On November 9, 2026 Epitopea, a clinical-stage, biotech company developing off-the-shelf, durable RNA-based cancer vaccines, reported that the first patient has been successfully dosed in OVACT, its first-in-human Phase 1/1b clinical trial evaluating its lead program, CryptiVax-1001, targeting advanced high-grade serous ovarian cancer (HGSOC).

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OVACT is a Phase 1/1b dose escalation trial designed to evaluate the safety, tolerability, immunogenicity, and early clinical activity of CryptiVax-1001 in HRP+/BRCA-wildtype advanced HGSOC patients. Up to 30 women will be enrolled into the trial across up to 10 leading clinical centres in the UK.

HGSOC remains one of the most difficult-to-treat solid tumors, with around 80% of patients presenting with advanced or metastatic disease. While most women respond to first-line platinum chemotherapy, nearly all ultimately relapse and progress to platinum-resistant disease. Existing maintenance options are only effective in half of the ovarian cancer population and leave a major therapeutic gap among HRP+/BRCA-wildtype patients.

Dr. Klaus Edvardsen, MD, PhD, Chief Medical Officer of Epitopea, commented, "HGSOC is the most common and aggressive subtype of ovarian cancer. Treating the first patient with CryptiVax-1001 in our OVACT Phase 1/1b trial for HGSOC is a major milestone for Epitopea. Epitopea’s approach targets a novel repertoire of tumor-specific antigens that have been selected to provide broader patient benefit. We are motivated by the potential to provide meaningful durable treatment options for this underserved patient population."

Professor Susana Banerjee (MBBS MA PhD FRCP), the Chief Investigator of Epitopea’s OVACT trial, Consultant Medical Oncologist and Research Lead for the Gynaecology Unit at The Royal Marsden NHS Foundation Trust and Professor in Women’s Cancers at The Institute of Cancer Research, London, said, "It is exciting to offer patients the option of the OVACT trial and I am delighted that we are underway with the first patient treated. The CryptiVax-1001 vaccine has the potential to meaningfully extend remission for women where currently available maintenance therapies deliver limited durable benefit."

(Press release, Epitopea, NOV 9, 2026, View Source [SID1234674470])

On November 9, 2026 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported financial results and business highlights for the third quarter ended September 30, 2026.

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Third Quarter 2026 Financial Results
•Total revenue of $35.1 million, compared with $20.6 million in the third quarter of 2025
◦HEPZATO KIT revenue of $32.7 million, compared to $19.3 million in the third quarter of 2025
◦CHEMOSAT revenue of $2.4 million, compared to $1.3 million in the third quarter of 2025
•Gross margins of 89%, compared to 87% in the third quarter of 2025
•Net income of $7.0 million, compared to $0.8 million in the third quarter of 2025
•Non-GAAP adjusted EBITDA of $11.5 million, compared to $5.3 million in the third quarter of 2025
•Cash provided by operations of $8.2 million in the quarter; compared to $4.8 million in the third quarter of 2025
•Cash and investments of $104.3 million as of September 30, 2026; and no debt

Business Highlights
•Currently 33 active treatment centers
•Approximately 72% growth in HEPZATO volume in the third quarter 2026 compared to the third quarter 2025
•Advanced the global Phase 2 DELUMA trial (NCT06875128), evaluating HEPZATO in combination with standard-of-care therapy versus standard of care alone in liver-dominant HER2-negative metastatic breast cancer; first patient dosed July 9, 2026, at the European Institute of Oncology in Milan, Italy. The randomized trial is designed to enroll approximately 90 patients at more than 20 U.S. and European sites.

"We are pleased with the continued momentum in our business, with meaningful progress across both commercial operations and clinical development," said Gerard Michel, Chief Executive Officer of Delcath Systems. "Growing physician experience with HEPZATO, strong engagement across our treatment center network, and increasing interest in its use alongside systemic therapies reinforce our confidence in the long-term opportunity. We are also expanding our pipeline, with a planned IND submission for cholangiocarcinoma in early 2027 and, pending FDA agreement, completion of ongoing preclinical development of an oxaliplatin-based PHP product by mid-2027."

