On May 14, 2024 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 financial results and business highlights for the first quarter ended March 31, 2024 (Press release, Delcath Systems, MAY 14, 2024, View Source [SID1234643217]).

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Recent Business Highlights
During and since the first quarter, Delcath:

Recognized over $2.0 million of revenue from sales of HEPZATO KIT (melphalan/Hepatic Delivery System) and $1.1 million in CHEMOSAT sales through March 31, 2024;

Updated U.S. center activation guidance from 15 active centers to a total of 20 active centers by the end of 2024;

Activated four treating centers during the first quarter with an additional two centers in April. A further five centers are accepting patient referrals in anticipation of activation;

Raised $7.0 million in a private placement transaction with certain accredited investors comprised of existing investors, Delcath senior executives, and members of its Board of Directors;

Appointed Martha S. Rook, Ph.D, an experienced industry leader with more than 25 years of academic and industry experience, as Chief Operating Officer;

Received a permanent, product-specific J-code (J9248) and transitional pass-through payment status for HEPZATO KIT from the Centers for Medicare & Medicaid Services (CMS) which became effective on April 1, 2024;

Executed an amendment with Synerx Pharma, LLC and Mylan Teoranta for Delcath’s supply of melphalan hydrochloride which extends the term of the original agreement to December 31, 2028; and

Announced the publication of results from the pivotal Phase 3 FOCUS study of HEPZATO KIT in patients with unresectable metastatic Uveal Melanoma on May 4, 2024, in the journal Annals of Surgical Oncology.
"We continue to make steady progress in the training and activation of new treatment centers which is a testament to both the emerging role of HEPZATO in the treatment of patients with metastatic uveal melanoma and the capability and dedication of our field force," said Gerard Michel, Delcath’s Chief Executive Officer. "We are committed to expanding the availability of HEPZATO to patients in need and I am confident that we will reach our goal of 20 treating centers by the end of 2024."

First Quarter 2024 Results
Cash, cash equivalents and investment totaled $27.2 million as of March 31, 2024, which includes a $7.0 million private placement financing which closed on March 19, 2024.

Total revenue for the quarter ended March 31, 2024 was $3.1 million compared to $0.6 million for the same period in the prior year from our sales of HEPZATO in the U.S. and CHEMOSAT in Europe.

Research and development expenses for the quarter ended March 31, 2024, were $3.7 million compared to $4.6 million for the same period in the prior year. The change in research and development expenses is primarily due to a decrease in clinical trial activities and expenses related to the FDA inspection offset by an increase in personnel related expenses.

Selling, general and administrative expenses for the quarter ended March 31, 2024, were $8.8 million compared to $4.2 million for the same period in the prior year. The increase primarily relates to commercial launch activities including marketing-related expenses and additional personnel in the commercial team.

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

Event Date:

Tuesday, May 14, 2024

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

International Toll:

1-412-317-0088

Replay Access Code:

9490444

End Date:

May 21, 2024

On May 14, 2024 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), a Canadian biopharmaceutical company developing novel immune-oncology vaccines and drug delivery technologies, reported the issuance of several new patents, as well as new allowances of patent applications belonging to different Patent Families in Defence’s vast and diverse portfolio (Press release, Defence Therapeutics, MAY 14, 2024, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-strengthens-and-expands-global-patent-protection-on-key-technologies [SID1234643216]).

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Defence’s vaccine enhancer platform technology based on simple admixture of Accum and variants thereof with specific antigens, is further expanded by the recent allowance of Defence’s US application no. 18/169,440 by the USPTO. The newly allowed subject-matter, which includes valuable composition-of-matter claims directed to Accum or variants thereof as standalone agents for enhancing antigen presentation, or in admixture with of any vaccine antigen, elegantly compliments Defence’s previously granted US patent no. 11,612,651 covering methods of improving polypeptide antigen immunogenicity. Importantly, this Patent Family is the first family broadly covering Defence’s anticancer ARM vaccine platform. Recent pre-clinical studies using Defence’s ARM-002 vaccine suggest potent antitumor responses in in vivo melanoma, lymphoma, and pancreatic cancer models when combined with the anti-PD-1 immune-checkpoint inhibitor, paving the way for upcoming Phase I clinical trials.

