On August 12, 2021 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer, bacterial diseases and viral infections, reported the second quarter 2021 financial results and provided an operational update (Press release, Evaxion Biotech, AUG 12, 2021, View Source [SID1234586414]).

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Lars Wegner, CEO of Evaxion, said: "Evaxion has made very encouraging clinical progress in the second quarter of 2021, reporting data in July which we believe support advancing both of our lead programs into Phase 2b trials. Phase 1/2a data on our lead program EVX-01 showed that 67% of the patients benefited from EVX-01 in combination with anti-PD-1 for the treatment of metastatic melanoma, compared to the historical data of only 40% benefiting from the check point inhibitor alone. In addition, EVX-02 showed T-cell activation in adjuvant melanoma and appeared to be well tolerated. We plan to initiate a Phase 2b trial for EVX-01 in melanoma in December 2021 and initiate a Phase 2b trial of EVX-02, in conjunction with our third program, EVX-03, in Q2 2022. We also reported preclinical proof of concept data for our RAVEN AI platform for vaccine design and development for viral infections, which we believe has the potential to make a significant contribution in addressing coronavirus infections and other viral diseases. Our cash reserves of $18.8 million provide a solid financial foundation and will facilitate the continued development of these four lead programs."

Operational and Business Highlights in Q2 2021

Reported preclinical proof of concept data in June for the Adaptive and Intelligent Vaccine for a Rapid Response against Corona Viruses (AICoV) program, supporting next-generation coronavirus vaccine technology. First-generation SARS-COV-2 vaccines are focused on the generation of neutralizing antibodies by B cells that bind to the spike protein of the virus and inhibit infection. Activation of T cells may help broaden the immune system’s response to coronavirus and protect against mutations on the spike protein that have been shown to circumvent immunity. Early data demonstrate our RAVEN platform identifies novel immunogenic T-cell epitopes beyond just the spike protein. The proof-of-concept data show RAVEN’s potential to rapidly support the design of novel SARS-COV-2 vaccines capable of tackling newly emerging coronavirus variants.
EVX-03, a novel patient-specific therapy for multiple cancer indications and EVX-B1, a vaccine for the prevention of Staphylococcus aureus including MRSA, continue to progress as expected through preclinical and Chemistry, Manufacturing and Controls (CMC) development.
Presentation in April at the 4th Neoantigen Summit Europe, described Evaxion’s recent improvement in determining cancer neoepitopes through measurement and prediction of peptide-MHC (pMHC) complex stability. We believe this is a significant improvement over AI models trained on traditional mass spectrometry ligand data and the data have already proven valuable in improving our discovery and design of patient-specific neoepitopes used to derive our cancer therapies.
Acceptance of a scientific paper by the International Conference on Machine Learning describing a novel predictive system based on deep probabilistic programming that enables the rapid conversion of sequence data into structural information on protein fragments, which we believe may be useful for drug and vaccine design.
Events after the Reporting Period

Reported new clinical data in early July from Phase 1/2a trials of EVX-01 and EVX-02.
EVX-01, our peptide-based patient-specific cancer therapy, demonstrated anti-tumor effect in combination with anti-PD-1 treatment, a checkpoint inhibitor anticancer drug, for metastatic melanoma. Results from the combination therapy compares favorably to historical data from anti-PD-1 treatment alone. A Phase 2b trial of EVX-01 is planned to start in December 2021.
Preliminary data with EVX-02, our DNA-based patient-specific cancer therapy, demonstrated T-cell activation induced by EVX-02 and appeared to be well tolerated. A Phase 2b trial of EVX-02, in combination with EVX-03, our novel patient-specific therapy for multiple cancer indications, is planned to start in Q2 2022 as a combination therapy with anti-PD-1 in adjuvant melanoma.
Expected milestones in 2021 & 2022

