On August 12, 2026 Aptevo Therapeutics Inc. (NASDAQ:APVO) ("Aptevo" or the "Company"), a clinical-stage biotechnology company developing novel multispecific immuno-oncology therapeutics, reported it has entered into warrant inducement letter agreements with certain holders of its existing common warrants (the "Existing Warrants"), pursuant to which such holders have agreed to exercise in full for cash their Existing Warrants to purchase up to an aggregate of 254,922 shares of common stock of the Company ("common stock") at a reduced exercise price of $4.03 per share. In consideration for such cash exercises, the Company will issue new unregistered common stock purchase warrants (the "Inducement Warrants") to purchase up to an aggregate of 1,274,610 shares of common stock at an exercise price of $4.03 per share. The Inducement Warrants will be exercisable on or after the date on which the Company obtains the required stockholder approval and will expire five years after their initial exercise date. The shares of common stock issuable upon exercise of the Existing Warrants are registered pursuant to effective registration statements on Form S-1 (File No. 333-288061),Form S-1MEF (File No. 333-288134), Form S-3 (File No. 333-284969) and Form S-3 (File No. 333-283983).

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Separately, pursuant to a securities purchase agreement, the Company agreed to sell to certain purchasers in a private placement (the "PIPE") up to 861,708 unregistered shares of common stock (the "Shares") at a purchase price of $4.03 per share (or, at a purchaser’s election to comply with a 4.99% or 9.99% beneficial ownership limitation, pre-funded common stock purchase warrants (the "Pre-Funded Warrants") to purchase up to 861,708 shares in lieu of such shares), together with common stock purchase warrants (the "Common Warrants") to purchase up to 4,308,540 shares of common stock at an exercise price of $4.03 per share. The Pre-Funded Warrants will be exercisable immediately and will expire upon exercise in full, and the Common Warrants will be exercisable on or after the date on which the Company obtains the required stockholder approval and will expire five years after their initial exercise date (together, the "PIPE Warrants").

The aggregate gross proceeds from the transactions described herein are expected to total approximately $4.5 million, before deducting placement agent fees and expenses.

Roth Capital Partners, LLC is acting as the Company’s exclusive placement agent in connection with these transactions.

The transactions are expected to close on or about August 13, 2026, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the transactions for working capital purposes.

The Inducement Warrants, the Shares, the Pre-Funded Warrants and the Common Warrants described above were offered in private placement transactions pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act"), and Rule 506 promulgated thereunder, as applicable, and, along with the shares of common stock issuable upon exercise of the Inducement Warrants, the Pre-Funded Warrants and the Common Warrants, have not been registered under the 1933 Act and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the SEC covering the resale of the Shares and the shares of common stock issuable upon exercise of the Inducement Warrants, the Pre-Funded Warrants and the Common Warrants.

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

(Press release, Aptevo Therapeutics, AUG 12, 2026, View Source [SID1234670023])

On August 12, 2026 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported financial results for the second quarter 2026 and business updates.

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"This was an important quarter for Atara. We and our partners, Pierre Fabre Pharmaceuticals (PFP), had a productive Type A meeting with the FDA where we confirmed the opportunity to resubmit the tabelecleucel BLA based on the existing Phase 3 single arm ALLELE trial. We are actively working with and supporting PFP in a resubmission that includes an updated dataset with additional patients and longer follow-up. Patients are still dying from EBV-driven PTLD, and we remain fully committed to ensuring that they have access to this new medicine," said Cokey Nguyen, President and Chief Executive Officer of Atara. "We continue to believe that tab-cel has significant commercial potential in the US, and we have taken steps to control expenses with the goal of protecting and maximizing shareholder value and enhancing our strategic flexibility."

Tabelecleucel (tab-cel or EBVALLO) for Post-Transplant Lymphoproliferative Disease (PTLD)

As previously communicated, PFP has indicated they intend to submit an updated dataset with additional patients and longer follow-up from the pivotal Phase 3 single arm ALLELE study as well as supportive data. Atara anticipates providing a further regulatory update later this quarter.

