On May 11, 2023 InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, reported its financial and operating results for the three months ended March 31, 2023, and provided a business update (Press release, InflaRx, MAY 11, 2023, View Source [SID1234631513]).

Recent Highlights and Business Update

Gohibic (vilobelimab): EUA Granted for Treatment of Critically Ill COVID-19 Patients
In April 2023, the FDA issued an EUA for Gohibic (vilobelimab) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO).

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InflaRx has an initial supply of Gohibic (vilobelimab) available and is currently ramping up production at its third-party manufacturer to be able to further supply the U.S. as soon as possible. InflaRx expects to make the product available in the U.S. for the treatment of hospitalized patients within the next weeks. Therefore, the Company is expecting to be able to record first revenues from sales of Gohibic already in Q3 2023. InflaRx is continuing discussions with the FDA related to the submission of a Biologics License Application (BLA) for the full approval of Gohibic (vilobelimab). InflaRx has also completed encouraging meetings with the rapporteur and co-rapporteur member state teams of the European Committee for Medicinal Products for Human Use (CHMP) related to a planned Marketing Authorization Application with the European Medicines Agency (EMA). The Company will provide updates on the status of regulatory submissions in the U.S. and elsewhere once available.

Vilobelimab in Pyoderma Gangrenosum (PG)
In January 2023, InflaRx presented details related to the design of its planned pivotal Phase III study with vilobelimab in ulcerative PG, following compelling Phase II results for the treatment of this rare neutrophilic and inflammatory skin disease with destructive, painful cutaneous ulcers. The multi-national, randomized, double-blind, placebo-controlled trial has an adaptive design with an interim analysis that will determine the planned total patient number. The Company has submitted the clinical trial protocol to the FDA. InflaRx expects the first patient to be enrolled in this study around mid-2023.

Vilobelimab in Cutaneous Squamous Cell Carcinoma (cSCC)
InflaRx is conducting an open-label, multicenter Phase II study, evaluating vilobelimab in two study arms – as stand-alone therapy and in combination with pembrolizumab – in patients with programmed cell death protein 1 (PD1) or programmed cell death ligand 1 (PDL1) inhibitor resistant/refractory, locally advanced or metastatic cSCC. The main objectives of this trial are to assess the safety and antitumor activity of vilobelimab in the monotherapy arm and to assess the maximum tolerated or recommended dose of vilobelimab and the safety and antitumor activity of this drug pair in the combination arm. First data from the monotherapy arm are expected to be available in Q2 2023, and data from an interim analysis of the combination arm are expected in H1 2024.

INF904
InflaRx is currently conducting a Phase I trial in healthy volunteers to assess the safety, tolerability and pharmacokinetic / pharmacodynamic properties of this new and proprietary low molecular weight C5aR inhibitor. The Company will explore the effect of INF904 on C5a-induced downstream activity and generate data in a format comparable with other published data on C5aR inhibitory molecules. Results are expected in H2 2023. In the future, InflaRx plans to develop INF904 for complement-mediated, chronic autoimmune and inflammatory diseases where oral administration is the preferred choice for patients.

Post-Period Financing Activities
In April 2023, the Company issued 3,235,723 ordinary shares under its ATM program, resulting in €14.4 million in net proceeds. Also in April 2023, the Company completed an underwritten public offering of an aggregate of 10,823,529 ordinary shares, which included the full exercise of an overallotment option granted to the underwriters to purchase 1,411,764 additional ordinary shares, resulting in €39.1 million in net proceeds. Aggregate proceeds from these equity offerings amounted to €53.5 million after deducting underwriting discounts.

Dr. Thomas Taapken, Chief Financial Officer of InflaRx, said: "Our recent successful financing activities have put us on an even firmer footing, not only to fund our development activities and advance our pipeline, including the Phase III trial with vilobelimab in pyoderma gangrenosum, but also to invest into the required commercial, manufacturing and logistical infrastructure in the U.S. for making Gohibic available to physicians and patients in the U.S. very soon. Despite a financial market environment that continues to be challenging, we are now well funded to support operations into 2026."

