On August 8, 2022 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders, reported that it will report financial results for the second quarter ended June 30, 2022 on Friday, August 12, 2022, after the close of U.S. markets (Press release, Inhibikase Therapeutics, AUG 8, 2022, View Source [SID1234617802]). Following the announcement, the Company will host a conference call and webcast at 8:00 a.m. ET on Monday, August 15, 2022 to provide a corporate update and review the financial results.

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The conference call can be accessed by dialing 844-825-9789 (United States) or 412-317-5180 (International) with the conference code 10169366. A live webcast may be accessed using the link here, or by visiting the investors section of the Company’s website at www.inhibikase.com. After the live webcast, the event will be archived on Inhibikase’s website for approximately 90 days after the call.

On August 8, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune and Infectimune T cell-activating technologies, reported that it will discuss its financial results for the quarter ended June 30, 2022 and provide a business update on its conference call today (Press release, PDS Biotechnology, AUG 8, 2022, View Source [SID1234617801]).

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Recent Business Highlights:

Granted Fast Track Designation by U.S. Food and Drug Administration (FDA) for PDS0101 in combination with KEYTRUDA (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.

Presented data from 17 evaluable patients (efficacy) enrolled in the VERSATILE-002 Phase 2 clinical trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting, demonstrating clinical efficacy (objective response rate [ORR] plus stable disease) in 76.5% of patients.

Announced acceptance of clinical trial application to expand VERSATILE-002 Phase 2 trial of PDS0101 in combination with KEYTRUDA (pembrolizumab) into the United Kingdom.

Presented data from 30 patients enrolled in National Cancer Institute-led triple combination Phase 2 clinical trial of PDS0101 in advanced, refractory HPV-positive cancers at ASCO (Free ASCO Whitepaper) 2022:

88% of checkpoint inhibitor (CPI)-naïve patients achieving an ORR (tumor shrinkage >30%). In published studies with CPI monotherapy, ORR ranged from 13-24%.

77% of CPI refractory patients were alive at a median of 12 months. In published studies, historical median survival rates for CPI refractory patients is 3-4 months.

Presented data from pre-clinical universal flu vaccine program at the American Society of Virology meeting, demonstrating the ability of PDS0202, the Company’s Infectimune candidate formulated with Computationally Optimized Broadly Reactive Antigens (or COBRA) influenza antigens, to neutralize multiple strains of influenza, including H1N1, and provide protection against infection with lethal challenge in animals.

Strengthened leadership team with addition of Spencer Brown as Senior Vice President and General Counsel, and Sanjay Zaveri as Senior Vice President, Business Development.
"We made tremendous progress this quarter with our lead candidate, PDS0101, across all four ongoing Phase 2 clinical trials, and also with our advancing oncology pipeline candidates PDS0102 and PDS0103," stated Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. "Our clinical data at this year’s ASCO (Free ASCO Whitepaper) meeting not only solidified our confidence in our Versamune platform, but also in the potential of PDS0101 to make a meaningful difference in the treatment of advanced HPV16-positive cancer patients with significant unmet needs. With these data, we are hopeful that our upcoming meetings with the FDA will clarify our regulatory path forward for PDS0101."

Dr. Bedu-Addo further commented, "We are also encouraged by the pre-clinical data from our PDS0202 universal flu vaccine candidate which we believe has the potential to transform the global approach to protecting the population against the flu virus. We believe we are well positioned to continue our drive to deliver significant value to both patients and our shareholders."

Second Quarter 2022 Financial Results
Net loss for the three months ended June 30, 2022 was approximately $5.8 million, or ($0.20) per basic share and diluted share, compared to a net loss of approximately $0.6 million, or ($0.03) per basic share and diluted share, for the three months ended June 30, 2021. The higher net loss reported for the three months ended June 2022 is primarily due to additional costs for expansion of the Company’s research and development, including costs associated with our ongoing clinical trials, additional general and administrative costs, and lower income tax benefit.

