On November 10, 2021 Acacia Pharma Group plc ("Acacia Pharma", the "Group" or the "Company") (EURONEXT: ACPH), reported that its Chief Executive Officer, Mike Bolinder will present at the Jefferies London Healthcare Conference 2021 on Tuesday, 16 November 2021 (Press release, Acacia Pharma, NOV 10, 2021, View Source [SID1234595187]).

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The presentation will begin at 09:20 GMT / 10.20 CET and a live video webcast will be available to registered conference attendees. The link to the webcast is available here.

A replay will also be available to registered attendees for 30 days post the event via the same link.

The conference will also be attended by Acacia Pharma’s Chief Financial Officer, Gary Gemignani, and Chief Medical Officer, Gabriel Fox and alongside the presentation the Company will be conducting a series of 1×1 meetings with investors.

Presentation slides will be made available through the investor section of the Company’s website following the presentation.

On November 10, 2021 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported financial results for the third quarter ended September 30, 2021 and provided a corporate update (Press release, Harpoon Therapeutics, NOV 10, 2021, View Source [SID1234595216]).

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"I look forward to working with the leadership team at Harpoon as we advance our novel immuno-oncology therapies to address the unmet medical needs of patients. We are encouraged by the clinical progress for our four proprietary TriTAC clinical programs, and we are excited to advance our ProTriTAC platform and to announce our third technology platform called TriTAC-XR at SITC (Free SITC Whitepaper)," said Julie Eastland, newly appointed President and Chief Executive Officer of Harpoon Therapeutics. "We remain focused on dose escalation and optimization across all four programs, and we plan to provide a corporate update by year end."

Third Quarter 2021 Business Highlights and Other Recent Developments

Harpoon recently appointed Julie Eastland as President and Chief Executive Officer, effective November 8, 2021. Ms. Eastland succeeds Jerry McMahon, Ph.D., who has resigned from his position as President and Chief Executive Officer and as a member of the company’s Board of Directors and will continue to serve as an advisor. Ms. Eastland joined the Harpoon Board in 2018 and her career spans more than 20 years of executive leadership in biotechnology, immunology, and clinical oncology.

Dose escalation for Harpoon’s four clinical stage programs, HPN424 (PSMA), HPN536 (mesothelin), HPN217 (BCMA) and HPN328 (DLL3) is ongoing and each program is enrolling patients. IND enabling studies are underway for HPN601 (EpCAM targeting ProTriTAC) for potential use in a broad range of solid tumors with high unmet medical need.

Two abstracts have been accepted for poster presentation at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held virtually and in person in Atlanta, Ga. from December 11-14, 2021. One of these presentations will report interim data from the Phase 1/2 study of HPN217, a half-life extended Tri-Specific T Cell Activating Construct (TriTAC) targeting B cell maturation antigen for the treatment of relapsed/refractory multiple myeloma.

The company’s third proprietary technology platform, extended release TriTAC-XR, is designed to mitigate cytokine release syndrome. Preclinical data supporting TriTAC-XR T cell engager platform will be highlighted in a poster presentation at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). The presentation will be available beginning at 7 a.m. on November 12.

Third Quarter 2021 Financial Results

Harpoon ended the third quarter of 2021 with $154.2 million in cash, cash equivalents, and marketable securities compared to $150.0 million as of December 31, 2020. The increase of $4.2 million to the cash balance at the end of the third quarter includes Harpoon’s follow-on financing that closed on January 11, 2021 resulting in net proceeds of approximately $107.6 million, less cash spend during the nine months on operating expenses.

Our cash used in operating activities for the fiscal year ending December 31, 2021 is expected to be $75 million to $80 million, below our original guidance of $85 million to $95 million that was initially provided in March 2021.

Revenue for the third quarter ended September 30, 2021 was $4.5 million compared to $3.9 million for the quarter ended September 30, 2020. For the nine months ended September 30, 2021, revenue was $19.3 million compared to $10.0 million for the nine months ended September 30, 2020. For the third quarter ended September 30, 2021, the increase in revenue was primarily due to an increase in revenue recognized related to Harpoon’s Development and Option Agreement with AbbVie, for research and development services performed. For the nine months ended September 30, 2021, the increase in revenue was primarily due to an increase in revenue recognized due to the delivery of the second target under Harpoon’s Amended and Restated Discovery Collaboration Agreement with AbbVie.

