On October 29, 2021 PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the "Company" or "PAVmed"), a highly differentiated, multi-product, commercial-stage medical technology company, reported that it hosted a virtual investor event with several hundred participants on October 26, 2021 (Press release, PAVmed, OCT 29, 2021, View Source [SID1234592202]). The event, Veris Heath: Bringing Digital Health to Cancer Care, focused on PAVmed’s digital health subsidiary Veris Health ("Veris").

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"When I first heard about Veris Health I was impressed by their big vision to make a measurable impact on cancer care"

The event recording and presentation deck are now available for viewing.

The panelists provided a comprehensive overview of Veris’ disruptive technology, vision, business model, and strategy. They discussed how PAVmed’s entry into the digital health sector fits within its broader long-term growth strategy and how Veris seeks to utilize the first intelligent implantable vascular access port with biologic sensors to facilitate and optimize cancer care through remote patient monitoring and data analytics. Panelists included:

Lishan

Aklog, MD

PAVmed Chairman & Chief Executive Officer

Veris Executive Chairman

James D.

Mitchell, MD

PAVmed VP, Digital Health

Veris Chief Medical Officer

Sumit

Shah, MD, MPH

Veris Medical Advisory Board Member

Director of Clinical Innovation & Digital Health, Division of Oncology, Stanford Cancer Institute, Stanford Health Care

Clinical Assistant Professor, Medicine-Oncology, Member, Stanford University School of Medicine

Timothy E.

Baxter

PAVmed Board of Directors

Former President & CEO of Samsung Electronics North America

Sunny

Webb

PAVmed VP, Data & Analytics

Veris Chief Technology Officer

The event concluded with a moderated question and answer session, which provided the attendees the opportunity to interact with the panelists.

Veris, a majority-owned subsidiary of PAVmed, acquired Oncodisc Inc., a digital health company with groundbreaking tools to improve personalized cancer care in May 2021. Veris is developing a remote cancer care platform that integrates an intelligent implantable vascular access port with physiologic sensing, software with symptom reporting and telehealth functions, as well as advanced data analytics. Veris’ groundbreaking vascular access port contains biologic sensors capable of generating continuous data on key physiologic parameters known to predict adverse outcomes in cancer patients undergoing treatment. Wireless communication to the patient’s smartphone and Veris’ cloud-based digital healthcare platform will deliver actionable real time data to patients and physicians efficiently and effectively. Veris is targeting FDA 510(k) clearance of the intelligent implantable vascular access port and launch of the remote digital healthcare platform for H2-2022.

"We have about 20% of the U.S. economy, which is what healthcare represents, finally leveraging digital tools that have been long available in other sectors," said Lishan Aklog, MD, PAVmed’s Chairman and Chief Executive Officer and Veris’ Executive Chairman. "The Veris technology…offers data-driven risk management tools for precision oncology, and incorporates additional prospects for substantial value-creation through data monetization and biotherapeutic clinical trial support."

James Mitchell, MD, PAVmed’s VP, Digital Health and Veris’ Chief Medical Officer noted, "today’s aggressive outpatient cancer treatments, including immunotherapy and chemotherapy, leave patients unmonitored and at risk of serious, avoidable complications, leading to high rates of hospitalization, poor patient quality of life, and increasing health system costs. Every year in the United States there are about 1.5 million unplanned hospital admissions in cancer patients…[which] cost up to $70,000 per patient on average. We also know through cancer research that 19-50% of these hospitalizations are potentially preventable with appropriate timely outpatient interventions."

"If we look at other solutions…there is no solution that really checks all the boxes—providing the uninterrupted data needed for true patient care, that tucks easily into the existing workflow, leverages existing reimbursement, and really takes advantage of telemedicine technology," said Dr. Mitchell.

"When I first heard about Veris Health I was impressed by their big vision to make a measurable impact on cancer care," said Sunny Webb, PAVmed’s VP, Data & Analytics and Veris’ Chief Technology Officer. "Like many of you, I have had people close to me that have battled cancer…Applying data science to cancer care is a world changer for future generations. Treatment has come a long way in recent years, but we can do better. I’m certain that Veris has the right approach…to build an integrated digital health care platform that will help millions of cancer patients and their oncologists."

"Veris is fundamentally a healthcare-oriented tech platform that uses smart devices," said Timothy E. Baxter, a member of PAVmed’s Board of Directors and former President & CEO of Samsung Electronics North America. "[In the tech sector] we are moving from…what some might call ‘dumb’ products to now ‘smart’ devices and ‘smart’ solutions…The growth we have seen is quite remarkable…driven by a host of new technologies…it’s AI, it’s big data, it’s cloud, it’s 5G, IoT, VR/AR…When you combine these new technologies with relevant data…we are now creating new possibilities and disrupting old."