2026 Full Year Financial Guidance
The Company’s financial outlook for fiscal year 2026:
•Total HEPZATO KIT and CHEMOSAT revenue to range from $115 million to $117 million, reflecting an increase in HEPZATO KIT volume of at least 41% over 2025
•Full year gross margins in the range of 87% to 89%
•Positive adjusted EBITDA

Third Quarter 2026 Results
Total revenue for the quarter ending September 30, 2026 was $35.1 million compared to $20.6 million for the same period in the prior year. Revenue in the quarter includes sales of $32.7 million of HEPZATO in the U.S. and $2.4 million of CHEMOSAT in Europe.
Research and development expenses for the quarter ending September 30, 2026, were $11.0 million compared to $8.0 million for the same period in the prior year. The increase is primarily due to increased clinical headcount and increased clinical trial activity.

Selling, general and administrative expenses for the quarter ended September 30, 2026, were $13.1 million compared to $10.3 million for the same period in the prior year. The increase is primarily due to continued commercial expansion activities.
Net income was $7.0 million for the quarter ended September 30, 2026, compared to $0.8 million for the same period in the prior year.
Non-GAAP adjusted EBITDA for the quarter ended September 30, 2026 was $11.5 million compared to adjusted EBITDA of $5.3 million for the same period in the prior year. A table reconciling non-GAAP measures is included in this press release for reference.
As of September 30, 2026, the Company had $104.3 million in cash and investments, and no debt.

Conference Call Information
To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call.

Event Date: Monday, November 9, 2026
Time: 8:30 AM Eastern Time

(Press release, Delcath Systems, NOV 9, 2026, View Source [SID1234674469])

On November 9, 2026 CorMedix Therapeutics (Nasdaq: CRMD) ("CorMedix") and Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron") reported that they have entered into a definitive asset purchase agreement (the "Agreement") under which CorMedix will acquire substantially all of the assets of Heron, and assume certain of Heron’s liabilities, for upfront consideration consisting of $145 million in cash, subject to customary purchase price adjustments, plus 14,583,333 shares of CorMedix common stock, plus up to $55 million in contingent earn-out payments and royalties on net sales of certain Heron products. The transaction has been unanimously approved by the Boards of Directors of both companies.

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The acquisition adds four commercial-stage products to CorMedix’s portfolio: ZYNRELEF (bupivacaine and meloxicam) extended-release solution for postoperative pain; APONVIE (aprepitant) injectable emulsion for the prevention of postoperative nausea and vomiting; CINVANTI (aprepitant) injectable emulsion and SUSTOL (granisetron) extended-release injection for the prevention of chemotherapy-induced nausea and vomiting. Each is administered in hospitals, ambulatory surgical centers or infusion centers — the institutional settings of care where CorMedix has built its commercial infrastructure. The transaction also includes the assumption of Heron’s rights with respect to products covered by Heron’s multi-product Development and License Agreement.

Management Commentary

"This acquisition is a meaningful step forward in our strategy to build a diversified portfolio of products used in institutional settings of care, which creates substantial value for CorMedix shareholders," said Joseph Todisco, Chairman & Chief Executive Officer of CorMedix. "Heron’s products are a natural fit for the commercial platform we have built, and we see ZYNRELEF in particular as an asset with significant untapped potential as hospitals and surgery centers increasingly adopt non-opioid approaches to postsurgical pain. We expect to realize $45-$60 million in operating cost synergies by leveraging our existing infrastructure, and we have structured this transaction in a manner which will be immediately accretive to earnings and free cash flow. Importantly, the Pharmakon facility gives us an efficient source of non-dilutive capital to fund this transaction while preserving dry powder for additional growth-oriented business development opportunities, including the flexibility of a second $75 million tranche to fund further growth."

