Entry into a Material Definitive Agreement

On March 8, 2023 As previously disclosed, on February 28, 2023, Invitae Corporation (the "Company") reported that it has entered into separate, privately negotiated purchase and exchange agreements (collectively, the "Exchange Agreements") with respect to (a) the issuance of $275,257,000 aggregate principal amount of the Company’s new 4.5% Series A Convertible Senior Secured Notes due 2028 (the "Series A New Notes") and 14,219,859 shares (the "New Shares") of the Company’s common stock, $0.0001 par value per share (the "Common Stock"), in exchange for $305,727,000 aggregate principal amount of the Company’s currently outstanding 2.00% Convertible Senior Notes due 2024 (the "Old Notes") and (b) the issuance and sale of $30,000,000 aggregate principal amount of the Company’s new 4.5% Series B Convertible Senior Secured Notes due 2028 (the "Series B New Notes" and, together with the Series A New Notes, the "Notes") for cash (Filing, 8-K, Invitae, MAR 8, 2023, View Source [SID1234628307]).

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On March 7, 2023, the Company issued the Notes and the New Shares. The Notes were issued pursuant to, and are governed by, an indenture (the "Indenture"), dated as of March 7, 2023, between the Company, the guarantor parties thereto and U.S. Bank Trust Company, National Association, as trustee (the "Trustee") and collateral agent (the "Collateral Agent").

The Notes accrue interest at a rate of 4.5% per annum, payable quarterly in arrears on March 15, June 15, September 15 and December 15 of each year, beginning on June 15, 2023. The Notes will mature on March 15, 2028, unless earlier repurchased, redeemed or converted.

Based on the initial conversion price of $2.5800, the Notes are convertible into 118,316,667 shares of Common Stock, subject to the potential issuance of additional shares in the event of optional redemptions or Major Transactions (discussed below).

At any time prior to the 60th day prior to the maturity date of the Notes, the Company has the option to redeem all or any portion of the principal amount of the Notes for cash equal to the principal amount of the Notes being redeemed, subject to certain conditions specified in the Indenture. Upon redemption of any Notes, the Company will (i) issue warrants to purchase shares of the Common Stock ("Warrants") covering the same number of shares of Common Stock underlying, and at an exercise price equal to the conversion price of, the redeemed Notes, unless the aggregate principal amount of Notes outstanding represents less than 10% of the aggregate principal amount of Notes initially issued and certain other conditions are satisfied, and (ii) make a make-whole payment as determined pursuant to the Indenture, together with accrued and unpaid interest through the redemption date. In addition, in certain circumstances, the Company may be required to issue additional shares of Common Stock for any Notes converted in connection with a notice of optional redemption. The Company will not be able to effect any optional redemption during a delisting event or unless all conversion shares and warrant shares are freely tradable and unless certain other conditions specified in the Indenture are satisfied.

The Notes are convertible at any time at the option of the holders thereof, provided that the holder is prohibited from converting Notes into shares of Common Stock if, upon such conversion, the converting holder (together with certain affiliates and "group" members) would beneficially own more than 4.9% of the total number of shares of Common Stock then issued and outstanding (the "Beneficial Ownership Cap"). In addition, prior to such time that the Company obtains stockholder approval for the issuance of shares of Common Stock upon conversion of the Series A New Notes in excess of the limitations imposed by the NYSE rules (the "NYSE Cap"), the holder is prohibited from converting Series A New Notes into shares of Common Stock in excess of such NYSE Cap, and the Company would instead be required to settle any such conversion in cash if the Company is not able to obtain the stockholder approval within the grace period specified in the Indenture.

If the Company undergoes a "Major Transaction" (as defined in the Indenture), holders may require the Company to repurchase for cash all or part of their Notes at a purchase price equal to 100% of the principal amount of the Notes to be repurchased, plus (i) accrued and unpaid interest to, but excluding, the repurchase date and (ii) the make-whole amount as determined pursuant to the Indenture. In addition, at the election of the holders of the Notes, the Company may be required to issue additional shares of Common Stock for any Notes converted in connection with a Major Transaction.

The Notes are guaranteed by the Company’s material subsidiaries and secured by (i) a security interest in substantially all of the assets of the Company and its domestic and material subsidiaries and (ii) a pledge of the equity interests of the Company’s direct and indirect subsidiaries, subject to certain customary exceptions. The Indenture contains certain specified events of default, the occurrence of which would entitle the holders of the Notes to demand repayment of all outstanding principal and accrued interest on the Notes, together with a make-whole payment as determined pursuant to the Indenture. Such events of default include, among others, failure to make any payment under the Notes when due, failure to observe or perform certain covenants under the Notes or the other transaction documents related thereto (subject in certain cases to specified cure periods), the failure of the Company to be able to pay debts as they come due, the commencement of bankruptcy or insolvency proceedings against the Company, a material judgment levied against the Company and any event of default by the Company under other indebtedness.

