On May 12, 2023 Delcath Systems, Inc. (Nasdaq: DCTH) (Delcath or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported business highlights and certain preliminary financial results for the first quarter ended March 31, 2023 (Press release, Delcath Systems, MAY 12, 2023, View Source [SID1234631592]).

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Recent Business Highlights

During and since the first quarter, Delcath:

Received an acknowledgement of Class 2 NDA resubmission from the U.S. Food and Drug Administration (FDA) for Hepzato Kit (melphalan hydrochloride for Injection/Hepatic Delivery System) with a Prescription Drug User Fee Act (PDUFA) goal date of August 14, 2023,

Completed a private placement of up to $85 million in gross proceeds, including the closing of initial upfront funding of $25 million. The financing was led by Vivo Capital with participation from Logos Capital, BVF Partners LP, Stonepine Capital Management LLC, and Serrado Capital LLC as well as existing investors including Rosalind Advisors,

Amended an existing loan agreement with Avenue Venture Opportunities Fund, L.P. to provide an interest only period spanning March 31, 2023, to September 30, 2023 thereby deferring $4.3 million in principal payments,
Appointed John R. Sylvester as Chairman of the Board, and
Announced that updated results from the CHOPIN phase 1B trial were published in the Journal Cardiovascular and Interventional Radiology. The article reported seven patients with advanced uveal melanoma treated with CHEMOSAT and ipilimumab plus nivolumab showed a median PFS of 29.1 months at a median follow-up of 29.1 months.

"With a critical financing behind us, the Company is focused on preparing to commercialize Hepzato if approved," said Gerard Michel, Chief Executive Officer of Delcath. Mr. Michel added, "Importantly, as we approach the August 14 PDUFA date, we continue to expand the list of institutions that have indicated their interest in becoming a treating center upon approval."

Preliminary First Quarter 2023 Financial Results

Delcath is in the process of completing its customary quarter-end close and review procedures, including certain valuation work associated with the issuance of warrants and preferred stock in Delcath’s previously announced private placement that closed on March 29, 2023, as of and for the quarter ended March 31, 2023, and the final results for this period could materially differ from the preliminary expected results disclosed in this press release. Delcath’s full first quarter 2023 financial results will be reflected in a Quarterly Report on Form 10-Q, which pursuant to Rule 12b-25, is expected to be filed no later than May 22, 2023. The financial performance measures presented in this press release for the first quarter of 2023 are forward-looking statements, preliminary estimates and unaudited, based on management’s initial review of the information presented, and are thus inherently uncertain and subject to change as Delcath completes its end-of-period reporting process and related activities for the first quarter of 2023. During the course of the review of Delcath’s condensed consolidated financial statements and related notes as of and for the quarter ended March 31, 2023, Delcath’s independent registered public accountants may identify items that could cause final reported results to be materially different from the preliminary estimates presented herein. Additional information and disclosures would be required for a more complete understanding of Delcath’s financial position and results of operations as of and for the quarter ended March 31, 2023. Accordingly, undue reliance should not be placed on this preliminary information.

Financial Highlights.

Revenue is expected to be approximately $0.6 million in revenue for the three months ended March 31, 2023, compared to $0.4 million for the three months ended March 31, 2022. The estimated increase in product revenue was due to the transition to direct sales in Europe which occurred in March 2022 as well as an approximately 37% increase in unit volume.

For the three months ended March 31, 2023, research and development expenses is expected to be relatively flat at approximately $4.5 million for both periods compared to the three months ended March 31, 2022.

As of March 31, 2023, the Company had cash, cash equivalents and restricted cash totaling $24.3 million, as compared to cash, cash equivalents and restricted cash totaling $11.8 million as of March 31, 2022. The increase in cash of $12.5 million was due to the proceeds from the private placement which closed on March 29, 2023, offset by the use of $4.3 million of cash in our operating activities and $6.3 million of principal payments toward the Company’s existing loan with Avenue.

Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

Event Date: Friday May 12, 2023

Time: 8:30 AM Eastern Time

Participant Numbers: Toll Free: 1-833-630-1960
International: 1-412-317-1841
Webcast: View Source

CONFERENCE REPLAY

US Toll Free: 1-877-344-7529

Canada Toll Free: 855-669-9658

Replay Access Code: 2940240

End Date: May 19, 2023

On May 12, 2023 Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company focused on discovering and developing medicines that are transformational for patients, reported its financial results and business highlights for the first quarter ended March 31, 2023 (Press release, Centessa Pharmaceuticals, MAY 12, 2023, View Source [SID1234631591]).