Phase 2b trial initiation of EVX-01 in metastatic melanoma – Q4 2021.
Phase 2b trial regulatory filing for EVX-02 in combination with EVX-03 in adjuvant melanoma – Q2 2022.
Phase 1a trial regulatory filing for EVX-B1 for S. aureus in skin and soft tissue infections (SSTIs) – H2 2022.
First viral candidate selected from RAVEN platform – Q1 2022.
Second Quarter 2021 Financial Results

Cash position: As of June 30, 2021, cash and cash equivalents were $18.8 million compared to $5.8 million as of December 31, 2020. On February 9, 2021, we closed our IPO raising net proceeds of $27.9 million after underwriting discounts and commissions, but before offering expenses.
Research and Development expenses were $5.1 million for the quarter ended June 30, 2021, compared to $2.6 million for the same period in 2020. The increase of $2.5 million was primarily related to increased spending, net of grant income, for ongoing development utilizing our AI platforms, preclinical product candidates, and clinical trials. In addition, employee-related costs increased due to higher headcount.
General and Administrative expenses were $1.9 million for the quarter ended June 30, 2021, compared to $1.4 million for the same period in 2020. The increase of $0.5 million was primarily related to increases in overhead and professional fees related to the expansion of our corporate function.
Net loss was $6.8 million for the quarter ended June 30, 2021 or ($0.36) loss per basic and diluted share, compared to $3.6 million, or ($0.24) loss per basic and diluted share, for the same period in 2020.
Guidance

Evaxion’s current cash position of $18.8 million is expected to be sufficient to fund key clinical programs into 2022.
Webcast and Conference Call

Alternatively to access the audio webcast, please visit the events page of Evaxion’s website at:

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On August 12, 2021 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported financial results for the second quarter ended June 30, 2021 and provided a business update (Press release, Selecta Biosciences, AUG 12, 2021, View Source [SID1234586413]).

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"We are very pleased about our continued progress across all aspects of the company," said Carsten Brunn, Ph.D., president, and chief executive officer of Selecta. "Building on our ongoing empty AAV8 capsid study, we are rapidly advancing our two proprietary gene therapy programs into the clinic and as we enter a critical inflection point in development, we are honored to have gene therapy pioneer, Jude Samulski, Ph.D., join as a special advisor. The recently published preclinical data is encouraging and further supports the advancement of our lead candidate in methylmalonic acidemia (MMA), SEL-302. We will build on this momentum and expect to file an IND in MMA during the third quarter of 2021, bringing us one step closer to addressing immunogenicity constraints in AAV-driven gene therapy and ultimately, providing patients with potentially transformative treatment options. Additionally, we are steadily executing across our enzyme and autoimmune development program. We have a well-defined work plan ahead of us and the financial resources to maximize the value of our innovative ImmTOR platform."

Recent Highlights and Anticipated Upcoming Milestones:

Enzyme Therapies:

SEL-212 for chronic refractory gout: Enrollment for the Phase 3 DISSOLVE clinical program for the treatment of chronic refractory gout, which was licensed to Sobi, is progressing as planned.
Topline data is expected in the second half of 2022.
Investigational New Drug, or IND, enabling studies are underway for a novel therapeutic approach that combines ImmTOR with an enzyme, IgA1 protease for the treatment of IgA nephropathy.
Selecta expects to file an IND in IgA nephropathy in 2022 and will provide additional updates later in the year.
Gene Therapies:

