NYKODE THERAPEUTICS INTERIM REPORT
1ST QUARTER 2024
Oslo, Norway, May 14, 2024 - Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, today announced its unaudited financial results for the quarter ended March 31, 2024.
FINANCIAL RESULTS FOR Q1 2024
- Total revenue and other income of USD 1.0 million, compared to USD 3.3 million for the first quarter of 2023.
- Total operating expenses of USD 16.6 million, compared to USD 18.0 million for the first quarter of 2023.
- Net loss of USD 14.9 million, compared to a net loss of USD 10.4 million for the first quarter of 2023.
- Strong cash position of USD 147.3 million as of March 31, 2024.
HIGHLIGHTS FOR Q1 2024
Highlights for the first quarter 2024:
- Updated survival data from the Phase 2 VB-C-02 trial in advanced cervical cancer affirm prolonged benefits and indicate a synergistic treatment effect of Nykode's VB10.16 and atezolizumab (Tecentriq®). The updated survival data closely mirrors the previously reported positive outcome with an observation time for remain- ing patients of at least 24 months compared to at least 12 months at the previous reported outcome. The data support the accelerated development of VB10.16, including the potential U.S. pivotal trial VB-C-04 in recurrent or metastatic cervical cancer, and advancing of the program into earlier stages of cervical cancer and expanding into head and neck cancer. Nykode will present detailed data in a future scientific publication or at a forthcoming conference.
Highlights after March 31, 2024:
- Initiated the Phase 2 VB-C-04 trial in second line HPV16-positive cervical cancer, evaluating VB10.16 alone or in combination with Roche's checkpoint inhibitor atezolizumab in patients with HPV16-positive,PD-L1-positive, recurrent, or metastatic cervical cancer. The Phase 2 trial will be conducted in the U.S. in collaboration with The GOG Foundation, a U.S. based not-for-profit organization with the purpose of promo ting excellence in the quality and integrity in clinical trials in gynecologic malignancies.
- For the first time, Nykode demonstrated a significant effect in a therapeutic setting using a preclinical model for Multiple Sclerosis (MS) with its inverse vaccine platform. The new data also illustrate the strong contribution of the specific targeting unit and confirm that the disease protection is antigen-specific.
- Presented additional preclinical data on the inverse vaccine platform, demonstrating that it provides long-term protection against the development of diabetes in the T1D model following treatment with- drawal. The preclinical data, which were presented at the annual J.P Morgan Healthcare Conference, again illustrate the potential of Nykode's technology in the field of autoimmune diseases.
- Concluded enrollment of the 6 mg cohort in the VB-C-03 trial, evaluating VB10.16 in combination with pembrolizumab in first-line head and neck cancer patients.
- Presented new preclinical data from our collaboration with Genentech, focusing on the differentiation of our proprietary vaccine technology.
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Michael Engsig, Chief Executive Officer at Nykode, comments:
"We are immensely proud of the progress Nykode has achieved this quarter, marking significant milestones across our clinical and preclinical programs. The latest results from our Phase 2 VB-C-02 trial not only reaffirm the prolonged benefits of VB10.16 in combination with atezolizumab for advanced cervical cancer, but also strongly support its accelerated development into a potential US pivotal trial. Furthermore, our innovative inverse vaccine platform has demonstrated promising potential in autoimmune disease management, showing significant effects in a Multiple Sclerosis preclinical model. This quarter's achievements underscore Nykode's commitment to advancing groundbreaking treatments that could transform patient care in cancer and auto immune diseases."
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KEY FINANCIAL FIGURES
1st Quarter | Full Year | ||
Amounts in USD '000 | 2024 | 2023 | 2023 |
Total revenue and other income | 1,016 | 3,307 | 13,323 |
Total operating expenses | 16,620 | 17,989 | 71,405 |
Operating profit (loss) | (15,604) | (14,682) | (58,082) |
Net profit (loss) for the period | (14,944) | (10,361) | (35,154) |
Net cash flow | (14,180) | (20,151) | (44,995) |
Cash and cash equivalents, end of period | 147,296 | 186,163 | 162,602 |
Outstanding shares, end of period | 326,546,444 | 295,494,309 | 326,546,444 |
Cash and cash equivalents/total assets | 77% | 91% | 78% |
Equity ratio | 83% | 72% | 82% |
Equity | 158,720 | 148,260 | 171,259 |
Total assets | 191,891 | 205,272 | 208,185 |
Employees, average | 175 | 154 | 159 |
Employees, end of period | 176 | 158 | 173 |
NYKODE THERAPEUTICS INTERIM REPORT Q1 2024 | 4 |
R&D UPDATE
Nykode's modular immunotherapy technology platform is versatile and may be adapted to generate immune therapies inducing the desired immune response profile. Hence, Nykode's platform may be applied across a broad range of oncology, infectious diseases and autoimmune disorders.
