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Aprea Therapeutics Announces One-for-Twenty Reverse Stock Split

On February 13, 2023 Aprea Therapeutics, Inc. (Nasdaq: APRE) (the "Company"), a biopharmaceutical company focused on developing novel synthetic lethality-based cancer therapeutics targeting DNA damage response (DDR) pathways, reported a one-for-twenty reverse stock split of the Company’s common stock, par value $0.001, which became effective at 5:00 pm Eastern Time on February 10, 2023 (Press release, Aprea, FEB 13, 2023, View Source [SID1234627112]). The Company’s common stock will trade on the Nasdaq Global Select Market on a split-adjusted basis beginning on February 13, 2023, under the Company’s existing trading symbol "APRE".

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The Company is implementing the reverse stock split as planned to increase the per share price of its common stock to regain compliance with the listing requirements of the Nasdaq Global Select Market. The reverse stock split will reduce the number of shares of common stock issued and outstanding from approximately 53,631,405 to approximately 2,681,570. There will be no change to the number of authorized shares or the par value per share. The new CUSIP number following the reverse stock split will be 03836J201.

The reverse stock split will affect all stockholders uniformly and will not alter any stockholder’s percentage ownership interest in the Company, except to the extent that the reverse stock split results in any of the Company’s stockholders owning a fractional share. No fractional shares will be issued in connection with the reverse stock split. Following the completion of the reverse stock split, the Company’s exchange agent will aggregate all fractional shares that otherwise would have been issued as a result of the Reverse Stock Split and those shares will be sold into the market. Stockholders who would otherwise hold a fractional share of common stock will receive a cash payment from the proceeds of that sale in lieu of such fractional share.

As of the effective date of the reverse stock split, the number of shares of common stock available for issuance under the Company’s equity incentive plans and issuable upon the exercise of stock options and restricted stock units outstanding immediately prior to the reverse stock split will be proportionately affected by the reverse stock split. The exercise prices of the Company’s outstanding options will be adjusted in accordance with their respective terms.

Computershare Trust Co., N.A. ("Computershare") is acting as the exchange agent for the reverse stock split and will provide notice and instructions to stockholders of record regarding the reverse stock split. Computershare will be issuing, automatically and without the need for stockholder action, all of the post-split shares in paperless, "book-entry" form, and Computershare will hold the shares in an account set up for each respective stockholder. Stockholders who currently hold certificates will need to exchange their certificates to receive their "book-entry" accounts at Computershare. Those stockholders holding common stock in "street name" will receive instructions from their brokers.

AnPac Bio-Medical Science Enters into Definitive Agreement to Make Another Acquisition to Significantly Expand Scope of Business in the U.S

On February 13, 2023 AnPac Bio-Medical Science Co., Ltd. (the "Company") (NASDAQ: ANPC), a company with operations in the United States and China reported that on February 13, 2023, the Company, through its subsidiary Foodbase Group Inc., entered into a definitive equity purchase agreement to acquire a group of affiliated companies, SLV Windfall Group LLC, Windfall SLV Development LLC and SLV Windfall Management, LLC, which are engaged in developing, marketing and selling real estate in Savannah Lakes Village, a planned community located in McCormick County, South Carolina (Press release, Anpac Bio, FEB 13, 2023, View Source [SID1234627111]). SLV Windfall Group LLC currently owns a few dozen buildable lots, approximately 500 acres of undeveloped land for future development projects, and has secured the exclusive right to purchase on favorable terms from the local land authorities over 2,000 buildable lot. Savannah Lakes Village is a well-developed community which has been in existence for more than 30 years. The Company plans to file the necessary applications to qualify the land development at Savannah Lakes Village as a U.S. EB-5 immigration investment project.

Pursuant to the equity purchase agreement, the Company agreed to purchase 100% of the issued and outstanding equity interests of the affiliated companies for an aggregate consideration of $28,000,000, payable in the form of cash in four installment payments pursuant to a payment schedule based on milestone events. The initial closing of the transaction is expected to take place in the second quarter of 2023.

Mr. Haohan Xu, the Co-CEO of the Company commented, "We believe this acquisition will expand the scope of our operations meaningfully and bring significant value to our shareholders. We are in the process of acquiring some business-to-business e-commerce food businesses. The acquisition of the SLV project will potentially give the Company an opportunity to use the 500 acres of undeveloped land to build low costs smart food warehouse and distribution centers. We also plan to build and sell residential properties with great profit potential, thanks to the favorable terms granted by the local land authorities and use the profits generated from the sale of these residential properties to fund the construction of the smart food warehouse and distribution centers."