"Following a thorough review of strategic alternatives, our Board concluded that this transaction offers the most compelling path forward for Heron stockholders," said Craig Collard, Chief Executive Officer of Heron. "The transaction provides substantial consideration through a combination of cash, CorMedix stock and earn-out payments, enabling Heron to complete the repayment of its outstanding credit facility with Hercules and become a significant stockholder of a company we believe is well-positioned for future growth and value creation. In addition, the earn-out and royalties provide the opportunity for Heron and our stockholders to further benefit from the success of the products our team has built. I am deeply grateful to the entire Heron team for their hard work advancing the standard of care for patients, and I believe that CorMedix has the scale, financial strength and institutional commercial focus to accelerate the growth of ZYNRELEF and APONVIE and to help ensure that CINVANTI continues to reach the patients who rely on it."

Transaction Terms

Under the terms of the Agreement, CorMedix will pay upfront consideration consisting of $145 million in cash, subject to customary purchase price adjustments, and issue 14,583,333 shares of CorMedix common stock. The number of shares was determined by dividing $105 million by $7.20 per share and is fixed, subject to customary adjustment for stock splits and similar events; it will not be adjusted for changes in CorMedix’s share price prior to closing. Based on the closing price of CorMedix common stock of $5.32 on November 6, 2026, the stock consideration has a value of approximately $77.6 million, and the upfront consideration has an aggregate value of approximately $222.6 million.

In addition to the upfront consideration, Heron will be eligible to receive:

Total earn-out payments of up to $55 million: $25 million if ZYNRELEF net sales equal or exceed $65 million for calendar year 2028, plus an additional $30 million if ZYNRELEF net sales equal or exceed $95 million for calendar year 2028; and
A 5% royalty on the portion of combined annual net sales of CINVANTI, SUSTOL and the products covered by Heron’s multi-product Development and License Agreement which exceed $25 million in calendar year 2027, calendar year 2028 and calendar year 2029.
In connection with the transaction, Rubric Capital Management LP ("Rubric"), the holder of Heron’s senior unsecured convertible notes due 2031, has agreed to exchange this debt, consisting of $35.0 million in aggregate principal amount of such notes plus accrued and unpaid interest (approximately $37.8 million in the aggregate as of September 30, 2026), for shares of CorMedix common stock received by Heron (the "Exchange"). This Exchange between Heron and Rubric is expected to occur in four quarterly tranches following the closing, subject to the terms and conditions of the exchange agreement.

Both Heron and Rubric have entered into respective governance agreements with CorMedix, wherein Heron shall have the right to name one new member to the CorMedix Board of Directors for so long as Heron continues to hold at least 10% of the outstanding shares of CorMedix and where each of Heron and Rubric have agreed to prohibitions on certain conduct and limitations on trading in CorMedix shares.

The transaction is subject to approval by Heron stockholders, the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other customary closing conditions. The transaction is not subject to any financing contingency and is expected to close in the first quarter of 2027.

In connection with the transaction, certain Heron stockholders holding approximately 22% of Heron’s outstanding common stock, including Rubric, have entered into voting agreements with Heron and CorMedix pursuant to which they have agreed to vote their shares in favor of the transaction.

Strategic Rationale

The acquisition advances CorMedix’s strategy of expanding its portfolio with differentiated products used in institutional settings of care. Following its acquisition of Melinta Therapeutics, CorMedix has assembled a commercial organization focused on hospitals, infusion centers, dialysis clinics and other institutional settings of care. The Heron portfolio is highly complementary to this footprint, sharing overlapping call points across hospital pharmacy and therapeutics committees, group purchasing organizations, integrated delivery networks and ambulatory surgical centers.

Scale and diversification: Adds an established revenue base of approximately $150 million on September 30, 2026, trailing twelve-month net product revenue across acute care and oncology supportive care, further broadening CorMedix’s revenue mix.
Commercial and operational leverage: Deploys Heron’s products through CorMedix’s existing institutional commercial, market access, medical affairs and supply chain infrastructure, driving the $45–$60 million in total expected operating cost synergies.
Growth from the acute care franchise: ZYNRELEF and APONVIE represent the fastest-growing products in the Heron portfolio and are positioned for continued expansion in the hospital and ambulatory surgical center settings.
Expanded hematology/oncology presence: CINVANTI, SUSTOL and products covered by Heron’s multi-product Development and License Agreement complement CorMedix’s emerging position in the space with REZZAYO (rezafungin for injection), which is currently indicated for treating candidemia and invasive candidiasis and in development for prophylaxis of invasive fungal disease in allogeneic stem cell transplant patients.
Expected Pro Forma Financial Profile and Financing[1]

CorMedix expects the transaction to be immediately accretive to earnings and free cash flow upon closing and to generate operating cost synergies of an estimated $45-$60 million on an annualized run-rate basis by year-end 2027, driven primarily by the elimination of redundant commercial, general and administrative, and public company expenses.

