On November 15, 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 third quarter ended September 30, 2023 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, NOV 15, 2023, View Source [SID1234637697]).

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"The third quarter marked a particularly progressive time at Bio-Path as we reported compelling clinical data from our Phase 2 trial of prexigebersen in acute myeloid leukemia (AML)," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "In October, we hosted a Key Opinion Leader (KOL) event with two physician experts who expressed their enthusiasm for the potential of prexigebersen to change the treatment landscape and patient outcomes in this most challenging patient population."

"As we look toward the balance of the year and into 2024, we are more encouraged than ever for the potential of our DNAbilize platform to positively impact a number of difficult to treat cancer indications," continued Mr. Nielsen.

Recent Corporate Highlights

• Announced Positive Results from Interim Analysis of Phase 2 Clinical Trial of Prexigebersen in Acute Myeloid Leukemia. In August, Bio-Path reported positive interim data from Stage 2 of the Company’s Phase 2 study of prexigebersen in combination with decitabine and venetoclax for the treatment of acute myeloid leukemia (AML). Prexigebersen continues to be well-tolerated and has now shown compelling efficacy results in two reporting cohorts including evaluable newly diagnosed AML patients and evaluable refractory/relapsed AML patients, which exceed outcomes with combination treatment of decitabine and venetoclax.

• Hosted Key Opinion Leader Event to Discuss Prexigebersen and Advances in the AML Treatment Landscape. In October, Bio-Path hosted a virtual KOL event to discuss the current AML treatment landscape and the growing body of clinical evidence in support of prexigebersen as a treatment for AML. The event featured presentations from Jorge Cortes, M.D., Director, Georgia Cancer Center, Augusta University and Maro Ohanian, D.O., Department of Leukemia, Division of Cancer Medicine, MD Anderson Cancer Center. Financial Results for the Third Quarter Ended September 30, 2023

• The Company reported a net loss of $3.2 million, or $0.32 per share, for the three months ended September 30, 2023, compared to a net loss of $3.5 million, or $0.49 per share, for the three months ended September 30, 2022.

• Research and development expense for the three months ended September 30, 2023 decreased to $2.3 million, compared to $2.4 million for the three months ended September 30, 2022, primarily due to decreased manufacturing development expenses partially offset by an increase in expense related to our clinical trial for prexigebersen in AML due to increased patient enrollment in 2023.

• General and administrative expense for the three months ended September 30, 2023 decreased to $1.0 million, compared to $1.2 million for the three months ended September 30, 2022, primarily due to decreased legal fees.

• Change in fair value of the Company’s warrant liability for the three months ended September 30, 2023 resulted in non-cash income of $0.1 million. The Company did not have the warrant liability in the comparable period for 2022.

• As of September 30, 2023, the Company had cash of $2.4 million, compared to $10.4 million as of December 31, 2022. Net cash used in operating activities for the nine months ended September 30, 2023 was $9.7 million, compared to $10.1 million for the comparable period in 2022. Net cash provided by financing activities for the nine months ended September 30, 2023 was $1.7 million.

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 third 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 November 15, 2023 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Propella Therapeutics, Inc. (President and CEO: William Moore, "Propella") reported that Astellas, through a U.S. subsidiary, and Propella have entered into a merger agreement pursuant to which Astellas will acquire Propella (Press release, Astellas, NOV 15, 2023, View Source [SID1234637696]). Propella is a privately held biopharmaceutical company that has leveraged a wholly owned proprietary platform that combines medicinal chemistry with lymphatic targeting to create new oncology drugs.

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Through the acquisition of Propella, Astellas will acquire PRL-02 (abiraterone decanoate), a next-generation androgen biosynthesis inhibitor being developed by Propella to treat prostate cancer. PRL-02 is a novel, long-acting prodrug* of abiraterone that, following intramuscular injection, is expected to achieve high concentrations in target tissues where the active moiety, abiraterone, is continuously released. PRL-02 may provide improved efficacy and safety compared to existing treatment options by high CYP17 lyase inhibition selectivity. PRL-02 is currently in a Phase 1 clinical trial and is expected to enter Phase 2a clinical trials in 2024.

Naoki Okamura, President and CEO, Astellas
"The acquisition fits with Astellas’ strategy to provide patients with therapeutic options for diseases with high unmet medical needs. Propella has a promising program, PRL-02, targeting prostate cancer. We believe that the synergy with Astellas’ global development and commercialization capabilities in the cancer and urology fields will accelerate the development of PRL-02 and deliver new VALUE to patients with prostate cancer."

William Moore, President and CEO, Propella
"Propella has focused on the research and development of proprietary, highly selective inhibitors that precisely block the synthesis of androgens, the main driver of prostate cancer, without significant changes in other steroids that are known to reduce clinical activity and safety. We are gratified that Astellas recognizes and values PRL-02’s potential as a best-in-class therapeutic for the treatment of men with prostate cancer. We are delighted that Astellas has chosen PRL-02 for further development and we are committed to supporting Astellas’ plans to accelerate PRL-02 development to improve treatment options for prostate cancer patients globally."

