Hepion Pharmaceuticals Announces Pricing of $20.0 Million Private Placement of Convertible Redeemable Preferred Stock

On November 4, 2022 Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI")-driven therapeutic drug development for the treatment of fibrotic diseases, including non-alcoholic steatohepatitis ("NASH"), hepatocellular carcinoma ("HCC"), and other chronic diseases, reported that it has entered into a securities purchase agreement with certain institutional investors to purchase 1,900,000 shares of Series F convertible redeemable preferred stock and 100,000 shares of Series G convertible redeemable preferred stock (Press release, Hepion Pharmaceuticals, NOV 4, 2022, View Source [SID1234623115]). Each share of Series F and Series G preferred stock has a purchase price of $9.50, representing an original issue discount of 5% of the $10.00 stated value of each share. Each share of Series F and Series G preferred stock is convertible into shares of the Company’s common stock at an initial conversion price of $1.00 per share. Shares of the Series F and Series G preferred stock are convertible at the option of the holder at any time following the Company’s receipt of stockholder approval of a reverse stock split of the company’s common stock that is effected by the company’s filing of the amendment with and acceptance by the Secretary of State of the State of Delaware. The Company and the holders of the Series F and Series G preferred stock also entered into a registration rights agreement to register the resale of the shares of common stock issuable upon conversion of the Series F and Series G preferred stock. Total gross proceeds from the offerings, before deducting discounts, placement agent’s fees and other estimated offering expenses, is $20.0 million.

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The Series F and Series G preferred stock permits the holders thereof to vote together with the holders of the Company’s common stock on a proposal to effectuate a reverse stock split of the company’s common stock. The Series G preferred stock permits the holder to cast 100,000 votes per share of Series G preferred stock on such proposal, provided, that such votes must be cast in the same proportions as the shares of common stock and Series F preferred stock are voted on that proposal (excluding any shares of common stock that are not voted on the proposal). Except as required by law or expressly provided by the certificates of designation, holders of the Series F and Series G preferred stock will not be permitted to vote on any other matters. The holders of the Series F and Series G preferred stock agreed not to transfer, offer, sell, contract to sell, hypothecate, pledge or otherwise dispose of their shares of preferred stock until after the receipt of stockholder approval of the reverse stock split.

The holders of the Series F and Series G preferred stock have the right to require the Company to redeem their shares of preferred stock for cash at 105% of the stated value of such shares during the period commencing on the earlier of (i) receipt of stockholder approval of the reverse stock split and (ii) the date that is 60 days after the closing of the offering and ending 90 days after the closing of the offering. The Company has the option to redeem the Series F and Series G preferred stock for cash at 105% of the stated value at any time following receipt of stockholder approval of the reverse stock split, subject to the holders’ rights to convert the shares prior to a redemption at the option of the Company.

The closing of the offering is expected to occur on or about November 7, 2022, subject to the satisfaction of customary closing conditions. Additional information regarding the securities described above and the terms of the offering are included in a Current Report on Form 8-K to be filed with the United States Securities and Exchange Commission ("SEC").

A.G.P./Alliance Global Partners is acting as the exclusive placement agent in connection with the offering.

The Series F and Series G preferred stock and shares of common stock into which these preferred shares are convertible are being issued in reliance upon the exemption from the securities registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act") and/or Rule 506 of Regulation D as promulgated by SEC under the 1933 Act.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Ayala Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Corporate Update

On November 4, 2022 Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare tumors and aggressive cancers, reported third-quarter 2022 financial results and provided a corporate update (Press release, Ayala Pharmaceuticals, NOV 4, 2022, View Source [SID1234623114]).

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"Our team looks forward to completing the recently announced merger with Advaxis which we believe will complement our pipeline. Importantly, we believe that the consummation of the merger will provide us with the financial resources to advance development of AL102 for desmoid tumors and enable an enhanced presence in the United States," said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. "We remain focused on the continued development of our candidates AL102 and AL101. We had an opportunity to share the very promising interim results from Part A of the ongoing RINGSIDE study of AL102 with the broader oncology community at ESMO (Free ESMO Whitepaper). We look forward to reporting longer-term data in 2023 and to executing on Part B, the randomized Phase 3 portion of RINGSIDE."

