On March 8, 2023 Adhera Therapeutics, Inc. (the "Company") reported that it has entered into a Securities Purchase Agreement ("SPA") with an accredited investor pursuant to which the Company issued and sold the investor a non-convertible Original Issue Discount Senior Secured Promissory Note (a "Note") in the principal amount of $214,285.72 and 424,652 Common Stock Purchase Warrants ("Warrants") for total gross proceeds of $150,000 The proceeds from these financings were used for working capital purposes (Filing, 8-K, Adhera Therapeutics, MAR 8, 2023, View Source [SID1234628327]).

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In connection with the January financing, the Company also agreed to increase the principal amount of prior Original Issue Discount Promissory Notes issued to the investors in May 2022 (the "Prior Notes") by 25%, from a total of $1,000,000 in principal to $1,250,000 in principal (not including accrued and unpaid interest). The Prior Notes rank pro rata with the new Notes with respect to interest payments. The terms of the Prior Notes are summarized in the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2022 under "Part II. – Item 5. – Other Information," and a form of the Prior Notes is filed as Exhibit 10.4 thereto.

The terms of the Notes and Warrants are summarized below.

The Notes are due on the earlier of (i) the 12 month anniversary of the issuance date, and (ii) the date on which the Company completes a public offering for cash of common stock and/or common stock equivalents which results in the listing of the Company’s common stock on a "national securities exchange" as defined in the Securities Exchange Act of 1934 (a "Qualified Financing"), provided that unless there is an event of default, the Company may extend the maturity date by six months in its discretion. The Notes bear interest at 8% per annum, payable monthly, subject to an increase to 15% in case of an event of default as provided for therein. Furthermore, at any time before the 12 month anniversary of the date of issuance of a Note, the Company may, after providing written notice to the holder, prepay all of the then outstanding principal amount of the Note for cash in an amount equal to the sum of 105% of the then outstanding principal amount of the Note, accrued but unpaid interest and all liquidated damages and other amounts due in respect of the Note (if any).

The Notes may, at the discretion of the Company, be converted into shares of a new class of convertible preferred stock of the Company (the "Convertible Preferred Stock") on the closing date of the Qualified Financing. In the event of the conversion, the holder will receive a number of shares of Convertible Preferred Stock equal to the quotient obtained by dividing (i) the unpaid principal amount of this Note (together with any interest accrued but unpaid thereon) by (ii) the closing price of the securities issued in the Qualified Financing on the closing date of the Qualified Financing. Upon issuance, the conversion price of the Convertible Preferred Stock (the "Preferred Conversion Price") will be equal to the closing price of the securities issued in the Qualified Financing, subject to adjustment.

The Notes provide for certain customary events of default which include failure to maintain the required reserve of shares for the Warrants, a restatement of the financial statements of the Company resulting in a reduction to the stock price by an enumerated threshold, and certain other customary events of default, subject to certain exceptions and limitations. Upon an event of default, the Notes will become immediately due and payable at a 125% premium, which will be reduced to 100% if the event of default occurs while the Company’s common stock is listed on a national securities exchange.

The Notes contain customary restrictive covenants which apply for as long as at least 75% of the Notes remain outstanding, including covenants against incurring new indebtedness or liens, repurchasing shares of common stock or common stock equivalents, paying dividends or distributions on equity securities, and transactions with affiliates, subject to certain exceptions and limitations. In addition, the SPA imposes certain additional negative covenants and obligations on the Company, including a prohibition on filing a registration statement (other than on Form S-8) unless at least 30% of the Notes have been repaid as of such filing, a prohibition on incurring new indebtedness at any time while any Notes are outstanding, and a 90-day restriction against issuing shares of common stock or common stock equivalents, subject to certain exceptions and limitations.

Under the SPA, the Company also granted each investor the right to participate in future financings that are exempt from registration under the Securities Act of 1933 (the "Securities Act") in an amount equal to 15% of such financings, which right has a term equal to the earlier of (i) the 24 month anniversary of the SPA, and (ii) the date the Notes are no longer outstanding. The SPA also provides the investors with most-favored nations treatment, giving them the right to amend their securities if the Company issues securities with more favorable terms while the investor’s securities are outstanding, subject to certain exceptions and limitations.

