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.

On August 8, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, reported that the company will host a conference call and live audio webcast on Monday, August 15, 2022, at 8:00 a.m. ET to review its second quarter 2022 financial results and provide an update on the company (Press release, Gamida Cell, AUG 8, 2022, View Source [SID1234617813]).

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To access the conference call, please register here and be advised to do so at least 10 minutes prior to joining the call. A live webcast of the conference call can be accessed in the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.

On August 8, 2022 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported a global collaboration that provides GSK plc (LSE/NYSE: GSK) an exclusive option to co-develop and commercialize XMT-2056, an Immunosynthen ADC that targets a novel epitope of HER2 (Press release, Mersana Therapeutics, AUG 8, 2022, View Source [SID1234617842]). XMT-2056 is designed to activate the innate immune system through STING signaling in both tumor-resident immune cells and in tumor cells.

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"GSK brings highly complementary development and commercial capabilities, a wealth of immuno-oncology experience, a deep knowledge of the STING pathway and a shared vision for XMT-2056’s broad potential," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "We believe this agreement solidifies Mersana’s position as a partner of choice during this momentous period in the ADC space and serves as validation for our Immunosynthen platform, which takes ADCs beyond the cytotoxic realm by enabling a targeted stimulation of the innate immune system. Additionally, the agreement structure demonstrates our ability to generate meaningful non-dilutive capital upfront to support the development of our innovative candidates while also providing the potential for meaningful downstream economics."

In preclinical models, XMT-2056 demonstrated robust anti-tumor activity as a monotherapy in both HER2-high and HER2-low expressing models, and enhanced efficacy has been shown when used in combination with multiple approved agents, including trastuzumab, pertuzumab, anti-PD-1, or trastuzumab deruxtecan. Preclinical data also suggest that XMT-2056 has the potential to enable immunological memory for prolonged anti-tumor activity.

Mersana expects to initiate a Phase 1 clinical trial of XMT-2056 to investigate its potential in a range of HER2-expressing tumors such as breast, gastric and non-small-cell lung cancers. The U.S. Food and Drug Administration recently granted an orphan drug designation to XMT-2056 for the treatment of gastric cancer.

John Lepore, Senior Vice President of Research, GSK, said, "At GSK, our goal is to bring transformational treatment options to patients with cancer, so we are pleased to be able to enter into this agreement for XMT-2056. Its preclinical data demonstrate how it might work to harness the immune system by activating the STING pathway, and its differentiated mechanism of action offers the potential for additional clinical benefit in patients with HER2-expressing tumors."

Under the terms of the agreement, Mersana will receive an upfront option purchase fee of $100 million. Mersana also is eligible to receive up to $1.36 billion in the form of an option exercise payment and development, regulatory and commercial milestone payments if GSK exercises its option.

Mersana has retained options to profit-share and to co-promote in the United States. If it exercises its profit-share option, Mersana will be eligible to receive tiered royalties on net sales outside of the United States. If Mersana does not elect to profit-share, it is eligible to receive double-digit tiered royalties on global net sales.

If GSK opts into the license, the effectiveness of the license grant may be subject to customary closing conditions, including review under the Hart-Scott-Rodino Act.

Conference Call Reminder
Mersana will host a conference call today at 4:30 p.m. ET to discuss this collaboration, other business updates and its financial results for the second quarter of 2022. To access the call, please dial 646-307-1963 (domestic) or 800-715-9871 (international) and provide the Conference ID 4656534. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com, and a replay of the webcast will be available in the same location following the conference call for at least 90 days.

On August 8, 2022 Applied DNA Sciences, Inc., (NASDAQ: APDN) (the "Company" or "Applied DNA"), a leader in polymerase chain reaction ("PCR")-based technologies, reported the closing of its previously announced public offering of 3,000,000 shares of its common stock (or common stock equivalents in lieu thereof), together with Series A warrants to purchase up to 3,000,000 shares of its common stock and Series B warrants to purchase up to 3,000,000 shares of its common stock at a combined offering price to the public of $4.00 per share (or common stock equivalent) and associated warrants, priced at a premium to market under Nasdaq rules (Press release, Applied DNA Sciences, AUG 8, 2022, View Source [SID1234617767]). The gross proceeds to the Company from the offering were $12 million before deducting the placement agent’s fees and other offering expenses payable by the Company.

