On August 11, 2026 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation (TPD) science, today reported financial results for the second quarter ended June 30, 2026, as well as recent business highlights.

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"The first half of 2026 was a period of execution for cemsidomide, our next-generation IKZF1/3 degrader, and our clinical development plan. At the EHA (Free EHA Whitepaper) Congress in June, we presented clinical data that further supported cemsidomide’s differentiated and potential best-in-class profile for the treatment of relapsed refractory multiple myeloma. In addition, insights from our June KOL webinar underscored the importance of IKZF1/3 degradation as a foundational mechanism in multiple myeloma and highlighted the potential for next-generation IKZF1/3 degraders to become a cornerstone therapy across the disease continuum," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "As we enter the second half of the year, we remain focused on advancing the Phase 2 MOMENTUM trial, the Phase 1b combination trial with elranatamab and start-up activities for our additional Phase 1b combination trial with approved standard-of-care multiple myeloma therapies. Together, these studies are expected to generate clinical milestones in 2027 and beyond and will support our vision of establishing cemsidomide as a potential backbone therapy for combination regimens in multiple myeloma."

SECOND QUARTER 2026 UPDATES AND RECENT ACHIEVEMENTS

•The ongoing Phase 2 MOMENTUM trial evaluating cemsidomide in combination with dexamethasone in late-line multiple myeloma (MM) treatment is on track to complete enrollment in the first quarter of 2027. The initial investigator-assessed overall response rate (ORR) data are expected in the second half of 2027.

•The ongoing Phase 1b trial evaluating cemsidomide and dexamethasone in combination with elranatamab (ELREXFIO), a B-cell maturation antigen CD3 targeted bispecific antibody, in earlier lines of MM treatment continues to progress. C4T expects to provide an update on the dose escalation progress in the second half of 2026 with data from all cohorts expected in mid-2027.

•Study start-up activities are underway for an additional Phase 1b trial evaluating cemsidomide across two treatment arms for relapsed refractory MM patients: (1) cemsidomide, dexamethasone, daratumumab, a CD38 antibody, and (2) cemsidomide, dexamethasone, carfilzomib, a proteasome inhibitor. The trial is expected to initiate in the first half of 2027 with the goal to characterize cemsidomide’s dose and safety with approved standard of care MM therapies.

•A poster presentation was accepted at the International Myeloma Society (IMS) Annual Meeting, featuring additional biomarker data on cemsidomide’s immunomodulatory effects on T cells and natural killer (NK) cells in combination with dexamethasone. These data further support cemsidomide’s potential as a combination partner for immune-based therapies. The meeting will take place September 23–26, 2026, in Glasgow, Scotland.

•Further analysis from the Phase 1 trial evaluating cemsidomide in combination with dexamethasone was presented at the EHA (Free EHA Whitepaper) 2026 Congress supporting its differentiated safety profile and compelling anti-myeloma activity in a heavily pretreated relapsed refractory MM patient population. At the two highest dose levels evaluated (75 µg and 100 µg), responses deepened over time and demonstrated a 40% ORR and a 53% ORR, respectively, including one stringent complete response and two complete responses. Two patients also achieved minimal residual disease negativity. Across all doses there were no cemsidomide-related discontinuations and minimal dose reductions were observed. These data further support cemsidomide’s potential best-in-class profile.

•C4T entered into a new collaboration agreement with Roche in April 2026 to advance research in the emerging degrader-antibody conjugate (DAC) modality. C4T and Roche are combining antibody-drug conjugation and targeted protein degradation to develop a new way to treat cancers. In May 2026, C4T received an upfront payment of $20 million.

•C4T raised approximately $33.5 million in net proceeds in the second quarter through its at-the-market (ATM) program. The proceeds are expected to support the continued advancement of cemsidomide, including the additional Phase 1b trial and Phase 3 trial planning activities and execution efforts.

•C4T hosted an educational KOL webinar featuring Nisha Joseph, M.D., associate professor at the Winship Cancer Institute at Emory University and investigator in the cemsidomide clinical trials. The event highlighted the evolving MM landscape, the foundational role of IKZF1/3 degradation and cemsidomide’s differentiated profile. An archived replay of the webinar is available under "Events and Presentations" within the Investors section of C4T’s website.

UPCOMING MILESTONES

•IMS Annual Meeting, September 23 – 26, 2026: Present a poster featuring additional biomarker data on cemsidomide’s immunomodulatory effects on T cells and NK cells in combination with dexamethasone.

•2H 2026: Provide an update on the dose escalation progress from the Phase 1b trial evaluating the combination of cemsidomide, dexamethasone, and elranatamab.

•By year-end 2026: Deliver at least one development candidate to a collaboration partner and advance collaborations toward key milestones.