- Clinical trial currently enrolling
- ClinicalTrials.gov Identifier: NCT06099418
- Clinical trial VB-C-05:
- Cancer indication: HPV16+ locally advanced cervical cancer in combination with pembrolizumab and chemoradiation
Oncology
VB10.16
VB10.16 is a therapeutic vaccine directed against HPV16+ induced malignancies and is currently being investigated in cervical cancer and head and neck cancer, two cancer types with significant unmet medical need. The product candidate is wholly owned by Nykode.
- Clinical trial VB-C-02:
- 3 mg dose, in combination with atezolizumab1
- Cancer indication: HPV16+ advanced or recurrent, non-resectable cervical cancer
- Clinical stage: Phase 2
- Fully enrolled and has reported final efficacy and safety results
- ClinicalTrials.gov Identifier: NCT04405349
- Clinical trial VB-C-03:
- Up to 9 mg dose, in combination with
pembrolizumab2 - Cancer indication: HPV16+ non-resectable, recurrent or metastatic squamous cell head and neck cancer
- Clinical stage: Phase 1/2a
- Clinical trial currently enrolling
- ClinicalTrials.gov Identifier: NCT06016920
- Up to 9 mg dose, in combination with
- Clinical trial VB-C-04:
- 9 mg dose, in combination with atezolizumab
- Cancer indication: HPV16+ recurrent/metastatic cervical cancer and refractory to pembrolizumab with chemotherapy with or without bevacizumab
- Clinical stage: Phase 2
- Clinical stage: Phase 2 - protocol in development
- Clinical trial in preparation phases
- ClinicalTrials.gov Identifier: N/A
Status and highlights
The VB-C-02 trial in cervical cancer patients reported positive final efficacy results and was also well tolerated. The updated results, which closely mirror the previously reported positive C-02 outcomes, affirm prolonged benefits and indicate a synergistic treatment effect of VB10.16 plus atezolizumab compared to the historical controls of monotherapy with checkpoint inhibitors. The updated analysis' observation time for the remaining patients was at least 24 months, compared to at least 12 months at the previously reported outcome The data announced indicate enhanced clinical activity over checkpoint inhibitor monotherapy and existing standard of care. It supports the next steps for Nykode's potentially registrational VB-C-04 trial which will enroll PD-L1+ patients with one prior line of systemic therapy.
The VB-C-03 trial will assess the safety and efficacy of VB10.16 in combination with pembrolizumab in first-line head and neck cancer patients. The trial is being conducted across eight countries in Europe. As of today, 15 clinical sites out of the expected 23 sites in total have been activated. The safety run-in phase for the lowest dose of 3 mg was successfully concluded and enrollment in the next dose level (6 mg) has been concluded. The highest dose level (9 mg) will be initiated upon the safety clearance of the 6 mg dose level.
The VB-C-04 trial will investigate VB10.16 in combination with atezolizumab in patients with HPV16+ recurrent/ metastatic cervical cancer who are refractory to pembro- lizumab with chemotherapy with or without bevacizumab. The trial was initiated in April 2024 and enrollment is now ongoing. Enrollment of Part 1 of the trial is expected finalized by year-end 2024. In total 36 sites are currently selected to participate in the trial which is being conduc-
- Atezolizumab is supplied by Roche. Nykode retains all commercial rights to VB10.16 worldwide.
2 Pembrolizumab is supplied by MSD. Nykode retains all commercial rights to VB10.16 worldwide.
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ted as a US-only trial. FDA IND approval has been obtained in 2023.
The protocol for the VB-C-05 trial in locally advanced cervical cancer in an adjuvant setting is currently being developed. It aims to incorporate VB10.16 into the existing treatment regimen of pembrolizumab with chemoradiation, which has recently gained approval for this specific cancer indication.
