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Hologic to Showcase Portfolio of Comprehensive Breast and Skeletal Health Solutions at RSNA 2022

On November 25, 2022 Hologic, Inc. (Nasdaq: HOLX) reported that it will exhibit its extensive portfolio of breast and skeletal health products at the 108th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) from Nov. 27 to Dec. 1 (Press release, Hologic, NOV 25, 2022, View Source [SID1234624428]). Among the full suite of breast biopsy and surgery solutions will be Hologic’s Affirm Contrast Biopsy software, which will be on display for the first time since becoming commercially available in the United States.

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"As the global leader in breast imaging, we are committed to addressing the unmet needs of physicians and their patients across the continuum of breast care and we’re eager to engage with industry leaders at this year’s RSNA meeting to share our vision for the future of breast health," said Erik Anderson, President of Hologic’s Breast and Skeletal Health Solutions Division. "We are equally excited to showcase our new Affirm Contrast Biopsy technology, which is a great example of our commitment to physicians and patients in action."

Affirm Contrast Biopsy software allows clinicians to target and acquire tissue samples in lesions identified with I-View Contrast-Enhanced Mammography software. The contrast solution provides healthcare facilities with a viable and attractive alternative to breast MRI, which historically has been used to find and biopsy more elusive lesions, such as those that cannot be seen via mammography or ultrasound. While breast MRI can be time-consuming and costly, contrast technology gives radiologists another option in the mammography suite that addresses these shortcomings.1,2 In a recent clinical study, 98% of patients had an overall positive opinion of their procedure experience with Affirm Contrast Biopsy software.3

RSNA attendees can experience Hologic’s portfolio at Booth 1911 in South Hall Level 3 at McCormick Place in Chicago. In addition to the Affirm Contrast Biopsy software, Hologic will feature its Dimensions mammography portfolio and Supersonic MACH ultrasound systems.

Hologic will also host a series of CME- and non-CME-accredited medical education symposiums and learning opportunities, accessible to attendees on-site and from remote locations. The medical education sessions include:

"Upright Biopsy with Brevera Breast Biopsy System: Real-Time Imaging, Verification & Automated Handling"
Sunday, Nov. 27: 11:45 a.m. – 12:45 p.m. CST
Dr. Krystal Airola will demonstrate new upright breast biopsy technologies that will enhance accuracy, workflow and patient experience. She will share her experiences with the Affirm 2D/3D upright biopsy, lateral arm approach and Brevera Breast Biopsy system, which integrates tissue acquisition, real-time imaging and verification, and post-biopsy sample handling. Dr. Airola will also share cases and explain how to significantly reduce the time and discomfort to patients in the biopsy suite while maximizing biopsy suite efficiencies and clinical decision-making.
"Emerging Ultrasound Technology in Liver Surveillance"
Monday, Nov. 28: 12:00 p.m. – 1:00 p.m. CST
Learn more about the advancements in ultrasound technology with ShearWave Elastography. There are many opportunities to improve workflow efficiencies in liver surveillance that drive superior patient experiences and outcomes. In this lecture, participants will review comparisons with existing and emerging ultrasound technologies and techniques.
"Current AI Applications in Mammography: Focus on Genius AI Detection Software"
Tuesday, Nov. 29: 12:00 p.m. – 1:00 p.m. CST
Attendees will hear from an expert on the benefits of artificial intelligence (AI) in mammography screening. With new high-resolution technologies being implemented, see how AI can reduce dose, file size and reading times. A focus will be on deep-learning AI and the benefits of Genius AI Detection software in clinical decision-making and increasing productivity.
"Panel Discussion: Options in Localization"
Wednesday, Nov. 30: 12:00 p.m. – 1:00 p.m. CST
Join a multidisciplinary conversation on localization. Hear perspectives from leading radiologists and breast surgeons about what they like, what they use and why. What is the role of wires? What other technologies are available? What are the strengths and weaknesses of different options?