The Indenture also includes a number of affirmative covenants, including covenants regarding compliance with applicable laws and regulations, reporting, maintenance of property, payment of taxes and maintenance of insurance, among other covenants. The Indenture also includes a number of restrictive covenants, including restrictions on business combinations, incurrence of additional liens or indebtedness, prepayments of other indebtedness, dispositions, investments, and transactions with affiliates, in each case subject to certain exceptions. The Company is also required to comply with certain financial maintenance covenants, including a minimum revenue covenant and, starting with the fiscal quarter ending March 31, 2025, a minimum liquidity covenant. The Company is also restricted from paying dividends or making other distributions or payments on its capital stock, subject to certain exceptions.

Registration Rights Agreement

On March 7, 2023, the Company also entered into a registration rights agreement (the "Registration Rights Agreement") with the investor party thereto, whereby the Company agreed to prepare and file with the Securities and Exchange Commission a Registration Statement on Form S-3, or such other form as required to effect a registration of no less than 101,641,085 shares of the Common Stock issued or issuable upon conversion of or pursuant to such investor’s Series B Notes and Warrants related to such investor’s Series A Notes and Series B Notes (the "Registrable Securities"), covering the resale of the Registrable Securities and such indeterminate number of additional shares of Common Stock as may become issuable upon conversion of or otherwise pursuant to the Series B New Notes and Warrants to prevent dilution resulting from certain corporate actions. Such Registration Statement must be filed within 10 business days from March 7, 2023.

The Notes, the New Shares, the Warrants and any shares of Common Stock issuable upon conversion of the Notes or exercise of the Warrants have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or the securities laws of any other jurisdiction. The Company sold the Notes and the New Shares to the investors party to the Exchange Agreements in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Rule 506 of Regulation D thereunder. The Company relied on this exemption from registration based in part on representations made by such investors in the Exchange Agreements. This Current Report on Form 8-K does not constitute an offer to sell any securities or a solicitation of an offer to purchase any securities.

The Indenture, certificates representing the Series A New Notes and Series B New Notes and the Registration Rights Agreement are filed as Exhibits 4.1, 4.2, 4.3 and 10.1, respectively, to this Current Report on Form 8-K and are incorporated herein by reference. The above descriptions of the material terms of the Indenture, the Notes and the Registration Rights Agreement are qualified in their entirety by reference to such exhibits.

HOOKIPA Pharma to Report Fourth Quarter and Full Year 2022 Financial Results and Provide a Corporate Update on March 15, 2023

On March 8, 2023 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that it will release fourth quarter and full year 2022 financial results before the market opens on Wednesday, March 15, 2023 (Press release, Hookipa Biotech, MAR 8, 2023, View Source [SID1234628305]). The Company will host a live conference call and webcast at 8:30 AM ET to discuss its financial results and provide a corporate update.

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Conference Call & Webcast:

Date: March 15, 2023
Time: 8:30 AM ET
USA Dial In: +1-800-715-9871
UK Dial In: 0800-260-6466
Austria Dial In: +43 800-070-441
Conference ID: 7669853
Webcast: Link

The webcast and the presentation will also be available within the Investors & Media section of HOOKIPA’s website at View Source

Genprex to Participate in March Investor and Industry Conferences 

On March 8, 2023 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 the Company’s participation in the following upcoming investor and industry conferences to be held in March 2023 (Press release, Genprex, MAR 8, 2023, View Source [SID1234628304]).

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Event: 35th Annual Roth Conference

Conference Date: March 12-14, 2023

Location: The Ritz-Carlton, Laguna Niguel, Dana Point, California

In attendance at the Roth Conference will be Genprex’s Chief Financial Officer, Ryan Confer. For those interested in meeting Mr. Confer during the Roth Conference, please request a meeting through the conference portal or reach out to investor relations at [email protected].

Event: BIO-Europe Spring

Conference Date: March 20 – 22, 2023

Location: Messe Basel, Basel, Switzerland

In attendance at BIO-Europe Spring will be several members of Genprex’s executive leadership team. For those interested in meeting Genprex management during BIO Europe Spring, please request a meeting through the conference portal or reach out to investor relations at [email protected].

