On March 24, 2022 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported financial results and provided a corporate update for the fourth quarter and full year 2021, as well as outlook for 2022 (Press release, Hookipa Pharma, MAR 24, 2022, View Source [SID1234610845]).

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"As we work to introduce a new class of novel arenaviral immunotherapies, we’re proud of the progress we made in 2021. Our data presentations, including at premier oncology meetings, continued to expand the body of evidence on the ability of our technology to induce potent T cell responses, drive tumor regression and potentially serve as a synergistic combination with other immunotherapies," said Joern Aldag, Chief Executive Officer at HOOKIPA. "With the recent capital raise from new and existing top-tier investors, as well as funding from our Gilead collaboration, our cash position provides funding into the first half of 2024, enabling us to advance our novel portfolio. This includes our Phase 2 HB-200 program in combination with pembrolizumab in multiple treatment settings for head and neck cancer and two planned IND applications, one in prostate cancer and the other for Hepatitis B, in collaboration with Gilead. We’re excited to grow the value proposition even further for our versatile arenaviral technology in addressing unmet needs in cancer."

Oncology Portfolio

Interim Phase 1 data highlight promise of HB-200 as a novel immunotherapy for head and neck cancers.
In November, HOOKIPA reported interim data from the ongoing Phase 1 dose escalation study (NCT04180215) showing HB-200 (either as sequential HB-201 or alternating two-vector HB-202/HB-201) rapidly induced high levels of tumor-specific CD8+ T cells considered to be necessary for response, with a favorable tolerability profile and promising, early anti-tumor activity. In heavily pre-treated patients with Human Papillomavirus 16-positive (HPV16+) squamous cell head and neck cancers (HNSCC), HB-200 demonstrated a 75 percent disease control rate and shrinkage of target lesions in 53 percent of patients. The clinical data were consistent with data presented as a late-breaker abstract in March at the American Association of Clinical Research and data presented as an oral presentation in June at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).
Based on these data, HOOKIPA initiated a Phase 2 trial to assess HB-200 in combination with pembrolizumab as 1st-line and 2nd-line treatment for HNSCC; the first patient was dosed in January 2022 and preliminary data is anticipated in the second half of 2022.
In November 2021, the Food and Drug Administration granted Fast Track designation to HB-200 in combination with pembrolizumab for the treatment of 1st-line advanced HPV16+ HNSCC
HOOKIPA prioritizes oncology pipeline based on strength of HB-200 results. HOOKIPA also announced in November 2021 that it is focusing future research and development in oncology; advancing its immuno-oncology pipeline with HB-300 for prostate cancer and HB-700 for KRAS-mutated colorectal, pancreatic and lung cancers; and evaluating combinations of HB-200 with other oncology treatment modalities. HOOKIPA expects to file an Investigational New Drug (IND) application for HB-300 in the third quarter of 2022.

Potential of novel arenaviral platform technology in cancer validated by publications in Cell Reports Medicine, Nature Communications, and Frontiers in Oncology.

Pre-clinical data published in the March 2021 issue of Cell Reports Medicine showed HOOKIPA’s alternating 2-vector immunotherapy induced tumor-specific responses exceeding 50 percent of circulating CD8+ T cells and resulted in tumor cures and long-term immunity in a pre-clinical setting for both oncoviral antigens and a cancer self-antigen. The data provide the scientific substantiation for the ongoing HB-200 program in HPV16+ cancers, as well as the HB-300 program in prostate cancer.
In August, Nature Communications published pre-clinical data demonstrating that a single administration of HOOKIPA’s arenaviral vector was able to modulate the tumor microenvironment and induce potent melanoma self-antigen specific T cell responses, resulting in tumor regression and tumor eradication in 60 percent of mice.
A comprehensive review article published in the October issue of Frontiers in Oncology reinforced the potential of HOOKIPA’s versatile and differentiated arenavirus platform as a promising strategy to elicit potent, tumor-specific T cell responses and address critical unmet needs in cancer treatment.
Clinical collaboration to evaluate HB-200 with pembrolizumab underscores broad potential for additive benefits in combination with current standard of care and novel agents to improve anti-tumor immune response. In September, HOOKIPA announced it entered into a clinical collaboration and supply agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as Merck MSD outside of the United States and Canada) to evaluate the combination of HB-200 with pembrolizumab. HOOKIPA plans to initiate a randomized Phase 2 trial of HB-200 in combination with pembrolizumab in the first half of 2023.
Infectious Disease Portfolio

