On March 25, 2022 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported its financial results for the year ended December 31, 2021 (Press release, Moleculin, MAR 25, 2022, View Source [SID1234610989]). The Company also provided an update on its portfolio of oncology drug candidates for the treatment of highly resistant tumors and viruses.

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"Over the course of 2021, we have made significant progress across multiple fronts. As we look ahead, I believe we are well positioned for an exciting 2022 with a number of clinical and regulatory milestones expected throughout the year," commented Walter Klemp, Chairman and CEO of Moleculin. "Our Annamycin development programs in STS lung mets and AML continue to progress and we remain encouraged by the data seen to date. Additionally, with the necessary regulatory approvals received, we are advancing parallel development of WP1122 for the treatment of COVID-19 and GBM. With our growing body of encouraging clinical data and our strong financing position, we remain laser focused on executing our initiatives, driving value for all stakeholders, and importantly, addressing unmet needs for people with highly resistant tumors and viruses."

Recent Highlights

●Appointed Joy Yan, M.D., Ph.D., an oncology physician-scientist with extensive experience in early and late clinical development with successful track record, to its Board of Directors.

●Successfully concluded the Company’s second Phase 1 trial (MB-105) in Poland evaluating Annamycin for the treatment of relapsed and refractory acute myeloid leukemia (AML), where Moleculin determined a dose of 240 mg/m2 as the Recommended Phase 2 Dose (RP2D) and demonstrated no signs of cardiotoxicity (a common problem with currently prescribed anthracyclines).

●Reported an updated independent safety review of certain preliminary data for the first 30 patients in its three Phase 1 clinical trials with Annamycin targeting relapsed or refractory AML and the metastases of soft tissue sarcoma to the lungs (STS Lung), which concluded there was no evidence of cardiotoxicity. The review included analysis of ejection fraction, echo strain and certain troponin levels intended to assess potential for both acute and chronic heart damage. Additionally, the Company reported evidence that Annamycin may have a substantially lower incidence of alopecia (hair loss) than currently prescribed anthracyclines such as doxorubicin.

●Reported preliminary interim results from its U.S. Phase 1b/2 clinical trial evaluating Annamycin for the treatment of STS lung metastases in its fourth cohort with three patients recruited and dosed which continues to document preliminary human activity for this drug. In this cohort one patient experienced a dose limiting toxicity (DLT) that resolved and continues in the trial. All three initial patients had their scans after two cycles and reported stable disease and are continuing in the study. This information is preliminary and subject to change.

●Received allowance from the U.S. Food and Drug Administration (FDA) for the Company’s Investigational New Drug (IND) application to study WP1122 for the treatment of GBM. With this IND now cleared, Moleculin plans to identify investigators interested in initiating a Phase 1 open label, single arm, dose escalation study of the safety, pharmacokinetics and efficacy of oral WP1122 in adult patients with GBM.

●Filed an amended protocol with both the Riverside Ethics Committee and Medicines and Healthcare Products Regulatory Agency (MHRA) to commence a Phase 1a clinical trial of WP1122 in the United Kingdom; once approved, the internally funded trial is expected to begin in the first half of 2022.

Programs Update

Next Generation Anthracycline – Annamycin

Annamycin is the Company’s next-generation anthracycline that has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin, as well as demonstrating the ability to avoid the multidrug resistance mechanisms that typically limit the efficacy of doxorubicin and other currently prescribed anthracyclines. Importantly, Annamycin has also demonstrated a lack of cardiotoxicity in multiple human clinical trials, including ongoing trials for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases, and the Company believes that the use of Annamycin may not face the same usage limitations imposed on doxorubicin, one of the most common currently prescribed anthracyclines. Annamycin is currently in development for the treatment of AML and STS lung metastases and the Company believes it may have the potential to treat a number of additional indications.

Annamycin currently has Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of STS lung metastases, in addition to Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia.

For more information about the Phase 1b/2 study evaluating Annamycin for the treatment of STS lung metastases, please visit clinicaltrials.gov and reference identifier NCT04887298.

Upcoming Milestones Expectations

●H1 2022: Initiate Phase 1/2 study in Europe for the treatment of AML evaluating combination therapy of Annamycin + Ara-C.

●H1 2022: Commencement of an investigator-funded, second Phase 1b/2 clinical trial of Annamycin in sarcoma lung metastases in Europe.

●H1 2022: Complete Phase 1b portion of ongoing Phase 1b/2 study of Annamycin for the treatment of sarcoma lung metastases in the US.

