On May 16, 2022 AIM ImmunoTech Inc. (NYSE: American AIM) ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, reported its financial results for the first quarter 2022 and provided a business update (Press release, AIM ImmunoTech, MAY 16, 2022, View Source [SID1234614582]).

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"The first quarter was marked by the rollout of important clinical data across our pipeline which gives us added confidence in the potential of Ampligen as an important treatment in high-value indications," commented Thomas Equels, Chief Executive Officer of AIM. "We published clinical efficacy data in our three lead indications, pancreatic, ovarian and triple negative breast cancers in a prestigious peer-reviewed journal and/or at leading oncology scientific congresses. These data were consistent with prior clinical data seen with Ampligen and we believe validate our conviction of its potential in these difficult to treat cancers, including data indicating potentially important effects in combination with checkpoint inhibitors. We remain committed to continue working with preeminent scientific institutions to advance our rich oncology pipeline towards commercialization that we believe will drive the execution of clinical, regulatory and operational catalysts that have the potential to build shareholder value in the near and long-term."

Recent Highlights

Provided a summary of clinical data that support the potential of Ampligen with checkpoint blockade therapies (see AIM’s 4/21/22 press release).
Engaged world-renowned CRO, Amarex Clinical Research LLC to conduct upcoming Phase 2 study of Ampligen as a therapy for locally advanced pancreatic cancer (AMP-270).
Presented data at the prestigious American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022:
Negative impact of paclitaxel on human breast tumor microenvironment and its reversal by the combination of interferon-α with TLR3 agonist rintatolimod
Initial results of a phase II study evaluating a chemokine-modulatory (CKM) regimen in patients with colorectal cancer metastatic to the liver
Systemic Rintatolimod and Interferon-α2b selectively reprogram local tumor microenvironment in patients with metastatic triple negative breast cancer for enhanced influx of cytotoxic T-lymphocytes but not regulatory T-cells
Combined loco-regional and systemic, triple agent chemoimmunotherapy increases biomarkers of T cell chemotaxis in ovarian cancer
Received notification from the U.S. Food and Drug Administration ("FDA") that the FDA’s Clinical Hold on AIM’s investigational new drug ("IND") application for a Phase 2 study of Ampligen as a therapy for locally advanced pancreatic cancer (AMP-270) has been lifted and the Company may proceed with the study.
Announced the publication of positive data from a single-center, named-patient program treating advanced and metastatic pancreatic cancer patients (see: Rintatolimod (Ampligen) enhances numbers of peripheral B cells and is associated with longer survival in patients with locally advanced and metastasized pancreatic cancer pre-treated with FOLFIRINOX: a single-center named patient program)
Announced a contract for the strategic sale of its facility located in New Brunswick, New Jersey for a purchase price of $3.9 million.
Appointed biotech and finance industry veteran Robert Dickey IV as Chief Financial Officer, effective April 4, 2022.
Announced the publication of positive results from Phase 1/2 study of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer.
Clinical Program Update

Ampligen (rintatolimod): dsRNA being developed for globally important cancers, viral diseases and disorders of the immune system

Ampligen has demonstrated in the clinic a potential for standalone efficacy in a number of solid tumors. Additionally, Ampligen has shown therapeutic synergy with checkpoint inhibitors, including increasing survival rates and efficacy, in the treatment of animal tumors when used in combination with checkpoint blockade therapies. The first detection of Ampligen’s synergistic potential with checkpoint blockade therapeutics was witnessed in pre-clinical mouse models of melanoma and pancreatic cancers. Additionally, the Company now has data from two clinical studies – in advanced recurrent ovarian cancer and triple negative breast cancer – that indicate that the drug may have similar anti-tumor activity in humans. (See AIM’s 8-K financial filing on 6/14/21 regarding a patent in the Netherlands)

Ampligen is being evaluated as a combinational therapy for the treatment of a variety of solid tumor types in multiple clinical trials – both underway and planned – at major cancer research centers. Ampligen is also being used as a monotherapy to treat pancreatic cancer patients in an Early Access Program (EAP) approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center.