Research and development expenses increased to $3.8 million for the three months ended June 30, 2022 from $2.8 million for the three months ended June 30, 2021. The increase of $1.0 million in 2022 was primarily attributable to an increase of $0.4 million in clinical study and research costs, $0.7 million in personnel costs, and $0.1 million in facilities, partially offset by a decrease of $0.2 million in manufacturing services.

General and administrative expenses increased to $3.3 million for the three months ended June 30, 2022 from $2.3 million for the three months ended June 30, 2021. The increase of $1.0 million is primarily attributable to an increase of $0.8 million in personnel costs and $0.2 million in legal fees.

Total operating expenses were approximately $7.1 million for the three months ended June 30, 2022, from approximately $5.1 million for the three months ended June 30, 2021.

PDS Biotech’s cash balance as of June 30, 2022 was approximately $53.0 million.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00 AM EDT today, August 8, 2022. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13731437. To access the webcast, please use the following link. The event will be archived in the investor relations section of PDS Biotech’s website for six months.

KEYTRUDA is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On August 8, 2022 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported financial results for the second quarter ending June 30, 2022 and provided a corporate update (Press release, VBI Vaccines, AUG 8, 2022, View Source [SID1234617800]).

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Jeff Baxter, VBI’s President and CEO commented:

"Since the U.S. launch of PreHevbrio, our field teams have been extremely productive, raising awareness of the persistent burden of hepatitis B, the new, recently implemented CDC guidelines for a universal HBV vaccine recommendation for adults aged 19 to 59 years, and of course, the differentiation and value proposition of PreHevbrio. Over recent months:

We have detailed more than 80% of 3,200 target accounts
60% of Medicare-insured lives, 55% of commercially insured lives, and 50% of lives under state Medicaid plans are estimated to have coverage in place for the PreHevbrio specific Current Procedural Terminology (CPT) code
As we advance through these initial commercial stage gates to establish our target network of distribution partners, we believe that as a differentiated 3-antigen HBV vaccine, PreHevbrio will be a meaningful new tool for healthcare providers as they work to tackle hepatitis B.

In addition to the U.S. launch of PreHevbrio, we continue to meet our clinical and regulatory milestones as we advance our lead pipeline candidates against chronic HBV, GBM, and COVID-19, with three new clinical studies expected to start and new therapeutic HBV Phase 2 data expected before the end of 2022. As VBI’s pipeline now includes both commercial and developmental stage assets, we rigorously prioritize our human and financial capital with efficient and well-managed program execution to maximize the impact of our programs in the medical and public health space, and to drive shareholder value."

Recent Key Program Achievements and Projected Upcoming Milestones

Hepatitis B (HBV)

PreHevbrio [Hepatitis B Vaccine (Recombinant)]

CDC’s Advisory Committee on Immunization Practices’ (ACIP) recommendation of PreHevbrio published in April 2022 Morbidity and Mortality Weekly Report (MMWR), which also included the updated universal HBV vaccination guidelines for adults aged 19-59
Following marketing authorization in the European Union/European Economic Area and in the United Kingdom, VBI expects to make its 3-antigen HBV vaccine available in select European countries beginning in early 2023 under the name PreHevbri [Hepatitis B vaccine (recombinant, adsorbed)]
Regulatory filing under review by Health Canada
VBI-2601 (BRII-179): HBV Immunotherapeutic Candidate

Year-end 2022: Interim topline data expected from Phase 2 human proof of concept combination study evaluating safety and efficacy of VBI-2601 (BRII-179) with BRII-835 (VIR-2218), an HBV-targeting siRNA
H1 2023: Interim topline results expected from two-part Phase 2a/2b combination study evaluating VBI-2601 (BRII-179) as an add-on therapy to standard-of-care treatment
Glioblastoma (GBM)