First-in-human trial of SEL-399: In collaboration with AskBio, Selecta initiated the first-in-human, dose-escalation trial of SEL-399, an adeno-associated viral serotype 8 (AAV8) empty vector capsid (EMC-101) containing no DNA combined with ImmTOR. The trial aims to determine the dose regimen of ImmTOR to mitigate the formation of antibodies to AAV8 capsids used in gene therapies.
Topline data is expected in the fourth quarter of 2021.
SEL-302 for methylmalonic acidemia (MMA): Selecta announced publication in the journal Molecular Therapy Methods & Clinical Development demonstrating that ImmTOR enhances transgene expression after both initial and repeat dosing of AAV in a mouse model of MMA. The publication further validates use of ImmTOR in Selecta’s gene therapy pipeline, including its lead candidate, SEL-302 (MMA-101 in combination with ImmTOR), for the treatment of MMA, a rare metabolic disease in which the body cannot break down certain proteins and fats.
The previously disclosed MMA-101 manufacturing issue was resolved. Manufacturing of a new lot has been completed and is currently undergoing final release testing.
Selecta expects to file an IND for SEL-302 during the third quarter of 2021.
SEL-313 for ornithine transcarbamylase deficiency (OTC deficiency): Selecta’s proprietary gene therapy product candidate, SEL-313, is being developed to treat OTC deficiency, a rare genetic urea cycle disorder that causes ammonia to accumulate in the blood due to mutations in the OTC gene.
SEL-313 is currently in preclinical development and a clinical trial application, or CTA and/or IND filing are expected in 2022.
Sarepta Therapeutics program in Duchenne Muscular Dystrophy (DMD) and certain Limb-Girdle Muscular Dystrophies (LGMD) subtypes: Selecta has achieved a $3 million milestone payment related to the completion of a preclinical study under the Research License and Option Agreement.
Restoring Self-Tolerance in Autoimmune Diseases:

Selecta announced Frontiers in Immunology publication showcasing the enhanced hepatic tolerogenic potential of ImmTOR. Data demonstrate that ImmTOR enhances the tolerogenic environment in the liver, shows induction of a tolerogenic phenotype in all major hepatic antigen presenting cell populations and is protective in an acute model of autoimmune hepatitis. The publication further supports development of Selecta’s ImmTOR platform for the treatment of liver-specific autoimmune diseases, including primary biliary cholangitis (PBC).
Selecta continues IND-enabling work on an ImmTOR-based approach to treating PBC and expects to file an IND in PBC in the second half of 2022.
Corporate Updates:

Jude Samulski, Ph.D., was appointed as a special advisor to help guide Selecta’s gene therapy programs into the clinic. Dr. Samulski is a professor of pharmacology and has been the director of the University of North Carolina Gene Therapy Center for over two decades. He was awarded the first patent for AAV as a viral vector and was the first recipient of the American Society of Gene & Cell Therapy Outstanding Achievement Award for lifetime achievements in gene therapy. Dr. Samulski has advanced gene therapies into human clinical trials for hemophilia, Duchenne muscular dystrophy, giant axonal neuropathy, Pompe disease and heart failure, and is the president, chief scientific officer and co-founder of Asklepios BioPharmaceutical Inc. (AskBio), a biotechnology company focused on AAV-driven gene therapy.

Nishan de Silva, M.D. was appointed to Selecta’s Board of Directors. Dr. de Silva has extensive leadership experience, most relevantly in gene therapy development, manufacturing, and regulatory activities. Dr. de Silva brings over 20 years of experience in biotechnology operations, biopharmaceutical venture capital and healthcare management consulting. He is currently chief executive officer and director of AFYX Therapeutics, a private venture-backed biotechnology company focused on addressing unmet needs in mucosal diseases. Previously Dr. de Silva served as president, chief operating officer and director of Poseida Therapeutics, a cell and gene therapy-focused biopharmaceutical company, where he oversaw clinical development, regulatory, manufacturing, finance, and business development activities.
Second Quarter 2021 Financial Results:

Cash Position: Selecta had $151.5 million in cash, cash equivalents, marketable securities, and restricted cash as of June 30, 2021, which compares to cash, cash equivalents, and restricted cash of $149.2 million as of March 31, 2021. Selecta believes its available cash, cash equivalents, marketable securities, and restricted cash will be sufficient to meet its operating requirements into the third quarter of 2023.

Net cash used in operating activities was $18.2 million for the six months ended June 30, 2021, as compared to $23.5 million for the same period in 2020.
Revenue: Revenue recognition for the second quarter of 2021 was $19.7 million, compared to no revenue recognition for the same period in 2020. Revenue was recognized under the license agreement with Sobi which began in July 2020 resulting from the shipment of clinical supply and the reimbursement of costs incurred for the Phase 3 DISSOLVE clinical program. Additionally, during the second quarter, Selecta recognized less than $0.1 million for shipments under the license agreement with Sarepta and $0.1 million resulting from the expiration of the contractual audit term under the Skolkovo Foundation grant.