UPCOMING INVESTOR EVENTS

•September 9, 2026: Management will participate in the 2026 Cantor Global Healthcare Conference taking place in New York, NY from September 9 – September 11, 2026.

•September 10, 2026, at 11:00 am ET: Management will participate in a fireside chat at the 2026 Wells Fargo Healthcare Conference taking place in Boston, MA from September 8 – September 10, 2026.

SECOND QUARTER 2026 FINANCIAL RESULTS

Revenue: Total revenue for the second quarter of 2026 was $6.6 million, compared to $6.5 million for the second quarter of 2025. The increase was primarily related to revenue recognized under the new Roche DAC collaboration agreement, offset by a decrease in revenue from the conclusion of certain research activities associated with the collaborations with Merck and Merck KGaA, Darmstadt Germany.

Research and Development (R&D) Expense: R&D expense for the second quarter of 2026 was $24.5 million, compared to $26.2 million for the second quarter of 2025. The decrease in R&D expense was primarily due to lower personnel costs resulting from reduced stock-based compensation expense.

General and Administrative (G&A) Expense: G&A expense for the second quarter of 2026 was $8.6 million, compared to $8.8 million for the second quarter of 2025. The decrease in G&A expense was primarily due to lower personnel costs resulting from reduced stock-based compensation expense.

Net Loss and Net Loss per Share: Net loss for the second quarter of 2026 was $23.6 million, compared to $26.0 million for the second quarter of 2025. Net loss per share for the second quarter of 2026 was $0.18, compared to $0.37 for the second quarter of 2025.

Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of June 30, 2026, were $300.4 million, compared to $268.3 million as of March 31, 2026, and $297.1 million as of December 31, 2025. The increase in cash, cash equivalents and marketable securities during the second quarter of 2026 primarily reflects $33.5 million in net proceeds from the company’s ATM program and a $20.0 million upfront payment related to its collaboration with Roche, offset by cash used to fund operations and advance programs. The company expects that its current cash, cash equivalents and marketable securities will fund its operations to the end of 2028.

About Cemsidomide
Cemsidomide is an investigational, next-generation orally bioavailable MonoDAC degrader (molecular glue) of IKZF1/3, transcription factors foundational to multiple myeloma biology. Data from the fully enrolled Phase 1 trial show cemsidomide’s differentiated safety and tolerability profile and potentially class-leading anti-myeloma activity that supports the potential for durable outcomes.

About the MOMENTUM Trial
MOMENTUM (Multi-center trial Of cemsidoMidE iN relapsed/refracTory mUltiple Myeloma) is a Phase 2, open-label, single-arm study to evaluate the efficacy and safety of cemsidomide in combination with dexamethasone in patients with relapsed/refractory multiple myeloma. Data from the Phase 1 trial identified 100 µg as the recommended Phase 2 dose. The primary endpoint is overall response rate per International Myeloma Working Group response criteria, as assessed by an independent review committee. Approximately 100 patients who have received at least three prior anti-myeloma regimens that must have included an IKZF1/3 degrader, a proteasome inhibitor, an anti-CD38 antibody, and a T-cell engager or CAR-T therapy will be enrolled in the trial. More information is available at clinicaltrials.gov (NCT07284758).

About Cemsidomide in Combination With Elranatamab (ELREXFIO)
The Phase 1b trial is designed to evaluate the safety, tolerability and preliminary efficacy of cemsidomide and dexamethasone in combination with elranatamab, an FDA-approved B-cell maturation antigen CD3 targeted bispecific antibody. Data generated from the cemsidomide Phase 1 trial in relapsed/refractory multiple myeloma demonstrate robust T-cell activation and cytokine expression across multiple doses. By activating immune T-cells, cemsidomide, when combined with a BCMAxCD3 bispecific such as elranatamab, may amplify the anti-myeloma immune response and lead to deeper and more durable responses. The study will evaluate different cemsidomide dose levels (beginning with 75 µg, with the opportunity to simultaneously explore 50 µg and 100 µg) in patients who have received one to four prior lines of therapy, which must have consisted of at least one IKZF1/3 degrader. Exclusion criteria for patients include those who have received prior treatment with a BCMA-directed T-cell engager or BCMA-directed CAR-T therapy. More information is available at clinicaltrials.gov (NCT07280013).

About Multiple Myeloma
Multiple myeloma is a blood cancer that affects plasma cells in the bone marrow. It is the second most common blood cancer, with approximately 36,000 people in the United States diagnosed each year. Multiple myeloma is characterized by cycles of remission and relapses, which leads to patients needing multiple lines of therapy to manage this persistent disease. More than 175,000 patients in the United States are estimated to be living with or in remission from myeloma. However, despite treatment advances, approximately 40% of patients do not survive beyond five years.

(Press release, C4 Therapeutics, AUG 11, 2026, View Source [SID1234669944])

On August 11, 2026 Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, reported financial results for the second quarter ended June 30, 2026, and provided a business update.

