On December 8, 2020 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy leveraging its novel allogeneic EBV T- cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune diseases, reported the pricing of an underwritten public offering of 5,102,041 shares of its common stock at a price to the public of $24.50 per share and, to certain investors, pre-funded warrants to purchase 2,040,816 shares of its common stock at a purchase price of $24.4999 per pre-funded warrant share, which represents the per share public offering price for the common stock, minus the $0.0001 per share exercise price of each such pre-funded warrant share (Press release, Atara Biotherapeutics, DEC 8, 2020, View Source [SID1234574479]). The aggregate gross proceeds from the offering are expected to be approximately $175.0 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by Atara Biotherapeutics. The offering is expected to close on or about December 11, 2020, subject to customary closing conditions. In connection with the offering, Atara Biotherapeutics has granted the underwriters a 30-day option to purchase up to an additional 1,071,428 shares of its common stock at the public offering price, less the underwriting discounts and commissions.

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Citigroup, Evercore ISI and Mizuho Securities are acting as joint book-running managers for the offering. Canaccord Genuity is acting as lead manager and Roth Capital Partners is acting as manager for the offering.

The securities described above are being offered by Atara Biotherapeutics pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Atara Biotherapeutics with the Securities and Exchange Commission (the "SEC") and that became automatically effective on February 27, 2018. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC, and a final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 800-831-9146; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at 888-474-0200, or by email at [email protected]; or Mizuho Securities USA LLC, Attention: Equity Capital Markets, 1271 Avenue of the Americas, 3rd Floor, New York, NY 10020, by telephone 212-205-7600, or by email: [email protected].

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

On December 8, 2020 Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases, reported that its Investigational New Drug Application (IND) to study the use of CERC-007 to treat relapsed or refractory multiple myeloma (MM) has been accepted by the United States Food and Drug Administration (FDA) and is now open (Press release, Cerecor, DEC 8, 2020, View Source [SID1234573112]). The first study will be a U.S. multicenter Phase 1b clinical trial. Initial data is expected in the first quarter of 2021.

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"Elevated levels of IL-18 are correlated with poor survival in patients with multiple myeloma1," said H. Jeffrey Wilkins, MD, Chief Medical Officer of Cerecor. "Targeting and reducing IL-18 using CERC-007 may substantially benefit relapsed or refractory multiple myeloma patients. Our first study under this new IND will give us important information about the pharmacokinetics, pharmacodynamics, dose, safety and preliminary efficacy that should illuminate the path forward. We look forward to sharing the data with the scientific and medical communities in the first quarter of 2021."

The planned Phase 1b clinical trial is a U.S. multicenter, open-label, dose-escalation, sequential group study of CERC-007 as a monotherapy in approximately 30 patients with relapsed or refractory MM. The primary objectives of the study will be to determine the safety and tolerability of CERC-007, the recommended Phase 2 dose, and preliminary efficacy as measured by response rate in accordance with International Myeloma Working Group (IMWG) criteria.

About Multiple Myeloma
Multiple myeloma is the second most common blood cancer, with approximately 140,000 patients in the United States.2 Multiple myeloma is characterized by an excess proliferation of plasma cells. Despite increased availability of new agents, the disease is characterized by a pattern of recurrent relapses and remains incurable for the majority of patients, with a 5-year survival rate of approximately 50%.2

About CERC-007
CERC-007 is a fully human monoclonal antibody targeting the proinflammatory cytokine IL-18. It is in development for multiple auto-immune diseases, including Still’s disease (adult onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (sJIA)), and multiple myeloma (MM).

On December 8, 2020 TAE Life Sciences (TLS) reported a new joint venture (JV) agreement with Neuboron Medtech (Neuboron) for the widespread adoption of Accelerator-based Boron Neutron Capture Therapy (AB-BNCT) for the treatment of invasive, recurrent and difficult to treat cancers (Press release, TAE Life Sciences, DEC 8, 2020, View Source [SID1234572716]). Under the agreement, TLS becomes the second shareholder in Neuboron Therapy System (NTS), originally a wholly owned subsidiary of Neuboron.

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Each day, 50,000 people are diagnosed with cancer worldwide, and the ability to provide a unique approach to deliver targeted therapy with biological precision is critical. This agreement is expected to further expand NTS’s influence and speed up the deployment of Neuboron’s AB-BNCT system.

Established in 2017, NTS has obtained Neuboron’s IP and technology licenses in the field of AB-BNCT. Through TLS’s new capital contribution, NTS becomes an equity joint venture with international capital. The business scope of NTS covers research, development, manufacturing, system integration, clinical trials, market accesses and sales of AB-BNCT system.