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The Series A warrants have an exercise price of $4.00 per share, are exercisable immediately upon issuance, and expire five years following the date of issuance. The Series B warrants have an exercise price of $4.00 per share, are exercisable immediately upon issuance and expire thirteen months following the date of issuance.

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The offering was conducted pursuant to the Company’s registration statement on Form S-1 (File No. 333-266223) previously filed with the Securities and Exchange Commission (SEC), which became effective on August 4, 2022, and an additional registration statement filed pursuant to Rule 462(b) which became automatically effective on August 4, 2022. The offering was made only by means of a prospectus, which is part of the effective registration statements. Electronic copies of the final prospectus may be obtained for free on the SEC’s website located at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On August 8, 2022 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported financial results for the second quarter 2022, an update to its corporate strategy, recent business highlights, and key upcoming catalysts (Press release, Atara Biotherapeutics, AUG 8, 2022, View Source [SID1234617783]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We are excited about the transformative potential of ATA188 in MS and are pleased that as a result of our significant and constructive engagement, the FDA has recommended a possible path towards a tab-cel BLA filing without the need for a new clinical study," said Pascal Touchon, President and Chief Executive Officer of Atara. "Atara’s R&D-centered strategy, clear portfolio prioritization, and purposeful partnerships are positioning us for success in reaching critical value-generating milestones for our key pipeline assets. I would like to extend my sincere gratitude and thanks to Atara’s staff for their significant contributions and unwavering commitment to advancing truly innovative medicines for patients in need."

Corporate Strategy Update

Atara announced plans to focus its activities as a leaner organization centered on R&D to further advance the Company’s innovative pipeline, while reducing cash burn
Staff will be reduced by approximately 20% across the organization
Future annual cash burn is anticipated to be reduced by over 20%, extending Atara’s cash runway into Q1 2024
Leveraging its differentiated allogeneic T-cell therapy platform and unique clinical experience in over 500 patients treated, Atara will prioritize R&D activities over the next 18 months on three core priorities:
Clinical development of ATA188, our potentially transformative Phase 2 asset for progressive multiple sclerosis
EU and potential U.S. regulatory filings and approvals for tab-cel while seeking a commercial partner for tab-cel in the U.S., including all related activities and costs, which is expected to further extend the Company’s cash runway
Anticipated Q4 2022 IND filing for ATA3219, a potential best-in-class allogeneic CD19 CAR T, with the potential to address the significant opportunity in the field for improving durable clinical response in hard-to-treat B-cell malignancies
These actions are part of a broader ongoing strategy to focus the organization on R&D, building on the previously announced manufacturing and commercialization collaborations with FUJIFILM Diosynth Biotechnologies (FDB) and Pierre Fabre, respectively, and continuing with the R&D-focused prioritization announced today
ATA188 for Progressive Multiple Sclerosis (MS)

Atara completed the Phase 2 EMBOLD study Interim Analysis (IA) in patients with progressive MS in June 2022 and the Company determined no sample size adjustment or modification would be made to the study
Based on enrollment at the end of July, approximately 90 patients are planned to be included in the read out of the study primary endpoint of confirmed disability improvement by EDSS at 12 months. Communication of these data is planned to occur at an appropriate forum in October 2023
Atara continues to plan for Phase 3 readiness, including interacting with the U.S. Food & Drug Administration (FDA) based on two Fast Track designations, and further developing its proprietary large-scale bioreactor manufacturing process
New Phase 1 MRI data providing further evidence of the potential clinical impact of ATA188 in progressive MS patients, as well as updated OLE data, are planned for presentation at an appropriate forum in Q4 2022
Tabelecleucel (tab-cel) for Post-Transplant Lymphoproliferative Disease (PTLD)