The Warrants are exercisable for a period of five-years and six months from issuance at an exercise price of $0.82 per share, subject to certain limitations including beneficial ownership limitations, and subject to adjustment including downward adjustment upon a dilutive issuance of securities at a per-share price that is below the exercise price. Unless the holder’s sale of shares of common stock issuable upon exercise of the Warrants at prevailing market prices (not at a fixed price) is registered on an effective registration statement under the Securities Act, the Warrants may be exercised cashlessly

The Company’s obligations under the Notes are secured by a lien on all assets of the Company and its subsidiaries pursuant to Security Agreements each dated the date of the respective SPA (the "Security Agreement").
The SPA requires a reserve of authorized but unissued shares equal to four times the number of shares issuable to the investors upon exercise of the Warrants, subject to reduction as the Warrants are exercised.

Aegis Capital Corp. (the "Placement Agent") served as placement agent in the financings and received a cash commission in the amount of 10% of the gross proceeds, or $15,000.

On March 8, 2023 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer, reported financial results for the three months and full year ended December 31, 2022, and highlighted upcoming anticipated milestones (Press release, TScan Therapeutics, MAR 8, 2023, View Source [SID1234628321]).

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"This will be a pivotal year for TScan. We expect to have patients enrolled in all three arms of our hematologic malignancies program and plan to provide a clinical update by mid-year," said David P. Southwell, President and Chief Executive Officer. "Our solid tumor program is also advancing to the clinic this year. TScan is the first company to launch a trial that will treat cancer patients with multiplexed TCR-T cell therapies matched to the HLA and target profile of their tumors. This approach should help overcome target and HLA loss, which are known mechanisms of resistance. Following the clearance of the first three INDs for our solid tumor program in January, including our T-Plex IND enabling the combination of different TCRs, we are rapidly populating our ImmunoBank to enable a broad range of multiplexed T cell therapies for patients. We plan to file INDs for four additional solid tumor TCRs throughout the year. With $120 million of cash on hand, we are well capitalized to execute on these upcoming milestones."

"We are now actively recruiting patients into our hematologic malignancies program," commented Debora Barton, M.D., Chief Medical Officer. "Several sites are currently recruiting patients, with additional sites to be activated throughout this year. We expect that we will reach the recommended Phase 2 dose for TSC-100 and TSC-101 and report further clinical safety and biomarker data for the program by the end of 2023. Many of the clinical sites enrolling patients in our hematologic malignancies program are planning to join our solid tumor study. That study is planned to begin enrolling patients into the screening protocol by the middle of this year, with patient dosing expected to commence in the third quarter. We plan to share initial safety and biomarker data for single agent TCRs by the end of 2023, with initial multiplexing data expected in the first half of 2024."

"TScan’s TCR-T cell products have been designed to improve upon first-generation TCR-T in two important ways: by increasing depth of response and by extending duration of response," said Gavin MacBeath, Ph.D., Chief Scientific and Operations Officer. "Our non-viral, in-house manufacturing platform allows us to add enhancements to our TCRs, including CD8α/β to

increase depth of response by enlisting helper T cells, and a dominant negative form of TGFβRII to overcome inhibition of T cells by TGFβ in the hostile tumor microenvironment. To address antigen heterogeneity and HLA loss, our recently approved T-Plex IND allows us to multiplex our enhanced TCR-Ts across targets and HLA types at the same time, bringing us closer to our goal of providing customized TCR-T therapy to treat patients with a wide variety of solid tumor malignancies."

Recent Corporate Highlights

·
TScan filed three investigational new drug (IND) applications with the U.S. Food and Drug Administration (FDA) for its solid tumor program in December 2022. The IND applications for T-Plex, TSC-204-A0201, and TSC-204-C0702 have now been cleared by the FDA. T-Plex will serve as the primary IND for TScan’s solid tumor program, enabling customized mixtures of TCR-Ts to be administered to patients based on tumor antigen positivity and HLA expression. Along with T-Plex, the FDA has approved secondary INDs for two TCR-T products, TSC-204-A0201 and TSC-204-C0702, that target melanoma-associated antigen 1 (MAGE-A1) presented on HLA A*02:01 and C*07:02, respectively. MAGE-A1 is a validated cancer-associated antigen overexpressed in 45% of head and neck cancers and 50% of melanoma, cervical, and non-small cell lung cancers. TScan believes that TSC-204-C0702 is the first TCR to enter clinical trials for an epitope of MAGE-A1 presented on an HLA type other than A*02:01.

