On November 12, 2026 Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biotechnology company advancing next-generation, half-life-extended multispecific antibodies, reported financial results for the third quarter ended September 30, 2026, and provided a business update.

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In October, Bolt completed its acquisition of Prana Therapies in a sign-and-close, stock-for-stock reverse merger and closed a concurrent $120 million private placement financing with leading healthcare institutional investors. Following the transaction, Prana’s pipeline became the primary development focus of the company, led by flagship program PRA-216, an IL-4Rα/TSLP bispecific antibody in Phase 2 development across multiple high-value inflammatory indications. In connection with the transaction, Sheila Gujrathi, M.D., Co-Founder and former Chief Executive Officer of Prana, was appointed Chief Strategy Officer of Bolt and joined the company’s Board of Directors.

"The transaction and financing provide us with the capital and public-company foundation to advance PRA-216 and the broader INSPIRE pipeline through what we believe will be an exciting and highly data-rich period ahead," said Sheila Gujrathi, M.D., Chief Strategy Officer of Bolt Biotherapeutics. "PRA-216 is our flagship program and the first clinical validation of the INSPIRE platform. It is now in Phase 2 development in asthma, COPD and atopic dermatitis, with an additional study planned in eosinophilic esophagitis, and we expect patient proof-of-concept data across all four studies beginning in the second quarter of 2027. These studies will evaluate the potential of PRA-216 to move beyond the efficacy ceiling of single-mechanism therapies by combining complementary IL-4Rα and TSLP inhibition, while offering the potential convenience of infrequent, at-home dosing. Beyond PRA-216, we look forward to advancing additional wholly owned programs from INSPIRE as we work to build a new generation of differentiated multispecific therapies."

"Completing the Prana acquisition marks an important transformation for Bolt," said Willie Quinn, President and Chief Executive Officer of Bolt Biotherapeutics. "With a strong balance sheet, an advanced clinical program and a differentiated platform, we believe we are well positioned to execute against the important milestones ahead."

Third Quarter 2026 Financial Results

•
Cash and Financing– In October 2026, subsequent to the end of the third quarter, Bolt completed a private placement financing resulting in approximately $120 million in gross proceeds. The financing is expected to fund the company’s operations into 2028 and through multiple anticipated clinical and preclinical milestones.
•
Collaboration Revenue – Total collaboration revenue was zero for the quarter ended September 30, 2026, compared to $2.2 million for the same quarter in 2025. Revenue in the comparative periods was generated from services performed under the R&D collaborations as we fulfill our performance obligations.
•
Research and Development (R&D) Expenses – R&D expenses were $2.2 million for the quarter ended September 30, 2026, compared to $6.5 million for the same quarter in 2025. The decrease between the comparable periods was mainly due to a R&D tax incentive, a decrease in salary and related expenses primarily as a result of our restructuring, and overall lower research and development activities.
•
General and Administrative (G&A) Expenses – G&A expenses were $2.5 million for the quarter ended September 30, 2026, compared to $3.3 million for the same quarter in 2025. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses primarily as a result of our restructuring as well as lower personnel expenses.
•
Loss from Operations – Loss from operations was $4.7 million for the quarter ended September 30, 2026, compared to $7.7 million for the same quarter in 2025.
Subsequent Events

•
Merger with Prana Therapies: Bolt acquired Prana on October 23, 2026 through the issuance of 430,746 shares of common stock and 16,360.929 shares of Series D non-voting preferred stock, each share of which is convertible into 1,000 shares of Common Stock. Bolt will call and hold stockholders’ meetings as soon as practicable to approve the conversion of the Series D Preferred Stock into Common Stock, and other matters as specified in the Merger Agreement. Bolt will provide the disclosures required by ASC 805, Business Combinations, once they are ready and no later than January 8, 2027.
•
Private Placement: Concurrent with the acquisition of Prana, Bolt sold and issued 13,995.311 shares of Series D Preferred Stock and accompanying warrants for aggregate gross proceeds of $120.0 million (not including any cash proceeds that may be received upon the exercise of such warrants), before deducting placement agent fees and other offering expenses.
•
Shares Outstanding: After the acquisition of Prana and the Private Placement, subject to stockholder approval of the conversion of the Series D non-voting convertible preferred stock, Bolt is expected to have approximately 34.2 million shares of common stock outstanding on an as-converted basis, before giving effect to the exercise of the PIPE warrants
•
Lease Termination: Following the October 2026 acquisition of Prana, the Chesapeake Master Lease has been terminated with an effective lease expiration date of January 1, 2027.

