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Miravo Healthcare™ Enters into Definitive Agreement to be Acquired by Searchlight Pharma Inc.

On December 23, 2022 Nuvo Pharmaceuticals Inc. d/b/a Miravo Healthcare (TSX:MRV; OTCQX:MRVFF) ("Miravo" or the "Company") and Searchlight Pharma Inc., a private Canadian-based specialty healthcare company ("Searchlight" or the "Purchaser"), reported that they have entered into a definitive agreement (the "Arrangement Agreement") pursuant to which the Purchaser has agreed to acquire all of the issued and outstanding common shares of the Company (the "Company Shares") in exchange for cash consideration of $1.35 per Company Share, representing a 79.8% premium to the 90-day volume-weighted average trading price of the Company Shares on the Toronto Stock Exchange for the period ended December 22, 2022 (Press release, Nuvo Pharmaceuticals, DEC 23, 2022, View Source [SID1234625573]). The transaction will be completed by way of an arrangement under Section 182 of the Business Corporations Act (Ontario) (the "Arrangement"). In connection with the closing of the Arrangement, all of the indebtedness (including convertible debt) owed to funds affiliated with Deerfield Management Company, in the aggregate principal amount of approximately US$78.1 million, will be repaid in full and the Company’s outstanding warrants will be cancelled for no consideration.

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The purchase price of $1.35 per Company Share represents a total equity value of the Company, on a fully diluted basis, of approximately $15.8 million and a total enterprise value of the Company of approximately $91.4 million.

"We are pleased to present an opportunity for shareholders of the Company to realize value at a significant premium to the trading price of the Company Shares," commented Jesse Ledger, Miravo’s President & CEO. "After careful deliberation, the Company’s Board of Directors has unanimously concluded that the transaction is in the best interests of the Company and is fair to the Company’s shareholders. Not only does an all-cash transaction provide immediate and certain value to shareholders, it also allows important healthcare products like Blexten, Cambia and Suvexx to remain available to healthcare providers and patients through the enhanced scale of the Searchlight business."

"This transaction presents a unique opportunity to add critical mass to Searchlight’s expanding business, and importantly, to onboard a proven team that we think shares a similar culture and set of foundational values," said Mark Nawacki, President and CEO at Searchlight. "We are excited that Miravo will add a portfolio of growing, category-leading brands in new therapeutic areas to our commercial business and that we will expand and have team members and offices in Montreal, Toronto and Dublin. We are confident that Miravo’s depth of talent, competencies and resources, which we are acquiring through this transaction, will enhance our competitiveness and ensure a seamless transition to patients and end customers."

Recommendation of Miravo Board of Directors

The board of directors of the Company (the "Board"), after receiving legal and financial advice, has unanimously determined that the Arrangement is in the best interests of the Company and is fair to the holders of Company Shares (the "Shareholders"). Accordingly, the Board approved the Arrangement Agreement and recommends that Shareholders vote in favour of the Arrangement at the special meeting of Shareholders to be called and held to approve the Arrangement. In making its recommendation, the Board considered a number of factors, including its receipt of an opinion from Bloom Burton Securities Inc., which concluded that, as at December 22 2022, the consideration payable to the Shareholders pursuant to the Arrangement is fair, from a financial point of view, to the Shareholders (the "Fairness Opinion").

Additional Transaction Details

Each of the directors and executive officers of the Company who are Shareholders, as well as one of the Company’s significant Shareholders, Red Oak Partners, LLC, who collectively own or control, directly or indirectly, approximately 23.16% of the Company Shares, have entered into voting support agreements with the Purchaser to, among other things, vote their Company Shares in favour of the Arrangement.

In order to become effective, the Arrangement will require court approval and must be approved by: (i) at least two-thirds of the votes cast by Shareholders, and (ii) a simple majority of the votes cast by Shareholders, excluding for this purpose votes attached to Company Shares held by persons described in items (a) through (d) of Section 8.1(2) of Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transaction.

In addition to court and shareholder approval, the Arrangement is subject to, among other things, the satisfaction or waiver of certain closing conditions customary in transactions of this nature. Subject to the satisfaction of such conditions, the Arrangement is expected to close in the first quarter of 2023.

