On May 8, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive, accurate tests for the detection of early-stage lung cancer and other lung diseases, reported financial results for the first quarter ended March 31, 2026.

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Q1 2026 Highlights

● CyPath Lung unit sales increased 146% year-over-year in the first quarter of 2026, reflecting accelerating physician adoption and expanding clinical use of the Company’s noninvasive lung cancer diagnostic.
● CyPath Lung testing revenue increased approximately 114% to $361,000, compared to $169,000 in the first quarter of 2025.
● Total consolidated revenue decreased approximately 27% to $1.4 million, compared to $1.9 million for the first quarter of 2025, resulting from the discontinuation of certain unprofitable pathology services in March 2025 to focus on higher margin services, including CyPath Lung testing.
● The number of physician offices and clinics ordering CyPath Lung increased 69% from first quarter 2025 to the same period in 2026, reflecting continued productivity and expansion of the Company’ sales force and focus on additional strategic markets. The Company expects growth to accelerate throughout 2026, as a result of these commercial initiatives and increasing awareness of the benefits of CyPath Lung.
● The Company launched a large-scale longitudinal clinical trial partially funded by the U.S. Department of Defense to further validate CyPath Lung performance and support establishing the noninvasive test as a standard of care for military and Veterans Administration (VA) medical centers. The trial is expected to include up to 20 clinical sites, including multiple Department of Veterans Affairs medical centers and leading U.S. military hospitals. The John P. Murtha Cancer Center Research Program is providing support and funding for the study at several federal facilities.

● As part of the Company’s commercial strategy to develop companion tests using its diagnostic platform to more precisely target drugs that treat asthma and COPD, bioAffinity Technologies announced that Brooke Army Medical Center, the military’s largest healthcare institution, was conducting a 40-patient collaborative study. The study will use bioAffinity Technologies’ flow cytometry+AI technology to evaluate whether its proprietary platform can detect biologic drug receptors in sputum, including those for dupilumab and benralizumab, to guide personalized therapy selection and monitor patient response over time. The Company presented findings from its early pipeline development activities at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2026 annual meeting.
● Nationally recognized pulmonary and lung cancer experts joined the Company’s Medical and Scientific Advisory Board (MSAB) to provide independent guidance on strategic priorities, including clinical implementation and broader adoption of CyPath Lung. David Ost, MD, MPH, University of Texas MD Anderson Cancer Center, Daniel Sterman, MD, New York University Langone Medical Center, and J. Scott Ferguson, MD, University of Wisconsin School of Medicine and Public Health, were named to the Company’s panel of experts.
● The Company released three additional patient case studies in first quarter 2026 in which CyPath Lung results of "Unlikely Malignancy" helped avoid unnecessary invasive and costly biopsies when other tests suggested the presence of lung cancer in patients at high risk. CyPath Lung test results were confirmed by follow-up imaging that showed stable or resolved lung nodules.

Management Commentary

"Our first quarter results demonstrate continued momentum for CyPath Lung in the marketplace. As more and more physicians adopt CyPath Lung and share their experiences with peers, we see the opportunity to expand our commercial reach and bridge the diagnostic gap between imaging and invasive procedures, especially when dealing with indeterminate nodules in high-risk patients," said Maria Zannes, President and CEO of bioAffinity Technologies. "We are accelerating our marketing strategy to expand access to CyPath Lung and educate healthcare practitioners and patients alike about the need for accurate, objective information to better stratify risk and improve patient outcomes. On April 8, we hosted our first webinar featuring a panel of pulmonologists who shared how they use CyPath Lung in their diverse practices."

Ms. Zannes continued, "Physicians continue to share their case studies in which CyPath Lung has identified lung cancer as early as Stage 1A when it is most treatable and conversely in which a negative CyPath Lung result helped avoid unnecessary invasive procedures. We believe the growing number of case studies and our longitudinal clinical trial, supported by leading military and VA institutions, will lead to broader adoption of CyPath Lung as part of the standard of care."

Ms. Zannes concluded, "We are uniquely positioned to fulfill the need for an accurate, noninvasive diagnostic for lung cancer, particularly when imaging and risk models are inconclusive or turn out to be wrong. The remainder of 2026 will be focused on scaling commercial execution, expanding into new geographic markets, and driving increased utilization of CyPath Lung through continued physician engagement while also leveraging our flow cytometry and AI platform to advance our pipeline of diagnostics for serious or life-threatening lung diseases."

