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 Theriva Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported financial results for the second quarter ended June 30, 2026, and provided a corporate update.

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"We have successfully converted last quarter’s regulatory achievements into clinical progress in the VCN-01 program," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "Dosing of the first patients in the VIRAGE2 trial brings us closer to refining a VCN-01 dosing regimen for potential evaluation in a future pivotal Phase 3 clinical trial in first-line metastatic PDAC patients when coadministered with chemotherapy. A repeated VCN-01 dosing regimen may also improve outcomes when combined with other cancer interventions, including immuno-oncology products, RAS inhibitors, and other emerging classes of cancer treatments. If more frequent repeated administration of VCN-01 is feasible and well-tolerated, use of this dosing regimen may further derisk future Phase 3 clinical trials."

Recent Highlights and Anticipated Milestones

VCN-01

Metastatic PDAC:

As recently announced, the first patients have been dosed in the VIRAGE2 Phase 2a clinical trial entitled "A Phase IIa, single-arm, single-center, open-label, proof-of-concept trial evaluating increased frequency dosing of zabilugene almadenorepvec (VCN-01) in combination with gemcitabine/nab-paclitaxel in patients with newly-diagnosed metastatic pancreatic cancer" (EUCT: 2026-525566-21-00; NCT07701486).
The VIRAGE2 study design incorporates feedback from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) recognizing improved survival outcomes in the VIRAGE Phase 2b trial in metastatic PDAC patients treated with 2 doses of VCN-01 (in combination with standard-of-care chemotherapy), highlighting the possibility that more frequent repeated dosing of VCN-01 may provide additional clinical benefit.
The VIRAGE2 trial will evaluate the safety and feasibility of administering at least 3 doses of VCN-01 given approximately 2 months apart in combination with standard-of-care chemotherapy. The trial is expected to enroll 6 evaluable patients. Results from the VIRAGE2 study will inform the VCN-01 dosing regimen for potential evaluation in a future pivotal Phase 3 clinical trial.
VIRAGE2 is expected to complete enrollment during the second half of 2026, and initial pharmacodynamic and safety/tolerability data are anticipated by Q3 2027.
Retinoblastoma:

Undertook extensive discussions with key opinion leaders and completed the design of a proposed Phase 2/3 clinical trial of intravitreal VCN-01 in combination with intravitreal topotecan in children with retinoblastoma with vitreous seeds that are refractory/resistant to the use of current intravitreal chemotherapy.
Proposed clinical trial protocol builds on compelling Phase 1 clinical data in this ultra rare population for which there is no current treatment.
Plan to discuss the proposed clinical trial protocol with the FDA in Q3 2026.
VCN-01 has Orphan Drug Designation from both the FDA and EMA and Rare Pediatric Disease Designation from the FDA for the treatment of retinoblastoma; if a Biologics License Application (BLA) for VCN-01 for the treatment of retinoblastoma is approved by the FDA by September 30, 2029, the Company may be eligible to receive a Priority Review Voucher.
Head & Neck Squamous Cell Carcinoma:

Clinical and translational results from the Phase 1 clinical trial of VCN-01 in refractory or metastatic head & neck squamous cell carcinoma (HNSCC) patients (whose disease progressed despite previous therapies, including anti-PD-(L)1 immune checkpoint inhibitors) were published in the journal Clinical Cancer Research in an online first article titled "Phase I trial of intravenous VCN-01 oncolytic adenovirus and durvalumab in patients with head and neck metastatic squamous cell carcinoma refractory to immunotherapy".
In the Phase 1 trial, prolonged overall survival (OS) was observed in these heavily pre-treated refractory HNSCC patients administered intravenous VCN-01 prior to the immune checkpoint inhibitor durvalumab (sequential delivery).
Pharmacokinetic, tissue biopsy, radiomic and transcriptomic results all support the proposed VCN-01 stroma-degrading and immune enhancing modes-of-action, resensitizing refractory tumors to durvalumab.
These findings support further clinical development of VCN-01 with immune checkpoint inhibitors or other immune modulating anticancer therapies in HNSCC and potentially other cancer indications.
Second Quarter Ended June 30, 2026 Financial Results

General and Administrative Expenses

General and administrative expenses decreased to $2.0 million for the three months ended June 30, 2026, from $11.2 million for the three months ended June 30, 2025. This decrease of 82% is primarily comprised of the prior year increase in fair value of the contingent consideration adjustment of $9.2 million due to the VIRAGE Phase 2b clinical trial of VCN-01 in PDAC achieving its primary survival and safety endpoints, offset set by current year increase in legal fees. The charge related to stock-based compensation expense was $110,000 for the three months ended June 30, 2026, compared to $97,000 for the three months ended June 30, 2025.

