On August 15, 2022 Exicure, Inc. (Nasdaq: XCUR), an early-stage biotechnology company focused on the development of next generation nucleic acid therapies targeting RNA to address both genetic and non-genetic neurological and hair loss disorders, reported financial results for the quarter ended June 30, 2022 and provided an update on its business strategy and corporate progress (Press release, Exicure, AUG 15, 2022, View Source [SID1234618360]).

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"Exicure continues to make progress with our preclinical SCN9A program for the treatment of pain with ongoing initial in vivo animal studies to support candidate selection in 2023," commented Matthias Schroff, Ph.D., Chief Executive Officer of Exicure. "We also continue to advance our partnered programs with Ipsen and AbbVie," concluded Dr. Schroff.

Corporate Progress

Corporate highlights for the second quarter of 2022 include:

We advanced the Company’s SCN9A preclinical discovery program. Exicure anticipates results from initial in vivo animal studies by year-end 2022, with the goal of therapeutic candidate selection in the second half of 2023.
We progressed work with partnered programs towards potential pre-clinical milestones in 2023.
We actively pursued out-license opportunities for the Company’s clinical asset, cavrotolimod.
We are continuing to pursue near-term partnering opportunities for pain and other neuroscience programs.
On June 28, 2022, we filed a Certificate of Amendment to our Amended and Restated Certificate of Incorporation (the "Amendment") with the Secretary of State of the State of Delaware to effect a one-for-thirty (1-for-30) reverse stock split of our outstanding common stock. The Amendment became effective at 5:00 p.m. Eastern Time on June 29, 2022.
At the effective time of the Amendment, every thirty (30) shares of our issued and outstanding common stock were automatically combined and converted into one issued and outstanding share of common stock, without any change in par value per share. No fractional shares of the Company’s common stock was issued to any stockholders in connection with the reverse stock split and holders of record received a cash payment in lieu of fractional shares.
Our common stock began trading on The Nasdaq Capital Market on a split-adjusted basis when the market opened on Thursday, June 30, 2022. The new CUSIP number for our common stock following the reverse stock split is 30205M 200.
On May 18, 2022, we closed the previously announced $5 million private placement transaction priced at market premium.
We sold an aggregate of 867,369 shares of the Company’s common stock to certain accredited investors in a private placement in public equity ("PIPE") financing at a purchase price of $5.81 per share, representing an approximately 45% premium to the 10-day volume weighted-average share price from May 9, 2022.
New investor CBI USA, Inc. led the transaction; existing investor, Abingworth LLP, also participated.
Net proceeds from the transaction are expected to support the Company’s advancement of its preclinical program, including the development of its SCN9A product candidate, as well as other working capital and general corporate purposes.
Second Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and short-term investments, and restricted cash were $23.4 million as of June 30, 2022, as compared to $48.3 million as of December 31, 2021. The Company expects that its existing cash and cash equivalents, and short-term investments will enable it to fund its current operations early into the first quarter of 2023.

Revenue: Revenue was $2.5 million for the quarter ended June 30, 2022, reflecting an increase of $2.4 million from revenue of $0.1 million for the quarter ended June 30, 2021. The increase in revenue of $2.4 million is mostly due to the recognition of non-cash revenue of $1.8 million associated with the Company’s collaboration with Ipsen Biopharm Limited, as well as an increase in revenue of $0.6 million associated with the Company’s collaboration with AbbVie Inc.

Research and Development (R&D) Expense: Research and development expenses were $6.7 million for the quarter ended June 30, 2022, as compared to $10.8 million for the quarter ended June 30, 2021. The decrease in R&D expense for the three months ended June 30, 2022 of approximately $4.1 million reflects a reduction in employee headcount and fewer discovery, preclinical, and clinical program activities resulting from the restructuring activities that the Company announced in December 2021.

General and Administrative (G&A) Expense: General and administrative expenses were $3.2 million for the quarter ended June 30, 2022, as compared to $3.1 million for the quarter ended June 30, 2021. The increase in G&A expense of approximately $0.1 million for the three months ended June 30, 2022 was mostly due to higher legal costs and retention award expense for current employees, partially offset by lower compensation and related costs in connection with a lower average headcount during the period resulting from the restructuring activities that were announced in December 2021, as well as lower costs for consulting, investor relations, and board fees.