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"Centessa continued strong clinical momentum in the first quarter with multiple clinical milestones planned for the year," said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. "We are advancing the registration program for SerpinPC for the treatment of hemophilia B; dosing subjects in the ongoing Phase 1/2a clinical trial for LB101, our first LockBody molecule for the treatment of solid tumors; and, conducting IND enabling activities for our newest product candidate, ORX750, for the treatment of narcolepsy with potential expansion into other sleep disorders."

Dr. Saha continued, "We expect to rapidly drive our pipeline forward and anticipate a lower cash burn rate for the remainder of the year. We believe we are well positioned with a cash runway into 2026 to support multiple clinical readouts across our programs."

Recent Highlights
•In March, the first subject was dosed in the Phase 1/2a first-in-human clinical trial of LB101, a conditionally tetravalent PD-L1xCD47 bispecific monoclonal antibody from the Company’s LockBody technology platform for the treatment of solid tumors. LB101 is the Company’s first

LockBody candidate to enter the clinic. The Company announced clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to initiate the Phase 1/2a trial in January.
•In March, the Company announced ORX750, an orally administered, selective orexin receptor 2 (OX2R) agonist, as a product candidate for the treatment of narcolepsy with potential expansion into other sleep disorders.
•In February, the Company presented additional data from the open-label extension (OLE) of the ongoing Phase 2a study of SerpinPC for the treatment of hemophilia during an oral presentation at the 16th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD). With total exposure of over 40 patient-years across multiple dosing regimens, the Phase 2a data showed a continued favorable safety and tolerability profile for SerpinPC, as well as evidence of sustained efficacy, as measured by a reduction in the all-bleeds annualized bleeding rates (ABR). To date, no thromboembolic events and no treatment-related sustained elevations of D-dimer have been observed across the Phase 2a study.

Anticipated Upcoming Program Milestones
•Hemophilia (SerpinPC)- The registrational program for hemophilia B is ongoing. PRESent-5, an observational feeder study, is enrolling subjects and the Company expects to begin dosing in the PRESent-2 and PRESent-3 studies later this year. In addition, the Company plans to share data from Part 5 of the OLE of the Phase 2a study of SerpinPC, subject to completion, at a scientific meeting this year.
•Solid Tumors (PD-L1xCD47 LockBody LB101)- The Phase 1/2a first-in-human clinical study is ongoing.
•Narcolepsy and Other Sleep Disorders (ORX750)- ORX750 is in preclinical development and undergoing IND-enabling activities. The Company plans to share preclinical data at a scientific meeting later this year.

The Company has multiple earlier-stage programs, including MGX292 and other LockBody molecules such as PD-L1xCD3, and discovery-stage programs. Where applicable, the Company plans to provide updates on preclinical programs as they advance toward clinical studies.
First Quarter 2023 Financial Results

•Cash, Cash Equivalents and Short-term Investments: $346.2 million as of March 31, 2023, which the Company expects will fund operations into 2026, without drawing on the remaining available tranches under the Oberland credit facility.
•Research & Development Expenses: $32.8 million for the first quarter ended March 31, 2023, compared to $36.9 million for the first quarter ended March 31, 2022.
•General & Administrative Expenses: $16.1 million for the first quarter ended March 31, 2023, compared to $14.4 million the first quarter ended March 31, 2022.
•Net Loss Attributable to Ordinary Shareholders: $50.7 million for the first quarter ended March 31, 2023, compared to $54.5 million for the first quarter ended March 31, 2022.

On May 12, 2023 Bio-Techne Corporation (NASDAQ: TECH) reported that Jim Hippel, Executive Vice President and Chief Financial Officer, reported that it will present at the 2023 RBC Capital Markets Global Healthcare Conference on Tuesday, May 16, 2023, at 2:35 p.m. EDT (Press release, Bio-Techne, MAY 12, 2023, View Source [SID1234631589]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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On May 12, 2023 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the first quarter ended March 31, 2023 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, MAY 12, 2023, View Source [SID1234631588]).

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"We continue to make important progress advancing our clinical programs as we await topline results from several key cohorts in our Phase 1/1b study of BP1001-A in solid tumors, Phase 1/1b study of BP1002 in relapsed/refractory AML, and Phase 2 study of prexigebersen in AML," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "Despite advances in the field, cancer deaths continue to rise. We believe our DNAbilize platform can overcome the challenges with current treatment options to address the urgent need for safe and effective new treatments."