VBI-1901: Cancer Vaccine Immunotherapeutic Candidate

June 2022: FDA granted Orphan Drug Designation to VBI-1901 for the treatment of GBM, building on the FDA Fast Track Designation that was granted in June 2021
Q3 2022: Expected initiation of next phase of development in recurrent GBM setting, aiming to expand the number of patients in the ongoing Phase 1/2a study and adding a control arm, with the potential for accelerated approval based on tumor response rates and improvement in overall survival
Q4 2022: Evaluation of VBI-1901 in the primary GBM setting expected to initiate as part of the Individualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT), a Phase 2 adaptive platform trial – data from which have potential to support an accelerated approval application
COVID-19 & Coronaviruses

VBI-2901: Trivalent Pan-Coronavirus Vaccine Candidate

Q3 2022: Expected initiation of the first clinical study of VBI-2901, which will be supported through Phase 2 clinical development as part of the Company’s partnership with the Strategic Innovation Fund (SIF) of the Canadian Government, through which up to CAD $56 million was earmarked for VBI’s coronavirus vaccine development program
Second Quarter 2022 Financial Results

Cash Position: VBI ended the second quarter of 2022 with $82.4 million in cash compared with $121.7 million in cash as of December 31, 2021.
Revenue: Revenue for the second quarter of 2022 was $0.3 million, compared to $0.1 million for the same period in 2021. The increase was due to the launch of PreHevbrio in the U.S. at the end of the first quarter of 2022, with revenue generation beginning in the second quarter. Over the coming months, VBI expects to expand the number of customers, continuing to broaden access to PreHevbrio in the U.S.
Cost of Revenue: Cost of revenues was $2.5 million in the second quarter of 2022 as compared to $2.6 million in the second quarter of 2021.
Research and Development (R&D): R&D expenses for the second quarter of 2022 were $5.6 million compared to $4.6 million for the same period in 2021. R&D expenses were offset by $1.0 million in the second quarter of 2022 and $3.3 million in the second quarter of 2021 by government grants and funding arrangements. The increase in R&D expenses is mainly driven by the advancement of VBI-1901 as we prepare for the next clinical studies in recurrent and primary GBM patients.
General and Administrative (G&A): G&A expenses for the second quarter of 2022 were $15.1 million compared to $9.4 million for the same period in 2021. The increase in G&A expenses, partially offset by government grants and funding arrangements, was a result of the increased commercial activities related to our 3-Antigen HBV Vaccine, most notably the deployment of our promotional field team and development of our distribution infrastructure. Additional increased costs include increased insurance costs, increased professional costs, and increased labor costs.
Net Cash Used in Operating Activities: Net cash used in operating activities for the six months ended June 30, 2022, was $37.4 million, compared to $17.4 million for the same period in 2021. The increase was largely due to an increase in net loss attributable to commercial expenses for the launch of PreHevbrio and a decrease in net change in operating working capital as we received $8.3 million of cash in advance from the CEPI Funding Agreement during the six months ended June 30, 2021, compared to $1.0 million cash received in advance from the CEPI Funding Agreement for the same period in 2022.
Net Loss and Net Loss Per Share: Net loss and net loss per share for the second quarter of 2022 were $45.7 million and $0.18, respectively, compared to a net loss of $17.5 million and a net loss per share of $0.07 for the second quarter of 2021.
Net Loss and Net Loss Per Share, Excluding Foreign Exchange Loss: Net loss and net loss per share, excluding foreign exchange loss, for the second quarter of 2022 were $23.8 million and $0.09, respectively, compared to a net loss and a net loss per share, excluding foreign exchange loss, of $17.3 million and $0.07 for the second quarter of 2021. Foreign exchange loss for the second quarter of 2022 was $21.9 million as compared to $0.2 million for the second quarter of 2021. Certain intercompany loans between VBI Vaccines Inc. and our subsidiaries are denominated in a currency other than the functional currency of each entity. The primary driver of the increase in foreign exchange loss was the impact of the relative strengthening of the U.S. and Canadian Dollars against the New Israeli Shekel upon translation of these intercompany loans.
Use of Non-GAAP Financial Measures

Net Loss Excluding Foreign Exchange Loss and Net Loss per Share Excluding Foreign Exchange Loss are non-GAAP financial measures. VBI’s management believes that the presentation of Net Loss Excluding Foreign Exchange Loss and Net Loss per Share Excluding Foreign Exchange Loss is useful to investors because management does not consider foreign exchange loss, which is primarily driven by changes in exchange rates related to certain intercompany loans, when evaluating VBI’s operating performance. Non-GAAP financial measures are meant to supplement, and to be viewed in conjunction with, GAAP financial results. The presentation of these non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP financial measures and should be read only in conjunction with the Company’s financial statements prepared in accordance with GAAP. Reconciliations of the Company’s non-GAAP measures are included below.