Collaboration with Gilead Sciences advances development of functional cures for Hepatitis B virus (HBV) and Human Immunodeficiency virus (HIV).
In November, HOOKIPA announced that its research collaboration with Gilead to develop a potential functional cure for HBV successfully passed Gilead’s Request for Development milestone. Gilead plans to progress the program to IND-enabling stage in 2022 to support IND filing for the arenavirus vector combination.
In February 2022, HOOKIPA and Gilead agreed to advance its partnered HIV program, triggering a $54 million commitment from Gilead. HOOKIPA assumed development responsibility for the HB-500 program through the completion of a Phase 1b clinical trial; Gilead has the exclusive right for further development thereafter. Financial terms included a $4 million preclinical milestone, a $15 million non-refundable initiation fee and $35 million equity commitment at a premium to market price. The $35 million equity commitment includes a first tranche of $5 million (purchased at a $3 share price on February 15) and the remaining $30 million can be drawn at a 30 percent premium in a second tranche or at market price in a third tranche. If Gilead pursues further development, HOOKIPA is entitled to potential development and sales milestone payments exceeding $237 million, as well as royalties on net product sales.
Positive updated interim Phase 2 data reported on HB-101 for Cytomegalovirus (CMV) in kidney transplant patients. In November, HOOKIPA shared updated interim data from the ongoing Phase 2 clinical trial (NCT03629080) of HB-101, a prophylactic CMV vaccine candidate. These data showed three doses of HB-101 were generally well tolerated, elicited strong immunogenicity, and reduced incidence of CMV viremia, consistent with results reported in November 2020. Final results are anticipated in 2023 once the 80 enrolled patients complete their 12-month observation period following kidney transplantation. HOOKIPA is pursuing partnership opportunities for continued development, as part of its updated corporate strategy to prioritize the oncology pipeline opportunities.
Corporate Updates

Klaus Orlinger, Ph.D. has been promoted from Executive Vice President, Research to Chief Scientific Officer. Klaus joined HOOKIPA in 2012 and has played a leading role in the development of novel arenaviral immunotherapies and advancing them to the clinic.
To express their confidence in and excitement about the Company, the executive team agreed to receive 50 percent of its 2021 bonus in the form of an options grant at $3 per share. Executive team members also waived portions of their salaries for the first half of 2022 in exchange for shares valued at $3 per share; the CEO waived 50 percent of his first half 2022 salary and other executives waived 20 percent each.
Upcoming Milestones

Phase 1 HPV16+ monotherapy data: Mid-2022
Phase 2 HPV16+ combination data in HNSCC
1st-line initial data: 2H 2022
2nd-line initial data: 2H 2022
Randomized Phase 2 in 1st line start with pembrolizumab: 1H 2023 (Fast Track designation)
Prostate cancer IND: 3Q 2022
Hepatitis B therapeutic IND: 2022 (Gilead-led)
Fourth Quarter and Full Year 2021 Financial Results
Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of December 31, 2021 was $66.9 million compared to $143.2 million as of December 31, 2020. When giving effect to (i) receipt of a $15.0 million initiation payment and the issuance of 1,666,666 shares of our common stock for an aggregate purchase price of $5.0 million pursuant to an agreement with Gilead in February 2022, and (ii) the net proceeds of $70 million from the issuance of common stock and convertible preferred stock in a follow-on financing in March 2022, HOOKIPA’s pro-forma cash, cash equivalents and restricted cash as of December 31, 2021 would have been $156.9 million.

Revenue was $3.9 million for the three months ended December 31, 2021, and $18.4 million for the year ended December 31, 2021 compared to $5.2 million for the three months ended December 31, 2020 and $19.6 million for the year ended December 31, 2020. The decrease was primarily due to lower revenue from research milestones and lower recognition of deferred revenue related to upfront and milestone payments under the Collaboration Agreement with Gilead.

Research and Development Expenses: HOOKIPA’s research and development expenses were $22.4 million for the three months ended December 31, 2021, and $82.9 million for the year ended December 31, 2021 compared to $15.7 million for the three months ended December 31, 2020, and $54.8 million for the year ended December 31, 2020.

The primary drivers of the increase in research and development expenses by $28.1 million compared to 2020 were an increase in manufacturing and quality control expenses of $9.9 million, an increase in clinical study expenses of $3.2 million, along with an increase in other direct expenses and laboratory expenses of $8.1 million and an increase in internal research and development expenses of $6.9 million. The increase was mainly due to the progress in the clinical trial of our HB-200 program, particularly, the increased patient recruitment and related clinical trial monitoring and testing activities, as well as manufacturing and quality control work in preparation of a further extension of the trial. Manufacturing and quality control expenses were also driven by the progress towards clinical development in our Gilead partnered programs and other preclinical programs.

