On May 11, 2026 Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, reported its first quarter 2026 financial results.

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

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

                  Schedule Your 30 min Free Demo!

First Quarter Highlights:
Revenue was $106.9 million, compared to $106.0 million in the first quarter of 2025, representing growth of 1%.
Software revenue was $49.7 million, compared to $46.4 million in the first quarter of 2025, representing growth of 7%.
Services revenue was $57.2 million, compared to $59.6 million in the first quarter of 2025, representing a decrease of 4%.
Net loss was $8.8 million, compared to a net income of $4.7 million in the first quarter of 2025, representing a decrease of 285%.
Adjusted EBITDA was $31.7 million, compared to $34.8 million in the first quarter of 2025, representing a decrease of 9%.
"I am pleased with the progress we made in my first quarter at Certara," said Jon Resnick, Chief Executive Officer. "We are taking decisive steps to sharpen our execution and position Certara for long-term growth, including divesting our Medical Writing business, reorganizing around two focused growth areas, and accelerating our enterprise-wide AI program. Together, these actions strengthen our ability to transform drug development and deliver greater value to our customers and shareholders."

"Our first quarter performance reflects improvement in software, which came in above plan across key metrics. Services performance was mixed, reflecting execution and go-to-market challenges that we expect to resolve during the second half of the year," said John Gallagher, Chief Financial Officer. "With the divestiture of our Regulatory and Medical Writing Business, we expect the mix of software and services revenue to be approximately even. Our updated 2026 guidance reflects the impact of the divestiture during the second quarter, and revenue growth expectations of 0% – 4% excluding the Regulatory and Medical Writing Business."

First Quarter 2026 Results
Total revenue for the first quarter of 2026 was $106.9 million, representing year-over-year growth of 1% on a reported basis. Software revenue for the first quarter of 2026 was $49.7 million, representing year-over-year growth of 7% on a reported basis. Services revenue for the first quarter of 2026 was $57.2 million, representing a year-over-year decrease of 4% on a reported basis.

Total Bookings for the first quarter of 2026 were $115.3 million, representing a year-over-year decrease of 2%.

Software Bookings for the first quarter of 2026 were $48.7 million, representing a year-over-year increase of 20%. The increase in software bookings was attributable to strong customer demand across our platform.

Services Bookings for the first quarter of 2026 were $66.6 million, representing a year-over-year decrease of 14%. The decrease in services bookings was primarily driven by the timing of contract recognition and execution.

Total cost of revenues for the first quarter of 2026 was $41.6 million, an increase of $0.1 million from $41.5 million in the first quarter of 2025. Cost levels were consistent with the same quarter in the prior year.

Total operating expenses for the first quarter of 2026 were $69.6 million, which increased by $12.7 million from $56.9 million in the first quarter of 2025. Higher operating expenses were primarily due to a $7.4 million increase in business acquisition contingent consideration expense, a $2.8 million increase in employee-related costs, a $1.0 million increase in equipment and software expenses, a $0.9 million increase in executive recruiting and retention expenses, a $0.8 million increase in lease abandonment expense, primarily due to the absence of a non-recurring gain recognized in the prior year that reduced expenses in that period, and a $0.8 million increase in amortization of intangible assets, partially offset by higher capitalized R&D costs.

Net loss for the first quarter of 2026 was $8.8 million, compared to a net income of $4.7 million in the first quarter of 2025. The $13.5 million decrease in net income was primarily driven by higher operating expenses, increased tax expenses, and increased total other expenses, partially offset by higher revenues.

Diluted loss per share for the first quarter of 2026 was $0.06, as compared to diluted earnings per share of $0.03 in the first quarter of 2025.

Adjusted EBITDA for the first quarter of 2026 was $31.7 million compared to $34.8 million for the first quarter of 2025, a decrease of $3.1 million. See note (1) in the section titled "A Note on Non-GAAP Financial Measures" below for more information on adjusted EBITDA.

Adjusted net income for the first quarter of 2026 was $14.5 million compared to $22.2 million for the first quarter of 2025, a decrease of $7.7 million. Adjusted diluted earnings per share for the first quarter of 2026 was $0.09, compared to $0.14 for the first quarter of 2025. See note (2) in the section titled "A Note on Non-GAAP Financial Measures" below for more information on adjusted net income and adjusted diluted earnings per share.

