On May 18, 2021 The United States Preventive Services Task Force (USPSTF) reported its final colorectal cancer screening recommendation that screening begin at age 45 (Press release, Exact Sciences, MAY 18, 2021, View Source [SID1234580201]). Exact Sciences’ (NASDAQ: EXAS) Cologuard, referred to as sDNA-FIT, is included as a recommended screening option for all average-risk patients between the ages of 45 and 75.

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Colorectal cancer is the second leading cause of cancer death in the United States, in part because many cancers go undetected until later stages when treatment options are limited.1 Colorectal cancer can be prevented or detected early through screening. However, approximately 44 million average-risk adults 45-74 are currently eligible for screening, including ˜19 million between the ages of 45 and 49.2§

According to this updated recommendation, all average-risk adults age 45 and older should now be screened for colorectal cancer. Colorectal cancer incidence has been increasing in American adults under the age of 50.3 Between 2004 and 2015, health care providers diagnosed more than 130,000 cases of colorectal cancer in Americans under age 50.4 More than half of these cases were diagnosed at later stages (stages III or IV), which are associated with lower survival rates than earlier stages (stages I or II).4 Only about one out of 10 people over the age of 50 with stage IV colorectal cancer survives beyond five years.1

"Health care providers often turn to the USPSTF guidelines when discussing cancer prevention with their patients," said Paul Limburg, M.D., Chief Medical Officer, Screening at Exact Sciences. "These final guidelines will encourage more clinicians to offer colorectal cancer screening to their patients starting at age 45."

Cologuard is a U.S. Food & Drug Administration (FDA)-approved non-invasive stool DNA test used to screen for colorectal cancer in average risk patients. In a large clinical study of nearly 10,000 patients 50 and older, Cologuard found 92% of colorectal cancers,5 including 94% in stages I and II.5,6,7* In September 2019, the FDA approved Cologuard for average-risk individuals beginning at age 45, expanding the Cologuard label to include this critical younger adult population.

A recent study showed that among average-risk adults between the ages of 45 and 49, Cologuard demonstrated test specificity of 95.2% in participants with non-advanced precancerous lesions.7 In patients with negative colonoscopy findings, Cologuard demonstrated specificity of 96.3%.7 According to the authors, using Cologuard to screen these younger individuals could help mitigate risks and reduce costs from unnecessary diagnostic procedures.

USPSTF guidelines play a key role in addressing the public health crisis caused by colorectal cancer. Under these final guidelines, colorectal cancer screening remains a Grade A recommendation for people ages 50-75 and screening for ages 45 to 49 is a Grade B recommendation. The task force continues to include Cologuard (referred to in the guidelines as sDNA-FIT) among the recommended screening test options. Since it was first included in the 2016 USPSTF recommendation, Cologuard has been used to screen more than 5 million Americans.

"We are proud of the role Cologuard has played in getting more people screened for colorectal cancer," said Kevin Conroy, chairman and CEO of Exact Sciences. "The task force’s recommendation that colorectal cancer screening begin at age 45 for all average risk people means that Cologuard can continue to positively impact screening rates as people work with their healthcare providers to choose the option that is right for them."

Making sure people have full access to using stool-based tests like Cologuard is critical to reaching the unscreened. A recent study conducted by researchers at Mayo Clinic showed that when given a choice, most individuals at average risk of colorectal cancer said they would prefer a stool-based screening test for colorectal cancer over colonoscopy.8

*Statistic calculated using data from the pivotal study and reported within the Ahlquist review article. Cologuard sensitivity, per stage of cancer: I: 90% (n=29); II: 100% (n=21); III: 90% (n=10); IV: 75% (n=4).1

§ Estimates based on US population aged 45-74 and 45-49 as of 2018, adjusted for the reported rates of high-risk conditions and prior screening history for CRC.

1 Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2021. CA Cancer J Clin. 2021;71:7-33. doi:10.3322/caac/21654

2 Piscitello A, Edwards DKV. Estimating the screening-eligible population size, aged 45 to 74, at average risk to develop colorectal cancer in the United States. Cancer Prev Res. 2020;13(5):443-448. doi:10.1158/1940-6207.CAPR-19-05

3 Wolf A, Fontham E, Church TR, et al. Colorectal cancer screening for average-risk adults: 2018 guideline update from the American Cancer Society. CA Cancer J Clin. 2018;68:250-281. doi:10.3322/caac.21457

4 Virostko J, Capasso A, Yankeelov TE, et al. Recent trends in the age at diagnosis of colorectal cancer in the US National Cancer Data Base, 2004-2015. Cancer. 2019;25(21):3828-3835. doi:10.1002/cncr.32347

5 Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297. doi:10.1056/NEJMoa1311194

6 Ahlquist DA. Multi-target stool DNA test: a new high bar for non-invasive screening. Dig Dis Sci. 2015;60(3):623-633. doi:10.1007/s10620-014-3451-5

7 Cologuard Physician Brochure. Exact Sciences Corporation. Madison, WI.

8Imperiale TF, Kisiel JB, Itzkowitz SH, et al. Specificity of the Multi-Target Stool DNA Test for Colorectal Cancer Screening in Average-Risk 45–49 Year-Olds: A Cross-Sectional Study. Cancer Prev Res. 2021;14(4):489-496. doi: 10.1158/1940-6207.CAPR-20-0294

9Zhu X, Parks PD, Weiser E. National Survey of Patient Factors Associated with Colorectal Cancer Screening Preferences. Cancer Prev Res. 2021;14(5):603-614. doi: 10.1158/1940-6207.CAPR-20-0524

On May 18, 2021 CNS Pharmaceuticals presented the corporate Presentation (Presentation, CNS Pharmaceuticals, MAY 18, 2021, View Source [SID1234580199]).

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On May 18, 2021 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets to improve treatment outcomes, reported the close of its US$125 million Series C financing round (Press release, Hummingbird Bioscience, MAY 18, 2021, View Source [SID1234580198]). The financing was led by Novo Holdings, with significant participation from new investors including Frazier Healthcare Partners, Octagon Capital, EDBI, AMGEN Ventures, DROIA Ventures, Morningside Ventures, Pureos Bioventures, Polaris Partners, Affinity Asset Advisors, Ally Bridge Group and Altium Capital Management. Existing investors including SK Inc, Heritas Capital, SEEDS Capital and Mirae Asset Venture Capital also joined the round.

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"We are delighted to have the support and confidence of leading global healthcare investors to advance the development of our unique pipeline of precision therapies against important, yet hard-to-drug targets. We have made tremendous progress since closing our Series B in 2019 and this financing reflects strong support for our platform, people, and development strategy," said Piers Ingram, Chief Executive Officer and co-founder, Hummingbird Bioscience. "With our world-class team of researchers and proprietary technologies, Hummingbird is at the cutting-edge of scientific discovery. These new funds give us further resources to invest in our early stage pipeline, as well as supporting the clinical development of our two lead programs that we believe can deliver very meaningful benefit for patients."

Proceeds from the financing will be used to advance the clinical development of Hummingbird’s lead assets including, HMBD-001, a best-in-class HER3 antibody for NRG1-fusion and HER3-driven tumors, and HMBD-002, a first-in-class anti-VISTA neutralizing antibody for advanced solid tumors. The funds will also be used to expand the capabilities of Hummingbird’s proprietary Rational Antibody Discovery platform and progress the development of its next-generation pipeline of precision therapeutics including HMBD-009, a BCMA-TACI dual-specific T cell engager.

"We are delighted to lead this financing in Hummingbird and pleased to have attracted a syndicate of sophisticated investors to enable the acceleration of the company’s clinical development activities. We believe that Hummingbird’s novel data-driven, systems biology approach brings new precision to the field of antibody drug discovery and development, and we are proud to support the team in realizing their vision," said Kenneth Harrison, Partner, Novo Ventures.

Kenneth Harrison along with Dan Estes, General Partner, Frazier Healthcare Partners, and Kiel Kim, Vice President, SK Inc., will join Hummingbird’s board of directors.

"Hummingbird is at an exciting point, on the cusp of starting clinical studies for both HMBD-001 and HMBD-002. I look forward to working with the Hummingbird team in developing and building out its portfolio of drug candidates that have transformative potential for patients with cancer and autoimmune diseases," said Dan Estes.

Kiel Kim said: "There is significant potential for novel antibody-based therapeutics and through Hummingbird’s Rational Antibody Discovery platform, we can now discover high value antibodies for challenging targets. We look forward to continuing our partnership with Hummingbird to solve complex challenges in antibody development, and deliver highly differentiated therapies to patients in need."

On May 18, 2021 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported its financial results for the first quarter ending March 31, 2021 (Press release, Akoya Biosciences, MAY 18, 2021, View Source [SID1234580197]).

