Janux Therapeutics Announces Closing of Underwritten Public Offering of Common Stock and Pre-Funded Warrants Including Full Exercise of Underwriters’ Option to Purchase Additional Shares for Total Gross Proceeds of $402.5 Million

On December 6, 2024 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported the closing of its previously announced underwritten public offering of 6,150,793 shares of its common stock, which includes the exercise in full by the underwriters of their option to purchase up to 833,333 additional shares of common stock, at a public offering price of $63.00 per share and pre-funded warrants to purchase 238,095 shares of common stock at a price of $62.999 per pre-funded warrant, which represents the per share price for the common stock less the $0.001 per share exercise price for each such pre-funded warrant (Press release, Janux Therapeutics, DEC 6, 2024, View Source [SID1234648858]). The aggregate gross proceeds to Janux from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses and excluding the exercise of any pre-funded warrants, were approximately $402.5 million.

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BofA Securities, TD Cowen, Stifel, Cantor and William Blair acted as joint book-running managers for the offering. Wedbush PacGrow, LifeSci Capital, BTIG and Jones acted as co-managers for the offering.

The Company intends to use the net proceeds from the offering to advance clinical development of its internal product pipeline and for general corporate purposes.

The securities were offered by the company pursuant to a Registration Statement on Form S-3 filed with the Securities and Exchange Commission (SEC) that became automatically effective upon filing. A final prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC’s website, located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained from BofA Securities, NC1-022-02-25, 201 North Tryon Street, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, or by email at [email protected]; TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, New York 10017, by telephone at (855) 495-9846 or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at (415) 364-2720, or by email at [email protected]; Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by email at [email protected]; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, Illinois 60606, by telephone at (800) 621-0687 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

UP Oncolytics Awarded Orphan Drug Designation by FDA

On December 6, 2024 UP Oncolytics, Inc’s reported that program to develop Zika Virus strains to treat glioblastoma has achieved two major milestones (Press release, UP Oncolytics, DEC 6, 2024, View Source [SID1234648856]).

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SBIR Fast Track Grant from the NINDS
Orphan Drug Designation from the FDA
"In the nearly 40 years I have been caring for glioblastoma patients, prognosis hasn’t changed. By using multiple resistance mechanisms, including the blood brain barrier, glioblastoma can defeat traditional chemotherapy, radiation, targeted therapy, and immunotherapy. Something needed to change," commented Richard A Rovin, MD, CEO and co-founder of UP Oncolytics. That change comes in the form of an oncolytic virus–a naturally occurring or genetically modified virus that can preferentially enter and kill cancer cells.

According to Parvez Akhtar, PhD, CSO and co-founder, "The Zika Virus strains we are testing have the unique combination of safety, efficacy, and the ability to cross the blood brain barrier."

The SBIR award and Orphan Drug Designation come after years of extensive pre-clinical testing led by Dr Akhtar. "Both of these validate the scientific work we have done and the company we have built," observed Dr Akhtar.

Dr Rovin: "I think the SBIR and Orphan Designation show that the NINDS and FDA understand the urgent and unmet need to develop novel, effective treatments for GBM. Parvez and I are humbled and excited to bring Zika Virus treatment to clinical trial."

About the SBIR Fast Track Grant

The Small Business Innovation Research (SBIR) program through the NIH provides seed funding to early-stage small businesses so that they can bring their innovation from "bench to bedside". The Fast-Track process allows companies to submit both Phase I and Phase II in one application for review. The Fast-Track mechanism minimizes the funding gap between phases but requires a fully developed Phase II application/plan at the time of submission. In 2023, fewer than 20% of applicants received funding.

About Orphan Drug Designation

The FDA Office of Orphan Products Development (OOPD) "supports and advances the development and evaluation of new treatments for rare diseases." A rare disease affects fewer than 200,000 people in the United States. The OOPD can grant Orphan Status to a drug or biologic for the treatment of a rare disease. An Orphan Drug Designation provides benefits to the sponsor including tax benefits, waiver of fees, and seven-year market exclusivity after approval.

About Gliomas

Gliomas are considered primary tumors as they originate in the brain. They account for 23% of all primary brain tumors and 81% of malignant primary brain tumors. Glioblastoma (GBM), the most aggressive brain cancer, accounts for 61% of gliomas. (Price et al., 2024a)

There are approximately 13,000 new cases of GBM each year (Price et al., 2024b) and about 25,000 people in the United States are living with GBM. (Neff et al., 2023)

In the United States, the median survival for patients with GBM is 9 months and the 5-year survival rate is 7.1%. (Price et al., 2024a)

Innate Pharma and the Institute for Follicular Lymphoma Innovation (IFLI) announce up to $7.9m investment from IFLI to support IPH6501 development in Follicular Lymphoma

On December 6, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company"), together with the Institute for Follicular Lymphoma (IFLI) reported that they have entered into an agreement to clinically study the potential of IPH6501, Innate’s anti-CD20 ANKET in follicular lymphoma (FL) (Press release, Innate Pharma, DEC 6, 2024, View Source [SID1234648853]).

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Innate’s ongoing Phase 1/2, open-label, multicenter trial investigating the safety, tolerability, and preliminary antineoplastic activity of IPH6501 in patients with relapsed and/or refractory CD20-expressing Non-Hodgkin Lymphoma will also include patients with relapsed / refractory (R/R) FL.

