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Innate Pharma(IPHA) - 2023 Q2 - Quarterly Report
2023-09-14 10:27
The following interim condensed consolidated financial statements have been approved by the Executive Board of the Company on September 13, 2023, and have been subject to a limited review by our Statutory Auditors. They have been examined by the Supervisory Board of the Company on September 13, 2023. INNATE PHARMA SA HALF-YEAR FINANCIAL REPORT JUNE 30, 2023 INNATE PHARMA S.A. French société anonyme governed by an Executive Board and a Supervisory Board with a share capital of 4,026,535.85 euros composed of ...
Innate Pharma(IPHA) - 2023 Q1 - Earnings Call Presentation
2023-05-14 02:34
Disclaimer on Forward-Looking Information and Risk Factors This document contains forward-looking statements. The use of certain words, including "believe," "potential," "expect" and "will" and similar expressions, is intended to i statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to various risks and uncertairi cause the Company's actual results or financial condition to differ materially from those anticipated. Thes ...
Innate Pharma(IPHA) - 2023 Q1 - Earnings Call Transcript
2023-05-14 02:17
Financial Data and Key Metrics Changes - The company ended Q1 2023 with a strong cash position, providing a runway into mid-2025, indicating effective resource management [16][44]. - The financial outlook remains stable with no significant changes in cash burn expected compared to previous communications [44]. Business Line Data and Key Metrics Changes - The lead proprietary asset, lacutamab, is in development for T-cell lymphoma, with final readouts expected in the second half of 2023 [3][54]. - The company is actively pursuing a fast-to-market strategy for lacutamab, which has received U.S. Fast Track and EU PRIME designations [54][56]. - The ANKET platform continues to expand, with multiple candidates in development, including IPH6501 targeting CD20, which is heading towards an IND this year [69][95]. Market Data and Key Metrics Changes - The company is focusing on niche markets such as Sézary syndrome and mycosis fungoides, with encouraging preliminary data from Phase II trials [86][64]. - The partnership with AstraZeneca for monalizumab is ongoing, with updates expected from the PACIFIC-9 study evaluating combinations in lung cancer [57][89]. Company Strategy and Development Direction - The company aims to maximize the ANKET platform and build strategic partnerships in oncology and beyond, as demonstrated by the recent deal with Takeda [42][94]. - The strategic priorities include advancing lacutamab, maximizing the ANKET platform, and continuing to build partnerships [42][76]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing regulatory discussions and the potential for lacutamab to meet significant unmet needs in aggressive disorders [34][18]. - The company is encouraged by the responses observed in clinical trials and is committed to further interactions with regulators [7][56]. Other Important Information - The recent deal with Takeda includes an upfront payment of $5 million and potential milestones totaling up to $410 million, showcasing the company's ability to monetize its pipeline [94]. - The company is leveraging its antibody engineering capabilities to develop novel molecules, focusing on both proprietary and partnered assets [61][85]. Q&A Session Summary Question: Regulatory strategy for lacutamab - Management confirmed ongoing discussions with the FDA regarding the regulatory strategy for lacutamab, emphasizing alignment with FDA guidelines [18]. Question: Rationale for using ADC in Celiac disease - Management stated that they are not experts in Celiac disease and referred to Takeda for more details on the rationale behind the ADC development [25]. Question: Context for upcoming oral presentation of CD123 ANKET at ASCO - Management indicated that the Phase I trial started in December 2021, focusing on AML and MDS, but could not disclose specific patient numbers or data points due to partnership agreements [26]. Question: Additional work needed for CD20-targeted ANKET to reach IND - Management confirmed that IND filing for the CD20-targeted ANKET is planned for this year, with the start of Phase I trials also expected in 2023 [31][32]. Question: Expected data from PTCL studies - Management highlighted that PTCL is an aggressive disorder with high unmet needs, and response rates from various agents typically range from 25% to 40% [34].