General and Administrative Expenses: General and administrative expenses amounted to $3.5 million for the three months ended December 31, 2021 and $17.3 million for the year ended December 31, 2021 compared to $4.7 million for the three months ended December 31, 2020, and $18.1 million for the year ended December 31, 2020. The decrease was primarily due to a decrease in personnel-related expenses and a decrease in other general and administrative expenses, partially offset by an increase in professional and consulting fees.

Net Loss: HOOKIPA’s net loss was $21.2 million for the three months ended December 31, 2021 and $75.7 million for the year ended December 31, 2021 compared to a net loss of $12.5 million for the three months ended December 31, 2020 and $44.1 million for the year ended December 31, 2020. This increase was primarily due to an increase in research and development expenses, mainly driven by the progression of HOOKIPA’s oncology programs, in particular the clinical trial of the HB-200 program.

Conference call: HOOKIPA will host a conference call and live webcast at 8:30 am EST today to discuss its financial results and provide a corporate update.

The webcast and the presentation will be available within the Investors & Media section of HOOKIPA’s website at View Source An archived replay will be accessible for 30 days following the event.

On March 24, 2022 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its consolidated financial results for the year ending December 31, 2021 (Press release, Innate Pharma, MAR 24, 2022, View Source [SID1234610844]). The consolidated financial statements are attached to this press release.

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"Throughout 2021, we made key progress across our portfolio – announcing promising data with our proprietary pipeline as well as the start of a new pivotal study by our partner AstraZeneca with our most advanced pipeline asset, monalizumab. Highlights from our pipeline included the encouraging lacutamab data in a subtype of cutaneous T-cell lymphoma, mycosis fungoides (MF), and the initiation of trials of the product in the broader indications of peripheral T-cell lymphomas (PTCL). We also showed further validation with our multi-specific NK cell engager platform, ANKETTM, including the start of a Phase 1 trial with Sanofi," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "The value in Innate is the strength and depth of our core R&D efforts, as we look to progress our pipeline in house, or with partnerships. We look forward to new milestones in the coming year including readouts from the lacutamab program, further progress in our early-stage R&D activities in ANKETTM and the adenosine franchise and not least in continued development of monalizumab."

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 dial-in details below:

France: 0805 620 704

United States: 1 844 200 6205 / 1 646 904 5544

United Kingdom: 44 208 0682 558 / 44 808 189 648

All other locations: +1 929 526 1599

Access code: 834852

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.

Pipeline highlights:

Lacutamab (IPH4102, anti-KIR3DL2 antibody):

The Company announces the opening of a new mycosis fungoides (MF) all-comers cohort in the TELLOMAK study. The all-comers cohort will recruit both KIR3DL2 expressors and non-expressors to explore the correlation between the level of KIR3DL2 expression and treatment outcomes utilizing a formalin-fixed paraffin embedded (FFPE) assay as a companion diagnostic. The KIR3DL2 non-expressing Cohort 3 has been closed to recruitment. As per the Simon 2-stage design, the number of responses to move to stage 2 was not reached, as such, recruitment into this cohort is stopped. Cohort 3 included KIR3DL2 non-expressing patients assigned via a KIR3DL2 immunohistochemistry assay for use on frozen biopsy samples and as a tool for stratification.
In June 2021, the Company announced preliminary data from its Phase 2 TELLOMAK trial, in which lacutamab demonstrated a 35% overall global response rate in patients with MF that express KIR3DL2 (Cohort 2). This first trial data set also established safety and demonstrated skin improvement. Lacutamab reached the pre-determined threshold to advance to stage 2 (six confirmed responses). These results were presented in an oral presentation at the 16th International Conference on Malignant Lymphoma (16-ICML).
Two parallel clinical trials to study lacutamab in patients with KIR3DL2-expressing, relapsed/refractory peripheral T-cell lymphoma (PTCL) are ongoing:
Phase 1b trial: a Company-sponsored Phase 1b clinical trial to evaluate lacutamab as a monotherapy in patients with KIR3DL2-expressing relapsed PTCL.
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):