THREE MONTHS ENDED MARCH 31,
2026 2025
Key Financials (in millions, except per share data)
Revenue $ 106.9 $ 106.0
Software revenue $ 49.7 $ 46.4
Service revenue $ 57.2 $ 59.6
Total bookings $ 115.3 $ 118.2
Software bookings $ 48.7 $ 40.8
Service bookings $ 66.6 $ 77.4
Net income (loss) $ (8.8 ) $ 4.7
Diluted earnings per share $ (0.06 ) $ 0.03
Adjusted EBITDA $ 31.7 $ 34.8
Adjusted net income $ 14.5 $ 22.2
Adjusted diluted earnings per share $ 0.09 $ 0.14
Cash and cash equivalents $ 149.5 $ 189.4
Divestiture of global medical writing and related regulatory services business:
On May 08, 2026, we completed the sale of our global medical writing and related regulatory services business to Veristat, LLC for cash consideration of $85.0 million, with an additional $15.0 million placed in escrow and to be released to the Company upon the satisfaction of certain post-closing covenants, and additional contingent consideration of up to $35.0 million in the form of an earn-out based on the financial performance of such business for a specified period following closing. Net proceeds from the transaction are expected to be used for general corporate purposes, including funding our ongoing operations.

2026 Financial Outlook
Certara is updating its guidance for the full year 2026, to reflect the completed divestiture of the Regulatory and Medical Writing Business:

Full year 2026 revenue is expected to be $395 million – $405 million, including Regulatory and Medical Writing revenue of approximately $18 million.
Growth excluding the Regulatory and Medical Writing Business is expected to be 0% – 4%.
Full year 2026 Adjusted EBITDA margin is expected to be approximately 30% – 32%, including contribution from the Regulatory and Medical Writing business.
Full year adjusted diluted earnings per share is expected to be in the range of $0.35 – $0.41.
Fully diluted shares are expected to be in the range of 157 million – 159 million.
Please note that the Company has not reconciled adjusted EBITDA, adjusted EBITDA margin or adjusted diluted earnings per share forward-looking guidance included in this press release to the most directly comparable GAAP measures because this cannot be done without unreasonable effort due to the variability and low visibility with respect to costs related to acquisitions, financings, and employee stock compensation programs, which are potential adjustments to future earnings. We expect the variability of these items to have a potentially unpredictable, and a potentially significant, impact on our future GAAP financial results.

Webcast and Conference Call Details
Certara will host a conference call today, May 11, 2026, at 8:30 a.m. ET to discuss its first quarter 2026 financial results. Investors interested in listening to the conference call are required to register online in advance of the call. A live and archived webcast of the event will be available on the "Investors" section of the Certara website at View Source

(Press release, Certara, MAY 11, 2026, View Source [SID1234665430])

On May 11, 2026 Perspective Therapeutics, Inc. ("Perspective," the "Company," "we," "us," and "our") (NYSE AMERICAN: CATX), a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body, reported a business update and announced results for the quarter ended March 31, 2026.

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

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

                  Schedule Your 30 min Free Demo!

"The first quarter of 2026 was marked by continued execution across our clinical programs and strengthening of our financial position," said Thijs Spoor, Perspective’s CEO. "Our focus on engineering the alpha advantage across every part of the radiopharmaceutical value chain – from the radioisotope to optimized structural chemistry, theranostic processes, and regional manufacturing – differentiates Perspective, and we look forward to providing clinical and manufacturing updates throughout 2026."

Clinical Highlights

VMT-α-NET

We are conducting a multi-center, open-label, dose-finding study (clinicaltrials.gov identifier NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2)-positive neuroendocrine tumors (NETs) who have not received prior radiopharmaceutical therapies (RPT).

Updated interim data from the study, as of a data cut-off (DCO) date of March 4, 2026, were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 in April 2026.

As of April 30, 2026, the first 23 patients in Cohort 2 have had the opportunity for at least 60 weeks of follow-up since beginning treatment. By late 2026, all 46 patients in Cohort 2 will have had the opportunity for at least 60 weeks of follow-up since beginning treatment.