Net Loss: The Company had a net loss of $7.5 million for the quarter ended June 30, 2022, as compared to a net loss of $14.3 million for the quarter ended June 30, 2021. The decrease in net loss was primarily driven by lower R&D expense and higher non-cash revenue during the period.

Going Concern: Given the Company’s current cash position, operating plans and forecasted negative cash flows from operating activities over the next twelve months, management believes there is substantial doubt regarding the Company’s ability to continue as a going concern within one year after the date that its unaudited condensed consolidated financial statements for the quarter ended June 30, 2022 are issued. The Company will require substantial additional financing to address the Company’s working capital and other financing needs to pursue its business strategy.

On August 15, 2022 Fusion Antibodies reported that it is delighted to be attending Antibody Engineering & Therapeutics (Press release, Fusion Antibodies, AUG 15, 2022, View Source [SID1234618359]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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This event will be delivered in San Diego from 4-8th December 2022.

This is the #1 Antibody Engineering Conference for acceleratinf next generation antibosies to commercial success.

On Tuesday December 6th at 12:05pm, our CSO Dr Richard Buick will be delivering a scientific briefing on the following topic:

OptiMAL – A Novel Library and Mammalian Display Platform for Antibody Discovery
We present a novel synthetic antibody library based on the natural human repertoire, coupled to a powerful CHO cell mammalian display platform. This
library has been screened by a combination of MACS and FACS to select antibodies against the immune-oncology target PD-1.

Get in touch below to organise a meeting with one of the Fusion Antibodies team.

On August 15, 2022 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 June 30, 2022 and provided a business update (Press release, Sonnet BioTherapeutics, AUG 15, 2022, View Source [SID1234618358]).

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"Sonnet is proud of its progress to date, with two clinical programs in SON-1010 and SON-080 currently advancing in human studies," said Pankaj Mohan, Ph.D., Founder and CEO. "During the fourth quarter of this year, we anticipate releasing initial safety and tolerability data from the SB101 study in oncology patients and the SB102 study in healthy volunteers. The initial pharmacokinetic and pharmacodynamic data from both studies should be available later this year, as well. Taken together, we anticipate that these trials will help the company optimize the clinical development strategies underpinning our multiple FHAB platform-based bispecific immunotherapy candidates."

"We remain focused on an effective financing strategy to help advance Sonnet’s growth and we are excited to continue our work with the FHAB technology, which we believe carries significant value for oncology therapeutic development," commented Jay Cross, CFO.

FY 2022 Third Quarter and Recent Corporate Updates

Sonnet provided the following corporate updates:

Initiated a second Phase 1 clinical trial of SON-1010 (IL12-FHAB), based on the successful initiation of the first two cohorts in the first-in-human (FIH) dose-escalation trial (SB101) in patients with advanced solid tumors; initial safety and tolerability data from the SB101 and SB102 studies expected during the calendar fourth quarter of this year; initial PK and PD data from both studies should also be available before the end of 2022
Initiated a Phase 1b/2a clinical trial of SON-080; this new study (SB211) will be conducted at multiple sites in Australia in patients with persistent chemotherapy-induced peripheral neuropathy (CIPN); initial safety data from this study are expected during the first half of 2023
Announced positive data from a preclinical combination study of SON-1010 with a commercially available anti-PD1 compound; combination increased survival rate in the study
Completion of the non-human primate (NHP) toxicology studies with SON-1210 is anticipated by the end of 2022; we expect to initiate the regulatory authorization process in the first half of 2023
Completed sequence confirmation for SON-3015 and preparing for initial in vivo mice studies during the calendar fourth quarter of this year
FY 2022 Third Quarter Ended June 30, 2022 Financial Results