Innate Pharma(IPHA) - 2022 Q4 - Annual Report
2023-04-06 10:41
Financial Performance - Revenue for 2022 was €57,674,000, a decrease of 76.5% from €69,773,000 in 2020[32] - Operating loss for 2022 was €57,425,000, compared to an operating income of €1,079,000 in 2020[32] - Net loss from continuing operations in 2022 was €57,972,000, compared to a net loss of €829,000 in 2020[32] - Total assets decreased to €207,863,000 in 2022 from €307,423,000 in 2020, a decline of 32.4%[33] - Total shareholders' equity fell to €54,151,000 in 2022, down 65.2% from €155,976,000 in 2020[33] - Innate Pharma incurred net losses of €(58.1) million and €(52.8) million for the years ended December 31, 2022 and 2021, respectively[162] - The company expects to incur significant expenses and operating losses for the foreseeable future due to ongoing research and development activities[162] - As of December 31, 2022, Innate Pharma had cash, cash equivalents, short-term investments, and non-current financial assets totaling €136.6 million, which is expected to fund operations for the next two years[166] - The company anticipates that expenses will increase substantially as it advances its product candidates through clinical trials and regulatory approvals[166] Product Development and Clinical Trials - The company is focusing on developing product candidates in immuno-oncology, with several in clinical trials[38] - Monalizumab is currently being investigated in multiple Phase 1, 2, and 3 clinical trials under a co-development agreement with AstraZeneca[53] - The company has agreements with AstraZeneca and Sanofi for the development of several product candidates, indicating a collaborative approach to R&D[51] - The company returned Lumoxiti commercial rights to AstraZeneca to refocus on its R&D portfolio[37] - The Company has not yet completed clinical trials for product candidates including monalizumab, lacutamab, and others, and there is no assurance they will gain regulatory approval or become commercially viable[54] - The Company is developing a broad pipeline of product candidates based on its ANKET technology, which includes tri-specific and tetra-specific antibodies, with IPH6101/SAR'579 currently in Phase 1 clinical trials[59] - Patient enrollment for clinical trials is critical and may be delayed due to various factors, including the limited patient population for rare diseases like cutaneous T-cell lymphoma[64] - The Company competes with larger pharmaceutical companies that have significantly greater resources and experience in drug development and regulatory approvals[68] Regulatory Challenges - The marketing approval process for the Company's product candidates is complex and may prevent the commercialization of some or all candidates, materially impairing revenue generation[71] - The Company has never submitted a product candidate for marketing approval in the United States or the European Union, which poses additional challenges[74] - Regulatory processes for product candidates are complex and may lead to delays or increased costs in development, testing, and marketing[79] - The company faces significant risks in obtaining marketing authorization in jurisdictions outside the United States and Europe, which could limit market potential[83] - The company must navigate varying regulatory requirements across different countries, which complicates the approval process[83] - Regulatory authorities may require additional testing or impose new requirements that could delay product launches[82] - The evolving nature of regulatory requirements may result in unexpected costs and challenges in obtaining approvals[79] Financial Obligations and Funding - The company may need to raise additional funding to complete the development and commercialization of its product candidates, which may not be available on acceptable terms[165] - The company has accumulated tax loss carryforwards of €466.2 million as of December 31, 2022, with limitations on their use under applicable French law[185] - The company received cash payments from collaboration agreements amounting to €56.9 million, €15.3 million, and €57.8 million for the years ended December 31, 2022, 2021, and 2020, respectively[177] - The company benefits from the Research Tax Credit, which represented €7.9 million, €10.3 million, and €13.1 million for the years ended December 31, 2022, 2021, and 2020, respectively[180] - The company may be eligible for approximately $3.6 billion in future contingent payments from existing collaboration agreements, dependent on the achievement of specified milestones[175] Compliance and Legal Risks - The company is subject to various anti-corruption laws, including the FCPA, which could lead to significant penalties if compliance is not maintained[125] - Compliance with healthcare laws and regulations is essential, as violations could result in substantial penalties, reputational harm, and