Research and Development Expenses: Research and development expenses for the second quarter 2021 were $14.5 million, which compares with $10.7 million for the same period in 2020. During the quarter ended June 30, 2021, there was an increase in expenses incurred for consulting, salaries, and the discovery and preclinical programs, offset by a decrease of AskBio collaboration costs.

General and Administrative Expenses: General and administrative expenses for the second quarter 2021 were $4.7 million, which compares with $5.6 million for the same period in 2020. The decrease in costs was primarily the result of reduced expense for salaries, professional fees and patent expense, offset by increased consulting and stock compensation expenses.

Net Income (loss): For the second quarter 2021, Selecta reported net income of $4.6 million, or basic net income per share of $0.04, compared to a net loss of $24.1 million, or basic net loss per share of $0.25 for the same period in 2020.

Conference Call and Webcast Reminder:
Selecta management will host a conference call at 8:30 AM ET today to provide a corporate update and review the company’s second quarter 2021 financial results. Individuals may participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10147802. Investors and the public can access the live and archived webcast of this call and a copy of the presentation via the Investors & Media section of the company’s website, www.selectabio.com.

On August 12, 2021 Scandion Oncology A/S reported that it will publish its Half-year report on Thursday, 19 August 2021 before 09:00 CET (Press release, Scandion Oncology, AUG 12, 2021, View Source,c3395664 [SID1234586412]).

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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 12 August 2021.

On August 12, 2021 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, reported financial results for the second quarter ended June 30, 2021 and highlighted recent corporate accomplishments (Press release, Zentalis Pharmaceuticals, AUG 12, 2021, View Source [SID1234586381]).

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"We have had an extremely productive second quarter, marked by significant clinical and regulatory advances that were outlined in our mid-year review in June. The data presented continue to support our candidates’ potential for best-in-class positioning – both as monotherapies and in combinations – for an array of difficult-to-treat cancers," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. "Of note, our lead candidate, ZN-c3, demonstrated additional deepening and durable tumor responses, and based on this maturing data presented in June, we have identified potential accelerated approval paths for this candidate in USC and a biomarker-driven setting, with the Phase 2 trial in USC already underway."

Continued Dr. Sun, "Furthermore, this momentous period for Zentalis was reinforced by the completion of a recent upsized public offering in which we raised approximately $173 million in gross proceeds. This financing ensures we are well-positioned to fund all upcoming key milestones, with the goal of delivering differentiated cancer treatments to patients globally."

Program Highlights:

In June 2021, Zentalis hosted a mid-year update webcast, providing key clinical and regulatory updates across its pipeline. Clinical highlights from the update included: five confirmed Partial Responses (PRs) and one unconfirmed PR in the Phase 1 monotherapy trial of ZN-c3 in a range of heavily pre-treated solid tumors; plans for two potentially registrational trials for ZN-c3 in USC and a biomarker-driven setting; an oral dose of 50 mg QD demonstrating a Clinical Benefit Rate of 40% in the Phase 1 monotherapy trial of ZN-c5 in ER+/HER2- breast cancer. For more information on the clinical results reported, click here.

In July 2021, the Company dosed the first patient in a Phase 2 trial of ZN-c3 in women with recurrent or persistent USC. Following an end-of-Phase 1 meeting, the U.S. Food and Drug Administration (FDA) agreed in principle that ZN-c3 has the potential for an accelerated approval pathway based on the Phase 2 global study design in USC.

In June 2021, the Company received orphan drug and rare pediatric disease designations from the FDA for ZN-c3 in combination with chemotherapy for the treatment of osteosarcoma. Zentalis expects to initiate a Phase 1/2 trial in 3Q 2021.

