On March 27, 2024 PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, reported an update to its clinical development strategy and reported its financial results for the year ended December 31, 2023 (Press release, PDS Biotechnology, MAR 27, 2024, View Source [SID1234641510]).

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"We have obtained compelling data from several Phase 2 trials in the fourth quarter of 2023, including long-term survival data from the National Cancer Institute (NCI)-led triple combination trial of PDS01ADC in combination with Versamune HPV (PDS0101) and an investigational immune checkpoint inhibitor (ICI), as well as our VERSATILE-002 study," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "We now have a better understanding of how our drug platform technology works in advanced cancer, and we have therefore made the strategic, data-driven decision to add our novel, investigational IL-12 fused antibody drug conjugate, PDS01ADC, to the promising combination of Versamune HPV and KEYTRUDA to advance the triple combination as our top clinical development priority."

"By initially addressing the rapidly growing unmet medical need in recurrent metastatic HPV+ head and neck squamous cell cancer (HNSCC), we strongly believe this approach may rapidly establish our proprietary combination of PDS01ADC and Versamune HPV as a transformative oncology treatment. The data suggest that the triple combination may result in a significant improvement in overall survival rates for patients who currently lack an effective treatment option. It may also significantly increase the rates of durable tumor shrinkage or overall responses," said Dr. Bedu-Addo. "We are grateful to the patients and physicians who participated in the clinical trials which have helped inform our understanding of how the drug therapies may be used most effectively to safely address advanced cancer, and our decision to prioritize the triple combination."

With the recent long-term survival Phase 2 data from the NCI-led triple combination trial, together with favorable safety and extended survival results seen in both ICI naïve and resistant patients in our VERSATILE-002 trial, PDS Biotech has decided to prioritize the triple combination in place of the VERSATILE-003 trial. This decision enables PDS Biotech to focus its resources on the drug regimen it believes has the highest potential to benefit patients with HNSCC and to drive shareholder value.

"We have had several discussions with key opinion leaders in HNSCC regarding the use of the triple combination in HNSCC. A clear unmet need is seen in HPV+ HNSCC with few agents being studied in this population due to the difficulty in treating advanced HNSCC," said Kirk V. Shepard, M.D., Chief Medical Officer of PDS Biotech. "These discussions with expert HNSCC oncologists have guided our decision to prioritize the triple combination in our efforts to address the growing incidence of advanced HPV+ HNSCC."

"Despite good outcomes in many patients with HPV-related HNSCC, approximately 20% of patients will develop recurrent, incurable disease, often in young individuals in the prime of their lives. HPV-related HNSCC that progresses after standard first-line chemotherapy is a devastating, hard-to-treat cancer with no HPV-related treatment currently approved. The NCI clinical trial data show significant promise in the use of PDS01ADC in combination with Versamune HPV," said Katharine A. Price, M.D., Associate Professor of Oncology, Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center and Principal Investigator of PDS Biotech’s upcoming triple combination trial. "A controlled randomized clinical trial that builds upon the current data is warranted, and I am intrigued by the potential of this unique combination to treat HNSCC."

Clinical Strategy Update

Triple Combination Clinical Trial (PDS01ADC, Versamune HPV and KEYTRUDA)

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Company in discussions with the U.S. Food and Drug Administration (FDA) on the design of potentially pivotal clinical trial to treat HPV+ HNSCC, with the trial expected to start in 2024.

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Previously announced data from Phase 2 NCI-led triple combination clinical trial for the treatment of recurrent/metastatic ICI naïve and ICI resistant HPV16-positive cancers including head and neck, anal, cervical, vaginal and vulvar cancers support rationale:

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ICI naïve group: 75% of patients remain alive at 36 months. The median OS was not reached. Published results show a 36-month survival rate of approximately 20% with ICIs. ORR of 75% and complete response of 38% were seen in patients treated with the triple combination. Published ORR of <40% seen with immunotherapeutic agents.

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ICI resistant group: 12-month overall survival (OS) rate of 72%, and 63% overall response rate (ORR) in patients with optimal dose of PDS01ADC. Median OS approximately 20 months; published 12-month OS rate in HPV-positive ICI-resistant cancer is ~30%; published median OS in HPV-positive ICI-resistant cancer is 3.4 months.

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Responses were seen in all HPV-positive tumor types.

Leadership Appointments

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In January 2024, announced the appointment of Dr. Shepard as Chief Medical Officer.

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In November 2023, announced the appointment of Lars Boesgaard as Chief Financial Officer.

Full Year 2023 Financial Results

Net loss for the year ended December 31, 2023, was approximately $42.9 million, or $1.39 per basic and diluted share, compared to a net loss of $40.9 million, or $1.43 per basic share and diluted share, for the year ended December 31, 2022. The higher net loss was primarily the result of increased operating loss and increased net interest expense.

Research and development expenses for the year ended December 31, 2023, decreased to $27.8 million, compared to $29.4 million for the year ended December 31, 2022. The decrease of $1.7 million was primarily attributable to the $10 million purchase of the rights to PDS01ADC in 2022, partially offset by an increase in clinical costs of $6.1 million and an increase in personnel costs of $2.1 million.

General and administrative expenses for the year ended December 31, 2023, increased to $15.3 million compared to $12.2 million for the year ended December 31, 2022. The $3.1 million increase was primarily attributable to an increase in personnel costs of $1.5 million and an increase in professional fees of $1.6 million.

Total operating expenses for the year ended December 31, 2023, were $43.0 million, an increase of approximately 3.3% compared to $41.7 million total operating expenses for the year ended December 31, 2022.

Net interest expense increased to $1.3 million for the year ended December 31, 2023, compared to $0.4 million for the year ended December 31, 2022. The change was due to higher interest expense related to the Company’s notes payable, partially offset by higher interest income on bank deposits.

During the fourth quarter of 2023, the Company raised approximately $10.5 million in net proceeds from its "at-the-market" sales agreement.

The Company’s cash balance as of December 31, 2023, was $56.6 million.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00 AM ET today, March 27, 2024. Participants should dial 877-704-4453 (United States) or 201-389-0920 (International) and reference conference ID 13745320. To access the webcast, please use the following link. The event will be archived on the Investor Relations section of PDS Biotech’s website for six months.

On March 27, 2024 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported it has received an Issue Notification from the United States Patent and Trademark Office (USPTO) for U.S. Patent number 11,951,118 titled, "Preparation of Preliposomal Annamycin Lyophilizate" (the ‘118 patent’) to be issued on April 9, 2024 to Moleculin and The University of Texas System Board of Regents (Press release, Moleculin, MAR 27, 2024, View Source [SID1234641508]).

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When issued, the patent will provide claims to compositions that contain Annamycin with a base patent term extending until June 2040, subject to extension to account for time required to fulfill regulatory requirements for FDA approval. Moleculin’s novel candidate for the treatment of acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases (STS lung mets) uses a unique lipid-based delivery technology. In addition to the expected ‘118 patent, Moleculin has additional patent applications pending in the U.S. and in major jurisdictions worldwide.

Walter Klemp, CEO and Chairman of Moleculin, stated, "We believe this critical milestone is very well timed, as it removes a major risk element in the overall assessment of the potential asset value for Annamycin just in time for the potential partnering discussions which we expect to have in the near future. Especially in light of our recent announcement that Annamycin has delivered a 60% CRc (complete response composite) rate in 2nd line AML subjects, outperforming the pivotal trial CRc rate of every other drug approved in this 2nd line space by a wide margin. Issuance of this patent underscores the importance and proprietary nature of the innovation that makes this next generation anthracycline possible."

Annamycin is Moleculin’s next-generation anthracycline, initially expected to fulfill a significant unmet need for the 2nd line treatment of relapsed or refractory AML patients. For a description of the magnitude of this opportunity, please see the Company’s video at this link. As described in the Company’s latest corporate update, Annamycin’s recent performance in a Phase 1B/2 clinical trial produced patient response data multiple times greater than the response rates used for the approval of all existing AML drugs approved for 2nd line treatment. Servier acquired two 2nd line AML drugs with lower pivotal clinical trial performance data with a valuation in excess of $1.8 billion.

Disclosure

MD Anderson has an institutional conflict of interest with Moleculin, and this relationship is managed according to an MD Anderson Institutional Conflict of Interest Management and Monitoring Plan.

On March 27, 2024 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) ("Merrimack" or the "Company") reported that it has received a $225 million payment which was due from Ipsen, S.A. as a result of its receipt of approval from the U.S. Food and Drug Administration, or FDA, to market ONIVYDE as a first-line treatment of metastatic adenocarcinoma on the pancreas (Press release, Merrimack, MAR 27, 2024, View Source [SID1234641506]).

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Merrimack’s Board of Directors has evaluated the likelihood of receiving additional milestone payments under the Ipsen Agreement and from the 2019 Agreement with Elevation Oncology and has concluded that it is unlikely that any additional milestone payments from either agreement will become payable. We have announced a special meeting of stockholders on May 10, 2024 to approve a Plan of Dissolution which includes plans for a liquidating dividend payable to stockholders. We currently anticipate the initial liquidating dividend to be in the range of between approximately $14.68 and $15.30 per share. The Plan of Dissolution will include establishment of a liquidating trust for the benefit of stockholders in the unlikely event that Merrimack might receive any future milestone payments from Ipsen or Elevation Technology.

IMPORTANT ADDITIONAL INFORMATION AND WHERE TO FIND IT

In connection with the proposed liquidation and Dissolution of the Company (the "Dissolution") and the Plan of Dissolution, the Company filed a definitive proxy statement (the "Proxy Statement") with the Securities and Exchange Commission (the "SEC") on March 21, 2024. BEFORE MAKING ANY VOTING DECISION, INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT, ANY AMENDMENTS OR SUPPLEMENTS THERETO, ANY OTHER SOLICITING MATERIALS AND ANY OTHER DOCUMENTS TO BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED DISSOLUTION, THE PLAN OF DISSOLUTION AND RELATED MATTERS, AND/OR INCORPORATED BY REFERENCE IN THE PROXY STATEMENT WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT MERRIMACK PHARMACEUTICALS, INC., THE PROPOSED DISSOLUTION,

THE PLAN OF DISSOLUTION AND RELATED MATTERS. Stockholders may obtain a free copy of the Proxy Statement and the other relevant materials (when they become available), and any other documents filed by the Company with the SEC, at the SEC’s website at View Source or on the "Investors" section of the Company’s website at www.merrimack.com.

Participants in the Solicitation

The Company and its executive officers and directors may be deemed to be participants in the solicitation of proxies from its stockholders with respect to the proposed Dissolution, the Plan of Dissolution and related matters, and any other matters to be voted on at the Special Meeting. Information regarding the names, affiliations and direct or indirect interests, by security holdings or otherwise, of such directors and executive officers in the solicitation are included in the Proxy Statement. Additional information regarding such directors and executive officers, and other important Company information, are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 9, 2024, as amended by a Form 10-K/A and a Proxy Statement for its Special Meeting of Stockholders, each of which was filed with the SEC on March 21, 2024.

Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies of the Company’s stockholders in connection with the proposed Dissolution, the Plan of Dissolution and related matters are forth in the Proxy Statement. These documents will be available free of charge as described in the preceding section.

For more information, visit View Source

On March 27, 2024 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported the expansion of the inclusion criteria in the open label 15- patient REM-001 study in cutaneous metastatic breast cancer (CMBC) to include patients receiving pembrolizumab (KEYTRUDA) for at least three months at screening (Press release, Kintara Therapeutics, MAR 27, 2024, View Source [SID1234641505]).

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CMBC patients are being screened and dosed in the 15-patient study which is evaluating REM-001, a second-generation photodynamic therapy (PDT) photosensitizer agent, and is designed to test the 0.8 mg dose as well as optimize the study design in advance of a Phase 3 trial initiation. The primary endpoint in the study is Best Overall Objective Response Rate (bORR) (complete response or partial response) of the target treatment fields at any time from treatment up to, and including, week 24. The majority of the costs to run this study will be covered by the $2.0 million Small Business Innovation Research (SBIR) grant Kintara was awarded from the National Institutes of Health (NIH).

"Expanding the inclusion criteria to include CMBC patients on pembrolizumab for at least three months at screening is expected to significantly increase enrollment in our REM-001 study" commented Robert E. Hoffman, Kintara’s President and Chief Executive Officer. "With a strengthened balance sheet, we continue to evaluate strategic options with the goal of maximizing shareholder value."

On March 27, 2024 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease ("PD"), Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, reported financial results for the fourth quarter and full year ended December 31, 2023 and highlighted recent developments (Press release, Inhibikase Therapeutics, MAR 27, 2024, View Source [SID1234641504]).

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"2023 was a year of clinical execution across our pipeline, culminating in the recent pre-NDA meeting with the FDA for IkT-001Pro and robust enrollment of untreated Parkinson’s patients in our 201 Trial evaluating Risvodetinib ("Risvo")," said Dr. Milton H. Werner, President and Chief Executive Officer of Inhibikase. "As we look ahead, we believe that FDA feedback from our pre-NDA meeting was constructive as we work on the requirements for NDA submission for IkT-001Pro. In addition, enrollment of patients into the 201 Trial supports our belief that topline data from the three-month, double-blind phase of the study may be available in the second half of this year. Our recent publication of Phase 1 safety, tolerability and pharmacokinetic clinical data for Risvo in the Journal of Parkinson’s Disease reinforces our belief that Risvo is well tolerated and reaches therapeutic exposures in patients with Parkinson’s disease and related disorders. We look forward to taking advantage of the recent momentum we have experienced as we continue to build value for our shareholders and bring new medicines to patients in need."