operational disruptions[131] - The Company faces potential increased costs and operational risks due to the complexities of compliance with various data protection regulations in the European Union[136] - The company has implemented a new Enterprise Resource Planning (ERP) system since August 1, 2020, to enhance the reliability of its financial information[197] - Despite improvements, management concluded that a material weakness still exists, primarily related to the classification and presentation of consolidated financial statements[198] - The company has initiated corrective actions to address identified control deficiencies, but there is no assurance that these measures will prevent future material weaknesses[199] Manufacturing and Supply Chain Risks - The Company relies on third-party manufacturers for all product candidates, lacking its own manufacturing capabilities, which introduces risks related to regulatory compliance and product quality[137] - Manufacturing issues previously led to a decision to limit patient enrollment in the Phase 1 clinical trial of lacutamab to ensure drug supply[139] - The transfer of manufacturing to another contract organization took several months and incurred additional costs, delaying patient enrollment in clinical trials[141] - The Company is dependent on a limited number of suppliers for key components, which poses risks if these suppliers fail to remain operational or compliant[143] - Non-compliance with regulatory standards by third-party suppliers could result in sanctions, including fines and delays in product approvals[146] Market and Competitive Environment - The company faces significant risks in product development, including regulatory approval and market commercialization challenges[36] - The company faces potential penalties if commercial prices increase faster than the consumer price index, affecting pricing strategies[101] - Legislative changes may increase Medicaid rebate liabilities and expand eligibility criteria, impacting the company's financial obligations[99] - The company anticipates ongoing pricing pressures that may hinder the ability to sell approved products at acceptable prices[105] - International operations may be adversely affected by geopolitical instability, impacting sales and financial conditions[114] Employee and Operational Risks - The company faces intense competition for qualified scientific and medical personnel, which is crucial for its success in clinical trials and product development[214] - Employee misconduct poses risks, including violations of regulatory standards, which could harm Innate's business and reputation[227] - The company has subscribed to cyber and fraud insurance, but it may be insufficient to cover potential financial and reputational impacts from system disruptions[203] - The company has obtained liability insurance coverage for its clinical trials, limited to €10 million per year[224] - A successful product liability claim exceeding insurance coverage could significantly impact Innate's earnings and capital resources[226]
Innate Pharma(IPHA) - 2022 Q4 - Annual Report
2023-04-06 10:00
Reporting Information - The report is filed under Form 6-K for the month of April 2023[2] - The registrant has indicated it will file annual reports under Form 20-F[2] Company Information - Innate Pharma S.A. is based in Marseille, France, with a principal executive office address at 117 Avenue de Luminy—BP 30191, 13009 Marseille[2] Financial Updates - The report includes a press release dated April 6, 2023, which may contain key financial updates[3] Signatory Information - The report is signed by Mondher Mahjoubi, Chairman of the Executive Board and Chief Executive Officer[7]
Innate Pharma(IPHA) - 2022 Q4 - Earnings Call Presentation
2023-03-27 18:13
Europe Demonstrates better anti-tumor efficacy than approved benchmark antibodies in preclinical tumor models. | --- | --- | --- | --- | --- | --- | --- | --- | |------------------|----------------------|--------|-----------------------------------|----------------|-------|-----------------------|----------------| | | | | | | | | | | | IPH6101/SAR'579 | | IPH6401/SAR'514 | IPH62 | | OPTION | | | Ongoing programs | CD123 Phase 1 in AML | | Progression towards IND | B7-H3 Research | | 2 undisclosed targets | ...
Innate Pharma(IPHA) - 2022 Q4 - Earnings Call Transcript
2023-03-23 19:13