As of June 30, 2022, Sonnet had $5.2 million cash on hand.
Research and development expenses were $5.6 million for the three months ended June 30, 2022, compared to $3.9 million for the three months ended June 30, 2021. The increase of $1.8 million was primarily due to increased expenditures for the development of the cell lines for IL12-FHAB, IL12-FHAB-IL15 and SON-080 in connection with the initiation of a Phase 1 clinical trial for SON-1010 and preparation for a Phase 1b/2a pilot-scale efficacy study with SON-080 in CIPN, the milestone payment incurred in connection with the XOMA Collaboration Agreement, and an increase in payroll expense as we continue to develop our product candidates.
General and administrative expenses were $2.3 million for the three months ended June 30, 2022, compared to $2.4 million for the three months ended June 30, 2021. The decrease of $0.1 million related primarily to a decrease in share-based compensation expense as a result of the restricted stock units issued in 2020 becoming fully vested at the beginning of April 2022 and a decrease in payroll expense as certain executives devoted more of their time to research and development activities, partially offset by an increase in consulting and professional fees.
At-the-Market Offering

Sonnet entered into an At-the-Market Sales Agreement with BTIG, LLC ("BTIG") on August 15, 2022 (the "Sales Agreement"). Pursuant to the Sales Agreement, Sonnet may offer shares having an aggregate gross sales price of up to $6,090,000 pursuant to the prospectus supplement dated August 15, 2022, to be filed with the Securities and Exchange Commission (the "SEC") in connection with the Sales Agreement.

Private Placement

On August 15, 2022, Sonnet entered into a securities purchase agreement with several accredited investors for the issuance and sale of (i) an aggregate of 22,275 shares of its Series 3 Convertible Preferred Stock, stated value $100 per share, (ii) 225 shares of its Series 4 Convertible Preferred Stock, stated value $100 per share, and (iii) Series 3 Warrants to purchase up to 3,865,982 shares of its common stock in a private placement for aggregate gross proceeds of $2,250,000, before deducting offering expenses. The shares of Series 3 Convertible Preferred Stock are convertible into an aggregate of 7,654,642 shares of common stock of Sonnet and the shares of Series 4 Convertible Preferred Stock are convertible into an aggregate of 77,323 shares of common stock of Sonnet, in each case, at a conversion price of $0.291 per share (the market price of the common stock of Sonnet under the rules of the Nasdaq Stock Market). The Series 3 Warrants have an exercise price of $0.291 per share (the market price of the common stock of Sonnet under the rules of the Nasdaq Stock Market), are exercisable commencing six months after issuance, and will expire five years from the issuance date. The shares of the Series 3 Convertible Preferred Stock and Series 4 Convertible Preferred Stock are convertible at the option of the holder at any time following the effective date of a reverse split of Sonnet’s outstanding common stock (the "Reverse Split"), expected to be submitted to stockholders in a proposal (the "Proposal") at a special meeting of stockholders. Sonnet expects to file a proxy statement with the SEC for a special meeting of stockholders at which the Proposal will be submitted to stockholders for approval. The Series 3 Convertible Preferred Stock and the Series 4 Convertible Preferred Stock will have the right to vote together with the common stock on the Proposal. Holders of the Series 3 Convertible Preferred Stock will have the right to a number of votes on the Proposal equal to the number of shares of common stock into which the Series 3 Convertible Preferred Stock is convertible. Holders of the Series 4 Convertible Preferred Stock will have the right to 250,000,000 votes per share of Series 4 Convertible Preferred Stock, provided that, the votes cast by the Series 4 Convertible Preferred Stock with respect to the Proposal will be cast in the same proportion as the shares of common stock and Series 3 Convertible Preferred Stock that vote on the Proposal. The private placement was completed directly between Sonnet and the investors without an investment bank and closed on August 15, 2022. Proceeds from the offering are expected to be used to further the Company’s research and development activities.

Information relating to the Proposal and the special meeting will be contained in Sonnet’s definitive proxy materials to be filed with the SEC in connection with the special meeting. Sonnet is not soliciting proxies for the special meeting at this time. Proxy solicitation for the special meeting will only be made pursuant to a definitive proxy statement and related materials filed by Sonnet with the SEC with respect to the special meeting.

The securities issued in connection with the private placement offering described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities laws. Accordingly, such securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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.

On August 15, 2022 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells for liquid and solid malignancies, reported financial results for the second quarter of 2022 (Press release, NexImmune, AUG 15, 2022, View Source [SID1234618357]).