CorMedix expects pro forma 2026 estimated revenue for the combined business to be $465-$490 million. In addition, CorMedix expects the acquired Heron assets to generate approximately $125–150 million of estimated pro forma revenue in 2027.

Concurrent with the signing of the Agreement, CorMedix entered into a new $150 million senior secured term loan facility with funds managed by Pharmakon Advisors, LP ("Pharmakon"). Under the facility, CorMedix expects to draw $75 million at the closing of the Heron asset acquisition, and an additional $75 million tranche may be drawn at CorMedix’s discretion through June 30, 2028 to support future business development transactions.

Pharmakon Advisors, LP is a leading investor in non-dilutive debt for the life sciences industry and serves as the investment manager for the BioPharma Credit funds. Established in 2009, funds managed by Pharmakon Advisors have committed $12.9 billion across 82 investments.

Key terms of the asset purchase agreement with Heron, the loan facility and other agreements referenced herein will be described in a Current Report on Form 8-K to be filed by CorMedix with the Securities and Exchange Commission.

Heron Commentary

Following the closing, Heron will exit the operation of its current biotechnology business and other historical operations, but it does not intend to liquidate and will remain a publicly traded company. Heron will retain significant federal and state net operating loss carryforwards (approximately $2.3 billion as of September 30, 2026), certain other tax attributes and other material assets, including the shares of CorMedix common stock issued to Heron, the right to receive future royalties and earn-out payments, and cash on hand. Following the closing, the Heron Board of Directors intends to actively evaluate various strategic transactions and opportunities for the use of the proceeds of the transaction, including acquiring or investing in additional businesses or assets, which may or may not be pharmaceutical or biotechnology businesses or assets. Such opportunities may include, but are not limited to, the acquisition of products, product candidates, milestone payments and royalty streams, programs or technologies as well as pursuing strategic alliances, joint ventures, investments in complementary businesses, out-licensing and in-licensing agreements, divestitures or other transactions. It is currently uncertain what businesses or assets Heron may acquire or invest in following the closing of the transaction, and the Heron Board of Directors intends to evaluate opportunities to create value for the benefit of stockholders.

Key terms of the asset purchase agreement with CorMedix and other agreements referenced herein will be described in a Current Report on Form 8-K to be filed by Heron with the Securities and Exchange Commission.

Third Quarter 2026 Financial Results

CorMedix will report third quarter 2026 financial results on November 12, 2026. Please refer to CorMedix’s press release issued here to register and for more information.

Heron reports its third quarter 2026 financial results today, November 9, 2026. In light of the transaction with CorMedix, Heron will not hold an associated conference call.

Advisors

Moelis & Company LLC is serving as exclusive financial and financing advisor to CorMedix, and Willkie Farr & Gallagher LLP is serving as legal counsel. Leerink Partners is serving as exclusive financial advisor to Heron, and DLA Piper LLP (US) is serving as legal counsel.

(Press release, CorMedix, NOV 9, 2026, View Source [SID1234674468])

On November 9, 2026 Compugen Ltd. (NASDAQ: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational drug target discovery powered by AI, reported financial results for the third quarter of 2026 and provided a corporate update.

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"During the third quarter, we continued to advance COM701 and GS-0321 in the clinic, as well as build the next generation of our pipeline," said Eran Ophir, Ph.D., President and Chief Executive Officer of Compugen. "MAIA-ovarian is now fully enrolled, and we remain on track to report results by the end of the first quarter of 2027.We are also excited to see partner AstraZeneca continue to progress rilvegostomig, with Phase 3 high-level trial results from ARTEMIDE-Biliary01 anticipated in the second half of 2027. In addition, we introduced UnigenX, which expands our discovery capabilities into novel tumor-associated antigens, that could enable specific tumor targeting of potent therapeutic modalities such as T cell engagers. With cash runway expected into 2029, we believe we are well positioned to execute on our strategy and look forward to 2027, which we expect to be a data-rich year."