Financial Data and Key Metrics Changes - The revenue and other income amounted to €57.7 million, primarily from collaboration and licensing agreements and governmental funding [70] - Operating expenses were €74.1 million, a 1% increase compared to 2021, while R&D expenses rose by 10% to €51.7 million due to clinical and nonclinical research [71] - Cash and cash equivalents stood at €136.6 million as of December 31, 2022, with an additional €25 million payment from Sanofi expected to be added [51][52] Business Line Data and Key Metrics Changes - The company is focusing on its lead product candidate, lacutamab, which is in development for T cell lymphoma, with final readouts expected in the second half of 2023 [9][21] - The ANKET platform continues to progress, with Sanofi signing a second deal, and multiple programs in early development [11][39] - Monalizumab is advancing in Phase 3 trials for lung cancer, with AstraZeneca leading the efforts [12][25] Market Data and Key Metrics Changes - The company is expanding its presence in the NK cell space, leveraging its antibody engineering capabilities to develop innovative molecules [18][36] - The partnership with AstraZeneca for monalizumab is expected to yield significant milestones, with a total package of up to $1.275 billion [34] Company Strategy and Development Direction - The company aims to create near-term value through its proprietary product candidate lacutamab and to build a sustainable foundation through various partnerships [8][19] - The focus remains on maximizing the value of its products while advancing its R&D engine to create a sustainable business [10][54] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in clinical trials and partnerships, highlighting the importance of upcoming data readouts over the next 24 months [44][93] - The company is strategically managing resources to ensure continued investment in its vision and pipeline [40][55] Other Important Information - The company has received Fast Track designation for lacutamab in the U.S. and PRIME designation in the EU, indicating regulatory support for its development [29] - The company is exploring ADC technology alongside its ANKET platform, indicating a diversified approach to drug development [63] Q&A Session Summary Question: Can you elaborate on the registrational pathway for mycosis fungoides? - Management indicated that they are keeping options open for a complete registration trial on mycosis fungoides or a combination with Sézary syndrome, ensuring alignment with regulators [58][60] Question: Where does the linker payload technology for the ADC program come from? - The company confirmed that they have selected a development candidate for the ADC program IPH4501 and will provide updates later in the year [61] Question: What changes have occurred in the guidance for outcomes in CTCL? - Management noted that there have been clarifications in the guidance, and they will provide more details in upcoming calls [64][79] Question: Can you provide more details on the inclusion and exclusion criteria for the COMBO study? - The monotherapy trial is focused on KIR3DL2 positive patients with no maximum lines of therapy, while the COMBO study includes a comparator arm with chemotherapy [82][96] Question: How should we think about costs in 2023? - Management indicated that the cash burn for 2023 will be in the same range or slightly lower than previous years, allowing for funding of new studies without increasing costs [101]
Innate Pharma(IPHA) - 2023 Q1 - Quarterly Report
2023-03-23 10:00
[2022 Annual Report Overview](index=1&type=section&id=Innate%20Pharma%20Reports%20Full%20Year%202022%281%29%20Financial%20Results%20and%20Business%20Update) Innate Pharma advanced its clinical pipeline and maintained a strong financial position in 2022, marked by key partnerships and milestone payments [2022 Business and Financial Highlights](index=1&type=section&id=2022%20Business%20and%20Financial%20Highlights) In 2022, Innate Pharma advanced its clinical and preclinical pipeline, notably expanding its ANKET® platform partnership with Sanofi, which included a €25 million payment. The company reported encouraging efficacy data for lacutamab and received a $50 million milestone payment from AstraZeneca for monalizumab. The company maintained a solid financial position with a cash runway anticipated into mid-2025 - Expanded partnership with Sanofi for NK cell engager therapeutics, including the B7-H3 ANKET® program, resulting in a **€25 million payment**[3](index=3&type=chunk)[5](index=5&type=chunk) - Reported encouraging preliminary Phase 2 efficacy data for lacutamab in advanced cutaneous T cell lymphoma (Sézary syndrome and mycosis fungoides)[3](index=3&type=chunk)[5](index=5&type=chunk) - Received a **$50 million milestone payment** from AstraZeneca after the first patient was dosed in the monalizumab PACIFIC-9 Phase 3 lung cancer trial[5](index=5&type=chunk)[3](index=3&type=chunk) - Cash position was **€136.6 million** as of December 31, 2022, with an anticipated cash runway into mid-2025. This figure does not include the **€25 million payment** from Sanofi received post-period[5](index=5&type=chunk) [Pipeline Update](index=2&type=section&id=Pipeline%20highlights%3A) Innate Pharma's pipeline progressed with key clinical trials for lacutamab and ANKET® programs, alongside strategic advancements in partnered assets [Lacutamab (IPH4102)](index=2&type=section&id=Lacutamab%20%28IPH4102%2C%20anti-KIR3DL2%20antibody%29%3A) Lacutamab