VB10.NEO
VB10.NEO is an individualized neoantigen cancer vaccine targeting multiple cancer indications. VB10.NEO is exclusively licensed to Genentech, a member of the Roche group.
- Clinical trial VB-N-02:
- VB10.NEO, 3-9 mg dose escalation, in combination with atezolizumab
- Cancer indications: Locally advanced and metastatic tumors covering more than ten indications
- Clinical stage: Phase 1b
- Clinical trial is active, not recruiting
- ClinicalTrials.gov Identifier: NCT05018273
Status and highlights
As per protocol, a safety clearance of the 9 mg dose has been conducted in the VB-N-02 trial with VB10.NEO, with no safety concerns. Trial is ongoing, but enrollment has been concluded.
Pre-clinical data generated in collaboration with Genen- tech was presented at the 7th International Neoantigen Summit in Amsterdam in May 2024.
NYK011
In December 2023, Nykode announced the expansion of its oncology pipeline with a preclinical program aimed at reducing the burden of colorectal cancer. NYK011
is a potential first-in-class preclinical oncology vaccine program to prevent and treat colorectal cancer, which typically develops from premalignant polyps in the colon or rectum. The program aims to identify and intervene early in high-risk patients and those with developed malignancies. Utilizing a selection of tumor-associated antigens linked to the progression from colonic polyps to cancer, the vaccine leverages Nykode's 4th module second-generation technology, enhancing immune responses across diverse patient groups. This approach capitalizes on Nykode's expertise in generating strong CD8 T cell responses against tumor-associated antigens.
Infectious Diseases
Nykode continues to explore the potential of the platform in infectious diseases in collaboration with our partners.
Autoimmune Disorders
Autoimmune disorders are caused by unwanted immuno- genicity to self-antigens.Antigen-specific tolerization for treating autoimmune diseases, also known as inverse vaccination, can suppress autoimmunity without compromising normal immune function. This approach could also potentially treat allergies and organ transplant rejection.
Nykode's platform is uniquely positioned to induce antigen specific tolerogenic T cell responses through the specific targeting of tolerogenic dendritic cells.
Nykode has demonstrated how its modular technology prevents serious disease in a preclinical model of Multiple Sclerosis (MS). Disease prevention was demonstrated using diverse targeting units directed at different targets on tolerogenic dendritic cells. Inverse vaccination based on Nykode's unique technology platform similarly prevents diabetes in a spontaneous type 1 diabetes preclini- cal model. The addition of Nykode's proprietary 4th module technology further enhances therapeutic efficacy in the model.
At the annual J.P. Morgan Healthcare Conference in January 2024, Nykode presented additional data on the inverse vaccine platform, demonstrating that it provides long-term protection against the development of diabetes in the T1D model following treatment withdrawal.
At the 7th Antigen-specific Immune Tolerance Summit in Boston in March 2024, Nykode also demonstrated a significant effect in a therapeutic setting in the preclinical model for Multiple Sclerosis (MS). The data also illustrated the strong contribution of the specific targeting unit and confirmed that the disease protection is antigen-specific.
Other
At the American Association for Cancer Research (AACR) in April 2024, Nykode presented data on delivery of APC- targeted neoepitope vaccines using mRNA-LNP. mRNA delivery of APC targeted vaccines led to faster and broader T cell responses compared to standard mRNA vaccines with identical antigens in a head-to-head comparison. Almost a doubling of the number of immuno- genic antigens was observed when targeting these to APCs compared to no targeting. The immune responses were primarily driven by CD8 T cells. Thus, whether delivered via DNA or mRNA, the APC-targeted approach is superior leading to stronger and broader T cell responses.
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FINANCIAL REVIEW
(Numbers in brackets are for the corresponding period versus the previous year unless otherwise specified)
Income statement for the first quarter 2024
The first quarter of 2024 showed a net loss of USD 14.9 million compared to a net loss of USD 10.4 million for the same period in 2023.
Total revenue and other income amounted to USD 1.0 million, compared to USD 3.3 million for the same period in 2023. Revenue from contracts with customers was USD
0.8 million (USD 3.1 million), and relates to R&D services provided under the agreements with Genentech and Regeneron. Other income was USD 0.2 million (USD 0.2 million) and relates to government grants.