Research and development expense for the third quarter ended September 30, 2021 was $17.0 million compared to $13.1 million for the quarter ended September 30, 2020. For the nine months ended September 30, 2021, R&D expense was $51.5 million compared to $37.5 million for the nine months ended September 30, 2020. The increase for both periods, primarily arose from higher clinical development and personnel-related expense, which included conducting preclinical studies and clinical trials for HPN424, HPN536, HPN217 and HPN328.

General and administrative expense for the third quarter ended September 30, 2021 was $4.2 million compared to $4.4 million for the quarter ended September 30, 2020. For the nine months ended September 30, 2021, G&A expense was $13.1 million compared to $12.3 million for the nine months ended September 30, 2020. For the third quarter ended September 30, 2021, the decrease was primarily attributable to a decrease in legal expenses associated with the Maverick litigation, partially offset by an increase in personnel expenses due to an increase in headcount. For the nine months ended September 30, 2021, the increase was due to an increase in personnel expenses related to an increase in headcount and other professional services to support our operations as a public company, partially offset by a decrease in legal expenses associated with Maverick litigation.

Net loss for the third quarter ended September 30, 2021 was $16.7 million compared to $13.3 million for the quarter ended September 30, 2020. The net loss for the nine months ended September 30, 2021 was $95.2 million compared to $38.6 million in the first nine months of the prior year. Net loss for the nine months ended September 30, 2021, includes Maverick litigation settlement of $50.0 million.
COVID-19 Business Update

In response to the ongoing COVID-19 pandemic, Harpoon has established testing and other protocols for personnel access to its headquarter offices and laboratory although the majority of the company’s employees continue to telecommute. Harpoon is currently continuing its clinical trials, and has not experienced any material delays or impacts as a result of the COVID-19 pandemic. In addition, Harpoon’s third-party contract manufacturers continue to operate at or near normal levels. Harpoon continues to assess the potential impact of the COVID-19 pandemic on its business and operations, including its programs, expected timelines, expenses, manufacturing activities and preclinical and clinical trials. The full extent to which the COVID-19 pandemic may have a negative impact on Harpoon’s business, assets, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted.

On November 10, 2021 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, reported financial results and provided a corporate update for the third quarter ended September 30, 2021 (Press release, Tempest Therapeutics, NOV 10, 2021, View Source [SID1234595233]).

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"The third quarter of 2021 saw continued execution and progress in our programs, including the opening of a collaborative clinical trial with Roche in first line HCC patients comparing TPST-1120 in combination with atezolizumab and bevacizumab to the standard of care regimen, atezolizumab and bevacizumab," said Stephen R. Brady, chief executive officer of Tempest. "In the fourth quarter of this year and the first half of 2022, we plan to continue this focused approach as our second clinical program, TPST-1495, is poised to move into a set of studies that select patients predicated on strong mechanistic rationale, genetically-defined histologies, and a potential mutation-based biomarker."

Recent Highlights

TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): continued enrollment in monotherapy dose optimization towards recommended Phase 2 dose ("RP2D").
TPST-1120 (clinical PPARα antagonist): (i) after completion of monotherapy dose escalation, continued enrollment in combination dose escalation towards RP2D; and (ii) commencement of first line, randomized global Phase 1b/2 study in HCC patients, under a collaboration with F. Hoffmann La Roche.
New Drug Discovery Program: entered into an exclusive license with U.C. Berkeley for intellectual property covering a new drug target discovered in the laboratory of Russell Vance, Ph.D., professor of molecular and cell biology at U.C. Berkeley and a Howard Hughes Medical Institute investigator.
Advisory Board: announced the appointment of Dr. Vance to Tempest’s Advisory Board, joining a distinguished roster consisting of Toni Choueiri, M.D., Benjamin Cravatt, Ph.D., Raymond DuBois, M.D., Ph.D., Jason Luke, M.D., Drew Pardoll, M.D., and Peppi Prasit, Ph.D.
Planned Near-Term Milestones

TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) selection of monotherapy RP2D expected in the first half of 2022; (ii) commencement of a combination study with anti-PD-1 checkpoint inhibitor expected prior to the end of 2021; and (iii) commencement of monotherapy expansion in targeted indications and biomarker-selected patient populations expected in the first half of 2022.
TPST-1120 (clinical PPARα antagonist): (i) identification of RP2D of TPST-1120 in combination with nivolumab expected prior to the end of 2021; and (ii) presentation of Phase 1 monotherapy and combination data in mid 2022.
TREX-1 Inhibitor (preclinical tumor-selective STING pathway activator): planned selection of development candidate in the first half of 2022.
Financial Results

Third Quarter

Tempest ended the third quarter of 2021 with $59.8 million in cash and cash equivalents and short-term restricted cash, compared to $18.8 million in December 31, 2020. The increase was primarily due to the merger and concurrent PIPE, which closed in June 2021.
Net loss and net loss per share for the third quarter of 2021 were $8.1 million and $1.21, respectively, compared to $5.4 million and $11.22, respectively, for the third quarter of 2020. The increase was primarily due to an increase in compensation expense and professional fees associated with the merger.
Research and development expenses for the third quarter of 2021 were $4.6 million, compared to $4.3 million for the same period in 2020. The $0.3 million increase was primarily attributable to increased outside services, insurance and compensation expenses.
For the three months ended September 30, 2021, general and administrative expenses were $3.1 million compared to $1.2 million for the same period in 2020. The increase was primarily due to growth in compensation and rent expense, as well as professional fees associated with the merger.
Year-to-Date

Net cash used in operations for the nine months ended September 30, 2021 was $18.0 million.
Net loss and net loss per share for the nine months ended September 30, 2021 were $20.5 million and $7.49, respectively, compared to $14.9 million and $31.91, respectively, for the same period in 2020.
Research and development expenses for the nine months ended September 30, 2021 were $12.5 million compared to $11.4 million for the same period in 2020. The $1.1 million increase was primarily due to increased compensation expenses and consulting services.
For the nine months ended September 30, 2021, general and administrative expenses were $7.2 million compared to $3.6 million for the same period in 2020.
Based on current cash position and operating plan, Tempest expects to have sufficient resources to fund operations into the second quarter of 2023.

On November 10, 2021 Aadi Bioscience, Inc. ("Aadi") (Nasdaq: AADI), a clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported financial results for the three and nine months ended September 30, 2021 and provided a general business update (Press release, Aadi Bioscience, NOV 10, 2021, View Source [SID1234595663]).

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Neil Desai, Ph.D., Founder, Chief Executive Officer and President of Aadi, commented, "Following the successful merger completed in the third quarter, we are now fortified on all fronts with a strengthened balance sheet and expanded management team ahead of our November 26 Prescription Drug User Fee Action ("PDUFA") target date for FYARRO. With a sizeable PIPE financing that closed in connection with our merger with Aerpio, we can effectively deploy capital toward the commercialization of FYARRO in advanced malignant PEComa and for our planned tumor-agnostic registrational trial in patients with solid tumors harboring inactivating alterations of TSC1 and TSC2 genes in the mTOR pathway. In addition, we are also planning for new studies to investigate ABI-009 in combination with other targeted agents in different cancers."

Key Business Updates for the Third Quarter:

Merger and PIPE Financing

On August 26, 2021, Aadi merged with Aerpio Pharmaceuticals, Inc., a publicly traded biotechnology company (previously traded on the Nasdaq Capital Market under "ARPO"), with Aadi being the surviving entity. As part of the merger, each share of Aadi common stock was converted into the right to receive 0.3172 shares of Aerpio common stock following a 15:1 reverse split of Aerpio’s common stock. Aadi’s common stock is traded on the Nasdaq Capital Market (Nasdaq) under the ticker symbol "AADI".
Concurrent to the closing of the merger, the combined company closed the previously announced $155 million private investment in public equity (PIPE) financing of its common stock.
Immediately following the merger, PIPE financing, and reverse split, Aadi had approximately 20.8 million shares of common stock outstanding, with prior Aadi stockholders collectively owning approximately 29.2% of the combined company, prior Aerpio stockholders owning approximately 15.2% of the combined company, and the PIPE investors collectively owning approximately 55.6% of the combined company, each on a fully-diluted basis.
NDA Acceptance