The Arrangement Agreement includes representations, warranties and covenants typical of a transaction of this nature, along with customary provisions relating to non-solicitation, subject to customary "fiduciary out" provisions that entitle the Company to consider and accept a superior proposal if the Purchaser does not match such proposal. The Company has agreed to pay a termination fee to the Purchaser, if the Arrangement Agreement is terminated in certain circumstances, including if the Company enters into an agreement with respect to a superior proposal or if the Board withdraws its recommendation with respect to the Arrangement.

The Arrangement is to be funded in part with equity commitments from investors of the Purchaser and committed debt financing by certain Canadian lenders. The Purchaser has agreed to pay a reverse termination fee to the Company if the Arrangement Agreement is terminated in certain circumstances, including if the Purchaser materially breaches a representation or warranty or fails to materially perform a covenant, which breach is not cured, and if after all other conditions to the closing of the Arrangement have been satisfied or waived, the Purchaser is not in a position to fund the closing of the Arrangement.

The Arrangement Agreement, which describes the full particulars of the Arrangement, will be made available on SEDAR (www.sedar.com) under the issuer profile of the Company. Additional information regarding the terms of the Arrangement Agreement, the Fairness Opinion and the background of the transaction will be provided in a management information circular of the Company (the "Circular") to be filed with applicable regulatory authorities and mailed to Shareholders in accordance with applicable securities laws. Shareholders and other interested parties are advised to read the materials relating to the Arrangement, including the Arrangement Agreement and the Circular when they become available.

Advisors

Bloom Burton Securities Inc. is acting as financial advisor to the Board and Goodmans LLP is serving as legal advisor to the Company. PricewaterhouseCoopers Corporate Finance Inc. is acting as financial advisor to Searchlight, with transaction support and tax advisory services provided by PricewaterhouseCoopers LLP, and McCarthy Tétrault LLP is serving as legal advisor to Searchlight.

HTG Molecular Diagnostics Announces Pricing of a $10 Million Public Offering

On December 22, 2022 HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company advancing precision medicine through its innovative transcriptome-wide profiling and advanced medicinal chemistry technology, reported that the pricing of a public offering of an aggregate of 1,290,322 shares of its common stock (or pre-funded warrants in lieu thereof), Series A-1 warrants to purchase up to 1,290,322 shares of common stock and Series A-2 warrants to purchase 1,290,322 shares of common stock, at a combined public offering price of $7.75 per share (or pre-funded warrant) and accompanying warrants (Press release, HTG Molecular Diagnostics, DEC 23, 2022, View Source [SID1234625572]). The Series A-1 warrants will have an exercise price of $7.50 per share, will be exercisable immediately upon issuance and will expire five years from the date of issuance, and the Series A-2 warrants will have an exercise price of $7.50 per share, will be exercisable immediately upon issuance and will expire twenty-four months from the date of issuance. The closing of the offering is expected to occur on or about December 23, 2022, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $10.0 million. The Company intends to use the net proceeds from this offering for general corporate purposes, which may include research and development expenses, clinical trial expenses, capital expenditures and working capital.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-268681), which was declared effective by the Securities and Exchange Commission (the "SEC") on December 21, 2022. The offering is being made only by means of a prospectus which forms a part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

Equillium and Metacrine Mutually Agree to Terminate Definitive Merger Agreement

On December 23, 2022 Equillium, Inc. (Nasdaq: EQ) and Metacrine, Inc. reported the mutual termination of their previously announced definitive merger agreement (Press release, Equillium, DEC 23, 2022, View Source [SID1234625571]).

"Equillium first set out to acquire Metacrine in an all-stock transaction in early 2022, with the intent of adding cash runway in a very difficult financing market," said Bruce Steel, chief executive officer of Equillium. "However, our recent strategic partnership with Ono Pharmaceutical is expected to extend our cash runway into 2025, and possibly further with potential option exercise and milestone payments. We therefore find ourselves in a strong financial position, and with our pipeline of wholly-owned multi-cytokine inhibitors in the clinic we are excited about the opportunity to unlock value in our programs during 2023 and beyond."

Additional information regarding the termination of the definitive merger agreement is set forth in a Current Report on Form 8-K filed by Equillium with the Securities and Exchange Commission today and is available at www.sec.gov and on Equillium’s website under the heading "Investors."

