On December 8, 2020 Sutro Biopharma, Inc. (Nasdaq: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported the pricing of an underwritten public offering of 6,000,000 shares of its common stock at a price to the public of $21.00 per share (Press release, Sutro Biopharma, DEC 8, 2020, View Source [SID1234572459]). The gross proceeds from this offering are expected to be $126.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Sutro. Sutro has also granted the underwriters a 30-day option to purchase up to an additional 900,000 shares of common stock in connection with the public offering. All of the shares of common stock are being offered by Sutro. The offering is expected to close on or about December 11, 2020, subject to the satisfaction of customary closing conditions.

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Cowen, Piper Sandler and Wells Fargo Securities are acting as joint book-running managers in the offering. Wedbush PacGrow and JMP Securities are acting as co-managers in the offering.

Sutro intends to use the net proceeds from the proposed offering, together with its existing cash, cash equivalents and marketable securities, to fund the continued clinical development of STRO-001 and STRO-002 and the remainder to fund the further development of its technology platform, including manufacturing, to broaden its pipeline of product candidates, and for working capital and general corporate purposes.

The shares are being offered by Sutro pursuant to registration statements filed and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to this offering have been filed with the SEC. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering, and when available, the final prospectus supplement, may be obtained from: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected]; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924, or by email at [email protected]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, New York 10001, by telephone at (800) 326-5897, or by email at [email protected]. Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at View Source

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

On December 8, 2020 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, reported the closing of its previously announced private placement of equity (Press release, Regulus, DEC 8, 2020, View Source [SID1234572427]). The Company received gross proceeds of approximately $19.4 million from the sale of 24,341,607 shares of the Company’s common stock ("Common Stock") and accompanying warrants to purchase up to an aggregate of 18,256,204 shares of Common Stock at a purchase price of $0.622 per share of Common Stock and $0.125 for each share of Common Stock underlying such warrants. In addition, the Company sold 272,970 shares of non-voting Class A-3 convertible preferred stock, in lieu of shares of Common Stock, at a price of $6.22 per share, and accompanying warrants to purchase an aggregate of 2,047,276 shares of Common Stock at a price of $0.125 for each share of Common Stock underlying these warrants. Each share of non-voting Class A-3 convertible preferred stock is convertible into 10 shares of Common Stock, subject to certain beneficial ownership conversion limitations. The Company expects to use the net proceeds from the transaction primarily to advance RGLS4326 for the treatment of Autosomal Dominant Polycystic Kidney Disease and for general corporate purposes. H.C. Wainwright and Co. acted as exclusive placement agent for the financing.

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The offer and sale of the foregoing securities were made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

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

Additional details regarding the private placement are included in the Form 8-K filed with the Securities and Exchange Commission on December 4, 2020.

On December 8, 2020 QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported that it has raised its full-year 2020 outlook for growth of net sales and adjusted earnings per share (EPS) and is looking forward to another strong performance in 2021 (Press release, Qiagen, DEC 8, 2020, View Source [SID1234572444]).

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These results are expected to be driven by QIAGEN’s focus on five pillars of growth that leverage differentiated testing solutions used in highly attractive, growing markets involving Life Sciences and Molecular Diagnostics customers.

"2020 has demonstrated QIAGEN employees worldwide stepping up to deal with demanding changes. We have responded to the demands of the COVID-19 pandemic by launching novel testing solutions and ramping up production capacity," said Thierry Bernard, Chief Executive Officer of QIAGEN N.V. "As we finish 2020 with an improved outlook, we have confidence in our future and in the benefits of our unwavering focus on our five pillars of growth. We expect another strong performance in 2021, balancing investments in our portfolio to create new organic long-term growth opportunities with improved near-term earnings to deliver significant value creation."

Roland Sackers, Chief Financial Officer of QIAGEN N.V., said: "QIAGEN has developed a solid foundation for continued financial success. This is reflected in our solid outlook for 2020 and 2021, along with expectations for double-digit CER net sales growth post-COVID from our non-COVID products. We have also reaffirmed our disciplined capital allocation strategy, anchored by our commitment to invest in our business and increase returns to shareholders."

Additionally, QIAGEN announced today that its Supervisory Board plans to expand the number of members from the current level of six. The Board intends to further diversify, complement and increase its already extensive expertise and experience in the Life Sciences and diagnostics.

QIAGEN is planning to hold a Virtual Deep Dive on Tuesday, December 8, from 16:30-19:00 CET / 10:30-13:00 EST. This webcast will feature top executives and be led by Thierry Bernard and Roland Sackers, who will provide a strategic and financial update. More details about the event are available via the Investor Relations section on www.qiagen.com.

Increased outlook for Q4 2020, full-year 2020 and full-year 2021 results

QIAGEN now expects net sales for the fourth quarter of 2020 to grow at least 32% at constant exchange rates (CER) from $413.5 million in the same period of 2019, and for adjusted EPS to increase to approximately $0.64-0.65 CER from $0.48 in the year-ago quarter.

QIAGEN also now expects full-year 2020 net sales to grow approximately 22% CER from $1.53 billion in 2019, and for adjusted EPS to increase to $2.13-2.14 CER from $1.43 in 2019.

These strong trends are expected to continue into 2021. QIAGEN now expects full-year 2021 net sales to grow 18-20% CER from the midpoint of the anticipated range for full-year 2020 net sales results. Adjusted EPS is now expected to be $2.42-2.46 CER. These results include significant investments planned for R&D and clinical trials to strengthen the competitive profile of QIAGEN’s five pillars of growth. In particular, these include initiatives to enlarge the test menu for the NeuMoDx and QIAstat-Dx systems in the U.S. and Europe.

QIAGEN plans to maintain or take a top leadership position in these areas identified as the five pillars of growth: (1) Sample technologies used to gain nucleic acids from biological samples; (2) QuantiFERON for immune response testing, especially tuberculosis (TB); (3) the integrated PCR system NeuMoDx; (4) the QIAstat-Dx syndromic testing solution; and (5) the QIAcuity digital PCR portfolio.

On December 8, 2020 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported a collaboration with Antengene Corporation for the development of a systems pharmacology modeling in immuno-oncology (Press release, Applied BioMath, DEC 8, 2020, View Source [SID1234572460]). Applied BioMath will develop a systems pharmacology model for a PDL1/41BB bispecific antibody, ATG-101, in immuno-oncology indications. The model will be used to predict clinical starting and efficacious doses for first-in-human studies. "Antengene Corporation is dedicated to developing first-in-class and/or best-in-class therapies in oncology," said Dirk Hoenemann, M.D., VP, Head of Medical Affairs for Asia Pacific Region (APAC) and Early Clinical Development. "We decided to collaborate with Applied BioMath in an effort to provide ourselves the highest likelihood possible of predicting accurate starting and efficacious doses which is a critical part of our first-in-human studies."

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Applied BioMath employs a rigorous fit-for-purpose model development process which quantitatively integrates knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their approach employs proprietary algorithms and software that were designed specifically for systems pharmacology model development, simulation, and analysis. "Predicting starting and efficacious doses for first-in-human studies is non-trivial for complex therapeutics such as Antengene’s bispecific therapeutic," said Dr. John Burke, Ph.D., Co-Founder, President, and CEO of Applied BioMath. "We have developed algorithms and tools specifically for this purpose that have a proven track record of predicting such doses. We look forward to collaborating with Antengene to support them in this project."

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

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