COM701

Compugen has completed enrollment in its MAIA-ovarian, its global, randomized, placebo-controlled adaptive platform trial evaluating COM701, a potential first-in-class anti-PVRIG antibody, as maintenance monotherapy in patients with second- and third-line relapsed platinum-sensitive ovarian cancer. The Company remains on track to report results by the end of the first quarter of 2027

The blinded trial enrolled 62 patients randomized two to one to receive either COM701 or placebo. MAIA-ovarian was designed to evaluate COM701 in a setting with no approved maintenance treatment option and significant unmet need.

At Compugen’s October 5, 2026, virtual key opinion leader event, Dr. Yeku of Harvard Medical School and Massachusetts General Hospital discussed the importance of extending the platinum-free interval in patients with relapsed platinum-sensitive ovarian cancer, the limitations of currently available maintenance options and the need to balance efficacy, tolerability and treatment sequencing.

In evaluating the MAIA-ovarian trial, Compugen intends to consider the totality of the data, including the magnitude and durability of separation between the COM701 and placebo arms and the proportion of patients remaining progression-free at six months. COM701 has the potential to serve as an important maintenance option for patients with relapsed platinum sensitive ovarian cancer who currently have very limited therapeutic alternatives.

Rilvegostomig

Rilvegostomig is an AstraZeneca-owned PD-1/TIGIT bispecific antibody whose TIGIT component is derived from Compugen’s COM902. Compugen is eligible to receive up to $195 million in additional regulatory and commercial milestone payments, as well as up to mid-single- digit tiered royalties on future sales, under its license agreement with AstraZeneca.

In September 2026, AstraZeneca reported the first overall survival data from the Phase 2 ARTEMIDE-01 trial in first-line, checkpoint inhibitor- and chemotherapy-naïve patients with PD-L1-positive non-small cell lung cancer. Median overall survival compared favorably with historical controls.

The Phase 3 high-level results from the clinical trial ARTEMIDE-Biliary01 studying rilvegostomig are now anticipated in the second half of 2027. ARTEMIDE-Biliary01 is assessing rilvegostomig plus investigator’s choice of chemotherapy compared to chemotherapy only as adjuvant treatment in 760 participants with biliary tract cancer who are at risk of recurrence after resection with curative intent. Rilvegostomig is being evaluated in 12 ongoing Phase 3 trials across indications including non-small cell lung cancer, biliary tract cancer and gastric cancer.

GS-0321

GS-0321, formerly known as COM503, is a potential first-in-class anti-IL-18 binding protein antibody licensed to Gilead. The program is designed to harness cytokine biology for the treatment of cancer while potentially overcoming limitations associated with direct cytokine administration.

The ongoing Phase 1 dose-escalation trial is continuing to advance.

Compugen has received gross payments totaling $90 million from Gilead under the license agreement and is eligible to receive up to $758 million in additional milestone payments, plus tiered royalties ranging from single digits to low double digits.

Early Pipeline

Unigen is Compugen’s AI-powered discovery engine for identifying novel immuno-oncology drug targets by connecting computational prediction, biological validation and clinical learning. Unigen has enabled the discovery of TIGIT, PVRIG and IL-18BP as drug targets, which have all progressed to clinical stage.

At its October 5, 2026, investor event, Compugen introduced UnigenX, a strategic expansion into targeted immune activation modalities such as T cell engagers, which can identify single targets and target pairs. Compugen intends to apply UnigenX to discover novel tumor-associated antigens that could enable more selective immune targeting of tumor cells.

This expanded capability is intended to support the next generation of Compugen’s early-stage pipeline.

Third Quarter 2026 Financial Highlights

· Cash: As of September 30, 2026, Compugen had approximately $117.5 million in cash, cash equivalents, short-term bank deposits and investments in marketable securities. Compugen expects its cash and cash-related balances to be sufficient to fund its operating plans into 2029. This does not include any additional cash inflows.