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"In the second quarter, we continued to make meaningful progress in the ongoing BDC-4182 Phase 1/2 study in patients with gastric and gastroesophageal cancer. We are currently treating patients in Cohort 4. To date, BDC-4182 has been well tolerated, and we are seeing activity consistent with our immune-stimulating mechanism," said Willie Quinn, President and Chief Executive Officer. "We expect to report initial clinical data from BDC-4182 with our third quarter 2026 results."

Recent Highlights and Anticipated Milestones

•
Initial clinical data from BDC-4182 Phase 1/2 study for patients with gastric and gastroesophageal cancer expected with third quarter 2026 results. BDC-4182 is a next-generation BoltbodyTM ISAC targeting claudin 18.2, a clinically validated target with expression in gastric cancer, gastroesophageal junction cancer, pancreatic cancer, and other tumor types. In preclinical models, including cancer models with low claudin 18.2 expression, BDC-4182 demonstrated significant anti-tumor activity, induced immunological memory, and outperformed cytotoxic ADCs. Bolt has implemented step-up dosing, which has been successfully used commercially for T-cell engagers, as a strategy to get to higher doses safely. The clinical trial in gastric and gastroesophageal cancers is progressing well with ongoing treatment of patients in Cohort 4 at the 4.0 mg/kg dose level.

•
Cash, cash equivalents, and marketable securities were $18.1 million as of June 30, 2026 . Cash on hand is expected to fund operations into first quarter 2027.

Second Quarter 2026 Financial Results

•
Collaboration Revenue – Total collaboration revenue was $5,000 for the quarter ended June 30, 2026, compared to $1.8 million for the same quarter in 2025. Revenue in the comparative periods was generated from services performed under the R&D collaborations as we fulfill our performance obligations.
•
Research and Development (R&D) Expenses – R&D expenses were $5.1 million for the quarter ended June 30, 2026, compared to $7.5 million for the same quarter in 2025. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses primarily as a result of our restructuring and overall lower research and development activities.
•
General and Administrative (G&A) Expenses – G&A expenses were $2.4 million for the quarter ended June 30, 2026, compared to $3.5 million for the same quarter in 2025. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses primarily as a result of our restructuring as well as lower consulting expenses.
•
Loss from Operations – Loss from operations was $8.4 million for the quarter ended June 30, 2026, compared to $9.2 million for the same quarter in 2025.
About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
Bolt Biotherapeutics’ Boltbody ISAC platform harnesses the precision of antibodies with the power of the innate and adaptive immune system to generate a productive anti-cancer response. Each Boltbody ISAC candidate comprises a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant. The antibody is designed to target one or more markers on the surface of a tumor cell and the immune stimulant is designed to recruit and activate myeloid cells. Activated myeloid cells initiate a positive feedback loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This increases the population of activated immune system cells in the tumor microenvironment and promotes a robust immune response with the goal of generating durable therapeutic responses for patients with cancer.

(Press release, Bolt Biotherapeutics, AUG 11, 2026, View Source [SID1234669943])

On August 11, 2026 Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies and candidates, reported its operational and financial results for the second quarter ended June 30, 2026.

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"In the second quarter we achieved substantial sales growth in the ongoing AUCATZYL launch, driven by physician enthusiasm and expanding product use within existing authorized treatment centers, as well as the addition of new centers coming online. We believe this adoption is testament to the product’s efficacy and differentiated safety profile, which was underscored by the ROCCA consortium real world data reported earlier in the year," said Dr. Christian Itin, Chief Executive Officer of Autolus. "The increased product volumes, combined with the ongoing operational efficiency initiatives announced in April, together drove a significant step up in gross margin. We expect improvement over time towards our peak estimate for adult ALL margins of 65-70%."

Dr. Itin added, "We see adoption of AUCATZYL in adult r/r B-ALL as a key near-term value driver. Longer-term, we believe there are meaningful opportunities to expand into new indications to continue driving scalable growth by leveraging obe-cel’s favorable profile and Autolus’ proven manufacturing and commercial capabilities."

Product and Pipeline Updates:

AUCATZYL Launch
Autolus reported net product revenue of $45.7 million for the three months ended June 30, 2026, compared to $20.9 million for the same period the prior year and compared to $26.2 million for three months ending March 31, 2026. Net revenues were primarily driven by increasing product demand both within existing treatment centers and expansion into new centers, supplemented by contribution from UK sales in the second quarter of launch in this market.
Additional data from the FELIX trial focusing on the impact of tumor burden and bridging therapy on safety and efficacy in adult r/r ALL patients treated with obe-cel were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper) annual meetings.
Obe-cel in pediatric r/r B-ALL
The Phase 2 portion of the ongoing CATULUS trial of obe-cel in pediatric relapsed or refractory (r/r) B-cell precursor ALL (B-ALL) patients is on track and data are expected to be reported at the end of 2027.
Obe-cel in lupus
The next data update from the Phase 1 CARLYSLE trial in patients with severe refractory systemic lupus erythematosus (SLE) has been submitted for presentation at the American College of Rheumatology (ACR) Annual Meeting in the fourth quarter of 2026. LUMINA, the pivotal Phase 2 study of obe-cel in patients with refractory lupus nephritis (LN) continues enrolling in five countries and the Company expects to report data in 2028.
Obe-cel in progressive multiple sclerosis
The Phase 1 BOBCAT trial is expected to include up to 18 adult patients and will determine the safety, tolerability, and preliminary efficacy of obe-cel in participants with refractory progressive forms of MS.
First preliminary results, including safety, PK/PD and biomarker data are planned to be presented at the ACTRIMS Forum in the first quarter of 2027. A larger data set with longer follow up will be reported in the second half of 2027.
AUTO8 in Light-Chain Amyloidosis
The Phase 1 ALARIC trial evaluating AUTO8 in light-chain amyloidosis is ongoing and initial data are expected to be reported at the end of 2026.

Q2 2026 Operational Updates:

On August 3, 2026, Autolus announced that the Company entered into a strategic financing with Perceptive Advisors, a leading global healthcare specialist investor, for the sale of notes of up to $250 million in aggregate principal amount in a five-year, interest-only senior credit facility, subject to certain conditions. An initial $75 million principal amount of notes has been issued by Autolus to Perceptive on July 30, 2026, and an additional $25 million in aggregate principal amount will be available at Autolus’ option for up to six months post-closing. An additional $150 million in aggregate principal amount of subsequent capital may become available in separate tranches upon achievement of certain pre-specified revenue milestones.
In June 2026, Autolus was awarded the 2026 Prix Galien UK Award for Best Biotechnology Product. Winners of the prestigious Prix Galien awards are selected by a UK Awards Committee, which comprises 12 experts in the field who are leaders in UK healthcare.
In April 2026, Autolus announced a strategic initiative and plan to improve operational efficiency and reduce operating expenses. As part of this initiative, Autolus implemented a reduction in force affecting approximately 13% of its existing overall workforce, impacting all areas of the business. The actions are expected to reduce operating expenses by approximately $15 million on an annualized basis beginning in 2027. The implementation of the workforce reduction plan is now substantially complete.

Outlook:
Autolus recently increased the full year 2026 guidance for AUCATZYL net product revenue to $140 million to $150 million, from between $120 million to $135 million.

Based on current operating plans, including anticipated AUCATZYL net revenues and proceeds of the combined first and second tranches totaling $100 million from the recently-announced credit facility, Autolus expects that its current and projected cash, cash equivalents and marketable securities will be sufficient to fund the Company’s operations into Q2 2028.

Summary of Anticipated News Flow:

Longer-term follow up data from CARLYSLE trial in patients with severe refractory systemic lupus erythematosus By year-end 2026
Initial clinical data from ALARIC Phase 1 trial in patients with light-chain amyloidosis By year-end 2026
Initial clinical data from BOBCAT Phase 1 trial in patients with progressive MS Q1 2027
Phase 1 data from BOBCAT trial in patients with progressive MS 2H 2027
Phase 2 data from CATULUS trial in patients with pediatric r/r B-ALL By year-end 2027
Phase 2 data from LUMINA trial in patients with LN In 2028

Financial Results for the Quarter Ended June 30, 2026
Product revenue, net increased to $45.7 million for the three months ended June 30, 2026, compared to $20.9 million the same period in 2025.

Cost of sales decreased to $20.5 million for the three months ended June 30, 2026, compared to $24.4 million the same period in 2025. Gross margin1 was 55% in the second quarter of 2026, increasing from 6% in the first quarter of 2026 and negative in all prior quarters in 2025. This improvement in gross margin was primarily driven by a reduction in manufacturing cost per batch, reflecting increased volumes and the ongoing operational efficiency initiatives, and lower inventory reserves and write-offs compared to the same period in the prior year.

Research and development expenses increased to $27.9 million for the three months ended June 30, 2026, compared to $27.4 million in the same period in 2025. This change was primarily due to an increase in research and development activities including clinical trial and clinical manufacturing supply costs and is partially offset by a decrease in salaries and other employment-related costs.

Selling, general and administrative expenses increased to $41.2 million for the three months ended June 30, 2026, compared to $30.3 million in the same period in 2025. This increase was primarily due to salaries, other employment-related costs and professional fees supporting commercialization activities in the US and UK. In addition, the quarter also included additional termination-related expenses, relating to the strategic operational efficiency and cost reduction initiative announced in April 2026.

Loss from operations for the three months ended June 30, 2026, was $43.8 million, as compared to $61.2 million for the same period in 2025.

