On April 28, 2023 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that a conference call will be held on Monday, May 1, 2023, at 8:30 ET to discuss results for the first quarter 2023 and provide a business outlook for remainder of the year. Michael S. Weiss, Chairman and Chief Executive Officer, will host the call (Press release, TG Therapeutics, APR 28, 2023, https://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-host-conference-call-first-quarter-2023 [SID1234630706]).

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In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Fourth Quarter and Year End 2021 Update Call. A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.

TG Therapeutics will announce its financial results for this period in a press release to be issued prior to the call.

On April 28, 2023, Alpine Immune Sciences, Inc, a Delaware corporation (the "Company"), entered into a sales agreement (the "Sales Agreement") with Cowen and Company, LLC ("TD Cowen") to sell shares of the Company’s common stock, par value $0.001 per share, having aggregate sales proceeds of up to $100.0 million, from time to time, through an "at the market" equity offering program under which TD Cowen will act as sales agent and/or principal (Filing, 8-K, Alpine Immune Sciences, APR 28, 2023, View Source [SID1234630704]).

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Under the Sales Agreement, the Company will set the parameters for the sale of shares, including the number of shares to be issued, the time period during which sales are requested to be made, limitation on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. Subject to the terms and conditions of the Sales Agreement, TD Cowen may sell the shares by methods deemed to be an "at the market offering" as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on The Nasdaq Stock Market LLC ("Nasdaq") or on any other existing trading market for the common stock or to or through a market maker. In addition, with the Company’s prior written approval, TD Cowen may also sell shares by any other method permitted by law, including in negotiated transactions. TD Cowen will use commercially reasonable efforts in conducting such sales activities consistent with its normal trading and sales practices, applicable state and federal laws, rules and regulations and the rules of the Nasdaq. The Sales Agreement may be terminated by the Company upon written notice to TD Cowen for any reason or by TD Cowen upon written notice to the Company for any reason or at any time under certain circumstances, including but not limited to the occurrence of a material adverse change in the Company.

The Sales Agreement provides that TD Cowen will be entitled to compensation for its services of up to 3.0% of the gross sales price per share of all shares sold through TD Cowen under the Sales Agreement. The Company has no obligation to sell any shares under the Sales Agreement, and may at any time suspend solicitation and offers under the Sales Agreement. The Sales Agreement contains customary representations, warranties and agreements by the Company, indemnification obligations of the Company and TD Cowen, other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Sales Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties.

The shares will be issued pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-271517), filed with the Securities and Exchange Commission (the "SEC") on April 28, 2023. The shelf registration statement has not yet been declared effective by the SEC and no sales may be made until such time as the shelf registration statement is declared effective. The Company will file a final prospectus supplement with the SEC following the effectiveness of the shelf registration statement relating to the offer and sale of the shares pursuant to the Sales Agreement.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of such 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.

The legal opinion of Wilson Sonsini Goodrich & Rosati, Professional Corporation, relating to the shares of common stock being offered is filed as Exhibit 5.1 to this Current Report on Form 8-K.

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 sale of such securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On April 28, 2023 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, reported that it granted inducement awards on April 28, 2023 (Press release, Adicet Bio, APR 28, 2023, View Source [SID1234630695]).

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Seven individuals were hired by Adicet in April 2023. In the aggregate, Adicet granted new hires non-qualified stock options to purchase 150,800 shares of Adicet’s common stock with an exercise price of $5.84 per share, the closing price of Adicet’s common stock as reported by Nasdaq on April 28, 2023. One-fourth of the shares underlying each employee’s option will vest on the one-year anniversary of each recipient’s start date and thereafter the remaining three-fourths of the shares underlying each employee’s option will vest in thirty-six substantially equal monthly installments, such that the shares underlying the option granted to each employee will be fully vested on the fourth anniversary of the recipient’s start date, in each case, subject to each such employee’s continued employment with Adicet on such vesting dates.

All of the above-described awards were granted outside of Adicet’s stockholder-approved equity incentive plans pursuant to Adicet’s 2022 Inducement Plan (the Inducement Plan), which was adopted by the board of directors in January 2022 and subsequently amended in January 2023. The awards were authorized by the compensation committee of the board of directors, which is comprised solely of independent directors, as a material inducement to the employees entering into employment with Adicet in accordance with Nasdaq Listing Rule 5635(c)(4).

On April 28, 2023 OnQuality Pharmaceuticals ("OnQuality"), a targeted oncology supportive therapy company developing innovative medications to address unmet needs in oncodermatology and oncogastroenterology (cancer therapy-induced toxicities occurring in the skin and gastrointestinal tract) and to improve the quality of life for patients receiving anticancer medications, reported that the U.S. Food and Drug Administration (FDA) has cleared our Investigational New Drug (IND) application for OQL036, a potential prophylactic treatment for capecitabine-induced hand-foot syndrome (HFS) (Press release, OnQuality Pharmaceuticals, APR 28, 2023, View Source [SID1234630694]).