The following represents a reconciliation of Net Loss to Net Loss Excluding Foreign Exchange Loss and Net Loss per Share Excluding Foreign Exchange Loss.

About PreHevbrio

VBI’s hepatitis B vaccine is the only 3-antigen hepatitis B vaccine, comprised of the three hepatitis B surface antigens of the hepatitis B virus – S, pre-S1, and pre-S2. It is approved for use in the United States, European Union/European Economic Area, United Kingdom, and Israel. The brand names for this vaccine are: PreHevbrio (US), PreHevbri (EU/EEA, UK), and Sci-B-Vac (Israel).

Please visit www.PreHevbrio.com for U.S. Important Safety Information for PreHevbrio [Hepatitis B Vaccine (Recombinant)], or please see U.S. Full Prescribing Information.

U.S. Indication

PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.

U.S. Important Safety Information (ISI)

Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio.

Immunocompromised persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio.

PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

The most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection site, myalgia, fatigue, and headache.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free).

On August 8, 2022 TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported that the company submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1/2 clinical study of YH001 in combination with envafolimab and doxorubicin for the treatment of sarcoma patients, including patients who have not received prior therapy (Press release, Tracon Pharmaceuticals, AUG 8, 2022, View Source [SID1234617799]).

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The Phase 1/2 trial will assess the safety and efficacy of YH001 and envafolimab with or without doxorubicin in patients with the rare sarcoma subtypes of alveolar soft part sarcoma and chondrosarcoma and in the common sarcoma subtypes of leiomyosarcoma and dedifferentiated liposarcoma.

"With the submission of the IND, we are one step closer to bringing our triple combination of YH001, envafolimab and doxorubicin to front-line sarcoma patients, and pending clearance of the IND, we look forward to initiating the trial before end of this year," said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer.

About YH001

YH001, an IgG1 antibody against CTLA-4 invented by Biocytogen, the parent company of Eucure Biopharma, and licensed by TRACON, has shown enhanced antibody dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro. In preclinical studies YH001 demonstrated superior T cell activation and superior tumor growth inhibition activity compared to ipilimumab. YH001 also demonstrated superior activity compared to ipilimumab in human transgenic mouse tumor models when combined with a PD-(L)1 antibody. In these models, single agent YH001 depleted regulatory T cells and increased CD8+ T cells in tumor tissue. YH001 has been dosed as a single agent in a Phase 1 trial in China (NCT04699929) and in combination with the PD-1 antibody toripalimab in a Phase 1 trial in Australia (NCT04357756).

About the Phase 1/2 Clinical Trial of YH001, envafolimab and doxorubicin (NCT05448820)

The Phase 1/2 clinical trial is a multicenter, open label study of YH001 initially given in combination with envafolimab, and then given in combination with envafolimab plus doxorubicin in patients with advanced or metastatic sarcoma, followed by Phase 2 cohorts of patients with select histologies of advanced or metastatic sarcoma, including treatment naive patients. The primary objective of the Phase 1 portion of the trial is to determine the recommended phase 2 dose of YH001 in combination with envafolimab and in combination with envafolimab with doxorubicin. The primary objective of the Phase 2 portion is to determine the objective response rate (ORR) of the combination of YH001 and envafolimab in patients with alveolar soft part sarcoma and chondrosarcoma and the ORR of the combination of YH001, envafolimab and doxorubicin in patients with leiomyosarcoma and dedifferentiated liposarcoma.