Net loss was $39.1 million for the three months ended June 30, 2026, compared to $47.9 million for the same period in 2025. Basic and diluted net loss per ordinary share for the three months ended June 30, 2026, was $(0.15), compared to basic and diluted net loss per ordinary share of $(0.18) for the same period in 2025.

Cash, cash equivalents and marketable securities at June 30, 2026, totaled $201.6 million, as compared to $229.4 million at March 31, 2026. The decrease was primarily driven by net cash used in operating activities, which includes cash received in relation to a UK R&D tax credit.

Unaudited Selected Consolidated Statements of Operations and Comprehensive Loss Data
(In thousands, except share and per share amounts)

Three Months Ended June 30, Six Months Ended June 30,
2026 2025 2026 2025
Revenue:
Product revenue, net $45,672 $20,923 $71,890 $29,905
License revenue 17 — 17 —
Total revenue, net 45,689 20,923 71,907 29,905
Cost and operating expenses:
Cost of sales (20,468) (24,445) (45,036) (42,396)
Research and development expenses, net (27,898) (27,430) (49,108) (54,164)
Selling, general and administrative expenses (41,161) (30,265) (81,114) (59,802)
Loss from operations (43,838) (61,217) (103,351) (126,457)
Total other income (expenses), net 5,192 13,697 (6,030) 10,999
Net loss before income tax
Income tax expense (465) (397) (1,328) (2,623)
Net loss (39,111) (47,917) (110,709) (118,081)
Other comprehensive (loss) income:
Total other comprehensive income (loss), net of tax 526 18,968 (745) 30,036

Total comprehensive loss $(38,585) $(28,949) $(111,454) $(88,045)

Basic and diluted net loss per ordinary share $(0.15) $(0.18) $(0.42) $(0.44)
Weighted-average basic and diluted ordinary shares 266,158,829 266,141,411 266,151,170 266,134,021

Unaudited Selected Consolidated Balance Sheet Data
(In thousands)

June 30, December 31,
2026 2025
Assets
Cash and cash equivalents $ 171,414 $ 104,132
Marketable securities – Available-for-sale debt securities $ 30,216 $ 196,578
Total current assets $ 336,091 $ 435,915
Total assets $ 493,226 $ 589,068
Liabilities and shareholders’ equity
Total current liabilities $ 68,790 $ 73,440
Total liabilities $ 418,387 $ 410,939
Total shareholders’ equity $ 493,226 $ 589,068

Conference Call
Management will host a conference call and webcast today at 8:30am EDT/1:30pm BST to discuss the company’s financial results. Conference call participants should pre-register using this link to receive the dial-in numbers and a personal PIN, which are required to access the conference call. A simultaneous audio webcast and replay will be accessible on the events section of Autolus’ website at View Source

(Press release, Autolus, AUG 11, 2026, View Source [SID1234669942])

On August 11, 2026 Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a potentially transformative first-in-class therapy for patients with ocular cancers, reported financial results for the second quarter ended June 30, 2026, and provided a business update.

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"Completing enrollment in our Phase 3 CoMpass trial of bel-sar for early choroidal melanoma positions us well for the next phase of our company’s evolution to become a leading ocular oncology company," said Natalie Holles, Chief Executive Officer of Aura Biosciences. "Given the promising therapeutic profile of bel-sar and the significant unmet need for a new treatment in this field, we are prioritizing our efforts and resources on delivering meaningful development milestones, providing ocular oncologists with frontline, vision-preserving treatment options for patients, and creating long-term value for shareholders."

Recent Business Highlights

Early Choroidal Melanoma

The Phase 3 CoMpass trial, the first registration-enabling study in patients with early choroidal melanoma, is fully enrolled with 108 patients, which exceeded the enrollment target. Topline data from the 15-month primary endpoint remain on track for the second half of 2027, consistent with previously communicated guidance.

The trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA), reflecting alignment with the FDA on the trial design and planned analyses to support a potential Biologics License Application (BLA). If successful, belzupacap sarotalocan (bel-sar) has the potential to become the first approved frontline vision-preserving therapy for patients with early choroidal melanoma, providing a meaningful new treatment option where no FDA-approved drug therapies currently exist.

Additional Ocular Oncology Programs

Aura continues to advance the clinical development of bel-sar in metastases to the choroid and cancers of the ocular surface. The Company is increasing resources directed toward both programs to support more robust clinical data generation in support of future development. Aura expects to provide an update on both programs, including guidance on study completion, in Q1 2027.