First Quarter 2026 Financial Results

Revenue for the quarter ended March 31, 2026, was $1.4 million. Revenue was primarily generated from patient service fees, histology services, and medical director fees.

Operating expenses for the first quarter of 2026 were $5.0 million, compared with $4.5 million in the first quarter of 2025.

Direct costs and expenses for the first quarter of 2026 were $0.9 million, down 32% from $1.4 million in the prior-year period, primarily due to targeted strategic actions implemented in March 2025. Research and development expenses decreased 5% year-over-year to $350,000, reflecting lower employee compensation and lab supply costs. Clinical development expenses rose to $334,000, driven by higher professional fees supporting the Company’s longitudinal clinical trial strategy.

Selling, general and administrative expenses were $3.2 million for the first quarter of 2026, up from $2.5 million in the same period last year. The increase was primarily driven by higher employee compensation related to administrative and sales functions, reflecting the addition of personnel and support services to scale the commercialization of CyPath Lung.

Net loss for the quarter ended March 31, 2026, was $3.6 million, or $(0.81) per share, compared with a net loss of $2.7 million, or $(4.80) per share, for the first quarter of 202

Cash and cash equivalents as of March 31, 2026, were $3.1 million, compared with $6.4 million as of December 31, 2025.

About CyPath Lung

CyPath Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a clinical trial of high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.

(Press release, BioAffinity Technologies, MAY 8, 2026, View Source [SID1234665383])

On May 8, 2026 Artiva Biotherapeutics, Inc. (Nasdaq: ARTV) (Artiva), a clinical-stage biotechnology company whose mission is to develop effective, safe and accessible cell therapies for patients with debilitating autoimmune diseases, reported financial results for the first quarter ended March 31, 2026, and highlighted recent progress.

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"Artiva has reached an important inflection point, with positive initial clinical data across multiple autoimmune diseases and FDA alignment on a single Phase 3 registrational trial design in refractory RA," said Fred Aslan, M.D., president and chief executive officer of Artiva Biotherapeutics. "The initial RA data demonstrated meaningful responses in highly refractory patients, alongside a tolerability profile supportive of outpatient administration in community rheumatology settings. Together, these data support AlloNK’s potential to become the first deep B-cell depleting therapy to advance into a Phase 3 trial in refractory RA, the autoimmune indication with the largest number of refractory patients."

Dr. Aslan continued, "By combining deep B-cell depletion, meaningful clinical responses and an outpatient profile suited to community rheumatology practices, AlloNK has the potential to redefine the treatment paradigm for patients with refractory autoimmune disease."

Recent Business Highlights

Reported positive initial clinical data from ongoing clinical trials evaluating AlloNK in combination with rituximab across multiple autoimmune diseases

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As of the April 3, 2026 data cutoff, the initial clinical dataset included 21 refractory RA patients with at least 12 weeks of follow-up, including 13 patients with at least six months of follow-up from Artiva’s company-sponsored Phase 2a basket trial and an investigator-initiated basket trial evaluating AlloNK in B-cell driven autoimmune disease. The broader autoimmune dataset also included 11 SjD patients and five SSc patients, including seven SjD patients and four SSc patients with at least six months of follow-up.

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In refractory RA, clinically meaningful improvements were observed across multiple measures of disease activity, including ACR responses, CDAI and DAS28-ESR. Five of seven patients (71%) with six months of follow-up in the company-sponsored Phase 2a basket trial achieved an ACR50 response. Nineteen of 21 RA patients demonstrated clinically meaningful reductions from baseline in both CDAI and DAS28-ESR.

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The AlloNK treatment regimen demonstrated tolerability results supportive of outpatient administration in community rheumatology settings, with no CRS, ICANS or treatment discontinuations related to AlloNK reported as of the data cutoff.

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Deep B-cell depletion was observed across evaluable patients, including complete B-cell depletion using a high-sensitivity assay in all 28 RA patients evaluated as of the data cutoff, supporting AlloNK’s proposed mechanism of action.

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Clinical responses in SjD and SSc were consistent with the RA data and support the potential of AlloNK across B-cell-driven autoimmune diseases.

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More than 70 autoimmune patients have been treated with AlloNK across more than 40 active clinical sites, mostly in community rheumatology settings, providing a strong foundation for planned registrational trial initiation.

Achieved FDA alignment on Phase 3 registrational trial design in refractory RA

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Artiva announced alignment with the FDA on a single Phase 3 registrational randomized controlled trial evaluating AlloNK plus rituximab versus rituximab alone in approximately 150 refractory RA patients, with ACR50 response at six months as the primary endpoint.

