Aura Biosciences Presents Preclinical Data Highlighting AU-011’s Anti-Tumor Activity in Choroidal Metastasis, an Additional Ocular Oncology Indication at the 2022 ARVO Annual Meeting

On May 3, 2022 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported the presentation of preclinical data for its first VDC product candidate, AU‑011 (Press release, Aura Biosciences, MAY 3, 2022, View Source [SID1234613440]). AU-011 is in development for the treatment of multiple ocular oncology indications, including primary choroidal melanoma and choroidal metastasis. The results presented today highlight AU-011’s targeted cytotoxicity towards tumor cells derived from the most common cancer types known to metastasize to the choroid. The results were presented as part of the 2022 Association of Research in Vision and Ophthalmology (ARVO) Annual Meeting taking place in Denver, CO on May 1 – 4 and virtually on May 11 – 12.

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"The data presented at ARVO demonstrates AU-011’s potent cytotoxicity in human cancer cell lines as well as in multiple in vivo tumor models including breast, renal and colon cancer which are well known to metastasize to the choroid," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. "These results support our commitment to build our ocular oncology franchise and provide a potential novel treatment for patients with cancers in the eye. We look forward to submitting the IND in choroidal metastases in the second half of this year."

In vitro potency was observed across a panel of human cancer cell lines. Cells were treated with AU-011 followed by light activation, and dose-dependent cell binding and cytotoxicity were noted. Addition of heparin to the binding studies prevented AU-011 association with the tumor cells demonstrating AU-011’s specific targeting of tumor associated heparan sulfate proteoglycans (HSPGs). Syngeneic murine models of breast, colon, and renal cancer were employed to evaluate AU-011’s anti-tumor activity in vivo and dose-dependent efficacy was observed across all models. The studies herein support further development of AU-011 for choroidal metastasis.

Details for the presentation are as follows:

Title: A first in class Virus-Like Drug Conjugate (VDC) shows anti-tumor activity in Cancers that Commonly Metastasize to the Choroid
Presentation Number: 2616
Presenter: Anneli Savinainen, Aura Biosciences
Session Title: Where art thou tumor? – Ocular tumor physiology and metastases
Date and time: Tuesday, May 3 at 3:00 – 3:17 PM ET
Location: 1AB Mile High Ballroom (Denver Convention Center)

The presentation can be accessed by visiting the "Scientific Presentations" section of "VDC Platform" page of the Aura Biosciences website.

Exscientia to Present at the BofA Securities 2022 Healthcare Conference

On May 3, 2022 Exscientia (Nasdaq: EXAI) reported that Ben Taylor, CFO & Chief Strategy Officer and Garry Pairaudeau, Chief Technology Officer, will participate in a fireside chat at the BofA Securities 2022 Healthcare Conference on Tuesday, May 10, 2022 at 5:20 p.m. P.T (Press release, Exscientia, MAY 3, 2022, View Source [SID1234613439]).

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A live webcast of the fireside chat will be available on the Company’s website, under the "Investors & Media" section at www.investors.exscientia.ai. An archived replay of the webcast will be available for approximately 30 days following the presentation.

SQZ Biotechnologies to Present at Upcoming Investor Conferences

On May 3, 2022 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported that Armon Sharei, Ph.D., Chief Executive Officer and Founder of SQZ Biotechnologies, will present at the Bank of America Securities 2022 Healthcare Conference on May 10, in Las Vegas, Nevada and at the H.C. Wainwright Global Investment Conference on May 25, in Miami, Florida (Press release, SQZ Biotech, MAY 3, 2022, View Source [SID1234613438]). Presentation times and webcast information are available below.

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PRESENTATION DETAILS

Tuesday, May 10
Bank of America Securities 2022 Healthcare Conference
5:00-5:30 p.m. ET / 2:00-2:30 p.m. PT
Webcast

Wednesday, May 25
H.C. Wainwright Global Investment Conference
9:30-10:00 a.m. ET
Webcast

Conference webcast details and the company’s most recent corporate overview presentation will be available on the Investors section of the SQZ website. Replays will be available for 90 days.