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Capecitabine, a chemotherapy drug, commonly used to treat colorectal and breast cancers, can cause HFS, a potential dose-limiting skin toxicity characterized by redness, swelling, pain, and even blistering, fissuring, or bleeding on the palms of the hands and soles of the feet. HFS can severely impact the quality of life, that may necessitate dose reduction, dose interruption or permanent discontinuation of capecitabine. There are no agents with FDA-approved labeling to prevent or treat capecitabine-induced HFS.

OQL036, a first-in-disease topical agent designed by our proprietary AI-enabled CARE platform is to prevent the development of HFS in patients receiving capecitabine by selectively targeting key pathways leading to capecitabine-induced HFS in addition to reducing local inflammation.

"We are excited to receive IND clearance for OQL036, which is a significant step forward in our efforts to address the urgent and growing unmet needs in oncodermatology, and make it accessible to the patients," said Hong Tang, MD, FACP, Chief Medical Officer at OnQuality. "We believe that OQL036 has the potential to make a meaningful difference in the lives of cancer patients by reducing the incidence and severity of HFS, allowing them to maintain their cancer treatment."

Upon receiving FDA’s clearance, OnQuality plans to initiate a global multi-center, double-blind, placebo-controlled Phase 2 trial in the coming months to evaluate the safety and efficacy of the drug in cancer patients who plan to receive capecitabine-based therapy.

"We are committed to bringing innovative and effective therapies to the market that address the unmet needs of cancer patients," said Michael McCullar, Ph.D., CEO of OnQuality. "The clearance of our IND application for OQL036 is another important milestone in this mission, and further strengthens our oncodermatology pipeline. We look forward to rapidly advancing this drug candidate through clinical development and hopefully to improving the lives of patients living with cancer."

About Hand-Foot Syndrome and OQL036

Hand-Foot Syndrome (HFS) is a common side effect of fluoropyrimidine chemotherapy, such as capecitabine and fluorouracil (5-FU). Capecitabine is an oral chemotherapy drug that is used in the treatment of several types of cancer, including colorectal and breast cancer.

HFS, also known as palmar-plantar erythrodysesthesia. The incidence of HFS induced by fluoropyrimidine chemotherapy, such as capecitabine, can be as high as 60% of patients. HFS may be a dose-limiting toxicity, which requires dose reduction, dose interruption or permanent discontinuation of fluoropyrimidine treatment, which may impact the effectiveness of the cancer therapy. There is currently no FDA-approved therapy for the prevention of HFS and the effectiveness of current symptom relief strategies remains limited.

OQL036 is a novel topical agent that locally alleviates the toxicities induced by capecitabine metabolites, and reduces the inflammation associated with HFS. OnQuality aims to keep patients in cancer treatment and to improve their quality of life.

On April 28, 2023 HanAll Biopharma Co., Ltd. (KRX: 009420. KS), a global biopharmaceutical company committed to discovering and developing innovative medicines for patients, reported financial results for the first quarter and provided business updates (Press release, HanAll Biopharma, APR 28, 2023, View Source [SID1234630693]).

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HanAll’s financial data demonstrated a strong momentum in the start of 2023, with revenues of KRW 28.8 billion, representing a 20 percent sales growth mainly driven by pharmaceutical sales from the first quarter of 2022. The company reported a net loss of 1.3 billion won due to continued investment in R&D.

Following the previous statement from the 2022 full-year financial report, HanAll expects to secure top-line data from the tanfanercept Phase 3 clinical study in dry eye disease in the first half of 2023 and plans to initiate a Phase 3 clinical study of batoclimab in generalized myasthenia gravis (gMG) in Japan this year.

"The recent positive top-line result from gMG Phase 3 study by Harbour BioMed suggests the potential of batoclimab as the first anti-FcRn treatment to be commercialized in China, reinforcing our confidence to develop batoclimab in an array of autoimmune diseases. With a strong focus on collaboration and innovation, we will continue to push forward with our R&D programs to deliver groundbreaking medicines that will make a difference in the patients’ lives," said Sean Jeong, M.D., MBA, CEO of HanAll Biopharma.

First Quarter 2023 BUSINESS UPDATE
Pipeline Development Highlights

A comprehensive update of HanAll’s pipeline development below includes an overview of research along with lists of compounds and targeted indications, along with developmental phase.

AUTOIMMUNE DISEASES PROGRAMS
Batoclimab (HL161BKN)

A novel, fully human, subcutaneously administered antibody targeting FcRn, with the potential to address multiple IgG-mediated autoimmune diseases. Batoclimab is designed to selectively bind to and inhibit FcRn, which plays a role in recycling IgG, thus leading to a reduction in IgG antibodies.

Harbour BioMed, a licensed partner of HanAll in China, announced the first positive Phase 3 top-line results for batoclimab in generalized myasthenia gravis (gMG) subjects in March 2023. Data from the trial met the primary endpoint as well as key secondary endpoints. Batoclimab treatment was also found to be overall safe and well-tolerated, without any new significant safety signals identified. Harbour BioMed plans to submit a Biologics License Application (BLA) to the National Medical Products Administration (NMPA) for batoclimab together with its sub-licensee CSPC NBP Pharmaceuticals Co., Ltd. (NBP Pharma), a wholly-owned subsidiary of CSPC Pharmaceutical Group Limited (CSPC Pharmaceutical), based on the study results. Batoclimab is also being developed for study in China in an array of other autoimmune disorders including thyroid eye disease (TED).

HanAll is progressing towards initiation of a Phase 3 clinical study of batoclimab in gMG in Japan this year. Additionally, HanAll is exploring options for developing batoclimab in TED and chronic inflammatory demyelinating polyneuropathy (CIDP) in Japan.

Another licensed partner, Immunovant in the U.S. and Europe, is conducting global Phase 3 trials with batoclimab in gMG and TED. Additionally, the initial data readout for a Phase 2 trial in Grave’s disease (GD) is anticipated in the second half of 2023 and an initial Phase 2b results in CIDP is expected in the first half of 2024.
HL161ANS

Another novel, fully human, subcutaneous antibody molecule that inhibits FcRn-mediated recycling of IgG, designed to deliver maximum lgG reductions while minimizing interference with albumin recycling.

Immunovant anticipates initial results from a Phase 1 trial for HL161ANS, a new FcRn inhibitor (Immunovant project designation: IMVT-1402), in the second half of 2023. Immunovant also plans to evaluate HL161ANS in multiple autoimmune diseases, based on strategic portfolio considerations.
OPHTHALMIC DISEASE PROGRAMS

Tanfanercept (HL036)

A novel topical protein therapy for ophthalmic diseases, including dry eye disease (DED), which inhibits TNF alpha, a key mediator of ocular inflammation

HanAll Biopharma and Daewoong Pharmaceutical are progressing with the second Phase 3 (VELOS-3) study in the U.S. in subjects with moderate to severe DED to examine the safety and efficacy of tanfanercept. Study enrollment is complete and the top-line results from the VELOS-3 study are expected in the first half of 2023.

Harbour BioMed, a licensed partner of HanAll in China, closed its Phase 3 China study in DED, based on the Independent Data Monitoring Committee’s (IDMC) evaluation of the efficacy data from the second interim analysis. The HanAll U.S. study (VELOS-3) differs from the Harbour Chinese study in a number of ways including key inclusion criteria, primary endpoints, as well as subject demographics. The future development plans for tanfanercept in China are under discussion.
ONCOLOGY PROGRAMS
HL187/ HL186

Monoclonal antibodies that respectively target T cell immunoreceptors with Ig and ITIM {Immunoreceptor tyrosine-based inhibitory motif} domains (TIGIT) and T cell immunoglobulin and mucin domain-3 (TIM-3) are being developed in collaboration with Daewoong Pharmaceutical. as potential oncology treatments

HanAll is continuing with the pre-clinical development of HL187 asset and plans to evaluate the further development of HL186 based on the strategic portfolio review.
FINANCIAL HIGHLIGHTS (CONSOLIDATED)
Key Highlights

(KRW in billion)

Q1 2023

Q1 2022

% change

Sales

28.8

24.0

+20 %

Gross Profit

15.7

12.8

+23 %

Selling, marketing and administrative expenses

11.5

10.2

+13 %

Research and development expenses

5.9

3.1

+88 %

Operating income

(1.7)

(0.6)

N/A

Net Income

(1.3)

(0.1)

N/A

Sales recorded 28.8 billion won in the first quarter of 2023, a 20 percent increase compared to the first quarter of 2022. Pharmaceutical sales remained strong with major products including Normix, Eligard, along with the newly launched products such as Abcito and Glucofree.

Research and development expenses for the first quarter ended March 31, 2023 were 5.9 billion won, up 88 percent from 3.1 billion won for the three months ended March 31, 2022. The increase was primarily due to continued progress in VELOS-3 study, along with the investment to the ongoing oncology projects.

Net loss for the three months ended March 31, 2023 recorded 1.3 billion won from the 0.1 billion won for the same period in 2022.