On August 12, 2024 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on the development of first-in-class and best-in-class targeted oncology therapies, reported financial results for the second quarter ended June 30, 2024, and provided a business update (Press release, Immunome, AUG 12, 2024, View Source [SID1234645730]).

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"Immunome is focused on establishing and developing a broad pipeline of differentiated oncology therapies. We continue to advance work required to prepare AL102 for regulatory submissions, and we are moving towards submitting INDs for IM-1021 and IM-3050," said Clay B. Siegall, Ph.D., President and Chief Executive Officer. "These programs are supported by an expanding team of drug developers, including leaders who previously contributed to the successful development and commercialization of ADCs and small molecules."

Dr. Siegall continued, "In addition to our clinical pipeline, we have identified multiple promising ADC targets, all of which offer first-in-class potential. We believe that cost-effective business development efforts combined with focused research can accelerate the expansion of our pipeline and that rigorous science provides the foundation for transformative cancer therapies."

Pipeline Highlights

Full enrollment for the Phase 3 RINGSIDE Part B study of AL102 for the treatment of desmoid tumors was completed in February 2024, and Immunome continues to expect to report topline data for RINGSIDE Part B in the second half of 2025. In parallel, Immunome is performing additional manufacturing and pharmacology work required to support a new drug application filing for AL102.

Immunome also anticipates submitting INDs for IM-1021 and IM-3050 in the first quarter of 2025, as previously disclosed.

These programs are complemented by robust discovery efforts centered on next-generation ADCs and active business development activity, including recent transactions with Atreca, Nectin Therapeutics, Bluefin Biomedicine, and OncoResponse intended to expand Immunome’s ADC toolbox.

Second Quarter 2024 Financial Results

· As of June 30, 2024, cash, cash equivalents and marketable securities totaled $278.4 million. Immunome’s current cash runway is expected to extend into 2026.

· Research and development expenses for the quarter ended June 30, 2024 were $29.1 million, including stock-based compensation costs of $1.0 million.
· In-process research and development expenses for the quarter ended June 30th, 2024 were $6.3 million. These expenses were related to Immunome’s business development activity.
· General and administrative expenses for the quarter ended June 30, 2024 were $7.0 million, including stock-based compensation expense of $2.2 million.
· Immunome reported a net loss of $36.1 million for the quarter ended June 30, 2024.

On August 12, 2024 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), reported its financial results for the second quarter ended June 30, 2024 and provided a business update (Press release, Gossamer Bio, AUG 12, 2024, View Source [SID1234645729]).

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"Between the continued progress made in the enrollment of the Phase 3 PROSERA Study and the transformational collaboration agreement with the Chiesi Group, Gossamer has made great strides in the second quarter to advance the clinical development and strengthen the market potential of seralutinib," said Faheem Hasnain, Co-Founder, CEO, and Chairman of Gossamer Bio.

"Additionally, we look forward to announcing seralutinib presentations and posters at major medical meetings in the coming months, which continue to support the potential of seralutinib as a novel agent in the treatment of patients with PAH and PH-ILD."

Seralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor for PAH and PH-ILD
•Enrollment is ongoing in the PROSERA Study, a global registrational Phase 3 clinical trial in patients with WHO Functional Class II and III PAH. The primary endpoint is change in six-minute walk distance (6MWD) from baseline at week 24. Topline results from the PROSERA Study are expected in the fourth quarter of 2025.
•In mid-2025, after engaging and discussing with global regulatory authorities, we expect to commence a global registrational Phase 3 clinical trial of seralutinib for the treatment of patients with PH-ILD.
•On May 6, Gossamer Bio and the Chiesi Group announced a development and co-commercialization collaboration for seralutinib. Gossamer and Chiesi will split global development costs for seralutinib, except for the PROSERA Study, for which Gossamer will remain solely responsible. In the United States, Gossamer and Chiesi will split profits and losses, and Chiesi will be solely responsible for commercialization of seralutinib outside of the United States, for which Gossamer will receive mid-to-high teens royalties.

Financial Results for Quarter Ended June 30, 2024
•Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of June 30, 2024, were $354.5 million. The Company expects the combination of current cash, cash equivalents and marketable securities will be sufficient to fund its operating and capital expenditures into the first half of 2027.
•Revenue from Sale of Licenses and from Contracts with Collaborators: For the quarter ended June 30, 2024, revenue from the sale of licenses was $88.8 million and revenue from contracts with collaborators was $7.1 million. Our revenue consists of a one-time development cost reimbursement payment for licenses related to the collaboration with Chiesi and ongoing payments for research and development services related to the collaboration with Chiesi.
•Research and Development (R&D) Expenses: For the quarter ended June 30, 2024, R&D expenses were $35.1 million, compared to $36.3 million for the same period in 2023.
•General and Administrative (G&A) Expenses: For the quarter ended June 30, 2024, G&A expenses were $8.7 million, compared to $10.0 million for the same period in 2023.
•Net Income (Loss): Net income for the quarter ended June 30, 2024, was $49.2 million, or $0.22 basic net income per share, compared to a net loss of $42.5 million, or $0.45 basic net loss per share, for the same period in 2023.