Third-quarter 2022 and Recent Business Highlights

In October, Ayala announced a definitive agreement to merge with Advaxis, Inc.: The merger would result in a combined company that will focus on the development and commercialization of Ayala’s lead program AL102 for the treatment of desmoid tumors. Ayala stockholders will own approximately 62.5% of the combined company’s outstanding common stock and Advaxis stockholders will own approximately 37.5%, subject to the terms of the merger agreement. At the closing of the merger, Ayala will be delisted from The Nasdaq Global Market, and the combined company’s common stock is expected to begin trading on the OTCQX, subject to Advaxis’s planned efforts to have the stock of the combined company listed on Nasdaq, as to which no assurances can be made. The merger is expected to close by the end of Q1 2023, subject to approval by Ayala’s shareholders and the satisfaction of customary closing conditions.
On October 6, the Company hosted a key opinion leader (KOL) webinar on the unmet medical needs and evolving treatment landscape of desmoid tumors: The webinar featured presentations by Professors Bernd Kasper, MD, Ph.D., from the Mannheim University Medical Center, and Robin Jones, MD, from The Royal Marsden Hospital and Institute of Cancer Research. A replay of the webinar, including slides, can be found here.
Positive interim data from Part A of the Phase 2/3 RINGSIDE study of AL102 in desmoid tumors presented at ESMO (Free ESMO Whitepaper): Data showed efficacy across all cohorts, with early responses that deepened over time. The first confirmed partial response (PR) was achieved at week 16 and 3 additional unconfirmed PRs over the follow-up period. AL102 was well tolerated at all three dosing regimens with no dose-limiting toxicities and no Grade 4/5 adverse events. Part B, the Phase 3 portion of RINGSIDE, is open for enrollment with a selected dose of 1.2mg once daily.
Fast Track designation granted for AL102: In September, the U.S. FDA granted Fast Track designation for AL102 for the treatment of progressing desmoid tumors. The designation holds important advantages that may expedite the development and regulatory review of AL102.
Upcoming Milestones

Continue enrollment in Phase 3 of the RINGSIDE trial: Part B, the Phase 3 portion of the RINGSIDE trial, is a double-blind placebo-controlled study enrolling up to 156 patients with progressive desmoid disease, randomized between AL102 or placebo. The primary endpoint is Progression Free Survival with secondary endpoints including objective response rates, duration of response, and patient-reported quality of life measures.
A poster featuring the interim data from Part A of RINGSIDE has been selected for presentation at the Connective Tissue Oncology Society (CTOS) 2022 Annual Meeting, taking place November 16-19 in Vancouver, Canada.
Gain clarity from U.S FDA on the registration path for AL101 in recurrent/metastatic adenoid cystic carcinoma (R/M ACC), expected in early 2023
Expected closing of merger with Advaxis, by the end of Q1 2023, subject to approval by Ayala’s shareholders and the satisfaction of customary closing conditions
Present longer-term data from Part A of RINGSIDE with AL102, expected in mid-2023
Third-Quarter 2022 Financial Results

Cash Position: Cash and cash equivalents were $11.2 million as of September 30, 2022.

Collaboration Revenue: Collaboration revenue was $91 thousand for the third quarter of 2022, as compared to $625 thousand for the corresponding quarter in 2021.

R&D Expenses: Research and development expenses were $7.2 million for the third quarter of 2022, compared to $7.4 million for the corresponding quarter in 2021.

G&A Expenses: General and administrative expenses were $2.9 million for the third quarter of 2022, compared to $2.2 million for the third quarter of 2021.

Net Loss: Net loss was $10.2 million for the third quarter of 2022, resulting in basic and diluted net loss per share of $0.66. This compares with a net loss of $9.8 million for the third quarter of 2021 or basic and diluted net loss per share of $0.68 for that quarter.

For further details on the company’s financial results, refer to our Quarterly Report on Form 10-Q for the three months ended September 30, 2022, filed with the Securities and Exchange Commission ("SEC") on November 3, 2022.

BeiGene to Present at Upcoming Investor Conferences

On November 4, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, reported that the Company will participate in two upcoming investor conferences (Press release, BeiGene, NOV 4, 2022, View Source/news-details/?id=92203083-0f98-430e-9653-a52d9d62fbea" target="_blank" title="View Source/news-details/?id=92203083-0f98-430e-9653-a52d9d62fbea" rel="nofollow">View Source [SID1234623113]):

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The 6th Annual Cowen IO Next Virtual Conference on Friday, November 11, at 9:40 a.m. (ET); and
The 13th Annual Jefferies Global Healthcare Conference in London on Wednesday, November 16 at 11:25 a.m. (ET).
A live webcast can be accessed from the investors section of BeiGene’s websites at View Source, View Source and View Source An archived replay will be available for 90 days following the event.

Cerus Corporation to Participate in Upcoming Investor Conferences

On November 4, 2022 Cerus Corporation (Nasdaq: CERS) reported that Vivek Jayaraman, Cerus’ chief operating officer, is scheduled to participate in two conferences (Press release, Cerus, NOV 4, 2022, View Source [SID1234623112]):

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The Stifel 2022 Healthcare Conference on Wednesday, November 16th at 1:50 p.m. EST, at the Lotte New York Palace Hotel.
The Stephens Annual Investment Conference on Thursday, November 17th, at 12:00 p.m. EST, at the Grand Hyatt in Nashville, TN.
To listen to webcasts of these presentations, please visit the investor relations section of Cerus’ website at: ir.cerus.com.

