On September 15, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that two abstracts highlighting proteomic and genomic data based on their diagnostic tests were presented at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC) (Press release, Biodesix, SEP 15, 2021, View Source [SID1234587810]).

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The Role of Serum Proteomic Signature in Predicting Survival by PD-L1 Status in Patients with Non-Small Cell Lung Cancer Receiving Immunotherapy
Session P57 – Predictive Tumor Based Assays/ Biomarkers/ Pathology – ICI Biomarkers
An independent study presented by Leeseul Kim, MD of AMITA Health Saint Francis Hospital Evanston, IL, demonstrated that blood-based proteomic testing (Biodesix, Inc.) predicts survival outcomes in patients with non-small cell lung cancer (NSCLC) receiving an immune checkpoint inhibitor (ICI)-based regimen. The authors point out that while immunotherapy is very effective treating many patients with lung cancer, not all patients with lung cancer benefit.

Turnaround Time and Variant Prevalence of a Blood-based KRAS Test in Patients With NSCLC
Session P24 – Liquid Biopsy and Other Non-invasive Diagnostic Modalities – Targeted Therapy
A study presented by Edgardo Santos, MD, Florida Precision Oncology, Aventura, FL, demonstrated that the blood-based GeneStrat test, focusing specifically on the KRAS G12C/V/D+ testing for this analysis, delivered results to ordering clinicians in under 30 hours on average in two large patient cohorts representing a real-world clinical setting, enabling rapid detection of 3 common KRAS mutations across all stages of NSCLC. Expedited time-to-treatment for patients with actionable driver mutations, now including people with NSCLC that have the KRAS G12C mutation (drug Lumakras (sotorasib), Amgen, Inc.) will improve patient access and overall outcomes to the ever-evolving targeted therapies for eligible patients.

"Our mission is to Improve overall patient outcomes and lower healthcare costs by developing diagnostic solutions that reduce ineffective and unnecessary treatments", said Scott Hutton, CEO, Biodesix. "Additionally, it is always our goal to expedite treatment and remain the leader in turn-around times. These abstracts highlight the effectiveness of our approach in utilizing multiple technologies to determine the best treatment plans as rapidly as possible for patients with lung cancer."

On September 15, 2021, Vaxart, Inc. ("Vaxart" or the "Company") reported that entered into a Controlled Equity OfferingSM Sales Agreement (the "Sales Agreement") with Cantor Fitzgerald & Co. ("Cantor") and B. Riley Securities Inc. ("B. Riley") and, together with Jefferies, the "Sales Agents"), pursuant to which Vaxart may offer and sell, from time to time through the Sales Agents, shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), having an aggregate offering price of up to $100.0 million (the "Shares") (Filing, 8-K, Vaxart, SEP 15, 2021, View Source [SID1234587809]). The Shares will be sold pursuant to an effective registration statement on Form S-3 (Registration Statement No. 333-239751), as previously filed with the U.S. Securities and Exchange Commission (the "Commission"). The Company filed a prospectus supplement, dated September 16, 2021, with the Commission in connection with the offer and sale of the Shares.

Under the Sales Agreement, the Sales Agents may sell the Shares by any method permitted by law and deemed to be an "at the market offering" as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the "Securities Act"), including sales made directly on the Nasdaq Capital Market, on any other existing trading market for the Common Stock. In addition, under the Sales Agreement, the Sales Agents may sell the Shares in privately negotiated transactions with the Company’s consent and in block transactions. Under certain circumstances, Vaxart may instruct the Sales Agents not to sell the Shares if the sales cannot be effected at or above the price designated by the Company from time to time

Vaxart is not obligated to make any sales of the Shares under the Sales Agreement. The Sales Agreement may be terminated by either party at any time upon ten days’ notice to the other party, or by Cantor or B. Riley at any time under certain circumstances.

The Sales Agreement contains customary representations, warranties and agreements by Vaxart, and customary indemnification and contribution rights and obligations of the parties. Vaxart will pay the Sales Agents an aggregate commission rate equal to up to 3% of the aggregate gross proceeds from each sale of the Shares. Vaxart will also reimburse the Sales Agents for certain specified expenses in connection with entering into the Sales Agreement.

