Entry into a Material Definitive Agreement

On February 2, 2023 Theralink Technologies, Inc. (the "Company") reported that it has consummated the second closing (the "Second Closing") of a private placement offering (the "Offering") pursuant to the terms and conditions of that certain Securities Purchase Agreement, dated as of November 29, 2022 (the "Purchase Agreement"), by and among the Company, certain accredited investors (the "Purchasers") and Cavalry Fund I Management LLC, a Delaware limited liability company, in its capacity as collateral agent (the "Collateral Agent") (Filing, 8-K, Theralink Technologies, FEB 1, 2023, View Source [SID1234626791]). At the Second Closing, the Company sold the Purchasers (i) 10% Original Issue Discount Senior Secured Convertible Debentures (the "Debentures") in an aggregate principal amount of $1,045,000 and (ii) warrants (the "Warrants" and together with the Debentures, the "Underlying Securities") to purchase up to 298,571,429 shares of common stock of the Company (the "Common Stock"), subject to adjustments provided by the Warrants, which represents 100% warrant coverage. The Company received a total of $950,000 in gross proceeds at the Second Offering, taking into account the 10% original issue discount, before deducting offering expenses and commissions.

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The Purchase Agreement contains customary representations, warranties, and covenants of the Company, including, among other things and subject to certain exceptions, covenants that restrict the ability of the Company without the prior written consent of the Debenture holders, to incur additional indebtedness, and repay outstanding indebtedness, create or permit liens on assets, redeem its Common Stock, settle outstanding litigation, or enter into transactions with affiliates.

As previously reported on the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on December 1, 2022, the Company and Joseph Gunnar & Co. LLC, a U.S. registered broker-dealer ("Gunnar"), entered into a placement agency agreement (the "Placement Agency Agreement" ), pursuant to which Gunnar agreed to act as the placement agent for the Offering (the "Placement Agent"). Pursuant to the terms of the Placement Agency Agreement, the Company agreed to (i) pay Gunnar a cash placement fee of 10% of the gross cash proceeds raised in the Offering, and (ii) issue to Gunnar warrants (the "PA Warrants") on the terms identical to the Warrants sold in the Offering in an amount equal to 10% of the Underlying Securities sold to investors.

As a result of the foregoing, the Company paid Gunnar an aggregate commission of $95,000 in connection with the Second Closing. The Company also paid $7,500 in fees to Gunnar’s legal counsel.

Debentures

The Debentures mature on November 29, 2023, subject to a three-month extension at the sole discretion of the Company. The Debentures bear interest at 10% per annum payable upon conversion or maturity. The Debentures are convertible into shares of Common Stock at any time after the maturity date and prior to Mandatory Conversion (as defined below) at the conversion price equal to the lesser of: (i) $0.003 per share and (ii) 70% of the average of the VWAP (as defined in the Debentures) (or 50% of the average of such VWAP if an event of default has occurred and has not been cured) of the Common Stock during the ten Trading Day (as defined in the Debentures) period immediately prior to the applicable conversion date. The Debentures are subject to mandatory conversion ("Mandatory Conversion") in the event the Company closes a registered public offering of its Common Stock and receives gross proceeds of not less than $5,000,000, with such offering resulting in the listing for trading of the Common Stock on a national exchange ("Qualified Offering"). The conversion price per share of Common Stock in the case of a Mandatory Conversion shall be the lesser of (i) $0.003 per share and (ii) 70% of the offering price per share in the Qualified Offering (the "Qualified Offering Price"). Alternatively, upon a Mandatory Conversion, the holders of the Debentures may elect to exchange their Debentures for newly issued convertible preferred securities at a price per share equal to the Qualified Offering Price or the five-day VWAP of the Common Stock prior to the date that is 181 days after the closing of the Qualified Offering.

Notwithstanding the preceding, holders of Debentures shall have the right to require satisfaction of up to 40% of all amounts outstanding under the Debentures, in cash, at the time of a Qualified Financing. The Debentures also contain certain price protection provisions providing for adjustment of the number of shares of Common Stock issuable upon conversion of the Debentures in case of certain future dilutive events or stock-splits and dividends.