NMIBC Program Update

Interim data from the ongoing Phase 1b/2 dose-escalation study of bel-sar in non-muscle invasive bladder cancer (NMIBC) demonstrate an encouraging early clinical profile. Among intermediate-risk patients treated with bel-sar alone (n=8) or with TURBT (n=8), 81% of patients achieved an objective response at 3 months, including 69% with a complete response at that timepoint. Responses have shown strong early durability: among evaluable patients who have reached the 9- (n=4) or 12-months (n=3) timepoints, 100% of evaluable patients remain disease-free at time of assessment. Three-month data collection is ongoing in the high-risk cohorts.

Bel-sar continues to demonstrate a favorable safety profile, with all treatment-related adverse events limited to Grade 1 events, no dose-limiting toxicities, and no treatment-related serious adverse events. These data provide encouraging early clinical proof-of-concept for intratumoral delivery of bel-sar and support the potential utility of this route of administration for ocular cancers.

While these early data are encouraging, as part of its strategic refocus on ocular oncology, the Company is minimizing resource allocation toward the NMIBC program on a going forward basis. The Company remains committed to the care of patients and intends to complete data collection through the protocol-defined 12-month follow-up period to preserve optionality for value creation in the context of future potential strategic discussions.

Organizational and Leadership Updates

Aura has streamlined its operating plan and organizational structure to focus resources in ocular oncology, including a reduction in force of approximately 20% of the workforce. Together with disciplined capital allocation, these actions are expected to extend the Company’s projected cash runway into the first half of 2029 to support execution of the Phase 3 CoMpass trial, advancement of its additional ocular oncology programs and preparation for potential commercialization.

Aura reported the appointments of Susan Abu-Absi as Chief Operating Officer, Erica Kratz as Chief Regulatory and Quality Officer, and Julie Person as Chief People Officer. As previously announced on July 8, 2026, Jeremy Bender also joined the Company’s Board of Directors.

"I am thrilled to welcome Susan, Erica and Julie to Aura," said Natalie Holles. "As we sharpen our focus on ocular oncology and advance bel-sar toward potential BLA filing, we are building a fit-for-purpose organization with the capabilities needed for our next stage of growth. Their collective experience will be invaluable as we execute on our strategy and prepare for potential registration and commercialization."

Aura also announced that Tony Gibney, Chief Financial and Business Officer and Conor Kilroy, Chief Legal Officer are stepping down, and Mark Plavsic has stepped down as Chief Technology Officer.

"On behalf of the Board and the entire Aura team, I want to thank Tony, Conor and Mark for their leadership and contributions to Aura," said Natalie Holles. "Each has played an important role in advancing the Company and positioning Aura for this next chapter, and we wish them all the very best in their future endeavors."

Susan Abu-Absi, Ph.D., Chief Operating Officer

Susan Abu-Absi, Ph.D., is a seasoned biopharmaceutical executive with more than 20 years of leadership experience spanning technical development, manufacturing, quality and global operations. Most recently, she served as Chief Operating Officer at Be Biopharma, where she led the company’s operational strategy and execution. Prior to Be Biopharma, she was Chief Technology Officer at 2seventy bio, leading technical development, supply and quality and supporting the commercialization of Abecma as well as the advancement of multiple cell therapy programs. Previously, Susan held senior leadership roles at bluebird bio, where she played an integral role in the approvals of Zynteglo and Skysona, and at Bristol Myers Squibb and Bayer Healthcare. She holds a Ph.D. in Chemical Engineering from the University of Minnesota and a B.S. in Chemical Engineering from the University of Toledo.

Erica Kratz, Ph.D., Chief Regulatory and Quality Officer

Erica Kratz, Ph.D., is a regulatory affairs and quality executive with more than 20 years of experience leading global regulatory strategy and development quality across the biotechnology industry. Most recently, she served as Senior Vice President, Regulatory Affairs and Head of Development Quality Assurance at Denali Therapeutics, where she built and led the team from the company’s first clinical trial through the advancement of multiple programs into the clinic, including the BLA submission and FDA approval of Avlayah in Hunter Syndrome. Prior to Denali, Erica spent a decade at Genentech, where she led global regulatory strategy for multiple oncology programs spanning early development through commercialization, including U.S. and Canadian marketing applications for Herceptin in gastric cancer. She holds a Ph.D. in Molecular and Cell Biology from the University of California, Berkeley and a B.S. in Cell and Molecular Biology from the University of Arizona.

Julie Person, Chief People Officer

Julie Person is a human resources executive with more than 20 years of experience leading people strategy and organizational development across the biopharmaceutical industry. Most recently, she served as Chief People Officer at Vera Therapeutics. Prior to Vera, Julie served as Chief People Officer at Third Harmonic Bio and held senior human resources leadership roles at Neumora Therapeutics, Audentes Therapeutics, Sangamo Therapeutics, Shire, Blue Shield of California and McKesson. Her experience spans organizational design, talent acquisition, leadership development, culture and change management, supporting organizations through all stages of growth from early development to commercialization. She holds a B.A. in Communications from Saint Mary’s College of California.