(Press release, Bolt Biotherapeutics, NOV 12, 2026, View Source [SID1234674667])

On November 12, 2026 Ascendis Pharma A/S (Nasdaq: ASND) reported financial results for the third quarter ended September 30, 2026, and provided a business update.

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"By always putting patients first, Ascendis has delivered three consecutive approved rare endocrine therapies that are the foundation of our transformation into a leading global biopharmaceutical company," said Jan Mikkelsen, President and Chief Executive Officer of Ascendis Pharma. "With many label expansion programs, new country launches, and the capabilities to reach patients worldwide and develop new products efficiently, we are well positioned to deliver durable long-term growth."

Select Highlights & Anticipated Milestones

•
YORVIPATH

(palopegteriparatide, developed as TransCon PTH)

•
YORVIPATH revenue for the third quarter of 2026 totaled €291 million (+103% Y/Y).

•
In the U.S., new patient demand was consistent with prior quarters. Outside the U.S., new patient demand accelerated through new commercial launches. YORVIPATH is now available commercially or through named patient programs in more than 40 countries.

•
Presented data from pooled analysis of Phase 2 PaTH Forward and Phase 3 PaTHway trials at ASN 2026 demonstrating sustained, clinically meaningful improvements in kidney function in adults with hypoparathyroidism treated with TransCon PTH for up to five years.

•
Results from the Phase 3 PaTHway China and PaTHway Japan trials evaluating TransCon PTH in adults with hypoparathyroidism demonstrated efficacy and safety findings consistent with those reported in the pivotal Phase 3 PaTHway Trial, reinforcing the consistency of results across geographies and ethnicities.

•
SKYTROFA

(lonapegsomatropin, developed as TransCon hGH)

•
SKYTROFA revenue for the third quarter of 2026 totaled €59 million.

•
Ongoing Phase 3 HighLiGHts basket trial across a range of established growth hormone indications: idiopathic short stature (ISS), SHOX deficiency, Turner syndrome, and small for gestational age (SGA). Completion of enrollment anticipated in the first half of 2027.

•
YUVIWEL

(navepegritide, developed as TransCon CNP)

•
YUVIWEL revenue for the third quarter of 2026 totaled €16 million.

•
In the U.S., approximately 340 unique YUVIWEL patient enrollments by nearly 150 prescribing healthcare providers, with more than 80% of enrollments approved for reimbursement through October 31, 2026.

•
In the EU, received positive CHMP and COMP opinions recommending marketing authorization as a treatment of achondroplasia in children and maintenance of orphan medicinal product designation, respectively, for once-weekly TransCon CNP. Final EC decision expected during the Q4 2026 with first EU launch planned in Germany in Q1 2027.

•
In select international markets, YUVIWEL is being made available through early access programs, and Ascendis expects to recognize revenue from multiple countries outside of the U.S. and EU in the coming quarters.

•
Presented infant sentinel cohort Week 52 data from the reACHin Trial at ESPE 2026, showing that treatment with once-weekly TransCon CNP stabilized or improved foramen magnum stenosis (a skull bone narrowing that can lead to brain stem and spinal cord compression), as well as linear growth benefits, in infants with achondroplasia aged 0 to <2 years. Pivotal data expected Q3 2027.

•
Expect to enroll first patients in Phase 3 trial evaluating TransCon CNP monotherapy in children with hypochondroplasia in Q4 2026. Expect to initiate a Phase 2 trial in adults with achondroplasia in Q4 2026.

•
TransCon CNP + TransCon hGH Combination Therapy

(navepegritide plus lonapegsomatropin)

•
Following presentation of additional Week 78 data from the Phase 2 COACH Trial at ASBMR 2026 showing durable increase in healthy, proportional growth in children with achondroplasia, 100% of the 21 enrolled children remain on therapy to date.

