Aprea Therapeutics Announces Private Placement Financing of up to $34.0 Million

On March 11, 2024 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, reported that it has entered into a securities purchase agreement with new and existing healthcare focused institutional investors and certain Company insiders to raise up to $34.0 million in gross proceeds, including initial upfront funding of $16.0 million and up to an additional $18.0 million upon cash exercise of accompanying warrants at the election of the investors (Press release, Aprea, MAR 11, 2024, View Source [SID1234641007]).

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The financing is being led by Sphera Healthcare and includes participation from new and existing healthcare-focused investors, including Nantahala Capital, DAFNA Capital Management, Exome Asset Management and Stonepine Capital Management, among others, as well as certain Company insiders.

"This meaningful financing led by high quality healthcare institutions will support Aprea in our goal to be a leader in the field of Synthetic Lethality (SL) and DNA Damage and Response (DDR)," said Dr. Oren Gilad, President and CEO of Aprea. "It will provide the capital to fund our Phase 1 ACESOT-1051 clinical trial evaluating a highly potent, oral WEE1 inhibitor for Cyclin E over-expressing cancers including breast and ovarian cancers as well as continuation of patient enrollment in the dose expansion portion of the Phase 1/2a clinical trial (AR-276-01) evaluating ATR inhibitor, ATRN-119, in patients with advanced solid tumors having mutations in defined DDR-related genes."

Maxim Group LLC is acting as the sole placement agent for the private placement.

Pursuant to terms of the securities purchase agreement, Aprea will issue an aggregate of 2,194,788 shares of its common stock (or pre-funded warrants in lieu thereof) and accompanying warrants to purchase up to an aggregate of 2,194,788 shares of its common stock at a combined purchase price of $7.29 per share and accompanying warrants, in accordance with the "Minimum Price" requirement as defined in the Nasdaq rules. The accompanying warrants will consist of two tranches:

Tranche A warrants to purchase up to 1,097,394 shares of common stock at an exercise price of $7.29 per share for an aggregate of up to $8.0 million and will expire at the earlier of (i) 30 days following the announcement of the recommended Phase 2 dose for the Company’s ATR inhibitor program for ATRN-119 and the daily VWAP of the Company’s common stock equaling or exceeding $14.58 per share for 30 consecutive trading days following the announcement and (ii) three years from the date of issuance.
Tranche B warrants to purchase up to 1,097,394 shares of common stock at an exercise price of $9.1125 per share for an aggregate of up to $10.0 million and will expire at the earlier of (i) 30 days following the announcement of the recommended Phase 2 dose for the Company’s WEE1 inhibitor program for APR-1051 and the daily VWAP of the Company’s common stock equaling or exceeding $18.225 per share for 30 consecutive trading days following the announcement and (ii) five years from the date of issuance.
In lieu of shares of common stock, certain investors are purchasing pre-funded warrants at a combined purchase price of $7.289 per pre-funded warrant and accompanying warrants, which equals the purchase price per share of common stock and accompanying warrant, less the $0.001 per share exercise price of each pre-funded warrant. The private placement is expected to close on or about March 13, 2024 subject to satisfaction of customary closing conditions.

Aprea intends to use the upfront net proceeds from the private placement for general corporate purposes and to fund clinical development of APR-1051, the Company’s WEE1 inhibitor product candidate which recently received IND clearance. The aggregate net proceeds (assuming the cash exercise of all accompanying warrants) are expected to be sufficient to fund the Company into 2026.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering, and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock purchased in the private placement and shares of common stock underlying the warrants.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

Aprea Therapeutics Announces FDA Clearance of IND for APR-1051, its Next Generation WEE1 Kinase Inhibitor for Cyclin E Overexpressing Cancers

On March 11, 2024 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application (IND 169359) for APR-1051 (Press release, Aprea, MAR 11, 2024, View Source [SID1234641006]).

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"APR-1051 is a next-generation inhibitor of WEE1 kinase and, based on its unique characteristics, we believe it will be best in class," said Dr. Oren Gilad, President and CEO of Aprea. "The FDA’s clearance of our IND is a critical step in the APR-1051 development program. We look forward to evaluating therapeutic activity in patients, focusing on Cyclin E overexpressing cancers, including ovarian and breast cancers."