Metabolism/Glycosylation Inhibitor – WP1122

Moleculin has new compounds designed to target the roles of glycolysis and glycosylation in both cancer and viral diseases. The Company’s lead Metabolism/Glycosylation Inhibitor, WP1122, is a prodrug of 2-DG that appears to improve the drug-like properties of 2-DG by increasing its circulation time and improving tissue/organ distribution. Based on recently published research that has identified that 2-DG has antiviral potential against SARS-CoV-2 in vitro, Moleculin believes WP1122 has significant potential as a COVID-19 therapy. Its unique mechanism of action may also be well-suited for combinations that potentiate existing therapies, including checkpoint inhibitors.

The Company has received authorization from the Medicines and Healthcare Products Regulatory Agency (MHRA) to commence a Phase 1a clinical trial of WP1122 in the United Kingdom. The Company also received a favorable opinion from the London – Riverside Research Ethics Committee in the UK to begin the study, which is expected to be conducted at the Medicines Evaluation Unit in Manchester, United Kingdom. In early March 2022, the Company filed an amended protocol with both the Riverside Ethics Committee and the MHRA. The amendment updated the dilution of the oral solution to achieve full dissolution of WP1122. No risk/benefit to the study was affected because of this change. The Phase 1a study in healthy human volunteers will investigate the effects of a single ascending dose (SAD) and multiple days of ascending dosing (MAD) of WP1122 administered as an oral solution. Dose escalation will take place in sequential SAD cohorts, and MAD will start as soon as SAD has completed at least 3 dosing cohorts in which WP1122 is found to be safe and well-tolerated. This study in healthy volunteers will explore safety and pharmacokinetics (PK), and subsequent clinical development will be in patients infected with SARS-CoV-2 to further evaluate safety and establish a favorable risk/benefit profile. The Company expects to enroll approximately 80 healthy volunteers in the United Kingdom.

Glioblastoma Multiforme

Additionally, the Company recently announced that the FDA is allowing the Company’s Investigational New Drug (IND) application to study WP1122 for the treatment of GBM to go forward. With this IND now cleared, Moleculin plans to identify investigators who are interested in initiating a Phase 1 open label, single arm, dose escalation study of the safety, pharmacokinetics and efficacy of oral WP1122 in adult patients with GBM.

Upcoming Milestones Expectations

●H1 2022: Commence Phase 1a study of WP1122 for the treatment of COVID-19 in the UK.

●H1 2022: Potential to launch Phase 2 pivotal study of WP1122 for the treatment of COVID-19 outside of the US.

●2022: Identify investigators interested in initiating a Phase 1 open label, single arm, dose escalation study of the safety, pharmacokinetics and efficacy of oral WP1122 in adult patients with GBM.

●Ongoing preclinical development work in additional anti-viral indications such as HIV, Zika, and Dengue. Collaborations targeted for 2022.

Summary of Financial Results for the Full Year 2021

Research and development (R&D) expense was $14.4 million and $12.8 million for the year ended December 31, 2021 and 2020, respectively. The increase in R&D of $1.6 million is mainly related to increase in the number of internally funded clinical trials and overall clinical trial activity, and costs related to manufacturing of additional drug product.

General and administrative expense was $8.4 million and $6.8 million for the year ended December 31, 2021 and 2020, respectively. The increase of $1.6 million is mainly related to an increase in headcount, consulting and advisory fees, and an increase in our corporate insurance.

For the year ended December 31, 2021 and 2020, the Company incurred net losses of $15.9 million which included non-cash gains of $6.7 million on warrants in 2021 as compared to $2.3 million in the prior year and approximately $2.4 million of stock-based compensation expense in 2021 as compared to $1.7 million in 2020.

The Company ended the year with $70.9 million of cash. The Company believes that this cash is sufficient to meet its projected operating requirements, which include a forecasted increase over its current R&D rate of expenditures, into 2024.

On March 25, 2022 Broncus Medical (02216HK), Inc., developer of diagnostic and therapeutic technology for a variety of lung diseases, reported online publication in the Respirology journal of a global, multicenter study demonstrating the effectiveness of the company’s Archimedes Virtual Bronchoscopic Navigation (VBN) System in guiding the sampling of peripheral pulmonary lesions (Press release, Broncus Technologies, MAR 25, 2022, View Source [SID1234611005]).