We believe our clinical data package positions us for meaningful regulatory engagement in 2026 to align on the path forward.

As of April 30, 2026, a total of 20 patients have been treated in Cohort 3. This cohort is now closed to enrollment. By late 2026, the eight patients initially enrolled for dose-limiting toxicity (DLT) assessment will have had the opportunity for at least 48 weeks of follow-up since beginning treatment.

Cohort 4 is now open for recruitment.

During the dose-finding phase of the study, we enrolled primarily NET patients whose disease originated in the pancreas or the digestive tract. We have an allowance for enrollment of NET patients whose disease originated in the lung (of which small cell lung cancer is a subset), pheochromocytoma/paraganglioma NETs, and SSTR2+ meningioma.

We opened a proof-of-concept cohort of meningioma patients. To date, there is no approved systematic therapy for this disease. The unmet medical need may support an expedited development path.

VMT01

VMT01 is an MC1R-targeted RPT that can be radiolabeled with either 203Pb for patient selection and dosimetry assessment or 212Pb for alpha-particle therapy. We are conducting a multi-center, open-label, dose-finding study (clinicaltrials.gov identifier NCT05655312) in heavily pre-treated patients with histologically confirmed melanoma and MC1R-positive imaging scans.

Since dosing re-opened for 3.0 mCi of VMT01 as monotherapy, and was initiated for 3.0 mCi of VMT01 in combination with nivolumab in September 2025, 10 patients had received VMT01 3.0 mCi treatment as of February 28, 2026; six patients had received VMT01 at 3.0 mCi in combination with nivolumab, and four patients had received 3.0 mCi of VMT01 as monotherapy, in addition to the three patients who received this monotherapy dose in late 2023. Both cohorts are now closed for enrollment.

By late 2026, the 10 patients who had received VMT01 3.0 mCi treatment since the initiation or re-opening of these cohorts in September 2025 will have had the opportunity for at least 24 weeks of follow-up after their initial doses, sufficient time to have completed at least one scan after the full course of treatment (up to three doses every eight weeks).

PSV359

We designed PSV359 to target and deliver 212Pb to tumor sites expressing fibroblast activation protein-α (FAP-α), which is associated with multiple highly prevalent solid tumors, in patients in need of additional treatment options.

As of April 30, 2026, two patients in Cohort 1 had been treated with [212Pb]PSV359 at 2.5 mCi, and seven patients in Cohort 2 had been treated at 5.0 mCi, for a total of nine patients. By late 2026, these patients will have had the opportunity for at least 32 weeks of follow-up after their initial doses, sufficient time to have completed at least one scan after the full course of treatment (up to four doses every eight weeks).

Cohort 3 is now open for recruitment.

Updates to the preclinical pipeline

Our discovery team is preparing additional novel constructs for potential first-in-human (FIH) imaging.

In May 2026, we presented an FIH image for PSV594, designed to target and deliver 212Pb to tumor sites expressing the Cholecystokinin 2 Receptor (CCK2R), which is expressed across a range of hard-to-treat cancers. The targeting moiety may also be radiolabeled with 203Pb or 68Ga to detect CCK2R expression in-vivo. Preclinical and FIH images suggest the targeting moiety has clean, precise tumor uptake with limited kidney retention, which may result in a desirable therapeutic index.

Updates on manufacturing infrastructure

We continue to make progress on expanding our manufacturing capabilities by increasing and enhancing capacity at existing facilities and building out recently acquired sites.

Our flagship site in the Chicago area is on track to complete construction this year. We are building a complementary site in the Los Angeles area and have plans beyond our current footprint.

First Quarter 2026 Financial Summary

Cash, cash equivalents, and short-term investments as of March 31, 2026, were approximately $271 million as compared to $145 million as of December 31, 2025. In February 2026, we announced the closing of an underwritten offering of securities with net proceeds of approximately $164 million after deducting underwriting discounts and commissions and other offering-related expenses. We believe our cash, cash equivalents, and short-term investments as of March 31, 2026, will be sufficient to fund our current clinical milestones and operational investments into late 2027.

