On November 15, 2024 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the third quarter ended September 30, 2024 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, NOV 15, 2024, View Source [SID1234648436]).

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"The third quarter was a particularly productive period for Bio-Path as we initiated our obesity program, which marks the first application of our DNAbilize platform beyond oncology and highlights its broad therapeutic potential," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "Importantly, we continued to advance our oncology programs and were delighted with the swift enrollment of the third cohort in our Phase 1/1b clinical trial of BP1002 in venetoclax-resistant AML patients, which was ahead of our projected timelines. We also published an article highlighting the broad anti-tumor effect of BP1003 in numerous preclinical solid tumor models, including breast, ovarian, and pancreatic cancer, in the peer-reviewed journal, Biomedicines."

Recent Corporate Highlights

Initiated BP1001-A Therapeutic Program for Treatment of Obesity. In October, the Company announced the initiation of a therapeutic program to develop BP1001-A for the treatment of obesity and related metabolic diseases. This program marks the first application of DNAbilize technology for development of a non-cancer application, which highlights the broad therapeutic potential of this technology. The disease pathology leading to obesity suggests that BP1001-A, which suppresses the adaptor protein Grb2, has the potential to treat insulin resistance, a major contributor to obesity, Type 2 diabetes and other related metabolic diseases. Bio-Path expects downregulating Grb2 expression with BP1001-A will enhance insulin sensitivity.

Completion of Enrollment for Third Dosing Cohort of Phase 1/1b Clinical Trial of BP1002 in Venetoclax-Resistant Acute Myeloid Leukemia (AML) Patients. In October, Bio-Path announced completion of enrollment for the third dosing cohort of the Company’s Phase 1/1b trial of BP1002 in venetoclax-resistant AML patients. The cohort enrolled more quickly than projected, which underscores the ongoing need for new treatment options for these relapsed/refractory patients.

Publication in Peer-Reviewed Journal, Biomedicines. In September, Bio-Path published an article highlighting the therapeutic potential of BP1003 in a variety of cancer types in the peer-reviewed journal, Biomedicines. The article describes the broad anti-tumor effect of BP1003 in numerous preclinical solid tumor models including breast, ovarian, and pancreatic cancer. BP1003 is a neutral liposome incorporated with a nuclease resistant P-ethoxy antisense oligodeoxynucleotide targeting the STAT3 mRNA and its unique design enhances stability, cellular uptake, and target affinity.

Reported Solid Tumor Patient Response Supporting BP1001-A’s Compelling Potential as Treatment for Advanced Solid Tumors. Bio-Path’s first patient in the second dose cohort in its Phase 1/1b advanced solid tumor clinical trial experiencing a positive response may signal that this analog of prexigebersen has potential as a new treatment for advanced solid tumors. The patient appears to be doing well on study after failing extensive chemotherapy and surgical treatment for gynecologic cancer, demonstrating a 15% reduction in her primary tumor through six cycles of treatment. Moreover, it appears that these positive outcomes may have contributed to allow her to continue with rigorous exercise and improved quality of life.

The dose finding portion of the Phase 1/1b trial is comprised of BP1001-A monotherapy with no accompanying chemotherapy. This clinical trial of BP1001-A in patients with advanced or recurrent solid tumors has successfully completed the initial prescribed dose in the first cohort of 60 mg/m2 and began enrollment in the higher dose cohort of 90 mg/m2. The Phase 1b portion of the study is expected to commence after completion of three planned BP1001-A monotherapy dose level cohorts and is intended to assess the safety and efficacy of BP1001-A in combination with paclitaxel in patients with recurrent ovarian or endometrial tumors. Phase 1b studies are also expected to be opened in combination with gemcitabine in late-stage pancreatic cancer.
Closed $4.0 Million Private Placement. In October, Bio-Path announced closing of a private placement priced at-the-market under Nasdaq rules for the issuance and sale of an aggregate of 4,597,702 shares of its common stock (or common stock equivalents in lieu thereof), series A warrants to purchase up to 6,407,657 shares of common stock and short-term series B warrants to purchase up to 6,407,657 shares of common stock at a purchase price of $0.87 per share of common stock (or per common stock equivalent in lieu thereof) and accompanying warrants in a private placement. The gross proceeds to the Company from the offering were approximately $4.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company, and excluding the proceeds, if any, from the exercise of the warrants.
Financial Results for the Third Quarter Ended September 30, 2024