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The prospective, single-arm, multicenter study of 104 patients studied biopsy yield (biopsy forceps and/or needle), sampling yield (including cytologic sampling) and diagnostic yield using the Archimedes System to guide bronchoscopic transparenchymal nodule access (BTPNA) and guided transbronchial needle aspiration (TBNA). The global study took place at:

U.S. – Beth Israel Deaconess Medical Center, Cancer Treatment Centers of America at Southwestern Regional Medical Center, Duke University, Houston Methodist Hospital, Temple University Hospital, University of Pennsylvania
China – The First Affiliated Hospital of Guangzhou Medical University, Shanghai Chest Hospital
Germany – ThoraxKlinik
Hong Kong – Hong Kong Sanatorium and Hospital
The study’s authors concluded that, "BTPNA and TBNA contribute to safe and effective sampling of peripheral pulmonary lesions. A relatively high biopsy yield was obtained independent of the presence or absence of a bronchus sign, and high sampling yield and diagnostic yield were obtained independent of location, lesion size and presence or absence of a broncus sign."

The Archimedes VBN System combines fused fluoroscopy, real-time bronchoscopy and virtual bronchoscopic navigation for 3D views and access to nodules anywhere in the lung, with the ability to avoid major blood vessels through vessel mapping. Archimedes uniquely enables BTPNA, a sampling method that enables a surgeon to precisely and quickly access a lesion via tunneling when the lesion is not adjacent to an airway.

The study showed that BTPNA enabled a sampling yield of 90.2 percent and a biopsy yield of 86.3 percent, while the sampling yield across both BTPNA and guided TBNA was 93.9 percent. This was achieved with a low pneumothorax rate of only 1.9 percent. The diagnostic yield from more than one-year follow-up across both procedures was 75.4 percent and 72.8 percent, respectively, on the high and low estimate. Sufficient histologic and/or cytologic samples were obtained in 107 of 124 lesions, resulting in a technical success rate of 86.3 percent.

"Despite new technologies to improve bronchoscopic diagnosis, their results are limited by their reliance on the presence of an airway leading to the lesion. The BTPNA approach using virtual bronchoscopic navigation is exciting as it is demonstrating the ability to achieve a very high biopsy yield no matter where the lesion is located, while avoiding blood vessels and minimizing the risk of pneumothorax," said Gerard Criner, MD, Chair and Professor, Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University and Director, Temple Lung Center. "Seeing these results in a global multicenter study in a real world setting is very encouraging as we look to advance the care we can provide every day to lung cancer patients."

"In this study, BTPNA showed a superior biopsy yield when compared to today’s bronchoscopic diagnostic approaches. While BTPNA is an emerging approach, its capabilities will become even more valuable with the advent of new therapeutics in the near future, when both diagnosis and treatment will be able to be accomplished bronchoscopically, no matter where the lesion is located in the lung," said Brandon Markle, Senior Director of Global Sales and Marketing, Broncus Medical.

On March 25, 2022 Vaccitech plc (NASDAQ: VACC) reported its financial results for the full year ended December 31, 2021 and provided an overview of the Company’s recent corporate developments (Press release, Vaccitech, MAR 25, 2022, View Source [SID1234610991]). Vaccitech is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer.

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"2021 was a pivotal year for Vaccitech during which we achieved a number of strategic, operational, and financial objectives, advanced multiple immunotherapeutic and prophylactic candidates in clinical development and strengthened and expanded our T cell activating discovery engine platform via the acquisition of Avidea Technologies," commented Bill Enright, Vaccitech’s CEO. "All of this progress puts us in a strong position to deliver on our long-term plans. We anticipate that 2022 will be a year where we continue to advance our product pipeline with key data readouts in several programs. We look forward to reporting on these developments throughout the year."

2021 and Recent Corporate Developments

·Raised $166.5 million of proceeds in a Series B private financing, including $41.2 million from previously issued convertible loan notes that converted into Series B shares.
·Completed a public listing on NASDAQ, raising gross proceeds of $110.5 million through an offering of American Depository Shares.
·Initiated patient dosing in HPV001, a Phase 1/2 clinical trial of VTP-200, an immunotherapeutic candidate in development for the treatment of persistent infection with high-risk HPV.
·Signed a clinical trial collaboration agreement with Arbutus Biopharma Corporation to evaluate an innovative therapeutic combination for the treatment of patients with chronic Hepatitis B virus (HBV) infection who are already receiving standard-of-care nucleos(t)ide reverse transcriptase inhibitor, or Nrtl, therapy. The Phase 2a clinical trial will evaluate the safety, pharmacokinetics, immunogenicity, and antiviral activity of Arbutus’s RNAi therapeutic, AB-729, followed by Vaccitech’s immunotherapy candidate, VTP-300, in Nrtl-suppressed patients with chronic HBV infection.
·Signed a lease for 31,000 square feet within the Zeus development at Harwell Science and Innovation Campus in Oxfordshire, United Kingdom. The site will house Vaccitech’s headquarters, state-of-the-art wet laboratory, and offices. Vaccitech anticipates completing the relocation by mid-2022.
·Online publication in The Lancet Microbe results of a Phase 1 clinical trial of VTP-500, a vaccine candidate in development to prevent Middle East Respiratory Syndrome (MERS). The study, sponsored and conducted by researchers at The King Abdullah International Medical Research Centre in Saudi Arabia in partnership with Oxford University, showed that the vaccine candidate was generally well tolerated and induced both humoral and cellular immune responses.