In July, the U.S. Food and Drug Administration (FDA) accepted Aadi’s New Drug Application (NDA) for its nanoparticle albumin-bound mTOR inhibitor, FYARRO (sirolimus albumin-bound nanoparticles for injectable suspension, nab-sirolimus ABI-009) for the treatment of advanced PEComa, and has granted the company Priority Review status with a PDUFA target action date of November 26, 2021.
Key Leadership Appointments

In September, Aadi announced key appointments of an additional independent board member as well as a Chief Operating Officer:
Emma Reeve was appointed to Aadi’s Board of Directors and as chair of the Audit Committee. Ms. Reeve brings over 25 years of value creation in pharmaceutical, medical device and bio-pharma service companies and a successful track record of transitioning companies from private to public.
Brendan Delaney was appointed to the role of Chief Operating Officer. Brendan has had an established career in oncology-focused commercial leadership roles, launching multiple groundbreaking new products and building effective and cohesive commercial teams.
Recent Updates Following the Close of the Quarter:

In the fourth quarter, the Company made two more key executive appointments:
Loretta M. Itri, M.D., FACP was appointed to the role of Chief Medical Officer. Dr. Itri’s extensive career spans clinical and regulatory global-leadership roles at both major pharmaceutical and biopharmaceutical companies. Most recently, Dr. Itri was Chief Medical Officer at Immunomedics, Inc., where she oversaw the development program and approval of TRODELVY, the first TROP-2 directed antibody-drug conjugate for the treatment of unresectable locally advanced or metastatic triple-negative breast and urothelial cancers. Immunomedics was subsequently acquired by Gilead Sciences, Inc.
Scott M. Giacobello, CPA, was appointed to the role of Chief Financial Officer and Treasurer, effective November 28, 2021. Most recently, Mr. Giacobello was the Chief Financial Officer of GW Pharmaceuticals plc until its $7.2 billion acquisition by Jazz Pharmaceuticals. Mr. Giacobello joined GW Pharmaceuticals in 2017 and played a key role in the buildout of the U.S. operations and commercial readiness for the company. While Chief Financial Officer, Mr. Giacobello was instrumental in devising the financing strategy to support the development, approval and highly successful launch of GW’s lead product, EPIDIOLEX, which had sales of over $296 million in its first full year of commercialization. Mr. Giacobello also raised over $620 million via follow-on offerings prior to the company’s acquisition by Jazz Pharmaceuticals.
Also in October, the Company presented at a medical conference and announced the publication of its registrational study of FYARRO (ABI-009) in a major medical journal:
Lead researchers at Aadi presented a poster at the Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) held from October 7th -10th. The poster consisted of preclinical data evaluating nab-sirolimus (ABI-009) in PTEN-deleted and TSC2-deleted cancer models and demonstrated that ABI-009 showed significantly higher tumor accumulation, increased inhibition of downstream mTOR targets S6 and 4EBP1 and greater tumor growth suppression in comparison with other mTOR inhibitors sirolimus and everolimus at equal dose.
The Company also announced the publication of "nab-Sirolimus for Patients With Malignant Perivascular Epithelioid Cell Tumors" in the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Journal of Clinical Oncology based on the results of the AMPECT registrational trial. The authors concluded that investigational nab-sirolimus (ABI-009), if approved, may represent an important new treatment option in malignant PEComa, a rare cancer and aggressive form of sarcoma, with no currently approved treatment.
Third Quarter 2021 Financial Highlights

As of September 30, 2021, cash and cash equivalents totaled $161.4 million, an increase from $4.5 million as of December 31, 2020, resulting primarily from the consolidated capital and proceeds received from the PIPE financing. Based on our current plans, we expect cash and cash equivalents to fund operations into 2024.

For the three months ended September 30, 2021, operating expenses totaled $87.3 million, an increase of $84.4 million compared to $2.9 million for the same period in 2020. For the nine months ended September 30, 2021, operating expenses totaled $95.4 million, an increase of $84.0 million compared to $11.4 million for the same period in 2020. The increase in operating expenses for the three- and nine-month periods ended September 30, 2021, is due primarily to a non-cash impairment charge related to an acquired contract intangible asset of $74.2 million incurred in conjunction with the merger compared to the same period in 2020.