Important Near-Term Clinical Milestones

BP1001-A Phase 1/1b Clinical Trial in Solid Tumors

● Important trial with advanced or recurrent solid tumors, including ovarian and uterine, pancreatic and breast cancer with initial cohort completion and data readout currently expected mid-year.

BP1002 Phase 1/1b Clinical Trial in Relapsed/Refractory AML

● Focus on patients who relapsed on venetoclax treatment with initial cohort completion and readout expected mid-year.

Prexigebersen (BP1001) Phase 2 Clinical Trial in AML

● Two of the three cohorts in the clinical trial already exceed the minimum efficacy required for enrollment expansion.
● Assess safety and efficacy of each cohort treatment combination therapy with potential to qualify for expedited program status after cohort’s initial interim analysis, which are expected to commence by cohort in the second quarter of 2023.

Financial Results for the First Quarter Ended March 31, 2023

● The Company reported a net loss of $5.3 million, or $0.66 per share, for the three months ended March 31, 2023, compared to a net loss of $3.4 million, or $0.47 per share, for the three months ended March 31, 2022.

● Research and development expense for the three months ended March 31, 2023 increased to $4.0 million, compared to $2.1 million for the three months ended March 31, 2022, primarily due to manufacturing expenses related to drug product releases during the quarter.

● General and administrative expense for both the three months ended March 31, 2023 and March 31, 2022 was $1.3 million.

● As of March 31, 2023, the Company had cash of $6.7 million, compared to $10.4 million as of December 31, 2022. Net cash used in operating activities for the three months ended March 31, 2023 was $3.7 million, compared to $2.5 million for the comparable period in 2022.

Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these first quarter 2023 financial results and to provide a general update on the Company. To access the conference call please dial (833) 630-1956 (domestic) or (412) 317-1837 (international). A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.

On May 12, 2023 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, reported its financial results for the first quarter ended March 31, 2023 and provided a business update (Press release, Adaptimmune, MAY 12, 2023, View Source [SID1234631580]).

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Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer: "We have entered 2023 at pace with the announcement of the strategic combination with TCR2, the finalization of the return of lete-cel from GSK and continued excellent progress on the rolling BLA submission to make afami-cel a transformative therapy for people with synovial sarcoma. In addition, we are deploying ADP-A2M4CD8 in ovarian cancer with the SURPASS-3 clinical trial. Following the strategic combination with TCR2, the combined company will have the most robust and advanced pipeline in the solid tumor cell therapy field and will position us as a preeminent integrated cell therapy company with a cash runway into early 2026."

Afami-cel – Adaptimmune’s first potential commercial product for the treatment of synovial sarcoma

BLA update

In Q1 2023, Adaptimmune completed submission of the clinical module (Part 2) of the afami-cel BLA, which is targeted for completion in mid-2023. This BLA is supported by data from Cohort 1 of the pivotal trial SPEARHEAD-1, which met its primary endpoint for efficacy. The Company has Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for afami-cel for the treatment of synovial sarcoma. Cohort 2 of the SPEARHEAD-1 trial has completed recruitment.

Data presentations

ASGCT: Translational analyses for afami-cel will be showcased on May 18th at 4:00 p.m. PST during the Cell Therapy Product Engineering and Development oral session in Room 502AB at the upcoming American Society of Cell and Gene Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting in a presentation entitled "Mechanistic Characterization of Afamitresgene Autoleucel." These analyses seek to correlate in-vitro T-cell effector functions with patient response.

ASCO: Data from SPEARHEAD-1 will be presented on June 3rd at 1:15 p.m. CDT during the Sarcoma Track Poster Session in Hall A at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in a presentation entitled: "The SPEARHEAD-1 trial of afamitresgene autoleucel ("afami-cel"): Analysis of overall survival in advanced synovial sarcoma."

AACR: Translational data from patients with sarcoma who received afami-cel were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April. Data demonstrated engagement of the broader immune system after a single dose of afami-cel correlating with durable antitumor activity (poster can be accessed here). These data further support the use of afami-cel for the treatment of synovial sarcoma.