Second Quarter 2026 Financial Results

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As of June 30, 2026, Aura had cash and cash equivalents and marketable securities totaling $323.8 million. The Company believes its current cash and cash equivalents and marketable securities are sufficient to fund its operations into 1H 2029.

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Research and development expenses increased to $30.7 million for the three months ended June 30, 2026 from $22.9 million for the three months ended June 30, 2025, primarily due to ongoing clinical and CRO costs associated with the progression of the CoMpass global Phase 3 trial of bel-sar in early choroidal melanoma and manufacturing and development costs for bel-sar.
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General and administrative expenses increased to $17.3 million for the three months ended June 30, 2026 from $5.7 million for the three months ended June 30, 2025. General and administrative expenses include $10.3 million and $1.8 million of stock-based compensation for the three months ended June 30, 2026 and 2025, respectively. The increase was primarily driven by increased stock-based compensation expense resulting from equity award modifications in connection with executive leadership transitions, as well as higher professional fees.

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Net loss for the three months ended June 30, 2026 was $45.6 million compared to $27.0 million for the three months ended June 30, 2025.

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In connection with the Company’s organizational restructuring to align resources behind its ocular oncology portfolio, the Company estimates to incur restructuring charges of approximately $2.9 million to $3.2 million, comprised of employee termination benefits which include severance, continuation of health care benefits, and outplacement services as well as incremental stock-based compensation expense resulting from the acceleration of vesting of certain stock-based awards. The restructuring plan is expected to be substantially complete by the end of the third quarter of 2026.

(Press release, Aura Biosciences, AUG 11, 2026, View Source [SID1234669941])

On August 11, 2026 AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical stage biopharmaceutical company focused on the discovery and development of novel small molecule therapeutics derived from its boron chemistry platform, reported financial results for the second quarter ended June 30, 2026.

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"AN2 will have three Phase 2 programs underway by the end of this year, all of which have the potential to address major unmet needs. Our near-term focus is advancing start-up activities for the Phase 2 EBO-PV-201 study in polycythemia vera. We recently held a pre-IND meeting with the FDA and are expanding the Phase 2 study to include sites in the U.S. and Australia," said Eric Easom, Co-Founder, Chairman, President and CEO of AN2 Therapeutics. "Enrollment is ongoing in an investigator-initiated Phase 2 study in M. abscessus lung disease. In our chronic Chagas program, compelling non-human primate efficacy data and a favorable clinical PK and safety profile from our Phase 1 study support planned initiation of a Phase 2 trial by year-end. We are also expanding our pipeline, having declared our first development candidate for solid tumors earlier this year and expecting to advance a second development candidate by the end of 2026. Collectively, these achievements underscore the potential of our boron chemistry platform to deliver differentiated therapies across multiple disease areas."

Second Quarter & Recent Business Updates:

Polycythemia vera

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Advancing start-up activities for the global Phase 2 trial of oral epetraborole in polycythemia vera
In March 2026, the Company outlined plans to expand the development of oral epetraborole into a Phase 2 proof-of-concept clinical study in adults with phlebotomy-dependent polycythemia vera (PV). PV is a slowly progressing blood cancer characterized by overproduction of red blood cells in the bone marrow. This overproduction increases hematocrit, which can lead to serious medical complications, including arterial and venous thromboembolic events. If untreated, PV can be life-threatening. Despite available therapies, such as burdensome periodic therapeutic phlebotomies, many patients experience uncontrolled hematocrit levels and persistent symptoms, requiring long-term management to maintain adequate disease control. PV is estimated to affect approximately 155,000 people in the U.S.

The Company recently held a pre-IND meeting with the FDA and now plans to expand the Phase 2 study (EBO-PV-201) to add sites in the U.S. and Australia, with an IND filing expected in the third quarter of 2026. As a result of this expansion, Phase 2 enrollment is anticipated to commence in the fourth quarter of 2026, beginning with an open-label sentinel cohort at a sub-therapeutic dose aimed at assessing pharmacokinetics and safety in PV patients. Following successful conclusion of the sentinel group, the safety monitoring committee will advise on dose selections for Part 1, an open-label, single arm, 28-week evaluation of epetraborole’s ability to maintain hematocrit control and reduce the frequency of phlebotomy in phlebotomy-dependent PV patients. The Company anticipates releasing Part 1 data periodically throughout 2027.

M. abscessus complex lung disease

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Enrollment ongoing in Phase 2 investigator-initiated clinical trial of epetraborole in patients with M. abscessus lung disease
Building on the learnings from AN2’s prior non-tuberculous mycobacterial (NTM) study in treatment-refractory MAC, the Company believes that epetraborole has the potential to address a critical unmet need in M. abscessus lung disease, one of the most difficult-to-treat NTM infections for which no FDA-approved therapy exists. M. abscessus lung disease is a serious NTM infection requiring prolonged therapy, initially often with IV-only antibiotics. People affected by this illness face limited, burdensome treatment options, and high rates of morbidity and mortality. NTM lung disease represents a growing global health concern. It is estimated that approximately 120,000–150,000 people in the U.S. are living with NTM lung disease, of whom 10-15% have infection caused by M. abscessus.