Under its commercialization agreement with Pierre Fabre Laboratories, Atara is eligible to receive a $31 million milestone payment upon FDA approval of the tabelecleucel BLA, as well as significant double-digit tiered royalties as a percentage of net sales, and milestones related to commercial sales of EBVALLO.

Second Quarter 2026 Financial Results:

Cash, cash equivalents and short-term investments as of June 30, 2026, totaled $9.9 million, as compared to $8.4 million as of March 31, 2026.
Net cash used in operating activities was $3.3 million for the second quarter 2026, as compared to $7.4 million in the same period in 2025.
Total revenues were $0.6 million for the second quarter 2026, as compared to $17.6 million for the same period in 2025. Total revenues decreased by $17.0 million year-over-year, primarily due to the accelerated recognition of deferred revenue in 2025 following the transition of development activities to Pierre Fabre Laboratories. As a result, less deferred revenue remained available for recognition in the comparative period.
Total costs and operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of $0.4 million for the second quarter 2026, as compared to $3.0 million for the same period in 2025.
Research and development expenses were $1.3 million for the second quarter 2026, as compared to $7.3 million for the same period in 2025.
Research and development expenses include $0.1 million of non-cash stock-based compensation expenses for the second quarter 2026, as compared to $0.7 million for the same period in 2025.
General and administrative expenses were $3.8 million for the second quarter 2026, as compared to $6.5 million for the same period in 2025.
General and administrative expenses include $0.3 million of non-cash stock-based compensation expenses for the second quarter 2026, as compared to $2.1 million for the same period in 2025.
Atara reported a net loss of $4.8 million, or ($0.32) basic and diluted loss per share, for the second quarter 2026, as compared to net income of $2.4 million, or $0.20 basic earnings per share and $0.19 diluted earnings per share, for the same period in 2025.
2026 Outlook and Cash Runway:

Operating expenses are expected to decline significantly year-over-year, reflecting the full-year benefit of cost-reduction initiatives implemented in 2025 and first half of 2026.
Atara expects its cash, cash equivalents, and short-term investments as of June 30, 2026, combined with operating efficiencies achieved in 2025 and first half of 2026, will be sufficient to fund planned operations into mid-2027.

(Press release, Atara Biotherapeutics, AUG 12, 2026, View Source [SID1234670002])

On August 12, 2026 Azitra, Inc. ("Azitra" or the "Company") (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology and high value cosmetic proteins and peptides, reported financial results for the quarter ended June 30, 2026, and provided a business update.

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Q2 2026 and Recent Business Highlights

Reported the first preclinical data from ATR-COSF demonstrating breakthrough repeat-dose distribution, controlled delivery into targeted skin layers and anti-wrinkle activity in ex vivo human skin, supporting advancement toward a planned proof-of-concept clinical study.
Continued enrollment of the first cohort in the Phase 1/2 clinical trial evaluating ATR-04 for EGFR inhibitor-associated rash.
Continued advancement of recombinant protein initiatives, including Tobacco Etch Virus (TEV) Protease and T7 RNA Polymerase, expanding the Company’s platform into biotechnology research and manufacturing applications.
Issued CEO Letter to Shareholders detailing Azitra’s expanded strategy to leverage its proprietary microbial genetic engineering platform across therapeutics, cosmetic ingredients and biotechnology products.
"The second quarter has marked an exciting evolution for Azitra with the first data from our ATR-COSF program, which provided validation of our strategy to leverage our microbial genetic engineering platform beyond traditional therapeutics," said Francisco Salva, Chief Executive Officer of Azitra. "Combined with the continued advancement of ATR-04 and our recombinant protein initiatives, these accomplishments reflect the breadth of opportunities we are creating in multiple billion dollar markets, including therapeutics, cosmetic ingredients and biotechnology applications."

Salva continued: "Our ATR-COSF program continues to excite our team, as it represents one of the first to demonstrate the wrinkle reducing potential of recombinant filaggrin ingredient in ex vivo human skin. It shows Azitra’s ability to translate our cutting edge science into observable benefits for consumers. The ATR-COSF program represents our first step in unlocking meaningful value for shareholders while positioning Azitra at the intersection of synthetic biology, artificial intelligence and next-generation biological manufacturing.