As of March 31, 2026, we had approximately 114.0 million shares of common stock and approximately 20.5 million warrants and options to purchase shares of common stock outstanding. In connection with the February 2026 underwritten offering of securities noted above, we issued 39.6 million shares of common stock along with pre-funded warrants to purchase 6.6 million shares of common stock.

Research and development expenses were $21.4 million for the three months ended March 31, 2026, compared to $14.3 million for the three months ended March 31, 2025, an increase of approximately 50%. The increase in research and development expenses was primarily related to higher personnel costs, including share-based compensation, due to additional headcount to support our ongoing clinical trials, as well as increased spending on contract development and manufacturing organizations, clinical site activities, drug programs and delivery, pipeline studies and consulting.

General and administrative expenses were $7.0 million for the three months ended March 31, 2026, compared to $7.8 million for the three months ended March 31, 2025, a decrease of approximately 10%. The decrease in general and administrative expenses was primarily due to decreased fees for professional and consulting services and fees related to operating as a public company, partially offset by increased personnel costs.

Net loss for the three months ended March 31, 2026, was $26.2 million, or $0.25 per basic and diluted share, compared to a net loss of $18.2 million, or $0.25 per basic and diluted share, for the same period in 2025. During the three months ended March 31, 2026 and 2025, there was a net benefit of $2.1 million and $2.3 million, respectively, in net interest income and other expenses. In addition, during the three months ended March 31, 2025 we recognized $1.4 million of Deferred Income, which was received in 2024.

(Press release, Perspective Therapeutics, MAY 11, 2026, View Source [SID1234665470])

On May 11, 2026 Coherus Oncology, Inc. (Nasdaq: CHRS), reported financial results for the first quarter 2026, and provided an overview of recent business highlights.

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

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

                  Schedule Your 30 min Free Demo!

"We are executing well on our integrated financial, commercial and development strategy that maximizes LOQTORZI’s potential in NPC and in combination with our pipeline products." said Denny Lanfear, Coherus Chairman and Chief Executive Officer. "We also continue to explore opportunities across cancers and non-proprietary novel combinations with tagmokitug, our potentially best-in-class CCR8 Treg depleter, and are encouraged given our previously reported clinical data including anti-tumor activity, safety data, tumor biomarker data and PK data."

"Casdozokitug is the only known clinical stage IL-27 antagonist, and the first line HCC study in combination with LOQTORZI is now fully enrolled. We are tracking to initial data around mid-year." said Rosh Dias, MD, Chief Medical Officer. "The tagmokitug program is also on track, with continued enrollment across all cohorts. We also continue to progress the first-in-class pasritamig combination study in metastatic castration-resistant prostate cancer (mCRPC), which we anticipate initiating in the fall. We are on target for multiple data readouts as planned in 2026."

RECENT BUSINESS HIGHLIGHTS

LOQTORZI (toripalimab-tpzi) Commercial Updates

● LOQTORZI revenue for Q1 2026 was $11.8 million, a 61% increase over $7.3 million in Q1 2025, and a 5% decrease versus the $12.4 million in Q4 2025, driven by the impact of severe weather events in Q1 as well as normal seasonality.
● Encouragingly, Q1 saw the highest volume of new patient starts to date. New patient starts came from increased breadth from new account starts and greater depth from prior ordering accounts. It is important to note that average duration of treatment among existing patients also continued to grow.
● LOQTORZI remains the only FDA-approved and available treatment in the U.S. for recurrent, locally advanced or metastatic nasopharyngeal carcinoma (NPC) representing an estimated overall $250 million addressable market.
● Commercial focus in 2026 is on educating physicians that LOQTORZI is:
o the only approved and available therapy for R/M nasopharyngeal carcinoma;

o the only preferred Category 1 first-line treatment option recommended by the National Comprehensive Cancer Network (NCCN) in combination with cisplatin and gemcitabine; and
o the only preferred subsequent-line treatment recommended by the National Comprehensive Cancer Network (NCCN).
We will continue to appropriately communicate the six-year overall survival (OS) follow-up results from the Phase 3 JUPITER-02 trial evaluating LOQTORZI plus chemotherapy versus chemotherapy alone.