The Company is supporting an investigator-initiated trial and anticipates that data from this study, if positive, could provide clinical proof-of-concept in M. abscessus lung disease and thereby inform the design of a subsequent pivotal trial. Patient enrollment is ongoing. The 84-patient multicenter, randomized, double-blind, placebo-controlled, prospective clinical study is being led by Dr. Kevin Winthrop, Professor of Public Health and Infectious Diseases at the Oregon Health and Sciences University, in conjunction with other investigators across an estimated 10-15 sites in the U.S. The Company anticipates reporting topline results in late 2027, subject to enrollment progress.

Chagas disease

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Announced positive enabling data from two studies of oral AN2-502998, under development for chronic Chagas disease, which support advancement to Phase 2 proof-of-concept study anticipated to start in 2026
The Company is studying AN2-502998, an oral, boron-based small molecule CPSF3 inhibitor for the treatment of chronic Chagas disease, also known as American trypanosomiasis. Chagas disease is caused by the parasite Trypanosoma cruzi (T. cruzi). Over 300,000 people are estimated to be infected in the U.S., 200,000 across Europe and Japan, and about 10 million worldwide. Left untreated, chronic T. cruzi infection is lifelong and can be life threatening. The parasite T. cruzi silently damages the heart and digestive system, with ~20-30% of people developing serious cardiac damage resulting in heart failure, stroke, or sudden death. There are no FDA-approved treatments for adults with Chagas disease.

In June 2026, the Company announced positive results from two studies that it believes support the planned initiation later this year of a Phase 2 trial of AN2-502998 in chronic Chagas disease. In the non-human primate (NHP) efficacy study, 28 days of treatment with AN2-502998 resulted in 100% parasitic elimination at target exposures attainable in humans, in NHP’s with naturally acquired, chronic T. cruzi infection. In the Phase 1 first-in-human study, AN2-502998 was generally well tolerated at exposure levels consistent with NHP efficacy thresholds.

AN2-502998 is the only compound of which the Company is aware to have demonstrated curative activity in preclinical studies across multiple species, including in NHPs with long-term, naturally acquired chronic infections caused by diverse T. cruzi genetic types. The Company believes that efficacy in naturally infected NHPs is the most clinically relevant predictor of efficacy for human chronic Chagas disease.

The Company expects to initiate a Phase 2 proof-of-concept study in adults with chronic Chagas disease in late 2026.

Boron chemistry pipeline

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Advancing ENPP1 candidate for the potential treatment of solid tumors
The Company is prioritizing targets in oncology and bone disorders where it believes boron chemistry may offer a competitive advantage in terms of binding-site differentiation, pharmacodynamics, drug-like properties and IP, including initially ENPP1 and PI3Kα. The unique binding modes of boron-containing compounds enable the discovery of inhibitors with high ligand efficiency against targets considered undruggable or difficult to access with traditional chemistry approaches. Boron chemistry has produced first-in-class molecules against a number of targets including CPSF3 (AN2-502998 and acoziborole) and LeuRS (epetraborole, ganfeborole and tavaborole). The Company has discovered preclinical compounds that demonstrate sub-nanomolar activity, high selectivity and excellent oral pharmacokinetic properties. Earlier this year, the Company declared a development candidate (ENPP1) for the treatment of solid tumors and expects to advance a second development candidate by the end of 2026.

Selected Second Quarter Financial Results

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Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2026 were $6.0 million, compared to $3.2 million for the same period during 2025 due to increased chemistry manufacturing and controls (CMC) expenses, other miscellaneous expenses, consulting and outside services, preclinical and research studies expenses, and clinical trial expenses. These increases were partially offset by a decrease in personnel-related expenses.
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General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2026 were $2.9 million, compared to $4.0 million for the same period in 2025 due to decreased professional and outside services expenses and personnel-related expenses.
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Interest Income: Interest income for the second quarter of 2026 was $0.7 million, compared to $0.8 million for the same period during 2025 due to lower average cash, cash equivalents, and investment balances and lower interest rates in 2026 as compared to 2025.
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Net Loss: Net loss for the second quarter of 2026 was $8.2 million, compared to $6.5 million for the same period during 2025.
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Cash Position: The Company had cash, cash equivalents and investments of $79.9 million at June 30, 2026. The Company projects that existing cash, cash equivalents, and investments will sustain operations into 2029 under the current operating plan.

(Press release, AN2 Therapeutics, AUG 11, 2026, View Source [SID1234669940])