·Presented at the AASLD The Liver Meeting data from a Phase 1 (HBV001) and Groups 1 and 2 of a Phase 1/2a (HBV002) clinical trial demonstrating that VTP-300 was tolerated and induced T cells against targeted HBV antigens in both healthy volunteers and patients with chronic HBV infection.
·Reported efficacy data from an interim analysis of the HBV002 clinical trial of VTP-300 in patients with chronic HBV infection. The data from 27 patients who completed three months in the trial demonstrated reductions in surface antigen (HbsAg) levels in patients receiving VTP300 both alone and in combination with nivolumab.
·Acquired Avidea Technologies, Inc. in a cash and stock transaction that added complementary synthetic T cell boosting technologies and expands Vaccitech’s pipeline to include autoimmunity to its current infectious disease and oncology therapeutic areas of focus. The transaction also furthers Vaccitech’s scientific expertise and establishes U.S.-based research and development capabilities.
·Cancer Research UK and the Ludwig Institute for Cancer Research initiated patient dosing in a Phase 1/2a clinical trial to test the safety and initial efficacy of VTP-600, an immunotherapeutic candidate in development for the treatment of non-small cell lung cancer. The therapeutic candidate employs Vaccitech’s viral vector prime-boost platform to induce T cell immunity against two cancer-associated proteins, MAGE-A3 and NY-ESO-1, found on some tumor cells.

Upcoming Milestones

·In the second quarter of 2022, the Company expects to present additional Phase 1/2a interim efficacy data of VTP-300 in patients with chronic HBV infection at the International Liver Congress on June 22 to 26, 2022, which is also expected to be followed by Phase 1/2a full efficacy clinical trial data in the second half of this year.
·In the third quarter of 2022, the Company expects to initiate dosing in a Phase 1/2 clinical trial of VTP-850 in patients with prostate cancer and also expects to initiate dosing of a Phase 2 clinical trial of VTP-300 in patients with chronic HBV infection.
·In the fourth quarter of 2022, the Company intends to conduct an interim efficacy review of HPV001, a Phase 1/2a clinical trial of VTP-200, a potential non-invasive treatment for low grade HPV-related cervical lesions.

Full Year 2021 Financial Highlights:

·Cash position: As of December 31, 2021, cash and cash equivalents were $214.1 million, compared to $43.3 million as of December 31, 2020. The increase was primarily due to completion of the Series B financing in the first quarter of 2021, which raised gross proceeds of $125.2 million, and to the initial public offering in the second quarter, which raised gross proceeds of $110.5 million. The Company believes its cash and cash equivalents are sufficient to fund operations into the second half of 2024.

·Research and development expenses: Research and development expenses were $20.4 million in 2021 compared to $14.4 million in the prior year. The increase in R&D expenses was primarily due to increased spending on the development of VTP-200, VTP-300, and VTP-850.

·General and administrative expenses: General and administrative expenses were $25.1 million in 2021 compared to $10.5 million in the prior year. This includes the share-based payment charge of $14.2 million and $6.0 million unrealized foreign exchange gain on revaluation of Company’s cash balances recorded in 2021. Net of this gain, the increase in general and administrative expenses between the periods was mainly attributable to higher personnel costs, reflecting an increase in the Company’s headcount over the period and higher insurance costs associated with operating as a public company.

·Net loss: The Company generated a net loss attributable to its shareholders of $50.9 million, or $1.96 per share on both basic and fully diluted bases in 2021, compared to a net loss of $17.7 million, or $2.24 per share on both basic and fully diluted bases, for the prior year.

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 Scandion Oncology (Scandion) reported that the Annual Report 2021 is available on the company’s website (Press release, Scandion Oncology, MAR 24, 2022, View Source;annual-report-2021,c3531342 [SID1234610885]).

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The information was provided by the contact person above for publication on March 24, 2022, at 08.30 CET.