Upcoming Milestones

Present AlloNK clinical data at EULAR 2026

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Multiple abstracts accepted for presentation at EULAR 2026, expected to further characterize AlloNK’s mechanism of action, clinical activity and outpatient feasibility, including:

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Late Breaking Oral Abstract Presentation – LB0003: AB-101, an Outpatient-Administered Allogeneic NK Cell Therapy Combined with Rituximab, Generates Robust Clinical Efficacy Responses Comparable with Autologous CAR T in 31 Patients with Rheumatologic Diseases

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Oral Abstract Presentation – OP0129: AB-101, an Allogeneic NK Cell Therapy, Combined with Rituximab was Highly Effective in Severe Sjögren Disease: Experience in First Patient Treated

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Poster View Presentation – POS1177: Robust and Durable Clinical Responses Observed Following Treatment with AB-101, an Allogeneic NK Cell Therapy, Combined with Rituximab in Patients with Severe Rheumatoid Arthritis and Inadequate Response to Multiple Prior Targeted Therapies

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Poster Tour – POS0355: AB-101, an Allogeneic NK Cell Therapy, in Combination with Anti-CD20 Monoclonal Antibodies, Consistently Achieves Deep B-cell Depletion Comparable with CAR T Cell Therapies in Patients with Rheumatologic Diseases

Initiate Phase 3 registrational trial in refractory RA

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In the second half of 2026, Artiva plans to initiate a Phase 3 randomized controlled trial evaluating AlloNK plus rituximab versus rituximab alone in approximately 150 RA patients who have had an inadequate response to two or more biologic or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) of distinct classes, with ACR50 response at six months as the primary efficacy endpoint.

First Quarter 2026 Financial Results

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Cash, Cash Equivalents and Investments. As of March 31, 2026, Artiva had cash, cash equivalents and investments of $86.8 million, which is expected to fund operations into Q2 2027.

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Research and Development Expenses. Research and development expenses were $19.3 million for the three months ended March 31, 2026, compared to $17.1 million for the three months ended March 31, 2025.

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General and Administrative Expenses. General and administrative expenses were $5.1 million for each of the three months ended March 31, 2026 and 2025.

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Other Income, net. Other income, net, was $0.9 million for the three months ended March 31, 2026, compared to other income, net, of $1.9 million for the three months ended March 31, 2025.

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Net Loss. Net loss totaled $23.5 million for the three months ended March 31, 2026, as compared to net loss of $20.3 million for the three months ended March 31, 2025, with non-cash stock-based compensation expense of $1.6 million and $2.1 million for the three months ended March 31, 2026 and 2025, respectively.

(Press release, Artiva Biotherapeutics, MAY 8, 2026, View Source [SID1234665382])

On May 8, 2026 ALX Oncology Holdings Inc. ("ALX Oncology" Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported financial results for the first quarter ended March 31, 2026, and provided a corporate update.

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"We are encouraged by the data presented yesterday at the ESMO (Free ESMO Whitepaper) Breast Cancer 2026 congress, which reinforce the potential of our CD47-inhibitor evorpacept to provide durable responses in patients with HER2-positive cancers that express high levels of CD47," said Jason Lettmann, Chief Executive Officer at ALX Oncology. "Coupled with the previous results from the ASPEN-06 gastric cancer trial, these findings validate our development strategy and reinforce our confidence in the ongoing Phase 2 ASPEN-09-Breast trial. Additionally, we are pleased with the progress of the Phase 1 trial for ALX2004, which remains on track to report dose-escalation safety data this year. With a strengthened balance sheet, we are well-positioned to deliver key data readouts from both ongoing clinical programs."

"It is encouraging to see clinical improvements in patients with heavily pre-treated HER2-positive breast cancer. As the landscape for HER2-positive advanced breast cancer continues to evolve, there remains a clear need for new options once patients’ disease progresses following treatment with currently available therapies, including trastuzumab deruxtecan," said Sara Hurvitz, M.D., Professor, Senior Vice President and Director, Clinical Research Division and Smith Family Endowed Chair in Women’s Health at Fred Hutchinson Cancer Center, University of Washington. "The findings from this Phase 1b/2 trial suggest that combining evorpacept with HER2-targeted agents, guided by CD47 biomarker-driven selection, may offer a promising strategy to address this unmet need."