About SLV Windfall Group LLC

SLV Windfall Group LLC, a Delaware limited liability company headquartered in South Carolina, currently owns a few dozens of buildable lots, approximately 500 acres of undeveloped land for future development projects, and has secured the exclusive right to purchase on favorable terms from the local land authorities over 2,000 buildable lot, located in the Savannah Lakes Village of McCormick County in South Carolina. The Savannah Lakes Village is a lakefront community spread over 4,300 acres and wrapped around a massive 71,000-acre waterside and forest. The community has been well developed for more than 30 years, with 90 miles of finished roads and all types of public infrastructure, including water supply, sewers, cable and high-speed internet. The fully constructed infrastructure and utilities are currently estimated to have a value of $350 million.

Moleculin Announces Final Topline Data from Successful European Phase 1 Trial Evaluating Annamycin as Single Agent Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML)

On February 13, 2023 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, reported the following topline results from its MB-105 European Phase 1 clinical trial assessing the safety and efficacy of Annamycin as a single agent for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) (Press release, Moleculin, FEB 13, 2023, View Source [SID1234627110]). The final MB-105 results align with the overall safety profile of Annamycin and observations made in previously completed and ongoing clinical studies evaluating Annamycin. Additionally in the last cohort where all subjects were at least 60 years of age, Annamycin demonstrated an overall response rate (ORR) of 80%.

"We are very pleased with these topline results, both in terms of safety and the initial data suggesting efficacy," said Moleculin Chairman and CEO Walter Klemp, "especially since these patients were relapsed or refractory." Mr. Klemp continued, "Given the recently published research showing that Annamycin in combination with Cytarabine substantially outperformed Annamycin as a single agent in an aggressive AML mouse model, these topline results are encouraging as we continue to develop Annamycin in combination with Cytarabine for the treatment of AML. Having previously announced the start of our open label MB-106 trial of Annamycin in combination with Cytarabine for the treatment of AML Phase 1/2 trial in Poland and Italy, we are optimistic about Annamycin’s potential for the treatment of AML, as we continue to gather the data that ultimately will be necessary to support approval."

"We also are encouraged by the absence of cardiotoxicity with Annamycin to date," Mr. Klemp added. "This is particularly relevant in light of a recently published retrospective study showing that the incidence of heart failure more than doubles for cancer patients treated with anthracyclines compared to cancer patients not receiving anthracyclines.1 Annamycin was designed to be non-cardiotoxic, and we believe the initial safety data, if replicated along with efficacy data as our development work continues, suggest an opportunity for Annamycin to become a preferred anthracycline treatment for AML and other indications."

Topline results in MB-105, an open label, single arm clinical trial conducted in Europe showed one CRi (complete response with incomplete recovery of peripheral blood count) and three PRs (Partial Response) for an 80% overall response rate (ORR) in the last cohort. In this cohort, the age range at time of treatment of the 5 subjects was 62-73. The subject who achieved the CRi was 65 years of age at time of treatment.

For purposes of this clinical trial, a CR means that the subject’s bone marrow blasts reduced to 5% or less (with CRi meaning a CR where there was incomplete recovery of white blood cell and/or platelet counts), and a PR means the subject’s bone marrow blasts reduced by 50% and resulted in a blast count of 25% or less. 20 subjects were enrolled in the trial with the age range of 24-76 years with a median age of 64.5. The median number of prior therapies for all subjects was 4 (range 1-18). Of the 20 subjects enrolled, 17 received the full 3 consecutive days of dosing per protocol. PRs (3) and CRi (1) were noted in 4 (80%) of the 5 subjects dosed according to protocol in the last cohort (240 mg/m2).

In earlier cohorts receiving lower doses, 2 subjects (1 at 120 mg/m2 and 1 at 180 mg/m2) although qualified to receive a second cycle (they exhibited a 50% decrease in marrow blasts and marrow blasts < 25%), did not meet what the protocol defined as a PR at that time. Per protocol at that time to achieve a PR, these subjects were required to have normalization of blood counts/hematologic values in addition to bone marrow blast reduction to qualify as a PR which did not occur. The final version of the protocol required just a >50% reduction in marrow blasts to qualify as a PR. Despite these subjects qualifying to receive a second cycle of treatment, the two subjects were recorded as having a best overall response of "treatment failure" as they did not mean the definition of PR as defined by the protocol at that time.

All subjects have been included in the evaluation for cardiotoxicity by an independent expert, with none noted. The most frequently reported adverse events (occurring in >10 % of subjects) were hematologic in nature, being neutropenia, thrombocytopenia and anemia.

The clinical study report for MB-105 has been finalized, internally published and reviewed and the Company expects to share detailed data in a paper and/or publication in the near future.

Annamycin currently has Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of STS lung metastases and the treatment of relapsed or refractory AML.

Study Design

The Company evaluated Annamycin in both the U.S. (MB-104) and Europe (MB-105) in open label, single arm clinical trials to assess the safety and efficacy of Annamycin for the treatment of adults with relapsed or refractory acute myeloid leukemia. Enrollment occurred in cohorts of at least 3 subjects in a conventional 3+3 escalating dose design, starting at a dose level of 120 mg/m2/day administered for 3 days. Dose escalation took place on the basis of safety assessments in sequential cohorts of at least 3 subjects each. The initial cohort received 120 mg/m2/day for 3 days. For Cohorts 1, 2, 3, 4, and 5 dose escalation occurred in 30-mg/m2/day increments until subjects are enrolled at a 240-mg/m2/day dose. The primary outcome of the study was evaluation of safety and identification of the maximum tolerated dose (MTD) and the recommend phase 2 dose (RP2D) for Annamycin. As announced in February 2022, upon safely reaching the RP2D of 240 mg/m2 in the MB-105 trial, the Company concluded recruitment for the trial. Based on the safety and dosage data from the two successfully concluded single agent Annamycin AML Phase 1 trials, MB-104 and MB-105, Moleculin is conducting its ongoing Phase 1/2 trial evaluating Annamycin in combination with Cytarabine (Ara-C) for the treatment of subjects with AML who are refractory to or relapsed after induction therapy (MB-106).

About Annamycin

Annamycin is the Company’s next-generation anthracycline that has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin. Importantly, Annamycin has also demonstrated a lack of cardiotoxicity in multiple early-stage human clinical trials, including ongoing trials for the treatment of acute myeloid leukemia (AML) and STS lung metastases. For that reason, although additional data will be necessary, the Company believes Annamycin may not face the same usage limitations imposed on doxorubicin, one of the most common currently approved anthracyclines. Annamycin is currently in development for the treatment of AML and STS lung metastases and the Company believes the drug may have the potential to treat additional indications.

BioNova Announces First Patient Dosed in a Phase 1/2 Study of BN301 for the Treatment of Hematologic Malignancies in China

On February 13, 2023 BioNova Pharmaceuticals Limited (BioNova), a company dedicated to the discovery, development and commercialization of innovative medicines for the treatment of diseases with unmet medical needs, reported that the first patient has been dosed in the phase 1 clinical study of BN301 (STRO-001) for the treatment of advanced B-cell Non-Hodgkin’s Lymphoma (NHL) (Press release, Sutro Biopharma, FEB 13, 2023, View Source [SID1234627109]).

BN301 is a novel target, site-specific antibody drug conjugate (ADC) comprised of a human aglycosylated anti-CD74 IgG1 antibody and 2 non-cleavable maytansinoid drug-linkers. BN301/STRO-001 was granted Orphan Drug Designation by the US FDA for multiplemyeloma in October 2018. Through a licensing agreement with Sutro Biopharma, Inc. (Sutro, NASDAQ: STRO) in October 2021, BioNova gained the option to obtain exclusive rights to develop and commercialize BN301 in Greater China territory, includingmainland China, Hong Kong, Macau and Taiwan.

The multi-center Phase 1/2 clinical trial of BN301 is to evaluate BN301 in patients with B-cell NHL who have previously failed standard therapy or who are intolerant to standard therapy. This study is comprised of a Phase 1 dose escalation part and a Phase 2dose expansion part.

"We are very pleased with the Sutro collaboration and very excited about this important milestone for BN301 global development." said Ye Hua, M.D., Founder and CEO of BioNova, "Patients with relapsed/refractory NHL have limited treatment options and their prognosis are usually poor. We are hopeful that this novel target ADC could provide those patients with a potential new treatment option. Together with Sutro colleagues, our development team is working diligently and efficiently to advance BN301 clinical development program in China."

8-K – Current report

On February 13, 2023 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported its financial results for the three months ended December 31, 2022 and provided a business update (Press release, Sonnet BioTherapeutics, FEB 13, 2023, View Source [SID1234627108]).