To support the Phase 1/2 trial and inclusion of FL patients, IFLI will initially invest 3m USD into new shares of Innate, issued through a capital increase reserved to IFLI at a price of €1.56 per share and representing 2.26% of the share capital of Innate.

IFLI may also invest up to an additional 4.9m USD into new shares of Innate, depending on the completion of certain milestones, at a price to be determined at the time of the said investments.

"At Innate Pharma, we are deeply committed to advancing innovative research and development to improve outcomes for patients with non-Hodgkin lymphoma and this agreement with the Institute for Follicular Lymphoma Innovation will contribute to our mission to bring forward therapeutic options that address critical needs and enhance the quality of life for those affected by this challenging disease," said Dr Sonia Quaratino, Chief Medical Officer of Innate Pharma.

"IFLI believes IPH6501 holds great promise for improving patient outcomes in non-Hodgkin lymphomas including follicular lymphoma," said Dr Michel Azoulay, Chief Medical Officer of IFLI. "We are delighted to support Innate and the investigation of IPH6501 in FL patients and, upon milestone achievement, to continue to support future clinical development of IPH6501 in FL. This collaboration provides a model for how IFLI’s philanthropic investments can catalyze FL development."

Biomea Fusion to Host Conference Call to Present initial Clinical Data from Phase I COVALENT-103 Study of BMF-500, a Covalent FLT3 Inhibitor, in Relapsed or Refractory Acute Leukemia

On December 6, 2024 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with diabetes, obesity, and genetically defined cancers, reported that it will host a conference call and webcast on Monday, December 9, 2024 at 4:30 pm EST to present data from COVALENT-103, the company’s Phase I trial of BMF-500, an investigational covalent FLT3 inhibitor developed using the proprietary FUSION System, in adult patients with relapsed or refractory acute leukemia (Press release, Biomea Fusion, DEC 6, 2024, https://investors.biomeafusion.com/news-releases/news-release-details/biomea-fusion-host-conference-call-present-initial-clinical-data [SID1234648852]).

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Conference Call and Webcast Details
Webcast of Biomea’s investor update on Monday, December 9, 2024 at 4:30 pm EST will be available to registered attendees under the Investors and Media section of the company’s website at View Source A replay of the presentation will be archived on Biomea’s site following the event.

About COVALENT-103
COVALENT-103 is a multicenter, open-label, non-randomized trial seeking to evaluate the safety and efficacy of BMF-500, a twice daily oral treatment, in adult patients with relapsed or refractory acute leukemia with FMS-like tyrosine kinase 3 (FLT3) wild-type and FLT3 mutations. Additional information about the Phase I clinical trial of BMF-500 can be found at ClinicalTrials.gov using the identifier, NCT05918692.

About BMF-500
BMF-500, an investigational, novel, orally bioavailable, highly potent and selective covalent small molecule inhibitor of FLT3, was discovered and developed in-house at Biomea using the company’s proprietary FUSION System and has demonstrated encouraging potential based on extensive preclinical studies. The kinase inhibitory profile of BMF-500 showed high target selectivity, suggesting the potential for reduced off-target liabilities. BMF-500 was designed to have a therapeutic profile to allow for combinations with standard of care and/or novel targeted agents like icovamenib, Biomea’s investigational covalent menin inhibitor currently in clinical development for solid and liquid tumors as well as diabetes.

Previous data presented at the 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting showed BMF-500’s picomolar affinity for inhibition of activating FLT3 mutations, including FLT3-ITD and various tyrosine kinase domain (TKD) mutations. BMF-500 demonstrated multi-fold higher potency and increased cytotoxicity than the commercially available non-covalent FLT3 inhibitor gilteritinib. These data also showed complete tumor regression in mouse models of FLT3-ITD acute myeloid leukemia (AML), with no tumor regrowth even after treatment cessation.

Data presented at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting exhibited the potential utility of combination strategies to achieve higher antileukemic cell killing with reduced concentrations of BMF-500 and icovamenib. Additionally, Biomea has shown the potential of combinatorial approaches of BMF-500 and icovamenib with MEK and BCL2 blockade in other preclinical studies. These data provide preclinical evidence for combining pathway-specific inhibitors as a promising therapeutic strategy for further investigation in acute leukemia.

About FLT3 in AML
FLT3 is a receptor tyrosine kinase (RTK) that plays a central role in the survival, proliferation, and differentiation of immature blood cells. FLT3 gene mutations are common in patients with AML and are associated with a poor prognosis. Nearly 30% of AML patients have a FLT3 mutation, representing more than 7,000 incident patients in the U.S. each year. In addition, academic literature suggests that more than 50% of AML patients with an NPM1 mutation also harbor a FLT3 mutation. While FLT3-specific and pan-tyrosine kinase inhibitors are approved by the FDA across various lines of therapy in AML, these agents have produced relatively low rates of durable responses and overall survival remains an unmet need.

Alpha Tau to Participate in Ladenburg’s Oncology Innovators & Investors Symposium

On December 6, 2024 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that CFO Raphi Levy will present at the Ladenburg Oncology Innovators & Investors Symposium (Press release, Alpha Tau Medical, DEC 6, 2024, View Source [SID1234648851]).

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Event: Ladenburg Oncology Innovators & Investors Symposium
Format: Presentation and 1-on-1 Meetings
Date: December 12, 2024
Time: 11:00AM – 11:25AM EST
Location: Virtual

Please reach out to your Ladenburg representative to schedule 1-on-1 meetings with Mr. Levy.