In December 2021, the Company announced that the first patient was dosed in a Phase 1/2 clinical trial by Sanofi, evaluating IPH6101/SAR443579, the first NKp46/CD16‑based NK cell engager, in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high risk-myelodysplastic syndrome (HR-MDS). The purpose of the dose escalation and dose expansion study, which is sponsored by Sanofi, is to evaluate the safety, pharmacokinetics, pharmacodynamics and initial clinical activity of IPH6101/SAR443579, Innate’s lead ANKETTM asset, in various CD123-expressing hematological malignancies. The start of the trial has triggered a milestone payment from Sanofi to Innate.
In November 2021, Innate Pharma in collaboration with Sanofi, presented preclinical data from Innate’s proprietary, multi-specific NK cell engager platform, ANKETTM, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). Data on IPH6101/SAR443579, using Innate’s proprietary multi-specific antibody format (Gauthier et al. Cell 2019) that targets CD123 on acute myeloid leukemia (AML) cells and co-engages NKp46 and CD16a on NK cells was presented. In preclinical studies, IPH6101/SAR443579 demonstrated potent antitumor activity against AML cell lines, including those resistant to ADCC by a comparator anti-CD123 antibody. IPH6101/SAR443579 also promoted strong and specific NK-cell activation and induced cytokine secretion only in the presence of AML target cells. In addition, IPH6101/SAR443579 had sustained pharmacodynamic effects in non-human primates, combining efficient depletion of CD123-expressing cells with minor systemic cytokine release in comparison to T-cell engagers. As expected, it also had a favorable safety profile.
In June 2021, the Company presented new data on its ANKETTM platform, at the Federation of Clinical Immunology Societies meeting. Specifically, Innate shared data from its tetra-specific ANKETTM molecule, which is the first NK cell engager technology to engage two NK cell activating receptors (NKp46 and CD16), a cytokine receptor (IL-2Rb) and a tumor antigen via a single molecule. In preclinical studies, the tetra-specific ANKETTM demonstrated in vitro the ability to induce human NK cell proliferation, cytokine production and cytolytic activity against cancer cells expressing the targeted antigen. The tetra-specific ANKETTM also demonstrated in vivo anti-tumor efficacy in several tumor models, allowing regression of established tumors as well as control of metastasis, associated with increased NK cell infiltration, cytokine and chemokine production at the tumor site. ANKETTM also showed a pharmacodynamic effect, low systemic cytokine release and a manageable safety profile in non-human primates.
In January 2021, it was announced that Sanofi will transition IPH6101/SAR443579 into investigational new drug (IND)-enabling studies. The decision triggered a €7 million milestone payment from Sanofi to Innate. In addition, in January 2021, a GLP-tox study was initiated for the IPH6101/SAR443579 program.
IPH64, the other drug candidate of the research collaboration with Sanofi is progressing and the Company look forward to updates on this asset.
The Company’s proprietary tetra-specific ANKETTM IPH65 is progressing to IND enabling studies.
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

In March 2022, the Phase 2 NeoCOAST study assessing the safety and efficacy of neoadjuvant durvalumab in combination with chemotherapy and oleclumab or monalizumab and adjuvant treatment in participants with resectable, early-stage non-small cell lung cancer (NSCLC) has been accepted for an oral presentation on 11 April 2022 at the Annual Meeting 2022 of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).
In February 2022, AstraZeneca initiated a Phase 3 clinical trial, PACIFIC-9, evaluating durvalumab (anti-PD-L1) in combination with monalizumab (anti-NKG2A) 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).
In December 2021, the Company presented data from the Phase 2 expansion cohort (‘cohort 3’), exploring the triplet combination of monalizumab, cetuximab and durvalumab in the first-line treatment of patients with recurrent or metastatic head and neck squamous cell cancer (R/M HNSCC) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress 2021. After a median follow-up of 16.3 months, preliminary data suggest anti-tumor activity in the triplet of monalizumab, cetuximab and durvalumab in first-line treatment of R/M HNSCC. As of August 1, 2021, 40 patients were enrolled. Thirteen patients had a confirmed response with a 32.5% overall response rate (95% confidence interval (CI): 20-48), including three complete responses. Seven out of 13 responders were still on treatment. Median duration of response was not yet reached (95% CI: 7.1-not available). The survival rate at 12 months was 58.6% (95% CI: 45-77) and the median overall survival was 15 months (95% CI: 11.4 – not available).
In September 2021, AstraZeneca commenced a Phase 2 clinical study, NeoCOAST-2, that includes a treatment arm with durvalumab in combination with chemotherapy and monalizumab in resectable, early-stage NSCLC.
In September 2021, AstraZeneca presented a late-breaker abstract on the randomized COAST Phase 2 trial in patients with unresectable, Stage III NSCLC at the ESMO (Free ESMO Whitepaper) Congress. The presentation highlighted progression-free survival (PFS) and overall response rate (ORR) results for durvalumab in combination with monalizumab, Innate’s lead partnered asset, and oleclumab, AstraZeneca’s anti-CD73 monoclonal antibody. After a median follow-up of 11.5 months, the results of an interim analysis showed a 10-month PFS rate of 72.7% for durvalumab plus monalizumab, versus 39.2% with durvalumab alone in unresectable, Stage III NSCLC patients following chemoradiation therapy. The results also showed an increase in the primary endpoint of confirmed ORR for durvalumab plus monalizumab over durvalumab alone (36% vs. 18%).
IPH5201 (anti-CD39), partnered with AstraZeneca:

AstraZeneca is conducting a Phase 1 trial in solid tumors with IPH5201 alone or in combination with durvalumab (anti-PD-L1). The data is expected to be presented in 2023. Innate is in discussions with AstraZeneca on potential next steps for this program.
IPH5301 (anti-CD73):

In March 2022, The Institut Paoli-Calmettes announced that the first patient had been dosed in the investigator-sponsored Phase 1 trial of IPH5301 (CHANCES). 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.
Avdoralimab (IPH5401, anti-C5aR antibody):

In July 2021, the Company announced that FORCE (FOR COVID-19 Elimination), the investigator-sponsored, Phase 2 clinical trial evaluating the safety and efficacy of avdoralimab, in COVID-19 patients with severe pneumonia, did not meet its primary endpoints in all three cohorts of the trial. Results from this trial, including translational data, are planned to be submitted for publication. The Company’s COVID-19 activities were covered by public funding from the French government.
Following a strategic review, the Company will now solely pursue avdoralimab in bullous pemphigoid, an inflammatory disease, through an investigator-sponsored study and stop further development in all other indications. Data in bullous pemphigoid is now expected in 2024.
Corporate Update:

In February 2022, Mrs Tracy Rossin, VP, Global Head of Communications, decided to pursue another opportunity outside the Company. Mr Henry Wheeler, Vice President of Investor Relations, who joined Innate in June 2021 is now responsible for Investor Relations and Communications.
In January 2022, Mr Nicola Beltraminelli PhD was appointed as Vice President, Chief Development Officer of Innate responsible for non-clinical development. Mrs Frederique Brune, Vice President Development CMC and Supply Chain decided to pursue another opportunity outside the company. Mr Beltraminelli brings more than 20 years of biotech experience to the role, and specifically in the development of biologic products from early discovery to GMP manufacture. Most recently, Mr Beltraminelli served as Chief Technical Officer at Lysogene, where he led the CMC activities for two late-stage assets.
In January 2022, Innate Pharma announced that it had obtained €28.7M in non-dilutive financing in the form of State Guaranteed Loans from Société Générale and BNP Paribas. The two agreements were signed and funds received in December 2021.
In November 2021, Jen Butler, Head of Global Commercial and US General Manager left her position at the Company.
In June 2021, Bpifrance informed Innate that its permanent representative at Innate’s Supervisory Board, Mrs Maïlys Ferrere will be replaced by Mr Olivier Martinez, Senior Investment Director in the Life Sciences Investments Department of the Direction of Innovation of Bpifrance, who has been Observer of Innate’s Supervisory Board since 2010.
Announced on May 28, 2021, Novo Nordisk A/S, represented by Marcus Schindler, M.D., decided not to seek re-election to the Supervisory Board due to Dr. Schindler’s new role as Executive Vice President Research & Early Development and Chief Scientific Officer of Novo Nordisk A/S. Novo Nordisk A/S remains a shareholder in the Company but no longer has a seat on its Supervisory Board.
Frederic Lombard was appointed as Chief Financial Officer on April 1, 2021. Mr Lombard has more than 20 years of financial experience in the pharmaceutical industry, holding senior finance roles at Ipsen, AstraZeneca and Novartis. Laure-Hélène Mercier, Executive Vice President, Chief Financial Officer and member of the Executive Board, decided to step down from her position, after leading the Company through more than 14 years of growth, including an initial public offering in the US. She left the Company on January 2022.
Financial highlights for 2021:

The key elements of Innate’s financial position and financial results as of and for the year ended December 31, 2021 are as follows:

Cash, cash equivalents, short-term investments and financial assets amounting to €159.7 million2 (€m) as of December 31, 2021 (€190.6m as of December 31, 2020), including non-current financial instruments amounting to €39.9m (€38.9m as of December 31, 2020).
As of December 31, 2021, financial liabilities amount to €44.3m (€19.1m as of December 31, 2020). This change is mainly linked to proceeds relating to State-Guaranteed Loans (Prêts Garantis par l’Etat "PGE") of €28.7m from Société Générale (€20.0m) and BNP Paribas (€8.7m) collected by the Company on December 2021.
Revenue and other income from continuing operations3 amounted to €24.7m in 2021 (2020: €69.8m, -64.6%). It mainly comprises revenue from collaboration and licensing agreements (€12.1m in 2021 vs €56.2m in 2020, -78.4%), and research tax credit (€10.3m in 2021 vs €13.1m in 2020, -21.2%):
Revenue from collaboration and licensing agreement with AstraZeneca amounted to €9.1m in 2021 (€49.0m in 2020, -81.4%) and mainly resulted from (i) the spreading of the upfront and opt-in payments received from AstraZeneca and (ii) the invoicing to AstraZeneca of certain fees for the work performed by Innate for the partnered programs. The variation between the two periods is notably explained by the (i) decrease in direct monalizumab research and development costs over the period, in connection with the Phase 1 & 2 trials maturity, and (ii) the absence of revenue relating to IPH5201 in 2021, the Company having fulfilled all of its commitments on preclinical work related to the start of Phase 1 as of December 31,2020.
Revenue of €3.0m from Sanofi following the initiation of a GLP-tox Study and the launching of the first Phase 1 clinical trial in humans in relapsed of refractory AML with IPH6101/SAR443579, respectively in January and December 2021.
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).
Operating expenses from continuing operations amounted to €72.5m in 2021 (2020: €68.7m, +5.6%):
General and administrative (G&A) expenses from continuing activities amounted to €25.5m in 2021 (2020: €19.0m, +34.4% 4). This increase results cumulatively from (i) an increase in wages mainly resulting from restructuring costs and higher annual bonuses level in 2021, (ii) an increase in non-scientific advisory fees and (iii) an increase in other general and administrative expenses.
Research and development (R&D) expenses from continuing activities amounted to €47.0m in 2021 (2020: €49.7m, -5.4%). This variation mainly results from a (i) decrease in depreciation and amortization of intangible assets acquired by the Company (IPH5201, fully amortized since December 2020, and monalizumab) partly offset by (ii) an increase in direct research and development expenses (clinical and non-clinical).
A net financial income of €2.3m in 2021 (2020: €1.9m loss).
A net loss from Lumoxiti discontinued operations of €7.3m in 2021 (2020 : net loss of €63.2m, -88.4%) mainly resulting from the Settlement Amount of $6.2m5 (€5.5m as of December 31, 2021) to be paid to AstraZeneca on April 30, 2022, as part of the Termination and Transition agreement effective as of June 30, 2021. The net loss in 2020 mainly resulted from the full impairment of Lumoxiti rights following the Company decision to return the marketing rights of Lumoxiti in the United States and in Europe to AstraZeneca.
A net loss of €52.8m in 2021 (2020: net loss of €64.0m).

On March 24, 2022 Redx (AIM: REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported it will present a poster entitled ‘Preclinical efficacy of the Wnt pathway inhibitor RXC004 in combination with anti-cancer therapies’ on 12 April 2022 at the forthcoming hybrid American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place inNew Orleans, US on 8-13 April 2022 (Press release, Redx Pharma, MAR 24, 2022, View Source [SID1234610843]).

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The poster will present preclinical data on the potential benefits of RXC004, Redx’s lead oncology asset, in combination with clinically relevant standard of care chemotherapy regimens. RXC004 is a potent, orally active porcupine inhibitor in clinical development as a targeted therapy for Wnt-ligand driven cancer. It is currently in Phase 1 clinical studies in combination with nivolumab, an anti-PD-1 antibody, and is also being evaluated as a monotherapy in Phase 2 proof-of-concept clinical studies for the treatment of genetically selected pancreatic cancer, genetically selected metastatic colorectal cancer and unselected biliary cancer.

