On August 14, 2025 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, reported financial results for the second quarter ended June 30, 2025, and highlighted recent corporate progress (Press release, MacroGenics, AUG 14, 2025, View Source [SID1234655309]).

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"Over the past several years, MacroGenics has established itself as a pioneer in the field of antibody-based therapeutics for patients battling cancer. Today, we have a promising portfolio spanning antibody drug conjugates and multi-specifics that we believe has the potential to generate significant value for both patients and shareholders alike," said Eric Risser, President and CEO of MacroGenics. "As we look ahead to the remainder of 2025 and beyond, we intend to drive MacroGenics to become an even more focused and capital-efficient biotechnology company as we advance our pipeline. In the coming quarters, we look forward to providing updates on our key strategic priorities related to pipeline and Company progress."

Key Strategic Priorities for 2025 and 2026

Determine development path for lorigerlimab based on data from the ongoing LORIKEET and LINNET studies.
Advance MGC026 and MGC028 programs to assess clinical proof-of-concept.
Submit Investigational New Drug (IND) application for MGC030.
Initiate IND-enabling studies for two new product candidates.
Forge partnerships and collaborations to accelerate development of the Company’s proprietary product candidates and technology platforms.
Improve MacroGenics’ financial position through a combination of enhanced operational efficiency, collaboration revenue, and monetization of assets.

Corporate Updates

Eric Risser named President, Chief Executive Officer and Director. Mr. Risser previously served as Chief Operating Officer at MacroGenics, overseeing several key company functions and has led the Company’s corporate development efforts, which have generated over $550 million in non-dilutive capital over the past three years. Mr. Risser succeeds Scott Koenig, M.D., Ph.D. who has stepped down after serving as President and Chief Executive Officer for the past 24 years.

Wholly Owned Programs

Lorigerlimab is a bispecific, tetravalent PD-1 × CTLA-4 DART molecule designed to enhance CTLA-4 blockade on dual-expressing, tumor-infiltrating lymphocytes compared to a PD-1/CTLA-4 monoclonal antibody (mAb) combination therapy, while maintaining maximal PD-1 blockade on all PD-1-expressing cells.

The ongoing Phase 2 LORIKEET study is a 150-patient randomized study evaluating lorigerlimab in combination with docetaxel vs. docetaxel alone in second-line, chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). The study was fully enrolled in late 2024 and the Company expects to provide a clinical update in the second half of 2025.
The ongoing Phase 2 LINNET study is a 60-patient monotherapy study evaluating lorigerlimab in patients with either platinum-resistant ovarian cancer or clear cell gynecologic cancer.

Emerging ADC Pipeline. MacroGenics is developing three antibody-drug conjugates (ADCs) that each incorporate a novel, glycan-linked topoisomerase I inhibitor (TOP1i)-based payload developed by the Company’s collaboration partner, Synaffix (a Lonza company).

MGC026 targets B7-H3, an antigen with broad expression across multiple solid tumors and a member of the B7 family of molecules involved in immune regulation. MGC026 is currently being evaluated in a Phase 1 dose escalation study in patients with advanced solid tumors, with dose expansion in selected indications expected to initiate in the second half of 2025.
MGC028 targets ADAM9, a member of the ADAM family of multifunctional type 1 transmembrane proteins that play a role in tumorigenesis and cancer progression and is overexpressed in multiple cancers. MGC028 is currently being evaluated in a Phase 1 dose escalation study in patients with advanced solid tumors.
MGC030 is a preclinical ADC that targets an undisclosed antigen expressed across several solid tumors. An IND application to the U.S. Food and Drug Administration (FDA) for MGC030 is planned for 2026.

Partnered Programs

MGD024 is a next-generation CD123 × CD3 DART molecule. Under an October 2022 exclusive option and collaboration agreement with Gilead Sciences, Inc. (Gilead), MacroGenics continues to enroll patients in a Phase 1 dose escalation study of MGD024 in patients with CD123-positive neoplasms, including acute myeloid leukemia and myelodysplastic syndromes. MacroGenics remains eligible to receive up to $1.7 billion in target nomination, option exercise and milestone payments related to MGD024 and two additional research programs under this agreement.
ZYNYZ (retifanlimab-dlwr) is a monoclonal antibody targeting PD-1 that the Company licensed to Incyte Corporation (Incyte) in 2017. In June 2025, MacroGenics and Sagard Healthcare Partners entered into a royalty purchase agreement in exchange for capped royalty interest on future global net sales of ZYNYZ. MacroGenics retains its other economic interests related to ZYNYZ including future potential development, regulatory and commercial milestones. MacroGenics will also continue to support a portion of global commercial manufacturing needs for ZYNYZ. MacroGenics remains eligible to receive up to $540.0 million in additional development, regulatory and commercial milestones.
TZIELD (teplizumab-mzwv) is a monoclonal antibody targeting CD3 that the Company sold in 2018 to a partner that was subsequently acquired by Sanofi S.A. (Sanofi). In November 2022, TZIELD was approved by U.S. FDA to delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients aged 8 years and older with Stage 2 T1D. In July 2025, Sanofi disclosed that they anticipate TZIELD-related regulatory decisions in the E.U. and China in the second half of 2025. MacroGenics remains eligible to receive up to $379.5 million in additional development, regulatory and commercial milestones.