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"We are encouraged by the increase in enrollment in our NEXI-001 trial and look forward to providing a clinical update in fourth quarter," said Kristi Jones, Chief Executive Officer. "The FDA has recently cleared the NEXI-003 IND, enabling us to advance our first solid tumor program in HPV-related malignancies and we plan to initiate the study before year end. Due to resource prioritization, and the evolving treatment landscape in relapsed refractory multiple myeloma, we plan to pause enrollment of NEXI-002 and provide an update on patients currently being treated. In parallel, we continue to make progress on our IND-enabling work for the AIM injectable modality, an ‘off-the-shelf’ multi-antigen specific approach to treating malignancies and autoimmune diseases, which we believe has the potential to be disruptive. We will provide an update on these early programs through the end of year. We continue to focus on generating data and demonstrating the potential of our ‘IND engine’ to enable a rapid path to clinical development and look forward to providing updates on our progress and upcoming catalysts."

Second Quarter 2022 Clinical and Business Highlights

Clinical and Preclinical Updates

NEXI-001

Currently enrolling patients in cohort 3, dose level 4, the final safety cohort, prior to expansion
Updated clinical results, including patients at the highest dose level, are expected to be announced in the 4Q22
Robust immune responses with signs of clinical activity and potential dose response have been observed
Due to the favorable emerging clinical profile, the protocol has been amended to include patients with haplo-identical donors
NEXI-001 continues to be well tolerated across all dose levels administered to date, with no Grade ≥3 treatment-related adverse events, including infusion reactions, GVHD, CRS or neurotoxicity (ICANS), reported
NEXI-003

Received IND clearance by the FDA for the treatment of HPV-related cancers
Finalized antigen selection for NEXI-003 and manufactured nanoparticles for clinical trials
Trial expected to be initiated by YE22
NEXI-002

Due to recent product approvals and the competitive environment in the relapsed refractory multiple myeloma space, the Company will pause enrollment to prioritize resources
Company will consider shifting enrollment to earlier disease at a future date
In this heavily pre-treated population, evidence of immune response and signs of clinical activity have been observed. NEXI-002 continues to be well tolerated with no Grade ≥3 treatment-related adverse events, including infusion reactions, GVHD, CRS or neurotoxicity (ICANS), reported
Manufacturing achieved higher final cell count yield in recent products by adjusting prior treatment washout period, updating cell collection guidance and other process adjustments
Further clinical data from existing patients are expected later this year
Injectable "Off-the-shelf" Antigen-Specific Immunotherapy and Other Preclinical Research

Advanced in vivo and preclinical work to support the development of injectable nanoparticles, as a therapeutic, in oncology and autoimmune diseases
Advanced work with Yale University Professor Kevan Herold to evaluate NEXI’s injectable nanoparticles for the treatment of type 1 diabetes. A JDRF-funded grant award supports the collaboration
Select Second Quarter 2022 Financial Highlights

Cash, cash equivalents and marketable securities for the Company as of June 30, 2022 were $53.1 million compared to $65.0 million for the quarter ending March 31, 2022. Based on current operating plans, NexImmune expects that its existing cash, cash equivalents and marketable securities will enable the Company to fund its operating and capital expenditure requirements into the second quarter of 2023.

Research and development expenses were $11.8 million in the second quarter of 2022, compared to $8.1 million for the same period in the prior year. The increase in research and development expenses was mainly attributable to costs for the two ongoing clinical trials, as well as personnel-related expenses driven by increased headcount.

General and administrative expenses were $4.1 million, compared to $4.0 million for the same period in the prior year. The slight increase was primarily due to increased fees related to professional and consulting services offset by reductions in personnel-related expenses.

Net loss, according to generally accepted accounting principles in the U.S. (GAAP), was $15.9 million for the quarter, or a basic and diluted GAAP loss per share of $0.69. This compares to a net loss of $12.2 million, or a basic and diluted GAAP loss per share of $0.54, for the same period in the prior year.

On August 15, 2022 Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need, reported financial results for the second quarter 2022 and provided an update on its clinical development programs (Press release, Equillium, AUG 15, 2022, View Source [SID1234618356]).