Warrants

The Warrants are exercisable for five years and six months from the earlier of the maturity date of the Debentures and the closing of the Qualified Financing, at an exercise price equal to (i) in the event that a Qualified Offering is consummated prior to the exercise of the Warrant, the price per share at which the Qualified Offering is made ("Qualified Offering Price"), or (ii) in the event that no Qualified Offering has been consummated, the lower of: (A) $0.003 per share and (B) an amount equal to 70% of the average of the VWAP (or 50% of the average of the VWAP if an event of default has occurred and has not been cured) for the Common Stock over the ten Trading Days preceding the date of the delivery of the applicable exercise notice. If there is no effective registration statement covering the resale of the shares underlying the Warrants within 180 days following the closing of the Qualified Offering: (i) exercise may be via cashless exercise, and (ii) 5% additional Warrants will be issued by the Company to the holders for any portion of each month without such effective registration statement.

The Warrants contain certain price protection provisions providing for adjustment of the amount of securities issuable upon exercise of the Warrants in case of certain future dilutive events or stock-splits and dividends.

Security Agreement and Exchanges

The Company’s obligations under the Purchase Agreement, the Debentures and the Exchanged Debentures (defined below) are secured by a first priority lien on all of the assets of the Company pursuant to that certain Security Agreement, dated November 29, 2022 (the "Security Agreement") by and among the Company, the Purchasers and the Collateral Agent. Additionally, in connection with the Offering, holders of certain existing convertible notes and shares of convertible preferred stock of the Company (the "Existing Securities") agreed pursuant to an agreement with the Company to convert the Existing Securities into an aggregate of approximately $13.6 million of debentures ("Exchanged Debentures") and warrants (representing 100% coverage of their original investment amount). Such Exchanged Debentures have the same terms as the Debentures described above, except that the holders are only entitled to repayment in cash of up to 10% of their outstanding amounts upon a Qualified Financing. To incentivize the existing noteholders and holders of convertible preferred stock to convert their Existing Securities, the Company increased the principal amount of such Existing Securities by 15%.

The foregoing description of the terms of the Debentures, the Warrants, the Exchanged Debentures, the Placement Agency Agreement, the Purchase Agreement, the Security Agreement, and the transactions contemplated thereby does not purport to be complete and is qualified in its entirety by reference to the Engagement Letter, the form of Debenture, the form of Warrant, the form of Purchase Agreement, the form of Security Agreement, and the form of Exchanged Debenture, which are included as Exhibits 4.1, 4.2, 4.3, 10.1, 10.2, and 10.3 to this Current Report on Form 8-K and are incorporated herein by reference.

The Offering

Neither the Debentures, Exchanged Debentures, the Warrants, the PA Warrants, nor equity securities issuable upon conversion of the Debentures or Exchanged Debentures or exercise of the Warrants or the PA Warrants, if any, have been registered for sale under the Securities Act of 1933, as amended (the "Securities Act"), and may not be offered or sold in the United States absent registration under the Securities Act or an applicable exemption from the registration requirements. The issuance and sale of the Debentures, Exchanged Debentures, the Warrants, the PA Warrants was made in reliance upon the exemption provided in Section 4(a)(2) of the Securities Act and/or Rule 506(b) of Regulation D promulgated thereunder. No form of general solicitation or general advertising was conducted in connection with the issuance. Each of the Debentures, Exchanged Debentures, the Warrants, the PA Warrants, and equity securities resulting from their conversion or exercise, if any, contain (or will contain, where applicable) restrictive legends preventing the sale, transfer, or other disposition of such securities, unless registered under the Securities Act, or pursuant to an exemption therefrom. The disclosure contained in this Current Report on Form 8-K does not constitute an offer to sell or a solicitation of an offer to buy any securities of the Company, and is made only as required under applicable rules for filing current reports with the Securities and Exchange Commission.

