On March 23, 2023 Affimed N.V. (Nasdaq: AFMD) ("Affimed" or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported financial results for the year ended December 31, 2022, and provided an update on clinical and corporate progress (Press release, Affimed, MAR 23, 2023, View Source [SID1234629289]).

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"During 2022, we presented data across our pipeline that show our innate cell engagers can deliver unprecedented efficacy when combined with NK cells, can activate and direct cytotoxic T cells to tumor cells, and can deliver meaningful single agent activity with a differentiated safety profile," said Adi Hoess, Chief Executive Officer at Affimed. "Supported by a cash runway into 2025, our Company is well positioned to execute on our strategic imperatives, with multiple catalysts across our pipeline expected in 2023. We are excited about this next critical stage of development which we believe can unlock the tremendous value of our platform."

Program Updates

AFM13 (CD30/CD16A)

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In January 2023, Affimed received feedback from the Food and Drug Administration (FDA) to its pre-investigational new drug (IND) meeting request in support of a planned clinical study to investigate AFM13 in combination with Artiva’s AB-101 natural killer (NK) cells. The Company is on track to submit the IND in the first half of 2023. Pending IND clearance, Affimed expects to initiate the combination clinical trial in 2023.

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AFM13-104: In December 2022, at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, Affimed reported updated data from AFM13-104, the investigator sponsored trial (IST) led by The University of Texas MD Anderson Cancer Center investigating the combination of AFM13 combined with cord blood-derived NK cells followed by AFM13 monotherapy.

AFM13 in combination with NK cells showed very high overall and complete response rates in 41 heavily pre-treated CD30-positive Hodgkin lymphoma (HL) and Non-Hodgkin lymphoma (NHL) patients.

Patients in the study had a median of seven prior lines of treatment and all patients had failed to demonstrate objective response to immediate prior line of therapy.

In the 35 patients treated at the recommended phase 2 dose (RP2D), a 94% objective response rate (ORR) and a complete response (CR) rate of 71% were observed.

In 31 patients with Hodgkin lymphoma treated at the RP2D, an ORR of 97% and a CR rate of 77% were observed.

In four NHL patients treated at the RP2D, three objective responses, including one CR in a patient with peripheral T-cell lymphoma, were observed.

63% of patients treated at the RP2D with at least 6 months of follow-up after the initial infusion (n=24) remained in complete response for at least 6 months. In addition, the treatment was well tolerated with no cases of cytokine release syndrome, immune effector cell-associated neurotoxicity or graft versus host disease observed.

Affimed expects to present updated data from this combination study at a scientific conference later in 2023.

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AFM13-202: An abstract highlighting AFM13 data from the monotherapy study (REDIRECT) investigating efficacy in patients with CD30-positive relapsed/refractory peripheral T cell lymphomas (PTCL) has been accepted for an oral presentation at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting.

AFM24 (EGFR/CD16A)

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Affimed expects to provide data updates from the three ongoing studies at scientific conferences in Q2 or Q3 of 2023. For AFM24-101, the Company expects to present data from approximately 15 patients from each of the non-small cell lung cancer and colorectal cancer cohorts. For AFM24-102 and AFM24-103, the update is expected to include data from the dose escalation portion of the respective clinical trials.

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AFM24-101: Affimed continues to enroll patients in the expansion phase of the AFM24 monotherapy study at the RP2D. The expansion cohorts include patients with renal cell carcinoma (clear cell), non-small cell lung cancer (EGFR mutant) and colorectal cancer.

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AFM24-102: In the phase 1/2a combination study of AFM24 with the anti-PD-L1 checkpoint inhibitor atezolizumab (Tecentriq) in patients with advanced epidermal growth factor receptor-expressing solid tumors, a 480 mg weekly dose of AFM24 was confirmed as the R2PD.

The expansion cohorts for AFM24-102, which include patients with non-small cell lung cancer (EGFR wildtype), gastric and gastroesophageal junction adenocarcinoma, and a basket cohort evaluating pancreatic/hepatocellular/biliary tract cancer, are now open and enrolling patients. The treatment showed a well-managed safety profile to date.

Data from the first cohort (4 patients at 160 mg dose) of the phase 1 dose escalation study presented at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November 2022 showed that clinical activity was observed in two patients. A patient with gastric cancer and skin metastases who had rapidly progressed following four prior lines of therapy, including a PD-1 inhibitor, achieved a partial response. A second patient with pancreatic adenocarcinoma showed stable disease beyond four months. Patients being enrolled in the study are required to have progressed or relapsed on standard of care therapies.