Based on constructive discussions with Atara, the FDA recommended a possible path to a Biologics License Application (BLA) submission that does not require a new clinical trial
Following planned interactions with FDA, Atara intends to provide further guidance on progress to a BLA submission at our next quarterly call
The European Medicines Agency (EMA) review of tab-cel is on-track and Atara anticipates European Commission (EC) approval in Q4 2022
Atara has successfully completed all six pre-approval inspections required to support the Marketing Authorization Application (MAA) for tab-cel in Europe
CAR T Programs

ATA2271/ATA3271 (Solid Tumors Over-Expressing Mesothelin)

Following Bayer’s strategic review and asset-level prioritization of its pipeline, the exclusive worldwide licensing agreement for next-generation mesothelin-directed CAR T-cell therapies ATA2271, an autologous version, and ATA3271, an armored allogeneic T-cell immunotherapy has been terminated
Accordingly, the IND for ATA3271 is paused pending funding for clinical development
Following the findings of the Memorial Sloan Kettering (MSK)-generated autopsy report and correlative data analyses, Atara intends to continue supporting the clinical development of ATA2271 through our collaboration with MSK and a protocol amendment to be discussed shortly with the FDA
ATA3219 (B-cell Malignancies)

Atara continues to make progress toward the anticipated IND filing for ATA3219 in Q4 2022. This allogeneic EBV CD19 CAR T program, using an optimized manufacturing process, is enriched for a memory T-cell phenotype and continues to show robust activity in preclinical studies
Second Quarter 2022 Financial Results

Cash, cash equivalents and short-term investments as of June 30, 2022 totaled $331.3 million, as compared to $301.8 million as of March 31, 2022. The increase includes the impact of net proceeds of $94.8 million from the sale of the ATOM facility during the second quarter
Atara believes that its cash and investments as of June 30, 2022, together with the expected reductions in operating cash burn, will be sufficient to fund the Company’s planned operations into the first quarter of 2024
Net cash used in operating activities was $64.0 million for the second quarter 2022, as compared to $61.6 million for the same period in 2021
Atara reported net income of $18.5 million, or $0.18 per share, for the second quarter 2022, as compared to a net loss of $83.8 million, or $0.91 per share, for the same period in 2021. Second quarter 2022 net income included a gain on the sale of the ATOM facility of $50.2 million.
License and collaboration revenue was $51.6 million for the second quarter 2022, primarily consisting of deferred revenue recognized due to the termination of the Bayer Collaboration Agreements, as compared to $3.9 million for the same period in 2021. We anticipate that license and collaboration revenues will decrease substantially in future quarters due to the termination of the Bayer Agreements.
Total operating expenses include non-cash expenses of $15.6 million for the second quarter 2022, as compared to $16.1 million for the same period in 2021
Research and development expenses were $64.9 million for the second quarter 2022, as compared to $68.5 million for the same period in 2021
The decrease in the second quarter 2022 was primarily due to lower employee-related and overhead costs as a result of the FDB transaction, partially offset by increased spending on the Company’s ATA188 and CAR T programs
Research and development expenses include $7.9 million of non-cash stock-based compensation expenses for the second quarter 2022 as compared to $8.3 million for the same period in 2021
General and administrative expenses were $18.8 million for the second quarter 2022, as compared to $19.4 million for the same period in 2021
General and administrative expenses include $6.2 million of non-cash stock-based compensation expenses for the second quarter 2022, as compared to $5.5 million for the same period in 2021
Conference Call and Webcast Details

Atara will host a live conference call and webcast today, Monday, August 8, 2022, at 4:30 p.m. EDT to discuss the Company’s financial results and recent operational highlights. Analysts and investors can participate in the conference call by dialing 877-407-8291 for domestic callers and 201-689-8345 for international callers, using the conference ID 13730293. A live audio webcast can be accessed by visiting the Investors & Media – News & Events section of atarabio.com. An archived replay will be available on the Company’s website for 30 days following the live webcast.