Under the agreement, Astellas will pay approximately US$175million to acquire all of the outstanding common stock and equity interests in Propella. Subject to customary closing conditions, the transaction is expected to occur during Astellas’ fiscal year 2023 (which ends on March 31, 2024).

The impact of this transaction on Astellas’ financial results in the fiscal year ending March 31, 2024, will be limited.

Overview of Acquisition

Stock acquirer: Astellas US Holding, Inc.
Major shareholders of Propella: TPC- API LLC, Employees, etc.
(including stock options)
Consideration: Cash (using cash on hand)
Financial terms: Astellas will pay approximately US$175million to acquire all of the outstanding common stock and equity interests in Propella
Estimated Date of Closing: Astellas’ fiscal year 2023 (which ends on March 31, 2024)
Overview of Propella

Company: Propella Therapeutics, Inc.
Address: Pittsboro, North Carolina, US
Representative’s Title and Name: President & CEO, William Moore
Year of Establishment: 2020
Employees: 5 employees (as of end of October 2023)
Business Relationship: There is no business relationship between Astellas and Propella.
Stifel, Nicolaus & Company, Incorporated is acting as exclusive financial advisor and Cooley LLP provided legal advice to Propella on this transaction.

* Prodrug: drugs with increased bioavailability by utilizing metabolic reactions in the body

On November 15, 2023 Alkermes plc (Nasdaq: ALKS) reported that it has completed the separation of its oncology business into Mural Oncology plc (Mural Oncology), a new, independent, publicly traded company (Press release, Alkermes, NOV 15, 2023, View Source [SID1234637695]). Alkermes is now a pure-play, profitable neuroscience company that will continue its work to develop innovative medicines for people living with difficult-to-treat psychiatric and neurological disorders. Mural Oncology will begin "regular way" trading on the Nasdaq Global Market under the stock ticker symbol "MURA" on Nov. 16, 2023. Alkermes will continue to trade under the Nasdaq ticker symbol "ALKS."

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"The separation of our oncology business was an important element of our strategy to transform Alkermes into a pure-play neuroscience company with the potential to generate strong profitability and cash flow. With a topline driven by the growth of our proprietary commercial products, proven drug development capabilities, and an important pipeline opportunity in our ALKS 2680 orexin program, we believe we are well positioned to drive value for Alkermes shareholders," said Richard Pops, Chief Executive Officer of Alkermes.

Updated Financial Expectations for 2023
Alkermes is providing the following updated financial expectations for 2023. These improved expectations reflect the company’s year-to-date financial results through Sept. 30, 2023 and the completion of the separation of the oncology business. The separation is associated with an anticipated reduction in operating expenses of approximately $20 million during the last six weeks of 2023, primarily consisting of Research and Development expenses.

Net income according to generally accepted accounting principles in the U.S. (GAAP) is now expected to be in the range of $250 million to $280 million, revised from the prior expectation of $225 million to $265 million. GAAP earnings per share (diluted)+ are now expected to be in the range of $1.46 to $1.63, revised from the prior expectation of $1.31 to $1.54.
Non-GAAP net income is now expected to be in the range of $270 million to $300 million, revised from the prior expectation of $230 million to $270 million. Non-GAAP earnings per share (diluted)+ are now expected to be in the range of $1.57 to $1.75, revised from the prior expectation of $1.34 to $1.57.
+2023 per share expectations are calculated based on a weighted average basic share count of approximately 166.5 million shares outstanding and a weighted average diluted share count of approximately 171.5 million shares outstanding.

At Sept. 30, 2023, Alkermes recorded cash, cash equivalents and total investments of $995.6 million. In connection with the completion of the separation, Alkermes capitalized Mural Oncology with cash of $275 million.

Upon completion of the separation, each of Alkermes’ shareholders received a distribution of one ordinary share of Mural Oncology for every 10 ordinary shares of Alkermes held as of the close of business on Nov. 6, 2023, the record date for the distribution. Cash will be delivered in lieu of any fractional ordinary shares of Mural Oncology.

The separation and distribution have been structured to qualify as a tax-free distribution (except for cash received in lieu of fractional shares) to Alkermes’ shareholders and the company and its affiliates for U.S. federal income tax purposes. Alkermes’ shareholders are urged to consult with their tax advisors with respect to the U.S. federal, state, local and foreign tax consequences of the separation.

Morgan Stanley & Co. LLC and BofA Securities, Inc. served as financial advisers to Alkermes, and Goodwin Procter LLP and Arthur Cox LLP served as its legal counsel.

On November 15, 2023 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported financial results for the third quarter 2023 and provided a business update (Press release, AIM ImmunoTech, NOV 15, 2023, View Source [SID1234637694]). As previously announced, the Company will host a conference call and webcast today, Wednesday, November 15, 2023, at 8:30 AM ET (details below).

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"Our team continues to make significant strides in the advancement of Ampligen through our active human clinical studies in multiple indications, including pancreatic cancer, ovarian cancer and post-COVID conditions. Our clinical and operational execution is supported by a strong cash position and we are poised for an exciting period ahead as we approach a number of value-driving milestones, particularly in our ovarian and pancreatic cancer programs. We are dedicated to driving our clinical programs forward and building momentum to generate value for our shareholders," commented Thomas K. Equels, Chief Executive Officer of AIM.