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In December 2022, the Company presented a poster on the clinical trial design and trial in progress for the Phase 1 umbrella trial of TSC-100 and TSC-101 to treat residual leukemia and prevent relapse after hematopoietic cell transplant (HCT) at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2022.

·
In November 2022, the Company presented two posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting:

o
Discovery of PRAME-specific TCR-T cell therapy candidates for the treatment of solid tumors, presented by Mollie Jurewicz, Ph.D.
o
Multiplexed TCR-T cell therapy targeting MAGE-A1 and PRAME enhances the activity of adoptive T cell therapy in pre-clinical models, presented by Antoine Boudot, Ph.D.

·
During the fourth quarter of 2022, TScan was named the best mid-sized biotechnology company in the Top Places to Work for 2022 by The Boston Globe. Top Places to Work recognizes the most admired workplaces in the state voted on by the people who know them best – their employees. The survey measures employee opinions about their Company’s direction, execution, connection, management, work, pay and benefits, and engagement.

Upcoming Anticipated Milestones

Hematologic Malignancies Program:

·
Expects to enroll patients in all three arms in the Phase 1 umbrella trial (NCT05473910) for TSC-100 and TSC-101 and start reporting preliminary safety and biomarker data mid-year 2023.
·
Expects to reach the recommended Phase 2 dose for TSC-100 and TSC-101 and report interim clinical data for the program by the end of 2023.

·
The Company expects to report prevention of relapse data in 2024.

Solid Tumor Program:

·
Anticipate further expansion of the ImmunoBank by filing INDs for four TCRs throughout 2023.
·
Anticipate sharing preliminary safety and biomarker data for the most advanced TCRs by the end of 2023.
·
The Company expects to report initial multiplex therapy data for its first combination of TCRs under T-Plex in the first half of 2024.

Fourth Quarter 2022 Financial Results

Revenue for the three months ended December 31, 2022, was $3.1 million, compared to $2.9 million for the three months ended December 31, 2021 (2021 Quarter). This increase is due to the timing of research activities related to our target discovery collaboration with Novartis (the "Novartis Agreement").

Research and development expenses for the three months ended December 31, 2022, were $15.6 million, compared to $12.6 million for the 2021 Quarter. The increase of $3.0 million was primarily driven by an increase in personnel expense, expansion of leased facilities, and preclinical activities to support solid tumors, and Phase 1 study start-up activities for TSC-100 and TSC-101.

General and administrative expenses for the three months ended December 31, 2022, were $6.1 million, compared to $4.4 million for the 2021 Quarter. The increase of $1.7 million in general and administrative expenses was primarily driven by increased personnel and facilities related costs to support the progress of the Company into the clinic.

For the three months ended December 31, 2022, TScan Therapeutics reported a net loss of $18.7 million, compared to a net loss of $14.2 million for the 2021 Quarter.

Full Year 2022 Financial Results

As of December 31, 2022, TScan Therapeutics had cash and cash equivalents of $120.0 million excluding $5.0 million of restricted cash. Based on current operating plans, the Company believes that existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into the second quarter of 2024.

Revenue for the year ended December 31, 2022, was $13.5 million, compared to $10.1 million for the year ended December 31, 2021 (2021 Period). This increase is due to the timing of research activities related to the Novartis Agreement.

Research and development expenses for the year ended December 31, 2022, were $59.8 million, compared to $45.0 million for the 2021 Period. The increase of $14.8 million was primarily driven by an increase in personnel expense, expansion of leased facilities, preclinical activities to support solid tumors, and Phase 1 study start-up activities for TSC-100 and TSC-101.

General and administrative expenses for the year ended December 31, 2022, were $20.4 million, compared to $13.8 million for the 2021 Period. The increase of $6.5 million in general and administrative expenses was primarily driven by increased personnel and facilities related costs to support the progress of the company into the clinic

For the year ended December 31, 2022, TScan Therapeutics reported a net loss of $66.2 million, compared to a net loss of $48.6 million for the 2021 Period

As of December 31, 2022, the Company had issued and outstanding a combined total of 24,225,954 shares of voting common stock and non-voting common stock.