Financial Highlights – Q1 2023

Research and Development Expenses
Research and development expenses in Q1 2023 increased by €4.3 million to €14.7 million compared to Q1 2022. This increase was primarily attributable to the establishment of a commercial-scale manufacturing process for vilobelimab and regulatory expenses in conjunction with the EUA filing and other regulatory activities, as well as for the manufacturing of clinical trial-related material.

General and Administrative Expenses
General and administrative expenses decreased by €0.8 million to €3.6 million, from €4.4 million in Q1 2022. This decrease was attributable to lower expenses associated with equity-settled share-based compensation recognized in personnel expenses of €0.8 million.

Other Income
Other income amounted to €7.7 million, which was primarily attributable to income recognized from the grant payments received from the German federal government for the development of vilobelimab for critically ill COVID-19 patients.

In 2021, InflaRx was awarded a grant from the German Ministry of Education and Research and the German Ministry of Health to support the development of vilobelimab for the treatment of COVID-19. As of March 31, 2023, the Company had received €25.6 million in grant funds and still has a maximum amount of €13.2 million available to claim through the end of the grant term in June 2023. The grant is structured as a reimbursement of 80% of certain pre-specified expenses related to the clinical development and manufacturing of vilobelimab.

Net Financial Result
Net financial result decreased by €1.3 million to net financial expense of €0.5 million in Q1 2023, from net financial result of €0.9 million in Q1 2022. This decrease is attributable to an aggregation of different factors, including higher interest income on investments of €0.4 million due to higher interest rates, lower foreign exchange gains, which decreased by €0.8 million, and higher foreign exchange losses of €1.0 million.

Net Loss
Net loss in Q1 2023, amounted to €11.1 million, compared to €14.0 million in Q1 2022.

Liquidity and Capital Resources
As of March 31, 2023, the Company had cash and cash equivalents and marketable securities amounting to €72.3 million. In addition, during April 2023, InflaRx raised proceeds of € 53.5 million through the utilization of the Company’s established ATM program and through an underwritten public share offering after deducting underwriting discounts. The Company’s current funds on hand are expected to be sufficient to fund operations into 2026.

Net Cash Used in Operating Activities
Net cash used in operating activities decreased to €10.5 million in Q1 2023, from €12.9 million in Q1 2022.

Additional Financial Information
Additional information regarding these results and other relevant information is included in the notes to the unaudited interim condensed consolidated financial statements as of March 31, 2023, and the three months ended March 31, 2022, and 2021, as well as the consolidated financial statements as of and for the year ended December 31, 2022, in "ITEM 18. Financial Statements," in InflaRx’s Annual Report on Form 20-F for the year ended December 31, 2022, as filed with the U.S. Securities and Exchange Commission (SEC).

On May 11, 2023 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, reported financial results for the three months ended March 31, 2023, and provided an update on its clinical development programs with IMNN-001 (formerly GEN-1), a DNA-based interleukin-12 (IL-12) immunotherapy in Phase 2 clinical development for the treatment of advanced-stage ovarian cancer, and PLACCINE, a proprietary, multivalent DNA plasmid technology utilizing synthetic, non-viral vaccine delivery vectors being evaluated in preclinical studies for superiority over the current generation of nucleic acid vaccines (Press release, IMUNON, MAY 11, 2023, View Source [SID1234631512]).