On August 12, 2024 FORE Biotherapeutics reported the appointment of Michael Byrnes as chief financial officer of the company (Press release, Fore Biotherapeutics, AUG 12, 2024, View Source [SID1234645728]). Mr. Byrnes brings over 20 years’ experience in the biotechnology industry, both in private and public companies, spanning all phases of development from pre-clinical to pre-commercial stages and across multiple indications. As CFO, he has led multiple companies through equity and debt transactions and been involved in M&A totaling close to $4B.

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Prior to joining Fore, Mr. Byrnes was chief financial officer for eFFECTOR Therapeutics where he took the company public in 2021. Previous to that, Mr. Byrnes was senior vice president of finance at Principia Biopharma, Inc. (PRNB), which was acquired by Sanofi in September 2020. Prior to that, Mr. Byrnes served as chief financial officer of Alkahest, Inc. and chief financial officer of Ocera Therapeutics, Inc. (OCRX) until its acquisition by Mallinckrodt Pharmaceuticals. Earlier in his career, Mr. Byrnes held finance positions of increasing responsibility with Maxygen, Inc. (MAXY), NeurogesX, Inc. (NGSX), Lipid Sciences, Inc. (LIPD) and ADAC Laboratories, Inc. (ADAC). Mr. Byrnes received his B.S.C. in finance from Santa Clara University and an M.B.A. from California State University, Hayward.

Bill Hinshaw, CEO of Fore commented: "I am excited to have Mike join as our CFO. He brings highly relevant experience to Fore given his background and track record in both private and public companies. He will be a key leader in supporting the performance and growth of the company. I would like to thank Jeff Sacher from Danforth Advisors and to acknowledge his valuable contributions during his interim tenure with the company.

Mike’s hire is part of our continued investment in talent to drive and support our growth, including the recent addition of Payman Darouian, PharmD, as Senior VP, Corporate Development, Strategy and Commercial."

"I’m excited to join Fore as chief financial officer and leverage my extensive experience from multiple high-growth biotechnology companies. This is an exciting time to join Fore, with multiple value-creating catalysts anticipated in the near-term and going forward across the trials. I believe the company and its lead asset plixorafenib are well positioned for significant growth and look forward to helping shape Fore’s future and its mission to reset the standard for BRAF treatment," said Mr. Byrnes.

On August 12, 2024 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported business updates and announced financial results for the fiscal quarter ended June 30, 2024 (Press release, Erasca, AUG 12, 2024, View Source [SID1234645727]).

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"This second quarter 2024 was transformative for Erasca, driven by the successful in-licensing of a RAS-targeting franchise of potentially best-in-class and first-in-class molecules along with initiating our SEACRAFT-2 Phase 3 registrational trial for naporafenib; in addition, we strengthened our balance sheet and significantly extended our cash runway from multiple equity financings and prioritization decisions," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "Naporafenib plus trametinib has shown clinically meaningful and differentiated progression free survival and overall survival benefits across Phase 1 and 2 trials in patients with NRAS-mutant (NRASm) melanoma. We may also have the opportunity to expand treatment options for patients with various RAS Q61X solid tumors based on the initial Phase 1b combination data from SEACRAFT-1 expected in the fourth quarter of the year."

Dr. Lim continued, "Our bolstered pipeline includes an exciting RAS-targeting franchise, including a pan-RAS molecular glue ERAS-0015 and a pan-KRAS inhibitor ERAS-4001, that exhibit complementary RAS inhibitory mechanisms, differentiated preclinical profiles, and the potential to expand treatment options across RAS-driven tumors. We are well-positioned to continue advancing our pipeline through multiple catalysts and deliver on our mission to develop therapies that shut down RAS-driven cancers for the benefit of patients."

Research and Development (R&D) Highlights

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Initiated SEACRAFT-2 Pivotal Phase 3 Trial: In June 2024, Erasca announced the initiation of the global SEACRAFT-2 Phase 3 trial evaluating the pan-RAF inhibitor naporafenib in combination with the MEK inhibitor trametinib (MEKINIST) in patients with NRASm melanoma. The two-stage design is expected to provide a randomized data readout of naporafenib plus trametinib against single agent trametinib in 2025 in Stage 1 and inform the randomized Phase 2 dose for the combination. In Stage 2, the trial is expected to compare the combination against physician’s choice of chemotherapy or a single agent MEK inhibitor using dual primary endpoints of progression free survival and overall survival for regulatory approval.

Corporate Highlights

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In-Licensed Potential Best-in-Class and First-in-Class RAS-Targeting Franchise: In May 2024, Erasca announced exclusive license agreements for two preclinical RAS programs—a potential best-in-class pan-RAS molecular glue (ERAS-0015) and a potential first-in-class pan-KRAS inhibitor (ERAS-4001). ERAS-0015 and ERAS-4001 are potent, orally bioavailable molecules with complementary RAS inhibitory mechanisms that have the potential to address unmet needs in approximately 2.7 million patients who are diagnosed annually globally with RAS-mutant (RASm) tumors, of which over 2.2 million patients are diagnosed with KRAS-mutant (KRASm) tumors.
•
Extended Cash Runway with $229 Million in Equity Financings: In March 2024, Erasca entered into a $45 million oversubscribed private placement financing led by high-quality new and existing healthcare-focused investors. Additionally, in May 2024, Erasca entered into a $184 million oversubscribed underwritten offering led by high-quality new and existing healthcare-focused investors. Together, these equity financings extended Erasca’s expected cash runway into the first half of 2027.