•
Initiated Phase 3 cAtCH Trial in children with achondroplasia; expect to complete enrollment in Q2 2027.

Key Financial Highlights

•
Total product revenue for the third quarter of 2026 increased to €366 million, reflecting year-over-year growth of +89%.

•
Total revenue for the third quarter of 2026 was €370 million.

•
Operating profit for the third quarter of 2026 totaled €125 million, reflecting a margin of 34%. On a non-IFRS basis, operating profit was €156 million*, reflecting a margin of 42%*.

•
Net profit for the third quarter of 2026 totaled €74 million, or €1.08 per diluted share. On a non-IFRS basis, net profit was €117 million*, or €1.71 per diluted share*.

•
Cash flow from operating activities was €189 million for the third quarter of 2026; expect full year 2026 cash flow from operating activities of at least €600 million.

•
As of September 30, 2026, cash and cash equivalents totaled €964 million, compared to cash and cash equivalents of €616 million as of December 31, 2025.

•
Through September 30, 2026, repurchased 794,304 Ascendis ordinary shares for total consideration of $186 million.

•
Year to date through November 11, 2026, repurchased 1,998,999 Ascendis ordinary shares for total consideration of $459 million.

*
See "Non-IFRS Financial Measures" below for definitions of these non-IFRS measures and a reconciliation to the most directly comparable IFRS measures.

Third Quarter 2026 Financial Results

Total revenue for the third quarter of 2026 was €370 million, compared to €214 million during the same period in 2025. The year-over-year increase in revenue was primarily attributable to the continued growth of YORVIPATH global sales.

Total Revenue
(In EUR’000s) Three Months Ended
September 30, Nine Months Ended
September 30,
2026 2025 2026 2025
Revenue

Commercial products

365,690 193,790 921,452 443,480
Other revenue

Milestones

—  12,922 17,046 12,922
Licenses, services and clinical supply

3,967 6,922 17,045 16,230

Total revenue

369,657 213,634 955,543 472,632

Revenue from Commercial Products
(In EUR’000s) Three Months Ended
September 30, Nine Months Ended
September 30,

2026 2025 2026 2025
Revenue from commercial products

YORVIPATH

290,626 143,089 739,634 290,735
SKYTROFA

59,424 50,701 158,595 152,745
YUVIWEL

15,640 —  23,223 — 

Total revenue from commercial products

365,690 193,790 921,452 443,480

Research and development expenses for the third quarter of 2026 were €70 million, compared to €67 million during the same period in 2025. The increase was due to increased clinical trial activities within the Endocrinology Rare Disease pipeline, partially offset by reduced clinical trial activities within Oncology.

Selling, general, and administrative expenses for the third quarter of 2026 were €147 million, compared to €113 million during the same period in 2025. The increase was primarily due to the continued commercial expansion, including global launch activities.

Total operating expenses for the third quarter of 2026 were €217 million, compared to €180 million during the same period in 2025.

Operating profit for the third quarter of 2026 was €125 million, reflecting a margin of 34%, compared to €11 million, reflecting a margin of 5% during the same period in 2025. The increase was primarily driven by higher revenue from the continued growth of YORVIPATH global sales, partially offset by higher operating expenses associated with global commercial expansion.

Net finance expenses for the third quarter of 2026 were €4 million, compared to €61 million in the same period in 2025. The change was primarily driven by non-cash items.

Net profit for the third quarter of 2026 was €74 million, or €1.13 per basic share and €1.08 per diluted share, compared to a net loss of €61 million, or €1.00 per basic and diluted share, for the same period in 2025.

Cash flows from operating activities for the nine months ended September 30, 2026, were €463 million compared to €20 million used in operating activities during the same period in 2025. The improvement was primarily attributable to commercial revenue growth and net proceeds from the sale of the PRV of €158 million (net of transaction costs), partially offset by less favorable changes in working capital of approximately €15 million and higher interest and income taxes paid.