The Sales Agreement is filed as Exhibit 1.1 to this Current Report on Form 8-K, and the description of the terms of the Sales Agreement is qualified in its entirety by reference to such exhibit. A copy of the opinion of Thompson Hine LLP relating to the legality of the issuance and sale of the Shares is attached as Exhibit 5.1 hereto.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

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On September 15, 2021 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that it will hire and train a 15-person oncology sales force to supplement the Boehringer Ingelheim oncology commercial team (Press release, G1 Therapeutics, SEP 15, 2021, View Source [SID1234587808]). The expansion will allow G1 to target top tier accounts in order to accelerate sales activities and help maximize the adoption of COSELA (trilaciclib).

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The new G1 sales representatives will supplement the existing Boehringer Ingelheim oncology commercial team. G1 entered into a three-year co-promotion agreement with Boehringer Ingelheim to collaborate on the commercialization of COSELA for its first indication in ES-SCLC. (press release)

"This additional sales force will allow us to expand the reach into our top tier accounts, who treat up to 50 percent of patients diagnosed with small cell lung cancer," said Andrew Perry, G1’s Chief Commercial Officer. "COSELA is the only multilineage myeloprotection therapy developed to proactively reduce the risk of some of the dangerous side effects of chemotherapy in certain patients. We envision working closely with our partners at BI to maximize demand and adoption of this important medicine among these top accounts, as we seek to ensure the availability of COSELA to as many appropriate patients living with ES-SCLC as possible."

On September 9, 2021, the G1 Board of Directors adopted the G1 Therapeutics, Inc. 2021 Sales Force Inducement Equity Incentive Plan (the "Plan"). There are 500,000 shares of common stock reserved under the Plan to be used exclusively for grants of awards to sales force individuals and support staff that were not previously employees or directors of G1, as an inducement material to the individuals’ entry into employment with G1 within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules. The Plan was approved by the Board of Directors without stockholder approval pursuant to Rule 5635(c)(4), and the terms and conditions of the Plan are substantially similar to G1’s stockholder-approved 2017 Equity Incentive Plan, as amended.

About COSELA (trilaciclib) for Injection

COSELA (trilaciclib) was approved by the U.S. Food and Drug Administration on February 12, 2021.

Indication
COSELA (trilaciclib) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.

Important Safety Information
COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity.

The most common adverse reactions (>10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

This information is not comprehensive. Please click here for full Prescribing Information. View Source

To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or call FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

On September 15, 2021 Obsidian Therapeutics, a biotechnology company pioneering engineered cell and gene therapies, reported that the Company will present data highlighting its cytoTIL15 program at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, which will be hosted virtually September 16-21, 2021 (Press release, Obsidian Therapeutics, SEP 15, 2021, View Source [SID1234587803]).

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The abstract for the poster describes how Obsidian’s cytoTIL15 product (TIL engineered with membrane-bound IL15, or mbIL15) demonstrates enhanced in vitro potency and phenotype and in vivo persistence in the absence of IL-2, paving the way for more durable efficacy and improved safety in patients with solid tumor malignancies. The abstract has been published in ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2021 Abstract Book.

Details of the poster presentation:

Title: cytoTIL15: A novel TIL therapy for melanoma with superior potency and enhanced persistence without IL2 to improve safety & efficacy and expand patient eligibility

Abstract Number: 1008P

Session: Investigational Immunotherapy

Abstract Summary: Tumor-infiltrating lymphocytes (TILs) have generated promising data in clinical trials as therapy for heavily pretreated patients with solid tumor malignancies, such as metastatic melanoma. TIL therapy currently requires IL2 for in vivo maintenance of TILs, significantly limiting its application due to patient safety and eligibility hurdles. Obsidian’s cytoTIL product is comprised of TILs engineered with mbIL15 that is regulatable using a drug responsive domain (DRD) designed via our cytoDRiVE platform. Our cytoTIL15 product displays a favorable cytotoxic CD8+ T cell phenotype while maintaining TCR Vbeta repertoire diversity during manufacturing. cytoTIL15 exhibit superior in vitro anti-tumor cytotoxicity as well as polyfunctionality, compared to conventional TILs + IL2. In vivo, cytoTIL15 demonstrate greater antigen-independent expansion and persistence compared to conventional TILs treated with IL2.