ALX Oncology Q1 2026 Highlights and Recent Developments

Evorpacept

Data from exploratory analyses in the Phase 1b/2 clinical trial evaluating the company’s investigational CD47-inhibitor evorpacept in combination with Jazz Pharmaceuticals’ zanidatamab (ZIIHERA) in patients with heavily pre-treated metastatic breast cancer (mBC), all of whom had received prior ENHERTU (fam-trastuzumab deruxtecan-nxki) therapy, were presented for the first time in a poster session at the ESMO (Free ESMO Whitepaper) Breast Cancer 2026 congress on Thursday, May 7. The findings show that patients with centrally confirmed HER2-positive (ccHER2-positive) mBC and high CD47 expression experienced promising, durable responses.
The exploratory analyses comprised 24 patients, including 10 with ccHER2-positive disease. Seventeen of 24 samples were evaluable for CD47 expression, including samples from nine of the 10 ccHER2-positive patients. Patients received zanidatamab plus evorpacept at dosages of 20 mg/kg (n=3) or 30 mg/kg (n=21). As of the August 1 2024, data cut-off, key findings from the analyses include:
The confirmed objective response rate (cORR) among all 24 patients was 33% and the median progression free survival (mPFS) was 3.6 months.
Patients with ccHER2-positive disease (n=10) had higher response rates, with a cORR of 60% and mPFS of 8.3 months.
All of the patients (n=5/5) with ccHER2-positive disease and high CD47 expression (defined as total membrane staining of >20%) responded (including one complete response and four partial responses), with a median duration of response (mDOR) of 20.2 months and mPFS of 22.1 months. In comparison, among the patients with ccHER2-positive disease and low CD47 expression (defined as total membrane staining of <20%), cORR was 25% (n=1/4) and mPFS was 3.4 months.
The findings are consistent with previous results from the randomized ASPEN-06 trial in HER2-positive gastric cancer, which indicated CD47 was predictive of evorpacept activity, and support a biomarker-driven approach. Together, these two independent trials suggest that adding evorpacept can yield positive, durable responses in heavily pretreated HER2-positive patients.
The ongoing ASPEN-09-Breast Phase 2 trial evaluating evorpacept plus trastuzumab and physician’s choice of chemotherapy in patients with HER2-positive breast cancer previously treated with ENHERTU is designed to enable this biomarker-driven approach. Enrollment in the trial remains on track globally and the Company expects to provide topline data for 80 patients in mid-2027.

ALX2004

The dose-escalation portion of the Phase 1 trial of ALX2004, a novel antibody-drug conjugate (ADC) for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors, continues to enroll patients at ascending dose levels and is on track to report safety data in 2H 2026.

Corporate Update

In February 2026, the company completed a registered equity offering, selling 76,979,112 shares of common stock at $1.57 per share and pre-funded warrants to purchase 18,574,120 shares of common stock at $1.569 per underlying share. Gross proceeds from the offering were $150 million. Net proceeds of the offering were $140.4 million, after deducting the underwriting discount and other offering expenses.
In April 2026, ALX Oncology appointed Jeff Knight as Chief Development and Operating Officer, strengthening the Company’s development capabilities and operational infrastructure to support high-quality execution and deliver on upcoming milestones. Mr. Knight has more than 30 years of experience across the biopharmaceutical industry, with demonstrated success advancing programs from early development through commercialization, including multiple oncology programs.

Upcoming Clinical Milestones

Phase 2 ASPEN-09-Breast trial: Topline data readout for 80 patients anticipated in mid-2027.
Phase 1 ALX2004 trial: Safety data from the dose-escalation phase of the trial anticipated in 2H 2026.

Q1 2026 Results Conference Call and Webcast Details

ALX Oncology management will host a webcast today, May 8, to provide an overview of Q1 2026 financial results. Sara Hurvitz, M.D., Professor, Senior Vice President and Director, Clinical Research Division and Smith Family Endowed Chair in Women’s Health at Fred Hutchinson Cancer Center; Professor and Head, Division of Hematology and Oncology, Department of Medicine, University of Washington will join the call to discuss and provide perspective on the Phase 1b/2 trial data shared at the ESMO (Free ESMO Whitepaper) Breast Cancer congress.

Date & Time: Friday, May 8, 2026, 8:30 a.m. ET
Guest Speaker: Sara Hurvitz, MD, Head of the Division of Hematology and Oncology, University of Washington
Webcast Access: View Source;tp_key=2800839c82
Participant Listening Options by Phone: To access the conference call, please dial 1-877-407-0752 or +1-201-389-0912 and ask to be joined into the ALX Oncology First Quarter 2026 Financial Results Conference Call.