Recently, Veris entered into a global program relationship with Microsoft, and engaged with leading full-service Silicon Valley-based full-stack software development firm Loka Inc. to build its remote digital healthcare platform.

On October 29, 2021 AbClon reported an additional material patent had been acquired (Press release, AbClon, OCT 29, 2021, View Source;wr_id=151 [SID1234638631]). This patent AC101 This is a follow-up patent in which stability enhancement technology was additionally applied to the patent.

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AC101 Discovery used AbClone’s proprietary antibody discovery technology ‘NEST (Novel Epitope Screening Technology)’ The platform was utilized. This platform is a technology that newly discovers antibody binding sites on disease proteins, Antibody treatments developed through this process can exhibit different therapeutic effects depending on the epitope, so when a patent is acquired, it is different from other existing patented technologies targeting the same disease protein. It has the advantage of being relatively free.

This AC101’s follow-up patent has already been Separate from the existing AC101 patent registered in several countries, technology to improve stability has been applied, .Also, applications have been filed in the U.S. and Europe and examination is in progress. Japan, and Before China, registration was also completed in Korea, Australia

AC101is a disease protein HER2 (Human It is a monoclonal antibody treatment targeting Epidermal Growth Receptor 2). Herceptin, Perjeta, etc. HER2 Although it has been approved as a targeted antibody treatment, it is reported that treatments with strong anticancer effects are still rare in the treatment of stomach cancer.

AC101 was superior to Herceptin+Perjeta co-administration in animal models co-administered with Herceptin. It showed efficacy, this data shows that AbClone Shanghai Henrius Biotech(hereinafter referred to as Henrius)at AC101 was an opportunity to transfer technology.

Henlius targeted stomach cancer last 9month. AC101 (Henrius codename: HLX22) and Herceptin biopsy miller In the combination clinical trial2, administration to the first patient began. Through advanced clinical trial1phase 2Dosage(25mg/kg) It has been decided, to be clinically targeted as the first standard treatment for gastric cancer patients. 2award is in progress. According to these results, AppClone’s follow-up milestones and royalties will be determined. Additional profits are also expected.

Company officials said "AC101 with improved stability Stronger intellectual property rights were secured through additional patent registration" "In the future, through the commercialization of AC101, our company will also be available in the global market. NEST expects that its platform technology will be recognized" revealed.

On October 29, 2021 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported financial results for the quarter ended September 30, 2021 (Press release, ImmunoGen, OCT 29, 2021, View Source [SID1234592168]).

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"We look forward to announcing top-line data from our pivotal SORAYA trial this quarter, including data on the primary endpoint of overall response rate and key secondary endpoint of duration of response. With positive data, we will move quickly to complete the BLA, with the goal of submitting the filing in the first quarter of 2022," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "In addition to SORAYA, we continue to advance a broad program to establish mirvetuximab as the standard of care for patients with FRα-positive ovarian cancer. Our confirmatory MIRASOL trial is enrolling at over 160 sites in 18 countries in North America, Europe, Asia, and Australia, and we have initiated the PICCOLO trial, which could support label expansion in recurrent platinum-sensitive ovarian cancer. Beyond mirvetuximab monotherapy, the first patients have been enrolled in the large investigator-sponsored studies evaluating mirvetuximab combined with carboplatin in both the neoadjuvant and recurrent platinum-sensitive settings to support our objective of making mirvetuximab the combination agent of choice in ovarian cancer, and we look forward to sharing our label-enabling combination strategy early next year."

Enyedy continued, "In addition, our IMGN632, IMGC936, and IMGN151 programs are advancing as planned. We anticipate presenting data on IMGN632 in AML at ASH (Free ASH Whitepaper) in December, have escalated dosing in multiple solid tumors with our ADAM-9 targeting ADC, IMGC936, and expect to file the IND for IMGN151, our next-generation FRα-targeting ADC, by year-end. As we close out 2021, we remain focused on execution and look forward to transforming ImmunoGen into a fully integrated oncology company with the potential for commercial launch next year."

RECENT PROGRESS

Further enrolled patients in the confirmatory MIRASOL study for mirvetuximab.
Initiated PICCOLO, a single-arm study of mirvetuximab monotherapy in high folate receptor alpha (FRα) recurrent platinum-sensitive ovarian cancer.
Enrolled the first patients in the investigator-sponsored trials of mirvetuximab plus carboplatin in a single-arm study in the neoadjuvant setting and a randomized study in patients with recurrent platinum-sensitive ovarian cancer.
Advanced accrual in the pivotal 801 Phase 2 study, now known as CADENZA, of IMGN632 in frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Continued patient enrollment in the 802 Phase 1b/2 study of IMGN632 in combination with Vidaza (azacitidine) and Venclexta (venetoclax) in R/R acute myeloid leukemia (AML) patients and as a monotherapy in minimal residual disease positive (MRD+) AML.
Escalated dosing in the Phase 1 study of IMGC936 in multiple solid tumor types.
Progressed activities to support an investigational new drug (IND) application for IMGN151.
Appointed Helen M. Thackray, MD, to the Board of Directors.
ANTICIPATED UPCOMING EVENTS

