On July 12, 2022 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported that it will release financial results for the second quarter of 2022 after the market close on Monday, August 8th, 2022 (Press release, Akoya Biosciences, JUL 12, 2022, View Source [SID1234616604]). Company management will host a conference call to discuss financial results at 5:00 p.m. ET.

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Investors interested in listening to the conference call are required to register online. It is recommended to register at least a day in advance. A live and archived webcast of the event will be available on the "Investors" section of the Akoya website at View Source

On July 12, 2022 Mercy and GRAIL, LLC, a health care company whose mission is to detect cancer early when it can be cured, reported plans to offer a multi-cancer early detection (MCED) blood test (Press release, Grail, JUL 12, 2022, View Source [SID1234616622]). GRAIL’s Galleri test uses advanced testing capabilities to detect early cancer signals of more than 50 types of cancer. Mercy is early among health systems to offer this first-of-its-kind test.

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"Recommended cancer screenings in the U.S. currently cover only five types of cancer – breast, cervical, colon, lung and prostate – and can screen just one at a time," said Dr. Jay Carlson, clinical chair of Mercy Research, gynecologic oncologist and head of Mercy’s cancer specialty council. "This innovative test has shown the ability to screen for hard-to-detect, aggressive and often deadly types of cancer like pancreatic, ovarian and esophageal, which oftentimes have no warning signs and are caught too late."

The MCED test, which is intended to complement U.S. guideline-recommended cancer screenings, looks for a shared signal present in the bloodstream that has been associated with many cancers.

"Early detection can play a critical role in cancer treatment, allowing cancers to be caught when treatment is more likely to be successful," said Bob Ragusa, chief executive officer at GRAIL. "We believe new approaches, including multi-cancer early detection tests, are the new front in the war on cancer and one of our best chances to bend the cancer mortality curve. We’re excited to work with Mercy to offer Galleri to their patients."

The MCED test is recommended for adults with an elevated risk for cancer, such as those age 50 or older. Galleri is available by prescription only and use of the test is not recommended for those who are pregnant, 21 years or younger, or undergoing active cancer treatment. Patients interested in the test can visit mercy.net/EarlyCancerDetection to fill out a form and, if eligible, be contacted by a Mercy care navigator to walk them through the ordering and testing process. Results will be delivered through care navigators approximately two weeks after blood is drawn and, if a positive signal is detected, they will coordinate additional testing and care.

One of the first Mercy patients to schedule the test was Nancy Dixon, a Mercy co-worker in Oklahoma City.

"My dad died when he was 51 from pancreatic cancer, one of the worst cancers because once you know you have it, the cancer is too far gone," Dixon said. "It’s always been a lingering fear. I was 16 then; I’m now 55. This test gives me some peace of mind rather than not knowing and just waiting. I wish my dad had been able to have access to this blood test. He might be alive today and know my daughter, his grandchild."

In a clinical study, the Galleri test demonstrated the ability to detect a shared signal from more than 50 types of cancer, over 45 of which lack recommended screen tests today. Because the blood test is not currently covered by insurance, patients will pay out of pocket. Mercy will work with patients who qualify for but are unable to pay the total cost of the test.

"Technology continues to push the boundaries on what we are able to do in medicine, making it more predictive, proactive and personalized for patients," said Dr. John Mohart, Mercy chief clinical officer and communities president, who leads operations for all Mercy hospitals. "Early detection has the potential to give us more years with our loved ones, and that’s invaluable."

On July 12, 2022 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that an article highlighting preclinical data from BT7480, a Bicycle tumor-targeted immune cell agonist (Bicycle TICA) targeting Nectin-4 and agonizing CD137 (4-1BB), was published in the Journal of Medicinal Chemistry (Press release, Bicycle Therapeutics, JUL 12, 2022, View Source [SID1234616605]). The article, titled "Discovery and Optimization of a Synthetic Class of Nectin-4-Targeted CD137 Agonists for Immuno-oncology" is available at the publications section of the Bicycle website at this link.

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"CD137 is a co-stimulatory receptor on immune cells that can drive anti-tumor immunity and Nectin-4 is a cell adhesion molecule that is overexpressed in a wide range of solid tumors. We discovered BT7480 by using a series of novel Bicycles targeting CD137, which were conjugated to novel Bicycles targeting Nectin-4," said Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics. "The work that was published today demonstrated our goal to discover a Nectin-4-targeted CD137 agonist clinical candidate with unique properties – small size, dependency on binding to Nectin-4 bearing tumor cells for activity and very potent CD137 agonism. Furthermore, we engineered the molecule so that it could be dosed once a week in the clinic. We deployed a multipronged approach to optimize the molecule’s affinity to both targets, linker length, binder stoichiometry, solubility, and pharmacokinetic properties. By exploring the valency of the Bicycles in rodent studies, it was demonstrated that the 1:2 format Nectin-4/CD137 may lead to promising immune response in solid tumors. BT7480 is currently in Phase I development with dose escalation ongoing."