Key Upcoming Milestones

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SEACRAFT-1: Phase 1b trial for naporafenib (pan-RAF inhibitor) plus trametinib in patients with RAS Q61X solid tumors
o
Initial Phase 1b combination signal-seeking efficacy data in relevant tumor types expected to be reported in Q4 2024
•
SEACRAFT-2: Randomized pivotal Phase 3 trial for naporafenib plus trametinib in patients with NRASm melanoma
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Phase 3 Stage 1 randomized dose optimization data expected to be reported in 2025
•
AURORAS-1: Phase 1 trial for ERAS-0015 (pan-RAS molecular glue) in patients with RASm solid tumors
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IND filing expected in H1 2025
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Initial Phase 1 monotherapy data in relevant tumor types expected to be reported in 2026
•
BOREALIS-1: Phase 1 trial for ERAS-4001 (pan-KRAS inhibitor) in patients with KRASm solid tumors
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IND filing expected in Q1 2025
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Initial Phase 1 monotherapy data in relevant tumor types expected to be reported in 2026

Second Quarter 2024 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $460.2 million as of June 30, 2024, compared to $322.0 million as of December 31, 2023. In April 2024, Erasca completed a $45 million private placement, raising net proceeds of $43.6 million after deducting placement agent fees and expenses. In May 2024, Erasca completed a $184 million underwritten offering, raising net proceeds of $174.4 million after deducting underwriting discounts and commissions, and offering costs. Erasca expects its current cash, cash equivalents, and marketable securities balance of $460.2 million to fund operations into the first half of 2027.

Research and Development (R&D) Expenses: R&D expenses were $33.0 million for the quarter ended June 30, 2024, compared to $26.2 million for the quarter ended June 30, 2023. The increase was primarily driven by an impairment charge on operating lease assets and property and equipment, and increases in expenses incurred in connection with clinical trials, preclinical studies, and discovery activities, personnel costs primarily due to termination benefits in connection with a reduction in force, facilities-related expenses and depreciation, and outsourced services and consulting fees. Erasca also recorded $22.5 million of in-process R&D expense during the quarter ended June 30, 2024 for upfront payments under Erasca’s ERAS-0015 and ERAS-4001 license agreements.

General and Administrative (G&A) Expenses: G&A expenses were $12.3 million for the quarter ended June 30, 2024, compared to $9.8 million for the quarter ended June 30, 2023. The increase was primarily driven by an impairment charge on operating lease assets and property and equipment, and an increase in legal fees.

Net Loss: Net loss was $63.2 million, or $(0.29) per basic and diluted share, for the quarter ended June 30, 2024, compared to $31.8 million, or $(0.21) per basic and diluted share, for the quarter ended June 30, 2023.

On August 12, 2024 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, reported that it completed a meeting with the U.S. Food and Drug Administration (FDA) to gain alignment on the rationale and proposed dosing for the Company’s Phase II study that will investigate the preliminary safety and activity of leronlimab in combination with trifluridine plus tipiracil (TAS-102) and bevacizumab in participants with CCR5+, microsatellite stable (MSS), relapsed or refractory metastatic colorectal cancer (mCRC) (Press release, CytoDyn, AUG 12, 2024, View Source [SID1234645726]).

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The Company intends to proceed with a submission of its final study protocol to the FDA, formal engagement of a clinical research organization (CRO), and related preparatory work towards initiating the proposed trial.

This open label, randomized (1:1), multicenter trial will evaluate the anti-tumor activity (via overall response rate, ORR) of leronlimab at doses of 350 mg and 700 mg in combination TAS-102 and bevacizumab in approximately 60 patients with CCR5+, microsatellite stable metastatic CRC (mCRC).

Patients enrolled in the trial must have measurable disease per RECIST v1.1 and have received prior treatment with fluoropyrimidine‐, oxaliplatin‐, and irinotecan‐based chemotherapy, an anti‐VEGF therapy, and, if RAS wild‐type and medically appropriate, an anti-EGFR therapy. CCR5 tumor expression will be determined by immunohistochemistry assay (IHC) and diagnosis of MSS CRC will be confirmed by IHC or next-generation sequencing (NGS).

TAS-102 and bevacizumab will be administered for three of four weeks in a four-week cycle, and leronlimab (at doses of 350 mg or 700 mg) will be administered weekly. The study will include a safety lead-in treating five patients in the 350 mg leronlimab arm prior to beginning enrollment to the 700 mg leronlimab arm.

"We are pleased to have received the FDA’s feedback on our Phase II study of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer, and remain on track to commence our oncology trial in the coming months. Advancing leronlimab in the oncology indication has been an important priority for our team as we progress CytoDyn’s clinical pipeline," said Dr. Jacob Lalezari, CEO.