Release top-line data from the pivotal SORAYA study this quarter, with the goal of submitting the biologics license application (BLA) in the first quarter of 2022 to support potential accelerated approval in 2022.
Present initial AML combination data for IMGN632 at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.
Submit the IND application for IMGN151 by the end of 2021.
Complete dose-escalation in the Phase 1 study evaluating IMGC936, with initial data anticipated in 2022.
Generate top-line data for the confirmatory MIRASOL study in the third quarter of 2022.
FINANCIAL RESULTS

Revenues for the quarter ended September 30, 2021 were $9.2 million, compared with $18.2 million for the quarter ended September 30, 2020. This decrease was driven by a reduction in non-cash royalty revenue due to the completion of the first tranche of payments under the 2015 transaction covering the sale of Kadcyla royalties. Revenues for the quarter ended September 30, 2021 also included recognition of an anticipated $2.5 million partner development milestone fee.

Operating expenses for the third quarter of 2021 were $43.4 million, compared with $34.9 million for the same quarter in 2020. Research and development expenses rose to $33.1 million for the third quarter of 2021, compared with $24.7 million for the third quarter of 2020, driven by increases in clinical trial expenses, personnel and temporary staffing costs, and third-party service fees in support of commercial readiness. General and administrative expenses were essentially flat at $10.3 million and $10.2 million for the third quarters of 2021 and 2020, respectively.

Net loss for the third quarter of 2021 was $37.3 million, or $0.18 per basic and diluted share, compared to a net loss of $22.4 million, or $0.13 per basic and diluted share, for the third quarter of 2020. Weighted average shares outstanding increased to 204.8 million for the 2021 period from 174.5 million in the prior year.

ImmunoGen had $245.8 million in cash and cash equivalents as of September 30, 2021, compared with $293.9 million as of December 31, 2020, and had $2.1 million of convertible debt outstanding as of December 31, 2020. There was no convertible debt outstanding as of September 30, 2021. Cash used in operations was $123.5 million for the first nine months of 2021, compared with cash used in operations of $87.2 million for the same period in 2020. Capital expenditures were $(1.1) million for the first nine months of 2021, compared with net proceeds from the sale of equipment of $0.6 million for the first nine months of 2020.

During the quarter ended September 30, 2021, the Company sold 2.2 million shares of its common stock through its At-the-Market (ATM) facility, generating gross proceeds to the Company of approximately $13 million. In August 2021, the Company entered into a Securities Purchase Agreement pursuant to which the Company agreed to sell to an investor a warrant to purchase up to an aggregate of 5,434,782 shares of the Company’s common stock for a nominal value, generating additional gross proceeds of approximately $30 million.

FINANCIAL GUIDANCE

ImmunoGen has updated its financial guidance for 2021 and now expects:

revenues between $65 million and $75 million;
operating expenses between $190 million and $200 million; and
cash and cash equivalents at December 31, 2021 to be between $190 million and $200 million.
ImmunoGen expects that its current cash will fund operations into the fourth quarter of 2022.

CONFERENCE CALL INFORMATION

ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, dial (877) 621-5803; the conference ID is 1587202. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.

On October 29, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that it has withdrawn its Premerger Notification and Report Form under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the "HSR Act"), in connection with Merck’s pending acquisition of Acceleron Pharma Inc. (Nasdaq: XLRN) (Press release, Merck & Co, OCT 29, 2021, View Source [SID1234592187]). As previously announced on October 12, 2021, Merck commenced, through a subsidiary, Astros Merger Sub, Inc., a cash tender offer to purchase all outstanding shares of common stock of Acceleron, for $180 in cash, without interest and less any required tax withholding.

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Merck has elected to withdraw its Premerger Notification and Report Form, which was initially filed on October 14, 2021, to provide the Federal Trade Commission (the "FTC") with additional time for review, and expects to refile such form on or about November 1, 2021. Following the refiling, the waiting period applicable to the pending acquisition will expire at 11:59 p.m., Eastern time, on or about November 16, 2021. The acquisition is expected to close in the fourth quarter of 2021.

Consummation of the tender offer remains subject to, among other conditions, the expiration or termination of the applicable waiting period under the HSR Act. As a result, Astros Merger Sub, Inc. is extending the tender offer, which was previously scheduled to expire at 5:00 p.m., Eastern Time, on November 10, 2021, until 5:00 p.m., Eastern time, on November 18, 2021. The tender offer may be extended further in accordance with the merger agreement and the applicable rules and regulations of the U.S. Securities and Exchange Commission (the "SEC"). All other terms and conditions of the tender offer will remain unchanged during the extended period.