Immuno-Therapy Targeting Multiple Cancers with High Unmet Need

Locally Advanced Pancreatic Cancer – Phase 2 study IND cleared by the U.S. Food and Drug Administration ("FDA"). Study will compare the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma. Approximately 90 subjects expected to be enrolled across up to 30 centers in the U.S. and Europe. Study is on track to commence in Q3 2022.
Advanced Recurrent Ovarian Cancer – Phase 1/2 study of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer. Phase 1 portion was completed. The Phase 2 portion of the study is planned to be conducted in the future. ClinicalTrials.gov: NCT02432378
Advanced Recurrent Ovarian Cancer – A follow-up Phase 2 study of advanced recurrent ovarian cancer using cisplatin and pembrolizumab, plus Ampligen; up to 45 patients to be enrolled; numerous patients have commenced treatment. ClinicalTrials.gov: NCT03734692
Stage 4 Colorectal Cancer Metastatic to the Liver – Phase 2a study of Ampligen as a component of a chemokine modulatory regimen on colorectal cancer metastatic to liver was completed and met primary endpoint, evidenced by increased CD8a expression post-treatment (p=0.046); 19 patients were enrolled and 12 patients were evaluable. Data suggest that chemokine modulatory (CKM) regimen with Ampligen may be useful to enhance effectiveness of immunotherapies. Data from the Phase 2a study were presented in April 2022 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022. ClinicalTrials.gov: NCT03403634
Stage 4 Metastatic Triple Negative Breast Cancer – a Phase 1 study of metastatic triple-negative breast cancer using CKM therapy, including Ampligen and pembrolizumab, successfully met its primary endpoint. Eight patients were enrolled and 6 patients were evaluable. Positive data from this proof-of-concept study indicate that short-term systemic CKM followed by pembrolizumab is well-tolerated and selectively enhances local cytotoxic T-lymphocyte (CTL) infiltration in the tumor microenvironment (TME). The data from the Phase 1 study was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 in April 2022. ClinicalTrials.gov: NCT03599453
Early-Stage Prostate Cancer – Phase 2 study investigating the effectiveness and safety of aspirin and Ampligen with or without interferon-alpha 2b (Intron A) compared to no drug treatments in a randomized three-arm study of patients with prostate cancer before undergoing radical prostatectomy. Patient enrollment has been initiated in this study designed for up to 45 patients. ClinicalTrials.gov: NCT03899987
Early-Stage Triple Negative Breast Cancer – Phase 1 study of chemokine modulation plus neoadjuvant chemotherapy in patients with early-stage triple negative breast cancer has received FDA authorization. The objective of this study is to evaluate the safety and tolerability of a combination of Ampligen and celecoxib with or without Intron A, when given along with chemotherapy. The goal of this approach is to increase survival. This study is recruiting patients and is designed for up to 24 patients. ClinicalTrials.gov: NCT04081389
Refractory Melanoma – Phase 2 study that will evaluate polarized dendritic cell vaccine, interferon alpha-2, Ampligen and celecoxib for the treatment of HLA-A2+ refractory melanoma at Roswell Park. Up to 24 patients to be enrolled. ClinicalTrials.gov: NCT04093323
Advanced Ovarian Cancer – AIM plans to develop a Phase 2 Cisplatin Resistant Advanced Recurrent Ovarian Cancer Clinical Study utilizing Ampligen at the University of Pittsburgh.
Broad-Spectrum Immune System Response Against SARS-CoV-2 (COVID-19)

Previous animal studies yielded positive results utilizing Ampligen to treat Western Equine Encephalitis Virus, Ebola and SARS-CoV-1. The Company has also conducted laboratory experiments in SARS-CoV-2 showing Ampligen has a powerful impact on viral replication. The prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against SARS-CoV-2. AIM is currently evaluating the safety and effectiveness of intravenous Ampligen to reduce replication of SARS-CoV-2 virus from upper airway in patients in an ongoing Phase 1/2 study for the treatment of COVID-19 cancer patients. The Company also plans to conduct an intranasal study of Ampligen to potentially enhance and expand natural immunity.

Immune System Disorders (ISD): Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) / COVID-19 Long Hauler

The Company is currently sponsoring an expanded access program (EAP) for ME/CFS patients in the United States, and in 2021 AIM dosed its first "Long Hauler" patient with Ampligen in its post-COVID-19 "Long Hauler" portion of the active AMP-511 EAP in the United States. Patients receiving Ampligen in the ongoing AMP-511 EAP with Long Hauler/Post-COVID conditions (such as fatigue and cognitive function deficiency) have reported improvements after receiving Ampligen.