Total operating expenses amounted to USD 16.6 million, compared to USD 18.0 million for the same period in 2023. Employee benefit expenses were USD 8.8 million in the first quarter of 2024 (USD 6.7 million). The increase in employee benefit expenses is mainly due to the increased number of employees. Other operating expenses decreased from USD 10.9 million in the first quarter of 2023 to USD 7.2 million in the first quarter of 2024.
Net financial income and costs were negative USD 0.8 million in the first quarter of 2024 (USD 2.7 million positive). Finance income and finance costs mainly relate to interest income, movements in foreign currency exchange rates and interest expense on lease liabilities. The decrease is mainly due to fluctuations in USD/NOK exchange rate.
The Group recognized tax income of USD 1.5 million in the first quarter of 2024 compared to a tax income of USD
1.6 million in the same period of 2023. The income tax expense is primarily related to movement in deferred tax.
Statement of financial position
Cash and cash equivalents amounted to USD 147.3 million at March 31, 2024 compared to USD 162.6 million at December 31, 2023.
Total equity amounted to USD 158.7 million at March 31, 2024, compared to USD 171.3 million at December 31, 2023. The decrease is mainly due to the net loss for the period of USD 14.9 million.
Other non-current receivables were USD 30.1 million (USD
31.9 million), which mainly reflects the NOK 325 million (USD 29.0 million) payment to the Norwegian Tax Autho rities in the fourth quarter of 2023 following their negative decision. Nykode has appealed the decision to the Norwegian Tax Administration (Norw: Skatteklagenemda).
Trade and other payables amounted to USD 4.0 million at March 31, 2024, compared to USD 7.1 million at Decem- ber 31, 2023. The decrease is mainly due to a reduction in accounts payable at the end of 2023 compared to year-end 2022.
At March 31, 2024, total contract liability amounted to USD 7.7 million, compared to a contract liability of USD 8.2 million at December 31, 2023. The contract liability is mainly due to timing of invoicing to Genentech as well as recognition of the service component under the Genen- tech agreement.
Cash flow for the first quarter 2024
Net change in cash and cash equivalents was negative USD 14.2 million in the first quarter of 2024 compared to negative USD 20.2 million for the same period in 2023.
Net cash flow from operating activities was negative USD
13.9 million in the first quarter of 2024 (USD 20.0 million negative).
Net cash flow from investing activities was positive USD
0.1 million in the first quarter of 2024 (USD 0.7 million
negative). The amounts mainly relate to interest received.
Net cash flow from financing activities was negative USD
0.3 million in the first quarter of 2024 (USD 0.5 million positive).
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OUTLOOK FOR THE NEXT 12 MONTHS
Expected outlook and upcoming milestones for Nykode's wholly owned programs include:
Dose level recommendation for the VB-C-03 trial determining the biological optimal dose of VB10.16 in combination with a fixed dose of pembrolizumab in H2 2024.
Finalization of enrolment for Part 1 of the VB-C-04 trial (VB10.16) in Q4 2024.
Update on Nykode's APC targeted vaccine technology delivered by mRNA in Q2 2024.
Update on Nykode's autoimmune disease program in Q2 2024.
Update on preclinical oncology vaccine program aimed at preventing and treating colorectal cancer (NYK011) in H2 2024.
Presentation of detailed clinical data from the updated analysis of the VB-C-02 trial (VB10.16) in advanced cervical cancer in a future scientific publication or at a forthcoming conference.
The company is in continuous dialogue with academic and industrial entities and will announce new key collabora tions and partnerships if or when they may occur. News flow from the programs under the Genentech and Regeneron agreements is subject to approval by the respective partners.
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.
Nykode's lead product candidates are VB10.16, a therapeutic vaccine for the treatment of human papilloma virus (HPV)-16 induced malignancies which demonstrated favorable safety and efficacy results from its Phase 2 trial for the treatment of cervical cancer. VB10.16 is being expanded into multiple trials for treatment of head and neck cancer and cervical cancer. VB10.NEO, an individua lized cancer neoantigen vaccine, is exclusively out licensed to Genentech, a member of the Roche Group.
The company's partnerships include Genentech within oncology and a multi-target collaboration with Regeneron within oncology and infectious diseases.