IMV Receives Nasdaq Notification Regarding Market Value of Listed Securities

On November 25, 2022 IMV Inc. ("IMV" or the "Company") (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported that, on November 22, 2022, the Company received a notification letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") indicating that the Company’s Market Value of Listed Securities ("MVLS") for the last 30 consecutive business days was below the required minimum of US$35 million for continued listing on Nasdaq under Nasdaq Listing Rule 5550(b)(2) (Press release, IMV, NOV 25, 2022, View Source [SID1234624426]).

The notification letter is only a notification of deficiency and has no immediate effect on the listing or trading of IMV’s common shares. The Company will continue to trade on the Nasdaq Capital Market under the symbol "IMV", subject to the Company’s compliance with the other listing requirements. The Company’s common shares are also listed on the Toronto Stock Exchange, and the notification letter does not affect the Company’s compliance status with such listing.

The letter also indicated that the Company will be provided with a compliance period of 180 calendar days, or until May 22, 2023, in which to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(C). If at any time before May 22, 2023, the Company’s MVLS closes at or above US$35 million for a minimum of ten consecutive business days, Nasdaq will provide written notification that the Company has achieved compliance under the MVLS requirement, and the matter will be closed. In the event the Company does not regain compliance by May 22, 2023, the Company may face delisting.

The Company’s business operations are not affected by the receipt of the notification letter and the Company fully intends to regain compliance with Nasdaq listing rules. The Company will actively monitor its MVLS and is evaluating all available options to regain compliance with Nasdaq’s continued listing criteria.

Special Meeting of Shareholders

Shareholders are reminded of the upcoming special meeting of shareholders to consider the proposed consolidation of IMV’s total issued and outstanding shares. Two leading independent proxy advisors have issued recommendations for IMV shareholders to vote FOR the proposed share consolidation. The special meeting is being held on December 7, 2022 at 11:00 a.m. (Eastern Time). We encourage you to vote your shares well in advance of the proxy voting deadline on December 5, 2022 at 11:00 a.m. (Eastern Time). For any questions or if you require assistance with voting your shares, please contact our proxy solicitation agent, Laurel Hill Advisory Group at 1-877-452-7184 (North America Toll Free), 416-304-0211 (Calls Outside North America) or by email at [email protected].

Can-Fite Reports Third Quarter 2022 Financial Results & Provides Clinical Update

On November 25, 2022 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported financial results for the quarter ended September 30, 2022 (Press release, Can-Fite BioPharma, NOV 25, 2022, View Source [SID1234624425]).

Corporate and Clinical Development Highlights Include:

Complete Clearance of Cancer in a Patient Treated with Namodenoson was Presented at the AASLD Liver Meeting – A poster titled "Complete Response Induced by Namodenoson, an A3 Adenosine Receptor Agonist, in a Patient with Advanced Hepatocellular Carcinoma" was presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting in November in Washington, D.C. The findings were published in the October 2022 supplement of HEPATOLOGY, a premier peer-reviewed journal in the field of liver disease. The poster detailed the patient, a 61-year-old woman with hepatocellular carcinoma (HCC), the most common form of liver cancer, and moderate hepatic dysfunction Child-Pugh B (CPB7), who participated in Can-Fite’s prior Phase II study. The patient was in the Namodenoson arm of the Phase II study and continued treatment with Namodenoson for 5 years under an open label extension program until the approval of a compassionate use program in Romania in August.

Namodenoson Approved for Compassionate Use in Romania to Treat Liver Cancer; Phase III Pivotal Global Study Open for Enrolment – Romania became the second country to approve Namodenoson for compassionate use in patients with advanced liver cancer. Can-Fite’s global pivotal Phase III liver cancer study for Namodenoson is open for enrollment of approximately 450 patients diagnosed with HCC and underlying CPB7 who have not responded to other approved therapies.