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AFM24-103: In the phase 1/2a combination study of AFM24 with SNK01, NKGen Biotech’s ex vivo expanded and activated autologous NK cell therapy, enrollment has been completed in the dose cohort of 480 mg AFM24 weekly, with no dose- limiting toxicities (DLTs) observed to date. The Company is recruiting three additional patients to confirm the 480 mg dose as the RP2D.

AFM24-103 is focused on the treatment of patients with non-small cell lung cancer (NSCLC, EGFR-wildtype), squamous cell carcinoma of the head and neck, and colorectal cancer.

AFM28 (CD123/CD16A)

In December 2022, the Company announced that Clinical Trial Applications (CTAs) were cleared in France and Spain. Since then, Belgium and Denmark have also approved the Company’s CTAs. The phase 1 study is now open and recruiting patients.

AFM28 is Affimed’s tetravalent, bispecific CD123- and CD16A-binding innate cell engager (ICE) designed to bring a new immunotherapeutic approach to patients with CD123-positive myeloid malignancies, including Acute Myeloid Leukemia and Myelodysplastic Syndrome (MDS). It engages NK cells to initiate tumor cell killing via antibody-dependent cellular cytotoxicity (ADCC), even at low CD123 expression levels.

Clinical development of AFM28 is planned as both single-agent and in combination with NK cells in patients with CD123+ myeloid disease.

Partnerships and Collaborations

Partnered programs with Genentech and Affivant Sciences (a Roivant company) continue to progress.

During 2022, Affimed continued to work with Genentech pursuant to the previously disclosed research collaboration and license agreement between the companies and handed over a number of product candidates for further investigation by Genentech.

Affivant Sciences submitted two preclinical abstracts for AFVT-2101 (formerly AFM32) which have been accepted for poster presentation at the AACR (Free AACR Whitepaper) annual meeting in April 2023. Affivant expects to submit an IND for AFVT-2101 in the first half of 2023.

Full Year 2022 Financial Highlights

Affimed’s consolidated financial statements are prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standard Board (IASB). The consolidated financial statements are presented in Euros (€), the Company’s functional and presentation currency.

As of December 31, 2022, cash and cash equivalents were €190.3 million, with an anticipated cash runway into 2025.

Net cash used in operating activities for the year ended December 31, 2022 was €104.9 million compared to €86.6 million in 2021.

Total revenue for the year ended December 31, 2022, was €41.4 million compared with €40.4 million for the year ended December 31, 2021. Revenue predominately relates to the Genentech and Roivant collaborations.

Research and development expenses for 2022 increased by 21.3% from €81.5 million in 2021 to €98.8 million in 2022. The increase was primarily due to higher expenses associated with the development of the AFM24 and AFM28 programs, a result of an increase in manufacturing of clinical trial material and costs for the preparation of the filing of the IND application, an increase in costs associated with other early-stage programs and infrastructure, and an increase in share-based payment expenses.

General and administrative expenses increased 32.4% from €24.2 million in 2021, to €32.1 million in 2022. The increase predominately relates to higher personnel and share-based payment expenses and an increase in insurance premiums and higher consulting costs.

Net finance income for the year decreased from €6.5 million in 2021, to €2.1 million in 2022. Net finance income is largely due to foreign exchange gains related to assets denominated in U.S. dollars as a result of currency fluctuations between the U.S. dollar and Euro during the year.

Net loss for the year ended December 31, 2022, was €86.0 million, or €0.60 loss per common share compared with a net loss of €57.5 million, or €0.48 loss per common share, for the year ended December 31, 2021.

The weighted number of common shares outstanding for the year ended December 31, 2022 was 142.4 million.

Additional information regarding these results will be included in the notes to the consolidated financial statements as of December 31, 2022, included in Affimed’s filings with the U.S. Securities and Exchange Commission (SEC).

Note on International Financial Reporting Standards (IFRS)

Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the IASB. None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles in the United States. Affimed maintains its books and records in Euro.

Conference Call and Webcast Information

Affimed will host a conference call and webcast on March 23, 2023, at 8:30 a.m. EDT / 13:30 CET to discuss full year and Q4 2022 financial results and corporate developments.

The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source To access the call by phone, please use link:

https://register.vevent.com/register/BIbfecf0c35a2946dc88d3ae439cb5d3e2, and you will be provided with dial-in details and a pin number.

Note: To avoid delays, we encourage participants to dial into the conference call 15 minutes ahead of the scheduled start time. A replay of the webcast will be accessible at the same link for 30 days following the call.