showed promising clinical activity and a favorable safety profile in advanced cutaneous T-cell lymphomas (CTCL). Final data from the TELLOMAK Phase 2 trial for mycosis fungoides (MF) and Sézary syndrome are expected in H2 2023. Additionally, two trials are ongoing for peripheral T-cell lymphoma (PTCL), with initial data also expected in H2 2023 - In the TELLOMAK Phase 2 trial, preliminary data for mycosis fungoides (MF) patients showed a global objective response rate (ORR) of **28.6%**[8](index=8&type=chunk) - For heavily pretreated Sézary syndrome patients, lacutamab demonstrated a global ORR of **21.6%** in the ITT population, with a **37.8% ORR** in blood and **35.1% ORR** in skin[8](index=8&type=chunk) - Two trials are ongoing for relapsed/refractory peripheral T-cell lymphoma (PTCL), a Phase 1b monotherapy trial and the Phase 2 KILT combination trial, with initial data for both expected in H2 2023[8](index=8&type=chunk) [ANKET® Platform](index=2&type=section&id=ANKET%C2%AE%20%28Antibody-based%20NK%20cell%20Engager%20Therapeutics%29%3A) The proprietary ANKET® platform is advancing with four public candidates. The partnership with Sanofi was expanded to include the B7-H3 targeted program (IPH62) and two additional targets, triggering a **€25 million** upfront payment. Sanofi is also progressing IPH6101 and IPH6401. Innate's proprietary tetra-specific ANKET®, IPH6501, is progressing towards a Phase 1 trial in 2023 - Sanofi licensed IPH62 (B7-H3 targeted) and has options for two more targets. Innate received a **€25 million upfront payment** and is eligible for up to **€1.35 billion** in milestones plus royalties[12](index=12&type=chunk) - Sanofi's decision to advance IPH6401 (BCMA-targeting) into IND-enabling studies triggered a **€3 million milestone payment** to Innate[12](index=12&type=chunk) - The proprietary CD20-targeted tetra-specific ANKET®, IPH6501, is on track for a Phase 1 clinical trial in 2023[10](index=10&type=chunk) [Monalizumab (Partnered with AstraZeneca)](index=3&type=section&id=Monalizumab%20%28anti-NKG2A%20antibody%29%2C%20partnered%20with%20AstraZeneca%3A) Monalizumab's development is focused on non-small cell lung cancer (NSCLC). The PACIFIC-9 Phase 3 trial in Stage III NSCLC is ongoing, triggering a **$50 million** milestone payment from AstraZeneca. However, the INTERLINK-1 Phase 3 study in head and neck cancer was discontinued due to futility - A **$50 million milestone payment** was received from AstraZeneca for dosing the first patient in the PACIFIC-9 Phase 3 trial for unresectable, Stage III NSCLC[13](index=13&type=chunk) - The Phase 3 INTERLINK-1 study in head and neck cancer was discontinued after a planned futility analysis did not meet the pre-defined efficacy threshold[13](index=13&type=chunk) - Phase 2 COAST trial results showed monalizumab with durvalumab reduced the risk of disease progression by **58%** (HR of **0.42**) compared to durvalumab alone in Stage III NSCLC[13](index=13&type=chunk) [Other Pipeline Assets](index=4&type=section&id=Other%20Pipeline%20Assets) The company is advancing other assets through partnerships and internal development. The MATISSE Phase 2 trial for IPH5201 (anti-CD39) in lung cancer has started, triggering a **$5 million** milestone from AstraZeneca. The Phase 1 trial for proprietary IPH5301 (anti-CD73) is ongoing. Conversely, development of avdoralimab (anti-C5aR1) in bullous pemphigoid has been discontinued - **IPH5201 (anti-CD39):** The MATISSE Phase 2 trial in neoadjuvant lung cancer has started, triggering a **$5 million milestone payment** from partner AstraZeneca[14](index=14&type=chunk)[17](index=17&type=chunk) - **IPH5301 (anti-CD73):** The investigator-sponsored CHANCES Phase 1 trial is ongoing, evaluating IPH5301 in combination therapy for HER2+ cancer patients[15](index=15&type=chunk) - **Avdoralimab (anti-C5aR1):** The company has discontinued the development of avdoralimab in bullous pemphigoid and will evaluate out-licensing options[16](index=16&type=chunk) [Corporate and Preclinical Update](index=5&type=section&id=Corporate%20Update%3A) Innate Pharma focused on advancing its ANKET® platform and ADCs, regained rights to preclinical programs, and made key corporate appointments in 2022 [Preclinical and Corporate Developments](index=5&type=section&id=Preclinical%20and%20Corporate%20Developments) Innate is focused on developing novel cancer treatments through its ANKET® platform and exploring Antibody Drug Conjugates (ADCs). The company regained full rights to four preclinical programs after AstraZeneca declined its option. Corporate actions in 2022 included establishing a **$75 million** At-The-Market (ATM) program, which remains unused, and making key appointments to the Supervisory Board and Leadership Team - Innate regained full rights to four preclinical molecules after AstraZeneca did not exercise its option under