Recent Ampligen Data Publications

Positive data from a single-center named patient program was published in March 2022. The manuscript titled, "Rintatolimod (Ampligen) enhances numbers of peripheral B cells and is associated with longer survival in patients with locally advanced and metastasized pancreatic cancer pre-treated with FOLFIRINOX: a single-center named patient program1," was published in the peer-reviewed journal, Cancers Special Issue: Combination and Innovative Therapies for Pancreatic Cancer.
Positive results of a Phase 1/2 study of intraperitoneal chemo- immunotherapy in advanced recurrent ovarian cancer were published in January 2022. The manuscript titled, "Phase I trial combining chemokine-targeting with loco-regional chemo-immunotherapy for recurrent, platinum-sensitive ovarian cancer shows induction of CXCR3 ligands and markers of type 1 immunity2" was published in the American Association for Cancer Research (AACR) (Free AACR Whitepaper) publication, Clinical Cancer Research.
Summary of Financial Highlights for First Quarter 2022

As of March 31, 2022, AIM reported cash and cash equivalents of $44.5 million. Based on management’s current expectation, the Company’s cash runway is expected to fund operations through 2023.
Research and development expenses for the three months ended March 31, 2022 were $1.0 million, compared to $1.4 million for the same period in 2021.
General and administrative expenses were $2.1 million for the three months ended March 31, 2022 and 2021.
The net loss from operations for the three months March 31, 2022 was $3.8 million, or $0.08 per share, compared to $3.6 million, or $0.08 per share, for the three months ended March 31, 2021.
Please refer to the full 10-Q for complete details.

On May 16, 2022 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported that Dr. Neal Walker, President and CEO of Aclaris, will virtually present a company overview at the H.C. Wainwright Global Investment Conference, which will be available beginning on Tuesday, May 24, 2022 at 7:00 a.m. ET (Press release, Aclaris Therapeutics, MAY 16, 2022, View Source [SID1234614581]). Management will be available May 23rd throughout the day for virtual 1×1 meetings.

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A webcast of the presentation may be accessed through the "Events" page of the "Investors" section of Aclaris’ website, www.aclaristx.com. The webcast will be archived for at least 30 days on the Aclaris website.

On May 16, 2022 Scandion Oncology (Scandion) reported that will publish its Q1 2022 interim report on Thursday, May 19, 2022 before 09:00 CET (Press release, Scandion Oncology, MAY 16, 2022, View Source;2022,c3567316 [SID1234614574]).

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Scandion Oncology’s Executive Management will host a webcast and conference call the same day at 10:00 CET presenting the results and a company update.

At the end of the presentation there will be a Q&A session.

The information was provided by the contact person above for publication on May 16, 2022, at 08.30 CET.

On May 16, 2022 Nykode Therapeutics reported that (Press release, Nykode Therapeutics, MAY 16, 2022, View Source [SID1234614573])

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Highlights:
• Nykode announced completion of patient enrollment in its Phase II trial of VB10.16 in combination with immune checkpoint inhibitor atezolizumab for the treatment of advanced cervical cancer
• Received milestone payment of USD 20 million for initiation of phase 1b trial Highlights after March 31st, 2022:
• Nykode Therapeutics announced positive interim results from its Phase II trial with VB10.16 in combination with atezolizumab in advanced cervical cancer o Anti-tumor activity of VB10.16 in combination with atezolizumab was observed in a heavily pretreated population of patients with HPV16-positive advanced cervical cancer. Strong overall response rate (ORR) was observed in both PD-L1 positive patients (ORR of 27%) and in PD-L1 negative patients (ORR of 17%). Overall ORR of 21% including two complete responses (CRs) and six partial responses (PRs) were observed in the 39 patients studied o VB10.16 in combination with atezolizumab demonstrated a very high disease control rate (DCR, which includes patients who have achieved complete response, partial response and stable disease) of 64% (77% in PD-L1 positive patients and 58% in PD-L1 negative patients)
• Nykode Therapeutics presented preclinical data from its second generation Vaccibody vaccine technology at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting
• At Nykode’s AGM on May 12, 2022, it was resolved to convert the Company from a private limited liability company (AS) to a public limited liability company (ASA)
• Elaine Sullivan and Anne Whitaker elected to join the Board of Directors at the Company’s AGM on May 12, 2022 Michael Engsig, Chief Executive Officer at Nykode, comments: "I am delighted that the interim results from the phase II study with VB10.16 in combination with atezolizumab in HPV-16 positive cervical cancer support Nykode’s unique approach of targeting Antigen Presenting Cells (APCs), designed to produce a robust and long-lasting CD8 killer T cell response against cancer cells. In particular I am excited about the signs of durable anti-tumor activity in a heavily pre-treated and hard to treat population of patients with late-stage HPV16-positive cervical cancer.