CytoDyn to Hold Webcast to Discuss the Performance of Leronlimab in Clinical Trials and Recent Charges Against Former CEO

On December 23, 2022 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications,reported that it will hold a webcast on December 29, 2022 at 8:00 a.m. Pacific Time (11:00 a.m. Eastern Time) to discuss the performance of leronlimab in its clinical trials and the recent charges against its former CEO Nader Pourhassan, who was previously terminated on January 24, 2022, and has had no affiliation with the Company since that time (Press release, CytoDyn, DEC 23, 2022, View Source [SID1234625570]).

Webcast Access Information

Date: Thursday, December 29, 2022
Time: 8:00 a.m. Pacific Time / 11:00 a.m. Eastern Time
Access: View Source
The replay will be available approximately 60 minutes after the conclusion of the webcast and can be accessed via the above link until January 29, 2023.

About CytoDyn
CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. CytoDyn is studying leronlimab in multiple therapeutic areas, including infectious disease, cancer, and autoimmune conditions.

Immutep Announces Successful Meeting with the FDA on Eftilagimod Alpha plus
Chemotherapy for the Treatment of Metastatic Breast Cancer

On December 23, 2022 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapiesfor cancer and autoimmune disease, reported the results of a positive follow-up Type C meeting with the US Food and Drug Administration (FDA) regarding late-stage clinical development plans for its first-in-class soluble LAG-3 protein, eftilagimod alpha ("efti"), in conjunction with standard-of-care chemotherapy for the treatment of metastatic breast cancer (MBC) (Press release, Immutep, DEC 23, 2022, View Source [SID1234625567]). The Company and the FDA have agreed to an integrated Phase II/III trial design that will help inform a Biologics License Application (BLA).

Based on the encouraging efficacy, favourable safety, and learnings from the randomised AIPAC Phase IIb trial, which administered efti and chemotherapy on different days and ceased chemotherapy at six months, patients will receive efti and paclitaxel on the same day and treatment will continue until disease progression. The patient population has also been expanded to include triple-negative breast cancer (TNBC), an aggressive form of breast cancer with limited treatment options.

Immutep CEO, Marc Voigt, commented: "As recently announced, our late-stage clinical development efforts for efti are now focused on frontline NSCLC in combination with anti-PD-1 therapy, given the large market opportunity and need for more durable and tolerable options. With this said, progress reported to date with the FDA and EMA provides Immutep and its potential partners flexibility for late-stage clinical development of efti plus standard-of-care chemotherapy to address the high unmet need for metastatic breast cancer patients, while maintaining their quality of life as was shown in the AIPAC trial."

Immutep CSO & CMO, Dr. Frédéric Triebel, stated: "We are excited about efti’s promise to stimulate the immune system and improve standard-of-care chemotherapy by activating dendritic cells to present antigens from chemo-induced cancer cell death to cytotoxic T cells. Our engagement with regulatory agencies to establish the optimal design of a registrational trial has steadily progressed during the year and we are pleased with the FDA’s positive feedback during this follow up meeting. The chosen trial design provides us with a very risk-balanced approach before potentially embarking on the Phase 3 part of this study."

Subject to regulatory and ethic committee feedback, the Phase II portion of the MBC trial is expected to begin during the first quarter of 2023. In addition to the biologically active 30mg dosing for efti, the Company and FDA have agreed to test 90mg efti dosing in combination with paclitaxel driven predominantly by the excellent safety profile of the AIPAC Phase IIb trial, along with the FDA’s Project Optimus initiative in oncology. The trial design has a safety lead in of 6 to 12 patients, given the higher 90mg dosing of efti, followed by 58 patients for the randomised Phase II portion of the trial. Depending on Phase II results and resources, the Phase III portion will follow and be directed to MBC patients most likely to benefit from treatment, taking into consideration the strong overall survival results in pre-specified and post-hoc subgroups from the AIPAC trial.

The Phase II portion of the MBC trial and the initiation of the registrational trial in 1st line NSCLC are included in the budget of the Company and have no impact on its expected cash runway to the end of the 1st half of calendar year 2024.

About Eftilagimod Alpha (Efti)

Efti is Immutep’s proprietary soluble LAG-3 clinical stage candidate that is a first-in-class antigen presenting cell (APC) activator for the treatment of cancer, capitalising on LAG-3’s unique characteristics to stimulate both innate and adaptive immunity. Efti binds to and activates antigen presenting cells via MHC II molecules leading to expansion and proliferation of CD8+ (cytotoxic) T cells, CD4+ (helper) T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and HER2–/HR+ metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track Designation in 1st line HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA).