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Atara Biotherapeutics Announces Pricing of $175.0 Million Public Offering

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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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.

Ionis highlights achievements, commercial strategy and technology advancements at Investor Day

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

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

Additional details are available in the replay of the webcast. It is available here for a limited time.

Forbion secures EUR 460 million for oversubscribed fifth fund

On December 8, 2020 Forbion, a leading European life science venture capital firm, reported having secured its fifth flagship fund, Forbion V, at the hard cap amount of EUR 460 million, exceeding its original target size (Press release, Forbion Capital Partners, DEC 8, 2020, View Source [SID1234572478]).

The Fund was launched at Forbion’s annual Limited Partners (LPs) meeting on 7 October 2020.

Investors in Forbion V include a mix of existing and new LPs, with both specialized institutional and corporate investors taking part, including Pantheon, Wilshire Associates, the Ewing Marion Kauffman Foundation and Argentum.

The investment period of Forbion V will commence in 2021, with the aim of building a portfolio of approximately 15 therapeutics companies, of which at least a third will be companies created by Forbion, so-called ‘Build’ opportunities, around either assets sourced from pharma or academic institutions, or around proven management teams. The remainder of investments by the Fund will be in highly impactful existing companies.

As with its previous funds, Forbion V will primarily focus on Europe comprising approximately 80% of investments, with the remainder of the fund targeting opportunities in North America.

Forbion will target substantial initial stakes of 20-50%, by taking lead positions and working closely with the entrepreneurial management teams to deliver outsized returns for Forbion LPs.

The demand for involvement in Forbion Fund V was driven by the firm’s long and consistent track record, as well as recent successful exits generating very substantial returns for its limited partners.

Recent exits include:

Roche acquired Promedior for up to USD 1.39 billion with an upfront payment of USD 390 million.
Women’s health company, KaNDy Therapeutics was acquired by Bayer for an upfront consideration of USD 425 million and significant additional consideration in the form of potential future milestone payments.
Roche acquired the full rights to the Inflazome portfolio of NLRP3 inflammasome inhibitors for an upfront payment of EUR 380 million plus additional, substantial, payments based on the achievement of certain predetermined milestones, making this a potential ‘fund returner’ for Forbion IV.
Enterprise Therapeutics’ novel TMEM16A potentiator portfolio was acquired by Roche for an upfront payment of GBP 75 million plus significant additional payments based on the achievement of certain predetermined milestones.
Neuromuscular disease company, Dyne Therapeutics successfully went public on Nasdaq in September of this year after closing a substantial cross-over round in August.
Recent new investments include: leading the USD 62 million Series A financing round for Prilenia Therapeutics, and the USD 35 million Series B financing round for Inversago Pharma.
Forbion V will be managed by Forbion’s highly specialized and experienced investment team and supported by a high-caliber group of Operating Partners, Venture Partners and Advisers. Forbion has one of the largest and most longstanding teams in Europe and continues to invest in team expansion to maintain its reputation for exceptional reach and depth into its chosen markets.

Breakthrough Breast Cancer Radiomics Patent Issued to Imaging Endpoints

On December 8, 2020 Imaging Endpoints reported that the U.S. Patent and Trademark Office has issued Patent No. 10,854,338 – "PREDICTING BREAST CANCER RESPONSIVENESS TO HORMONE TREATMENT USING QUANTITATIVE TEXTURAL ANALYSIS" to Imaging Endpoints’ and its inventor, Chief Medical Officer, Ron Korn, M.D., PhD (Press release, Imaging Endpoints, DEC 8, 2020, View Source [SID1234572465]).

This breakthrough radiomic evaluation tool provides a biomarker for predicting tumor aggressiveness in breast cancer patients, and thus the ability to determine whether less invasive treatment (e.g., hormone therapy) or more invasive treatment (e.g., chemotherapy) is warranted.

Breakthrough radiomic evaluation tool provides biomarker signature for predicting breast cancer tumor aggressiveness.

The technology enables a real-time evaluation that is otherwise available only through an invasive biopsy and avoids the time involved in obtaining and processing the biopsied tissue. Imaging Endpoints is excited to share with the market this new technology that may provide patients and physicians the advantage of faster, less invasive information that is critical to treatment decisions and patient outcomes.