Research and Development Expenses

Research and development expenses decreased to $1.3 million for the three months ended June 30, 2026, from $2.0 million for the three months ended June 30, 2025. This decrease of 35% is primarily the result of lower indirect cost related to compensation expense and lower direct clinical trial expenses related to the Company’s Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients and lower expenses related to SYN-020, offset by higher direct expenses related to VCN-01 manufacturing activities and expenses associated with the planning for the Phase 2a study in metastatic PDAC patients evaluating more frequent VCN-01 dosing for a longer period.

Other Income/Expense

Other income was $78,000 for the three months ended June 30, 2026, compared to other income of $74,000 for the three months ended June 30, 2025. Other income for the three months ended June 30, 2026 is comprised of interest income of $79,000 and an exchange loss of $1,000. Other income for the three months ended June 30, 2025 is comprised of interest income of $54,000 and an exchange gain of $20,000.

Cash and Cash Equivalents

Cash and cash equivalents totaled $11.3 million as of June 30, 2026, a decrease of $1.7 million from December 31, 2025. During the year ended December 31, 2025 and the quarter ended June 30, 2026, the primary use of cash was for working capital requirements and operating activities, which resulted in a net loss of $23.7 million and $5.3 million for the year ended December 31, 2025 and the six months ended June 30, 2026, respectively.

(Press release, Theriva Biologics, AUG 11, 2026, View Source [SID1234669964])

On August 11, 2026 NeOnc Technologies (NASDAQ:NTHI) reported it is heading into Wednesday with the kind of setup that can put a clinical-stage biotech squarely on the market’s radar: a stock trading near its 52-week low, a relatively small trading float, more than 500,000 shares reported short, three Wall Street Buy ratings and a long-awaited brain-cancer data readout.

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The question is whether the clinical data can justify the attention.

NeOnc is scheduled to release topline Phase 2a results from its NEO100-01 trial at 8:30 a.m. ET on Wednesday, August 12, evaluating intranasal NEO100 in patients with recurrent or progressive Grade III and Grade IV IDH1-mutant glioma. The company says management will discuss efficacy and safety observations as well as planned regulatory next steps. The trial is fully enrolled.

For a stock recently trading around $3.50, the timing is significant.

A Stock Near the Bottom of Its Range

NTHI’s recent trading level is close to its approximately $3.01 52-week low, versus a $12.99 52-week high. Finviz currently shows the shares roughly 74% below that high and only modestly above the yearly low.

Wednesday’s data could provide the next major catalyst.

Unlike an earnings release or routine corporate update, a Phase 2a readout can directly change investors’ expectations for a drug’s clinical and commercial prospects. In NeOnc’s case, the readout concerns a program the company has already positioned as a central part of its development strategy.

NeOnc previously reported encouraging historical observations for NEO100, including a 24% radiographic remission rate in an expanded 25-patient cohort, 44% six-month progression-free survival, and 36% of patients alive at least 18 months after treatment initiation. Those figures are from earlier company-reported experience and should not be confused with Wednesday’s prospective Phase 2a topline results.

The Reported Float Is Small

The share structure adds another layer to the setup.

Finviz currently lists approximately 2.06 million shares in the public float, against roughly 24.13 million shares outstanding. It also reports approximately 520,000 shares short, a 25.33% short-float figure, and average volume of roughly 97,590 shares.

Other market-data providers calculate the float differently. StockAnalysis, for example, currently estimates a float of approximately 9.05 million shares, which would put the same 521,841-share short position at about 5.77% of float.

Regardless, that is more than half a million shares are reported short in a stock whose normal trading volume is relatively limited, so the short position represents over the highly sought-after 5 days to cover threshold.

If clinical results bring substantially more volume into NTHI, both short covering and new buyers could become meaningful sources of demand. That does not guarantee a squeeze or a higher share price, but it creates the potential for unusually fast price discovery.

Wall Street Is Already Looking Much Higher

NeOnc also enters the event with unusually wide analyst expectations relative to its recent share price.

Three firms currently carry Buy ratings:

Maxim Group — $20 price target
BTIG — $15 price target
Alliance Global Partners — $13 price target

The simple average is $16 per share.

Against a roughly $3.50 stock price, those targets represent a substantial valuation gap. Maxim’s $20 target is nearly six times that level, while the $13 target from Alliance Global Partners is still several multiples higher.

Those are analyst expectations, not guarantees, and Wednesday’s data could strengthen, weaken or completely change the assumptions supporting those targets.

