On November 14, 2024 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported that the Company has entered into a debt financing agreement with Hercules Capital, Inc. (NYSE: HTGC) for up to $50 million (Press release, Alector, NOV 14, 2024, View Source [SID1234648387]).

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"Alector is in a strong cash position with more than $457 million in cash and investments. This credit facility further enhances our financial strength and provides the Company with increased strategic and operational flexibility," said Marc Grasso, M.D., Chief Financial Officer of Alector. "We anticipate transformational data from both the AL002 INVOKE-2 Phase 2 trial and the latozinemab INFRONT-3 pivotal Phase 3 trial within our runway. This credit facility provides additional funding to advance our preclinical pipeline including our proprietary, versatile Alector Brain Carrier blood-brain barrier platform and programs."

Under the terms of the agreement, Alector drew an initial $10 million at closing. An additional $15 million is available at the Company’s request through June 30, 2026, with an additional $25 million available upon lender approval. The Company is under no obligation to draw funds in the future. The credit facility carries a low double-digit cost of capital.

"Hercules is pleased to enter into a strategic relationship with Alector as it advances its portfolio of assets aimed at treating neurodegenerative diseases," said Lake McGuire, Managing Director at Hercules Capital. "This capital commitment from Hercules seeks to help Alector deliver new therapeutic options to patients and further advance their novel and proprietary blood-brain barrier technology."

Alector’s cash, cash equivalents and investments were $457.2 million as of September 30, 2024. Excluding this $50 million credit facility, the Company believes that its current cash, cash equivalents and investments will be sufficient to fund its operations through 2026.

On November 14, 2024 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported its third quarter 2024 financial and operating results (Press release, Lineage Cell Therapeutics, NOV 14, 2024, View Source [SID1234648403]). The Company will host a conference call today at 4:30 p.m. Eastern Time to discuss these results and to provide a business update.

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"We were delighted to see our partners’ continued commitment to the OpRegen program, in this instance by seeking and successfully obtaining RMAT designation," stated Brian M. Culley, Lineage CEO. "We believe OpRegen continues to showcase itself as an asset with the potential to be ‘a transformational medicine’ and view the recent RMAT designation as additional positive progress for this pioneering cell transplant program. As we worked to return our second cell transplant program, OPC1 for spinal cord injury, back into the clinic, we also presented promising preclinical results from our third program, ReSonance, for sensorineural hearing loss. We look forward to continuing to create value through the advancement of our clinical and preclinical pipelines, applying both our technology and extensive manufacturing expertise to validate our cell transplant approach."

Recent Operational Highlights
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RG6501 (OpRegen)
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Roche and Genentech, a member of the Roche Group, announced receipt of RMAT designation from the U.S. FDA for OpRegen, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
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Continued execution under our collaboration with Roche and Genentech across multiple functional areas, including support for the ongoing Phase 2a clinical study (the "GAlette Study") in patients with GA secondary to AMD.
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Continued activities under the separate services agreement with Genentech to support ongoing development of OpRegen. Lineage has been providing additional clinical, technical, training and manufacturing services funded by Genentech, that further support the ongoing advancement and optimization of the OpRegen program and include: (i) activities to support the ongoing Phase 1/2a study and currently-enrolling Phase 2a study; and (ii) additional technical training and materials related to Lineage’s cell therapy technology platform to support commercial manufacturing strategies.

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OPC1
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DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) clinical study for the treatment of subacute and chronic spinal cord patient start-up activities and FDA interactions continue.

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ReSonance (ANP1)
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Preclinical results presented at 59th Annual Inner Ear Biology Workshop
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ReSonance manufactured by a proprietary process, developed in-house, at clinical scale, with relevant in-vitro functional activity

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Immediate-use, thaw-and-inject formulation durably engrafted in multiple preclinical hearing loss models
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ReSonance is currently being evaluated in a functional model of hearing loss through a collaboration with the University of Michigan Kresge Hearing Research Institute.

Balance Sheet Highlights

Cash, cash equivalents, and marketable securities of $32.7 million as of September 30, 2024 is expected to support planned operations into Q1 2026.

Third Quarter Operating Results

Revenues: Revenue is generated primarily from collaboration revenues, royalties, and other revenues. Total revenues for the three months ended September 30, 2024 were $3.8 million, a net increase of approximately $2.5 million as compared to approximately $1.2 million for the same period in 2023. The increase was primarily driven by more collaboration revenue recognized from deferred revenues under the collaboration and license agreement with Roche.

Operating Expenses: Operating expenses are comprised of research and development (R&D) expenses and general and administrative (G&A) expenses. Total operating expenses for the three months ended September 30, 2024 were $7.6 million, a decrease of $0.3 million as compared to $7.9 million for the same period in 2023.

R&D Expenses: R&D expenses for the three months ended September 30, 2024 were $3.2 million, a net decrease of approximately $0.6 million as compared to $3.7 million for the same period in 2023. The net decrease was primarily driven by $0.6 million for our OPC1 program, $0.4 million for our preclinical programs, and partially offset by $0.5 million for our OpRegen program.