Furthermore, the indication that the treatment may benefit not only PD-L1 positive patients but also PD-L1 negative patients and patients with immune excluded tumors may bode well for the continued development." Michael Engsig continues "Building on the promising clinical efficacy and favorable safety profile that was observed with VB10.16, Nykode has started planning the NYK003-C-03 Phase 1b trial of VB10.16 in combination with a check point inhibitor in patients with HPV16-positive squamous cell head and neck cancer (HNSCC). The trial is expected to start in the second half of 2022. In addition to the positive development of the wholly owned pipeline, and the disclosure of exciting new preclinical data from our second generation Vaccibody technology platform, I am pleased to report that the Regeneron collaboration is off to a good start. It is progressing according to plan, with lots of energy and good discussions."R&D update Nykode’s modular technology platform is very versatile and may be adapted to generate the desired immune response profile. Hence, Nykode’s platform may be applied across a broad range of immunotherapy areas as innovative solutions to an unmet medical need. Nykode continues to increase the headcount across all functions including R&D to continue to build competencies and support the strategy execution. Please find below an update on Nykode’s current research and development activities.

Oncology VB10.16 VB10.16 is a therapeutic HPV vaccine directed against HPV16+ induced malignancies:
• Clinical trial VB C-02: − Clinical stage: Phase II − Cancer indication: HPV16+ advanced, non-resectable cervical cancer − Fully enrolled − ClinicalTrials.gov Identifier: NCT04405349 Status and highlights The trial is fully enrolled and reported positive interim efficacy and safety data on May 9, 2022. Interim results from 39 patients with a median follow up of 6 months show an ORR of 21%, including two patients who achieved a complete response and six who achieved a partial response, and a very high disease control rate of 64%. The trial enrolled a heavily pre-treated patient population with more than two thirds of the patients having received at least two previous systemic lines of treatment. Interestingly, anti-tumor activity was observed in both PD-L1 positive (ORR of 27% and DCR of 77%) and PD-L1 negative patients (ORR of 17% and DCR of 58%) indicating a potential clinical benefit also in the PD-L1 negative population. In addition, a DCR of 71% was observed in patients with noninflamed tumors, including both immune desert and T cell excluded tumors.

Together these findings suggest a differentiated anti-tumor response pattern of the combination treatment compared to checkpoint inhibitor monotherapy. Nykode expects to report updated efficacy data read-outs from VB C-02 during the first half of 2023. VB10.NEO VB10.NEO is an individualized neoantigen cancer vaccine, exclusively licensed to Genentech:
• Clinical trial VB N-01: − Clinical stage: Phase I/IIa − Cancer indications: Melanoma, non-small cell lung cancer (NSCLC), clear renal cell carcinoma, urothelial cancer or squamous cell carcinoma of the head and neck (SCCHN) − Fully enrolled − ClinicalTrials.gov Identifier: NCT03548467
• Clinical trial VB N-02: − Clinical stage: Phase Ib − Cancer indications: Locally advanced and metastatic tumors − ClinicalTrials.gov Identifier: NCT05018273 Org.no. N-990 646 066 MVA 5 Status and highlights News flow updates relating to VB10.NEO are in general at Genentech’s discretion. Recruiting sites are open in US, Germany and Spain. Infectious Diseases Nykode’s infectious disease initiative continues to generate supportive data and explore and evaluate a diverse set of pathogens as potential next future clinical vaccine targets. VB10.COV2 Nykode has chosen a 2-arm strategy for its VB10.COV2 project to fight SARS-CoV2 variants of concern (VoC*).

VB10.2129 (RBD candidate) and VB10.2210 (T cell candidate) are two vaccines designed using Nykode’s modular and APC targeted technology:
• Clinical trial VB-D-01, investigating the two vaccine candidates, VB2129 and VB2210. − Clinical stage: Phase I/II − Pathogen: SARS CoV-2 − ClinicalTrials.gov Identifier: NCT05069623 VB10.2129 – 2nd generation vaccine addressing novel variants of concern* VB10.2129 contains the RBD domain of the Beta variant of concern B1.351. Importantly, preclinical data demonstrate induction of rapid, strong and persistent neutralizing antibody responses in animal models by VB2129 not only against the Beta variant, but also across several other major variants of concern. Nykode’s RBD vaccine candidate has the potential to induce rapid and strong levels of neutralizing antibody responses addressing both existing and emerging variants of concern.