There is another potentially important ownership detail. NeOnc’s latest available market-data estimates put insider ownership at roughly 55%, while institutional ownership is estimated at about 6.6%. The company has also disclosed insider buying, including a purchase of more than $500,000 of NTHI shares by CEO Amir Heshmatpour referenced in its first-quarter update.

Biotech Traders Have Seen How Fast Good Data Can Move a Stock

The broader biotech market has provided recent reminders that clinical data can radically change a company’s valuation in a single session.

Tango Therapeutics (NASDAQ:TNGX) surged after reporting initial Phase 1/2 data showing a 92% objective response rate among response-evaluable pancreatic-cancer patients treated with vopimetostat plus daraxonrasib. Six-month progression-free survival was 90%, and disease control reached 100% in the reported pancreatic-cancer cohort. Tango’s shares jumped approximately 53% that day, closing at $30.93.

The comparison is not a prediction for NTHI. The studies, drugs, patient populations and clinical-stage risks are different.

But the market reaction illustrates the mechanism: when clinical results materially exceed expectations, investors can rapidly reassess an entire company’s opportunity.

Intensity Therapeutics (NASDAQ:INTS) offers an even more dramatic example. Following positive Phase 1/2 data for INT230-6 in advanced cancers, the stock rose approximately 394% in a single session, from about $0.27 to $1.32, according to Genetic Engineering & Biotechnology News. The data showed a 75% disease-control rate among 64 patients and median overall survival of 11.9 months.

Again, those outcomes do not establish what NTHI will do.

They demonstrate why small biotechnology companies can become extremely volatile when meaningful clinical data arrives against a limited share supply.

Wednesday Is the Inflection Point

That leaves NTHI approaching the August 12 readout with several forces already in place:

A stock near its 52-week low.

A reported public float that varies significantly by data provider but is small under some methodologies.

521,841 shares reported short as of July 15.

Three Buy ratings with $13, $15 and $20 targets.

A fully enrolled Phase 2a brain-cancer trial.

And a scheduled topline data presentation Wednesday morning.

The bullish case is straightforward: compelling efficacy and safety data could force investors to reassess the value of NEO100 and the company’s broader CNS pipeline. A stronger-than-expected regulatory path could add another layer to that repricing.

The bearish case is equally straightforward: disappointing efficacy, safety concerns, ambiguous results or an uncertain regulatory path could overwhelm the technical setup. A low float can amplify selling just as easily as buying.

That is ultimately what makes Wednesday important.

The question isn’t whether NTHI has the ingredients for volatility. It clearly does.

The question is whether the NEO100 Phase 2a data are strong enough to change the fundamental story.

If they are, the market will have to determine how much that new information is worth.

And with NTHI trading near the bottom of its 52-week range, analyst targets extending as high as $20 and more than half a million shares reported short, that repricing could be anything but quiet.

The Catalyst

NeOnc Technologies Holdings (NASDAQ:NTHI)
NEO100-01 Phase 2a topline data presentation
Wednesday, August 12, 2026
8:30 a.m. ET / 5:30 a.m. PT

NeOnc says management will present topline efficacy and safety observations, discuss planned regulatory next steps and conduct a question-and-answer session.

Live webcast: View Source

Investor relations: View Source

A replay is expected to be available following the presentation.

(Press release, Neonc, AUG 11, 2026, View Source [SID1234669980])

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 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage biotechnology company developing immuno-oncology therapeutics based on its proprietary INTASYL gene-silencing technology, reported the receipt of a U.S. Notice of Allowance for a patent covering PH-894, further strengthening the Company’s intellectual property portfolio.

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The patent allowance represents a critical milestone in protecting Phio’s strategic interest in the Company’s INTASYL platform. PH-894, designed to selectively silence BRD4, is a key regulator of gene expression associated with proliferative and infectious disease.

"Robust intellectual property protection is a continuous focus in our development strategy to advance novel immuno-oncology therapies and maximize the long-term value of the INTASYL platform," said Robert Bitterman, President and Chief Executive Officer of Phio Pharmaceuticals. "This patent advancement solidifies our commitment to advance PH-894 in the U.S. and pursue strategic collaborations internationally."

Phio has built a comprehensive patent estate supporting its INTASYL technology and therapeutic pipeline. The Company’s portfolio currently includes 54 issued patents covering INTASYL chemistry, specific gene targets, immuno-oncology compounds, and therapeutic applications across major global markets.

The newly allowed patent further reinforces Phio’s commitment to protecting its proprietary innovations and advancing next-generation cancer therapies based on targeted gene silencing.

(Press release, Phio Pharmaceuticals, AUG 11, 2026, View Source [SID1234669965])