Cardinal Health Reports First Quarter Fiscal 2023 Results

On November 4, 2022 Cardinal Health (NYSE: CAH) reported first quarter fiscal year 2023 revenues of $49.6 billion, an increase of 13% from the first quarter of last year (Press release, Cardinal Health, NOV 4, 2022, View Source [SID1234623111]). First quarter GAAP operating earnings were $137 million, including a non-cash, pre-tax goodwill impairment charge of $154 million in the Medical segment. GAAP diluted earnings per share (EPS) were $0.40. Non-GAAP operating earnings decreased 20% to $423 million in the quarter due to a decline in Medical segment profit, primarily resulting from net inflationary impacts, partially offset by an increase in Pharmaceutical segment profit. Non-GAAP diluted earnings per share decreased 7% to $1.20, reflecting the change in non-GAAP operating earnings, partially offset by lower interest expense and a lower non-GAAP effective tax rate and share count.

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"Our performance in the first quarter demonstrated stable fundamentals in the Pharmaceutical segment and tangible progress in the Medical segment," said Jason Hollar, CEO of Cardinal Health. "We are reaffirming our full year non-GAAP EPS guidance as we remain focused on our Medical Improvement Plan initiatives and building upon the growth of our Pharmaceutical business. Across the company, we are operating with urgency to drive our businesses forward and remain committed to creating shareholder value."

First-quarter revenue for the Pharmaceutical segment increased 15% to $45.8 billion, driven by branded pharmaceutical sales growth from existing and net new Pharmaceutical Distribution and Specialty customers.

Pharmaceutical segment profit increased 6% to $431 million in the first quarter, driven by generics program performance and a higher contribution from brand and specialty products, partially offset by inflationary supply chain costs.

First-quarter revenue for the Medical segment decreased 9% to $3.8 billion, driven by lower Products and Distribution sales, primarily due to PPE pricing and volumes. To a lesser extent, this also reflects the divestiture of the Cordis business, which was mostly offset by sales growth in at-Home Solutions.

Medical segment loss of $8 million in the first quarter was primarily due to net inflationary impacts in Products and Distribution and a lower contribution from PPE. The first quarter loss reflects $20 million in total inventory charges related to the previously-announced simplification actions, including the sale of certain disposable gloves primarily utilized in non-healthcare industries.

Fiscal year 2023 outlook1
The company reaffirmed its fiscal year 2023 guidance range for non-GAAP diluted earnings per share attributable to Cardinal Health, Inc. of $5.05 to $5.40.

This guidance includes an update to Medical segment profit outlook to flat to 20% decline, from 10% growth to 10% decline, which reflects the impact of the previously announced simplification actions. Additionally, the company updated expectations for its fiscal 2023 interest and other to $140 million to $160 million, from $140 million to $170 million; its non-GAAP effective tax rate to 23% to 24%, from 23% to 25%; and its diluted weighted average shares outstanding to 262 million to 264 million, from 262 million to 266 million.

The company does not provide forward-looking guidance on a GAAP basis as certain financial information, the probable significance of which cannot be determined, is not available and cannot be reasonably estimated. See "Use of Non-GAAP Measures" following the attached schedules for additional explanation.

Recent highlights

Cardinal Health announced initiatives aimed at positioning the company for long-term success, building on Cardinal Health’s previously announced growth plans. These initiatives have benefited from input received from Elliott Investment Management L.P and include (1) the appointment of four new independent directors to the Board of Directors ("Board"); (2) the formation of the Business Review Committee of the Board, to support a comprehensive review of the company’s strategy, portfolio, capital-allocation framework and operations with the goal of maximizing Cardinal Health’s potential for the benefit of all stakeholders; and (3) the company’s plan to hold an Investor Day in the first half of calendar 2023 to share the conclusions of the Business Review Committee’s review and to provide additional guidance.
Cardinal Health announced Debbie Weitzman became CEO of the company’s Pharmaceutical Segment on September 19, 2022, after serving in her prior role of President of Pharmaceutical Distribution. As part of the company’s broader simplification efforts, Cardinal Health took actions to further streamline the Pharmaceutical Segment with efforts aimed to strengthen Pharmaceutical Distribution and Specialty, a key growth area, as well as bring together similar services under one team.
Cardinal Health announced the exit of its non-healthcare disposable gloves portfolio on September 13, 2022. The sale of this product portfolio is part of the company’s ongoing simplification actions, which resulted in approximately $20 million in total inventory charges in the first quarter of fiscal year 2023.
Cardinal Health was named to Seramount’s 2022 Inclusion Index, an honor recognizing companies committed to advancing diversity, equity and inclusion (DE&I) in the workplace.
Upcoming webcasted investor events

Evercore ISI Healthcare Conference at 8:50 a.m. EST, November 30, 2022
J.P. Morgan Healthcare Conference, January 9-12, 2023
Webcast
Cardinal Health will host a webcast today at 8:30 a.m. EST to discuss first quarter results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required.

Presentation slides and a webcast replay will be available on the Investor Relations page for 12 months.