· Revenues for the third quarter of 2026 were approximately $3.8 million, compared with approximately $1.9 million for the comparable period in 2025. Revenues in the third quarters of 2026 and 2025 reflect the recognition of portions of both the upfront payment and the investigational new drug milestone payment under the license agreement with Gilead.

· Research and development expenses were approximately $5.8 million for each of the third quarters of 2026 and 2025.

· General and administrative expenses for the third quarter of 2026 were approximately $2.3 million, compared with approximately $2.2 million in the third quarter of 2025.

· Net loss for the third quarter of 2026 was approximately $5.8 million, or $0.06 per basic and diluted share, compared with a net loss of approximately $7.0 million, or $0.07 per basic and diluted share, in the third quarter of 2025.

Conference Call and Webcast Information

The Company will hold a conference call today, November 9, 2026, at 8:30 AM ET to review its third quarter 2026 results. To access the conference call by telephone, please dial 1-866-744-5399 from the United States, or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

(Press release, Compugen, NOV 9, 2026, View Source [SID1234674467])

On November 9, 2026 Coherus Oncology, Inc. (Nasdaq: CHRS) reported financial results for the third quarter 2026 and provided an overview of recent business highlights.

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"The strategic prioritization of esophageal cancer as our best-in-disease focus for tagmokitug, together with the Transition Services Agreement wind-down and the toripalimab process transfer completion, provides an ideal opportunity to right-size the organization and deliver financial benefits that flow directly from this prioritization," said Denny Lanfear, Chief Executive Officer of Coherus Oncology. "Over the next four or five quarters we will remain intensely focused on growing LOQTORZI market share in relation to chemo-only, an inferior therapeutic approach, and off-label IO, which has not demonstrated standard-of-care level of benefit for patients living with nasopharyngeal carcinoma. We believe this approach can provide a path to financial self-sufficiency."

"Esophageal cancers constitute difficult-to-treat tumors with significant unmet medical need. The compelling anti-tumor activity observed in both ESCC and EAC tumors suggests that Tregs are a critical driver of resistance. Importantly, we saw tagmokitug enhance PD-1’s activity, demonstrate activity in PD-L1 negative tumors, and rescue PD-1 refractory patients," said Rosh Dias, M.D., Chief Medical Officer of Coherus Oncology. "Our immediate next step is to align with the FDA on our plans to expand the signal observed in esophageal cancer, with an initial focus on the second-line setting. This represents the fastest path to market in this underserved patient population."

"The financial benefits of right-sizing the organization and reducing the scope of our forward-focused efforts provide substantial and durable benefits to our operating model," said Bryan McMichael, Chief Financial Officer of Coherus Oncology. "These benefits will be realized over the next two quarters, lowering our core cash burn by $6 million to $7 million quarterly, which in turn lowers the quarterly LOQTORZI revenues required to cover core burn to $25 million to $30 million, down from $30 million to $35 million, as previously guided."

RECENT BUSINESS HIGHLIGHTS

LOQTORZI (toripalimab-tpzi) Commercial Updates

● LOQTORZI revenue for Q3 2026 was $14.0 million, a 25% increase over $11.2 million in Q3 2025, and a 3% increase versus $13.6 million in Q2 2026.

● Demand continued to grow in the third quarter, driven by an increasing number of patients on therapy and increasing treatment duration.
● LOQTORZI remains the only FDA-approved and available treatment in the U.S. for recurrent, locally advanced or metastatic nasopharyngeal carcinoma (NPC). It is the only preferred Category 1 first-line treatment option recommended in combination with cisplatin and gemcitabine and the only preferred subsequent-line treatment recommended by the National Comprehensive Cancer Network (NCCN).