In April 2021, Zentalis reported initial results from the Phase 1 portion of a Phase 1/2 trial of ZN-c3 in advanced solid tumors in a late-breaking session at the AACR (Free AACR Whitepaper) Annual Meeting, which was further discussed at a webcast event with Key Opinion Leaders.

In April 2021, Zentalis entered into a Clinical Trial Collaboration and Supply Agreement with GSK to investigate the combination of ZN-c3 and niraparib, GSK’s poly (ADP-ribose) polymerase (PARP) inhibitor, in patients with advanced epithelial ovarian cancer. The Company expects to initiate a Phase 1b trial with this combination in the second half of 2021.
Zentera Highlights:

In July 2021, Zentera, a Shanghai-based clinical-stage biopharmaceutical company formed by Zentalis, announced the completion of a $75 million Series B financing. The proceeds will be used to advance the clinical development of three Zentalis-discovered candidates, ZN-c3, ZN-c5 and ZN-d5, in China, in addition to business development opportunities for pipeline expansion.

As of July 2021, Zentera had received CTA acceptances in China for ZN-c3, ZN-c3 in combination, ZN-c5 and ZN-d5. Two clinical trials are ongoing with plans to initiate one more trial by year-end 2021.
Corporate Highlights:

In July 2021, Zentalis closed an underwritten public offering of 3,565,000 shares of its common stock at a public offering price of $48.50 per share. The total gross proceeds were approximately $172.9 million, before deducting underwriting discounts and commissions and offering expenses payable by Zentalis.
Second Quarter 2021 Financial Results

Cash and Marketable Securities Position: As of June 30, 2021, Zentalis had cash, cash equivalents and marketable securities of $250.9 million. We believe that our existing cash, cash equivalents and marketable securities as of June 30, 2021, together with the net proceeds from our July 2021 follow-on offering, will enable us to fund our operating expenses and capital expenditure requirements into the third quarter of 2023.

Research and Development Expenses: Research and development expenses for the three months ended June 30, 2021 were $44.8 million, compared to $17.5 million for the three months ended June 30, 2020. The increase of $27.3 million was primarily due to increases in external research and development expenses related to our lead product candidates, as we advanced our Phase 1/2 clinical trials for ZN-c3 and ZN-c5. In addition, in the three months ended June 30, 2021, we conducted additional preclinical studies, incurred additional manufacturing costs, and incurred increased costs for study and lab materials.

General and Administrative Expenses: General and administrative expenses for the three months ended June 30, 2021 were $10.4 million, compared to $9.9 million during the three months ended June 30, 2020. This increase of $0.5 million was primarily attributable to an increase of $2.0 million in employee-related and supply costs, partially offset by a reduction in allocable overhead facility expenses.

Net Loss: Net loss was $55.1 million for three months ended June 30, 2021, compared to $27.3 million for the three months ended June 30, 2020. The $27.8 million increase in net loss was primarily the result of the increases in research and development and general and administrative expenses discussed above.

Impact from COVID-19 Pandemic: Though the impact of the COVID-19 pandemic to our business and operating results presents additional uncertainty and cannot be predicted with confidence, we continue to use the best information available to inform our critical accounting estimates.

On August 12, 2021 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported financial results and business highlights for the second quarter of 2021 (Press release, Hookipa Biotech, AUG 12, 2021, View Source [SID1234586380]).

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"During the second quarter, we gained considerable momentum in highlighting the promise of our novel arenaviral platform to redefine success in cancer immunotherapy. Our HB-200 program in advanced Human Papillomavirus 16-positive (‘HPV16+’) cancers was featured prominently at both AACR (Free AACR Whitepaper) and ASCO (Free ASCO Whitepaper), with compelling tumor antigen-specific T cell responses and tumor control that replicate pre-clinical results," said Joern Aldag, Chief Executive Officer at HOOKIPA. "We are focused on advancing our oncology and infectious disease programs through the second half of the year, as we aim to deliver first-in-class arenaviral immunotherapies that induce potent, targeted immune responses to fight or prevent serious disease."