Recent Highlights

Announced encouraging translational data from an ongoing Phase 2 clinical trial utilizing AIM’s drug Ampligen in patients with platinum-sensitive advanced recurrent ovarian cancer.
Engaged Azenova, LLC, a professional business development consulting firm, to support efforts to partner AIM’s pipeline programs with a particular focus on the company’s lead asset, Ampligen, for the treatment of various malignant solid tumors.
Presented an overview of Ampligen’s clinical progress in oncology at the 3rd Annual Marie Sklodowska-Curie Symposium on Cancer Research and Care.
Announced that Roswell Park Comprehensive Cancer Center has reported the complete topline data from its Phase 1 study evaluating Ampligen (rintatolimod) as a component of a CKM regimen for the treatment of early-stage triple negative breast cancer (TNBC). The complete topline results are now available on ClinicalTrials.gov: NCT04081389.
Upcoming Expected Ampligen Milestones

Q4 2023

Locally advanced pancreatic cancer (AMP-270) – Open European site
Metastatic pancreatic cancer (DURIPANC, Collaboration with AstraZeneca) – Begin clinical trial
Advanced Recurrent Ovarian Cancer – Protocol-planned interim results
Post-COVID Conditions (AMP-518) – Final subject completes Phase 2 study
Q1 2024

Post-COVID Conditions (AMP-518) – Topline data from Phase 2 study expected
Summary of Financial Highlights for Third Quarter 2023

As of September 30, 2023, AIM reported cash, cash equivalents and marketable investments of $22.4 million. Based on management’s current expectation, the Company’s cash runway is expected to fund operations through multiple key milestones.
Research and development expenses for the three months ended September 30, 2023, were $2.7 million, compared to $1.4 million for the same period in 2022.
General and administrative expenses were $5.4 million for the three months ended September 30, 2023, compared to the $5.2 million for the same period in 2022.
The net loss from operations for the three months ended September 30, 2023, was $7.8 million, or $0.16 per share, compared to $6.4 million, or $0.13 per share, for the three months ended September 30, 2022.
Please refer to the full 10-Q for complete details.

Conference Call and Webcast Details

As previously announced, the Company will host a quarterly conference call and live audio webcast to discuss the operational and financial results today, Wednesday, November 15, 2023, at 8:30 AM ET.

The call will be hosted by members of AIM’s leadership team, Thomas K. Equels, Chief Executive Officer and Christopher McAleer, PhD, Scientific Officer. Interested participants and investors may access the conference call by dialing (877) 407-9219 (domestic) or (201) 689-8852 (international) and referencing the AIM ImmunoTech Conference Call. The webcast will be accessible on the Events page of the Investors section of the Company’s website, aimimmuno.com, and will be archived for 90 days following the live event.

On November 14, 2023 EMulate Therapeutics, Inc. (EMTx) reported the acceptance of their abstract for presentation and publication in the 28th Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO), November 2023, in Vancouver, British Columbia (Press release, EMulate Therapeutics, NOV 14, 2023, View Source [SID1234637680]). The accepted abstract will be published in SNO’s official journal, Neuro-Oncology, which is now available at View Source

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The abstract describes the poster material developed by EMTx for the SNO meeting and can be downloaded from EMTx’s website for viewing here. The title of the abstract and poster are: "Low/Ultra-low Radio Frequency Magnetic Field Therapies for the Treatment of CNS Tumors: rGBM and DIPG – Past and Current Results Using the EMulate Therapeutics, Inc. Technology."

"EMTx continues to move forward with research in support of the humanitarian device exemption (HDE) application to FDA," said Chris Rivera, CEO of EMTx. "The data we are presenting in our SNO poster demonstrates mechanisms of action and increased survival time in a DMG/DIPG animal model of the EMTx technology using the A1A signal. These data are in addition to safety and benefit data demonstrated in our compassionate use study for the DMG/DIPG indication."

"We believe that the results and publication of our recurrent glioblastoma clinical trials may provide support in our HDE application for DMG/DIPG," stated Dr. Xavier Figueroa, Pre-clinical Director for EMTx. "While there is no guarantee that our HDE application will be approved, the needs of this underserved pediatric population and the demonstrated safety profile of our therapeutic device give us reason to feel confident that the FDA will grant us HDE approval."

Diffuse intrinsic pontine glioma (DIPG, a subset of diffuse midline glioma) primarily affects children, mostly diagnosed between 5 and 7 years of age. DIPG makes up 10-15% of all brain tumors in children, with about 150-300 new diagnoses per year in the United States. Unfortunately, median survival for children diagnosed with this disease is only 9-10 months.

Glioblastoma multiforme (GBM) is the most common type of malignant (cancerous) brain tumor in adults. More than 13,000 Americans are diagnosed with GBM every year. GBM accounts for almost half of all cancerous brain tumors. GBM commonly affects people aged 45 to 70. Most people live on average 12 to 18 months after diagnosis. Only about 7% of people are still alive in five years.

EMTx is dedicated to changing the treatment and prolonging survival in both DIPG and GBM.