"We are pleased to have members of our Senior Leadership Team participate in these upcoming conferences as they offer an excellent opportunity to highlight the significant potential for our novel gene therapies to address unmet medical needs in oncology and diabetes," said Rodney Varner, Chief Executive Officer of Genprex. "We look forward to providing an overview and update on our clinical development programs, including our Phase 1 dose escalation portion of the Acclaim-1 Phase 1/2 clinical trial of REQORSA (quaratusugene ozeplasmid) in combination with Tagrisso (osimertinib) to treat late-stage non-small cell lung cancer and our recent groundbreaking data from a non-human primate study evaluating our innovative gene therapy to treat Type 1 diabetes presented at a global medical meeting."

In Move to Power Precision Oncology for Patients, COTA and Genomic Testing Cooperative Form New Data Partnership

On March 8, 2023 COTA, Inc., an oncology real-world data and analytics company, reported a new partnership with Genomic Testing Cooperative (GTC), a molecular testing company (Press release, Genomic Testing Cooperative, MAR 8, 2023, View Source [SID1234628303]). The two companies are joining forces to integrate COTA’s deep clinical oncology real-world data with GTC’s comprehensive genomics testing data. This strategic and oncology-specific partnership, grounded in deep comprehensive clinical data, will support more precise, personalized cancer research particularly across early discovery and translational epidemiology functions.

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"Integrating both DNA and RNA profiling in the management of patients with cancer has become essential in the proper practice of precision medicine," said Maher Albitar, M.D., Chief Executive Officer and Chief Medical Officer at GTC. "We are proud to partner with COTA to streamline access to comprehensive DNA and RNA profiling, and to combine this data with real-world clinical and outcome data. Together, these highly valuable data sets will not only help advance scientific discovery, but will enable researchers to create predictive models that will allow for more personalized approaches to treatments for people facing cancer now and in the future."

Genomic Testing Cooperative’s innovative approach to genetic testing provides valuable molecular information, which is critical for determining the correct patient diagnosis and selecting the most appropriate treatment. GTC tissue-based and liquid biopsy testing uniquely leverages DNA and RNA sequencing for both solid and hematologic cancers to generate information on mutations, chromosomal structural abnormalities, biomarkers that can replace or complement immunohistochemistry, flow cytometry, and standard tumor markers. This comprehensive profiling is captured before treatment and frequently after relapse so a fuller picture of treatment impact on a specific patient population can be understood.

"It’s no secret that up to 90 percent of clinical drug development fails despite the industry’s best efforts and ongoing innovation," said Chris Boone, Ph.D., Vice President of HEOR at AbbVie. "The key to curbing this failure rate, driving down costs, and the ‘holy grail’ of a future grounded in precision medicine, is wholly dependent on our ability to access, integrate, and derive insights from multimodal data sets. Building these types of data platforms is hard, time and resource intensive work. But it is absolutely mission critical if we hope to accelerate personalized treatments and care for all patients."

"Care teams and researchers simply can’t make the highest quality decisions for patients if they don’t have advanced oncology real-world data coupled with genomic testing data that fully reflects the patient journey," said Miruna Sasu, President and CEO at COTA. "While COTA previously had access to clinically actionable biomarker data, it was not as complete as what GTC offers today. Our partnership will provide researchers and clinicians with the multi-modal data needed to conduct more targeted research and deliver personalized cancer treatments that result in the best possible outcomes for patients."

This latest partnership builds on COTA’s recent announcement with the Clinical Research Data Sharing Alliance (CRDSA) and its broader focus on bringing clarity to cancer care. Last month, COTA joined CRDSA — a collection of biopharma companies, data sharing platforms, academic institutions, and service and technology partners — focused on ushering in the next generation of data-driven healthcare.

For more information about how COTA will be integrating GTC data and other clinical genomics data assets into their real-world data platform, please visit this page.

Galera Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Corporate Updates

On March 8, 2023 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported financial results for the fourth quarter and year ended December 31, 2022 and provided recent corporate updates (Press release, Galera Therapeutics, MAR 8, 2023, View Source [SID1234628302]).

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"2023 is a pivotal year for Galera, as we received Priority Review designation for our NDA for avasopasem, and we look forward to continuing productive discussions with the FDA over the coming months," said Mel Sorensen, M.D., Galera’s President and CEO. "Avasopasem has the potential to be the first FDA-approved drug to reduce SOM, a debilitating radiotherapy-induced toxicity, in head and neck cancer patients undergoing standard-of-care treatment. Each year approximately 43,500 U.S. patients with HNC are at high risk of developing SOM as a result of their cancer treatment. Following our recent financing, we believe that we are well-equipped to build out our operations and expand our commercial leadership team in preparation for potential approval of avasopasem in the second half of the year."

