VAXINIA trial advances to Combination Cohort 1 & Monotherapy Cohort 3

On February 2, 2023 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, is pleased to reported that its Phase 1 MAST (metastatic advanced solid tumours) study evaluating the safety of novel cancer-killing virus CF33-hNIS (VAXINIA) has cleared cohort 2 of both the intravenous (IV) and intratumoral (IT) arms of the monotherapy trial, allowing it to open cohort 1 of the combination study (with Pembrolizumab) and cohort 3 for both arms of the monotherapy dose escalation (Press release, Imugene, FEB 2, 2023, https://mcusercontent.com/e38c43331936a9627acb6427c/files/6edfd8aa-45a9-b542-d933-70735f592bbf/Imugene_VAXINIA_trial_advances_to_Combination_Cohort.pdf [SID1234626725]).

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The company announced the first patient had been dosed in IV cohort 2 on 5 December 2022, with the trial continuing its unimpeded progress since.

Imugene MD & CEO Leslie Chong said: "Early data arising from our patients dosed at low levels with our CF33 oncolytic virus have indicated immune activation is occurring in the tumour microenvironment, turning the tumour from ‘immunologically cold to hot’. This is a perfect time to introduce an immune checkpoint inhibitor such as pembrolizumab."

The multicenter Phase 1 MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models¹.

The patients treated to date in the monotherapy group have received the lowest doses of VAXINIA and have demonstrated acceptable safety, allowing new study participants to receive it in combination with the immunotherapy pembrolizumab. Overall, the study aims to recruit up to 100 patients across approximately 10 trial sites in the United States and Australia.

The clinical trial is titled "A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33-hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumours (MAST)." The trial commenced in May 2022 and is anticipated to run for approximately 24 months while being funded from existing budgets and resources.

Boston Scientific Announces Results For Fourth Quarter And Full Year 2022

On February 1, 2023 Boston Scientific Corporation reported net sales of $3.242 billion during the fourth quarter of 2022, growing 3.7 percent on a reported basis, 8.7 percent on an operational1 basis and 7.1 percent on an organic2 basis, all compared to the prior year period (Press release, Boston Scientific, FEB 1, 2023, View Source [SID1234633022]). Included within organic results is a negative approximately 200 basis point impact associated with unplanned reserves established for Italian government payback provisions3. The company reported GAAP net income available to common stockholders of $126 million or $0.09 per share (EPS), compared to $80 million or $0.06 per share a year ago and achieved adjusted4 EPS of $0.45 for the period, which includes an approximate $0.04 negative impact of the Italian payback, compared to $0.45 a year ago.

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For the full year 2022, the company generated net sales of $12.682 billion, growing 6.7 percent on a reported basis, 11.1 percent on an operational1 basis and 8.7 percent on an organic2 basis, including a negative 50 basis point impact associated with the Italian government payback provisions, all compared to the prior year period. The company reported GAAP net income available to common stockholders of $642 million or $0.45 per share, compared to $985 million or $0.69 per share a year ago, and delivered full year adjusted4 EPS of $1.71, including the approximate $0.04 negative impact of the Italian payback, compared to $1.63 a year ago.

"Our global team continues living our mission to transform lives, and I’m proud of the results we achieved in the fourth quarter and throughout 2022," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "In the year ahead we remain committed to our goals of delivering new, meaningful innovations to benefit patients globally while continuing to deliver differentiated financial performance."

Fourth quarter financial results and recent developments:

Reported net sales of $3.242 billion, representing an increase of 3.7 percent on a reported basis, compared to the company’s guidance range of 2 to 4 percent; 8.7 percent on an operational basis; and 7.1 percent on an organic basis, compared to the company’s guidance range of 7 to 9 percent, all compared to the prior year period.
Reported GAAP net income available to common stockholders of $0.09 per share, compared to the company’s guidance range of $0.23 to $0.28 per share, and achieved adjusted EPS of $0.45 per share, compared to the guidance range of $0.45 to $0.48 per share.
Achieved the following net sales growth in each reportable segment5, compared to the prior year period:
MedSurg: 4.4 percent reported, 8.5 percent operational and organic
Cardiovascular: 6.4 percent reported, 12.1 percent operational and 9.4 percent organic
Achieved the following net sales growth/(declines) in each region, compared to the prior year period:
U.S.: 10.5 percent reported and operational
EMEA (Europe, Middle East and Africa): (0.8) percent reported and 10.8 percent operational
APAC (Asia-Pacific): (4.1) percent reported and 9.8 percent operational
LACA (Latin America and Canada): 14.6 percent reported and 17.7 percent operational
Emerging Markets7: 11.6 percent reported and 23.3 percent operational
Received approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the AGENT Drug Coated Balloon (DCB) in Japan to treat patients with in-stent restenosis (ISR) and coronary small vessel disease (SVD), with launch anticipated in the first half of this year.
Completed enrollment in the CHAMPION-AF clinical trial, a randomized, head-to-head study with 3,000 patients evaluating the safety and efficacy of the WATCHMAN FLX Left Atrial Appendage Closure Device compared to non-vitamin K antagonist oral anticoagulants for stroke prevention in a broad population of patients with non-valvular atrial fibrillation.
Completed enrollment in the SOLIS randomized clinical trial to assess WaveWriter Spinal Cord Stimulator Systems (SCS) for the treatment of patients with chronic low back and/or leg pain who have not undergone spinal surgery (NSBP, Non-Surgical Back Pain/VB, Virgin Back). The study met its primary endpoint; SCS demonstrated superior outcomes compared with Conventional Medical Management at three-month follow-up.
Began enrollment in the ACURATE Prime XL Nested Registry, which is designed to assess outcomes from patients receiving the larger ACURATE Prime Aortic Valve XL within the ACURATE IDE clinical study in the U.S. Also announced, at PCR London Valves, late-breaking data from the European ACURATE neo2 Post Market Clinical Follow-up study supporting the clinical procedural success and safety of the ACURATE neo2 Aortic Valve System to treat patients with severe aortic stenosis, including a high procedural success rate and low rates of mortality and paravalvular leak.
Presented positive data from the ELEGANCE registry during a late-breaking presentation at the 2022 Vascular InterVentional Advances (VIVA) conference, which highlighted that the study is currently exceeding its goal to increase the representation of women and underrepresented minorities in clinical trials for drug-eluting peripheral therapies. Patients enrolled in the registry will be followed for up to five years, allowing for the evaluation of long-term outcomes and the gathering of critical clinical insights into underrepresented patient populations.
Announced agreement to acquire Apollo Endosurgery, Inc. (Nasdaq: APEN) , subject to customary closing conditions, to expand the Boston Scientific endoluminal surgery portfolio and enable a measured entry into the endobariatric market.
Announced strategic investment to acquire majority stake in Acotec Scientific Holdings Limited, a Chinese medical technology company that offers solutions designed for a variety of interventional procedures, subject to customary closing conditions.