"During the quarter, we also continued enrollment of the first cohort in our Phase 1/2 clinical trial evaluating ATR-04 for EGFR inhibitor-associated rash. With six active clinical sites, including MD Anderson Cancer Center, we remain on track to report topline data from the first cohort around year end. Additionally, we are in the process to open eligibility criteria to other cancer treatment related rashes driven by inhibitors along the same EGFR/KRAS/MEK/ERK pathway. EGFR inhibitor-associated rash remains a significant unmet medical need, affecting an estimated 50% to 90% of patients receiving EGFR-targeted cancer therapies and frequently leading to dose reductions, treatment interruptions or discontinuation."

Salva concluded: "Looking ahead, we remain focused on implementing the strategy outlined in our recent shareholder letter. That includes advancing ATR-COSF toward a planned proof-of-concept clinical study, continuing development of our recombinant protein portfolio, including TEV Protease and T7 RNA Polymerase, and progressing ATR-04 as our lead clinical therapeutic program. We believe these initiatives position Azitra to unlock the full potential of our platform while creating multiple avenues for long-term growth and shareholder value."

Pipeline Achievements and Upcoming Milestones

ATR-COSF – New Consumer Initiative to Improve the Appearance of Fine Lines and Wrinkles

Results from synthesized filaggrin ingredients, repeat application study on explanted cosmetic surgery skin.
Announced positive preclinical data demonstrating breakthrough repeat-dose delivery and distribution together with anti-wrinkle activity in ex vivo human skin, supporting advancement toward a planned proof-of-concept cosmetic study evaluating the safety and efficacy of ATR-COSF.
Human cosmetic application study planned to start in Q3 2026.
ATR-04 – Addressing an Unmet Need for Cancer Patients in a Billion Dollar Market Opportunity

Continued enrollment of the first cohort of the ongoing Phase 1/2 clinical trial evaluating ATR-04 for the treatment of EGFRi-associated rash.
Topline data from first cohort of Phase 1/2 trial expected in Q4-2026.
Recombinant Protein Platform

Announced plans to advance development of its recombinant protein portfolio, including TEV Protease and T7 RNA Polymerase.
Platform provides opportunity to develop high-quality recombinant proteins for biotechnology research and manufacturing applications, representing potential opportunities to leverage its microbial genetic engineering expertise while broadening its long-term commercial potential.
ATR-12 – Advancing Phase 1b Clinical Trial in Netherton Syndrome

Consistent with the priorities outlined in the Company’s recent shareholder letter, Azitra plans to strategically pause further enrollment in the ongoing Phase 1b study evaluating ATR-12 for Netherton syndrome.
This decision reflects the Company’s disciplined approach to capital allocation and its focus on advancing programs with the greatest near-term opportunities for clinical, commercial and shareholder value creation.
Financial Results for the Quarter Ended June 30, 2026

Research and Development (R&D) expenses: R&D expenses for the quarter ended June 30, 2026, were $1.4 million compared to $1.4 million for the comparable period in 2025.
General and Administrative (G&A) expenses: G&A expenses for the quarter ended June 30, 2026, were $2.1 million compared to $1.5 million for the comparable period in 2025.
Net Loss was $3.3 million for the quarter ended June 30, 2026, compared to $2.9 million for the comparable period in 2025.
Cash and cash equivalents: As of June 30, 2026, Azitra had cash and cash equivalents of $6.7 million.

(Press release, Azitra, AUG 12, 2026, View Source [SID1234670024])

On August 12, 2026 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, reported an update on the regulatory status of its two lead drug candidates, Piclidenoson and Namodenoson. Both drug candidates are being advanced in Phase III clinical development programs under regulatory frameworks established with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), providing defined regulatory pathways toward potential marketing approval.