ADVANCEMENT OF INNOVATIVE, NEXT-GENERATION ONCOLOGY PIPELINE

Tagmokitug is a highly selective cytolytic CCR8 antibody that specifically binds and preferentially depletes CCR8+ tumor regulatory T cells (Tregs) with no off-target binding. Preclinical and clinical biomarker research published in Molecular Cancer Therapeutics, show that tagmokitug demonstrates no off-target binding and selectively and significantly eliminates CCR8+ T regulatory cells, with a pronounced increase in intratumoral CD8 T cells, enabling the presence of tumor killing T cells.

● The Phase 1b tagmokitug/toripalimab combination dose optimization studies in 2L HNSCC and 2L upper GI adenocarcinoma cancers are underway, with initial data readouts expected in mid-2026.
● A Phase 1b study evaluating the tagmokitug/toripalimab combination, with and without chemotherapy, in 1L and 2L esophageal squamous cell carcinoma (ESCC), respectively, is underway with a first data readout expected in 2H 2026.
● A Phase 1b/2a study evaluating tagmokitug/toripalimab combination in 4L+ colorectal cancer is enrolling patients and initial data is expected in 2H 2026.
● A Phase 1b clinical study in patients with metastatic castration-resistant prostate cancer (mCRPC) in combination with pasritamig, a T-cell engaging bispecific antibody, is anticipated to begin in the fall of 2026.
Casdozokitug is a first-in-class IL-27 antagonistic antibody currently being evaluated in a Phase 2 study in patients with first line unresectable hepatocellular carcinoma (uHCC) to assess treatment benefit, safety and response biomarkers. Data presented during ASCO (Free ASCO Whitepaper) GI 2025 demonstrated a 38% overall response rate and a 17% complete response rate with the addition of casdozokitug to the current standard of care.

● Enrollment is complete in the randomized Phase 2 trial of casdozokitug/toripalimab/bevacizumab in 1L uHCC and the first data readout is expected in mid-2026.
EQUITY FINANCING

● During the first quarter of 2026, Coherus sold 32,890,000 shares of its common stock in a public offering, including 4,290,000 shares issued pursuant to the exercise of the underwriters’ over-allotment option in full for proceeds of $53.6 million, net of underwriters’ discounts, commissions and offering expenses.
FIRST QUARTER 2026 FINANCIAL RESULTS

Net revenue from continuing operations was $12.3 million and $7.6 million during the three months ended March 31, 2026 and 2025, respectively. LOQTORZI net product revenue increased $4.5 million compared to the three months ended March 31, 2025, driven primarily by volume growth of LOQTORZI.

Cost of goods sold (COGS) from continuing operations was $3.8 million and $2.7 million during the three months ended March 31, 2026 and 2025, respectively. The increase was primarily due to volume growth of LOQTORZI.

Research and development (R&D) expenses from continuing operations were $21.5 million and $24.4 million for the three months ended March 31, 2026 and 2025, respectively. The decrease was primarily due to savings from reduced headcount and lower infrastructure costs, partially offset by increased development costs for casdozokitug.

Selling, general and administrative (SG&A) expenses from continuing operations were $23.1 million and $26.0 million during the three months ended March 31, 2026 and 2025, respectively. The decrease was driven primarily by lower headcount and decreased operating costs resulting from Coherus completing the exit from the biosimilar business in 2025.

Net (loss) from continuing operations for the first quarter of 2026 was $36.9 million, or $(0.27) per share on a diluted basis, compared to a net loss of $47.4 million, or $(0.41) per share on a diluted basis, for the same period in 2025.

Non-GAAP net loss from continuing operations for the first quarter of 2026 was $33.9 million, or $(0.25) per share on a diluted basis, compared to $40.9 million, or $(0.35) per share for the same period in 2025. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net loss from continuing operations and a reconciliation to the most directly comparable GAAP measures.

Cash, cash equivalents and marketable securities totaled $167.0 million as of March 31, 2026, compared to $172.1 million as of December 31, 2025. These balances were inclusive of Transition Service Agreement (TSA)-related collections that will be applied to associated TSA payables and accrued liabilities which totaled $61.6 million and $65.1 million as of March 31, 2026 and December 31, 2025, respectively.

