On January 3, 2022, Kinnate Biopharma Inc. (the "Company") reported that entered into a sales agreement (the "Sales Agreement") with SVB Leerink LLC ("SVB Leerink"), pursuant to which the Company may offer and sell shares of the Company’s common stock, par value $0.0001 per share, from time to time, through an "at the market offering" program under which SVB Leerink will act as sales agent (Filing, 8-K, Kinnate Biopharma, JAN 3, 2022, View Source [SID1234597958]). Pursuant to the sales agreement prospectus supplement included in the Company’s Form S-3 filed on January 3, 2022, the Company may offer and sell common stock having aggregate gross sales proceeds of up to $150 million.

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Under the Sales Agreement, the Company will set the parameters for the sale of shares, including the number or dollar value of shares to be issued, the time period during which sales are requested to be made, limitation on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. Subject to the terms and conditions of the Sales Agreement, SVB Leerink may sell the shares by methods deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the "Securities Act"). SVB Leerink will use commercially reasonable efforts in conducting such sales activities consistent with its normal trading and sales practices, on mutually agreed terms between SVB Leerink and the Company. The Company is not obligated to sell, and SVB Leerink is not obligated to sell, any shares of common stock under the Sales Agreement. No assurance can be given that the Company will sell any shares of common stock under the Sales Agreement, or, if it does, as to the price or amount of shares of common stock that it sells or the dates when such sales will take place. The Sales Agreement may be terminated by either party by giving ten trading days’ prior written notice to the other party for any reason, subject to further qualifications as described in the Sales Agreement.

The Sales Agreement provides that SVB Leerink will be entitled to compensation for its services equal to up to 3.0% of the gross proceeds of any shares sold through SVB Leerink under the Sales Agreement. SVB Leerink and the Company have no obligation to sell any shares under the Sales Agreement and may at any time, upon notice to the other party, suspend solicitation and offers under the Sales Agreement.

In the Sales Agreement, the Company has agreed to indemnify SVB Leerink against certain liabilities, including under the Securities Act and to contribute payments that SVB Leerink may be required to make because of such liabilities. Further, SVB Leerink agreed to indemnify the Company, the Company’s board of directors and its executive officers against certain liabilities, including under the Securities Act.

The shares of common stock sold pursuant to the Sales Agreement will be issued pursuant to the Company’s shelf registration statement on Form S-3, including the prospectus supplement contained therein, filed with the Securities and Exchange Commission (the "SEC") on January 3, 2022, which was automatically effective upon filing with the SEC.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

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 sale of such 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.

On January 3, 2022 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported that David Marek, Chief Executive Officer of Myovant Sciences, Inc., will present at the 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12, 2022 at 3:00 p.m. Eastern Time (Press release, Myovant Sciences, JAN 3, 2022, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-present-40th-annual-jp-morgan-healthcare [SID1234597957]).

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Investors and the general public are invited to listen to the presentation, which will be accessible on the Events page under the Investors & Media section of the Myovant website at www.myovant.com.

On January 3, 2021 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio" or the "Company"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation for IMX-110 for the treatment of a life-threatening form of pediatric cancer in children, rhabdomyosarcoma. IMX-110, an investigational product, is currently being evaluated in a Phase 1b/2a clinical trial (Press release, Immix Biopharma, JAN 3, 2022, View Source [SID1234597956]).

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The FDA grants Rare Pediatric Disease designation for serious and life-threatening diseases that primarily affect children aged 18 years or younger and impact fewer than 200,000 people in the United States.

If a New Drug Application in the United States for IMX-110 is approved, ImmixBio may be eligible to receive a Priority Review Voucher (PRV) from the FDA, which can be redeemed to obtain priority review for any subsequent marketing application, or may be sold or transferred.

"We are pleased by FDA’s acknowledgment of the urgent need for a safe and effective treatment for children with this devastating disease," stated ImmixBio’s Chief Executive Officer Ilya Rachman, M.D., PhD. "We are encouraged by our Phase 1b/2a clinical data in soft tissue sarcoma. IMX-110 is a tissue-specific therapeutic that simultaneously attacks all 3 components of the tumor micro-environment, severing the critical lifelines between the tumor and its metabolic and structural support. We believe our SMARxT platform generating Tissue-Specific Therapeutics represents a distinct alternative to the traditional ‘single target, single mutation’ development model."

Rhabdomyosarcoma ("RMS") is a high-grade, malignant neoplasm, the most common soft tissue sarcoma in pediatric and adolescent populations and which rarely occurs in adults. The prevalence of RMS in the United States is approximately 20,000 children of all ages. The five-year survival rate ranges from 20% to 30% for children in the high-risk group where cancer spreads widely in the body.