Instil Bio Announces Extension of Cash Runway Beyond 2026 with the Consolidation of R&D Operations to its Manchester, U.K. Site

On February 2, 2023 Instil Bio, Inc. ("Instil" or the "Company") (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing next-generation tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported an extension of its previously reported reduction-in-force to a team of approximately 15 employees in the U.S. to lead global business operations, including the consolidation of clinical manufacturing and trial operations of its CoStAR-TIL to its active Manchester, U.K. operations (Press release, Instil Bio, FEB 1, 2023, View Source [SID1234626784]). Instil’s Manchester, U.K. operations have extensive experience and success in the manufacture and development of TIL and other cell therapy products since 2011. With these changes, Instil expects cash resources to provide runway beyond 2026 and continues to expect initial clinical data from the ITIL-306 program in 2023. Instil is also evaluating opportunities for a potential sale of the Tarzana manufacturing site which would further extend the cash runway.

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"I am confident in the ability of our Manchester team to progress ITIL-306 in the clinic, building on more than a decade of proven experience in manufacturing TIL, including our historical compassionate use program in metastatic melanoma," said Bronson Crouch, CEO of Instil Bio. "The consolidation we announce today, while difficult, is consistent with our responsibilities as an early clinical phase company. We look forward to presenting initial clinical data in 2023 and continuing to progress the CoStAR-TIL platform."

Applied DNA to Report First Quarter Fiscal 2023 Financial Results and Host Investor Conference Call and Webcast on Thursday, February 9, 2023

On February 1, 2023 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in polymerase chain reaction ("PCR")-based technologies, reported that it will release financial results for the three months ended December 31, 2022, after the market closes on Thursday, February 9, 2023 (Press release, Applied DNA Sciences, FEB 1, 2023, View Source;id=253561&p=2256785&I=1206939-c7Z3G6f3m8 [SID1234626751]). The Company will host a conference call for the investment community to discuss its results and answer questions at 4:30 p.m. ET.

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Date & Time: Thursday, February 9 @ 4:30 p.m. ET

Dial In (ask to be joined into the Applied DNA Sciences call):

Domestic callers (toll free): 844-887-9402
Canadian callers (toll free): 866-605-3852
International callers: 412-317-6798
Live webcast: View Source
A telephonic replay of the conference call will be available for 1 week following the conclusion of the live call:

Replay for domestic callers (toll free): 877-344-7529, replay access code 2079390
Replay for Canadian callers: 855-669-9658, replay access code 2079390
An archived webcast replay of the conference call will be available for 1 year following the conclusion of the live call: View Source

An accompanying slide presentation will be embedded in the webcast (live and replay) and can also be accessed in the ‘Company Events’ section of the ‘News & Events’ tab of the Applied DNA investor relations website at View Source

JAYPIRCA™ (pirtobrutinib) Now Available from Onco360 for the Treatment of Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma (MCL) after at least Two Lines of Systemic Therapy, Including a BTK Inhibitor

On February 1, 2023 Onco360, the nation’s leading independent Specialty Pharmacy, reported that it has been selected by Eli Lilly to be a specialty pharmacy partner for JAYPIRCA (pirtobrutinib), which is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor (BTKi) (Press release, Onco360, FEB 1, 2023, View Source [SID1234626750]). This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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"Onco360 is excited to announce our partnership with Eli Lilly and become a specialty pharmacy provider for JAYPIRCA patients," said Benito Fernandez, Chief Commercial Officer, Onco360. "We are committed to supporting the highly specialized needs of patients battling relapsed/refractory mantle cell lymphoma which has failed prior lines of systemic therapy across the United States."

