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.

On August 15, 2022 Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a biopharmaceutical company focused on autoimmune diseases, reported second quarter 2022 results and provided a business update (Press release, Tocagen, AUG 15, 2022, View Source [SID1234618355]).

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"Forte is excited to continue down our new path as we develop novel compounds for the treatment of autoimmune diseases, including potentially graft versus host disease (GvHD), vitiligo and alopecia areata which represent combined markets of over $6 billion." said Paul Wagner, Ph.D., President and Chief Executive Officer of Forte Biosciences. "We expect FB-102, our lead molecule, to be in the clinic late 2023 or early 2024. We believe that our innovative approach to treating autoimmune disease has the potential to drive significant value for Forte shareholders. Beyond FB-102 we will continue to strategically evaluate opportunities to create value for shareholders."

Second Quarter 2022 Business Highlights

In May 2022, Forte appointed Steve Doberstein, Ph.D. to its board of directors, which further strengthened Forte’s board of directors. Dr. Doberstein previously served at the Chief Research and Development Officer at Nektar Therapeutics and has led research efforts at Xencor, FivePrime, Exelixis and Xoma.

In June 2022, Forte announced that Dr. Hubert Chen, M.D., joined the company as Chief Scientific Officer and President. Dr. Chen previously served as Chief Medical Officer at Metacrine, a clinical-stage company focused on the treatment of liver and gastrointestinal diseases. Prior, he was the Chief Scientific and Medical Officer of Pfenex, vice president of clinical development at Aileron Therapeutics, vice president of translational medicine at Regulus Therapeutics, and senior director of clinical research at Amylin Pharmaceuticals.

"Forte is tremendously fortunate that Steve and Hubert have agreed to join Forte. They are both thought leaders in the industry and will add significant experience and perspective to our pre-clinical and clinical development efforts." said Dr. Wagner.

Forte ended the second quarter of 2022 with approximately $38.5 million in cash and cash equivalents. Forte had approximately 14.8 million shares of common stock outstanding as of June 30, 2022. Subsequent to the June quarter-end, Forte issued an additional 5.6 million shares of common stock between July 1 and August 10, 2022 for gross proceeds of approximately $7.0 million under its At-the-Market (ATM) financing facility further strengthening its balance sheet.

Second Quarter 2022 Operating Results

Research and development expenses were $1.0 million and $3.5 million for the three months ended June 30, 2022 and 2021, respectively. Research and development expenses were $1.7 million and $6.8 million for the six months ended June 30, 2022 and 2021, respectively. The decreases in 2022 were primarily due to the wind down of our FB-401 program as the Company began the shift in development activities to autoimmune indications with FB-102.

General and administrative expenses were $2.0 million and $2.2 million for the three months ended June 30, 2022 and 2021, respectively. The decrease in 2022 was primarily due to a decrease in legal and professional expenses partially offset by an increase in stock-based compensation and other expenses. General and administrative expenses were $3.8 million and $3.6 million for the six months ended June 30, 2022 and 2021, respectively. The increase in 2022 was primarily due to an increase in stock-based compensation expense partially offset by a decrease in legal and professional expenses.

Net loss per share were ($0.21) and ($0.43) for the three months ended June 30, 2022 and 2021, and ($0.38) and ($0.79) for the six months ended June 30, 2022 and 2021, respectively.

On August 15, 2022 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company leveraging the power of the mitochondria and the peptides encoded in its genome to develop potential breakthrough therapeutics targeting chronic and age-related diseases, reported its financial results for the second quarter ended June 30, 2022 and highlighted recent corporate progress (Press release, CohBar, AUG 15, 2022, View Source [SID1234618354]).

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"We remain excited about the opportunity for CB5138-3 and its potential to make a significant impact on the treatment of IPF. During the prior quarter, we continued to build out our clinical capabilities to support this second program entering the clinic," stated Dr. Joseph Sarret, Chief Executive Officer. "Looking ahead, we are moving forward with promising interim formulations of CB5138-3 to support our planned IND filing in the second half of 2023. In addition, we continue to expand our research and target identification activities to further explore the potential of our mitochondrial peptide library using our Mito+ platform."

Recent Updates and Second Quarter 2022 Highlights

IND Filing for CB5138-3 on Track: The company continued to advance CB5138-3, its lead program for Idiopathic Pulmonary Fibrosis (IPF), through IND-enabling studies and formulation activities. In the second half of 2023, CohBar expects to submit an Investigational New Drug Application (IND) for CB5138-3 to the US Food and Drug Administration.