VB10.2210 – 3rd generation universal broadly protective T cell vaccine Increasing evidence highlights the importance of broad T cell responses in providing rapid as well as long-term memory responses against COVID-19 with limited sensitivity to viral mutations. The vaccine includes SARS-CoV2 T cell epitopes identified and validated by Adaptive Biotechnologies. Nykode aims to boost and broaden the most clinically relevant and conserved T cell responses against a broad set of SARS-CoV-2 epitopes identified by Adaptive Biotechnologies. Preclinical data confirm induction of strong T cell responses against multiple SARS-CoV2 antigens in several mouse models. The aim is to induce long-lasting protective immunity across all population groups and across current and future variants. VB-D-01 trial The VB-D-01 trial is a Phase I/II, open label, dose escalation trial to determine safety and immunogenicity of two SARS CoV-2 vaccine candidates VB10.2129 and VB10.2210. Status and highlights VB10.2129 (RBD candidate): First subject dosed November 3, 2021.

The trial is fully enrolled at two out of three dose levels in the dose-escalation cohort. VB10.2210 (T cell candidate): First subject dosed December 27, 2021. The trial is fully enrolled at all three dose levels in the dose-escalation cohort. Results from the Phase I dose-escalation cohort is expected during the second half of 2022.

*Note: All viruses, including SARS-CoV-2, mutate and change over time. Most changes have limited impact on the virus’ properties. However, some changes may affect the virus’s properties, e.g., as how easily it spreads, the associated disease severity, or the performance of vaccines, diagnostic tools and so forth. The emergence of variants that poses an increased risk to global public health has prompted the characterization of specific variants of concern, in order to prioritize global monitoring and research, and ultimately to inform the ongoing response to the COVID19 pandemic. Source: Tracking SARS-CoV-2 variants (who.int)

MVA 6 Autoimmune disorders Autoimmune disorders are caused by unwanted immunogenicity to autoantigens. Antigen-specific tolerization for the treatment of auto-immune diseases has the potential to blunt autoimmunity without compromising normal immune function. Nykode is exploring autoimmunity model systems to generate pre-clinical proof-of-concept for the ability to induce meaningful antigen-specific immune tolerance. Nykode has demonstrated that its exploratory tolerizing vaccines induce proliferation of epitope specific T regulatory cells in such model systems and will continue its research and know-how building in the area. Other Uplift on Oslo Stock Exchange Nykode has initiated a process for transfer of the listing of its shares from Euronext Growth to the main market of the Oslo Stock Exchange. The expected timing is end of the second quarter of 2022.

Financial review Income statement The net result for the first quarter of 2022 was a net loss of USD 6.9 million compared to a net loss of USD 6.5 million in the first quarter of 2021. The change in net loss was mainly due to increased activities and operations in Nykode, leading to increased operating expenses and employee benefit expenses. This was offset by an increase in total revenue as well as a decrease in the social security cost accrual related to share-based payments included under employee benefit expenses. Revenue and other income Total revenue and other income amounted to USD 1.0 million in the first quarter of 2022 (Q1 2021: USD 0.8 million).

The increase was mainly due to increased R&D service activities under the agreements with Genentech and Regeneron. Operating expenses Total operating expenses amounted to USD 9.6 million in the first quarter of 2022 (Q1 2021: USD 8.3 million). Employee benefit expenses were USD 1.3 million in the first quarter (Q1 2021: USD 3.9 million). The decrease in employee benefit expenses in 2022 is primarily due to the reduction of the social security cost accrual related to share-based payments. This accrual is dependent on the share price as Nykode is required to accrue for the social security cost for all warrants and options that are in-the-money at the balance sheet date. This relates to both the current and the non-current portion. As the share price decreased during the quarter the accrual is also reduced. The corresponding reduction is USD 4.8 million.

The decrease is offset by the planned increase in headcount. Other operating expenses increased from USD 4.3 million in the first quarter of 2021 to USD 7.9 million in the first quarter of 2022, driven by increased operating activity. Net financial income and expenses Net financial income and expenses were USD 0.1 million in the first quarter of 2022 (Q1 2021: USD 0.8 million loss). Finance income and finance costs mainly relate to movements in foreign currency exchange rates and fair value adjustments of financial instruments. Income tax expenses The Group recognized tax income of USD 1.7 million in the first quarter of 2022 and USD 1.7 million in the first quarter of 2021.