Quarter Highlights

At the virtual American Association for Cancer Research (AACR) (Free AACR Whitepaper) (‘AACR’) Annual Meeting in April 2021, HOOKIPA presented positive preliminary Phase 1 immunogenicity data for HB-200 for the treatment of advanced HPV16+ cancers. These data demonstrated a robust increase in HPV16+-specific T cells, including an increase of up to 8% of antigen-specific circulating CD8+ T cells, after one dose of HB-201 or HB-202. Early HB-201 monotherapy data also highlighted immune system activation of increasing interferon-gamma and other immune stimulatory cytokines with a single dose.

In June, HOOKIPA reported positive Phase 1 data from the ongoing Phase 1/2 study of HB-200 for the treatment of advanced HPV16+ cancers. The clinical data, presented as an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (‘ASCO’) Annual Meeting, showed HB-200 is highly immunogenic, inducing unprecedented levels of activated, tumor antigen-specific CD8+ T cells (an average of 6 percent and up to 40 percent of the T cell pool). In addition, HB-201 monotherapy showed an 18 percent overall response rate and median progression-free survival of 3.45 months in heavily pre-treated head and neck cancer patients who progressed on standard of care, including checkpoint inhibitors.

HOOKIPA completed enrollment in the Phase 2 clinical trial of its prophylactic Cytomegalovirus (‘CMV’), vaccine candidate, HB-101; the last patient was enrolled in June 2021. We expect to report additional safety, immunogenicity, and efficacy data from evaluable patients in the second half of 2021, with final top-line data readout in the first half of 2023. The protocol requires a 12-month follow up after transplantation, which is typically two to three months after enrollment.

Jean-Charles Soria resigned as a Non-Executive Director of HOOKIPA’s Board of Directors to avoid any conflicts of interest following a decision to join Amgen as senior vice president and lead of the oncology therapeutic area.
Upcoming Milestones

Additional HB-201/HB-202 Phase 1/2 data in HPV16+ cancers and recommended Phase 2 dose for the HB-200 program in the fourth quarter of 2021
HB-101 CMV Phase 2 data in the second half of 2021
Advancing our HB-300 program to IND for the treatment of metastatic prostate cancer
HBV and HIV collaboration with Gilead Sciences advancing towards clinical studies
Second Quarter 2021 Financial Results

Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of June 30, 2021 was $102.9 million compared to $143.2 million as of December 31, 2020. The decrease was primarily attributable to cash used in operating activities.

Revenue was $5.4 million for the three months ended June 30, 2021, and $6.7 million for the three months ended June 30, 2020. The decrease was primarily due to receipt of a $1.0 million milestone payment under the Gilead collaboration during this time period in 2020, but not in 2021.

Research and Development Expenses: HOOKIPA’s research and development expenses were $19.6 million for the three months ended June 30, 2021, compared to $11.6 million for the three months ended June 30, 2020.

The primary drivers of the increase in direct research expenses were an increase in manufacturing and quality control expenses of $1.6 million, and an increase in clinical operations expenses of $1.4 million, along with a general increase in other direct research and development expenses and laboratory expenses of $2.4 million. These expenses were mainly due to the progress in our HB-201 and HB-202 clinical trial, in particular for monitoring and testing activities, and 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.

Internal research and development expenses increased by $2.6 million, mainly due to our increased research and development headcount.

General and Administrative Expenses: General and administrative expenses for the three months ended June 30, 2021 were $5.1 million, compared to $4.3 million for the three months ended June 30, 2020. The increase was primarily due to an increase in personnel-related expenses, partially offset by a decrease in professional and consulting fees. The increase in personnel-related expenses resulted from a growth in headcount along with increased salaries in our general and administrative functions, and increased stock compensation expenses.

Net Loss: HOOKIPA’s net loss was $17.2 million for the three months ended June 30, 2021, compared to a net loss of $7.1 million for the three months ended June 30, 2020. This increase was due to an increase in research and development expenses, an increase in general and administrative expenses, a decrease in revenues from collaboration and licensing and a decrease in other income, partially offset by an increase in grant income.