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First Quarter Financial Highlights:

Total revenue for the first quarter of 2021 was $12.2 million, at the high end of the previously provided range of $12.0 million to $12.2 million.
Solid quarter of instrument sales, especially CODEX with 20 units sold: 28% increase in total company installed base over the last 12 months.
Gross profit was $7.4 million in the first quarter of 2021, compared to $6.7 million in the first quarter of 2020, resulting in a gross profit margin of approximately 61% in each period.
Akoya completed an initial public offering of 7.6 million shares of common stock in April, raising $151.3 million in gross proceeds, before deducting underwriting discounts and commissions and offering expenses.
First Quarter Business Highlights:

Record number of scientific publications related to our platforms: over 60 new publications in Q1, compared to 109 for all of 2020.
Aggressive hiring plans underway with 21 new employees in Q1 bringing the total headcount to 190; moving quickly to add personnel in all areas of the business, with Commercial and R&D being the near-term priorities.
Hired Frederic Pla as our Chief Operating Officer to accelerate our strong momentum across all of our spatial biology platforms.
Strong presence at AACR (Free AACR Whitepaper) including presentations by Dr. Garry Nolan from Stanford University and Akoya Founder, Dr. Janis Taube from Johns Hopkins University and Dr. Laura Esserman from University of California, San Francisco.
Announced collaboration agreement with Johns Hopkins University for immunotherapy biomarker discovery and validation, a co-marketing agreement with Zeiss, and the industry’s first Imaging Innovators (I2) Network to drive application innovation on CODEX.
"Akoya’s performance in the first quarter demonstrates the continued adoption of our Codex and Phenoptics solutions for discovery, translational and clinical research. Our dedicated team delivered strong financial results and important progress across of range of metrics which position Akoya for continued growth and leadership in spatial biology," said Brian McKelligon, CEO of Akoya. "We successfully completed our IPO in April and are now well positioned to execute on our mission of delivering a revolutionary new class of spatially derived biomarkers that empower life sciences researchers to better understand disease and response to therapy."

First Quarter Financial Results

Total revenue for the first quarter of 2021 was $12.2 million, compared to $11.0 million in the first quarter of 2020.

Product revenue was $10.0 million in the first quarter of 2021, compared to $8.9 million in the prior year period. Within product revenue, instrument revenue was $6.8 million in the first quarter 2021, compared to $6.7 million in the first quarter 2020. Reagent revenue was $2.5 million in the first quarter 2021, compared to $2.1 million in the first quarter 2020.

Services and other revenue totaled $2.2 million in the first quarter of 2021, as compared to $2.1 million in the first quarter of 2020.

We also monitor instruments sold and installed based as key performance indicators for our business:

We sold 37 instruments in Q1 2021; 20 Codex, 17 Phenoptics (includes Polaris, Vectra, and Mantra). The total of 37 exceeds the number sold in any quarter in 2020.
Instrument installed base of 587 as of March 31, 2021; Codex 132, Phenoptics 455
2021 Guidance

Akoya expects full year 2021 revenue to be at least $52.0 million. The second quarter of 2021 is expected to have revenue growth of approximately 45% over the prior year quarter. Also, as of April 30, 2021 the total common shares outstanding are 37.1 million, and the fully diluted common shares are 41.1 million.

Webcast and Conference Call Details

Akoya will host a conference call today, May 18, 2021, at 5:00 p.m. Eastern Time to discuss its first quarter 2021 financial results. The dial-in numbers are (833) 562-0146 for domestic callers or (661) 567-1226 for international callers, followed by Conference ID: 7824008. A live webcast of the conference call will be available on the "Investors" section of the Company’s website at View Source The webcast will be archived on the website following the completion of the call for three months.

On May 18, 2021 The board of directors of Targovax ASA (OSE:TRVX) ("Targovax" or the "Company") repoted that it has resolved to increase the share capital of the Company following the completion of an settlement period for vested Restricted Stock Units ("RSUs") (Press release, Targovax, MAY 18, 2021, View Source [SID1234580195]). The settlement period lasted from 7 May 2021 at 10:00 hours (CEST) to 18 May 2021 at 10:00 hours (CEST).

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1. Settlement of RSUs

In total were 21,299 RSUs settled by one current and one former board member, giving the RSU holders the right to subscribe for 21,299 shares in total, each with a par value of NOK 0.10, at a subscription price of NOK 0.10 per share.

The RSU holders received the RSUs as part of their remuneration for their directorship at the board. The number of RSUs granted was calculated as the NOK amount of the RSU selected portion of the total remuneration to the respective board member, divided by the market price for the shares, calculated as the volume weighted average share price for the 10 trading days prior to the relevant AGM, being NOK 12.20 per share in 2016, NOK 14.33 per share in 2018 and NOK 6.34 per share in 2019.

2. Resolution to increase the share capital in Targovax ASA

The Company’s board of directors has on 18 May 2021, in accordance with the authorisation granted by the general meeting on 17 March 2021, resolved to increase the share capital with NOK 2,129.90 by the issuance of 21,299 new shares, each with a par value of NOK 0.10 in order to facilitate the settlement of RSUs.

Accordingly, the new share capital of the Company is NOK 8,658,240.50 divided between 86,582,405 shares, each with a par value of NOK 0.10. The share capital increase will be registered with the Norwegian Register of Business Enterprises (Nw. Foretaksregisteret) as soon as practically possible after the share contribution has been fully paid.