Nykode Therapeutics' shares are traded on Oslo Stock Exchange (OSE: NYKD). Further information about Nykode Therapeutics may be found at http://www.nykode.comor you may contact the company at IR@nykode.com.
About Nykode
Nykode Therapeutics is a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies with a focus on the treatment of cancer and autoimmune diseases. Nykode's modular vaccine technology specifically targets antigens to Antigen Presenting Cells, which have been shown to induce broad, strong, and long-lasting antigen specific immune
response in cancer, which correlates with clinical responses.
NYKODE THERAPEUTICS INTERIM REPORT Q1 2024 | 8 |
CONDENSED CONSOLIDATED INTERIM STATEMENT OF
COMPREHENSIVE INCOME
Amounts in USD '000 | Notes | Q1 2024 | Q1 2023 |
Revenue from contracts with customers | 4 | 827 | 3,126 |
Other income | 5 | 189 | 181 |
Total revenue and other income | 1,016 | 3,307 | |
Employee benefit expenses | 6.1 | 8,822 | 6,657 |
Other operating expenses | 6.2 | 7,228 | 10,867 |
Depreciation | 570 | 465 | |
Operating profit (loss) | (15,604) | (14,682) | |
Finance income | 2,245 | 3,308 | |
Finance costs | 3,089 | 618 | |
Profit (loss) before tax | (16,448) | (11,992) | |
Income tax expense (income) | (1,504) | (1,631) | |
Profit (loss) for the period | (14,944) | (10,361) | |
Other comprehensive income: | |||
Items that subsequently may be reclassified to profit or loss: | |||
Foreign currency translation effects | 2 | - | |
Total items that may be reclassified to profit or loss | 2 | - | |
Total other comprehensive income for the period | 2 | - | |
Total comprehensive income for the period | (14,942) | (10,361) | |
Earnings per share ("EPS"): | |||
Basic EPS - profit or loss attributable to equity holders | (0.05) | (0.04) | |
Diluted EPS - profit or loss attributable to equity holders | (0.05) | (0.04) |
NYKODE THERAPEUTICS | 9 |
CONDENSED CONSOLIDATED INTERIM STATEMENT OF FINANCIAL POSITION
Amounts in USD '000 | Notes | 31/03/2024 | 31/12/2023 |
ASSETS | |||
Non-current assets | |||
Property, plant and equipment | 4,242 | 4,413 | |
Right-of-use assets | 5,686 | 6,104 | |
Intangible assets | 68 | 70 | |
Other non-current receivables | 4 | 30,063 | 31,923 |
Total non-current assets | 40,059 | 42,510 | |
Current assets | |||
Trade receivables | 220 | - | |
Other receivables | 4,316 | 3,073 | |
Cash and cash equivalents | 147,296 | 162,602 | |
Total current assets | 151,832 | 165,675 | |
TOTAL ASSETS | 191,891 | 208,185 | |
EQUITY AND LIABILITIES | |||
Equity | |||
Share capital | 7 | 367 | 367 |
Share premium | 128,986 | 128,986 | |
Other capital reserves | 17,298 | 15,395 | |
Other components of equity | (3,046) | (3,048) | |
Retained earnings | 15,115 | 29,559 | |
Total equity | 158,720 | 171,259 | |
Non-current liabilities | |||
Non-current lease liabilities | 3,744 | 4,269 | |
Non-current provisions | 1 | 2 | |
Other non-current liabilities | 864 | - | |
Deferred tax liabilities | 10,543 | 12,047 | |
Total non-current liabilities | 15,152 | 16,318 | |
Current liabilities | |||
Government grants | 5 | 98 | 104 |
Current lease liabilities | 1,387 | 1,457 | |
Trade and other payables | 3,993 | 7,064 | |
Current provisions | 4,794 | 3,750 | |
Current contract liabilities | 4 | 7,747 | 8,233 |
Income tax payable | - | - | |
Total current liabilities | 18,019 | 20,608 | |
Total liabilities | 33,171 | 36,926 | |
TOTAL EQUITY AND LIABILITIES | 191,891 | 208,185 |
NYKODE THERAPEUTICS INTERIM REPORT Q1 2024 | 10 |
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Nykode Therapeutics AS published this content on 14 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 14 May 2024 05:18:02 UTC.