AB-BNCT is a powerful alternative cancer treatment to traditional radiotherapy and other particle therapies because it delivers targeted radiation selectively to cancer cells and spares surrounding healthy tissue. BNCT has demonstrated compelling responses for some of the most difficult to treat cancers and has been successful in treating cancer patients for whom other treatment options have been exhausted. Typically, patients only need to undergo 1 or 2 treatments with BNCT vs. dozens with conventional therapies. This provides patients with greater flexibility in their treatment regimen as well as enhance efficiency of the cancer center.

"China is one of the largest market opportunities for BNCT. Our partnership with Neuboron Therapy System includes delivering our accelerator-based neutron system and has the potential to transform the cancer therapy landscape. BNCT provides a new treatment modality for patients diagnosed with the most aggressive and recurrent cancers like gliomas, head and neck tumors, and melanomas," said Bruce Bauer, Chief Executive Officer of TAE Life Sciences. "We have found a true partner in NTS as we both work toward the common goal to enable AB-BNCT to become a first-line treatment for patients globally."

On December 8, 2020 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy leveraging its novel allogeneic EBV T- cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune diseases, reported the pricing of an underwritten public offering of 5,102,041 shares of its common stock at a price to the public of $24.50 per share and, to certain investors, pre-funded warrants to purchase 2,040,816 shares of its common stock at a purchase price of $24.4999 per pre-funded warrant share, which represents the per share public offering price for the common stock, minus the $0.0001 per share exercise price of each such pre-funded warrant share (Press release, Atara Biotherapeutics, DEC 8, 2020, View Source [SID1234572525]). The aggregate gross proceeds from the offering are expected to be approximately $175.0 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by Atara Biotherapeutics. The offering is expected to close on or about December 11, 2020, subject to customary closing conditions. In connection with the offering, Atara Biotherapeutics has granted the underwriters a 30-day option to purchase up to an additional 1,071,428 shares of its common stock at the public offering price, less the underwriting discounts and commissions.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Citigroup, Evercore ISI and Mizuho Securities are acting as joint book-running managers for the offering. Canaccord Genuity is acting as lead manager and Roth Capital Partners is acting as manager for the offering.

The securities described above are being offered by Atara Biotherapeutics pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Atara Biotherapeutics with the Securities and Exchange Commission (the "SEC") and that became automatically effective on February 27, 2018. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC, and a final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 800-831-9146; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at 888-474-0200, or by email at [email protected]; or Mizuho Securities USA LLC, Attention: Equity Capital Markets, 1271 Avenue of the Americas, 3rd Floor, New York, NY 10020, by telephone 212-205-7600, or by email: [email protected].

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

On December 8, 2020 Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) reported that highlighted the company’s significant achievements in 2020 and outlined its strategy to realize the substantial opportunity of its pipeline (Press release, Ionis Pharmaceuticals, DEC 8, 2020, View Source [SID1234572490]).

Ionis has been preparing and prioritizing its growing wholly owned pipeline for commercialization in line with its commercial strategy. The company’s commercial priorities are three-fold: (1) Initially focusing its commercial efforts on rare diseases within its prolific neurology and cardiology franchises (2) pioneer new markets where there are no available treatments (3) create new standards of care where there has been a lack of innovation to optimize patient care.

Delivering on these three priorities will have meaningful impact to patients, their families, and healthcare providers all while reducing the burden on healthcare systems and driving value for all Ionis’ stakeholders including patients and shareholders.

Ionis also has plans to expand opportunistically to new products in additional treatment areas such as hematology, endocrinology and pulmonology.

Ionis projects having the opportunity to launch six or more new products through 2026, with each being ready for launch in a close window, ranging from 18 to 24 months between each new product launch. The expectation is that the implementation of this strategy will drive double-digit revenue growth and substantial earnings growth.

Brett P. Monia, Ph.D., chief executive officer at Ionis, said, "In 2020, we pursued an aggressive agenda focused on building our commercial plans and capabilities, progressing the Ionis-owned pipeline, advancing our technology and growing our leadership position in RNA-targeted therapeutics. We are pleased to say that we delivered against all these objectives. We invested in building our commercial plans and capabilities and began implementation. These actions were accelerated through the acquisition of our commercial affiliate Akcea. We have also progressed and substantially expanded the Ionis-owned pipeline. In addition, we have six Phase 3 trials underway, initiated 13 Phase 2 trials, achieved multiple, positive clinical proof-of-concept readouts, and advanced new delivery platforms."

Dr. Monia continued, "For years we have been recognized for our excellence in research, early drug development and scientific innovation. We will now add to this by building a strong and efficient commercial organization of equal excellence. All of which will provide substantial benefit to patients and shareholders for years to come."