"A reliable imaging signature for guiding treatment decisions based on Luminal vs Basilar type cancer has remained elusive until now," said Ronald Korn, MD, PhD. "The Imaging Endpoints’ invention provides a biomarker for evaluating the treatment options that are most likely to be effective. The signature is derived from aggregate breast tumor imaging data in conjunction with quantitative textural analysis. Imaging Endpoints believes that its technology offers a real-time advantage with rapid results over tests such as Oncotype DX, however additional studies are needed to further validate the correlation of the signature with pathologic variables."

Imaging Endpoints is a pioneer and global leader in analyzing diagnostic images to identify imaging patterns linked to tumor biology. The Company currently offers its advanced imaging technologies through its imaging CRO services for clinical trials, and is actively seeking partners to help commercialize its technologies for routine patient care.

Amgen’s Sotorasib Granted Breakthrough Therapy Designation For Advanced Or Metastatic Non-Small Cell Lung Cancer Patients With KRAS G12C Mutation

On December 8, 2020 Amgen (NASDAQ: AMGN) reported that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for its investigational KRASG12C inhibitor, sotorasib, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation, as determined by an FDA-approved test, following at least one prior systemic therapy (Press release, Amgen, DEC 8, 2020, View Source [SID1234572464]).

"For more than 40 years, scientists have been trying to target KRAS. Today’s news is a welcome update for the many non-small cell lung cancer patients with the KRAS G12C mutation, who currently have no targeted therapies," said Bonnie J. Addario, cofounder and board chair of the GO2 Foundation for Lung Cancer. "We are pleased that the FDA and Amgen recognize the unmet need for these patients and are working to make new treatment options available as quickly as possible."

KRAS G12C is the most common KRAS mutation in NSCLC.1,2 In the U.S., about 13% of patients with NSCLC adenocarcinoma harbor the KRAS G12C mutation3 and each year approximately 25,000 new patients in the U.S. are diagnosed with KRAS G12C-mutated NSCLC.4 Unmet need remains high and options are limited for NSCLC patients with the KRAS G12C mutation that have failed first-line treatment. The outcomes with current therapies are suboptimal with response rates of approximately 9-18% and a median progression-free survival of approximately 4 months for second-line NSCLC.5,6,7

Amgen has taken on one of the toughest challenges of the last 40 years in cancer research8 by developing sotorasib. Sotorasib was the first KRASG12C inhibitor to enter the clinic and is being studied in the broadest clinical program exploring 10 combinations with global sites spanning across 4 continents. In just over two years, the sotorasib clinical program has also established the deepest clinical data set with more than 600 patients studied across 13 tumor types.

"Breakthrough Therapy designation and Real-Time Oncology Review bring Amgen closer to potentially providing a targeted therapy to patients with a KRAS G12C mutation and establishing sotorasib as the foundational therapy in KRAS G12C-driven cancers," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We are pleased to receive these regulatory designations and plan to submit a new drug application by end of year as we rapidly work to get sotorasib to the patients who need it."

A Breakthrough Therapy designation is designed to expedite the development and regulatory review of medicines that may demonstrate substantial improvement on a clinically significant endpoint over available medicines.9 The Real-Time Oncology Review (RTOR) pilot program aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible.10

The designation and RTOR are supported by positive Phase 2 results in patients with advanced NSCLC from the CodeBreaK 100 clinical study, whose cancer had progressed despite prior treatment with chemotherapy and/or immunotherapy. In the study, treatment with sotorasib provided durable anticancer activity with a positive benefit-risk profile.11

About CodeBreaK
The CodeBreaK clinical development program for Amgen’s investigational drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. As the most advanced KRAS G12C clinical development program, CodeBreaK has enrolled more than 600 patients across 13 tumor types since its inception.

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 123 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and topline results are expected in 2021.

A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) is currently recruiting. Amgen also has several Phase 1b combination studies across various advanced solid tumors (CodeBreaK 101) open for enrollment.

For information, please visit www.codebreaktrials.com.

About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

To learn more about Amgen’s innovative pipeline with diverse modalities and genetically validated targets, please visit AmgenOncology.com. For more information, follow us on www.twitter.com/amgenoncology.