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Highlights of the first quarter of 2023 and recent weeks include:

Opened enrollment in a Phase 1/2 clinical study of IMNN-001 in combination with Avastin in advanced ovarian cancer
Announced compelling results from a non-human primate study confirming PLACCINE as a viable modality for the development of the next generation of prophylactic vaccines; PLACCINE is a non-viral, non-device plasmid DNA-based vaccine modality targeting multiple antigens from a single vector
Reported data suggesting PLACCINE vaccines elicit robust and more durable T-cell responses than commercial mRNA vaccines, signaling that these vaccines may provide greater protection against reinfection, hospitalization or death
Signed new research collaborations with The Wistar Institute to develop new vaccine formulations utilizing PLACCINE for infectious diseases
Reported cash and cash equivalents of $37.3 million as of March 31, 2023, which is expected to fund operations into 2025
"Our PLACCINE modality continues to advance with very promising data. We demonstrated the validity of this proprietary technology in prophylactic vaccines, with impressive proof-of-concept data in a COVID-19 model coupled with final data from non-human primate studies showing excellent immunological response and viral clearance. We also demonstrated in a recent mouse study that a single dose of our PLACCINE vaccine without a booster dose produced longer duration of IgG responses and higher T-cell activation than an mRNA vaccine. We are now more than nine months into a 12-month PLACCINE stability study and have demonstrated continued drug stability at the standard refrigerated temperature of 4°C, representing a significant commercial advantage over mRNA-based vaccines," said Dr. Corinne Le Goff, IMUNON’s President and Chief Executive Officer.

"In March we applied for a pre-IND consultation with the U.S. Food and Drug Administration (FDA) to receive guidance on our proposed program for our seasonal COVID-19 booster vaccine prior to submitting an Investigational New Drug (IND) application with the FDA in the fourth quarter of 2023. Our objective is to confirm in a Phase 1 clinical study the safety of our PLACCINE modality. We will also select our next pathogen target for our PLACCINE modality. We likely will choose a pathogen from the list of priority pathogens established by the Coalition for Epidemic Preparedness Innovations. Our vaccine program objective is to establish the safety and efficacy of our platform in a Phase 1 human study, and then seek to license this powerful technology to pharmaceutical companies for the utilization of our platform and/or to establish non-dilutive partnerships to develop vaccines for pathogens of interest," she added.

"We have now developed an in-house pilot manufacturing capability for DNA plasmids and nanoparticle delivery systems. Our scientists can select any protein from the human or pathogen proteomes to be engineered. Our existing labs also have the ability to conduct testing and to run experiments in a variety of animal disease models. These internal capabilities will allow us to control both the costs and the development timelines in support of our goal to attract corporate partners.

"With the continued volatility of the public equity markets, our decision to raise significant capital in 2021 and early 2022 to extend our cash runway into 2025 was well timed. We expect to report several value-creating developments over the next six to 18 months, among them reporting additional interim data on IMNN-001 from our OVATION 2 Study and the combination study with bevacizumab in advanced ovarian cancer, reporting topline data from the OVATION 2 Study, filing the IND for our SARS-CoV-2 vaccine and announcing proof-of-concept vaccine data for our next pathogen," Dr. Le Goff concluded.

RECENT DEVELOPMENTS

PLACCINE: Developing the Prophylactic Vaccines of the Future

Presentation at Vaccine Technology Summit 2023 Describes Compelling Preclinical Data Supporting Continued Development of PLACCINE as a Differentiated, Next-Generation Vaccine. In March 2023 Khursheed Anwer, Ph.D., IMUNON’s Executive Vice President and Chief Science Officer, presented data on the Company’s PLACCINE platform at the Vaccine Technology Summit 2023. Dr. Anwer’s presentation is titled "A Novel DNA Vaccine Platform with Potential to Create Next Generation Vaccines," and can be found on the Company’s website here.

Dr. Anwer reviewed the company’s work in advancing its PLACCINE modality and the promising preclinical data generated to date. Among topics presented was the ability of this multi-valent technology to achieve broad spectrum immunity from a single DNA plasmid with a synthetic delivery system. This ability is independent of virus, device or liquid nanoparticle formulations. The data presented showed:

Robust immunogenicity and protection in SARS-CoV-2 models
Durable cellular or humoral responses detectable for more than 12 months
Comparable protection activity to a commercial mRNA vaccine in a booster-dose comparison
Superior immune quality versus the mRNA vaccine in a single-dose comparison
In addition, the PLACCINE modality had important distinguishing advantages for a commercial vaccine, including a shelf-life at 4⁰C for greater than nine months, and the ability for simple, rapid and scalable manufacturing.