New Psoriasis Data from Phase III COMFORT Trial Show Superior Safety & Improved Efficacy – The latest findings on Piclidenoson, Can-Fite’s lead drug candidate, from its Phase III COMFORT trial were presented in September at the 31st European Academy of Dermatology and Venerology by Dr. Kim A. Papp, MD, a prominent thought leader in the treatment of psoriasis. In addition to the study meeting its primary endpoint of Piclidenoson’s superiority over placebo, the latest data showed that Piclidenoson had a significantly better tolerability profile than Otezla, the leading oral psoriasis treatment on the market today. GI-related adverse events were 1% for Piclidenoson vs. 6% for Otezla, nervous system disorders were 0.7% for Piclidenoson vs. 9.9% for Otezla and 3.3% for the placebo. The discontinuation rate was significantly higher for Otezla than for Piclidenoson. In achieving psoriasis disability index (PDI) response at week 32, Piclidenoson was comparable to Otezla. Patients treated with Piclidenoson showed an improving progressive response over time, a critically important finding given psoriasis is a chronic disease that may require long-term treatment.

Pivotal Phase III Psoriasis Registration Study is Under Preparation for Submission to FDA & EMA – The pivotal Phase III psoriasis study’s protocol is being developed in conjunction with Dr. Kim Papp, a Key Opinion Leader in dermatology and an investigator in the COMFORT study. Marketing registration plans including chemistry, manufacturing, and controls (CMC), nonclinical data, and human pharmacokinetic data are being prepared for submission to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for Piclidenoson in the treatment of moderate to severe psoriasis.

Safety Study of Piclidenoson for Osteoarthritis in Dogs Successfully Concluded, Efficacy Study to Commence – Following a successful safety study in dogs that explored dose-range safety and pharmacokinetics, Piclidenoson is set to enter efficacy studies in the treatment of canine osteoarthritis through a development and commercialization agreement signed with Vetbiolix, a France based veterinary biotech company. Vetbiolix is financially responsible for the clinical studies. The canine osteoarthritis market is projected to reach $3 billion by 2028 and regulatory approval pathways tend to be shorter than those required for humans.

"The latest Phase III findings for Piclidenoson are highly encouraging and inform the potential for a successful psoriasis registration study which will be conducted under both the FDA and EMA. A favorable outcome could mean marketing approval in two of the largest markets in the world," stated Can-Fite CEO Dr. Pnina Fishman. "While we have distribution agreements in place for Piclidenoson and Namodenoson in the treatment of psoriasis and liver cancer in certain European and Asian markets, we maintain full distribution rights for these late-stage assets in the U.S., the largest market in the world. We are strategically evaluating partnerships in the U.S. as we continue to forge ahead on each of our other indications including Namodenoson in NASH and Piclidenoson for canine osteoarthritis."

Financial Results

Revenues for the nine months ended September 30, 2022 were $0.61 million, a decrease of $0.04 million, or 6.1%, compared to $0.65 million for the nine months ended September 30, 2021. The decrease is considered to be not material.

Research and development expenses for the nine months ended September 30, 2022 were $5.31 million, a decrease of $1.44 million, or 21.3%, compared to $6.75 million for the nine months ended September 30, 2021. Research and development expenses for the nine months ended September 30, 2022 comprised primarily of expenses associated with the completion of the Phase III study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase III study in the treatment of advanced liver cancer and a Phase IIb study for NASH. The decrease is primarily due to the wrap up of the Phase III study of Piclidenoson for the treatment of psoriasis in 2022.

General and administrative expenses for the nine months ended September 30, 2022 were $2.31 million a decrease of $0.40 million, or 14.7%, compared to $2.71 million for the nine months ended September 30, 2021. The decrease is primarily due to the decrease in professional services and public and investor relations expenses. We expect that general and administrative expenses will remain at the same level through 2022.

Financial expenses, net for the nine months ended September 30, 2022 were $0.14 million compared to finance income, net of $0.31 million for the nine months ended September 30, 2021. The decrease in financial income, net was mainly due to revaluation of the Company’s short-term investment which in 2021 was recorded as income and in 2022 was recorded as expense.

Net loss for the nine months ended September 30, 2022 was $7.15 million compared with a net loss of $8.50 million for the nine months ended September 30, 2021. The decrease in net loss for the nine months ended September 30, 2022 was primarily attributable to a decrease in research and development expenses and a decrease in general and administrative expenses.

As of September 30, 2022, Can-Fite had cash and cash equivalents and short term deposits of $10.79 million as compared to $18.90 million at December 31, 2021. The decrease in cash during the nine months ended September 30, 2022 is due to the ongoing operations of the Company.

