncology indications where there remains significant unmet need. We continue to work with our partners and believe the data and information will be invaluable as we look to realize the full potential of our DNase platform technology. Looking ahead, we remain focused on building momentum across all fronts and driving development toward an IND and Phase 1 clinical trial," commented James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic.

Xenetic continues to advance its DNase-based technology towards Phase 1 clinical development for the treatment of pancreatic carcinoma and other locally advanced or metastatic solid tumors. Preclinical proof-of-concept studies combining DNase I with chemotherapy, immunotherapies, and CAR-T therapy in hematological and solid tumor and metastatic cancer models have been completed. Building on proof-of-concept success, the program has now advanced to mechanism-of-action and translational studies in preparation for a Phase 1 clinical trial.

Additionally, as previously announced in December 2024, Xenetic entered into a Clinical Trial Services Agreement with PeriNess, under which PeriNess will lead in the regulatory approval, operational execution and management of potential exploratory, investigator initiated studies of recombinant DNase as an adjunctive treatment in patients with pancreatic carcinoma and other locally advanced or metastatic solid tumors receiving chemotherapy and immunotherapy in Israeli medical centers.

Summary of Financial Results for Second Quarter 2025

Net loss for the quarter ended June 30, 2025 was approximately $0.7 million. Research & development expenses for the three months ended June 30, 2025 decreased by approximately $277,000, or 29.7%, to approximately $0.7 million from $0.9 million in the comparable quarter in 2024. General and administrative expenses for the three months ended June 30, 2025 decreased by approximately $472,000, or 41.8%, to approximately $0.7 million from approximately $1.1 million in the comparable quarter in 2024. These decreases were primarily due to certain severance and benefits expensed in connection with separation agreements entered into during the second quarter of 2024 with the Company’s former Chief Executive Officer and Chief Scientific Officer.

The Company ended the quarter with approximately $4.8 million in cash.

On August 13, 2025 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies, reported its second quarter 2025 financial results and provided a corporate update (Press release, Instil Bio, AUG 13, 2025, View Source [SID1234655144]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Recent Highlights:

In June, announced the appointment of Jamie Freedman, M.D., Ph.D., as Chief Medical Officer
In July, announced the Investigational New Drug (IND) application for ‘2510 was cleared by the U.S. FDA
In July, ImmuneOnco, Instil’s collaborator, announced preliminary safety and efficacy data from the Phase 2 open-label, multicenter study of ‘2510 in combination with chemotherapy for front-line patients with advanced non-small cell lung cancer (NSCLC) conducted in China by ImmuneOnco
In August, ImmuneOnco announced that an abstract has been accepted for poster presentation at IASLC’s 2025 World Conference on Lung Cancer (September 6th-9th, 2025), which will provide updated results from additional patients with relapsed/refractory squamous-NSCLC treated with ‘2510 as monotherapy
Second Quarter 2025 Financial and Operating Results:

As of June 30, 2025, Instil had cash, cash equivalents, restricted cash, marketable securities and long-term investments of $103.6 million, which consisted of $7.7 million in cash and cash equivalents, approximately $0.2 million in restricted cash, $84.1 million in marketable securities, and $11.7 million in long-term investments, compared to $115.1 million in cash, cash equivalents, restricted cash and marketable securities as of December 31, 2024, consisting of $8.8 million in cash and cash equivalents, $1.8 million in restricted cash, and $104.5 million in marketable securities. Instil expects that its cash, cash equivalents, marketable securities and long-term investments as of June 30, 2025 will enable it to fund its operating plan beyond 2026.

In-process research and development expenses were $10.0 million for both the three and six months ended June 30, 2025, compared to nil for both the three and six months ended June 30, 2024.

Research and development expenses were $6.7 million and $12.1 million for the three and six months ended June 30, 2025, respectively, compared to $2.9 million and $10.2 million for the three and six months ended June 30, 2024, respectively.

General and administrative expenses were $6.2 million and $15.3 million for the three and six months ended June 30, 2025, respectively, compared to $10.7 million and $23.1 million for the three and six months ended June 30, 2024, respectively.

Restructuring and impairment charges were $0.5 million and $16.6 million for the three and six months ended June 30, 2025, respectively, compared to $0.5 million and $4.8 million for three and six months ended June 30, 2024, respectively.

Net loss per share, basic and diluted were $3.24 and $7.55 for the three and six months ended June 30, 2025, respectively, compared to $2.29 and $6.03 for the three and six months ended June 30, 2024, respectively. Non-GAAP net loss per share, basic and diluted, were $2.88 and $4.21 for the three and six months ended June 30, 2025, respectively, compared to $1.57 and $3.95 for the three and six months ended June 30, 2024, respectively.