Recent Corporate Updates

Radiotherapy-Induced Toxicity Programs:

Severe Oral Mucositis (SOM)


In December 2022, the Company submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for avasopasem manganese (avasopasem) for radiotherapy-induced SOM in patients with head and neck cancer (HNC) undergoing standard-of-care treatment. There are currently no FDA-approved drugs to reduce SOM for these patients.


On February 15, 2023, the Company announced that the FDA accepted for filing and granted priority review to the NDA for avasopasem. With Priority Review designation, the Prescription Drug User Fee Act (PDUFA) target date assigned by the FDA for the NDA is August 9, 2023. The FDA indicated in its acceptance of filing letter that it is not planning to hold an advisory committee meeting on the application.


Data from the Phase 3 ROMAN trial is scheduled to be presented by Dr. Carryn Anderson, MD, Clinical Associate Professor of Radiation Oncology at the University of Iowa, at the European


Congress on Head and Neck Oncology (ECHNO), taking place March 8-11, 2023, in Lisbon, Portugal. The presentation will include a generalized pairwise comparisons (GPC) analysis, a statistical method to assess the net treatment benefit of avasopasem compared to placebo.

Esophagitis


In May 2022, the Company announced topline results from the open-label, single-arm Phase 2a AESOP trial evaluating avasopasem for its potential to reduce the incidence of radiotherapy-induced esophagitis in patients with lung cancer. The results demonstrated that avasopasem was generally well tolerated and substantially reduced the incidence of severe esophagitis in patients with lung cancer receiving chemoradiotherapy compared to expectations based on review of historical data in the literature. Based on these data, Galera intends to pursue a strategy for avasopasem, if approved for the reduction of SOM, to support the use of avasopasem to reduce radiotherapy-induced esophagitis in patients with lung cancer as a medically accepted indication in published drug compendia.

Anti-Cancer Programs:

Locally Advanced Pancreatic Cancer (LAPC)


Enrollment is ongoing in the randomized, placebo-controlled Phase 2b GRECO-2 trial of rucosopasem in combination with stereotactic body radiation therapy (SBRT) in patients with LAPC. The primary endpoint of the trial is overall survival. The Company continues to anticipate completion of enrollment in the second half of 2023.

Non-Small Cell Lung Cancer (NSCLC)


Enrollment is ongoing in the randomized, placebo-controlled Phase 2 stage of the GRECO-1 trial of rucosopasem in combination with SBRT in patients with NSCLC. The Company continues to anticipate completion of enrollment in the second half of 2023.

General Corporate Updates


On February 17, 2023, the Company completed a registered direct offering, which resulted in the issuance and sale of 14,320,000 shares of common stock and warrants to purchase up to 14,320,000 shares of common stock at a combined offering price of $2.095 per share and accompanying warrant, generating gross proceeds of $30 million. The warrants have an exercise price of $1.97 per share of common stock, are exercisable immediately following their issuance and will expire five years from the date of issuance. The Company received net proceeds of approximately $27.7 million from this offering, after deducting placement agent fees and offering expenses.

Fourth Quarter 2022 Financial Highlights


Research and development expenses were $8.1 million in the fourth quarter of 2022, compared to $9.2 million for the same period in 2021. The decrease was primarily attributable to a decrease in avasopasem development costs, partially offset by an increase in rucosopasem development costs.


General and administrative expenses were $5.0 million in the fourth quarter of 2022, compared to $5.3 million for the same period in 2021. The decrease was primarily attributable to the timing of spend for avasopasem commercial preparations.


Galera reported a net loss of $(16.2) million, or $(0.58) per share, for the fourth quarter of 2022, compared to a net loss of $(16.8) million, or $(0.64) per share, for the same period in 2021.


As of December 31, 2022, Galera had cash, cash equivalents and short-term investments of $31.6 million. Galera expects that its existing cash, cash equivalents and short-term investments, together with the net proceeds from its February 2023 registered direct offering, will enable Galera to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2023.

Full Year 2022 Financial Highlights


Research and development expenses were $31.0 million for the year ended December 31, 2022, compared to $52.4 million for the year ended December 31, 2021. The decrease was primarily attributable to a decrease in avasopasem development costs and decreased manufacturing expenses, partially offset by an increase in rucosopasem development costs.


General and administrative expenses were $20.2 million for the year ended December 31, 2022, compared to $21.0 million for the year ended December 31, 2021. The decrease was primarily attributable to the timing of spend for avasopasem commercial preparations.


Galera reported a net loss of $(62.2) million, or $(2.30) per share, for the year ended December 31, 2022, compared to a net loss of $(80.5) million, or $(3.12) per share, for the year ended December 31, 2021.