Recent Developments and Upcoming Milestones:

Completed Pre-NDA Meeting with the FDA for IkT-001Pro: On January 19, 2024, Inhibikase met with the FDA Review Team ("Review Team") from the Division of Hematologic Malignancies to discuss requirements for a 505(b)(2) NDA submission for IkT-001Pro in up to 11 blood and stomach cancer indications. Final Meeting Minutes were provided by the FDA on February 12, 2024. The Meeting Minutes confirmed that the 505(b)(2) pathway appears to be appropriate for approval of IkT-001Pro. The Review Team removed the requirement to perform a formal use-related risk assessment but expects the NDA package to justify how medication errors will be avoided for physicians, pharmacists and patients who are prescribed IkT-001Pro. The Company plans to manufacture dosage forms at 150 mg and 300 mg to discriminate IkT-001Pro from the 100 mg and 400 mg dosage forms of imatinib mesylate. These alternative dosage forms do not require any manufacturing process development. In terms of bioequivalence, clinical studies completed to date indicate that imatinib delivered by 600 mg and 800 mg IkT-001Pro provide similar exposures to imatinib delivered by 400 mg and 600 mg imatinib mesylate, respectively. Imatinib mesylate is approved for use between 300 mg and 800 mg once daily for 11 blood or stomach cancers. To cover the range of approved doses of imatinib mesylate, the Company plans to study the 1200 mg dose of IkT-001Pro that is expected to lead to exposures equivalent to 800 mg imatinib. The Review Team also suggested the Company analyze how IkT-001Pro and imatinib mesylate behave with respect to certain gut transporters that regulate absorption from the gastrointestinal tract. Inhibikase is in alignment with the FDA on this point and is initiating the necessary pre-clinical test to compare IkT-001Pro and imatinib mesylate. The Review Team and Company also agreed on the size of drug substance and drug product batches needed to meet the quality control requirements for approval. The Company will request milestone-based meetings as it completes the manufacturing and quality control processes to ensure the Company and the Review Team remain aligned throughout the process. The Company also continues to evaluate the market potential of IkT-001Pro in non-oncology indications to which imatinib has already been shown to have clinical benefit.

Actively enrolling patients in the Phase 2 201 Trial of Risvodetinib (IkT-148009) in untreated Parkinson’s disease: As of March 22, 2024, 73 participants have been enrolled, 20 prospective participants are in medical screening and 48 potential participants are being evaluated for suitability to initiate medical screening. Additionally, 34 participants have completed the 12-week dosing period. 15 mild and 2 moderate adverse events that may have been related to Risvo have been reported thus far in the trial. As the trial remains blinded, it is unknown whether any or how many of these mild or moderate adverse events are actually related to Risvo itself. Depending on the enrollment of the last participant, the Company may report topline results from the 201 Trial in the second half of 2024, including measurement of novel biomarker data as it relates to alpha-synuclein aggregates.

Published Phase 1 Results of Risvodetinib in the Journal of Parkinson’s Disease: In January 2024, Inhibikase published the results of its Phase 1 clinical studies with Risvo entitled "A Phase I, Randomized, SAD, MAD, and PK Study of Risvodetinib in Older Adults and Parkinson’s Disease," online in the peer reviewed Journal of Parkinson’s Disease. The publication highlighted data demonstrating that Risvo was well tolerated up to 7 days of daily dosing with no clinically meaningful events in healthy volunteers or worsening of symptoms in participants taking anti-PD medications. Of note, voluntary lumbar puncture was used to measure the concentration of Risvo in cerebrospinal fluid (CSF) in six participants with or without PD. Measures of the CSF concentration of Risvo indicate that it crossed the blood-brain barrier and was persistently present in the central nervous system.
Full Year 2023 Financial Results

Net Loss: Net loss for the year ended December 31, 2023, was $19.0 million, or $3.57 per share, compared to a net loss of $18.1 million, or $4.28 per share for the year ended December 31, 2022.

R&D Expenses: Research and development expenses for the year ended December 31, 2023 were $13.6 million compared to $12.0 million for the full year 2022. The $1.6 million increase was primarily due to a $1.5 million increase in CML expenditures, a decrease of $0.6 million in PD expenses and a net increase of $0.7 million in all other research and development activities.

SG&A Expenses: Selling, general and administrative expenses for the year ended December 31, 2023 were $6.7 million compared to $6.2 million for the year ended December 31, 2022. The $0.5 million increase was primarily the result of an increase in investor relations costs of $1.0 million and an increase in employee costs of $0.3 million that were partly offset by a decrease in D&O insurance of $0.6 million, a decrease in legal and consulting fees of $0.4 million and a net increase of $0.2 million in all other selling, general and administrative expenses.

Cash Position: Cash, cash equivalents and marketable securities were $13.3 million as of December 31, 2023. The Company expects that existing cash and cash equivalents will be sufficient to fund operations into the first quarter of 2025.

Conference Call Information
Inhibikase will host a conference call and webcast to discuss its full-year 2023 financial results and business highlights tomorrow, March 28, 2024, at 8:00am ET. The conference call can be accessed by dialing 1-877-407-0789 (United States) or 1-201-689-8562 (International) and referencing Inhibikase Therapeutics. 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.