Another option for instant telephone access to the event is to use the Call Me link below:
View Source;passcode=13755276&h=true&info=company&r=true&B=6

A live audio webcast of the call, along with the ALX Oncology corporate presentation, will be available under "Events & Presentations" in the Investor section of the Company’s website, www.alxoncology.com. An archived webcast will be available on the Company’s website after the event.

First Quarter 2026 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of March 31, 2026, were $169.1 million. The Company believes its cash, cash equivalents and investments are sufficient to fund planned operations through the first half of 2028.
Research and Development ("R&D") Expenses: R&D expenses consist primarily of preclinical, clinical and development costs related to the development of the company’s current product candidates, evorpacept and ALX2004, and R&D personnel-related expenses, including stock-based compensation. R&D expenses for the three months ended March 31, 2026 were $13.6 million compared to $23.9 million for the prior-year period, or a decrease of $10.3 million. This decrease was primarily attributable to a decrease of $4.4 million in personnel and related costs driven by the reduction in workforce in early 2025, a decrease of $2.3 million in clinical and development costs due to change in clinical development strategy reducing the number of active clinical trials, a decrease of $1.8 million in stock-based compensation expense, and a decrease of $1.3 million in preclinical costs due to pipeline prioritization strategy.
General and Administrative ("G&A") Expenses: G&A expenses consist primarily of administrative personnel-related expenses, including stock-based compensation and other costs such as legal and other professional fees, patent filing and maintenance fees, and insurance. G&A expenses for the three months ended March 31, 2026 were $5.4 million compared to $7.9 million for the prior year period, or a decrease of $2.6 million. This decrease was primarily attributable to a decrease of $1.0 million in personnel and related costs driven by the reduction in workforce in early 2025, a decrease of $0.9 million in stock-based compensation expense, and a decrease of $0.7 million in legal and corporate costs.
Net loss: GAAP net loss was ($17.9) million for the three months ended March 31, 2026, or ($0.17) per basic and diluted share, as compared to a GAAP net loss of ($30.8) million for the three months ended March 31, 2025, or ($0.58) per basic and diluted share. The lower net loss is primarily attributed to lower R&D expenses. Non-GAAP net loss was ($15.4) million for the three months ended March 31, 2026, as compared to a non-GAAP net loss of ($25.5) million for the three months ended March 31, 2025. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.

(Press release, ALX Oncology, MAY 8, 2026, View Source [SID1234665381])

On May 8, 2026 AIM ImmunoTech, Inc. (NYSEAM:AIM) ("AIM ImmunoTech" or the "Company"), a late-stage biotechnology company focused on the discovery and development of drugs for the treatment of cancer, reported an agreement between the Company and certain accredited investors to exercise certain outstanding Class A, Class B, Class C, Class D, Class E and Class F Warrants (the "Existing Warrants") to purchase up to an aggregate of 8,719,928 shares of common stock at a reduced exercise price of $0.48 per share for gross proceeds of approximately $4.2 million, before deducting placement agent fees and other estimated offering expenses. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes.

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Ladenburg Thalmann & Co. Inc. acted as the exclusive placement agent for this transaction.

The shares of common stock issuable upon exercise of the Existing Warrants are registered pursuant to registration statements which were filed and declared effective by the Securities and Exchange Commission (the "SEC").

In consideration for the immediate exercise of the Existing Warrants for cash, the exercising holders will receive new unregistered warrants (the "Replacement Warrants") to purchase shares of common stock in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act"). The Replacement Warrants will be exercisable, beginning on the effective date of stockholder approval, into an aggregate of up to 17,439,856 shares of common stock, at an exercise price of $0.60 per share, and a term of exercise equal to five years from the date of stockholder approval.

The offering is expected to close on or about May 8, 2026, subject to satisfaction of customary closing conditions.

The Replacement Warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the 1933 Act and, along with the shares of common stock issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the Replacement Warrants.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

(Press release, AIM ImmunoTech, MAY 8, 2026, View Source [SID1234665380])

On May 8, 2026 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, reported that on Thursday May 14, 2026, at 9:35 AM PT, Aclaris’ President and Chief Operating Officer Dr. Hugh Davis will provide a corporate presentation during the 2026 Bank of America Healthcare Conference in Las Vegas, NV.

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A live and archived webcast of this event will be accessible on the Events page of the Aclaris website, www.aclaristx.com. The webcast will be available on the Aclaris website for at least 30 days.

(Press release, Aclaris Therapeutics, MAY 8, 2026, View Source [SID1234665379])