The Company reported a net loss of $2.1 million, or $0.70 per share, for the three months ended September 30, 2024, compared to a net loss of $3.2 million, or $6.36 per share, for the three months ended September 30, 2023.

Research and development expense for the three months ended September 30, 2024 decreased to $1.3 million, compared to $2.3 million for the three months ended September 30, 2023 primarily due to decreased manufacturing expenses related to drug product releases as well as a decrease in expense related to our clinical trial for BP1001 in AML due to timing of patient enrollment during the quarter.

General and administrative expense for the three months ended September 30, 2024 increased to $1.3 million, compared to $1.0 million for the three months ended September 30, 2023 primarily due to increased legal fees and salaries and benefits expense.

As of September 30, 2024, the Company had cash of $0.6 million, compared to $1.1 million as of December 31, 2023. Net cash used in operating activities for the nine months ended September 30, 2024 was $7.7 million compared to $9.7 million for the comparable period in 2023. Net cash provided by financing activities for the nine months ended September 30, 2024 was $7.2 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 2024 financial results and to provide a general update on the Company. To access the conference call please dial (844) 481-3014 (domestic) or (412) 317-1879 (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, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported its financial results for the third quarter 2024 (Press release, AIM ImmunoTech, NOV 15, 2024, View Source [SID1234648435]). Also, the Company will host a conference call and webcast today, November 15, 2024 at 8:30 AM ET (details below).

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AIM Chief Executive Officer Thomas K. Equels stated, "We are driving significant momentum across multiple clinical programs and studies that are demonstrating Ampligen’s significant potential to address high value and high need indications, especially in the pancreatic cancer space. Over the course of 2024, our team has made important progress in executing our clinical strategy, facilitating potential partnerships with big pharma and leveraging commercialization opportunities to create value. Our Board of Directors is dedicated to helping patients in need and delivering enhanced value for our shareholders."

Recent Highlights

Pancreatic Cancer:
Reported positive preliminary data in Phase 1b/2 study of Ampligen and Imfinzi as a combination therapy for late-stage pancreatic cancer.
Announced further positive findings from a study evaluating Ampligen in the treatment of pancreatic cancer.
Long-COVID:
Announced that analysis of AMP-518 complete clinical patient data underscores Ampligen’s potential to improve the post-COVID condition of fatigue.
Endometriosis: Company granted U.S. patent for Ampligen for composition of matter and method of treatment of endometriosis.
Please refer to previously released CEO Corner segments for additional highlights around the Company’s news and programs.

Summary of Financial Highlights for Third Quarter 2024

As of September 30, 2024, AIM reported cash, cash equivalents and marketable securities of $7.2 million.
Research and development expenses for the three months ended September 30, 2024 were $1.4 million, compared to $2.7 million for the same period in 2023.
General and administrative expenses were $3.1 million for the three months ended September 30, 2024, compared to $5.4 million for the same period 2023.
The net loss from operations for the three months ended September 30, 2024 was $3.7 million, or $0.06 per share, compared to $7.8 million, or $0.16 per share, for the three months ended September 30, 2023.
Please refer to the full 10-Q for complete details.

Conference Call and Webcast Details

As previously announced, the Company will host a conference call and webcast to discuss the Company’s Q3 2024 operational and financial results on November 15, 2024 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, 2024 Ascendis Pharma A/S (Nasdaq: ASND) reported financial results for the third quarter ended September 30, 2024, and provided a business update (Press release, Ascendis Pharma, NOV 14, 2024, View Source [SID1234649389]).