"This was a productive quarter for Sonnet and one of which we are particularly proud. We believe the successful early clinical data we announced sets the stage for SON-1010 as a potentially best-in-class IL-12 therapeutic candidate with unique properties for targeting the tumor microenvironment," commented Pankaj Mohan, Ph.D., Founder and CEO. "Our prioritized business development initiatives culminated in the work Janssen is currently undertaking to evaluate three of our pipeline assets. We continue to progress our platform with our first bispecific, bifunctional pipeline compound, SON-1210, a first-in-class combination of interleukins 12 and 15 and we look forward to delivering on our 2023 research and development initiatives while remaining focused on partnering as a key component of our strategy."

"Having recently completed a $15 million financing, we are advancing our stated objective to reduce operating expenses by approximately 30% beginning in our second fiscal quarter, with an eye to making additional cuts to further extend our cash runway. These next few quarters will play an important role in shaping Sonnet’s future, and we remain confident in the promise of our FHAB technology," said Jay Cross, CFO.

FY 2023 First Quarter and Recent Corporate Updates

Sonnet provided the following corporate updates:

On October 31, 2022, announced a collaboration agreement with Janssen Biotech, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, where in vitro and in vivo efficacy of SON-1010 (IL12-FHAB), SON-1210 (IL12-FHAB-IL15) and SON-1410 (IL18-FHAB-IL12) will be evaluated in combination with certain Janssen proprietary cell therapy assets. The agreement was facilitated by Johnson & Johnson Innovation.

On November 2, 2022, announced interim data from the SB101 and SB102 Phase 1 dose-escalation trials of SON-1010. At the time of the press release, 36 subjects had been dosed across the two studies, where cytokine data showed extended pharmacokinetics of SON-1010 with controlled induction of IFNγ and no signs of cytokine release syndrome, or dose-limiting toxicities. Subsequent to this announcement, on January 19, 2023, Sonnet announced follow-up data from the SB102 study in a total of 24 healthy volunteers, where the PK profile supported an extended half-life of SON-1010 of approximately 112 hours, compared to 12 hours for rhIL-12. Observed increases in IFNγ were dose-related, controlled and prolonged. Sonnet expects to announce additional data from both studies during the second calendar quarter of 2023.

During December 2022, successfully completed two IND-enabling toxicology studies with SON-1210 in non-human primates. As announced on January 19, 2023, the compound elicited no serious adverse events in repeat, subcutaneous dosing and was well-tolerated using dosing levels at least 50x higher than the highest anticipated human clinical dose level. Data analysis and reporting for both of the studies will enable the preparation of regulatory filings to begin during the first half of 2023 for first-in-human trials of SON-1210.

FY 2022 Third Quarter Ended December 31, 2022 Financial Results

As of December 31, 2022, Sonnet had $1.7 million cash on hand and $0.0 million in debt. On February 10, 2023, the company closed a public offering for gross proceeds of $15 million (net proceeds of approximately $13.5 million), issuing 11,664,888 shares of common stock, pre-funded warrants to purchase 2,224,000 shares of common stock, with an exercise of $0.0001 per share, and common warrants to purchase 27,777,776 shares of common stock, with an exercise price of $1.08 per share. After the offering, the Company has 20,232,904 shares of common stock outstanding.

Research and development expenses were $3.7 million for the three months ended December 31, 2022, compared to $4.3 million for the three months ended December 31, 2021. The decrease of $0.6 million was primarily due to the establishment of cost savings by transitioning product development activities to cost advantaged locations such as India and Australia and by reducing expenditures on tertiary programs such as SON-3015, which has been placed on a development hold, as well as a decrease in share-based compensation expense.

General and administrative expenses were $1.9 million for the three months ended December 31, 2022, compared to $2.1 million for the three months ended December 31, 2021. The decrease of $0.2 million relates primarily to a decrease in share-based compensation expense and consulting expense related to investor relations.

About Sonnet BioTherapeutics Holdings, Inc.

Sonnet BioTherapeutics is an oncology-focused biotechnology company with a proprietary platform for innovating biologic drugs of single or bispecific, bifunctional action. Known as FHAB (Fully Human Albumin Binding), the technology utilizes a fully human single chain antibody fragment (scFv) that binds to and "hitch-hikes" on human serum albumin (HSA) for transport to target tissues. Sonnet’s FHAB was designed to specifically target tumor and lymphatic tissue, with an improved therapeutic window for optimizing the safety and efficacy of immune modulating biologic drugs. FHAB is the foundation of a modular, plug-and-play construct for potentiating a range of large molecule therapeutic classes, including cytokines, peptides, antibodies, and vaccines.

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential, "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.