IMNN-001 Immunotherapy

Phase 1/2 Clinical Study of IMNN-001 in Combination with Bevacizumab in Advanced Ovarian Cancer was Opened to Enrollment. In February 2023, the company announced a collaboration to evaluate IMNN-001 in a Phase 1/2 clinical trial in combination with bevacizumab in ovarian cancer in the frontline, neoadjuvant setting. Working with four of the foremost comprehensive cancer centers in the world, the goal of this project is to transform the care of women with ovarian cancer by developing unprecedented capabilities for understanding and targeting persistent minimal residual disease (MRD), as explained here.

This new Phase 1/2 study is expected to enroll 50 patients with Stage III/IV advanced ovarian cancer and is being led by principal investigator Amir Jazaeri, M.D., Professor of Gynecologic Oncology and Reproductive Medicine at MD Anderson. A third party will partially fund the study.

The trial is open to enrollment at the University of Texas MD Anderson Cancer Center with expected additional participation at The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and Memorial Sloan Kettering Cancer Center. The Koch Institute for Integrative Cancer Research at the Massachusetts Institute of Technology will provide artificial intelligence services throughout the trial, including biomarker and genomic analyses, which is expected to expand the company’s knowledge of the treatment paradigm.

Presentation at American Association for Cancer Research (AACR) (Free AACR Whitepaper) Describes Findings from Mouse Model of Peritoneally Disseminated Ovarian Cancer Suggest Biweekly Dosing Regimen for Further Evaluation in Human Clinical Studies. In April 2023 Jean Boyer, Ph.D., IMUNON’s vice president of preclinical research, presented a poster titled "Efficacy of IMNN-001, an Interleukin-12 Immune Gene Therapy, at Different Dose Frequencies" at AACR (Free AACR Whitepaper). The poster can be found on the company’s website here.

Researchers concluded that IMNN-001 demonstrated stimulation of the immune response in the ID8 ovarian tumor model. Of the three dosing regimens tested, the once every 2-week regimen demonstrated comparability to the weekly regimen while showing superiority to the once every 3-week regimen, particularly with respect to mortality and tumor burden. Thus, exploring once every 2-week dosing of IMNN-001 in human studies is warranted.

Partnerships. Collaborations and Corporate Developments

Collaborative Research Agreement Signed with The Wistar Institute’s Vaccine & Immunotherapy Center. In January 2023, the Company announced a collaborative research agreement with The Wistar Institute, a global leader in biomedical research, through its Vaccine & Immunotherapy Center, to research and develop new vaccine formulations utilizing the Company’s PLACCINE modality for the development of vaccines for infectious diseases. The Wistar Institute Vaccine & Immunotherapy Center possesses world-renowned expertise in cancer, immunology, infectious diseases and vaccine creation. They are uniquely positioned to advance new vaccine formulations and will facilitate further expansion and development of PLACCINE with the goal of expanding vaccine targets ideally matched for the Company’s novel formulated DNA delivery platform.

Received $1.6 Million in Non-Dilutive Funding from the Sale of New Jersey Net Operating Losses. In January 2023, the Company announced it received $1.6 million in net cash proceeds from the sale of approximately $1.7 million of its unused New Jersey net operating losses (NOLs). The NOL sales cover the tax year 2021 and are administered through the New Jersey Economic Development Authority’s (NJEDA) Technology Business Tax Certificate Transfer (NOL) program. This non-dilutive funding further strengthened the Company’s balance sheet. The Company plans to sell an additional $1.9 million of unused New Jersey NOLs available to the Company under the program in 2023.

FIRST QUARTER FINANCIAL RESULTS

IMUNON reported a net loss for the first quarter of 2023 of $5.6 million, or $0.68 per share, compared with a net loss of $10.5 million, or $1.82 per share, for the first quarter of 2022. Operating expenses were $5.7 million for the first quarter of 2023, a decrease of $0.3 million or 5% from $6.0 million for the first quarter of 2022.