Conference Call Information

When: Monday, May 11, 2026, starting at 5:00 p.m. Eastern Standard Time

To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: View Source

Webcast: View Source

A live and archived webcast will be available on the "Investors" section of the Coherus website at

View Source

Please dial in 15 minutes early to ensure a timely connection to the call.

(Press release, Coherus Oncology, MAY 11, 2026, View Source [SID1234665431])

On May 11, 2026 Aktis Oncology, Inc. (NASDAQ:AKTS) (Aktis or the Company), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large populations, including those not addressed by existing platform technologies, reported financial results and business highlights for the first quarter ended March 31, 2026.

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

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

                  Schedule Your 30 min Free Demo!

"We continue to build momentum toward delivering a new class of radiopharmaceuticals targeting tumor types with large patient populations, leveraging our differentiated miniprotein radioconjugate platform and patient-first end-to-end supply chain," said Matthew Roden, Ph.D., President and Chief Executive Officer of Aktis Oncology. "Last week, we announced the initiation of our Phase 1b clinical trial of AKY-2519 in patients with mCRPC. This is the first of two trials in our clinical development strategy designed to expand the breadth of tumors studied and augment speed to data, with preliminary data from the mCRPC trial anticipated in 2027. We plan to initiate a second Phase 1b basket trial of AKY-2519 in additional solid tumors in the second half of this year. We also look forward to presenting our first AKY-2519 clinical imaging and dosimetry data for AKY-2519 at ASCO (Free ASCO Whitepaper), which informed our clinical development strategy."

Dr. Roden continued, "AKY-2519 marks the second program we have advanced from our proprietary miniprotein radioconjugate platform to the clinic in the last twelve months. In parallel, we continue to enroll patients in our ongoing Phase 1b trial of AKY-1189 targeting Nectin-4 expressing tumors, with preliminary data expected in the first quarter of 2027. We remain focused on generating clinical data intended to support advancement of both programs and maximizing the potential clinical benefit for patients."

Q1 and recent business highlights

AKY-1189 highlights

AKY-1189 is a novel, clinical-stage miniprotein radioconjugate designed to selectively deliver actinium-225 (225Ac) to Nectin-4 expressing tumors.

Received Fast Track designation from the U.S. Food and Drug Administration (FDA) for AKY-1189 for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have progressed on or after prior systemic therapies.
Enrolling patients in the ongoing Phase 1b clinical trial of AKY-1189 in patients with locally advanced or mUC, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer.
Expect to report preliminary data from the Phase 1b trial in the first quarter of 2027.

AKY-2519 highlights

AKY-2519 is a novel, clinical-stage miniprotein radioconjugate designed to selectively deliver 225Ac to B7-H3 expressing tumors, including prostate, lung, and other solid tumors.

Received FDA clearance for the Company’s Investigational New Drug (IND) applications to proceed to a Phase 1b clinical trial with AKY-25191.
Announced two-trial clinical development strategy for AKY-2519, which was informed by insights from the Company’s clinical advisory boards and reflects the distinct treatment patterns and clinical needs of patients with mCRPC compared to other solid tumor patients. This strategy is designed to enable the broad evaluation of AKY-2519 in multiple patient segments while efficiently generating indication-relevant data.
Initiated Phase 1b, multicenter, open label clinical trial of AKY-2519 in PLUVICTO-naïve and PLUVICTO-experienced patients with mCRPC.
Plan to initiate a Phase 1b basket trial in patients with lung, colorectal, and other B7-H3 expressing solid tumors in the second half of 2026. The protocol for this trial has been finalized and is currently under regulatory review.
Announced clinical imaging and dosimetry data for AKY-2519 has been accepted for presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held May 29 – June 2, 2026, in Chicago. The data facilitate initial understanding of AKY-2519 biodistribution and predicted absorbed doses in tumors and normal tissues in patients with B7-H3 expressing solid tumors.
1 IND applications were cleared for [64Cu]Cu-AKY-2519 for imaging and [225Ac]Ac-AKY-2519 for therapeutic use.