GSK delivers strong 2022 performance with full year sales of £29.3 billion +19% AER, +13% CER; Total EPS 371.4p >100% Adjusted EPS of 139.7p +27% AER, +15% CER from continuing operations

On February 1, 2023 GlaxoSmithKline reported that strong 2022 performance with full year sales of £29.3 billion +19% AER, +13% CER; Total EPS 371.4p >100% Adjusted EPS of 139.7p +27% AER, +15% CER from continuing operations
(Press release, GlaxoSmithKline, FEB 1, 2023, View Source [SID1234629799]).

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Highlights
Step change in commercial execution drives strong sales growth across Specialty Medicines and Vaccines
• Sales of £29.3 billion +19% AER, +13% CER. Sales +15% AER, +10% CER excluding COVID-19 solutions
• Specialty Medicines £11.3 billion +37% AER, +29% CER; HIV +20% AER, +12% CER; Oncology +23% AER,
+17% CER; Immuno-inflammation and other specialty +29% AER +20% CER; COVID-19 solutions (Xevudy)
sales £2.3 billion
• Vaccines £7.9 billion +17% AER, +11% CER; Shingrix £3 billion +72% AER, +60% CER
• General Medicines £10.1 billion +5% AER, +1% CER

Prioritised investment and cost discipline support strong growth in operating profit and EPS
• Total continuing operating margin 21.9%. Total EPS 371.4p > 100% primarily reflecting the gain from
discontinued operations arising on the demerger of the Consumer Healthcare business. Total continuing EPS
110.8p +34% AER, +18% CER
• Adjusted operating margin 27.8%. Adjusted operating profit growth +26% AER, +14% CER. This included a
decline in growth from COVID-19 solutions of approximately 3% AER and CER
• Adjusted EPS 139.7p +27% AER, +15% CER. This included a decline in growth from COVID-19 solutions of
approximately 4% AER, 3% CER
• Full-year 2022 cash generated from operations attributable to continuing operations £7.9 billion. Full-year free
cash flow £3.3 billion
R&D delivery and business development supports future growth
• Innovative pipeline of 69 vaccines and specialty medicines based on science of the immune system, with 18 in
phase III/registration
• Potential best in class RSV older adults candidate vaccine filed in US, EU, Japan; Shingrix interim 10-year data
presented at ID Week 2022; acquisition of Affinivax completed, including phase II next-generation vaccine for
pneumococcal disease and use of innovative MAPs technology
• Continued progress in development of long-acting HIV treatments; positive phase II data on N6LS broadlyneutralising antibody presented at HIV Glasgow
• Pivotal phase III trials for gepotidacin antibiotic for uncomplicated UTIs stopped early for efficacy; positive phase
IIb data for bepirovirsen, potential functional cure for chronic hepatitis B; exclusive licence agreement with Spero
Therapeutics for tebipenem Hbr, late-stage antibiotic for complicated UTIs
• Expansion of depemokimab phase III programme with trials for long-acting IL-5 inhibitor in three additional
eosinophil-driven diseases
• 4 approvals anticipated in 2023: RSV OA vaccine (US, EU, JP); Jemperli in 1L endometrial cancer (US);
momelotinib in myelofibrosis (US) and daprodustat in chronic kidney disease (US, EU)
Confident in outlooks for turnover and Adjusted operating profit growth
• 2023 Turnover expected to increase between 6% to 8%; Adjusted operating profit expected to increase between
10% to 12%; EPS expected to increase between 12% to 15%
• 2023 Guidance at CER and excludes any contribution from COVID-19 solutions
• 13.75p dividend declared for the Q4 2022. No change to expected dividend from GSK of 56.5p/share for 2023
Emma Walmsley, Chief Executive Officer, GSK:
"2022 was a landmark year for GSK delivering the step change in performance we committed to, driven by strong
growth in specialty medicines and vaccines, including record sales for Shingrix. We enter 2023 with good
momentum, underpinning confidence in our ambitious sales and profit outlooks for 2026. At the same time, we
continue to build a stronger portfolio and pipeline based on infectious diseases and the science of the immune
system, including our potential new RSV vaccine. This momentum, together with further targeted business
development, means GSK will also be in a strong position to deliver growth from 2026 onwards."

Novartis Fourth Quarter and Full Year 2022

On February 1, 2023 Novartis reported its fourth quarter and full year results (Presentation, Novartis, FEB 1, 2023, View Source [SID1234626840]).

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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.