Net cash used for operating activities was $4.1 million for the first quarter of 2023, compared with $8.0 million for the comparable prior-year period. This decrease was primarily due to the one-time payment of $4.5 million in interest expense resulting from the sale and subsequent redemption of $30.0 million of convertible, redeemable preferred stock during the first quarter of 2022.

Cash provided by financing activities of $2.5 million during the first quarter of 2023 resulted from equity sales under the Company’s At-the-Market Equity Facility. The Company had $37.3 million in cash, investments and restricted cash as of March 31, 2023. Combined with $1.9 million in planned future sales of the Company’s State of New Jersey NOLs, the Company believes it has sufficient capital resources to fund its operations into 2025.

Research and development (R&D) expenses were $2.6 million for the first quarter of 2023, a decrease of $0.5 million from $3.1 million for the comparable period in 2022. R&D costs associated with the development of IMNN-001 to support the OVATION 2 Study as well as development of the PLACCINE DNA vaccine technology platform increased to $1.7 million for the first quarter of 2023, compared with $1.9 million for the same period of 2022. Other clinical and regulatory costs were $0.3 million for the first quarter of 2023, compared with $0.8 million for the first quarter of 2022. CMC costs increased to $0.7 million for the first quarter of 2023, compared with $0.3 million for the first quarter of 2022 due to higher costs related to the development of in-house pilot manufacturing capabilities for DNA plasmids and nanoparticle delivery systems.

General and administrative expenses were $3.1 million for the first quarter of 2023, compared with $2.9 million for the comparable prior-year period. This increase was primarily attributable to lower non-cash stock compensation expense offset by higher professional fees, including legal fees to defend various lawsuits filed after the announcement in July 2020 of the OPTIMA Phase 3 study results, higher compensation expenses related to the CEO succession plan announced in July 2022 and higher staffing costs.

Other non-operating income was $93,085 for the first quarter of 2023, compared with other non-operating expenses of $4.6 million for the prior-year period. In the first quarter of 2022, the Company incurred a one-time payment of $4.5 million in interest and offering expenses resulting from the sale and subsequent redemption of $30.0 million of convertible redeemable preferred stock. The Company incurred higher interest expense on its loan facility with Silicon Valley Bank in the first quarter of 2023 due to rising interest rates. This loan facility has since been assumed by First Citizen Bank under the same terms. Investment income from the Company’s short-term investments increased by $0.3 million for the first quarter of 2023 compared with the prior-year period due to higher returns on these investments.

Conference Call and Webcast

The Company is hosting a conference call to provide a business update, discuss first quarter 2023 financial results and answer questions at 11:00 a.m. EDT today. To participate in the call, please dial 866-777-2509 (Toll-Free/North America) or 412-317-5413 (International/Toll) and ask for the IMUNON First Quarter 2023 Earnings Call. A live webcast of the call will be available here.

The call will be archived for replay until May 25, 2023. The replay can be accessed at 877-344-7529 (U.S. Toll-Free), 855-669-9658 (Canada Toll-Free) or 412-317-0088 (International Toll), using the replay access code 6902750. A webcast of the call will be available here for 90 days.

On May 11, 2023 ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, reported its final results for the twelve months ended 31 December 2022 (the "Period") (Press release, ImmuPharma, MAY 11, 2023, View Source [SID1234631511]).

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Key Highlights (including post Period review)

Financial

Loss for the Period of £3.8m (2021: £8.2m)
Research and development expenses of £2.0m (2021: £3.7m)
Administrative expenses of £0.8m (2021: £1.0m)
Exceptional items of £nil (2021: £1.4m, representing corporate reorganisation costs)
Cash balance at 31 December 2022 of £0.7m (31 December 2021: £1.6m)
Successful subscription and placing, raising in total £2.0m (gross) – August 2022
Lanstead derivative financial asset of £0.3m (2021: £0.9m)
Incanthera financial asset of £0.7m (2021: £1.2m)
Warrants financial asset of £0.001 (2021: £0.2m)
Product Development

