On March 1, 2024 FogPharma, a clinical-stage biopharmaceutical company dedicated to delivering a new class of therapies that go beyond the limits of currently available medicines using its Helicon peptide platform, reported the successful closing of a $145 million Series E financing round (Press release, FogPharma, MAR 1, 2024, View Source [SID1234640697]). The financing was led by Nextech Invest with participation from other new investors including RA Capital Management, Rock Springs Capital, General Catalyst, Marshall Wace, Samsara Biocapital, Foresite Capital, Symbiosis, Catalio Capital Management, Sixty Degree Capital and former chairman and CEO of Johnson & Johnson, Alex Gorsky.

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There was strong support by existing investors, including ARCH Venture Partners, Fidelity Management & Research Company, GV, Cormorant Asset Management, funds and accounts advised by T. Rowe Price Associates, Inc., Farallon Capital Management, venBio Partners, Invus and Milky Way Investments. Alexis Borisy, an accomplished investor and entrepreneur, also joined the company’s board of directors in the position designated to Nextech.

The financing will fund the ongoing clinical development of FOG-001, the company’s first-in-class intracellular TCF-blocking β-catenin inhibitor currently being evaluated in a Phase 1/2 study in solid tumors. The round will also accelerate the development of its robust portfolio of unique discovery programs, deepen its data science capabilities and strengthen its core Helicon therapeutics platform.

FOG-001 is a Helicon designed to block the key oncogenic step in the Wnt/β-catenin signaling pathway, one of the most frequently activated pathways in a variety of cancers. Mutations in the pathway are particularly prevalent in colorectal cancer, the second leading cause of all global cancer deaths, with an estimated two million new cases per year, according to the World Health Organization. Despite significant biological validation of the β-catenin:TCF interaction as a cancer driver, no existing treatment has been able to disrupt it due to its inaccessibility to antibody and traditional small molecule medicines.

"Millions of colorectal cancer patients have been told by their oncologists that no more can be done for them. We believe FOG-001 may represent the long-awaited major technological breakthrough needed to address one of the most common yet unaddressed oncogenic signaling pathways," said Mathai Mammen, M.D., Ph.D., FogPharma’s chairman, president and chief executive officer. "This financing will allow us to execute on our expanded clinical development and commercialization strategy to deliver FOG-001 to patients, while simultaneously strengthening our discovery efforts against other compelling intracellular targets that drive a range of diseases."

FOG-001 is the first of several wholly-owned programs generated by FogPharma’s Helicon platform being advanced to address biologically validated disease-driving intracellular targets by modulating protein-protein and protein-DNA interactions inside the cell. FogPharma’s Helicon platform combines ultra-diverse and tunable stabilized helical peptides with custom-built computational physics and artificial intelligence (AI) techniques to enable the discovery and development of novel programs across a vast array of intracellular targets that have never before been drugged.

"We are excited by the tremendous potential of FOG-001 to meaningfully change the therapeutic landscape through a novel approach, and are equally impressed by FogPharma’s robust pipeline of programs for significant drivers of cancer," said Nextech Managing Partner Thilo Schroeder, Ph.D. "The company’s rapid progress across its growing pipeline demonstrates FogPharma’s team is enabled to deliver on the vast potential of its Helicon therapeutics platform."

The financing follows a period of rapid growth for the company as its leadership team has expanded with industry veterans with track records in clinical, commercial and data science execution. This includes the company’s Chairman, President and Chief Executive Officer Mathai Mammen, M.D., Ph.D.; healthcare data science pioneer and Chief Data Officer Brandon Allgood, Ph.D.; Chief Technical Operations Officer Rohin Mhatre, Ph.D.; and Chief Business Officer Gregory Miller, MPH, MBA.

On March 1, 2024 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, reported that the Company will participate in the following upcoming investor conferences (Press release, Fate Therapeutics, MAR 1, 2024, View Source [SID1234640696]):

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TD Cowen’s 44th Annual Health Care Conference on Wednesday, March 6th, 2024 at 9:10 AM ET in Boston, Massachusetts

Participating in an industry panel and hosting 1×1 investor meetings
Leerink Global Biopharma Conference on Monday, March 11th, 2024 at 2:00 PM ET in Miami, Florida

Participating in a fireside chat and hosting 1×1 investor meetings
Barclays 26th Annual Global Healthcare Conference on Tuesday, March 12th, 2024 at 11:15 AM ET in Miami, Florida

Participating in a fireside chat and hosting 1×1 investor meetings
Jefferies Biotech on the Bay Summit on Wednesday, March 13th, 2024 in Miami, Florida

Hosting 1×1 investor meetings
2nd Annual H.C. Wainwright Cell Therapy Virtual Conference on Tuesday, March 26th, 2024 at 3:00 PM ET

Participating in a fireside chat
A live webcast, if recorded, of each presentation can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website shortly after the event.