the "Future Programs Option Agreement"[19](index=19&type=chunk) - An At-The-Market (ATM) program was established to potentially offer and sell up to **$75 million** in American Depositary Shares (ADS), with the full amount remaining available as of year-end 2022[19](index=19&type=chunk) - Key leadership changes included the appointment of Dr. Sally Bennett to the Supervisory Board and two new members to the Leadership Team in January 2023[19](index=19&type=chunk) [Financial Performance](index=6&type=section&id=Financial%20highlights%20for%202022%3A) In 2022, Innate Pharma saw significant revenue growth from collaborations but reported an increased net loss due to a substantial non-cash impairment charge [Financial Summary](index=6&type=section&id=Financial%20Summary) For the year ended December 31, 2022, Innate Pharma's revenue more than doubled to **€57.7 million**, driven by collaboration agreements. However, the company recorded a net loss of **€58.1 million**, an increase from 2021, primarily due to a significant non-cash impairment charge of **€41.0 million** related to the discontinuation of the avdoralimab program. The company ended the year with a cash position of **€136.6 million** Financial Metric (in thousands of euros) | Financial Metric (in thousands of euros) | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | **Income Statement** | | | | Revenue and other income | 57,674 | 24,703 | | Total operating expenses | (74,099) | (72,528) | | Impairment of intangible asset | (41,000) | — | | Operating income (loss) | (57,425) | (47,825) | | Net income (loss) | (58,103) | (52,809) | | Basic loss per share (€) | (0.73) | (0.66) | | **Balance Sheet** | | | | Cash, cash equivalents and financial assets | 136,604 | 159,714 | | Total assets | 207,863 | 267,496 | | Shareholders' equity | 54,151 | 107,440 | | Total financial debt | 42,251 | 44,251 | - A significant non-cash impairment charge of **€41.0 million** was recorded for the avdoralimab intangible asset, following the decision to halt its development[22](index=22&type=chunk)[49](index=49&type=chunk) - Cash position stood at **€136.6 million** at year-end. This does not include a **€25.0 million payment** from Sanofi received in March 2023[22](index=22&type=chunk)[57](index=57&type=chunk) [Revenue Analysis](index=13&type=section&id=Revenue%20and%20other%20income) Total revenue and other income increased significantly to **€57.7 million** in 2022 from **€24.7 million** in 2021, primarily driven by a more than fourfold increase in collaboration and licensing agreements, partially offset by decreased government funding for research Revenue Source (in thousands of euros) | Revenue Source (in thousands of euros) | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | Revenue from collaboration and licensing agreements | 49,580 | 12,112 | | Government financing for research expenditures | 8,035 | 12,591 | | **Total Revenue and other income** | **57,674** | **24,703** | - Collaboration revenue growth was driven by several key events: Monalizumab: **€14.9 million** increase due to a milestone from the PACIFIC-9 trial; IPH5201: **€4.7 million** recognized from a milestone payment; AstraZeneca Preclinical Programs: **€17.4 million** recognized after AstraZeneca declined its license option; Sanofi: **€3.0 million** milestone payment for advancing IPH6401/SAR'514[37](index=37&type=chunk) - Government funding for research decreased by **€4.6 million** (**36.2%**), mainly due to a reduction in the research tax credit from lower eligible expenses and a provision following a tax inspection[38](index=38&type=chunk) [Operating Expenses Analysis](index=14&type=section&id=Operating%20expenses) Operating expenses rose slightly by **2.2%** to **€74.1 million** in 2022, driven by increased R&D costs for preclinical programs, while G&A expenses decreased due to lower personnel and advisory fees Expense Category (in thousands of euros) | Expense Category (in thousands of euros) | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | Research and development expenses | (51,663) | (47,004) | | Selling, general and administrative expenses | (22,436) | (25,524) | | **Total Operating expenses** | **(74,099)** | **(72,528)** | - R&D expenses increased by **€4.7 million**, mainly due to a **€5.0 million** increase in preclinical development program costs (notably IPH6501), partially offset by a **€4.3 million** decrease in clinical program expenses[41](index=41&type=chunk)[42](index=42&type=chunk) - G&A expenses decreased by **€3.1 million**, primarily due to lower wages, reduced non-scientific advisory fees, and a decrease in legal and compliance support costs[45](index=45&type=chunk)[46](index=46&type=chunk)[47](index=47&type=chunk) [Balance Sheet and Cash Flow](index=17&type=section&id=Balance%20sheet%20and%20Cash-flow%20items) As of December 31, 2022, Innate Pharma held **€136.6 million** in cash, with net cash