P140 Pharmokinetic ("PK") study successfully completed in April 2022 with key findings shared with the FDA*
In February 2023 an adaptive Phase 2/3 study for Lupuzor in SLE/Lupus patients was agreed with US partner, Avion Pharmaceuticals, following guidance from the FDA
Type C meeting confirmed with FDA for 7 June 2023 for consideration of the new protocol of the Phase 2/3 adaptive study for Lupuzor in SLE patients
Pre-IND meeting confirmed with FDA for 16 May 2023 for feedback on the new protocol of the Phase 2/3 adaptive study for CIDP
Collaboration with Orano – ImmuPharma peptide technology as a vector for cancer radiotherapy – an initial collaboration for 12 months
*FDA (Food and Drug Administration)

Commenting on the statement and outlook Tim McCarthy, CEO, said:

"As a Board, we remain focused on bringing our two key late stage clinical assets, Lupuzor for lupus and CIDP closer to the market. We now have a clinical roadmap for Lupuzor and remain on track to commence the Phase 2/3 adaptive trial in H2 2023, with potentially CIDP moving into clinical studies in parallel. This illustrates the potential franchise we have within our P140 autoimmune platform.

We will also continue to concentrate on further commercial and partnering opportunities. In conjunction with the above objectives, we continue to take prudent measures on managing our cost base.

In closing, we would like to thank our shareholders for their support as well as our staff, corporate and scientific advisers and our partners including CNRS and Avion."

On May 11, 2023 ImmunityBio, Inc. (the "Company") reported that it has received a complete response letter from the U.S. Food and Drug Administration ("FDA") on May 9, 2023 regarding its Biologics License Application ("BLA") for its product candidate, Anktiva (N-803) in combination with Bacillus Calmette-Guérin ("BCG") for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer ("NMIBC") with carcinoma in situ ("CIS") with or without Ta or T1 disease (Press release, ImmunityBio, MAY 11, 2023, View Source [SID1234631510]). The letter indicates that the FDA has determined that it cannot approve the BLA in its present form, and the FDA has made recommendations to address the issues raised.

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The deficiencies relate to the FDA’s pre-license inspection of the Company’s third-party contract manufacturing organizations. Satisfactory resolution of the observations noted at the pre-license inspection is required before the BLA may be approved. The FDA further provided recommendations specific to additional Chemistry, Manufacturing and Controls ("CMC") issues and assays to be resolved.

No new preclinical studies or Phase 3 clinical trials to evaluate safety or efficacy were requested by the FDA. The FDA requested that the Company provide updated duration of response data of the efficacy population as identified by the FDA in the Company’s resubmission, as well as a safety update.
The Company plans to request a meeting with the FDA as soon as possible to address the subject matter of the letter and a response timeline, and plans to diligently address and resolve the issues identified and seek approval as expeditiously as possible.

Business Development Updates

On May 9, 2023, the Company’s Executive Chairman and Global Chief Scientific and Medical Officer agreed to provide immediate non-convertible debt financing to the Company in an amount of $30.0 million on substantially similar terms as prior financings, including an interest rate of Term Secured Overnight Financing Rate ("SOFR") plus 8% per annum and a maturity date of December 31, 2023.

As previously disclosed, the Company has been exploring partnering with a large biopharmaceutical company for commercialization of N-803 for intravesical administration. The Company has confirmed with the potential partner that these negotiations will continue notwithstanding the letter referenced above, with the view of completing such a transaction during 2023, though there can be no assurance that the Company will complete a transaction on acceptable terms in accordance with this timeline or at all.

On May 11, 2023 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported its financial results and business highlights for the first quarter of 2023 (Press release, Hookipa Biotech, MAY 11, 2023, View Source [SID1234631509]).