On March 8, 2023 Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, reported entry into a Cooperative Research and Development Agreement (CRADA) with the U.S. National Cancer Institute (NCI), part of the National Institutes of Health (NIH), to investigate TT11X, Tessa’s allogeneic "off-the-shelf" CD30.CAR-modified Epstein-Barr virus-specific T-cell (EBVST) therapy, in multiple subtypes of non-Hodgkin lymphoma (Press release, Tessa Therapeutics, MAR 8, 2023, View Source [SID1234628320]).

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Under terms of the CRADA, Tessa will collaborate with the NCI’s Division of Cancer Treatment and Diagnosis (DCTD) to identify potential opportunities to expand the applicability of TT11X as a treatment of non-Hodgkin lymphoma. In this collaboration, NCI Cancer Therapy Evaluation Program (CTEP) will serve as the regulatory sponsor and conduct mutually approved clinical trials through NCI funded clinical network groups and using drug supply and other necessary support provided by Tessa. Tessa is currently advancing a Phase 1 clinical trial in the United States investigating TT11X in CD30-positive lymphomas. Data from the Phase 1 study presented at the 64th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) demonstrated TT11X to be well-tolerated at all dosing levels, eliciting a 79% overall response rate and 43% complete response rate among 14 heavily pre-treated CD30-positve Hodgkin lymphoma patients.

"We are pleased to enter into a CRADA with NCI.," said Tessa President and CEO Thomas Willemsen. "The collaboration is a strong incentive and encouragement for us to continue developing our scientific platform and will significantly expand our ability to conduct clinical trials with TT11X in a wide number of indications. Based on compelling safety and efficacy data from the Phase 1 trial of TT11X in patients with CD30-positive Hodgkin lymphoma, we believe there is a substantial opportunity to direct our ‘off-the-shelf’ therapy to other CD30-positive subtypes of non-Hodgkin lymphoma, where there is high patient need. We look forward to working with the clinical research team at the DCTD as well as DCTD’s funded extramural clinical network groups and benefitting from their breadth of research experience and scientific resources."

Tessa is advancing a pipeline of products that utilize CD30.CAR-modified EBVSTs, including its lead allogeneic cell therapy, TT11X, which is being co-developed with the Baylor College of Medicine for the treatment of relapsed or refractory CD30-positive lymphomas (NCT04288726). Tessa plans to extend its allogeneic EBVST platform to other cancer indications, including solid tumors.

Tessa’s proprietary "off-the-shelf" CD30.CAR-EBVST allogeneic cell therapy platform is based on decades-long research and development by researchers at Baylor College of Medicine into the unique properties of virus-specific T-cells (VSTs). These highly specialized T cells have the ability to recognize and kill infected cells while activating other parts of the immune system for a coordinated response. CD30.CAR-modified allogeneic EBVSTs without gene editing have demonstrated a strong safety profile and efficacy in early trials with minimal risk of graft-versus-host disease (GVHD).

On March 8, 2023 Synlogic, Inc. (Nasdaq: SYBX), the leading company advancing therapeutics based on synthetic biology, reported that Aoife Brennan, M.B. Ch.B., Synlogic President and Chief Executive Officer, and members of the leadership team, will provide a company presentation at the Oppenheimer 33rd Annual Healthcare Conference being held virtually from March 13-15, 2023 (Press release, Synlogic, MAR 8, 2023, View Source [SID1234628319]). Presentation details are provided below:

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Date: Monday, March 13, 2023
Time: 3:20-3:50 p.m. ET
Webcast: Register for the presentation here.

A replay of the presentation will be available for 90 days. Recorded presentations, if available, can be found on the Events section of the Synlogic website.

On March 8, 2023 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of tumor-directed oncolytic immunotherapies, reported that members from the Replimune management team will present and host investor meetings at the following two conferences (Press release, Replimune, MAR 8, 2023, View Source [SID1234628318]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Barclays Global Healthcare Conference
Date: Wednesday, March 15, 2023
Fireside Chat Time: 2:05 pm EDT
Location: The Loews Miami Beach Hotel, Miami, FL

Jefferies Biotech on the Bay Summit
Date: Thursday, March 16, 2023
Location: 1 Hotel South Beach, Miami, FL
In-person 1×1 investor meetings only