used in operations improving to **€19.2 million**, influenced by significant milestone receipts from partners - Total cash, cash equivalents, and financial assets stood at **€136.6 million**, down from **€159.7 million** in 2021[54](index=54&type=chunk) - Shareholders' equity decreased to **€54.2 million** from **€107.4 million**, largely due to the net loss of **€58.1 million** for the period[56](index=56&type=chunk) Cash Flow Activity (in thousands of euros) | Cash Flow Activity (in thousands of euros) | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | (19,154) | (58,457) | | Net cash from / (used in) investing activities | 1,877 | (917) | | Net cash from / (used in) financing activities | (1,828) | 26,818 | - A post-period event in March 2023 was the receipt of a **€25.0 million payment** from Sanofi related to the B7-H3 ANKET® program license agreement[57](index=57&type=chunk)
Innate Pharma(IPHA) - 2022 Q3 - Earnings Call Transcript
2022-11-14 19:40
Financial Data and Key Metrics Changes - The company reported a strong cash position with $151 million as of September 30, 2022, providing a runway into the second half of 2024 [37][86] - The financial outlook includes ongoing discussions with regulators regarding accelerated approval pathways, particularly for lacutamab [55] Business Line Data and Key Metrics Changes - The lead proprietary product candidate, lacutamab, is in development for T-cell lymphoma, with readouts expected in the second half of the year [8] - Encouraging preliminary data from the TELLOMAK trial for lacutamab showed a 28.6% overall response rate (ORR) in mycosis fungoides [15] - The company is advancing its multi-specific NK cell engager platform, ANKET, with the most advanced candidate, IPH6501, expected to file an IND next year [28][36] Market Data and Key Metrics Changes - The company is focusing on leveraging partnerships across industry and academia, including collaborations with AstraZeneca and Sanofi [10][36] - The competitive landscape for CD20 targeting bi-specifics is acknowledged, with plans to differentiate IPH6501 based on safety and efficacy [73] Company Strategy and Development Direction - The strategy centers around three key priorities: creating near-term value from lacutamab, developing innovative molecules through the ANKET platform, and building sustainable partnerships [8][10] - The company aims to validate its science and reinvest capital to advance its early portfolio [10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of lacutamab in heavily pretreated populations, with ongoing discussions with regulators about accelerated approval [55][80] - The company is encouraged by preliminary data and expects to achieve several milestones over the next two years, including updates on clinical trials [34][36] Other Important Information - The company plans to present data at upcoming conferences, including the ASH Annual Congress and ESMO IO [30][36] - The ANKET platform is designed to create a new class of tri- and tetra-specific engagers to induce synthetic immunity against cancer [25] Q&A Session Summary Question: What are the expectations for the TELLOMAK trial and the tetra-specific ANKET? - Management confirmed that the selection of CD20 as a target for the tetra-specific ANKET was to limit variables and leverage a well-validated target [41][46] - Responses in Cohort 3 of the TELLOMAK trial were attributed to tumor heterogeneity and assay conditions [48] Question: What are the regulatory expectations for accelerated approval? - Management indicated that discussions with regulators are ongoing, and the benchmark for accelerated approval has become tougher recently [55] Question: What is the future of lacutamab if PTCL does not deliver? - Management stated that while PTCL data is crucial, the company has multiple avenues to explore the potential of lacutamab, including monotherapy and combination trials [80] Question: How will the patient population change as moga is used earlier? - Management noted that the trial will likely continue to recruit heavily pretreated patients, as access to moga has not significantly changed [82] Question: How does the company plan to file for approval in Sézary syndrome and mycosis fungoides? - The decision will depend on data strength, regulatory landscape, and potential partnerships [77]
Innate Pharma(IPHA) - 2022 Q3 - Earnings Call Presentation
2022-11-14 15:59
Q3 2022 Financial Results and Business Update November 14, 2022 PARIS: IPH.PA NASDAQ: IPHA © 2021 Innate Pharma. All rights reserved. Disclaimer on Forward-Looking Information and Risk Factors This document has been prepared by Innate Pharma S.A. (the "Company") solely for the purposes of a presentation to investors concerning the Company. This document is not to be reproduced by any person, nor to be distributed. This document contains forward-looking statements. The use of certain words, including "believ ...