G&A Expenses: G&A expenses for the three months ended September 30, 2024 were $4.4 million, a net increase of $0.4 million as compared to $4.0 million for the same period in 2023. The net increase was primarily driven by $0.3 million for personnel costs and $0.1 million for stock-based compensation expense.

Loss from Operations: Loss from operations for the three months ended September 30, 2024 were $3.8 million, a decrease of $2.9 million as compared to $6.7 million for the same period in 2023.

Other Income/(Expenses): Other income (expenses) for the three months ended September 30, 2024 reflected other income of $0.8 million, compared to other expenses of approximately ($0.4) million for the same period in 2023. The change was primarily driven by exchange rate fluctuations related to our international subsidiaries.

Net Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended September 30, 2024 was $3.0 million, or $0.02 per share (basic and diluted), compared to a net loss attributable to Lineage of $7.1 million, or $0.04 per share (basic and diluted), for the same period in 2023.

Conference Call and Webcast

Interested parties may access the conference call on November 14th, 2024, by dialing (800) 715-9871 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through November 21st, 2024, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 2238934.

On November 14, 2024 Azurity Pharmaceuticals reported that the U.S. Food and Drug Administration (FDA) has approved Danziten, the first and only nilotinib with no mealtime restrictions indicated for adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase and adult patients with chronic phase (CP) and acute phase (AP) resistant or intolerant to prior therapy that included imatinib (Press release, Azurity Pharmaceuticals, NOV 14, 2024, View Source [SID1234648420]).

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"Danziten offers a new nilotinib treatment option with the equivalent efficacy to Tasigna, but without the fasting requirements of Tasigna," said Richard Blackburn, CEO of Azurity Pharmaceuticals, Inc. "Unlike Tasigna, the boxed warning on the Danziten label has no requirement for patients to take their medication in a fasted state, liberating CML patients from mealtime restrictions."

Tasigna has established efficacy in adults with newly diagnosed Ph+ CML-CP and resistant or intolerant Ph+ CML-CP and CML-AP.1 However, Tasigna has variable bioavailability that considerably increases when taken with food. In a concentration dependent manner, Tasigna may significantly prolong QT interval on surface electrocardiogram (ECG) when inappropriately taken with food. As such, strict fasting with Tasigna is crucial to avoid cardiotoxicity.2

Danziten is a re-engineered formulation of nilotinib without mealtime restrictions that offers equivalent efficacy to Tasigna but with improved bioavailability, allowing for a lower dose.1,3,4 Danziten demonstrates consistent pharmacokinetics, with no clinically significant differences in nilotinib exposure regardless of fasting state or meal type, while offering the proven efficacy expected from nilotinib.1,5,6 With optimal tyrosine kinase inhibitor (TKI) therapy, patients can achieve deep molecular responses, and some may even attain treatment-free remission.7 The life expectancy of newly diagnosed CP-CML patients who have responded to appropriate treatment is now approaching that of the general population. However, challenges remain, including patient adherence to treatment. Danziten has the potential to improve adherence due to the removal of fasting requirements.7,8

Danziten will be available in the coming weeks through Biologics by McKesson and Limited Specialty Distribution. For full prescribing information including boxed warning, please visit www.Danziten.com.

Azurity will offer patient support through DanzitenCONNECT, a comprehensive program, subject to terms and conditions, that includes Prior Authorization support and Benefits Investigation, a free first month of Danziten, a co-pay of as little as $0, and a Patient Assistance Program (PAP).

On November 14, 2024 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE:DTC, OTCQB: DTCFF, FSE: DTC) a Canadian biopharmaceutical company developing radiopharmaceuticals and ADC products using its proprietary platform and drug delivery technologies in addition to novel immune-oncology vaccines, reported that it offers new unsecured convertible debentures (the "New Debentures") for aggregate gross proceeds of up to CAD$1,570,000 (the "Offering") in consideration for the settlement of the principal amounts owing to holders of the Previous Debentures (as defined below) (the "Outstanding Debt") (Press release, Defence Therapeutics, NOV 14, 2024, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-announces-securities-for-debenture-financing [SID1234648440]).

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The New Debentures will be issued on a non-brokered private placement basis, bear interest at the rate of 8.0% per annum, be subject to a Conversion Event (as defined below), and mature on November 16, 2025 (the "Maturity Date"). Each New Debenture is unsecured and rank pari passu in right of payment of principal and interest with all the existing and future unsecured indebtedness of the Company. The principal amount of each New Debenture is convertible at the option of the holder into common shares in the capital of the Company (the "Common Shares") at a price of $0.60 per Common Share at any time up to and including the Maturity Date (the "Conversion Event"). Assuming each New Debentures holder exercises their respective Conversion Event, the Company would issue an aggregate total of 2,616,666 Common Shares to the holders thereof.

The Outstanding Debt was incurred in connection with the Previous Debentures that were underlying previously issued units of the Company (the "Units") at a price of $1,000 per Unit on November 16, 2022. Each Unit consisted of: (i) one $1,000 principal amount 8.0% convertible debenture (the "Previous Debenture"), and (ii) 636 common share purchase warrants.