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"We are happy to report continued progress across our oncology and infectious disease portfolios, as our HB-300 program for advanced prostate cancer and Gilead-partnered HB-400 program for the treatment of chronic hepatitis B both entered the clinic. Further, our HB-700 program in collaboration with Roche achieved a success-based milestone payment associated with manufacturing for our clinical supplies," said Joern Aldag, Chief Executive Officer at HOOKIPA. "We are on track to report Phase 2 data from our lead program, HB-200 in combination with pembrolizumab, in the second quarter of 2023, which is an exciting step forward as we expect the results to inform our next, potentially registrational trial."

Quarter highlights

Oncology

In February, HOOKIPA announced that it had achieved a $10 million milestone payment under its collaboration agreement with Roche to develop HB-700, a novel arenaviral immunotherapy for KRAS-mutated cancers. The success-based milestone payment reflects the start of the HB-700 manufacturing process to support a Phase 1 clinical trial.

In April, HOOKIPA announced the acceptance of a trial-in-progress presentation at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on its ongoing Phase 1/2 study of HB-300 for the treatment of advanced prostate cancer. Enrollment is ongoing and initial data are expected in the first half of 2024.
Infectious disease

In January, HOOKIPA received a $5 million milestone payment under its collaboration agreement with Gilead Sciences for the completion of the regulatory support package for Gilead’s Phase 1 clinical trial of HB-400, an alternating, 2-vector non-replicating arenaviral therapeutic vaccine for the treatment of chronic hepatitis B. The first participant was dosed in April 2023. Gilead is solely responsible for further development and commercialization of the hepatitis B product candidate.
Corporate

In March, HOOKIPA announced the appointment of Terry Coelho to its Board of Directors, Audit Committee and Compensation Committee. Terry brings more than 35 years of experience in business strategy, broad financial transactions and business development of large pharmaceutical and smaller biotechnology companies.
Upcoming Milestones

Phase 2 HB-200 in HPV16+ head and neck cancers
1st-line initial data in combination with pembrolizumab: 2Q 2023
2nd+-line initial data in combination with pembrolizumab: 2Q 2023
Post-standard of care monotherapy: additional data 2Q 2023
Randomized Phase 2 in 1st-line with pembrolizumab: study kick-off 2023 (Fast Track designation)
HB-300 in prostate cancer: preliminary safety, tolerability and immunogenicity data expected 1H 2024
HB-700 in KRAS-mutated cancers: submit IND 1H 2024
HB-500 in HIV: submit IND 2023
First Quarter 2023 Financial Results
Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of March 31, 2023 was $110.0 million compared to $113.4 million as of December 31, 2022. The decrease was primarily attributable to cash used in operating activities, partly offset by funds resulting from the Gilead and Roche collaborations.

Revenue: Revenue was $3.2 million for the three months ended March 31, 2023 compared to $1.4 million for the three months ended March 31, 2022. The increase was primarily due to higher recognition of upfront and milestone payments under the Gilead and Roche collaborations, partially offset by lower cost reimbursements received under the Gilead collaboration.

Research and Development Expenses: HOOKIPA’s research and development expenses were $20.9 million for the three months ended March 31, 2023, compared to $16.6 million for the three months ended March 31, 2022. The primary drivers of the increase in research and development expenses by $4.3 million compared to the three months ended March 31, 2022 were higher clinical study expenses for our HB-200 program and higher expenses for research and development services for our HB-200 program, as well as increased spending for our Gilead and Roche partnered programs, partially offset by lower manufacturing expenses for our HB-200 and Gilead partnered programs.

General and Administrative Expenses: General and administrative expenses amounted to $4.9 million for the three months ended March 31, 2023, compared to $5.0 million for the three months ended March 31, 2022. The decrease compared to the three months ended March 31, 2022 was primarily due to a decrease in professional and consulting fees and in other expenses, partially offset by an increase in personnel-related expenses.

Net Loss: HOOKIPA’s net loss was $19.7 million for the three months ended March 31, 2023, compared to a net loss of $18.0 million for the three months ended March 31, 2022. This increase was primarily due to an increase in research and development expenses, partially offset by an increase in revenues from collaboration and licensing, and an increase in grant income, and a decrease in general and administrative expenses.