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"2024 has been another transformative year for Ascendis. Now, all three of our three endocrinology rare disease programs have delivered clinically differentiated pivotal data, each demonstrating potential ability to address major unmet medical needs and the potential for each to achieve blockbuster status. We are ready and very excited about launching YORVIPATH in the U.S. with product availability expected in mid-January of 2025," said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. "In addition, our new partnership with Novo Nordisk highlights our ability to extend the success of our TransCon platform and positions Ascendis to benefit patients and capture significant value in this large, high volume therapeutic areas."

Select Highlights & Anticipated 2024 Milestones

TransCon hGH:
(lonapegsomatropin, marketed as SKYTROFA)
SKYTROFA revenue for the third quarter of 2024 totaled €47.2 million compared to €47.0 million during the same period in 2023. Volume growth was offset by higher sales deductions and a negative adjustment to prior period sales deductions of €2.5 million.
SKYTROFA revenue for the first nine months of 2024 totaled €138.5 million, a 21% year-over-year increase compared to €114.4 million during the same period of 2023. Volume growth was partially offset by higher sales deductions. In addition, sales deductions attributable to periods prior to January 1, 2024 totaled €9.3 million.
Submitted U.S. Food & Drug Administration (FDA) supplemental Biologics License Application for TransCon hGH for the treatment of adults with growth hormone deficiency.
Topline results from Phase 2 New InsiGHTS Trial in Turner syndrome expected in the fourth quarter of 2024.
Expect to initiate a basket trial evaluating SKYTROFA in other established daily growth hormone indications in the first half of 2025.
TransCon PTH:
(palopegteriparatide, marketed as YORVIPATH)
YORVIPATH launching in U.S. with our expanded U.S. field teams engaging with health care providers, our Ascendis Signature Access Program accepting prescriptions and enrolling patients starting in December in preparation for product availability in mid-January 2025
Third quarter YORVIPATH revenue outside the U.S. totaled €8.5 million, a sequential quarter-over-quarter revenue increase of more than 60%, reflecting growing physician and patient demand with now over 600 patients on treatment, partially offset by accruals reflecting the end of the free pricing period in the third quarter. Final pricing in Germany is expected to be completed next year.
TransCon CNP
(navepegritide)
Announced positive topline data from pivotal ApproaCH Trial with children with achondroplasia (ages 2-11 years) treated with once-weekly TransCon CNP.
Plan to submit New Drug Application (NDA) to the FDA for TransCon CNP for the treatment of children with achondroplasia during the first quarter of 2025 and a Marketing Authorisation Application (MAA) for the treatment of children with achondroplasia to the European Medicines Agency during the third quarter of 2025.
Expect topline Week 26 data from COACH, the combination TransCon hGH and TransCon CNP trial of children with achondroplasia (ages 2-11 years) in the second quarter of 2025.
Oncology Programs
Presented first results from platinum-resistant ovarian cancer (PROC) cohort of the Phase 1/2 IL-Believe Trial at ESMO (Free ESMO Whitepaper) 2024. Initial data suggest clinical activity in heavily pre-treated PROC patients and that TransCon IL-2 β/γ in combination with chemotherapy was generally well-tolerated.
Recently, we closed enrollment to dose expansion cohorts involving TransCon TLR7/8 Agonist in the transcendIT-101 and IL Believe trials to prioritize our efforts on TransCon IL-2 β⁄γ.
Strategic Collaboration
In November, granted Novo Nordisk A/S an exclusive, multi-product, worldwide license to the TransCon technology platform to develop, manufacture and commercialize Novo Nordisk proprietary products in metabolic diseases and a product-by-product exclusive license in cardiovascular diseases. The lead program in the collaboration is a once-monthly GLP-1 receptor agonist product candidate that will initially target obesity and type 2 diabetes.
For the lead program, Ascendis will be eligible to receive total payments of up to $285 million in upfront, development, and regulatory milestone payments, plus sales-based milestone payments and escalating tiered, mid-single digit royalties on global net sales.
Novo Nordisk will be responsible for Ascendis’ early development costs as well as for clinical development, regulatory, commercial manufacturing, and commercialization activities.
Financial Update and Outlook Based on Current Plans
As of September 30, 2024, Ascendis Pharma had cash, cash equivalents, and marketable securities, totaling €626 million, compared to €399 million as of December 31, 2023.
Full year 2024 SKYTROFA revenue excluding sales deductions related to prior years expected to be €200 – €220 million.
Expect total operating expenses (SG&A and R&D) to be approximately €600 million for 2024.
Third Quarter 2024 Financial Results
Total revenue for the third quarter of 2024 was €57.8 million, compared to €48.0 million during the same period for 2023. The year-over-year increase in total revenue was primarily attributable to revenue contribution of €8.5 million from YORVIPATH following commercial launch in the first quarter of 2024. Non-product revenue was €2.1 million in the third quarter of 2024, compared to €1.1 million for the same period for 2023.