ADP-A2M4CD8 – Adaptimmune’s next-generation product with responses in multiple solid tumor indications

● Initiating the Phase 2 SURPASS-3 trial in combination with nivolumab for platinum resistant ovarian cancer. This trial has the potential to become registrational. ADP-A2M4CD8 has been granted FDA RMAT designation for treatment of patients with platinum resistant ovarian cancer.
● Initiating additional cohorts in the Phase 1 SURPASS trial in combination with pembrolizumab to treat patients in the first-line treatment setting for head & neck cancer and second-line setting for urothelial cancer.

Additional pipeline updates

● Adaptimmune and GSK agreed terms for transfer of PRAME and NY-ESO target programs back to Adaptimmune. Adaptimmune will receive ~$37 million from GSK in relation to the transition of the ongoing NY-ESO clinical trials
● Adaptimmune and GSK will work collaboratively to ensure continuity for patients in ongoing clinical trials for lete-cel and next generation TCR T-cells targeting NY-ESO
● Adaptimmune will continue to focus on its MAGE-A4 franchise while determining the optimal development path for complementary PRAME and NY-ESO programs
● Partnered programs with Genentech continue with the allogeneic pipeline

Strategic combination with TCR2

● Adaptimmune announced a strategic combination with TCR² Therapeutics Inc.
● As a result, and following the closing of the transaction, it is anticipated that the combined company’s cash runway will extend into 2026.
● The Adaptimmune General Meeting will be held on May 30, 2023 and, subject to receipt of approvals of Adaptimmune shareholders and TCR² stockholders and satisfaction or waiver of other closing conditions, the transaction is expected to close in Q2 2023, following which Adaptimmune shareholders will own approximately 75% of the combined company and TCR2 stockholders will own approximately 25% of the combined company.
● Further information about the combined pipeline, catalysts and changes to the Board of Directors was provided in the March Press Release.

Financial Results for the first quarter ended March 31, 2023

● Cash / liquidity position: As of March 31, 2023, Adaptimmune had cash and cash equivalents of $119.9 million and Total Liquidity1 of $165.6 million, compared to $108.0 million and $204.6 million, respectively, as of December 31, 2022.
● Revenue: Revenue for the first quarter ended March 31, 2023 was $47.6 million, compared to $3.6 million for the same period in 2022. Revenue has increased primarily due to the termination of the Astellas collaboration, resulting in a release of the remaining deferred income for the collaboration being released as revenue in March 2023.
● Research and development (R&D) expenses: R&D expenses for the first quarter ended March 31, 2023 were $25.5 million, compared to $36.8 million for the same period in 2022. R&D expenses decreased due to a decrease in the average number of employees engaged in research and development, decreases in subcontracted expenditures, a decrease in share-based compensation expenses and a decrease in offsetting reimbursements receivable for research and development tax and expenditure credits.
● General and administrative (G&A) expenses: G&A expenses for the first quarter ended March 31, 2023 were $20.4 million, compared to $16.8 million for the same period in 2022 due to restructuring charges recognised in the quarter and an increase in other corporate costs due to an increase in accounting, legal and professional fees incurred in relation to the TCR2 Therapeutics Inc merger agreement, offset by a decrease in share-based compensation expenses.
● Net profit/(loss): Net profit attributable to holders of the Company’s ordinary shares for the first quarter ended March 31, 2023 was $1.0 million ($0.00 profit per ordinary share), compared to a net loss of $50.3 million ($(0.05) loss per ordinary share), for the same period in 2022.

Financial Guidance

The Company believes that its existing cash, cash equivalents and marketable securities, together with the additional payments under the Strategic Collaboration and License Agreement with Genentech and payments under the Termination and Transfer Agreement with GSK, will fund the Company’s current operations into early 2025, as further detailed in the Company’s Quarterly Report on Form 10-Q for the first quarter ended March 31, 2023, to be filed with the Securities and Exchange Commission following this earnings release.

On March 6, 2023 the Company announced entry into a merger agreement under which the Company will combine with TCR² Therapeutics Inc in an all-stock transaction. Following the closing of the transaction, we currently estimate that the cash runway of the combined company will extend into early 2026.

Webcast Information

The Company will host a live webcast to provide additional details at 8:00 a.m. EDT (1:00 p.m. BST) today, May 12, 2023. A live webcast of the conference call and replay can be accessed at View Source Call in information is as follows: (800)-319-4610 (US or Canada) or +1 (416)-915-3239 (International and additional options available HERE). Callers should dial in 5-10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call.