Based on preclinical studies, APR-1051 is differentiated from other WEE1 inhibitors in its:

Molecular structure;
Selectivity for WEE1 versus off-target inhibition of the polo-like kinase, or PLK, family of kinases;
Potentially superior pharmacokinetic (PK) properties;
Potential absence of QT prolongation at doses that significantly inhibit WEE1*
APR-1051 was discovered and preclinically evaluated by Aprea’s team of chemists and scientists. Aprea has conducted extensive pre-clinical studies with APR-1051, which have demonstrated that the molecule has potent anti-tumor activity, along with a favorable pharmacokinetic (PK) profile. Additionally, pre-clinical data show that APR-1051 may demonstrate less toxicity than other WEE1 inhibitors.*

Clearance of the IND application will allow Aprea to initiate the Phase 1 ACESOT-1051 dose escalation trial to evaluate the safety, tolerability, and preliminary efficacy of APR-1051. Enrollment of the first patient in this study is expected in the first half of 2024 with an update expected in the fourth quarter of the year.

* No head-to-head studies have been conducted with APR-1051

Anaptys Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

On March 11, 2024 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported operating results for the fourth quarter and year ended December 31, 2023 and provided a business update.

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"2023 was a remarkable year for Anaptys as we implemented a multi-year development plan investing across our best-in-class immune cell modulators (ICMs) to bring transformational medicines to patients living with heterogeneous, systemic autoimmune and inflammatory diseases, with the goal of restoring immune balance," said Daniel Faga, president and chief executive officer of Anaptys. "Enrollment is ongoing in three global Phase 2 trials for ANB032, our BTLA agonist, in atopic dermatitis and rosnilimab, our PD-1 agonist, in rheumatoid arthritis and ulcerative colitis. Additionally, we expanded our portfolio by acquiring the rights to ANB101, a BDCA2 modulator, which targets plasmacytoid dendritic cells, known to be key drivers of interferon secretion and antigen presentation."

"We will have a number of important events in 2024 including the top-line data readout of ANB032’s Phase 2b trial in atopic dermatitis by year end," adds Faga. "We also plan to move our third and fourth ICMs — ANB033, our anti-CD122 antagonist, and ANB101 — into the clinic this year, with IND filings planned for Q2 and H2, respectively."

Updates on Wholly Owned Immune Cell Modulator Pipeline

ANB032 (BTLA agonist antibody)

Enrollment ongoing for global Phase 2b trial in moderate-to-severe atopic dermatitis (AD)
160-patient placebo-controlled trial assessing three dose levels of subcutaneously administered ANB032 (randomized 1:1:1:1) for a 14-week treatment duration and then followed for a six-month off-drug follow-up period on well-established endpoints, including EASI75 and IGA 0/1
Reiterating top-line Week 14 data anticipated by year-end 2024
Presented poster on ANB032 preclinical data supporting the modulation of dendritic cell (DC) maturation and function, representing one of the mechanisms to address atopic dermatitis pathophysiology, at the 2024 AAD Annual Meeting in March 2024
Poster presentation is available here
Rosnilimab (PD-1 agonist antibody)

Enrollment ongoing for global Phase 2b trial in moderate-to-severe RA
420-patient placebo-controlled trial assessing three dose levels of subcutaneously administered rosnilimab (randomized 1:1:1:1) for a 12-week treatment duration on well-established endpoints, including DAS28-CRP, CDAI and ACR20/50/70
At Week 14, rosnilimab-treated patients who achieve low disease activity, defined as CDAI<=10, are eligible to be dosed for an additional 16-week all-active treatment period and then followed for a three-month off-drug follow-up period
Reiterating top-line Week 12 data anticipated by mid 2025
Enrollment ongoing for global Phase 2 trial in moderate-to-severe UC
130-patient placebo-controlled trial assessing two dose levels of subcutaneously administered rosnilimab (randomized 1:1:1) for a 12-week treatment duration on well-established endpoints, including clinical response on modified Mayo score (mMS), clinical remission on mMS and endoscopic remission
Rosnilimab and placebo-treated patients who achieved clinical response on mMS are eligible to continue on their assigned treatment for an additional 12 weeks, while patients on placebo who are non-responders will be crossed over to the high-dose rosnilimab treatment arm, in an all-active treatment period and then followed for a three-month off-drug follow-up period
Reiterating top-line Week 12 data anticipated by H1 2026
Presented posters on previously reported rosnilimab Phase 1 data and membrane proximal binding epitope to optimize PD-1 agonist signaling at the American College of Rheumatology (ACR) Convergence 2023 in November 2023 and at the 19th Congress of the European Crohn’s and Colitis Organisation (ECCO) in February 2024
Poster presentations are available here
Hosted a virtual Rosnilimab (PD-1 Agonist) R&D Event in October 2023
Replay of the audio webcast is available here
ANB033 (anti-CD122 antagonist antibody)

Plan to submit an Investigational New Drug (IND) application in Q2 2024
ANB101 (BDCA2 modulator antibody)

Announced exclusive global license of ANB101 in November 2023
Anaptys also received the same rights to ANB102, an extended half-life BDCA2 modulator with the potential to enable quarterly or less frequent dosing
License from Centessa Pharmaceuticals in exchange for a one-time upfront cash payment of $7 million, inclusive of $3 million for manufactured and released GMP supply of ANB101
Plan to submit an IND application in H2 2024
Updates on Legacy Clinical-Stage Cytokine Antagonist Programs Available for Out-Licensing

Announced positive top-line GEMINI-1 Phase 3 clinical trial results of imsidolimab (IL-36R) in generalized pustular psoriasis (GPP) in October 2023
Plan to submit comprehensive data abstract for GEMINI-1 and top-line GEMINI-2 results to a medical meeting in H2 2024
Intend to out-license imsidolimab in 2024
Updates on GSK Immuno-Oncology Financial Collaboration

GSK anticipates top-line data in H2 2024 from COSTAR Lung Phase 3 trial comparing cobolimab, a TIM-3 antagonist, plus dostarlimab, a PD-1 antagonist, plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and chemotherapy
GSK anticipates top-line data in H1 2024 from the FIRST Phase 3 trial for platinum-based therapy with dostarlimab and niraparib versus platinum-based therapy as first-line treatment of Stage III or IV nonmucinous epithelial ovarian cancer
Cash Position

Year end 2023 cash and investments of $417 million and reiterating cash runway through year-end 2026
Fourth Quarter and Full Year 2023 Financial Results

Cash, cash equivalents and investments totaled $417.9 million as of December 31, 2023, compared to $584.2 million as of December 31, 2022, for a decrease of $166.3 million. The decrease relates primarily to cash used for operating activities and the $50 million stock repurchase program.
Collaboration revenue was $9.0 million and $17.2 million for the three and twelve months ended December 31, 2023, compared to $6.8 million and $10.3 million for the three and twelve months ended December 31, 2022. The change is due primarily to increased royalties recognized for sales of Jemperli offset by one development milestone achieved for cobolimab in 2022.
Research and development expenses were $33.5 million and $132.3 million for the three and twelve months ended December 31, 2023, compared to $23.4 million and $88.8 million for the three and twelve months ended December 31, 2022. The increase was due primarily to manufacturing and development costs for rosnilimab, ANB032 and ANB033. The R&D non-cash, stock-based compensation expense was $2.5 million and $10.2 million for the three and twelve months ended December 31, 2023 as compared to $1.8 million and $6.8 million in the same period in 2022.
General and administrative expenses were $10.3 million and $41.9 million for the three and twelve months ended December 31, 2023, compared to $9.4 million and $36.6 million for the three and twelve months ended December 31, 2022. The G&A non-cash, stock-based compensation expense was $5.6 million and $23.0 million for the three and twelve months ended December 31, 2023 as compared to $4.9 million and $20.6 million in the same period in 2022.
Acquired in-process research and development of $7.3 million for the three and twelve months ended December 31, 2023 related to the exclusive licensing agreement with Centessa Pharmaceuticals.
Net loss was $42.2 million and $163.6 million for the three and twelve months ended December 31, 2023, or a net loss per share of $1.59 and $6.08, compared to a net loss of $26.4 million and $128.7 million for the three and twelve months ended December 31, 2022, or a net loss per share of $0.93 and $4.57.

Anixa Biosciences Announces Presentation at 24th Annual World Vaccine Congress

On March 11, 2023 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a clinical-stage biotechnology company focused on the treatment and prevention of cancer, reported that Dr. Amit Kumar, Chairman and CEO of Anixa, will participate in the 24th Annual World Vaccine Congress being held April 1-4, 2024 (Press release, Anixa Biosciences, MAR 11, 2024, View Source [SID1234641001]). Dr. Kumar will speak on Thursday, April 4th, in the Cancer Immunotherapy Track.

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Details are as follows:

Location:

Walter E. Washington Convention Center, Washington, D.C.

Tickets:

Visit the conference website.

Session:

April 4, 2024 | Cancer Immunotherapy

Emerging Targets & Strategies track

11:45 a.m.: "Early-stage clinical results from a novel preventative breast cancer vaccine."

Dr. Kumar will speak about positive interim results from the Phase 1 clinical trial of Anixa’s breast cancer vaccine. In the most recent data, 75% of women showed immune responses, with responses observed at all dose levels. The vaccine is designed to direct the immune system to destroy triple negative breast cancer (TNBC) cancer cells through a mechanism that has never previously been utilized for cancer vaccine development. The trial is being conducted in collaboration with Cleveland Clinic with funding by a grant from the U.S. Department of Defense.

Dr. Kumar will be available during the Congress for one-on-one meetings.

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meetings of their kind across the globe since 2000. The World Vaccine Congress Washington 2024 will host 4,000+ attendees, 450+ speakers, and 350+ exhibitors.

Phase 1 onCARlytics solid tumour trial advances to combination arm treatment

On March 11, 2024 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported that its Phase 1 clinical trial of CD19 oncolytic virotherapy drug candidate onCARlytics (on-CAR-19, CF33-CD19 HOV4) has cleared its first cohort within the intratumoural monotherapy arm of the study and is therefore ready to commence combination dosing solid tumour patients with CD19 targeting drug blinatumomab (Blincyto marketed by Amgen) (Press release, Imugene, MAR 11, 2024, https://mcusercontent.com/e38c43331936a9627acb6427c/files/29d98be7-23cc-5260-9e48-e0e4a65ee3ac/Phase_1_onCARlytics_Trial_Advances_to_Combination_Arm.pdf [SID1234640982]).

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Known as OASIS, the first-in-class clinical trial is targeting adult patients with advanced or metastatic solid tumours, and aims to evaluate the safety and efficacy of two routes of administration, intratumoural (IT) injection and intravenous (IV) infusion, either alone, or in combination with blinatumomab.

The trial is titled: "A Phase I, Dose Escalation and Dose Expansion, Safety and Tolerability Study of onCARlytics (CF33-CD19), Administered Intravenously or Intratumorally in Combination with Blinatumomab in Adults with Advanced or Metastatic Solid Tumors." See View Source

The combination arm of the study will see onCARlytics combined with CD19 targeting bispecific monoclonal antibody blinatumomab (marketed as Blincyto by Amgen which currently is specifically approved only for liquid blood cancers). OnCARlytics has the potential to target and eradicate solid tumours that otherwise cannot be treated with Blincyto therapy alone and will represent a paradigm shift in solid tumour treatment.

OASIS is a dose escalation trial that will be conducted across multiple sites across the United States, with 52 patients proposed to take part in the trial.

Imugene Managing Director and CEO Leslie Chong said:

"It’s once again a credit to our team and collaborators to see yet another study progressing positively and on schedule. Completion of this first monotherapy intratumoural cohort where ovarian, breast and melanoma patients were dosed paves the way for us to move into an important combination dosing with Blincyto, where we’ll be eager to see the greater potential of onCARlytics in targeting and eradicating solid tumours."

OnCARlytics is a CD19-expressing oncolytic virus that enters tumour cells and forces them to express the CD19 protein on the cell surface, presenting a target for CD19 targeting therapies.