General corporate highlights

Appointed industry veteran Glenn Gormley, MD, PhD as an independent director to the Company’s Board of Directors (Board) and as co-chair of the Board’s newly established Science and Technology Committee.
In January 2026, completed an initial public offering of 20,297,500 shares of common stock, including the exercise in full by the underwriters of their option to purchase an additional 2,647,500 shares of common stock, at $18.00 per share, resulting in gross proceeds of approximately $365.4 million, before deducting underwriting discounts and commissions and other offering expenses.

Anticipated pipeline and corporate milestones for the next 12 months

AKY-1189: Expect preliminary data from the ongoing Phase 1b clinical trial in the first quarter of 2027.
AKY-2519:
Will present clinical imaging and dosimetry data of AKY-2519 in patients with mCRPC and various solid tumors at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting.
Expect to commence Phase 1b basket trial in lung, colorectal, and other solid tumor cancers in the second half of 2026.
Expect preliminary data from the Phase 1b mCRPC clinical trial in 2027.
Early pipeline: Two programs are tracking toward development candidate nomination and commencement of IND-enabling activities in the first quarter of 2027.
Corporate: In-house Good Manufacturing Practices (GMP) facility expected to be operational in the second half of 2026 as part of the Company’s hybrid manufacturing strategy to expand capabilities and support clinical supply demand.

First quarter 2026 financial results

Cash position: Cash, cash equivalents and marketable securities were $538.5 million as of March 31, 2026, compared to $226.8 million as of December 31, 2025. The increase of $311.7 million primarily reflects net proceeds from the Company’s initial public offering in January 2026, primarily offset by cash used in operations. The Company’s cash, cash equivalents and marketable securities as of March 31, 2026 are expected to fund its operations into 2029.
Collaboration revenue: Collaboration revenue was $3.2 million for the quarter ended March 31, 2026, compared to $1.4 million for the comparable prior year period. The increase of $1.8 million was attributable to continued advancement of the Company’s research collaboration with Eli Lilly and Company, with revenue recognized over time using the cost incurred input method.
R&D expenses: Research and development expenses were $20.0 million for the quarter ended March 31, 2026, compared to $15.9 million for the comparable prior year period. The increase of $4.1 million was primarily driven by Phase 1b clinical trial expenses for AKY-1189, which initiated in the second quarter of 2025, increased expenses with advancing AKY-2519 through IND-enabling studies, and increased employee-related costs (including stock-based compensation) associated with increased hiring to support the advancing clinical pipeline.
G&A expenses: General and administrative expenses were $5.9 million for the quarter ended March 31, 2026, compared to $3.7 million for the comparable prior year period. The increase of $2.2 million was primarily due to higher employee-related costs (including stock-based compensation) related to increased hiring to support the Company’s growth, and increased expenses associated with operating as a public company.
Net loss: Net loss was $18.3 million for the quarter ended March 31, 2026, compared to $15.0 million for the comparable prior year period. The increase in net loss of $3.3 million was primarily driven by increased operating expenses.

About Aktis’ miniprotein radioconjugate platform
Aktis has developed a proprietary, isotope-agnostic miniprotein radioconjugate platform to selectively deliver the tumor-killing properties of radioisotopes to targeted tumors. Aktis’ therapeutic miniprotein radioconjugates are designed to maximize anti-cancer activity through high tumor penetration coupled with internalization and retention in cancer cells, while rapidly clearing from normal organs and tissues. The Aktis platform further enables clinicians to visualize and verify target engagement with imaging isotopes prior to exposure to therapeutic radioisotopes. Leveraging this platform, and its patient-first end-to-end supply chain, Aktis is advancing a pipeline of next-generation targeted radiopharmaceuticals to address the unmet needs of patients across a broad spectrum of solid tumors.

(Press release, Aktis Oncology, MAY 11, 2026, View Source [SID1234665455])

On May 11, 2026 Elicio Therapeutics, Inc. (Nasdaq: ELTX, "Elicio" or the "Company"), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, reported financial results for the quarter ended March 31, 2026, and provided recent corporate and clinical updates. "We remain focused on advancing the Phase 2 AMPLIFY-7P trial and anticipate reaching the event-driven primary DFS analysis of ELI-002 7P in post-resection KRAS-driven PDAC mid-year 2026," said Robert Connelly, Chief Executive Officer of Elicio. "We are encouraged by the durability of T-cell responses and clinical observations to date, supporting the potential of ELI-002 7P to favorably impact outcomes as monotherapy in the adjuvant PDAC setting. With our cash runway now expected to extend into Q4 2026, beyond the anticipated DFS readout, we believe we are well positioned to execute on this key milestone and further advance our amphiphile ("AMP") platform in KRAS-mutant pancreatic cancer and other indications, with the goal of delivering meaningful long-term value for patients and shareholders."