Defence is also pleased to announce the securing of a new patent in Australia protecting its ADC platform technology based on the ability of the original Accum to form potent antibody-drug conjugates leading to targeted cellular accumulation of a payload. Granted on February 1, 2024, Australian patent no. 2017233725 broadly protects not only Defence’s original Accum but also important variants thereof, which further strengthens the company’s patent protection in this valuable and growing therapeutic space. This represents a significant milestone in the future development and commercialization of novel ADCs for treating and detecting many cancers, and adds to Defence’s previous granted patents in the United States (US 11,352,437), Japan (JP 7,126,956), and Israel (IL 261765).

In addition, Defence’s vaccine platform technology based on covalent conjugation of Accum and variants thereof to specific antigens, which already included US patent no. 11,291,717, now includes Canadian patent no. 3,201,103 granted on December 12, 2023, as well as Australian patent no. 2021402007 granted on March 14, 2024. Furthermore, counterpart Japanese application no. 2023-535891 was recently allowed by the Japanese Patent Office and the Japanese patent is expected to be granted imminently. These patents include claims broadly covering a method of improving polypeptide antigen immunogenicity by covalently conjugating any antigen to Accum or any variant thereof, and also include independent composition-of-matter claims covering potential vaccine compositions.

"We are thrilled to announce the issuance of these patents and allowances with broad claims covering our ADC and vaccine platforms, which underscore our relentless pursuit of innovation and our unwavering commitment to improving human health" says Mr. Plouffe, CEO and president of Defence.

Acceleration of examination of the remaining applications in both of Defence’s vaccine platform Patent Families via the Patent Prosecution Highway (PPH) program is currently being pursued based on these broad issued and allowed claims. The issuance of new patents in these families is therefore expected shortly.

On May 14, 2024 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported first quarter financial results and provided a business update (Press release, Cyclacel, MAY 14, 2024, View Source [SID1234643215]).

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"We are excited to report that we have begun enrolling patients in the Phase 2, proof of concept (PoC) stage of our 065-101 study of fadraciclib, our oral CDK2/9 inhibitor, and are on track to deliver key readouts this year," said Spiro Rombotis, President and Chief Executive Officer. "Receipt of $8.0 million gross proceeds in a private placement together with existing resources support our ongoing clinical program. Pharmacokinetic, pharmacodynamic, safety and anticancer activity data from the Phase 1, dose escalation stage of 065-101 in patients with advanced solid tumors and lymphoma will be presented at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Data to date suggest that fadraciclib is differentiated from other next generation CDK inhibitors."

"Having determined the recommended Phase 2 dose for fadraciclib we are now enrolling patients in the Phase 2 PoC stage of 065-101" said Brian Schwartz, M.D., interim Chief Medical Officer. "We are initially concentrating on the biomarker cohort which is enrolling patients prospectively selected for CDKN2A/CDKN2B alterations to be followed by patients with T-cell lymphoma. There are no approved medicines for patients with CDKN2A/CDKN2B alterations. Including currently opened trial sites, we expect a total of up to seven sites will participate with the majority in the United States. We are encouraged about fadra’s prospects and look forward to presenting emerging data from the 065-101 study later in the year."

Key Upcoming Milestones for 2024

· Report final data from dose escalation stage and RP2D determination from the 065-101 study of oral fadraciclib in patients with advanced solid tumors and lymphoma at the ASCO (Free ASCO Whitepaper) 2024 Annual Meeting
· Report interim data from initial cohorts in Phase 2 proof-of-concept stage of 065-101 study with oral fadraciclib in patients with advanced solid tumors and lymphoma

Financial Highlights

As of March 31, 2024, pro forma cash and cash equivalents totalled $9.9 million, including proceeds from this month’s private placement and $0.8 million received for the United Kingdom research & development tax credit. Cash and cash equivalents as of March 31, 2024, totalled $2.8 million, compared to $3.4 million as of December 31, 2023.