The income tax expense is primarily related to movement in deferred tax. Statement of financial position Cash At March 31, 2022, Nykode had a cash position of USD 225.7 million compared to USD 216.2 million at December 31, 2021. The increase in cash is mainly a result from operating activities. Equity At March 31, 2022, total equity amounted to USD 188.6 million, compared to USD 194.1 million at December 31, 2021. The change mainly reflects the net loss of the period of USD 6.9 million, the exercise of warrants and options and recognition of share-based payments. Trade receivables At March 31, 2022, trade receivables amounted to USD 2.5 million, compared to USD 23.8 million at December 31, 2021. The decrease is mainly due to the receipt of the USD 20 million milestone payment from Genentech in the first quarter of 2022.

Trade and other payables At March 31, 2022, trade and other payables amounted to USD 7.0 million, compared to USD 8.5 million at December 31, 2021. Contract liability At March 31, 2022, total contract liability amounted to USD 18.0 million, compared to a contract liability of USD 16.0 million at December 31, 2021. The contract liability is mainly due to timing of invoicing to Genentech as well as recognition of the service component under the Genentech agreement. Other current financial assets At March 31, 2022, total other current financial assets amounted to USD 12.2 million compared to USD 12.2 million at December 31, 2021. Cash flow Net change in cash and cash equivalents was positive USD 9.5 million in the first quarter of 2022 (Q1 2021: USD 4.1 million negative).

Cash and cash equivalents increased to USD 225.7 million at the end of the period, compared to USD 179.7 million at the end of the same period in 2021. Cash flow from operating activities Net cash flow from operating activities was positive USD 10.9 million in the first quarter of 2022 (Q1 2021: USD 5.0 million negative). This was primarily driven by the decrease in trade receivables due to the receipt of the milestone payment from Genentech, offset by a negative profit before tax. Cash flow from investing activities Cash flow from investing activities was negative USD 1.6 million in the first quarter of 2022 (Q1 2021: USD 0.6 million positive).

The amounts mainly relate to the purchase of property, plant and equipment. Cash flow from financing activities Cash flow from financing activities was positive USD 0.1 million in the first quarter of 2022 (Q1 2021: USD 0.3 million positive). The amounts primarily relate to the proceeds from equity issuance, offset by payment of lease liabilities. Outlook The first major clinical objective for 2022 has been reached, namely:-VB C-02 clinical trial, positive interim efficacy and safety results have been reported Expected outlook and news flow regarding Nykode’s key priorities for the remainder of 2022 include: Uplift from Euronext Growth to the main list of Oslo Stock Exchange VB10.16 – Initiation of NYK003-C-03 Phase Ib trial in HNSCC VB-D-01 trial – Phase I key results with Nykode’s two COVID vaccine candidates measuring T cell and antibody responses Update on manufacturing strategy The Company has a strong cash position and no debt.

The Company is in continuous dialogue with academic and industrial entities and will announce new key collaborations and partnerships if or when they may occur. The COVID-19 pandemic and the situation in Ukraine may impact timelines and operations.

Disclaimer This announcement and any materials distributed in connection with this announcement may contain certain forward-looking statements. By their nature, forward-looking statements involve risk and uncertainty because they reflect the company’s current expectations and assumptions as to future events and circumstances that may not prove accurate. A number of material factors could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements.

On May 15, 2022 Immunowake reported the company has raised $20M in pre-series A financing (Press release, Immunowake, MAY 15, 2022, View Source [SID1234656120]).

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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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This funding round was led by Hyfinity Investments, followed by South China Venture, Lapam Capital, and HEDA Ventures. To date, Immunowake has raised $23.5M. Hyfinity Investments will join the board of directors as part of the financing.

The funds raised in this round will be used to accelerate our cytokine pipeline through pre-IND studies and Phase I clinical trials. We expect the submit our first IND application by the last quarter of 2025.

"We are excited to have such a strong group of investors backing our company at this stage. This represents strong confidence in our technology. Our bi-specific antibody platform has the capacity to solve the issues that have been long been plaguing cytokine therapy," says Xiaoyun Wu, CEO and founder of Immunowake.