Highlights of Investor Day

Ionis estimates the total market opportunity for the indications targeted by its pipeline is well in excess of $15 billion, with a significant portion from its wholly owned medicines.

Ionis’ cardiovascular franchise includes many potential first-in-class and/or best-in-class medicines targeting a full spectrum of cardiovascular disease risk factors. The company is positioned to potentially launch multiple Ionis-owned cardiovascular medicines through 2026, including:

AKCEA-APOCIII-LRx: One product with the potential for addressing multiple indications targeting elevated triglycerides and the opportunity to set a new standard of care for triglyceride management

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91% of patients achieved normal serum triglycerides levels with favorable safety and tolerability in Phase 2

As announced on Dec. 1, 2020, a Phase 3 study in patients with familial chylomicronemia syndrome (FCS) is now underway

Evaluating additional indications with plans to initiate an additional Phase 3 study in 2021

AKCEA-TTR-LRx: Opportunity to significantly expand ATTR franchise

Robust target reductions of more than 90% and favorable safety and tolerability demonstrated in Phase 1

Flexibility of at-home monthly self-administration

Two Phase 3 studies underway – CARDIO-TTRransform for patients with hereditary or wild type TTR cardiomyopathy and NEURO-TTRansform for patients with hereditary TTR polyneuropathy.

IONIS-AGT-LRx: Large unmet need in patients with treatment-resistant hypertension (RHTN)

Two Phase 2 clinical studies: Patients with mild HTN and patients with uncontrolled HTN who are on two (65%) or three (35%) antihypertensive medications

Positive Phase 2 study in patients in uncontrolled HTN: patients achieved mean reductions of 12 mmHg and 6 mmHg in systolic and diastolic blood pressure from their own baseline, respectively, after eight weeks of once-weekly 80 mg IONIS-AGT-LRx

IONIS-AGT-LRx has demonstrated a favorable safety and tolerability profile in clinical trials to date

More detailed results to be presented at an upcoming medical conference

Ionis’ neurology franchise has the potential to establish the standard of care for millions of patients and generate substantial value as it advances its first-in-class medicines to the market. The neurological disease market is a nascent market poised for substantial growth. Ionis believes it can be the catalyst for this growth as it is positioned to launch multiple Ionis-owned medicines through 2026, including:

ION363: First medicine in development to specifically target FUS-ALS, a rare, rapidly progressing form of ALS

Pivotal study on track for initiation in 2021

Potential for a rapid path to the market

ION716: Potential to be first approved treatment for prion diseases

Designed to reduce production of prion protein, root cause of prion disease

Pursuing pre-symptomatic (genetic carriers) and symptomatic (genetic and sporadic) indications

Pivotal study planned for 2021, design should provide a rapid path to market

Akcea Integration Update

The recently completed acquisition of Akcea has created a stronger, more efficient company, further bolstering Ionis’ financial strength. The integration of Akcea is ahead of schedule, delivering cost synergies and efficiencies. It was also announced that Akcea is going to commercialize TEGSEDI and WAYLIVRA in Europe through a distribution agreement with Swedish Orphan Biovitrum AB ("Sobi"), an international biopharmaceutical company that focuses on rare diseases. Under the terms of this agreement, Akcea retains the marketing authorization ("MAH") for both medicines in Europe. Additionally, Akcea will continue to maintain limited European operations including regulatory, manufacturing, and the management of relationships with key opinion leaders. Akcea will continue to lead the TEGSEDI and WAYLIVRA global commercial strategy. The agreement provides Ionis the flexibility to reinvest resources to support its other commercial plans.

Oral Delivery Development Update

Ionis and AstraZeneca are committed to bringing the best possible PCSK9 antisense treatments to patients and have been collaborating on both the subcutaneous and oral formulations. The subcutaneous formulation of ION449 has a potential best-in-class profile and is advancing rapidly toward Phase 3 development.

Preclinical and early clinical data give Ionis and AstraZeneca confidence that they can achieve effective oral delivery of ION449 and other ASOs. Based on ongoing research and experience to date, both companies believe they can improve upon the current oral formulation. Therefore, Ionis and AstraZeneca have decided to terminate the Phase 1 PCSK9 oral study. Ionis and AstraZeneca will continue to broadly work together to further optimize the oral delivery of ASOs, including ION449.

Ionis is expanding its oral delivery to include medicines from its pipeline and has increased its internal investment in oral delivery research. The company plans on initiating one or more programs from its pipeline within the next year or two. Candidates for consideration include IONIS-TTR-LRx, IONIS-PKK-LRx, ION994 (AGT), and ION547. Success would further enhance the commercial value of Ionis-owned programs.

Webcast

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