Net cash used in operating activities was $0.5 million for the three months ended March 31, 2024, which includes $2.9 million received in March in respect of the United Kingdom research & development tax credit, compared to $6.9 million for the same period of 2023. The Company estimates that its current cash resources will fund planned programs into the fourth quarter of 2024.

Research and development (R&D) expenses were $2.8 million for the three months ended March 31, 2024, as compared to $5.7 million for the same period in 2023. R&D expenses relating to fadraciclib were $1.8 million for the three months ended March 31, 2024, as compared to $4.1 million for the same period in 2023 due to a decrease in clinical trial and other non-clinical expenditures. R&D expenses related to plogosertib were $1.0 million for the three months ended March 31, 2024, as compared to $1.4 million for the same period in 2023 due to a decrease in manufacturing and other non-clinical expenditures.

General and administrative expenses remained relatively flat at approximately $1.6 million for each of the three months ended March 31, 2024 and 2023.

Total other expenses, net, for the three months and year ended March 31, 2024, were $0.1 million, compared to $0.2 million for the same period of the previous year.

United Kingdom research & development tax credits for the three months March 31, 2024, were $1.4 million, which includes $0.8 million related to the 2023 claim which was received in May 2024, compared to $1.3 million for the same period of the previous year and are directly correlated to qualifying research and development expenditure.

Net loss for the three months March 31, 2024, was $2.9 million (including stock-based compensation expense of $0.2 million), compared to $5.8 million (including stock-based compensation expense of $0.4 million) for the same period in 2023.

Conference call information:

Call: (888) 632-3384 / international call: (785) 424-1794

Archive: (800) 938-1584 / international archive: (402) 220-1542

Code for live and archived conference call is CYCCQ124. Webcast link

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

On May 14, 2024 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, reported updated data from the ongoing TakeAim Leukemia study (CA-4948-102) in relapsed/refractory (R/R) AML to be presented at the ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) conferences (Press release, Curis, MAY 14, 2024, View Source [SID1234643214]).

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This update includes data for 25 new patients in the FLT3 mutation (FLT3m) and U2AF1/SF3B1 Splicing Factor mutation (SFm) cohorts who had received fewer than 3 lines of prior therapy and were treated with emavusertib as monotherapy at the Recommended Phase 2 Dose (RP2D) of 300 mg BID.

Prior

Data

New
Data*

Total

FLT3m AML

3

9

12

SFm AML

3

17

20

adjustment for patients with dual mutation**

(1)

(1)

(2)

5

25

30

* data cut-off as of February 26, 2024
** 2 patients had both FLT3m and SFm (dual mutation)
1 patient in the initial group of 5 patients; 1 patient in the new group of 25 additional patients

FLT3m Cohort – 12 relapsed/refractory patients enrolled to date

12 R/R AML patients with FLT3m were treated with emavusertib. Prior therapies included venetoclax (8/12), hypomethylating agents or HMA (9/12), and FLT3 inhibitors (9/12). Preliminary data show 6 objective responses in 11 response-evaluable patients: 3 complete remission (CR), 1 CR with partial hematologic recovery (CRh) and 2 morphologic leukemia-free state (MLFS) with on-treatment duration range of 46-324 days. 4 patients are ongoing at the data-cutoff, including 1 CRh and 1 MLFS.

3 of 3 patients who were naïve to FLT3i treatment achieved objective response (2 CR, 1 MLFS)
3 of 8 patients who progressed on, or following, prior FLT3i treatment achieved objective response (1 CR, 1 CRh, 1 MLFS)
1 patient is not response-evaluable
All responders demonstrated complete normalization of blast counts in the bone marrow. One of these patients proceeded to allogenic stem cell transplantation. Responses were achieved rapidly in this population, with 5 of 6 responses occurring within one cycle of treatment.

SFm Cohort – 20 relapsed/refractory patients enrolled to date

20 R/R AML patients with SFm were treated with emavusertib. Prior therapies included venetoclax (18/20) and HMA (17/20). Preliminary data show 4 of 18 response-evaluable patients in this population have achieved objective response (CR/CRh/MLFS). 8 of 20 patients are ongoing at the data-cutoff, including 1 MLFS and 3 non-responding patients who have shown increased neutrophil counts.

All 4 responders (1 CR, 2 CRh, 1 MLFS) had received prior treatment with an HMA; 3 of whom had also received prior treatment with venetoclax
3 additional non-responding patients are ongoing and have shown increased neutrophil counts
2 patients are not response-evaluable
All responders demonstrated complete normalization of blast counts in the bone marrow. One of these patients proceeded to allogenic stem cell transplantation. "In addition to the responders, we see increased neutrophil counts in several additional ongoing patients. Since a leading cause of death in patients with AML is infection (related to low neutrophil counts), an increase in neutrophils represents a meaningful clinical improvement for these patients," said Dr. Robert Martell, MD, PhD, Chief Scientific Officer of Curis.

"We are encouraged by emavusertib’s continued demonstration of clear single-agent activity supporting its potential in both monotherapy and combination therapy in AML," said James Dentzer, President and CEO of Curis.

On May 14, 2024 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, reported business and financial results for the fiscal second quarter 2024 ended March 31, 2024 (Press release, Citius Pharmaceuticals, MAY 14, 2024, View Source [SID1234643213]).

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Second Quarter 2024 Business Highlights and Subsequent Developments

- LYMPHIR (denileukin diftitox) biologics license application (BLA) accepted by the U.S. Food and Drug Administration (FDA) with August 13, 2024, assigned as Prescription Drug User Fee Act (PDUFA) target action date;

- Data analysis underway for completed Mino-Lok Pivotal Phase 3 trial with topline results anticipated in calendar 2Q 2024;

- Continued engagement with FDA following end of Phase 2b meeting to determine next phase in the development of Halo-Lido for the treatment of hemorrhoids;

- Merger of our wholly owned subsidiary with TenX Keane Acquisition (Nasdaq: TENK) to form publicly listed Citius Oncology, Inc. is progressing and pending review by Securities and Exchange Commission (SEC) and TENK shareholder approval;

- Robert Smith elected to the Citius Board of Directors at the Annual Meeting of Stockholders; and,

- Completed $15 million registered direct offering in April 2024 extending the Company’s cash runway.

Financial Highlights

- Cash and cash equivalents of $12.6 million as of March 31, 2024;

- $15 million in gross proceeds from a registered direct offering on April 30, 2024, extends the Company’s cash runway through December 2024;

- R&D expenses were $3.6 million and $6.2 million for the three and six months ended March 31, 2024, respectively, compared to $4.7 million and $8.2 million for the three and six months ended March 31, 2023, respectively;

- G&A expenses were $4.3 million and $7.9 million for the three and six months ended March 31, 2024, respectively, compared to $4.8 million and $7.4 million for the three and six months ended March 31, 2023, respectively;

- Stock-based compensation expense was $3.1 million and $6.1 million for the three and six months ended March 31, 2024, respectively, compared to $1.2 million and $2.4 million for the three and six months ended March 31, 2023, respectively; and,

- Net loss was $8.5 million and $17.8 million, or ($0.05) and ($0.11) per share for the three and six months ended March 31, 2024, respectively, compared to a net loss of $10.5 million and $14.1 million, or ($0.07) and ($0.10) per share for the three and six months ended March 31, 2023, respectively.

"I am pleased to share that we made solid progress this quarter as we focused on execution and managing our finances. The data analysis of our late-stage asset, Mino-Lok, the only treatment of its kind in development to salvage infected catheters, remains on track. We look forward to reporting the topline results later this quarter. Once we review the results, we plan to engage with the FDA to determine the optimal next steps in the program and look forward to advancing this much-needed alternative to the current standard of care, which often involves painful and costly catheter removal and replacement," stated Leonard Mazur, Chairman and CEO of Citius.