Expanded Coverage for CB4211 with Two New Patents: The U.S. Patent and Trademark Office issued a patent, U.S. No. 11,332,497, covering methods of use of CB4211 for treating obesity. In addition, a Japanese patent covering CB4211 and related compositions, as well as a CB4211 medicine for treating NASH, was issued.

Strengthened Board with Appointment of Effie Tozzo, Ph.D: CohBar announced the appointment of Dr. Effie Tozzo as an independent director to the company’s board of directors. Dr. Tozzo brings 26 years of research and development expertise at both established pharmaceutical and innovative biotechnology companies, including extensive experience in mitochondria research.

Garnered Shareholder Approval to Effect a Reverse Stock Split: CohBar shareholders approved an amendment to the company’s certificate of incorporation to effect a reverse stock split by a ratio not to exceed 1-for-30. The company may utilize this corporate action to regain compliance with the Nasdaq $1.00 minimum bid price requirement. The company previously received an extension from Nasdaq to November 7, 2022 to achieve compliance with the Nasdaq listing requirements.
Second Quarter 2022 Financial Highlights

Cash, Cash Equivalents and Investments: The company had cash, cash equivalents and investments of $20.1 million as of June 30, 2022, compared to $26.2 million as of December 31, 2021. The cash burn for the quarter ended June 30, 2022 was approximately $3.5 million.

R&D Expenses: Research and development expenses were $1.2 million for the three months ended June 30, 2022, compared to $2.6 million in the prior year quarter. The decrease in research and development expenses was primarily due to lower preclinical and clinical trial costs due to the timing of those expenses.

G&A Expenses: General and administrative expenses were $1.6 million for the three months ended June 30, 2022, compared to $2.6 million in the prior year quarter. The decrease in general and administrative expenses was due to a decrease in compensation and stock-based compensation costs primarily due to the departure of the company’s former CEO in the prior year period.

Net Loss: For the three months ended June 30, 2022, net loss, which included $0.5 million of non-cash expenses, was $2.7 million, or $0.03 per basic and diluted share. For the three months ended June 30, 2021, net loss, which included $1.0 million of non-cash expenses, was $5.2 million, or $0.08 per basic and diluted share.
Details for the Conference Call:

A simultaneous webcast of the call will be accessible via the Investors section of the CohBar website at www.cohbar.com.
For individuals participating in the Investor Call or webcast, please call or login to the conference audio approximately 10 minutes prior to its start.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on August 15, 2022, through 11:59 p.m. Eastern Time on September 5, 2022. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID No. 13730421. The audio recording will also be available at www.cohbar.com during the same period.

On August 15, 2022 Aileron Therapeutics (Nasdaq: ALRN), a chemoprotection oncology company that aspires to make chemotherapy safer and thereby more effective to save more patients’ lives today, reported financial results and business highlights for the second quarter ended June 30, 2022 (Press release, Aileron Therapeutics, AUG 15, 2022, View Source [SID1234618353]).

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"As we announced earlier this month, we are pleased that we have extended our cash runway, which is now expected to fund our operations through the end of 1Q 2024. We expect that our cash resources will support key planned data readouts from our ongoing breast cancer trial, including initial data in 4Q 2022, an interim readout in 2Q 2023, and topline results in 3Q 2023, in addition to pivotal trial readiness activities, subject to the breast cancer trial data and discussions with the FDA," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron.

Dr. Aivado continued, "Supportive care continues to be a severely underserved medical need. Available pharmacologic therapies, like G-CSF for severe neutropenia and EPO for anemia, have limited efficacy and are associated with severe toxicities of their own. For several other toxicities, like alopecia, there are no approved pharmacologic therapies. Chemotherapy-induced toxicities frequently can lead to dose reductions and delays, significant adverse impact on quality of life, and premature treatment discontinuations. By delivering a chemoprotective agent that can effectively protect multiple tissue types simultaneously, we have the potential to usher in a new era in supportive care where ‘whole patient care’ becomes the accepted and expected standard."