On March 1, 2024 Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions and services company, reported a corporate update and announced its financial and operating results for the fourth quarter and year ended December 31, 2023 (fiscal 2023) (Press release, Biodesix, MAR 1, 2024, View Source [SID1234640695]).

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"I am exceptionally proud of the Biodesix team and our record of accomplishments in 2023," said Scott Hutton, CEO of Biodesix. "We were focused on three goals: driving increased revenue through adoption of our Lung Diagnostic tests and Biopharmaceutical Services, implementing operational efficiencies to improve gross margins, and maintaining a strict cost discipline. I am very pleased with our significant progress on each of these goals."

Mr. Hutton continued, "The Biodesix team delivered 65% growth in Lung Diagnostic test volume for the full year 2023 and a sixth straight quarter of over 50% year-over-year growth, with the fourth quarter FY23 growing 54% over the fourth quarter of FY22. We made tremendous progress driving Lung Diagnostic test adoption in 2023, but we have just scratched the surface of a massive market opportunity addressing a critical unmet need to help improve the lives of patients with potentially cancerous lung nodules and lung cancer with our five blood-based tests. At the same time, our focus on growing Biodesix while maintaining a cost disciplined approach has resulted in a dramatic 77% gross profit margin and 55% improvement in Adjusted EBITDA in the fourth quarter FY23 compared to the fourth quarter FY22, and a clear path towards profitability. In 2024 we are committed to executing on those same three goals and we expect to deliver $65 to $68 million in total revenue."

Fourth Quarter and Full Year 2023 Financial Results

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Total revenue of $14.7 million and $49.1 million for the fourth quarter and fiscal 2023, respectively, an increase of 52% and 49% over the respective prior year comparable periods excluding COVID testing revenues, and an increase of 53% and 28% over the respective prior year comparable periods including COVID testing revenues;
o
Lung Diagnostic revenue of $12.8 million and $45.1 million for the fourth quarter and fiscal 2023, respectively, an increase of 55% and 54% over the respective prior year comparable periods, primarily driven by the continued adoption of Nodify Lung Nodule Risk Assessment tests;
o
Biopharma Services and other revenue of $1.9 million and $3.9 million for the fourth quarter and fiscal 2023, respectively, an increase of 38% and 6% over the respective prior year comparable periods, a result of both delivering against our expanding book of business and securing new agreements; entering 2024 with increasing dollars under contract;

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Gross profit was $11.3 million or 77% and $36.1 million or 73% for the fourth quarter and fiscal 2023, respectively, as a percentage of revenue compared to 66% and 63% in the prior year comparable periods, primarily driven by growth in Lung Diagnostic testing and optimization of testing workflows that resulted in improvements in costs per test, the ongoing recovery of our Biopharma Services business, and the commercial discontinuation of lower-margin COVID-19 testing;
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Operating expenses (excluding direct costs and expenses) of $18.2 million and $77.4 million for the fourth quarter and fiscal 2023, a decrease of 10% and increase of 4% over the respective prior year comparable periods;
o
Decrease in fourth quarter 2023 is primarily attributable to a decrease in research and development costs, partially offset by increased sales and marketing costs to support Lung Diagnostic sales growth, enhance product awareness and drive adoption, while the full year increase in operating expenses was driven by an increase in sales and marketing costs, partially offset by a reduction in research and development costs;
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Includes non-cash stock compensation expense of $1.1 million and $5.4 million during fourth quarter and fiscal 2023, respectively, a decrease of 48% and 10% over the respective prior year comparable periods;
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Net loss of $9.1 million and $52.1 million for the fourth quarter and fiscal 2023, respectively, an improvement of 55% and 20% over the respective prior year comparable periods;
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Fourth quarter and fiscal 2023 included a gain of $0.1 million and loss of $1.3 million, respectively, from the change in fair value of warrant liabilities associated with our term loan facility with Perceptive Advisors (Perceptive);
o
Fourth quarter and fiscal 2022 included loss on debt extinguishment and modification of $4.0 million and $7.0 million, respectively;
•
Adjusted EBITDA was a loss of $4.9 million and $32.7 million for the fourth quarter and fiscal 2023, respectively, an improvement of 55% and 24% over the respective prior year comparable periods;
•
Cash and cash equivalents of $26.3 million as of December 31, 2023;
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The Company successfully drew down the second tranche of $10 million from its $50 million term loan facility with Perceptive in the fourth quarter of 2023;
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Cash balance includes the remaining $12.2 million of the $27.5 million private placement announced in August 2023.
2024 Financial Outlook

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The Company anticipates generating between $65 million to $68 million in total revenue in 2024, representing an approximate 32% to 39% year-over-year growth rate.
Conference call and webcast information

Listeners can register for the webcast via this link. Analysts wishing to participate in the question-and-answer session should use this link. A replay of the webcast will be available via the Company’s investor website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.