Second Quarter 2025 Financial Results

Cash Position: Cash, cash equivalents and marketable securities balance as of June 30, 2025, was $176.5 million, compared to $201.7 million as of December 31, 2024.
Revenue: Total revenue was $22.2 million for the quarter ended June 30, 2025, compared to $10.8 million for the quarter ended June 30, 2024. Total revenue included contract manufacturing revenue of $15.4 million for the quarter ended June 30, 2025, compared to $2.9 million for the quarter ended June 30, 2024, reflecting higher manufacturing volume on behalf of Contract Development and Manufacturing Organization (CDMO) clients. Collaboration revenue was $6.9 million for the quarter ended June 30, 2025, compared to $2.2 million for the quarter ended June 30, 2024, with this increase primarily due to deferred revenue recognition under the Company’s collaboration agreements. Total revenue reflected a decrease in net product sales resulting from the sale of MARGENZA to TerSera Therapeutics, LLC in November 2024.
R&D Expenses: Research and development expenses were $40.8 million for the quarter ended June 30, 2025, compared to $51.7 million for the quarter ended June 30, 2024. The decrease was primarily due to decreased costs related to vobramitamab duocarmazine development and decreased manufacturing and IND-enabling costs related to MGC028, offset by increased costs related to MGC030 development.
Cost of Manufacturing Services: Cost of manufacturing services was $8.9 million for the quarter ended June 30, 2025, compared to $2.6 million for the quarter ended June 30, 2024. The increase was primarily due to an increase in manufacturing volume on behalf of CDMO clients.
SG&A Expenses: Selling, general and administrative expenses were $9.3 million for the quarter ended June 30, 2025, compared to $14.4 million for the quarter ended June 30, 2024. The decrease was primarily due to lower stock-based compensation expense and reduced professional fees. The reduction in professional fees was largely driven by the cessation of commercialization activities for MARGENZA.
Net Loss: Net loss was $36.3 million for the quarter ended June 30, 2025, compared to net loss of $55.7 million for the quarter ended June 30, 2024.
Shares Outstanding: Shares of common stock outstanding as of June 30, 2025 were 63,205,703.
Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities balance of $176.5 million as of June 30, 2025, in addition to projected and anticipated future payments from partners and anticipated savings from the Company’s ongoing cost-reduction initiatives, is expected to support its cash runway through the first half of 2027.

MACROGENICS, INC.
SELECTED CONSOLIDATED BALANCE SHEET DATA
(Amounts in thousands)

June 30, 2025 December 31, 2024
(unaudited)
Cash, cash equivalents and marketable securities $ 176,486 $ 201,667
Total assets 245,416 261,655
Deferred revenue 63,617 71,822
Total stockholders’ equity 46,618 116,057

MACROGENICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(Amounts in thousands, except share and per share data)

Three Months Ended June 30, Six Months Ended June 30,
2025 2024 2025 2024
Revenues:
Collaborative and other agreements $ 6,869 $ 2,163 $ 13,911 $ 3,772
Product sales, net — 5,248 — 10,109
Contract manufacturing 15,372 2,893 21,523 5,169
Government agreements — 493 — 851
Total revenues 22,241 10,797 35,434 19,901
Costs and expenses:
Cost of product sales — 176 — 446
Cost of manufacturing services 8,906 2,647 14,306 4,493
Research and development 40,791 51,732 80,489 97,760
Selling, general and administrative 9,302 14,423 20,020 29,133
Total costs and expenses 58,999 68,978 114,815 131,832
Loss from operations (36,758 ) (58,181 ) (79,381 ) (111,931 )
Interest and other income 1,414 2,523 3,093 5,216
Interest and other expense (802 ) (6 ) (894 ) (1,139 )
Loss before income taxes (36,146 ) (55,664 ) (77,182 ) (107,854 )
Income tax provision 105 — 105 —
Net loss (36,251 ) (55,664 ) (77,287 ) (107,854 )
Other comprehensive loss:
Unrealized (loss) gain on investments (6 ) 11 (12 ) (18 )
Comprehensive loss $ (36,257 ) $ (55,653 ) $ (77,299 ) $ (107,872 )

Basic and diluted net loss per common share $ (0.57 ) $ (0.89 ) $ (1.23 ) $ (1.73 )
Basic and diluted weighted average common shares outstanding 63,136,057 62,663,677 63,051,207 62,477,108

On August 14, 2025 Tvardi Therapeutics, Inc. ("Tvardi") (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases, reported its financial and operating results for the second quarter ended June 30, 2025, and provided a business update (Press release, Tvardi Therapeutics, AUG 14, 2025, View Source [SID1234655324]).