The Depositary for the tender offer is Computershare Trust Company, N.A., c/o Voluntary Corporate Actions, P.O. Box 43011, Providence, RI 02940-3011. The Depositary has advised Merck that, as of 5:00 p.m., Eastern time, on October 28, 2021, the last business day prior to the announcement of the extension of the tender offer, approximately 8,395,093 shares of Acceleron had been validly tendered and received, and not validly withdrawn, pursuant to the tender offer, representing approximately 13.7% of Acceleron’s outstanding shares. Stockholders who have already tendered their shares do not need to retender such shares or take any other action as a result of the extension of the tender offer.

The Information Agent for the tender offer is Innisfree M&A Incorporated, 501 Madison Avenue, 20th floor, New York, NY 10022. The tender offer materials may be obtained at no charge by directing a request by mail to Innisfree M&A Incorporated or by calling toll free at (877) 800-5195, and may also be obtained at no charge at the website maintained by the SEC at www.sec.gov.

On October 29, 2021, CASI Pharmaceuticals, Inc. ("CASI" or "Company"), reported that it entered into a Common Stock Sales Agreement (the "Sales Agreement") with H.C. Wainwright & Co., LLC ("HCW") (Filing, 8-K, CASI Pharmaceuticals, OCT 29, 2021, View Source [SID1234593965]). Pursuant to the terms of the Sales Agreement, the Company may sell from time to time, at its option, shares of the Company’s common stock, par value $0.01 per share, through HCW, as sales agent, with an aggregate sales price of up to $20 million (the "Shares"). The Company does not currently intend to make any sales under the Sales Agreement at the present time and will use discretion in initiating sales, taking into account among other factors, market conditions, the trading price of the Company’s common stock, alternative financing opportunities, and need for capital. The Company believes that it is in the best interests of its stockholders to have the flexibility to raise additional capital under favorable market conditions to support its efforts to build long-term stockholder value.

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Any sales of Shares pursuant to the Sales Agreement will be made under the Company’s effective "shelf" registration statement (the "Registration Statement") on Form S-3 (File No. 333-250801) which became effective on December 2, 2020 and the related prospectus supplement and the accompanying prospectus, as filed with the Securities and Exchange Commission (the "SEC") on October 29, 2021.

Under the terms of the Sales Agreement, the Company may sell shares of its common stock through HCW by any method permitted that is deemed an "at the market offering" as defined in Rule 415 under the Securities Act of 1933, as amended (the "Securities Act"). HCW will use its commercially reasonable efforts consistent with its normal trading and sales practices to sell the Company’s common stock from time to time, based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose). Actual sales will depend on a variety of factors to be determined by the Company from time to time, including (among others) market conditions, the trading price of the Company’s common stock, capital needs and determinations by the Company of the appropriate sources of funding for the Company. The Company is not obligated to make any sales of common stock under the Sales Agreement and the Company cannot provide any assurances that it will issue any Shares pursuant to the Sales Agreement. The Company will pay a commission rate of 3.0% of the gross sales price per share sold and agreed to reimburse HCW for certain specified expenses, including the fees and disbursements of its legal counsel in an amount not to exceed $50,000 and have agreed to reimburse HCW an amount not to exceed $2,500 per quarter during the term of the Sales Agreement for legal fees to be incurred by HCW. The Company has also agreed pursuant to the Sales Agreement to provide HCW with customary indemnification and contribution rights.

The Company or HCW upon notice to the other, may suspend the offering of the Shares under the Sales Agreement at any time. The offering of the Shares pursuant to the Sales Agreement will terminate upon the sale of Shares in an aggregate offering amount equal to $20 million, or sooner if either the Company or HCW terminate the Sales Agreement pursuant to its terms.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. The Sales Agreement is also incorporated by reference into the Registration Statement.

A copy of the opinion of Arnold & Porter Kaye Scholer LLP relating to the legality of the Shares issuable under the Sales Agreement, is filed as Exhibit 5.1 to this Current Report on Form 8-K and is also incorporated by reference into the Registration Statement.

The above disclosure 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.

The representations, warranties and covenants contained in the Sales Agreement were made solely for the benefit of the parties to the Sales Agreement. In addition, such representations, warranties and covenants (i) are intended as a way of allocating the risk between the parties to the Sales Agreement and not as statements of fact, and (ii) may apply standards of materiality in a way that is different from what may be viewed as material by stockholders of, or other investors in, the Company. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the Sales Agreement, which subsequent information may or may not be fully reflected in public disclosures.