For a full list of Biodesix press releases and webinars, please visit the Investors Page on biodesix.com.

On February 29, 2024 4SC AG (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL), reported that it has filed its Marketing Authorisation Application (MAA) for resminostat (Kinselby) with the European Medicines Agency (EMA) and that its MAA has been accepted by the EMA as sufficient for examination (Press release, 4SC, MAR 1, 2024, https://www.pressetext.com/news/20240301006 [SID1234640681]).

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In September 2023, the Company announced data from its RESMAIN study on resminostat (Kinselby) that showed:

A statistically significant improvement in progression free survival (median PFS: 8.3 vs. 4.2 months; p=0.015; HR: 0.623)
A median time to next treatment versus placebo showed a significant improvement of 8.8 months compared to 4.2 months
A clinically meaningful improvement in median "total" PFS of 24.3 months, compared to 14.9 months for those in the placebo group

Side effects of resminostat were mainly mild to moderate, manageable and reversible.
Jason Loveridge, Ph.D., CEO of 4SC, commented: "The team has worked hard to successfully file the Marketing Authorisation Application for resminostat in CTCL ahead of schedule. This represents a significant step forward for 4SC and a great achievement for our team as it further de-risks our resminostat program and will assist our ongoing efforts to bring this important treatment to patients suffering with this disease, commercialise the asset and create value for shareholders."

On February 29, 2024 Taiho Pharmaceutical Co., Ltd. (hereinafter "Taiho") and Haihe Biopharma Co., Ltd. (hereinafter "Haihe") reported that two companies have entered into an exclusive license agreement regarding the development, manufacturing and commercialization of gumarontinib (development code : SCC244), agent for non-small cell lung cancer, which application for marketing authorization has been submitted and is currently being reviewed in Japan by Haihe Biopharma K. K., fully owned affiliate of Haihe (Press release, Taiho, MAR 1, 2024, View Source [SID1234640679]).

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Under the license agreement, Taiho will obtain exclusive rights in Japan, Asia (excluding China) and Oceania to develop, manufacture and commercialize, gumarontinib, Haihe will receive an upfront payment, development and sales milestones, and royalty based on sales revenue from Taiho.

Gumarontinib is an oral, small molecule MET inhibitor discovered by Haihe. In September 2023, Haihe Biopharma K. K., submitted new drug application of gumarontinib in Japan for the treatment of unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping mutations as possible indications. Gumarontinib has been approved in China in March 2023 by NMPA (National Medical Products Administration) for the treatment of non-small cell lung cancer (NSCLC) with METex14.

"We are pleased to announce that we will be entering into a partnership withHaihe on gumarontinib, a new treatment option for the patients with non-small cell lung cancer. We will be preparing for the successful launch of gumarontinib with Haihe to contribute to the patients and healthcare professionals." stated Masayuki Kobayashi, President and Representative Director of Taiho.

"We are pleased to announce that we are entering into partnership with Taiho, one of the leading companies of oncology in Japan. We hope our collaboration shall be able to provide a promising treatment option for the patients with nonsmall cell lung cancer." stated Ruiping Dong, M.D., Ph.D., Chief Executive Officer of Haihe.

Taiho and Haihe through its alliance, will make every effort to deliver gumarontinib to patients and healthcare professionals as soon as possible.

About NSCLC with METex14 Skipping Mutations

Primary lung cancer is the malignant tumor with one of the highest morbidity and mortality. Globally, the number of new patients with lung cancer is estimated to be 2.2 million/year and the number of deaths to be 1.79 million/year (2020)1). In Japan, the number of new patients with lung cancer is more than 120,000/year (2019) and the number of deaths is over 70,000. /year (2020) 2). The proportion of non-small cell lung cancer among lung cancer patients in Japan is 88%, and the frequency of mesenchymal epithelial transforming factor (MET) gene exon 14 skipping mutation is about 3% 3). Thus, in Japan, the number of patients eligible for treatment with this drug is estimated to be around 3,000/year.