On November 14, 2024 Affimed N.V. (Nasdaq: AFMD) ("Affimed" or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported financial results and provided an update on clinical and corporate progress for the quarter ended September 30, 2024 (Press release, Affimed, NOV 14, 2024, View Source [SID1234649279]).

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"Our innate cell engager therapies are meeting the critical needs of cancer patients who often come to us after exhausting nearly all other treatment options. The responses we’ve observed, even in the heavily pre-treated populations, give us tremendous confidence," said Dr. Shawn Leland, Chief Executive Officer of Affimed. "With clinical proof of concept established for all our innate cell engagers, the demonstrated activity across both hematological and solid tumors, combined with a strong safety profile, underscores the potential of our platform. We are refining our strategy to focus on clinical priorities and commercial viability, ensuring that our therapies deliver meaningful, long-term impact. I’m also very excited about expanding our efforts to seek collaborations with potential partners who share our vision to drive success for both patients and stakeholders."

Pipeline Highlights:

AFM24 (EGFR / CD16A)
In the AFM24-102 trial (combination with atezolizumab):

The cohort of NSCLC EGFRwt patients who failed chemotherapy and PD-1/PD-L1 has completed enrollment. ORR and safety data for this cohort will be presented on a Company conference call on December 17, 2024.
As previously reported at ASCO (Free ASCO Whitepaper) 2024, in 17 EGFRwt NSCLC patients who failed chemotherapy and PD-1/PD-L1 treatment, 1 complete response (CR), 3 partial responses (PRs) and 8 stable diseases (SDs) had been observed. Disease control was 71%. At the time, 3 of the 4 responses were ongoing for more than 7 months and median progression free survival (PFS) was 5.9 months.
PFS data from the EGFRwt and ORR and PFS data from the EGFR mutant (EGFRmut) cohorts expected to be presented at a major scientific conference in H1 2025.
Acimtamig (AFM13) (CD30 / CD16A)

Updated clinical data from the four cohorts of the run-in phase of the LuminICE-203 study will be shared in a poster session at ASH (Free ASH Whitepaper) 2024.
As previously reported on the Company’s Q2 2024 earnings call, in the phase 2 LuminICE-203 trial, 12 patients with advanced, treatment-refractory Hodgkin Lymphoma in cohorts 1 and 2, treated with a combination of the CD30-targeting innate cell engager acimtamig (AFM13) and AlloNK, demonstrated high efficacy, with an ORR of 83.3% and a CRR of 50%.
AFM28 (CD123 / CD16A)

An oral presentation at ASH (Free ASH Whitepaper) 2024 will feature updated clinical data including efficacy and safety data from the AFM28 phase 1 dose escalation study in relapsed/refractory acute myeloid leukemia (AML).
A poster with preclinical data will highlight the in vitro efficacy of AFM28 in combination with both patient-derived autologous NK cells and healthy volunteer-derived allogeneic NK cells against leukemic blasts.
As previously reported, initial data on the six patients treated at dose level 6 at 300 mg in the multi-center phase 1 open-label, dose-escalation study (AFM28-101), of AFM28 monotherapy in CD123-positive r/r AML, showed 1 patient with a CR, 2 patients with a CRi for a composite complete remission (CRc) rate (defined as CR+CRi) of 50% (3/6).
An additional six patients have been enrolled in the 300 mg cohort.
Upcoming Milestones:

LuminICE-203: Efficacy update of four cohorts to be presented at ASH (Free ASH Whitepaper) 2024.
AFM24-102: ORR and safety data from the EGFRwt cohort to be presented at a Company conference call on December 17, 2024.
AFM28-101: Updated data from the dose escalation to be presented at ASH (Free ASH Whitepaper) 2024.
AMF24-102: ORR and PFS data from the EGFRmut and PFS data from the EGFRwt cohorts expected to be presented at a major scientific conference in H1 2025.
Third Quarter 2024 Financial Highlights
Affimed’s consolidated financial statements are prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standard Board (IASB). The consolidated financial statements are presented in Euros (€), the Company’s functional and presentation currency.

As of September 30, 2024, cash, cash equivalents and short-term investments totaled €24.1 million. Based on current operating and budget assumptions, the Company expects that cash, cash equivalents and investments, together with anticipated proceeds from its ATM program and the sale of AbCheck, will finance its operations into Q4 of 2025.

Net cash used in operating activities for the quarter ended September 30, 2024, was €11.1 million compared to €18.3 million for the quarter ended September 30, 2023. The decline was mainly due to lower research and development expenditure and personnel expenses.

Total revenue for the quarter ended September 30, 2024, was €0.2 million compared with €2.0 million for the quarter ended September 30, 2023. Revenue in 2024 only related to a platform license provided to Genentech and 2023 predominantly related to the Roivant research collaborations for which all work has been completed.

Research and development expenses for the quarter ended September 30, 2024, were €10.1 million compared to €21.5 million in 2023. The decrease was primarily a result of lower expenses associated with the development of acimtamig and AFM24, due to a decrease in procurement of clinical trial material, clinical trial costs and manufacturing costs, decrease in head count due to the corporate restructuring.

General and administrative expenses for the quarter ended September 30, 2024, were €4.3 million compared to €5.4 million for the quarter ended September 30, 2023. The decrease was due to the decline in headcount, in legal and consulting expenses, insurance expenses and share-based payment expenses.

Net loss for the quarter ended September 30, 2024, was €15.1 million, or €0.94 loss per common share compared with a net loss of €24.4 million, or €1.63 loss per common share, for the quarter ended September 30, 2023.

The weighted number of common shares outstanding for the quarter ended September 30, 2024, was 16,100,185 shares.

Additional information regarding these results will be included in the notes to the consolidated financial statements as of September 30, 2024, included in Affimed’s filings with the U.S. Securities and Exchange Commission (SEC).

Note on International Financial Reporting Standards (IFRS)
Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the IASB. None of the financial statements were prepared in accordance with U.S. Generally Accepted Accounting Principles. Affimed maintains its books and records in Euro.

Conference Call and Webcast Information
Affimed will host a conference call and webcast on November 14, 2024, at 8:30 a.m. EST / 14:30 CET to discuss third quarter 2024 financial results and corporate developments.

The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source To access the call by phone, please use link: https://register.vevent.com/register/BIb9251d6bc6504a4da37a53cdb1b0ac94, and you will be provided with dial-in details and a pin number.

Note: To avoid delays, we encourage participants to dial into the conference call 15 minutes ahead of the scheduled start time. A replay of the webcast will be accessible at the same link for 30 days following the call.

On November 14, 2024 Merck, a leading science and technology company, accelerated its growth in the third quarter of 2024 (Press release, Merck KGaA, NOV 14, 2024, View Source [SID1234648982]). All three business sectors achieved organic increases in sales and earnings. Accordingly, the company remains on course to return to profitable growth in fiscal 2024, as previously announced.

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