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Namodenoson, Can-Fite’s orally administered A3 adenosine receptor (A3AR) agonist, is currently being evaluated in a pivotal Phase III study for the treatment of patients with advanced liver cancer, hepatocellular carcinoma (HCC) and underlying Child-Pugh B7 liver cirrhosis. The Phase III study is being conducted under regulatory guidance from both the FDA and EMA and is designed to support potential marketing authorization applications in the United States and Europe, if the study meets its predefined efficacy and safety endpoints.

Piclidenoson, Can-Fite’s oral A3AR agonist for inflammatory diseases, is currently being evaluated in a Phase III clinical program for the treatment of moderate-to-severe plaque psoriasis.

Can-Fite’s clinical development strategy is focused on advancing its lead drug candidates through late-stage clinical development under regulatory pathways established with leading regulatory authorities.

Namodenoson’s FDA Fast Track and FDA and EMA Orphan Drug designations provide additional regulatory advantages as the Company advances its pivotal HCC program, while Piclidenoson is progressing through Phase III development in psoriasis.

Can-Fite believes that the advanced regulatory status of both programs significantly strengthens the Company’s late-stage clinical pipeline and provides a clear framework for advancing Piclidenoson and Namodenoson toward potential regulatory submissions and commercialization.

"Can-Fite has reached an important stage in its development, with both of our lead drug candidates in Phase III programs and with established regulatory pathways in the United States and Europe," stated Dr. Pnina Fishman, Can-Fite’s Chief Scientific Officer and Executive Chairperson. "Namodenoson’s Fast Track and Orphan Drug designations, together with our ongoing pivotal Phase III HCC study, and the Phase III development of Piclidenoson in psoriasis, demonstrate the maturity of our clinical pipeline. We believe these regulatory achievements provide greater clarity regarding the development and potential approval pathways for our drug candidates and bring us closer to our goal of delivering new oral therapies to patients with significant unmet medical needs."

(Press release, Can-Fite BioPharma, AUG 12, 2026, View Source [SID1234670003])

On August 12, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the China National Medical Products Administration (NMPA) has approved the supplemental New Drug Application (sNDA) for ivonescimab injection in combination with chemotherapy for the first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC).

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The approval of ivonescimab combination therapy as a first-line treatment for squamous NSCLC marks the third lung cancer indication for ivonescimab. In a randomized, double-blind Phase III trial, this regimen demonstrated statistically significant improvements in both progression-free survival (PFS) and overall survival (OS) compared with a PD-1 inhibitor plus chemotherapy. These results establish a new first-line standard of care for squamous NSCLC and mark a major milestone in the treatment of lung cancer worldwide.

This latest approval is supported by the breakthrough results from the Phase III HARMONi-6/AK112-306 study. The positive OS data were presented in a Plenary Session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, the first time a China-originated novel therapy has been featured in an ASCO (Free ASCO Whitepaper) Plenary Session. The full results were simultaneously published in The Lancet. The positive PFS results were previously presented in a Presidential Symposium at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, with the full paper concurrently published in The Lancet as well.

The HARMONi-6 study enrolled a total of 532 patients. Approximately 63% had centrally located squamous tumors, 39.0% had PD-L1 TPS <1%, and 33.8% had multi-site metastases, liver metastases, or brain metastases. The study met all primary and secondary endpoints, demonstrating clinically meaningful and statistically significant improvements in both PFS and OS, with a favorable safety profile.

Key findings from the HARMONi-6 study:

Ivonescimab plus chemotherapy significantly prolonged OS. Ivonescimab plus chemotherapy reduced the risk of death by 34% versus tislelizumab plus chemotherapy (HR=0.66 [95% CI: 0.50-0.87], P=0.0017). Median OS was 27.9 months in the ivonescimab arm versus 23.7 months in the control arm. The 12-month OS rate was 78.9% with ivonescimab plus chemotherapy versus 72.2% in the control arm, and the 24-month OS rate was 64.7% versus 48.6%, respectively. The survival benefit continued to widen over time, reflecting a more durable and clinically meaningful long-term survival advantage compared with PD-1 inhibitor plus chemotherapy.
At the prespecified interim analysis for PFS, ivonescimab plus chemotherapy had already demonstrated a clinically meaningful and statistically significant improvement in PFS compared with tislelizumab plus chemotherapy, with a median PFS of 11.1 months versus 6.9 months (HR=0.60 [95% CI: 0.46-0.78], P<0.0001).
Consistent and substantial OS benefit was observed across all prespecified subgroups, regardless of PD-L1 expression levels or metastatic burden.
The overall safety profile of the ivonescimab combination was favorable and comparable to that of the control arm.
Professor Shun Lu, Principal Investigator of HARMONi-6, Director of the Oncology Department, Shanghai Chest Hospital:

"We are highly encouraged by the dual-positive PFS and OS results from HARMONi-6 and proud to see the approval of ivonescimab plus chemotherapy for first-line sq-NSCLC. By outperforming PD-1 plus chemotherapy, this regimen has rewritten the gold standard of care and represents a landmark advance in the treatment of lung cancer.

HARMONi-6 provides clear evidence that compared to PD-1 plus chemotherapy, the ivonescimab treatment significantly prolongs both OS and PFS, reduces the risks of death and disease progression, delivers consistent benefit across subgroups, and helps patients maintain better quality of life for longer. These findings fully demonstrate the breakthrough clinical value of the PD-1/VEGF bispecific mechanism and the strengths of this next-generation immuno-oncology therapy. The regimen also overcomes the previous limitation that anti-angiogenic agents could not be used in sq-NSCLC, filling an important clinical gap.

Ivonescimab combination therapy offers patients a new, more effective and safer treatment option, bringing particular hope to those with squamous cell carcinoma who have had limited choices. This is what we as clinicians and patients have long been waiting for. We look forward to seeing ivonescimab continue to deliver strong results globally and help reshape cancer treatment worldwide."

Dr. Xia Yu, Founder, Chairwoman, President and CEO of Akeso:

"We are incredibly pleased by the approval of ivonescimab plus chemotherapy for first-line advanced squamous NSCLC. This approval marks a critical milestone in the development of next-generation immuno-oncology therapies worldwide. We sincerely thank all the investigators, patients, and regulatory authorities who made this possible. Since its inception, ivonescimab’s every advance has drawn significant global attention and is recognized as a benchmark therapy poised to shape the pharmaceutical landscape from 2026 onward and redefine treatment paradigms. With robust dual-positive PFS and OS data, it has successfully challenged PD-1 plus chemotherapy, rewritten the first-line standard of care for squamous NSCLC, and established a new benchmark for clinical benefit.

Currently, ivonescimab stands as the cornerstone of Akeso’s IO2.0 + ADC2.0 strategy. We are advancing a portfolio of highly differentiated therapies that continue to elevate and reshape the global treatment landscape in major cancers such as lung and breast cancer. This work includes extensive combination studies with our proprietary next-generation ADCs and bispecific ADCs, as well as partnerships with multiple high-potential ADC candidates from collaborators around the world. The breakthrough results from HARMONi-6 further strengthen our confidence in ivonescimab’s transformative clinical value and its potential for even greater success worldwide. Together with Summit, we are committed to bringing the full value of ivonescimab to patients worldwide."

Previously, in patients with advanced non-squamous NSCLC who had progressed on EGFR-TKI therapy, the HARMONi-A study of ivonescimab became the first immunotherapy trial to demonstrate clinically meaningful and statistically significant improvements in both PFS and OS. In the Phase III HARMONi-2 study, first-line ivonescimab delivered a median PFS of 11.14 months in PD-L1-positive NSCLC, compared with 5.8 months for pembrolizumab, making it the first drug to demonstrate a positive Phase III result against the leading PD-1 therapy.

These results position ivonescimab as a cornerstone of the immuno-oncology 2.0 era. Across comparisons with PD-1 monotherapy, PD-1 plus chemotherapy (the current optimal standard of care in many tumors), and VEGF-targeted therapies, ivonescimab has shown clear clinical advances and a strong capacity to improve upon existing treatment options.

(Press release, Akeso Biopharma, AUG 12, 2026, View Source [SID1234670025])