"Importantly, the BLA submission for LYMPHIR, our novel IL-2 receptor targeted oncology therapy, was accepted by the FDA, and assigned a late summer 2024 PDUFA target action date. In anticipation of potential approval, we continue to align the organization for a successful launch," added Mazur.

"Despite a tough capital market environment for pre-revenue companies, we successfully completed a $15 million registered direct offering, expanding our cash runway and providing capital to support the execution of our strategic plan. We believe that the merger of our oncology subsidiary with TenX to form a publicly listed company will make our company more attractive to investors and increase the value of our assets. This transaction is progressing, and we expect it to be completed in the coming months as we finalize SEC review and await approval by TENK shareholders. As we continue to meet our goals, we believe additional opportunities to strengthen our capital structure will become available," concluded Mazur.

SECOND QUARTER 2024 FINANCIAL RESULTS:

Liquidity

As of March 31, 2024, the Company had $12.6 million in cash and cash equivalents.

As of March 31, 2024, the Company had 159,094,781 common shares outstanding.

Based on our cash and cash equivalents as of March 31, 2024, and after giving effect to a capital raising that closed on April 30, 2024, we expect to have sufficient funds to continue our operations through December 2024. We expect to raise additional capital in the future to support our operations beyond December 2024.

Research and Development (R&D) Expenses

R&D expenses were $3.6 million for the quarter ended March 31, 2024, compared to $4.7 million for the quarter ended March 31, 2023. For the six months ended March 31, 2024, R&D expenses were $6.2 million as compared to $8.2 million during the six months ended March 31, 2023, a decrease of $1.9 million. The decrease primarily reflects incremental costs related to the completion of the Mino-Lok Phase 3 trial and remediation activities for the LYMPHIR BLA resubmission, offset by lower costs in the current period due to the completion of the Halo-Lido Phase 2b trial.

We expect that research and development expenses will stabilize at current levels in fiscal 2024 as we focus on the commercialization of LYMPHIR, complete our Phase 3 trial for Mino-Lok, and analyze the data from our Phase 2b trial and begin planning our Phase 3 trial for Halo-Lido

General and Administrative (G&A) Expenses

G&A expenses were $4.3 million for the quarter ended March 31, 2024, compared to $4.8 million for the quarter ended March 31, 2023. The decrease was primarily due to lower costs for pre-launch and market research activities associated with LYMPHIR during the period.

For the six months ended March 31, 2024, G&A expenses were $7.9 million as compared to $7.4 million during the six months ended March 31, 2023. The primary reason for the increase was higher costs for pre-launch and market research activities associated with LYMPHIR.

General and administrative expenses consist primarily of compensation costs, professional fees for legal, regulatory, accounting, and corporate development services, and investor relations expenses.

Stock-based Compensation Expense

For the quarter ended March 31, 2024, stock-based compensation expense was $3.1 million as compared to $1.2 million for the quarter ended March 31, 2023. For the six months ended March 31, 2024, stock-based compensation expense was $6.1 million as compared to $2.4 million for the six months ended March 31, 2023. The increase is primarily due to the Citius Oncology stock plan.

Net loss

Net loss was $8.5 million, or ($0.05) per share for the quarter ended March 31, 2024, compared to a net loss of $10.5 million, or ($0.07) per share for the quarter ended March 31, 2023. The $2 million decrease in the net loss was due to decreases of $1.1 million in research and development expenses and $0.5 million in general and administrative expenses, and the increase in other income of $2.3 million, being partially offset by the increase in stock-based compensation expense of $1.9 million.

Net loss was $17.8 million, or ($0.11) per share for the six months ended March 31, 2024, compared to a net loss of $14.1 million, or ($0.10) per share for the six months ended March 31, 2023. The increase in the net loss was primarily due to the increase in stock-based compensation expense.