Innate Pharma Establishes an At-The-Market (“ATM”) Program on Nasdaq

On May 3, 2022 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that it has filed a prospectus supplement with the Securities and Exchange Commission ("SEC") relating to an At-The-Market ("ATM") program (Press release, Innate Pharma, MAY 3, 2022, View Source [SID1234613437]). Pursuant to this program, the Company may offer and sell to eligible investors (as described below) a total gross amount of up to $75 million of American Depositary Shares ("ADS"), each ADS representing one ordinary share of Innate, from time to time in sales deemed to be an "at the market offering" pursuant to the terms of a sales agreement with SVB Securities LLC ("SVB Securities"), acting as sales agent. The timing of any sales will depend on a variety of factors. The ATM program is presently intended to be effective unless terminated in accordance with the sales agreement or the maximum amount of the program has been reached.

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The Company currently intends to use the net proceeds, if any, of sales of ADSs issued under the program to fund the research and development of our product candidates and for working capital and general corporate purposes.

SVB Securities, as sales agent, will use commercially reasonable efforts to arrange on the Company’s behalf for the sale of all ADSs requested to be sold by the Company, consistent with SVB Securities’ normal sales and trading practices. Sales prices may vary based on market prices and other factors.

The ADSs and the underlying ordinary shares will be issued through a capital increase without shareholders’ preferential subscription rights under the provisions of Article L. 225-136 of the French Commercial Code (Code de commerce), Article L. 411-2 1° of the French monetary and financial code (Code monétaire et financier) and pursuant to the 25th resolution adopted by the Annual General Meeting of Shareholders held on May 19, 2020, within the limit of a maximum number of 23,673,831 ordinary shares and ADSs (being the maximum authorized by the shareholders in such resolution), representing a maximum potential dilution of approximately 26% based on the existing share capital of the Company.

It should be noted that the 2022 Annual General Meeting of Shareholders has been convened for May 20, 2022 (the "2022 Annual General Meeting"). During the 2022 Annual General Meeting, new resolutions allowing for capital increases will be put to the shareholders’ vote. If they are approved, they will replace, inter alia, the aforementioned 25th resolution adopted by the 2020 Annual General Meeting of Shareholders held on May 19, 2020 (the "2020 Annual General Meeting"). Therefore, from then on, ADSs offered in the ATM and the underlying ordinary shares would be issued either (i) through a capital increase without shareholders’ preferential subscription rights under the provisions of Article L. 225-136 of the French Commercial Code (Code de commerce), Article L. 411-2 1° of the French monetary and financial code (Code monétaire et financier) and pursuant to the 20th resolution adopted by the 2022 Annual General Meeting, or (ii) through a capital increase without shareholders’ preferential subscription rights and reserved to a category of investors under the provisions of Article L. 225-138 of the French Commercial Code (Code de commerce) and pursuant to the 22nd resolution adopted by the 2022 Annual General Meeting. In both cases (i) and (ii) above, the maximum number of ordinary shares and ADSs that can be issued is 23,922,825 ordinary shares (being the maximum authorized by the shareholders in both such resolutions).

Pursuant to the 25th resolution adopted by the 2020 Annual General Meeting and, if and when applicable, the 20th resolution that would adopted by the 2022 Annual General Meeting of Shareholders, the ADSs offered in the ATM can only be offered to "Qualified Institutional Buyers" as defined in Rule 144A under the US 1933 Securities Act, as amended (the "Securities Act") or to "accredited investors" as defined in Regulation D under the Securities Act. If after the 2022 Annual General Meeting, we were to decide to rely instead on the aforementioned 22nd resolution that would be adopted at such meeting, the ADSs offered in the ATM could only be offered to the following categories of investors: (i) industrial or commercial companies involved in the pharmaceutical / biotechnological sector, or (ii) investment companies or investment funds’ management companies or investment funds, governed by French or foreign law, or (iii) any other legal person (including a trust) or natural person that invest on a regular basis, in the pharmaceutical / biotechnological sector, meeting, in each of the cases (i) to (iii) above, the criteria for participating in an offer made pursuant to Article L. 411-2 1° of the French monetary and financial code (Code monétaire et financier) (i.e. also being Qualified Institutional Buyers or Accredited Investors as described above).