Upon closing of the Offering, their will be no Previous Debentures outstanding; and concurrent with the closing of the Offering, the total accrued interest owing on the Previous Debentures in the amount of approximately $251,200 will be settled via the conversion of such outstanding amount into Common Shares at a price per share equal to the closing market price of the Common Shares as of the trading day prior to such issuance, and in accordance with the terms and conditions of the Previous Debentures.

All securities issued in connection with the Offering are subject to a statutory hold period of four months plus a day in accordance with applicable securities legislation. The closing of the Offering and issuance of the New Debentures and the Common Shares to settle outstanding interest owing from the Previous Debentures are subject to receipt of all necessary regulatory and corporate approvals, including but not limited to approval from the Canadian Securities Exchange.

On November 14, 2024 ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported financial results for the third quarter ended September 30, 2024, and highlighted recent Company progress (Press release, ArriVent Biopharma, NOV 14, 2024, View Source [SID1234648388]).

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"Our lead clinical program of firmonertinib in non-small cell lung cancer (NSCLC) is strongly advancing with encouraging potential to expand across EGFR mutant types. In September, we announced compelling monotherapy data for firmonertinib from our FURTHER study supporting rapid and robust anti-tumor activity across EGFR PACC mutations building on the strong activity observed in patients with EGFR exon 20 insertion mutations," said Bing Yao, Chairman and Chief Executive Officer of ArriVent. "Importantly, the high activity in tough to treat patients with central nervous system (CNS) metastases or compound mutations points to firmonertinib as a promising candidate for front-line patients with PACC mutations. Collectively, the broad activity in EGFR PACC mutations, the high responses in the CNS, and consistent, manageable safety profile across trials reinforces the promise firmonertinib holds to address unmet needs across the spectrum of EGFR mutant NSCLC."

Dr. Yao continued, "We expect several near-term catalysts for our firmonertinib program including initiating dose expansion for the combination study in classical EGFR mutant NSCLC with SHP2 inhibitor ICP-189 in the fourth quarter of the year, an update on the Phase 1b PACC study and plans for our potential registration study in the first half of 2025, and topline pivotal data from our global Phase 3 FURVENT study in front-line EGFR exon 20 mutant NSCLC in 2025. With our strong balance sheet and operating runway into 2026, we are well-positioned to execute across our near-term catalysts."

Third Quarter 2024 and Recent Highlights

Firmonertinib

● Positive proof-of-concept data in EGFR PACC mutant NSCLC. In September, ArriVent presented interim FURTHER Phase 1b clinical data for first-line firmonertinib monotherapy in patients with EGFR PACC mutant NSCLC during the Presidential Symposium at the 2024 annual World Conference on Lung Cancer and hosted a virtual webinar. In what we believe to be the first clinical dataset testing an EGFR inhibitor in a randomized defined population of EGFR PACC

mutant NSCLC, firmonertinib demonstrated robust systemic and CNS anti-tumor activity with a manageable safety profile consistent with previous trials.
Upcoming Milestones

● Dose expansion for SHP2 inhibitor combination. Initiation of dose expansion cohort for the ongoing Phase 1b trial evaluating firmonertinib in combination with SHP2 inhibitor ICP-189 by InnoCare in patients with classical EGFR mutations expected in the fourth quarter of 2024.
● EGFR PACC pivotal study plan. Data from the FURTHER Phase 1b (NCT05364043) trial continues to mature for first-line firmonertinib monotherapy in patients with EGFR PACC mutant NSCLC. ArriVent expects to provide an update on EGFR PACC plans in the first half of 2025.
● Selection of next-generation antibody drug conjugate (ADC) candidate. ArriVent and its partner, Aarvik Therapeutics, Inc., continue to make progress, including initiating CMC activities, on selecting a multi-target multivalent ADC candidate for the treatment of solid tumors in the ARR-002 program, and expect to complete selection of a candidate that will be advanced into IND enabling studies in late 2024 or early 2025.
● Top-line pivotal Phase 3 data in 2025. Firmonertinib is currently being studied as a monotherapy in the pivotal, global Phase 3 FURVENT trial (NCT05607550) evaluating firmonertinib in previously untreated NSCLC patients whose tumors contain EGFR exon 20 insertion mutations with topline data expected in 2025.
Third Quarter 2024 Financial Results

● As of September 30, 2024, the Company had cash and cash equivalents of $282.9 million, which is expected to fund operations into 2026. Net cash used in operations was $54.1 million and $40.9 million for the nine months ended September 30, 2024 and 2023, respectively.

● Research and development expenses were $58.9 million and $44.9 million for the nine months ended September 30, 2024 and 2023, respectively. The increase in expense was primarily due to increased headcount and clinical expense related to firmonertinib.

● General and administrative expenses were $11.8 million and $6.6 million for the nine months ended September 30, 2024 and 2023, respectively. The increase in expense was primarily due to expenses related to expanding the infrastructure necessary for operating as a public company.

● Net loss was $59.9 million and $48.1 million for the nine months ended September 30, 2024 and 2023, respectively.