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

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

                  Schedule Your 30 min Free Demo!

Updates on the AMPLIFY-7P Phase 2 Trial

The event-driven primary DFS endpoint analysis for Elicio’s randomized Phase 2 AMPLIFY-7P trial in post-resection mKRAS PDAC is anticipated mid-year 2026
Fewer disease progressions and deaths than projected to date have been observed in the ongoing 2:1 randomized Phase 2 AMPLIFY-7P trial
The Company remains blinded to the Phase 2 AMPLIFY-7P trial clinical efficacy outcomes
Following completion of the primary DFS endpoint analysis, the Company plans to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration ("FDA") to align on the Phase 3 trial design for ELI-002 7P in resected mKRAS PDAC and to advance ELI-002 7P toward initiation of a registrational study
First Quarter 2026 Financial Results

R&D expenses were $6.8 million for the three months ended March 31, 2026, compared to $7.8 million for the three months ended March 31, 2025. The decrease in R&D expenses was primarily due to lower clinical trial costs as the Phase 2 study of ELI-002 7P continues and the patients moved out of the active dosing phase and into the follow up phase of the trial.

G&A expenses were $3.8 million for the three months ended March 31, 2026, compared to $3.0 million for the three months ended March 31, 2025. The increase in G&A expenses was primarily due to increased Company headcount resulting in increased personnel costs and a slight increase in professional fees.

Net loss was $11.8 million for the three months ended March 31, 2026, compared to $11.2 million for the three months ended March 31, 2025. Net loss for the three months ended March 31, 2026 includes $1.0 million of non-cash other expense primarily resulting from the change in fair value of the warrant liability. Net loss per share for the three months ended March 31, 2026 was $0.65, compared to $0.87 for the three months ended March 31, 2025.

Cash and cash equivalents were $14.9 million as of March 31, 2026, compared to $18.6 million as of December 31, 2025.

The Company raised net proceeds of $8.0 million in Q1 2026 and an additional $5.0 million in Q2 2026 to date, for aggregate net proceeds of approximately $13.0 million, through its established at-the-market program.

The Company expects its current cash and cash equivalents to support planned operations into Q4 2026, beyond the anticipated AMPLIFY-7P Phase 2 event-driven DFS analysis expected mid-year 2026.

ELICIO THERAPEUTICS, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(unaudited)

Three Months Ended March 31
2026 2025
Operating expenses:
Research and development $ 6,757 $ 7,778
General and administrative 3,845 2,958
Total operating expenses 10,602 10,736
Loss from operations (10,602 ) (10,736 )
Total other expense, net (1,221 ) (473 )
Net loss (11,823 ) (11,209 )
Other comprehensive gain:
Foreign currency translation adjustment 5 31
Comprehensive loss $ (11,818 ) $ (11,178 )
Net loss per common share, basic and diluted $ (0.65 ) $ (0.87 )
Weighted average common shares and pre-funded warrants outstanding, basic and diluted 18,211,745 12,950,574

ELICIO THERAPEUTICS, INC.

Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)

March 31, 2026 December 31, 2025
Assets
Cash and cash equivalents $ 14,948 $ 18,563
Other current assets 1,252 748
Total current assets 16,200 19,311
Other assets 6,489 6,551
Total assets $ 22,689 $ 25,862

Liabilities and stockholders’ equity (deficit)
Current liabilities $ 7,229 $ 8,110
Long-term liabilities 16,897 16,116
Total liabilities 24,126 24,226

Total stockholders’ equity (deficit) (1,437 ) 1,636

Total liabilities and stockholders’ equity (deficit) $ 22,689 $ 25,862

(Press release, Elicio Therapeutics, MAY 11, 2026, View Source [SID1234665471])