On an illustrative basis, assuming the issuance of the full amount of $75 million of ADSs under the ATM program at an assumed offering price of $3.10, the last reported sale price of the ADSs on Nasdaq on April 21, 2022, a holder of 1.0% of the outstanding Company’s share capital as of the date of this press release, would hold 0.74% of the outstanding Company’s share capital after the completion of the transaction (calculated on the basis of the number of outstanding shares on the date of publication of this press release).

During the term of the ATM program, the Company will include in the publication of its financial results information about its use of the program during the preceding quarter and will also provide an update after each capital increase on a dedicated location on its corporate website in order to inform investors about the main features of each issue that may be completed under the ATM program from time to time. In addition, in case of a particularly significant capital increase, the Company will publish an ad hoc press release.

A shelf registration statement on Form F-3 (including a prospectus) relating to Innate’s ADSs was filed with the SEC and became effective upon filing on January 31, 2021. Before purchasing ADSs in the offering, prospective investors should read the prospectus supplement and the accompanying prospectus, together with the documents incorporated by reference therein. Prospective investors may obtain these documents for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, a copy of the prospectus supplement (and accompanying prospectus) relating to the offering may be obtained from SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]. Unless total issuances of ordinary shares under the ATM program over a rolling twelve months period were to represent (together, as the case may be, with other issuances of ordinary shares effected on the basis of Article 1, paragraph 5.a) of Regulation (EU) 2017/1129 of June 14,2017) 20% or more of the then outstanding share capital of the Company, no prospectus will be subject to the approbation of the Autorité des Marchés Financiers ("AMF").

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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. In particular, no public offering of the ADSs will be made in Europe.

RefleXion Announces Real-World Evidence Outcomes Registry to Evaluate Treatment Impact on all Stages of Cancer

On May 3, 2022 RefleXion Medical, a therapeutic oncology company pioneering the use of biology-guided radiotherapy (BgRT)* for all stages of cancer, reported the enrollment of the first patient into its PREMIER registry, a prospective, real-world evidence clinical outcomes registry for patients with all stages of cancer, at the University of Texas (UT) Southwestern in Dallas (Press release, RefleXion Medical, MAY 3, 2022, View Source [SID1234613436]).

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The PREMIER registry was created to collect data to demonstrate the impact of the RefleXion X1 radiotherapy system, the first-ever system with onboard fast fan-beam KVCT, on patients with all solid tumor and lymphoma cancer types. The registry will expand to include BgRT procedures, a new radiotherapy treatment modality that uses signals detected from positron emission tomography (PET) to guide radiotherapy. The X1 is the first and only system designed with onboard PET detectors. The PREMIER registry will assess health-related quality of life, acute and long-term side effects in patients, and cancer-related outcomes.

"We believe that adapting radiotherapy plans based on how the tumor responds to the first radiation dose will be a key component in bringing together radiotherapy with drug therapies, such as targeted and immune-oncology agents," said Tu Dan, M.D., assistant professor in the Department of Radiation Oncology at UT Southwestern Medical Center. "However, to fully understand the utility of this approach, robust and accurate data collected through longitudinal endpoints in prospective registries, such as RefleXion’s PREMIER registry, are imperative."

The PREMIER registry will include extensive baseline data as well as follow-up data collected at the end of treatment, and then again at three, six, nine, 12, 18 and 24 months. The registry will enroll a minimum of 750 patients from a minimum of four sites throughout the United States.

"Our prospective registry will capture and organize an unprecedented level of data including patient, demographic, tumor, biomarker, imaging and treatment information for all stages of cancer," said Sean Shirvani, M.D., MPH, chief medical officer at RefleXion. "Our hope is that collecting this rich repository of information before, during, and after treatment will enable our clinical partners to investigate and identify the factors that best determine cancer outcomes, which may then arm patients with the information they need to make better decisions around their care."

Prospective registries define specific information and characteristics in advance, before data collection or the impacts of a treatment are known, including the check-in interval for patient follow-up. Known as longitudinal data over time, this improves data accuracy because it minimizes the dependency on patient recall. Therefore, prospective registries can draw closer associations between the treatment delivered and a patient’s outcome.