Second Quarter 2022 and Recent Highlights

Preparing to re-initiate enrollment of Phase 1b breast cancer clinical trial. As recently announced, Aileron anticipates reinitiating enrollment in the breast cancer trial under the amended protocol in the coming weeks. The Phase 1b open-label, single-arm, multicenter trial is designed to evaluate the chemoprotective effect of 1.2 mg/kg dose of ALRN-6924 against severe neutropenia, as well as chemotherapy-induced alopecia, and other hematologic and non-hematologic toxicities in breast cancer patients with p53-mutant tumors who are undergoing either neoadjuvant or adjuvant treatment with docetaxel, doxorubicin and cyclophosphamide, also known as TAC. Previous data has shown that up to 75% of patients receiving TAC experience severe neutropenia in cycle 1 despite prophylactic use of G-CSF1, and up to 98% of patients experience alopecia2.

Presented new non-clinical data demonstrating ALRN-6924 protected human hair follicles and their stem cells from paclitaxel-induced toxicity and irreversible stem cell damage. The new ex vivo data – developed in collaboration with Professor Ralf Paus, M.D., DSc, FRSB and his colleagues at the Dr. Phillip Frost Department of Dermatology & Cutaneous Surgery at the University of Miami Miller School of Medicine – were highlighted in a late-breaking oral presentation at the Society of Clinical Dermatology Annual Meeting. The data demonstrated proof of principle that ALRN-6924 can temporarily arrest the cell cycle in human scalp hair follicles and their stem cells as well as protect hair follicles from paclitaxel-induced toxicity and irreversible stem cell damage.

Reported new pharmacodynamic (PD) effect and mechanism of action data from the recently completed Phase 1 pharmacology study of ALRN-6924 in healthy human volunteers. Previous PD data demonstrated that serum levels of MIC-1 were correlated with bone marrow p21, which is a marker for cell cycle arrest. The most recent PD data demonstrated that higher doses of ALRN-6924 prolonged the elevation of serum MIC-1 in a dose-dependent fashion. Based on these findings, Aileron believes that prolonged elevation of serum levels of MIC-1 at higher ALRN-6924 dose levels should indicate prolonged cell cycle arrest in bone marrow and other tissues, and thereby prolonged chemoprotection. Aileron has submitted these and other results from the healthy volunteer study for presentation at a scientific congress in 2H 2022.

Strengthened intellectual property (IP) portfolio with additional composition of matter patent for ALRN-6924 in China. The China National Intellectual Property Administration granted Aileron patent No. ZL 2020114599292, providing exclusivity over the composition of matter of ALRN-6924. Aileron’s strong IP portfolio comprises over 160 U.S. and foreign patents, including ALRN-6924 compositions of matter, drug product formulations, methods of manufacture, and methods of use. Aileron maintains exclusive worldwide rights to its proprietary peptide drug technology and ALRN-6924.

Appointed Susan L. Drexler, MBA, CPA, as Interim CFO. Ms. Drexler is an accomplished executive with over 25 years of experience with development- and commercial-stage life science companies in financial management, M&A and licensing deals, financial planning & analysis, and business analytics. Ms. Drexler was most recently CFO with Harmony Biosciences Holdings, Inc., where she oversaw finance, accounting, and IT operations.
Second Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents, and investments on June 30, 2022, were $32.4 million, compared to $45.9 million on December 31, 2021. Based on its current operating plan, the company expects its existing cash, cash equivalents, and investments will fund operations through the end of first quarter of 2024.

Research and Development (R&D) Expenses: R&D expenses for the quarter ended June 30, 2022, were $5.4 million, compared to $3.9 million for the quarter ended June 30, 2021. R&D expenses increased by $1.6 million which was primarily due to $1.0 million of spending for our Phase 1b clinical trial in breast cancer, $0.2 million of increased spending for our Phase 1b clinical trial in non-small cell lung cancer, and $0.3 million of increased manufacturing costs for ALRN-6924 to support our clinical trials and research studies.

General and Administrative (G&A) Expenses: G&A expenses for the quarter ended June 30, 2022, were $2.6 million compared to $2.2 million for the quarter ended June 30, 2021. G&A expenses increased by $0.5 million, which was primarily due to an increase in professional services fees during the second quarter of 2022 as compared to the same period in 2021.

Net Loss: Net loss for the quarter ended June 30, 2022, was $8.0 million, compared to $5.7 million for the corresponding quarter in 2021. The basic and diluted net loss per share for the second quarter of 2022 was $0.09 compared to $0.06 for the second quarter of 2021.