IMX-110 is the first clinical-stage product of ImmixBio’s SMARxT Tissue-Specific Platform, which produces Tissue-Specific Therapeutics that accumulate at intended therapeutic sites at 3 to 5 times the rate of conventional medicines. The FDA has already granted orphan drug designation (ODD) to IMX-110 for the treatment of soft tissue sarcoma.

ImmixBio recently shared clinical data across multiple soft tissue sarcoma subtypes in several heavily pretreated patients demonstrating median progression-free survival (PFS) of 4 months with zero drug-related severe adverse events and zero dose interruptions due to toxicity. The data can be viewed in the Immix Biopharma Corporate Presentation at View Source

On January 3, 2022 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the Company’s lead drug candidate, REQORSA Immunogene Therapy, in combination with Merck & Co’s Keytruda in patients with histologically-confirmed unresectable stage III or IV non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Keytruda (Press release, Genprex, JAN 3, 2022, View Source [SID1234597954]). In the first quarter of 2022, Genprex expects to initiate its Acclaim-2 clinical trial, which is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Keytruda, for this patient population. The Company previously received its first FTD for REQORSA in combination with AstraZeneca PLC’s Tagrisso in patients with histologically confirmed unresectable stage III or IV NSCLC, with EGFR mutations that progressed after treatment with Tagrisso.

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"We are thrilled to receive a second Fast Track Designation from the FDA for REQORSA in patients with late-stage NSCLC, this time in combination with the checkpoint inhibitor Keytruda," said Rodney Varner, President and Chief Executive Officer at Genprex. "This Fast Track Designation is an important step in our efforts to accelerate clinical development of REQORSA and another validation of the potential of REQORSA to treat the unmet medical need of patients with late-stage NSCLC. With a strong balance sheet of $42 million in cash as of the end of the third quarter of 2021 and expert clinical trial management led by Chief Medical Officer and industry veteran Mark Berger, MD who joined Genprex in September 2021, we are well positioned to advance our Acclaim-1 and Acclaim-2 clinical trials in a meaningful way in 2022."

Dr. Berger added, "Fast Track Designation provides a company opportunities to have more frequent engagement with the FDA to discuss the drug candidate’s development plan and also provides potential eligibility for priority review, which has a six-month review timeline. FDA may award Fast Track Designation if it determines that non-clinical or clinical data demonstrate the potential for a drug to address unmet medical need for a serious or life-threatening disease or condition. This provision is intended to facilitate development and expedite review of such drugs so that a product, if approved, can reach the market expeditiously. Advanced NSCLC represents a large patient population that is in desperate need of new therapies."

Previously presented preclinical data have shown synergy between REQORSA and Keytruda. Those data showed that REQORSA combined with Keytruda was more effective than Keytruda alone in increasing the survival of mice with a humanized immune system that had metastatic lung cancers. Those studies in mice with a humanized immune system also documented multiple effects of REQORSA on the immune system, such as an increase in Natural Killer cells and a decrease in PD-L1 expression on tumor cells, that is believed likely to contribute to the synergy seen with Keytruda.

Fast Track Designation recipients may also be eligible for accelerated approval or rolling review of the recipient’s Biologics License Application (BLA) if other qualifying criteria are met. In addition, Fast Track product candidates could be eligible for priority review if supported by clinical data at the time of BLA submission.

The initial intended disease indication for development of REQORSA is NSCLC. According to the World Health Organization, in 2020 lung cancer was the leading cause of cancer deaths worldwide, causing more deaths than colorectal, breast, liver or stomach cancers. There were more than 2 million new lung cancer cases and 1.8 million deaths from lung cancer worldwide. In the United States, according to the American Cancer Society, it is estimated that in 2021, there will be more than 235,000 new cases of lung cancer and more than 131,000 deaths from lung cancer. The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) reports that NSCLC represents 84 percent of all lung cancers and the five-year survival rate for patients with NSCLC with distant spread is 7 percent.

For more information on the U.S. FDA’s Fast Track Designation, please visit the FDA’s Fast Track webpage.

On January 3, 2021 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that management will present a company overview at the 40th Annual J.P. Morgan Virtual Healthcare Conference on Monday, Jan. 10, at 7:30 a.m. EST (Press release, PTC Therapeutics, JAN 3, 2022, View Source [SID1234597953]).

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The presentation will be webcast live on the Events and Presentations page on the Investor section of PTC Therapeutics’ website at View Source and will be archived for 30 days following the presentation. It is recommended that users connect to PTC’s website several minutes prior to the start of the webcast to ensure a timely connection.