ADVANCEMENT OF INNOVATIVE, NEXT-GENERATION ONCOLOGY PIPELINE

Tagmokitug is a highly selective, cytolytic anti-CCR8 antibody designed to preferentially deplete CCR8-positive regulatory T cells (Tregs) in the tumor microenvironment, with the goal of overcoming immune resistance and enhancing antitumor immune responses. Tagmokitug is being evaluated in the TREGCHECK Phase 1b/2a clinical program in combination with toripalimab, with and without chemotherapy. As part of the strategic prioritization plan, Coherus will focus near-term tagmokitug development on esophageal cancer and deprioritize the other tagmokitug-toripalimab cohorts presented during our October 28, 2026, data release. The Company will continue ongoing first-line ESCC and second-line ESCC and EAC indications and pursue regulatory alignment on an expedited development path, initially focused on second-line esophageal cancer.

● Enrollment remains ongoing in the Phase 1b cohorts evaluating tagmokitug in combination with toripalimab with or without chemotherapy in first- and second-line ESCC. The second-line EAC patients were enrolled as part of the upper gastrointestinal adenocarcinoma cohort, which has completed accrual and remains in follow-up.

● The overall interim clinical activity across second-line ESCC and second-line EAC of 22 treated and 13 evaluable patients demonstrated a confirmed ORR of 33.3% and a CBR of 55.6%. Coherus plans to initiate a new study evaluating tagmokitug in combination with toripalimab in patients with second line esophageal cancer (EAC and ESCC), an area of high unmet medical need. The Company intends to align with the FDA on the design of the new study and the proposed 700 mg dose, with the objective of pursuing an expedited development path.

● The Company plans to go forward with the Phase 1b clinical study evaluating tagmokitug in combination with pasritamig, a T-cell engaging bispecific antibody, in patients with metastatic castration-resistant prostate cancer (mCRPC), which is expected to initiate 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.

● Enrollment in the randomized Phase 2 trial of casdozokitug/toripalimab/bevacizumab in 1L uHCC is complete and the first data readout is expected in 1H 2027.

THIRD QUARTER 2026 FINANCIAL RESULTS

Net revenue from continuing operations was $14.3 million and $11.6 million during the three months ended September 30, 2026 and 2025, respectively, and $40.9 million and $29.4 million during the nine months ended September 30, 2026 and 2025, respectively. The increases were driven primarily by volume growth of LOQTORZI.

Cost of goods sold (COGS) from continuing operations was $4.1 million and $3.7 million during the three months ended September 30, 2026 and 2025, respectively, and $12.1 million and $9.8 million during the nine months ended September 30, 2026 and 2025, respectively. The increases were primarily due to volume growth of LOQTORZI.

Research and development (R&D) expenses from continuing operations were $22.6 million and $27.3 million for the three months ended September 30, 2026 and 2025, respectively, and $65.6 million and $77.9 million during the nine months ended September 30, 2026 and 2025, respectively. The decreases were primarily due to savings from reduced headcount, lower infrastructure costs, and lower clinical trial and R&D manufacturing costs.

Selling, general and administrative (SG&A) expenses from continuing operations were $21.2 million and $24.9 million during the three months ended September 30, 2026 and 2025, respectively, and $65.3 million and $77.0 million during the nine months ended September 30, 2026 and 2025, respectively. The decreases were 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 third quarter of 2026 was $38.9 million, or $(0.25) per share on a diluted basis, compared to $44.5 million, or $(0.38) per share on a diluted basis, for the same period in 2025. Net loss for the nine months ended September 2026 was $109.2 million, or $(0.73) per share on a diluted basis, compared to $136.8 million, or $(1.18) per share on a diluted basis for the same period of 2025.

Non-GAAP net loss from continuing operations for the third quarter of 2026 was $31.2 million, or $(0.20) per share on a diluted basis, compared to $38.9 million, or $(0.33) per share for the same period in 2025. Non-GAAP net loss for the nine months ended September 2026 was $95.3 million, or $(0.64) per share on a diluted basis, compared to $118.8 million, or $(1.02) 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 $83.6 million as of September 30, 2026, compared to $172.1 million as of December 31, 2025. These balances were inclusive of Transition Services Agreement (TSA)-related collections that will be applied to associated TSA payables and accrued liabilities which totaled $19.6 million and $65.1 million as of September 30, 2026 and December 31, 2025, respectively.

Conference Call Information

When: Monday, November 9, 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, NOV 9, 2026, View Source [SID1234674466])