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"The second quarter focused largely on the execution of our development programs with itolizumab and our plans to advance the clinical development of our new multi-cytokine inhibitors, EQ101 and EQ102," said Bruce Steel, chief executive officer at Equillium. "We are actively preparing to initiate a Phase 2 clinical study of EQ101 in alopecia areata and a Phase 1 SAD/MAD study of EQ102 – both of which are on track to commence during the second half of this year. At the same time, we continue to enroll our recently initiated Phase 3 EQUATOR study in acute graft-versus-host disease and look forward to the pending interim data from the Phase 1b EQUALISE study of itolizumab in patients with lupus nephritis."

Program Highlights Since the Beginning of Q2 2022:

Presented translational and clinical data demonstrating itolizumab’s impact on effector T cell function in acute graft-versus-host disease (aGVHD) and treatment associated with high rates of overall clinical response in the treatment of aGVHD at the Transplantation & Cellular Meetings of the American Society of Transplantation and Cellular Therapy, and the 48th Annual Meeting of the European Society for Blood and Marrow Transplantation
Announced data confirming CD6 as a target to prevent pathogenic T cell recruitment into inflamed organs and that itolizumab-induced reduction of CD6 from T effector cells promotes the development and activity of T regulatory cells at the 48th Annual Meeting of the European Society for Blood and Marrow Transplantation, and IMMUNOLOGY2022, the annual meeting of The American Association of Immunologists
Introduced data from the company’s multi-cytokine inhibitor technology and platform focusing on the design and development of multi-specific cytokine inhibitors, and the importance of targeting biological synergy to optimize therapeutic outcomes at the 3rd Annual Cytokine-Based Drug Development Summit
Anticipated Upcoming Milestones & Catalysts:

Itolizumab – EQUALISE Phase 1b study: interim data from the Type B part of the study in patients with lupus nephritis expected mid-2022
EQ101 – Phase 2 study in alopecia areata initiation expected 2H 2022
EQ102 – Phase 1 study in normal healthy volunteers (NHV) and celiac disease patients expected to initiate in 2H 2022
Second Quarter 2022 Financial Results

Research and development (R&D) expenses for the second quarter of 2022 were $9.5 million, compared with $6.0 million for the same period in 2021. The increase was primarily due to greater clinical development expenses, driven by start-up costs related to the Phase 3 EQUATOR study.

General and administrative (G&A) expenses for the second quarter of 2022 were $4.1 million, compared with $2.9 million for the same period in 2021. The increase was primarily due to higher legal fees related to business development activities and greater employee compensation and consulting costs.

Net loss for the second quarter of 2022 was $14.1 million, or $(0.41) per basic and diluted share, compared with a net loss of $9.2 million, or $(0.31) per basic and diluted share for the same period in 2021. The increase in net loss was largely attributable to greater operating expenses.

Cash used in operations for the second quarter of 2022 was $11.3 million compared to $12.1 million in the first quarter of 2022. Key drivers of the quarter-over-quarter decrease in cash used in operations include payments made in the first quarter of 2022 related to 2021 annual bonuses and the Bioniz acquisition.

Cash, cash equivalents and short-term investments totaled $57.6 million as of June 30, 2022, compared to $68.8 million as of March 31, 2022. Equillium believes that its cash and investments, together with its existing and available committed equity line, are sufficient to fund its operations for at least the next 12 months.

About Itolizumab

Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.

About Multi-Cytokine Platform: EQ101 & EQ102

Our proprietary multi-cytokine platform (MCP) generates rationally designed composite peptides that selectively block key cytokines at the shared receptor level targeting pathogenic cytokine redundancies and synergies while preserving non-pathogenic signaling. This approach provides multi-cytokine inhibition at the receptor level and is expected to avoid the broad immuno-suppression and off-target safety liabilities that may be associated with other therapeutic classes, such as JAK inhibitors. Many immune-mediated diseases are driven by the same combination of dysregulated cytokines, and we believe identifying the key cytokines for these diseases will allow us to target and develop customized treatment strategies for multiple autoimmune and inflammatory diseases.

Current MCP assets include EQ101, a first-in-class, tri-specific inhibitor of IL-2, IL-9 and IL-15, and EQ102, a first-in-class, selective inhibitor of IL-15 and IL-21.