On March 23, 2023 Capstan Therapeutics, Inc., a biotechnology company dedicated to advancing in vivo reprogramming of cells through targeted lipid nanoparticles, reported that Capstan management will participate in the following upcoming investor conferences (Press release, Capstan Therapeutics, MAR 23, 2023, View Source [SID1234629273]).

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BMO Biopharma Spotlight Series: Novel Technologies for the Delivery of Genetic Medicines

Founding Chief Scientific Officer and Executive Vice President of R&D, Adrian Bot, M.D., Ph.D., will participate in a panel discussion titled "Novel LNPs Targeting Diverse Tissues" at 10:00 a.m. ET on Tuesday, March 28, 2023, at the virtual BMO Biopharma Spotlight Series: Novel Technologies for the Delivery of Genetic Medicines.

2nd Annual Goldman Sachs Healthcare Disruption Conference

President and Chief Executive Officer, Laura Shawver, Ph.D., will attend the Goldman Sachs Healthcare Disruption Conference in New York City and will participate in a panel discussion titled "The Cell Therapy Re-Awakening" at 2:15 p.m. ET on Tuesday, April 4, 2023.

About Capstan (www.capstantx.com)

On March 23, 2023 Incyte (Nasdaq:INCY) reported that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for ruxolitinib extended-release (XR) tablets, a JAK1/JAK2 inhibitor, for once-daily (QD) use in the treatment of certain types of myelofibrosis (MF), polycythemia vera (PV) and graft-versus-host disease (GVHD) (Press release, Incyte, MAR 23, 2023, View Source [SID1234629271]).

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The complete response letter states that the FDA cannot approve the application in its present form. The FDA acknowledged that the study submitted in the New Drug Application (NDA) met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval. Incyte intends to meet with the FDA to determine appropriate next steps.

"While we are disappointed that the FDA issued a complete response letter for ruxolitinib extended-release tablets, we remain committed to advancing care for people with myeloproliferative neoplasms and GVHD," said Hervé Hoppenot, Chief Executive Officer, Incyte. "We will work closely with the FDA on the appropriate next steps to address their comments."

The NDA was based on two studies designed to show that ruxolitinib XR tablets are dosage strength proportional and bioequivalent to Jakafi (ruxolitinib) tablets. The first study was designed to determine the relative bioavailability of ruxolitinib XR tablets to Jakafi tablets and to demonstrate that ruxolitinib XR tablets are dosage strength proportional to Jakafi tablets. The second study was an open-label, randomized, two-period, two-way crossover study in 63 healthy adults evaluating the bioequivalence of the highest strength of ruxolitinib XR tablets (50 mg) dosed once-daily (QD) to the highest strength of Jakafi tablets (25 mg) dosed twice-daily (BID), following a single dose and at steady-state. Study results demonstrated that ruxolitinib XR 50 mg tablets dosed QD is bioequivalent to Jakafi 25 mg tablets dosed BID, based on AUC parameters.

About Jakafi (ruxolitinib)
Jakafi (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older1.

Jakafi is a registered trademark of Incyte.

Important Safety Information

Jakafi can cause serious side effects, including:

Low blood counts: Jakafi (ruxolitinib) may cause low platelet, red blood cell, and white blood cell counts. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will do a blood test to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.

Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.

Cancer: Some people have had certain types of non-melanoma skin cancers during treatment with Jakafi. Your healthcare provider will regularly check your skin during your treatment with Jakafi. Tell your healthcare provider if you develop any new or changing skin lesions during treatment with Jakafi.

Increases in cholesterol: You may have changes in your blood cholesterol levels during treatment with Jakafi. Your healthcare provider will do blood tests to check your cholesterol levels about every 8 to 12 weeks after you start taking Jakafi, and as needed.

Increased risk of major cardiovascular events such as heart attack, stroke or death in people who have cardiovascular risk factors and who are current or past smokers while using another JAK inhibitor to treat rheumatoid arthritis: Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Jakafi, including: discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back, severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw, pain or discomfort in your arms, back, neck, jaw, or stomach, shortness of breath with or without chest discomfort, breaking out in a cold sweat, nausea or vomiting, feeling lightheaded, weakness in one part or on one side of your body, slurred speech

Increased risk of blood clots: Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) have happened in people taking another JAK inhibitor for rheumatoid arthritis and may be life-threatening. Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with Jakafi, including: swelling, pain, or tenderness in one or both legs, sudden, unexplained chest or upper back pain, shortness of breath or difficulty breathing

Possible increased risk of new (secondary) cancers: People who take another JAK inhibitor for rheumatoid arthritis have an increased risk of new (secondary) cancers, including lymphoma and other cancers. People who smoke or who smoked in the past have an added risk of new cancers.

The most common side effects of Jakafi include: for certain types of myelofibrosis (MF) and polycythemia vera (PV) – low platelet or red blood cell counts, bruising, dizziness, headache, and diarrhea; for acute GVHD – low platelet counts, low red or white blood cell counts, infections, and swelling; and for chronic GVHD – low red blood cell or platelet counts and infections including viral infections.

These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Call your doctor for medical advice about side effects.

Before taking Jakafi, tell your healthcare provider about: all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had low white or red blood cell counts, have or had tuberculosis (TB) or have been in close contact with someone who has TB, had shingles (herpes zoster), have or had hepatitis B, have or had liver or kidney problems, are on dialysis, have high cholesterol or triglycerides, had cancer, are a current or past smoker, had a blood clot, heart attack, other heart problems or stroke, or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change your dose or stop taking Jakafi without first talking to your healthcare provider.

Women should not take Jakafi while pregnant or planning to become pregnant. Do not breastfeed during treatment with Jakafi and for 2 weeks after the final dose.

Please see the Full Prescribing Information, which includes a more complete discussion of the risks associated with Jakafi.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

You may also report side effects to Incyte Medical Information at 1-855-463-3463.

On March 23, 2023 Pionyr Immunotherapeutics, Inc., a company developing first-in-class Myeloid TuningTM antibody therapeutics that enhance the body’s anti-tumor immunity by altering, or "tuning," immune cells within the tumor microenvironment, reported that Pionyr and Gilead Sciences, Inc. (Nasdaq: GILD) have mutually agreed to change their 2020 exclusive option agreements. Gilead has waived its exclusive option to acquire Pionyr and certain other rights under the 2020 agreements (Press release, Pionyr Immunotherapeutics, MAR 23, 2023, View Source [SID1234629270]). Gilead will retain its 49% equity stake in Pionyr as well as its right, under certain conditions, to review new data as it emerges. Pionyr is now free to pursue fundraising and partnering opportunities as part of its ongoing strategy.

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"We’ve made significant progress with our Myeloid Tuning platform and our clinical stage pipeline, and we are in a strong position to reach multiple inflection points for all of our programs in the next 12 to 18 months"

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"We’ve made significant progress with our Myeloid Tuning platform and our clinical stage pipeline, and we are in a strong position to reach multiple inflection points for all of our programs in the next 12 to 18 months," noted Steven P. James, Chief Executive Officer of Pionyr. "We have appreciated the collaboration with Gilead over the last two and a half years, and their support has put us in a strong position to continue our mission of dramatically improving the treatment of cancer."

Pionyr is continuing Phase 1b development of two monoclonal antibody drugs targeting TREM1 and TREM2 and is poised to file an IND this year for a third program targeting MARCO. TREM2, TREM1 and MARCO represent novel targets present on distinct populations of myeloid cells in the tumor microenvironment associated with suppression of the immune response to multiple tumor types. In Phase 1a and 1b studies, PY314 and PY159 have demonstrated encouraging safety and tolerability both alone and in combination with pembrolizumab warranting further clinical investigation. PY314, PY159 and PY265 are first-in-class assets that target these cellular populations to enhance anti-tumor immunity.

In 2020, Gilead paid $275 million for its equity stake in Pionyr and agreed to fund Pionyr’s clinical and research activities in exchange for an exclusive option to acquire Pionyr for a pre-set price and contingent payments. As part of this agreement, Gilead waives its exclusive option to acquire Pionyr. Pionyr will be responsible for ongoing development of its pipeline, which includes PY159, PY314 and PY265. The company has the resources to advance its pipeline for the next two years. Within that timeframe, Pionyr will continue enrollment in Phase 1b expansion cohorts for both PY159 and PY314 in the refractory setting and is planning to add new frontline cohorts for both candidates. Pionyr has also completed IND-enabling studies for PY265 and will be ready to file an IND for that program in 2023.

About Myeloid TuningTM

Pionyr has developed a therapeutic platform called Myeloid TuningTM, a process that rebalances the tumor microenvironment (TME) to promote anti-tumor immunity. Myeloid cells are a type of immune cell and are part of a family of cell types that regulate both the activation and suppression of the immune response to cancer.

One such critical type of myeloid cell, tumor-associated macrophages (TAMs), are a key component of the TME. TAMs are generally categorized into two functionally contrasting subtypes, called M1-like and M2-like macrophages. M1-like macrophages are inflammatory and have anti-tumor functions, including directly mediating antibody-dependent cell-mediated cytotoxicity (ADCC) to kill tumor cells.

Alternatively, M2-like macrophages are immune suppressive, and thereby inhibit T-cell-mediated anti-tumor responses, allowing for tumor angiogenesis, growth, and progression.

Myeloid Tuning describes the process of introducing agents that shift the balance of inhibitory myeloid cells—including M2-like TAMs—toward a more inflammatory, M1-like phenotype, to promote anti-tumor immune responses in the TME that destroy solid tumors.

On March 23, 2023 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its consolidated financial results1 for the year ending December 31, 2022 (Press release, Innate Pharma, MAR 23, 2023, View Source [SID1234629269]). The consolidated financial statements are attached to this press release.

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"In 2022 we made important progress in our pipeline, both on our clinical and preclinical projects as well as maintaining a strong financial position. We’re continuing to see encouraging efficacy signals for our proprietary program lacutamab in advanced cutaneous T cell lymphomas. In the meantime, our innovative R&D pipeline progression was marked by the expansion of our partnership with Sanofi to develop new NK Cell Engager Therapeutics from our ANKET platform, including solid tumors. The Sanofi collaboration is an example of how we use partnerships to build value at Innate, also underlined by our partnership with AstraZeneca for monalizumab which is in a Phase 3 trial for non-small cell lung cancer," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "As we look to progress our pipeline in house or with partnerships, we look forward to new milestones in 2023 with important inflection points, including final readouts from the TELLOMAK Phase 2 trial with lacutamab and further updates for our ANKET assets."

Webcast and conference call will be held today at 2:00pm CET (9:00am EDT)

Access to live webcast:

View Source

Participants may also join via telephone using the registration link below:

View Source

This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com.

A replay of the webcast will be available on the Company website for 90 days following the event.

1 This press release contains financial data approved by the Executive Board based on our consolidated financial statements for the year ended December 31, 2022. The audit is in progress at the date of this communication.

2 Including short term investments (€17.3m) and non-current financial instruments (€35.1m).

Pipeline highlights:

Lacutamab (IPH4102, anti-KIR3DL2 antibody):

Innate continues to see progress for lacutamab with final data from the TELLOMAK Phase 2 trial for both mycosis fungoides and Sézary syndrome expected in H2 2023.
In preliminary results confirming clinical activity and a favorable safety profile in patients with mycosis fungoides (MF) who were previously treated with at least two lines of systemic therapy, lacutamab produced a global objective response rate (ORR) of 28.6% (95% confidence interval [CI]: 13.8-50.0) in the KIR3DL2-expressing MF patients (n=21), including 2 complete responses and 4 partial responses (EORTC-CLTG (European Organisation for Research and Treatment of Cancer – Cutaneous Lymphoma Tumours Group) 2022 meeting – September 2022).
In a preliminary analysis, lacutamab demonstrated clinical activity and a favorable safety profile in heavily pretreated, post-mogamulizumab patients with advanced Sézary syndrome. In the Intention To Treat (ITT) population (n=37), the global ORR was 21.6% (8/37). ORR in the blood was 37.8% (95% CI: 24.1-53.9), with 21.6% (8/37) achieving complete response (CR). ORR in the skin was 35.1% (95% CI: 21.8-51.2). In the Evaluable for Efficacy (EES) population (n=35), global objective response rate (ORR) was 22.9% (8/35). ORR in the blood was 40.0% (95% CI: 25.6-56.4) and ORR in the skin was 37.1% (95% CI: 23.2 53.7) (2022 ASH (Free ASH Whitepaper) (American Society Hematology) Annual Meeting – December 2022).
Two parallel clinical trials to study lacutamab in patients with KIR3DL2-expressing, relapsed/refractory peripheral T-cell lymphoma (PTCL) are ongoing. Initial PTCL data are expected in H2 2023.
Phase 1b trial: a Company-sponsored Phase 1b clinical trial to evaluate lacutamab as a monotherapy in patients with KIR3DL2-expressing relapsed PTCL. A poster on the trial design was presented at the ESMO (Free ESMO Whitepaper) (European Society for Medical Oncology) 2022 conference.
Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial: The Lymphoma Study Association (LYSA) initiated an investigator-sponsored, randomized trial to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine in combination with oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL.
ANKET (Antibody-based NK cell Engager Therapeutics):

ANKET is Innate’s proprietary platform for developing next-generation, multi-specific NK cell engagers to treat certain types of cancer. Innate’s pipeline includes four public drug candidates born from the ANKET platform: IPH6101 (CD123-targeted), IPH6401 (BCMA-targeted), IPH62 (B7-H3-targeted) and tetra-specific IPH6501 (CD20-targeted). Several other undisclosed proprietary preclinical targets are being explored.