According to the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program, it is estimated that 80,470 new cases of Non-Hodgkin Lymphoma (NHL) will be diagnosed in 2022 in the United States with a corresponding 20,250 deaths in 2022.1 According to the National Comprehensive Cancer Network (NCCN) Guidelines for the Treatment of B-Cell Lymphomas, 3-5% of annual new NHL diagnoses are mantle cell lymphoma (MCL) cases. MCL is thought to possess the unfavorable characteristics of both indolent and aggressive NHL subtypes owing to the incurability of disease with conventional chemotherapy and a typically more aggressive disease course compared to indolent lymphomas. The five-year overall survival (OS) for MCL ranges from 50-70% dependent upon stage of disease.2

JAYPIRCA, a non-covalent BTKi, is commercialized by Eli Lilly. The FDA approval of JAYPIRCA is based on results Phase I/II BRUIN trial (NCT03740529), which was an open-label, single-arm study that, in part, evaluated the efficacy/safety of JAYPIRCA in 120 patients with relapsed/refractory MCL who were previously treated with BTKi therapy. JAYPIRCA administration resulted in a 50% overall response rate (ORR) in the aforementioned patient population. The most common adverse reactions (> 15%) in patients with MCL are fatigue, musculoskeletal pain, diarrhea, edema, dyspnea, pneumonia, and bruising.3

Ellipses Pharma Announces FDA Approval of IND Application for EP0042 for Patients With Acute Myeloid Leukaemia

On February 1, 2023 Ellipses Pharma ("Ellipses"), a global drug development company focused on accelerating the development of cancer medicines and treatments through an innovative drug development model, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for EP0042, a dual FLT-3 and Aurora kinase inhibitor (Press release, Ellipses Pharma, FEB 1, 2023, View Source [SID1234626749]).

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EP0042 is being developed as a new potential treatment to combat acquired resistance to FLT3 inhibitors in patients with AML. Around one third of patients with AML are diagnosed with FLT3-mutations, which are associated with a higher risk of relapse and poor clinical outcome.1

This approval will allow Ellipses to expand its ongoing first in human phase 1/2 clinical trial, which is currently undergoing its dose ranging phase. Once a recommended Phase 2 dose is confirmed, Ellipses will continue to evaluate EP0042 as a monotherapy and explore EP0042 in combination with established standard treatments.

In December 2022, Ellipses presented preliminary data from this ongoing study at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which demonstrated that EP0042 had acceptable safety and tolerability with evidence of prolonged disease control in a number of heavily pre-treated patients.2

Dr Rajan Jethwa, Chief Executive Officer & Founder of Ellipses, commented:
"This FDA approval of EP0042’s Investigational New Drug application allows us to open additional trial sites in the world’s foremost pharmaceutical market. This will help us in achieving our strategic goal of bringing potential new treatment options to patients in need at unprecedented speed, whilst also allowing us to engage with key industry and academic partners. The data we presented in December at ASH (Free ASH Whitepaper), one of the leading conferences in our sector, demonstrated the potential of EP0042, and as a team we are now focused on doing all we can to progress this potential towards reality."

Professor Tobias Arkenau, Global Head of Drug Development and Chief Medical Officer, Ellipses Pharma commented:
"We are delighted to continue progressing through the regulatory pathway for EP0042, and this FDA IND approval is another successful milestone for our team. We will now work with our clinical partners to bring US sites online as quickly as possible as we look to continue this positive momentum in EP0042, and indeed across our broader portfolio."

EP0042’s ongoing clinical-stage study follows earlier drug discovery and development work led by The Institute of Cancer Research, London, which was funded by organisations including The Institute of Cancer Research, Breast Cancer Now and Cancer Research UK.

About EP0042

EP0042 is a dual FLT3 and Aurora kinase inhibitor under development as a new treatment for AML patients who have developed FLT3 inhibitor resistance. Dual inhibition of FLT3 and Aurora kinase has been shown to overcome acquired resistance to selective FLT3 inhibition both in vitro and in vivo.3

About acute myeloid leukaemia

Acute myeloid leukaemia (AML) is a cancer of the bone marrow, which begins to produce excess volumes of monocytes and granulocytes. It is one of the most common types of leukaemia in adults. Approximately 20,000 patients are diagnosed with AML in the US each year,4 and a further 18,000 patients in Europe, with around 40% of cases being diagnosed in people over the age of 75.5 The 5-year survival rate following an initial diagnosis is currently 15%.6