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines.

On August 8, 2022 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported business highlights and financial results for the second quarter ended June 30, 2022 (Press release, Delcath Systems, AUG 8, 2022, View Source [SID1234617798]).

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Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. (PRNewsfoto/Delcath Systems, Inc.)

Recent Business Highlights

During and since the second quarter, Delcath:

Held a pre-NDA meeting with FDA and locked the phase 3 FOCUS Trial database for the purpose of resubmitting the NDA for the Hepzato Kit (melphalan hydrochloride for injection/hepatic delivery system) in the third quarter of 2022,
Presented a poster updating the results from the FOCUS Trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting,
Opened two Expanded Access Program (NCT05022901) sites, and
Raised $5 million in a private placement priced at market.
In addition, during and since the fourth quarter, independent investigators:

Published Predictive Parameters in Patients Undergoing Percutaneous Hepatic Perfusion with Melphalan for Unresectable Liver Metastases from Uveal Melanoma: A Retrospective Pooled Analysis in the journal Cardiovascular and Interventional Radiology,
Presented two abstracts on the use of Chemosat Hepatic Delivery System with Melphalan in the treatment of metastatic uveal melanoma at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting, including:
Safety and efficacy of combined melphalan percutaneous hepatic perfusion (M-PHP) and ipilimumab plus nivolumab (IPI+NIVO) in metastasized uveal melanoma: First results of the phase Ib part of the CHOPIN trial, and
Temporal evolution in quality-of-life following melphalan percutaneous hepatic perfusion for patients with metastatic uveal melanoma.
"As we prepare to resubmit the Hepzato Kit NDA by the end of the third quarter, Chemosat usage in Europe continues to result in publications supportive of both Chemosat and by extension the Hepzato Kit," said Gerard Michel, Chief Executive Officer of Delcath. Mr. Michel continued, "We would expect that within 30 days of the resubmission, the FDA will confirm receipt of the submission and, if they agree the resubmission is sufficiently complete to warrant review, establish a PDUFA date sometime late in the first quarter of 2023."

First Quarter 2022 Results

Income Statement Highlights.

Total revenue for the three months ended June 30, 2022, was approximately $0.8 million, compared to $0.5 million for the prior year period, from our sales of CHEMOSAT in Europe. This increase in product revenue is primarily due to a full quarter of direct product sales by Delcath compared to the revenue share arrangement with our distribution partner in Europe in 2021.

Research and development expenses for the quarter were $5.5 million, compared to $3.5 million in the prior year quarter. The growth in R&D expense is primarily due to increased activity related to the NDA preparation. Selling, general and administrative expenses for the quarter were approximately $4.1 million, compared to $3.3 million in the prior year quarter. Total operating expenses for the quarter were $9.6 million, compared with $6.8 million in the prior year quarter.

The Company recorded a net loss for the three months ended June 30, 2022, of $9.7 million, compared to a net loss of $6.4 million for the same period in 2021.

Balance Sheet Highlights

On June 30, 2022, the Company had cash, cash equivalents and restricted cash totaling $14.4 million, as compared to cash, cash equivalents and restricted cash totaling $27.0 million on December 31, 2021. During the three months ended June 30, 2022, and June 30, 2021, we used $6.1 million and $7.1 million, respectively, of cash in our operating activities.

On July 20, 2022, Delcath closed a private placement for the issuance and sale of 690,954 shares of common stock (the "Common Stock") and 566,751 pre-funded warrants to purchase Common Stock (the "Pre-Funded Warrants") to certain investors. Each share of Common Stock was sold at a price per share of $3.98 and the Pre-Funded Warrants were sold at a price of $3.97 per Pre-Funded Warrant. The Pre-Funded Warrants have an exercise price of $0.01 per share of Common Stock and are immediately exercisable. Delcath received gross proceeds from the Private Placement of approximately $5.0 million before deducting offering expenses payable by Delcath. Delcath intends to use the net proceeds from the Private Placement for working capital purposes and other general corporate purposes.