IPH6101, IPH6401 and IPH62 (partnered with Sanofi)

The Phase 1/2 clinical trial by Sanofi is progressing well, evaluating IPH6101/SAR’579, the first NKp46/CD16-based CD123-targeted ANKET platform NK cell engager, in patients with relapsed or refractory acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia or high-risk myelodysplastic syndrome.
Preclinical data showing the control of AML cells by a trifunctional NKp46-CD16a-NK cell engager targeting CD123 were published in Nature Biotechnology in January 2023.
On July 21, 2022, the Company announced that its partner Sanofi had made the decision to progress IPH6401/SAR’514, a BCMA-targeting NK cell engager into investigational new drug (IND)-enabling studies. Selection of IPH6401/SAR’514 triggered a €3M milestone payment to Innate.
As announced on December 19, 2022, Sanofi licensed IPH62, a NK cell engager program targeting B7-H3 from Innate’s ANKET platform. Sanofi also have the option to add up to two additional ANKET targets. Upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization. Under the terms of the agreement, Innate received a €25m upfront payment and is eligible for up to €1.35bn total in preclinical, clinical, regulatory and commercial milestones plus royalties on potential net sales.
IPH6501 (proprietary)

Progress continues toward a Phase 1 clinical trial in 2023 for the proprietary CD20 targeted tetra-specific ANKET, IPH6501.
An October 2022 edition of Cell Reports Medicine described the development of Innate’s fit-for-purpose ANKET antibody-based tetra-specific molecule to harness the antitumor functions of NK cells, boosting their capacity to proliferate, to accumulate at the tumor site and to kill tumor cells.
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

Innate continues to see progress for monalizumab in the early non-small cell lung cancer (NSCLC) setting, with the ongoing Phase 3 PACIFIC-9 study run by AstraZeneca. The study is evaluating durvalumab (anti-PD-L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III NSCLC who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT).
On April 29, 2022, Innate announced a $50 million milestone payment from AstraZeneca was triggered for dosing the first patient in the PACIFIC-9 Phase 3 clinical trial.
Detailed results from the randomized AstraZeneca-sponsored Phase 2 COAST clinical trial, including monalizumab data in combination with durvalumab, were published in the Journal of Clinical Oncology in April 2022. The results were initially presented during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021. The results of the interim analysis showed monalizumab in combination with durvalumab reduced the risk of disease progression by 58% (improved progression-free survival (PFS) with a hazard ratio of 0.42) and improved objective response rate (ORR) compared to durvalumab alone in patients with unresectable, Stage III NSCLC who had not progressed after concurrent CRT. The Journal of Clinical Oncology publication includes exploratory subgroup analysis.
Partner AstraZeneca presented data from Phase 2 NeoCOAST randomized trial in resectable, early-stage NSCLC at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and ESMO (Free ESMO Whitepaper) 2022 congress. The presentations highlighted improved disease responses with durvalumab in combination with monalizumab, oleclumab or danvatirsen, when compared to durvalumab alone. The follow-up randomized Phase 2 clinical trial, NeoCOAST-2, is enrolling patients with resectable, stage IIA-IIIB NSCLC to receive neoadjuvant durvalumab combined with chemotherapy and either oleclumab or monalizumab, followed by surgery and adjuvant durvalumab plus oleclumab or monalizumab.
On August 1, 2022, Innate announced that a planned futility interim analysis of the Phase 3 INTERLINK-1 study sponsored by AstraZeneca did not meet a pre-defined threshold for efficacy. The Company announced that, based on the result and the recommendation of an Independent Data Monitoring Committee, the study was to be discontinued. There were no new safety findings. AstraZeneca plan to share the data in due course. The INTERLINK-1 study evaluated monalizumab in combination with cetuximab vs. cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors.
IPH5201 (anti-CD39), partnered with AstraZeneca:

The MATISSE Phase 2 clinical trial conducted by Innate in neoadjuvant lung cancer for IPH5201, an anti-CD39 blocking monoclonal antibody developed in collaboration with AstraZeneca, has started and is awaiting first patient dosed.
In August 2022 Innate received a $5 million milestone payment from AstraZeneca and will be responsible for conducting the study. AstraZeneca and Innate will share study costs and AstraZeneca will supply clinical trial drugs.
Preclinical data supporting the rationale for the Phase 2 development in NSCLC were presented at the 2022 ESMO (Free ESMO Whitepaper) Immuno-Oncology (IO) Annual Congress in December.
AstraZeneca conducted a Phase 1 trial in solid tumors with IPH5201 alone or in combination with durvalumab and presented a poster entitled "IPH5201 as Monotherapy or in Combination with Durvalumab in Advanced Solid Tumours" at the 2022 ESMO (Free ESMO Whitepaper) IO Annual Congress in December.
IPH5301 (anti-CD73):

The investigator-sponsored CHANCES Phase 1 trial of IPH5301, in collaboration with Institut Paoli-Calmettes is ongoing. The trial will be conducted in two parts, Part 1, the dose escalation, followed by a Part 2 safety expansion study cohort. Part 2 will evaluate IPH5301 in combination with chemotherapy and trastuzumab in HER2+ cancer patients. The design of the Phase 1 study was highlighted at the 2022 ESMO (Free ESMO Whitepaper) IO congress in December.
Avdoralimab (anti-C5aR1):

The Company has decided to discontinue the development of avdoralimab in bullous pemphigoid. The Company will continue to evaluate out-licensing as a potential next step.
Preclinical assets:

Fueling the R&D engine, the Company continues to develop different approaches for the treatment of cancer utilizing its antibody engineering capabilities to deliver novel assets, with its innovative ANKET platform and continuing to explore Antibody Drug Conjugates (ADC) formats.
During the period, the Company received from AstraZeneca a notice that it will not exercise its option to license the four preclinical programs covered in the "Future Programs Option Agreement". This option agreement was part 2018 multi-term agreement between AstraZeneca and Innate. Innate regained full rights to further develop the four preclinical molecules.
Corporate Update:

On May 3, 2022 Innate announced the commencement of an At-The-Market (ATM) program, pursuant to which it may, from time to time, offer and sell to eligible investors a total gross amount of up to $75 million American Depositary Shares ("ADS"). Each ADS representing one ordinary share of Innate. As of December 31, 2022, the balance available under our May 2022 sales agreement remains at $75 million.
Dr Sally Bennett was appointed as new member of the Supervisory Board in May 2022. She was appointed as a member of the Audit Committee. On the same date it was announced that Mr Patrick Langlois decided to resign from his mandate of Supervisory Board member of Innate Pharma.
In January 2023, Mrs Claire de Saint Blanquat, Vice President Legal and Corporate Affairs, and Mr Henry Wheeler, Vice President Investor Relations and Communications, were appointed to the Leadership Team.
Financial highlights for 2022:

The key elements of Innate’s financial position and financial results as of and for the year ended December 31, 2022 are as follows:

Cash, cash equivalents, short-term investments and financial assets amounting to €136.6 million (€m) as of December 31, 2022 (€159.7m as of December 31, 2021), including financial instruments amounting to €35.1m (€39.9m as of December 31, 2021). Cash, cash equivalents as of December 31, 2022 do not include the €25.0 million payment received from Sanofi in March 2023.
As of December 31, 2022, financial liabilities amount to €42.3m (€44.3m as of December 31, 2021). In August 2022, the Company obtained an extension for a period of five year (starting in 2022) with a one-year grace period (2023) of its State-Guaranted Loans (Prêts Garantis par l’Etat "PGE") from Société Générale (€20.0m) and BNP Paribas (€8.7m).
Revenue and other income from continuing operations amounted to €57.7m in 2022 (2021: €24.7m). It mainly comprises revenue from collaboration and licensing agreements (€49.6m in 2022 vs €12.1m in 2021), and research tax credit (€7.9m in 2022 vs €10.3m in 2021, -23.1%):
Revenue from collaboration and licensing agreements, which mainly resulted from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca and Sanofi and which are recognized on the basis of the percentage of completion of the works performed by the Company under such agreements:
(i) Revenue from collaboration and licensing agreements for monalizumab increased by €14.9m to €22.4m in 2022 (€7.5m in 2021). This change mainly results from the transaction price increase of €13.4m ($14.0m) triggered by the launch of the "PACIFIC-9" Phase 3 trial announced on April 29, 2022. This change in the transaction price generated a €12.6 million favorable cumulative adjustment in the revenue related to monalizumab agreements for the first half of 2022, partially offset by effects of the decrease in direct monalizumab research and development costs over the period as compared to the first half of 2021, in connection with the Phase 1 & 2 trials maturity;
(ii) Revenue related to IPH5201 for the year ended 2022 amounted to €4.7m and results from the entire recognition in revenue of the $5.0m milestone payment received in August 2022 from AstraZeneca following the signature on June 1, 2022 of an amendment to the initial contract signed in October 2018. This amendment sets the terms of the collaboration following AstraZeneca’s decision to advance IPH5201 to a Phase 2 study;
(iii) During 2022 first semester, the Company received from AstraZeneca a notice that it will not exercise its option to license the four preclinical programs covered in the "Future Programs Option Agreement". This option agreement was part of the 2018 multi-term agreement between AstraZeneca and the Company under which the Company received an upfront payment of $20.0m (€17.4m). Innate has now regained full rights to further develop the four preclinical molecules. Consequently, the entire initial payment of $20.0m, or €17.4m was recognized as revenue in 2022.
(iv) During 2022 first semester, the Company was informed of Sanofi’s decision to advance IPH6401/SAR’514 into investigational new drug (IND)-enabling studies. As such, Sanofi has selected a second multispecific antibody engaging NK cells as a drug candidate. This selection triggered a €3.0m milestone payment from Sanofi. This amount was received by the Company on September 9, 2022.
The variation in the research tax credit mainly results from a decrease in the amortization for the intangible assets related to acquired licenses (monalizumab and IPH5201) and to the decrease in personnel expenses allocated to research and development operations. In addition, there was a decrease in public subcontracting included in the calculation of the CIR. This decrease is the consequence of the end of the doubling of public subcontracting expenses eligible for the CIR since January 1, 2022, partly offset by an increase in private subcontracting expenses with accredited suppliers.
Operating expenses from continuing operations amounted to €74.1m in 2022 (2021: €72.5m, +2.2%):
General and administrative (G&A) expenses from continuing activities amounted to €22.4m in 2022 (2021: €25.5m, -12.1%). This variation results cumulatively from (i) a decrease in wages mainly resulting from restructuring costs and higher annual bonuses level in 2021, (ii) a decrease in non-scientific advisory fees and (iii) a decrease in other general and administrative expenses.
Research and development (R&D) expenses from continuing activities amounted to €51.7m in 2022 (2021: €47.0m, 9.9%). This variation mainly results from (i) an increase in direct research and development expenses (clinical and non-clinical) and (ii) an increase in other indirect research and development expenses, mainly linked to non-scientific and scientific fees.
The avdoralimab intangible asset (anti-C5aR rights) total impairment of €41.0m (non-cash expense) following the Company’s decision to stop avdoralimab development in bullous pemphigoid indication in inflammation.
A net financial income of €0.5m in 2022 (2021: €2.3m gain).
A net loss from Lumoxiti discontinued operations of €0.1m in 2022 (2021: net loss of €7.3m, -98.2%). This decrease mainly resulted from the Settlement Amount of $6.2m (€5.5m as of December 31, 2021) paid to AstraZeneca in April 2022 for an amount of €5.9m under the Termination and Transition agreement.
A net loss of €58.1m in 2022 (2021: net loss of €52.8m).
The table below summarizes the IFRS consolidated financial statements as of and for the year ended December 31, 2022, including 2021 comparative information.

In thousands of euros, except for data per share

December 31, 2022

December 31, 2021

Revenue and other income

57,674

24,703

Research and development

(51,663)

(47,004)

Selling, general and administrative

(22,436)

(25,524)

Total operating expenses

(74,099)

(72,528)

Operating income (loss) before impairment

(16,425)

(47,825)

Impairment of intangible asset

(41,000)

—

Operating income (loss) after impairment

(57,425)

(47,825)

Net financial income (loss)

(546)

2,347

Income tax expense

—

—

Net income (loss) from continuing operations

(57,972)

(45,478)

Net income (loss) from discontinued operations

(131)

(7,331)

Net income (loss)

(58,103)

(52,809)

Weighted average number of shares outstanding (in thousands)

79,640

79,543

Basic income (loss) per share

(0.73)

(0.66)

Diluted income (loss) per share

(0.73)

(0.66)

Basic income (loss) per share from continuing operations

(0.73)

(0.57)

Diluted income (loss) per share from continuing operations

(0.73)

(0.57)

Basic income (loss) per share from discontinued operations

—

(0.09)

Diluted income (loss) per share from discontinued operations

—

(0.09)

December 31, 2022

December 31, 2021

Cash, cash equivalents and financial asset

136,604

159,714

Total assets

207,863

267,496

Shareholders’ equity

54,151

107,440

Total financial debt

42,251

44,251