On September 15, 2021 Francis Medical, Inc., a privately-held medical device company developing an innovative and proprietary water vapor ablation therapy for the treatment of prostate, kidney, and bladder cancer, reported the completion of the company’s $55.0 million Series B equity financing (Press release, Francis Medical, SEP 15, 2021, View Source [SID1234587863]).

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Solas BioVentures led the Series B round with other previous investors, including Arboretum Ventures, Coloplast A/S, H2Oey Ventures and Tonkawa. The company plans to use the Series B proceeds to fund the development of its proprietary prostate cancer treatment through FDA 510(k) approval, which includes a pivotal clinical study (VAPOR 2) for the management of prostate cancer, scheduled to begin enrollment in August 2022.

"We are thrilled to be leading the Series B round of financing for Francis Medical," said Dr. David Adair, managing director of Solas BioVentures. "At Solas, we focus our investments on technologies that have the potential to transform the standard of care and directly impact patient outcomes. We strongly believe that Francis Medical’s water vapor technology will become the preferred first-line therapy for treating prostate cancer. If we achieve our goals, men facing prostate cancer will have a less invasive option that not only aggressively treats their cancer, but also helps preserve their quality of life."

The funding comes on the heels of strong results from VAPOR 1, a prospective, multicenter, single-arm study that treated 15 patients with intermediate-risk, localized prostate cancer at four U.S. clinical centers. The VAPOR 1 study reported no serious adverse events, no device-related adverse events, and no unanticipated adverse device effects as its primary endpoint. In 87% of patients treated, six-month biopsy results indicated no remaining Gleason Grade Group 2 or greater clinically significant disease in the targeted treatment areas.

As the second most common cancer in U.S. men, the American Cancer Society estimates one in eight American men will be diagnosed with prostate cancer during their lifetime. Prostate cancer is a serious disease often treated with therapies that cause complications, such as urinary incontinence and erectile dysfunction. Francis Medical’s water vapor technology applies the thermal energy stored in a few drops of sterile water to deliver targeted treatments to the cancerous tissue through a simple transurethral procedure. The therapy is designed to ablate cancer cells while protecting surrounding structures, lessening the likelihood of life-altering side effects common with other prostate cancer treatments.

"Our Founder and Chief Technology Officer, Michael Hoey, and I would like to thank our investors, employees, and physician partners for achieving this important milestone," said Michael Kujak, president and CEO of Francis Medical. "This financing is a real testament to the significant accomplishments of the entire team. At Francis Medical, our shared vision from the beginning has been to bring this breakthrough technology to market to improve the lives of prostate cancer patients worldwide. We look forward to deploying these proceeds toward making this vision a reality."

On September 15, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported the outcome of the exercise of the warrants of series ALLR TO 3 that were issued in connection with the Company’s issue of units in June 2021 (Press release, Allarity Therapeutics, SEP 15, 2021, View Source [SID1234587827]). In total, 13,719,266 warrants of series TO 3 were exercised, corresponding to approximately 9.5 percent of the total number of outstanding warrants, for subscription of 13,719,266 shares at a subscription price of SEK 1.7 per share. Through the exercise of the warrants, Allarity will receive approximately SEK 23.3 million (U.S. $2.7 million) before issuing costs amounting to approximately SEK 1.4 million.

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UPDATE on the outcome of the exercise of the warrants of series ALLR TO 2 that were issued in connection with the Company’s issue of units in December 2019. In total, 8,820 warrants of series TO 2 were exercised, corresponding to approximately 0.02 percent of the total number of outstanding warrants, for subscription of 8,820 shares at a subscription price of SEK 6.0 per share. Through the exercise of the TO 2 warrants, Allarity will receive approximately SEK 53,000 before issuing costs. The final exercise period for the warrants of series TO 2 took place from September 1 up to and including September 15, 2021.

Chairman of Allarity’s Board of Directors Duncan Moore (who exercised 283,407 warrants) and the Company’s largest shareholder, Sass & Larsen ApS, were among the subscribers.

The exercise period for the warrants of series TO 3 took place from August 30 up to and including September 13, 2021. The accelerated exercise period was established, as previously announced, due to the Board of Directors’ determination that it was in the best interest of all shareholders as part of the Company’s plan to move to the U.S. Nasdaq stock market and to meet the requirements of the previously announced U.S. $20 Million recapitalization investment with 3i LP (New York).

Exercised warrants will be replaced with interim shares, pending registration with the Danish Business Authority. The interim shares are expected to be converted to shares within approximately two (2) weeks. Through the exercise, the number of shares in the Company increase from 390,063,114 shares to 403,791,200 shares, and the share capital increase by DKK 686.404,30, from DKK 19.503.155,70 to DKK 20,189,560,00.

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.