Title: Pre-clinical efficacy of the Wnt pathway inhibitor RXC004 in combination with anti-cancer therapies
Abstract: 2566
Day/Date: Tuesday 12 April 2022
Session name and category: PO.ET06.09-Cell Cycle, Replication Inhibitors, and Immunotherapy Agents

The abstract is available via the AACR (Free AACR Whitepaper) Annual Meeting website at:View Source!/10517/presentation/15373

The poster will be available from Friday 8 April on the AACR (Free AACR Whitepaper) e-poster website and the investor section of the Company’s website at: View Source

On March 24, 2022 Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the "Company") reported financial results (according to IFRS) for fiscal year 2021 (Press release, Epigenomics, MAR 24, 2022, View Source [SID1234610842]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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OPERATIONAL DEVELOPMENTS

In 2021, Epigenomics started preparations for the FDA clinical trial for the Company’s Epi proColon "Next-Gen" test. Epigenomics expects to start enrollment this summer. The study will require approximately 16,000 participants and will take about two years to complete. If the test receives FDA approval and meets the criteria for blood-based colorectal cancer screening tests set by the Centers for Medicare and Medicaid Services (CMS) – which Epigenomics is confident of – Epi proColon "Next-Gen" will be automatically reimbursed by CMS. The Company will focus its efforts on the activities required to bring Epi proColon "Next-Gen" to market.
Until the FDA approval of Epi proColon "Next-Gen", Epigenomics still has the opportunity to obtain CMS reimbursement for its current test Epi proColon via legislation. Recently President Biden announced a reignition of the Cancer Moonshot, a program launched in 2016 with the mission to accelerate the rate of progress against cancer. The passage of a bill to reimburse a blood test for CRC screening would serve the program’s target as well as two other core goals of the Biden administration: Fighting racial healthcare discrimination and the COVID-19 pandemic, since CRC affects a disproportionate number of People of Color, and the pandemic has significantly reduced CRC screening participation rates in the U.S. As promising as the initiative is, it is currently impossible to make a reliable statement on whether a relevant bill will be passed.
In 2021, the Company has also focused on maximizing its financial position to enable the development of the Epi proColon "Next-Gen" test. In this context, cost-cutting measures were initiated, the sale of a non-essential portion of the Company’s biobank as well as the issuance of convertible bonds in the amount of EUR 22.0 million have strengthened the balance sheet and given Epigenomics the ability to move forward with the FDA trial in 2022. However, the Company will need to raise additional capital to complete the trial and the subsequent FDA approval. The Company is evaluating numerous financing alternatives including exchanges with more potential access to capital.
The Executive Board has added two new members. President and Chief Scientific Officer Andrew Lukowiak, Ph.D., started as President and Chief Scientific Officer in December 2021 and Jens Ravens has taken over the CFO position in February 2022. The Executive Board looks forward to working together and is convinced that Epigenomics is well positioned to master the challenges to achieve the Company’s goals.
Greg Hamilton, CEO of Epigenomics AG: "We are excited about the future of Epigenomics and see our improved Epi proColon "Next-Gen" test as a major untapped opportunity in the cancer screening market. We expect to initiate the clinical trial this summer and to publish preliminary data for the "Next-Gen" test. We believe our blood based "Next-Gen" will be a cost-effective solution in the market."

Financial results 2021

Total revenue increased to EUR 6.2 million (2020: EUR 0.8 million), mainly due to the sale of the blood sample database ("biobank") in August 2021. In contrast, revenues from Epigenomics’ test kits remained low both in the U.S.A. and in Europe, amounting in total in the fiscal year to EUR 0.4 million (2020: EUR 0.6 million) in line with the expectations, due to the pandemic-related reduction of patient office visits.
Selling, general and administrative costs in the amount of EUR 7.5 million remained roughly equivalent to previous year’s level of EUR 7.3 million and is inclusive of the costs related to the biobank sale.
EBITDA (before share-based payment expenses) improved to EUR -1.8 million (2020: EUR -10.5 million) and exceeded the forecast of EUR -3.0 million adjusted in the third quarter due to currency effects.
The net loss for the year fell to EUR -2.4 million (2020: EUR -11.7 million); the loss per share also decreased to EUR -0.22 (2020: EUR -2.02).
Cash consumption improved to EUR -4.2 million in fiscal year 2021 compared to EUR -9.6 million in 2020.
Outlook 2022

Revenue

As the Company is not currently actively marketing Epi proColon due to the lack of CMS reimbursement, Epigenomics estimates its 2022 revenue between EUR 0.3 million and EUR 0.8 million. If Medicare reimbursement is indeed achieved via legislation in 2022, the Company is likely to amend the revenue forecast.