The Company’s consolidated financial results for the nine months ended September 30, 2022 are presented in accordance with US GAAP Reporting Standards.

Entry into a Material Definitive Agreement

On November 25, 2022, Biomea Fusion, Inc. (the "Company") reported that entered into an equity distribution agreement (the "Agreement") with Piper Sandler & Co., as sales agent (the "Sales Agent"), with respect to an "at the market offering" program. Pursuant to the prospectus supplement relating to the Offering (as defined below), dated as of November 25, 2022 (the "Prospectus Supplement"), the Company may offer and sell, from time to time in its sole discretion, shares of its common stock, par value $0.0001 per share (the "Common Stock"), having an aggregate offering price of up to $100 million (the "Shares") through the Sales Agent (the "Offering") (Filing, 8-K, Biomea Fusion, NOV 25, 2022, View Source [SID1234624424]).

Any Shares offered and sold in the Offering will be issued pursuant to the Company’s effective registration statement on Form S-3 (File No. 333-267884), filed with the Securities and Exchange Commission (the "Commission") on October 14, 2022 (the "Registration Statement"), including the base prospectus contained therein, the Prospectus Supplement, and any applicable additional prospectus supplements related to the Offering that form a part of the Registration Statement.

The Sales Agent may sell the Shares by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended, including sales made directly through The Nasdaq Global Select Market ("Nasdaq") or on any other existing trading market for the Common Stock. The Sales Agent will use commercially reasonable efforts to sell the Shares from time to time consistent with their normal sales practices and applicable federal rules, regulations and Nasdaq rules, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay the Sales Agent a commission up to 3.0% of the gross sales proceeds of any Shares sold through the Sales Agent under the Agreement, and also has provided the Agent with customary indemnification and contribution rights.

The Sales Agent is not required to sell any specific number or dollar amount of securities, but will use commercially reasonable efforts to sell, on behalf of the Company, all of the shares of Common Stock requested to be sold by the Company, consistent with their normal trading and sales practices, on mutually agreed terms between the Sales Agent and the Company. There is no arrangement for funds to be received in any escrow, trust or similar arrangement.

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. A copy of the opinion of Goodwin Procter LLP relating to the legality of the issuance and sale of the shares in the Offering is attached as Exhibit 5.1 hereto.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

Spectrum Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for Poziotinib; Reaffirms Focus on the Commercialization of ROLVEDON™ (eflapegrastim-xnst) injection

On November 25, 2022 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI) ("Spectrum" or the "Company"), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding Spectrum’s New Drug Application (NDA) for poziotinib for the treatment of patients with previously treated locally advanced or metastatic non-small cell lung cancer ("NSCLC") harboring HER2 exon 20 insertion mutations (Press release, Spectrum Pharmaceuticals, NOV 25, 2022, View Source [SID1234624420]). The FDA issued a CRL indicating the poziotinib application cannot be approved in its present form. Based on the CRL, the Company would have to generate additional data including a randomized controlled study prior to approval.

"While we are not surprised by the CRL given the ODAC recommendation in September, we are disappointed. After multiple interactions with the FDA since ODAC, and following careful consideration, we have made the strategic decision to immediately de-prioritize the poziotinib program," said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We continue to believe that poziotinib could present a meaningful treatment option for patients with this rare form of lung cancer, for whom other therapies have failed."

Mr. Riga continued, "We are committed to exploring potential strategic alternatives for poziotinib, including partnerships and business development opportunities, and will determine the best path forward in support of patients. We are grateful to the patients, families, and clinicians who participated in the poziotinib program and to the team members who have dedicated their time and efforts."

The Company will de-prioritize poziotinib program activities, effective immediately, and is in the process of reducing its R&D workforce by approximately 75%. Based on the anticipated cost savings from the restructuring, Spectrum believes it will be able to generate the working capital required to support its strategic refocusing through 2024.

The Company will focus efforts on driving growth for its recently launched commercial drug, ROLVEDON. ROLVEDON was approved by the FDA in September 2022. It is for adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. Spectrum launched ROLVEDON, which has an estimated market opportunity of approximately $2 billion, shortly following the FDA’s approval.