As of September 30, 2026, Ascendis Pharma had 66,400,738 ordinary shares outstanding, of which 805,528 were held as treasury shares.

For the third quarter of 2026, non-IFRS operating profit was €156 million*, compared to a non-IFRS operating profit of €42 million* for the same period in 2025.

For the third quarter of 2026, non-IFRS net profit was €117 million*, or €1.71 earnings per diluted share*, compared to a non-IFRS net profit of €24 million*, or €0.40 earnings per diluted share*, for the same period in 2025.

Conference Call and Webcast Information

Ascendis Pharma will host a conference call and webcast today at 8:00 a.m. Eastern Time (ET) to discuss its third quarter 2026 financial results. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at View Source A replay of the webcast will be available in this section of the Ascendis Pharma website shortly after the conclusion of the event for 30 days.

(Press release, Ascendis Pharma, NOV 12, 2026, View Source [SID1234674666])

On November 12, 2026 AnaptysBio, Inc. (Nasdaq: ANAB), a company focused on managing the financial collaborations for Jemperli with Tesaro, a GSK company, and Quimilza (imsidolimab) with Vanda, reported financial results for the fiscal first quarter ended September 30, 2026, and provided a business update.

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"Jemperli’s continued commercial growth in endometrial cancer, with global net sales reaching $1 billion through September 30, 2026, and its recent U.S. approval in adults with stage II and III MSI-H/dMMR locally advanced rectal cancer reinforce our confidence in its long-term potential in monotherapy indications," said Daniel Faga, president and chief executive officer. "We remain focused on protecting and returning the value of our financial collaborations to shareholders as we approach a judgment in our litigation with GSK and Tesaro in calendar Q4 2026 or Q1 2027 and the FDA target action date for Quimilza in December 2026."

GSK Jemperli Financial Collaboration

•
GSK announced commercial performance for Jemperli
o
$365 million (£273 million) in global net sales for the three months ended September 30, 2026, representing 20% year-over-year growth1
o
$1.0 billion (£753 million) in global net sales for the nine months ended September 30, 2026, representing 29% year-over-year growth1
▪
Anaptys receives royalties equal to 12% of net sales between $1.0 billion and $1.5 billion in a given calendar year
•
Anaptys continues to expect to achieve >$390 million in annualized Jemperli royalties payable to Anaptys as early as 2029 at GSK’s peak monotherapy sales guidance of >$2.7 billion2
•
Anaptys estimates Sagard will have accrued ~$330 million in royalties and sales milestones through September 30, 2026 and anticipates paydown of the remaining ~$270 million non-recourse debt monetization in calendar H2 2027
•
Jemperli development and regulatory updates announced by GSK include:
o
AZUR-1 – dostarlimab monotherapy in adults with stage II and III MSI-H/dMMR locally advanced rectal cancer
▪
In October 2026, GSK received U.S. Food and Drug Administration (FDA) approval
▪
GSK presented first results from the AZUR-1 trial as a late-breaking abstract at ESMO (Free ESMO Whitepaper) Congress 2026 in Madrid, Spain, on October 25, 2026
▪
Regulatory submission expected in Japan in calendar H1 2027 and in Europe and China in calendar H2 2027

▪
Regulatory decision expected in Europe in calendar H2 2027
o
AZUR-2 – pivotal Phase 3 – dostarlimab versus standard of care in untreated TN40 or stage III dMMR/ MSI-H resectable colon cancer
▪
Data expected in 2028
o
AZUR-4 – Phase 2 – dostarlimab plus chemotherapy versus standard of care (chemotherapy) in untreated stage III MMRp/MSS resectable colon cancer
▪
Primary completion date in Q4 2026
o
JADE – pivotal Phase 3 – dostarlimab monotherapy versus placebo in locally advanced unresected head and neck squamous cell carcinoma (PD-L1 CPS≥1) post chemoradiation
▪
Data expected in 2028
Vanda Quimilza (imsidolimab) Financial Collaboration

•
FDA target action date (PDUFA) of December 12, 2026, for Quimilza in generalized pustular psoriasis (GPP)
GSK and Tesaro Litigation Update

•
The post-trial hearing was held before the Delaware Chancery Court on October 20, 2026
•
Anaptys is seeking reversion of Jemperli rights as a remedy; the Company anticipates a judgment in calendar Q4 2026 or Q1 2027
Fiscal First Quarter Financial Results

•
The separation of AnaptysBio and First Tracks Biotherapeutics was completed on April 20, 2026. Beginning in the second quarter of 2026, AnaptysBio reclassified historical First Tracks Biotherapeutics, Inc. related assets, liabilities and expenses as discontinued operations.
•
Cash, cash equivalents and investments totaled $153.0 million as of September 30, 2026, compared to $164.1 million as of June 30, 2026, for a decrease of $11.1 million due primarily to $15.5 million used for operating activities offset by $4.4 million received from stock option exercises.
•
Collaboration revenue was $30.3 million for the three months ended September 30, 2026, compared to $76.3 million for the three months ended September 30, 2025. The decrease is primarily due to $50 million in milestone revenue recognized in Q3 2025 offset by Jemperli royalties increasing 11% quarter over quarter for the three months ended September 30, 2026.
•
General and administrative expenses from continuing operations were $11.6 million for the three months ended September 30, 2026, compared to $1.1 million for the three months ended September 30, 2025. The increase was due primarily to legal costs for the GSK and Tesaro lawsuit, audit and tax costs to support the June 30, 2026 transition year financials, and the allocation of G&A costs between AnaptysBio and First Tracks Biotherapeutics, Inc. for the three months ended September 30, 2025.
o
The expenses recognized for the three months ended September 30, 2026, include $4.8 million in legal costs for the GSK and Tesaro litigation and $2.2 million in recurring expenses, including contractor support, legal services unrelated to the GSK and Tesaro litigation, and other public company expenses.
o
The G&A non-cash, stock-based compensation expense was $3.2 million for the three months ended September 30, 2026, as compared to $0.5 million in the same period in 2025.
•
Research and development expenses from continuing operations were a negative $1.3 million for the three months ended September 30, 2026, compared to a negative $2.0 million for the three months ended September 30, 2025.

The decrease for the three months ended September 30, 2026 was primarily due to adjustments related to the closeout of clinical contracts reducing expenses incurred prior to the separation.
•
Net income from continuing operations was $3.9 million for the three months ended September 30, 2026, or a net income per share of $0.13, compared to a net income from continuing operations of $56.3 million for the three months ended September 30, 2025, or a net income per share of $2.02.

(Press release, AnaptysBio, NOV 12, 2026, View Source [SID1234674665])

On November 12, 2026 Alpha Tau Medical Ltd. (Nasdaq/TASE: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that it will host a conference call and webcast on Monday, Nov. 16, 2026, at 8:30 a.m. ET to discuss new interim results from REGAIN (Recurrent Glioblastoma Alpha DaRT Intratumoral Therapy), its U.S. multicenter trial exploring the use of Alpha DaRT in patients with recurrent glioblastoma. The call will take place on the back of the presentation of the results at the 31st Annual Meeting of the Society for Neuro-Oncology (SNO), to be held Nov. 12-15, 2026, in Philadelphia.

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The call will feature REGAIN principal investigator Dr. Joshua Palmer of The Ohio State University; Uzi Sofer, CEO of Alpha Tau; Robert Den, MD, Chief Medical Officer of Alpha Tau; and Raphi Levy, CFO of Alpha Tau.

Conference Call and Webcast Details

● Date: Monday, Nov. 16, 2026

● Time: 8:30 a.m. ET

● Web Access: View Source

An archived webcast will be available on the Company’s website following the event.

About the REGAIN Study

The clinical trial is expected to enroll up to 20 U.S. patients with recurrent glioblastoma not amenable to surgical resection who have undergone a prior course of central nervous system radiation. The primary objective of the study is to evaluate the feasibility and safety of the treatment, following the Company’s promising results from pre-clinical studies. Additional information about the trial can be found at View Source

(Press release, Alpha Tau Medical, NOV 12, 2026, View Source [SID1234674664])

On November 12, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX) ("Akari" or the "Company"), an oncology biotechnology company developing antibody drug conjugates (ADCs) with a novel RNA splicing disrupting payload, reported financial results for the third quarter ended September 30, 2026, and highlighted significant progress advancing its proprietary PH1 payload platform toward Phase 1 clinical development.

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Akari continues to execute against its strategic priorities, achieving important milestones to advance its novel ADC payload toward clinical validation. With GLP toxicology studies initiated for its lead candidate AKTX-101, and new preclinical findings demonstrating activity in models resistant to existing ADC therapies, the Company is advancing toward its planned first-in-human Phase 1 clinical trial in mid-2027, subject to obtaining additional financing. In parallel, the Company continues to pursue strategic opportunities to develop the PH1 payload in unique ways, including a dual ADC payload concept, as announced through the Whitehawk Therapeutics research collaboration.

"We are entering an increasingly important phase in Akari’s evolution, as we translate the differentiated potential of our PH1 payload platform into a defined path toward clinical development," said Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics. "The initiation of GLP toxicology studies represents a critical step toward bringing AKTX-101 into the clinic. Our latest preclinical findings provide further evidence of what we believe could be a meaningful competitive advantage of our unique ADC payload that disrupts RNA splicing: initial focus on treating the increasing number of patients refractory to current ADCs utilizing topoisomerase or microtubule inhibitor payloads, while subsequently, expanding the opportunity to be the first-line ADC of choice."

"The ADC landscape is rapidly evolving, and we believe the next wave of innovation will be driven not simply by new targets, but by novel payloads capable of overcoming the limitations of current treatments. That is precisely the opportunity we are pursuing with the PH1 payload," continued Mr. Gaslightwala. "With continued execution towards Phase 1 and unique collaborations as announced with Whitehawk Therapeutics, we believe Akari is increasingly well positioned to accelerate the value and impact of our differentiated ADC payload technology."

Third Quarter and Recent Strategic Highlights

Advancing AKTX-101 Towards Planned Phase 1 Initiation in 2027

Initiated GLP toxicology studies for AKTX-101, Akari’s lead TROP2-targeted ADC utilizing its proprietary PH1 payload, representing an important milestone in the Company’s transition toward clinical-stage development.
Continued IND-enabling activities, including required non-clinical and CMC/manufacturing work needed to file an IND to support Phase 1 clinical studies by mid-2027.
Announced collaboration with Whitehawk Therapeutics to explore the development of a novel dual payload construct for an ADC utilizing Akari’s PH1 payload, supporting the Company’s broader strategy of working with partners to further unlock the potential of the PH1 ADC payload.
New Preclinical Data Reinforce PH1’s Potential to Address ADC Therapy Resistance

Akari reported new preclinical findings demonstrating encouraging anti-tumor activity of AKTX-101 across multiple clinically relevant urothelial cancer models, including settings where existing ADC therapies showed limited effectiveness.

Key findings included:

Statistically significant tumor growth inhibition compared with vehicle in the UM-UC-14 advanced urothelial carcinoma model, in which Padcev (enfortumab vedotin) showed limited activity.
Encouraging activity in a tumor model of acquired resistance to Trodelvy (sacituzumab govitecan), a first-generation TROP2-targeted ADC, with Trodelvy resistant tumors slowing in growth after being switched to AKTX-101.
These findings provide important preclinical support for the potential of AKTX-101 to offer a differentiated therapeutic approach in cancers with limited responsiveness to existing ADCs. The results also support further investigation of PH1-based ADCs as potential treatment options following progression on currently available therapies.

"AKTX-101 showed encouraging activity in an advanced urothelial cancer model in which Padcev had limited activity, and slowed tumor growth in a separate model after tumors developed resistance to Trodelvy," said Satyajit Mitra, Executive Director, Head of Oncology at Akari Therapeutics. "Together, these findings support further evaluation of AKTX-101 after progression on prior ADC therapy. The Trodelvy findings also reinforce our hypothesis that a different payload mechanism may help address payload-specific resistance while retaining the same TROP2 target."

Expanding the Pipeline and Intellectual Property Estate of the PH1 Payload Platform

Continued early discovery work for AKTX-102, the Company’s CEACAM5-targeted ADC candidate utilizing PH1.
Expanded intellectual property protection through the filing of international patent application PCT/US2026/45955, covering PH1’s modulation of alternative RNA splicing pathways implicated in tumor growth, survival and therapeutic resistance.
The patent application builds on preclinical findings demonstrating PH1-mediated modulation of cancer-associated pathways, including VEGF-A, FAS and androgen receptor splice variants.
Akari’s strategy extends beyond a single drug candidate. By establishing PH1 as a potentially versatile ADC payload, the Company is pursuing opportunities to create value through both internally developed programs and external strategic collaborations, with the potential to broaden the platform’s application without relying exclusively on Akari-funded clinical development.

Strengthening Business Development Capabilities to Capitalize on Strategic Opportunities

In October 2026, Akari appointed Vatnak Vat-Ho as Chief Business Officer, further strengthening the Company’s ability to pursue strategic partnerships, licensing arrangements and corporate development opportunities.

Mr. Vat-Ho brings more than 20 years of experience in oncology business development, biopharmaceutical strategy and capital markets, including involvement in transactions totaling more than $25 billion in aggregate value.

His experience includes originating and executing ADC payload collaborations involving Exelixis and BioNTech, providing relevant expertise as Akari seeks to expand the reach of its PH1 platform through potential strategic partnerships.

Upcoming Development Priorities and Potential Value Drivers

Akari remains focused on executing a series of development and strategic initiatives designed to advance its lead candidate and expand the potential applications of its proprietary PH1 payload.

AKTX-101 Clinical Advancement: Progress in GLP toxicology, GMP manufacturing and remaining IND-enabling activities toward planned Phase 1 clinical development in mid-2027.
Strengthening Scientific Platform: Continue generating evidence demonstrating PH1’s differentiated activity in tumors resistant to existing ADC therapies.
Business Development and Strategic Partnerships: Advance ongoing collaborations and evaluate licensing and business development opportunities that could expand PH1’s application to new ADC molecules, as well as novel ADC constructs like dual payloads built around PH1.
Internal Pipeline Expansion: Continue to advance PH1-based ADC candidates targeting additional tumor-associated antigens, including the CEACAM5-targeted AKTX-102.
Summary of Financial Results for Third Quarter 2026

The Company closed the third quarter with $5.7 million in cash, the second highest cash balance since 2024. Operating expenses were $4.7 million, compared to $7.4 million for the comparable period in 2025. The Company received proceeds of approximately $2.9 million from the exercise of previously issued warrants and repaid in full its $0.7 million of outstanding convertible notes.

Research and development expenses were approximately $2.1 million for the three months ended September 30, 2026, compared to approximately $0.2 million for the comparable period in 2025. This reflects the Company’s increased investment in advancing its ADC development platform and related research and development activities.

General and administrative expenses were approximately $2.6 million for the three months ended September 30, 2026, compared to approximately $2.0 million for the comparable period in 2025. The increase was primarily attributable to higher professional fees and a one-time cost associated with the termination of an agreement with a prior placement agent.

Loss from operations was approximately $4.7 million for the three months ended September 30, 2026, compared to approximately $7.4 million for the comparable period in 2025. The prior-year quarter included a $5.2 million impairment charge related to the Company’s former PHP-303 program.

Net loss was approximately $4.8 million for the three months ended September 30, 2026, compared to approximately $6.4 million for the comparable period in 2025.

Cash totaled approximately $5.7 million as of September 30, 2026, compared to approximately $5.2 million as of December 31, 2025. The Company reported net cash used in operating activities of approximately $9.8 million for the nine months ended September 30, 2026. During the third quarter of 2026, the Company received approximately $2.9 million in proceeds from the exercise of outstanding warrants. The Company also repaid in full its $0.7 million of outstanding convertible notes at their August 31, 2026 maturity and had no convertible notes or notes payable outstanding as of September 30, 2026.

(Press release, Akari Therapeutics, NOV 12, 2026, View Source [SID1234674659])