EBITDA / Cash consumption

For EBITDA (before share-based payment expenses), Epigenomics forecasts a range of EUR -15.0 million to EUR -17.0 million. This assumes that the Company initiates the Epi proColon "Next-Gen" trial in the summer of 2022. If this trial is delayed or enrollment is slower than anticipated then the forecast for the adjusted EBITDA is likely to improve. The anticipated spend for the clinical trial in 2022 will be aligned with the Company’s ability to raise funds for the remainder of the trial in 2023 and 2024.
Further information

The Annual Report 2021 is available on the Epigenomics website at: View Source

Conference call for analysts and investors

Epigenomics AG will host a conference call for analysts and investors today at 4.00 pm (CET) / 11.00 am (EDT). The webcast can be accessed on the Company’s website: View Source

Participants are asked to dial in 10 minutes prior to the start of the conference call and to register using the link above.

An audio replay of the conference call will be provided on the Epigenomics’ website subsequently.

On March 24, 2022 Glycotope GmbH, a biotechnology company developing antibodies against proteins carrying tumor-specific carbohydrate structures, reported that is has completed a re-focusing of its strategy to better deliver value from its powerful, proprietary glycobiology-informed technology platform (Press release, Glycotope, MAR 24, 2022, View Source [SID1234610841]). The Company has also expanded its senior leadership team to accelerate the execution and delivery of this strategy.

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Following the recent spin-out of its services business Glycotope is now entirely focused on drug discovery and development, utilizing its proprietary technology platform to develop uniquely tumor-specific monoclonal antibodies.

As a result of this shift in strategy and to optimize its delivery, the Company has undertaken an expansion of its senior leadership roles. Henner Kollenberg remains as Chief Executive Officer of Glycotope, Antje Danielczyk has been appointed Chief Operating Officer, responsible for Research & Development operations, while Patrik Kehler has been appointed Chief Scientific Officer, leading research and development.

Glycotope’s antibodies target specific tumor-associated carbohydrate structures or protein/carbohydrate combined glyco-epitopes (GlycoTargets). Targeting these specific antigens enables broad indication range, long-term treatment potential and reduced on-target/off tumor toxicity, key elements of highly potent therapies. Based on this unrivalled tumor-specificity, Glycotope’s antibodies are highly suitable for a multi-function platform approach with independent modes of action to provide a tailored therapy format for as many patients as possible.

The Company is currently developing a pipeline of antibody therapeutics which includes in-house and partnered pre-clinical programs:

GT-001: A humanized IgG1 mAb with unrivaled fine-specificity, specifically targeting the tumor-associated Lewis Y (LeY, CD174) carbohydrate antigen. GT-001 binds to a high percentage of breast cancers, non-small cell lung cancer, colorectal cancer, head and neck cancer, small cell lung cancer and ovarian cancer patient samples and is effectively internalized, making it suitable for ADC or CAR development.

GT-002: An IgG1 mAb targeting LYPD3 (C4.4A) with increased tumor-specificity. LYPD3 is expressed in various cancer indications with high medical need, including squamous cell carcinoma of the head and neck (HNSCC). Upon binding to LYPD3, the antibody is effectively internalized. The improved tumor-specificity of GT-002 results in reduced binding to healthy-tissue expressed LYPD3 making it suitable for the development of highly potent therapies like ADCs or CARs.

GT-00A: A humanized IgG1 mAb targeting a carbohydrate/protein combined epitope on MUC1 called tumor-associated (TA)-MUC1. GT-00A is in pre-clinical development as an IL-15-based immuno-cytokine and as an antibody-drug-conjugate (ADC) developed by Daiichi-Sankyo. TA-MUC1 is a novel tumor-specific protein/carbohydrate combined glyco-epitope on the tumor-marker MUC1. The target is expressed on many epithelial tumor types including primary tumor, metastases and cancer stem cells, but is virtually absent on normal cells. The main target indications are ovarian, lung and breast cancers but Glycotope believes GT-00A has further potential for treatment of cervical, endometrial, gastrointestinal, kidney, urothelial and other cancers.

Henner Kollenberg, Glycotope’s Chief Executive Officer, said "We believe there are a wealth of opportunities for our platform to deliver powerful new antibody therapeutics for oncology indications. The recent sale of our services business and the leadership team expansion we are announcing today marks a renewed focus on drug discovery and development. We look forward to the next stage of Glycotope’s development with great excitement about what we will be able to achieve as Company, for our partners and, ultimately, for patients."