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Second Quarter 2025 Highlights:

Announced completion of enrollment in its REVERT IPF clinical trial, a Phase 2 trial of TTI-101, for patients with idiopathic pulmonary fibrosis (IPF); topline data on track for Q4 2025.
Submitted an Investigational New Drug (IND) application for its second clinical candidate, TTI-109, with the U.S. Food and Drug Administration (FDA) in June 2025.
Announced that an abstract, entitled Single Cell Transcriptomics in A Treatment Status Segregated Cohort Exposes a STAT-3-Regulated Therapeutic Gap in Idiopathic Pulmonary Fibrosis, was presented at the American Thoracic Society (ATS) 2025 Annual Conference.
Completed its merger with Cara Therapeutics, transitioning Tvardi into a publicly traded company.
Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, stated, "We are on track for topline data in the fourth quarter from our fully enrolled REVERT IPF Phase 2 clinical trial. These data will offer important additional insights into the safety and efficacy of TTI-101, and, if positive, we believe will further validate our approach of targeting STAT3, a central mediator of fibrosis, to treat patients with IPF.

"In parallel, our Phase 2 REVERT Liver Cancer trial continues to enroll patients, and we remain on track to report topline results in the first half of 2026. Prior interim data from this ongoing study demonstrated clinically meaningful activity of TTI-101 as both monotherapy and in combination with established anti-cancer agents across treatment lines.

"Importantly, we are well-financed through these potential value inflection points, and into Q4 of next year. We believe we are very well positioned to bring meaningful innovation to patients living with fibrosis driven-diseases while creating significant value for our company."

Upcoming Milestones:

Data from the company’s ongoing REVERT IPF Phase 2 clinical trial of TTI-101 anticipated in 4Q 2025
Preliminary topline data from the company’s ongoing REVERT Liver Cancer Phase 1b/2 clinical trial of TTI-101 anticipated in 1H 2026
Second Quarter 2025 Financial Results

Research and development expenses for the three months ended June 30, 2025, were $5.8 million as compared to $6.5 million for the comparable period in 2024. The decrease of $0.7 million was primarily driven by clinical, pre-clinical, and CMC costs associated with TTI-101.

General and administrative expenses for the three months ended June 30, 2025, were $3.1 million as compared to $650,000 for the comparable period in 2024. The increase of $2.4 million was primarily driven by increases in professional fees of $1.6 million, attributable to increased legal, accounting and audit fees incurred as a result of the merger. The remaining increase was attributable to increases in personnel costs, insurance costs, and other costs.

Net income for the three months ended June 30, 2025, was $4.2 million as compared to a net loss of $7.0 million for the comparable period in 2024. The improvement in net income was due primarily to a $12.8 million remeasurement gain on Tvardi’s Convertible Notes recognized in the second quarter of 2025.

Basic and diluted net income (loss) per share attributable to common shareholders for the three months ended June 30, 2025, were a net gain of $0.51 and net loss of $1.00, respectively, compared to a net loss of $2.71 on a basic and diluted basis for the comparable period in 2024.

Cash, cash equivalents and short-term investments as of June 30, 2025, were $41.0 million, as compared to $31.6 million as of December 31, 2024.

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]).

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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 Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported the strategic importance of its preclinical asset APVO442-an investigational CD3-engaging bispecific antibody designed to treat prostate cancer (Press release, Aptevo Therapeutics, AUG 13, 2025, View Source [SID1234655211]). APVO442 is built on Aptevo’s next-generation ADAPTIR-FLEX platform and is engineered to selectively activate T cells within the PSMA-expressing tumor microenvironment, offering potential for precision targeting and reduced systemic toxicity.

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APVO442 is built on the same CRIS-7-derived anti-CD3 binding domain as clinical candidate mipletamig but is specifically engineered for solid tumors, with lower binding affinity and a monovalent format that reduce the risk of immune activation outside the tumor. This design helps ensure that T cells are activated only within the tumor microenvironment, improving safety while maintaining anti-tumor potency. Preclinical data show that APVO442 effectively localizes to PSMA-expressing prostate tumors, triggering a targeted immune response while potentially sparing healthy tissue. The same solid tumor-optimized architecture has also been applied to newly added pipeline candidate APVO455.

"With mipletamig performing as designed in the clinic and the addition to the pipeline of APVO455 for multiple solid tumors, we’re confident in the strength of our CD3-based bispecific approach," said Marvin White, President and CEO of Aptevo. "APVO442 is engineered for the same balance-potent immune activation precisely where it’s needed – in the tumor. It represents yet another high-conviction opportunity to expand into solid tumors, a market where the need is large and growing."

Prostate cancer is the second most common cancer in men, with over 300,000 new cases annually* in the U.S. The global treatment market-currently valued at $14 billion-is projected to reach $24 billion within the next decade**. APVO442 is differentiated in this space as a tumor-specific immunotherapy designed for combination potential and scalable manufacturing. (*American Cancer Society, **Global Data)

APVO442 is currently in preclinical studies, and supports the Company’s goal of expanding its clinical pipeline and driving long-term value through modular, platform-based innovation. The Company continues to leverage insights from its CD3 bispecific programs to accelerate future development and partnership opportunities.

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]).

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"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.