On July 12, 2022 Worldwide Clinical Trials, Inc. (Worldwide), the industry’s leading global, midsize, full-service contract research organization (CRO), reported its strategic partnership with Invitae, a leading medical genetics company (Press release, Invitae, JUL 12, 2022, View Source [SID1234616623]). The partnership makes Worldwide the first CRO to use Invitae’s Explorer tool – part of its real-world data platform that enables access to aggregated genetic testing results.

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Around the world, 300 million people have a rare disease, and 72 percent of those diseases have genetic origins (source). This partnership underscores Worldwide’s global leadership in rare disease research – one of its five major therapeutic areas of focus. A rare disease is generally considered to be a disease that affects fewer than 200,000 people in the United States or 5 in 10,000 people in the European Union at any given time. Patient populations for these diseases are small and geographically widespread – a challenge for achieving access to conduct patient education and rare disease clinical research.

Through this partnership, Worldwide has access to data insights based on prevalence, incidence, demographics, geography, and epidemiology for rare disease patients. This aggregated data enables Worldwide to recruit patients faster and pinpoint optimal study locations to help its sponsors uncover new and potentially lifesaving treatments for people suffering from rare diseases.

"This is a game-changer for both our sponsors and patients enrolled in clinical trials," said Peter Benton, President and Co-CEO, Worldwide. "Our unique access to Invitae’s database provides us with superior visibility to an aggregate-level view of patients we otherwise wouldn’t be aware of and enables us to offer advanced clinical trial strategies to our sponsors. This also helps us boost much-needed patient recruitment efforts, expanding our reach and ability to connect the right patients with the right clinical trial opportunities."

"Our strategic collaboration enables Worldwide to gain valuable insight into the genetic etiology of rare disease to help shape and improve the future of clinical trials," said Sean George, Ph.D., Co-Founder and CEO of Invitae. "Our cutting-edge tools empower Worldwide with the opportunity to set clinical trial strategies based on specific disease and geographic prevalence to yield the data needed to treat genetic disorders globally."

With access to Invitae’s aggregated genetic testing data, Worldwide has enhanced its capability to combat the complexities of rare disease trials through quicker visibility of where patients are – with the ultimate goal of providing much-needed and meaningful treatments.

Aligned with their commitment to excellence in rare disease clinical trial design, Worldwide team members are attending and contributing to the World Orphan Drug Congress at the Hynes Center in Boston. Speakers include Dr. Michael Murphy, Chief Medical and Scientific Officer, Worldwide, on the topic of "Endpoints – Where Are We Now and How Does the Development Process Need to Evolve?" on 12 July at 12:15 p.m. ET; and Derek Ansel, Senior Director, Therapeutic Strategy Lead, Rare Diseases, Worldwide, on the topic of "Trends & Challenges: Patient-Focused Rare Disease Research in 2022" on 12 July at 2:00 p.m. ET.

On July 12, 2022 Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing both restorative therapeutics and pan-caspase and caspase selective inhibitors focused on treatments for infectious and inflammatory diseases, reported that it has entered into a securities purchase agreement with a single healthcare-focused institutional investor to issue 1,774,309 shares of common stock (or pre-funded warrants in lieu thereof), Series A warrants to purchase up to an aggregate of 1,774,309 shares of common stock and Series B warrants to purchase up to an aggregate of 1,774,309 shares of common stock, at a purchase price of $2.818 per share of common stock (or pre-funded warrant) and associated warrants, in a private placement priced at-the-market under Nasdaq rules, for expected gross proceeds to Histogen of approximately $5 million, before deducting placement agent fees and other offering expenses payable by the Company (Press release, Conatus Pharmaceuticals, JUL 12, 2022, View Source [SID1234616606]).

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the private placement.

Each share of common stock (or pre-funded warrant) was sold in the private placement together with a Series A warrant to purchase one share of common stock and a Series B warrant to purchase one share of common stock. The Series A warrants have an exercise price of $2.568 per share of common stock, will be exercisable commencing immediately upon issuance for a period of five and one-half years from the date of issuance. The Series B warrants have an exercise price of $2.568 per share of common stock, will be exercisable commencing immediately upon issuance for a period of eighteen months from the date of issuance.

The closing of the private placement is expected to occur on or about July 15, 2022, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from the private placement for working capital and general corporate purposes.

The Company also has agreed that certain warrants to purchase an aggregate of 447,800 shares of common stock of the Company that were issued to such investor in November 2020 through December 2021 with exercise prices ranging from $8.50 to $34.00 per share and expiration dates ranging from May 18, 2026 to June 21, 2027, will be amended, among others, to have a reduced exercise price of $2.568 per share, will expire five and one-half years following the closing of the private placement, at an additional offering price of $0.0316 per amended warrant.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities 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 offered or sold 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. Under an agreement with the investors, the Company agreed to file an initial registration statement with the Securities and Exchange Commission (the "SEC") covering the resale of the shares of common stock to be issued to the investors (including the shares of common stock issuable upon the exercise of the warrants) no later than 15 days and to use commercially reasonable efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 75 days in the event of a "full review" by the SEC.

This press release shall not constitute an offer to sell or a 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.