Jan ter Meulen, M.D., Ph.D., Chief Scientific Officer of Obsidian, commented, "We are very excited about the superior persistence and cytotoxicity profile exhibited by cytoTIL15 in our preclinical models, and are eager to continue to advance our mission to translate these benefits to patients with metastatic melanoma and other solid tumor malignancies."

About cytoTIL15

cytoTIL15 is Obsidian’s lead cytoTIL program, currently in preclinical development for the treatment of patients with metastatic melanoma and other solid tumors. cytoTIL15 is a novel engineered tumor infiltrating lymphocyte therapy engineered with regulated membrane-bound IL15 that does not require patients to receive concomitant IL2 therapy, a toxic and costly requirement for conventional TILs. The Company expects to submit an IND for cytoTIL15 in mid-2022.

On September 15, 2021 Herantis Pharma Plc ("Herantis" or the "Company") reported the result of the offering of new shares (the "Placing Shares") in a private placement to institutional and other qualified investors (the "Placing") (Press release, Herantis Pharma, SEP 15, 2021, View Source,c3416074 [SID1234587799]). The Company announced the launch of the Placing by way of a company release published on 15 September 2021. Herantis raises gross proceeds of EUR 4.04 million in the Placing.

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In the Placing, the Company expects to issue a total of 1,346,500 Placing Shares in a directed share issue. The Placing Shares represent approximately 13.8 per cent. of the issued shares in Herantis prior to the Placing and approximately 12.1 per cent. of the issued shares in Herantis following the Placing. The total number of issued shares in the Company after the Placing will be 11,103,568.

The subscription price of the Placing Shares is EUR 3.00 per Placing Share, corresponding to a discount of 6.5 per cent to the closing price on First North Growth Market Finland immediately before the commencement of the Placing on 15 September 2021. The subscription price shall be recorded in the invested unrestricted equity reserve.

The Placing was carried out based on offers received in an accelerated book building and based on the authorisation given to the board of directors by the Company’s extraordinary general meeting of 2 December 2020.

As previously announced, Acme Investments SPF Sarl, a company controlled by Timo Syrjälä, and Nanoform Finland Plc participated in the Placing among several other investors.

The Placing Shares (ISIN code FI4000087861) will be registered with the trade register maintained by the Finnish Patent and Registration Office on or about 16 September 2021. The Placing Shares are expected to be ready for delivery to the investors against payment through Euroclear Finland Oy or, as applicable, through Euroclear Sweden AB on or about 20 September 2021.

Herantis intends to make applications for the admission into trading of the Placing Shares on Nasdaq First North Growth Market Finland and on Nasdaq First North Growth Market Sweden. Trading in the Placing Shares is expected to commence on Nasdaq First North Growth Market Finland and Nasdaq First North Growth Market Sweden on or about 20 September 2021, subject to the respective listing applications being approved.

The CEO of Herantis, Craig Cook comments: "We are pleased with the support amongst existing as well as respected new shareholders in Herantis. The funds will clearly enable us to continue the important development activities of our novel disease-modifying CNS drugs rhCDNF and xCDNF (HER-096). These assets are the epitome of our ground-breaking science and have the potential to slow, stop or even reverse the progression of neurodegenerative diseases with high impact for patients and society. Herantis is well positioned to capitalize on this momentum and create value for our growing list of world class shareholders."

Swedbank AB (publ) is acting as the global coordinator and bookrunner of the Placing in association with Kepler Cheuvreux. Krogerus Attorneys Ltd is acting as the legal counsel to the Company as to Finnish law and Borenius Attorneys Ltd is acting as the legal counsel to the global coordinator and bookrunner of the Placing as to Finnish law.