Research and development expenses for the three months ended September 30, 2021, increased approximately $3.4 million, to $5.8 million compared to $2.4 million for the same period in 2020. Research and development expenses for the nine months ended September 30, 2021, increased approximately $2.7 million, to $12.4 million compared to $9.7 million for the same period in 2020. This increase was primarily the result of increased expenses associated with our clinical drug manufacturing process in the three and nine-month periods ended September 30, 2021, compared to the same periods in 2020.

General and administrative expenses for the three months ended September 30, 2021, increased approximately $6.9 million to $7.4 million compared to $0.5 million for the same period in 2020. General and administrative expenses for the nine months ended September 30, 2021, increased approximately $7.1 million, to $8.8 million from $1.7 million, in the nine months ended September 30, 2020. This increase was primarily the result of increased personnel expenses, including approximately $2.0 million of compensation expense related to former Aerpio executives as a result of the merger.

Net loss attributable to common stockholders for the three and nine months ended September 30, 2021, was $87.2 million and $94.7 million, respectively, primarily driven by the non-cash impairment charge of $74.2 million discussed above.

On November 10, 2021 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported financial results for the third quarter ended September 30, 2021 and provided corporate updates (Press release, Cogent Biosciences, NOV 10, 2021, View Source [SID1234595050]).

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"We are pleased to announce that we have started the SUMMIT trial, a Phase 2 study of bezuclastinib in patients with nonadvanced systemic mastocytosis," said Andrew Robbins, President and CEO of Cogent Biosciences. "Based on recently presented preclinical data, we believe that bezuclastinib has best-in-class potential as a highly potent and selective KIT mutant inhibitor and look forward to initiating the PEAK trial for GIST patients in the coming weeks."

Recent Program and Corporate Highlights

SUMMIT trial initiated in NonAdvSM patients
Cogent initiated SUMMIT, a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 clinical trial. The study is designed to explore the safety and efficacy of bezuclastinib in patients with moderate to severe Indolent Systemic Mastocytosis (ISM) or Smoldering Systemic Mastocytosis (SSM).
SUMMIT is designed in three parts. Part 1 will enroll approximately 48 patients across 3 dose cohorts, plus one placebo arm, and is designed to confirm the optimal bezuclastinib dose. In addition, Part 1 will serve to validate a patient-reported outcomes (PRO) tool for use in assessing efficacy during Part 2 of the trial. Part 2 of SUMMIT will be randomized, double-blind, and placebo-controlled at a single dose level and will include a primary endpoint of disease improvement using the PRO tool from Part 1. After participation in Part 1 or Part 2, all patients may receive bezuclastinib in a long-term extension.
Learn more about the SUMMIT trial at cogentclinicaltrials.com
APEX trial on track for preliminary clinical data readout in the first half of 2022
Cogent is currently enrolling APEX, a Phase 2 clinical trial of bezuclastinib in patients with Advanced Systemic Mastocytosis (AdvSM) and expects to report preliminary clinical data at a scientific conference during the first half of 2022, including levels of serum tryptase, a validated biomarker of mast cell activity.
Learn more about the APEX trial at cogentclinicaltrials.com.
PEAK trial of bezuclastinib and sunitinib for GIST patients to start in 2021
Following recent positive interactions with the FDA, Cogent remains on track to initiate PEAK, a Phase 3 clinical trial of bezuclastinib in combination with sunitinib in imatinib-resistant GIST patients, during 2021.
Announces updated bezuclastinib formulation in partnership with Serán Biosciences
Leveraging Serán’s expertise in formulation and process optimization, an updated formulation of bezuclastinib has been developed. This formulation is expected to reduce the number of daily tablets, improving the overall patient experience.
Updated formulation will be used in PEAK trial beginning in 2021.
Presented new preclinical data supporting bezuclastinib as potential best-in-class KIT inhibitor
Preclinical data presented at the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) showed further evidence of bezuclastinib as a differentiated, potent, and selective KIT inhibitor.
In head-to-head studies comparing several commercial and development-stage KIT mutant inhibitors, bezuclastinib demonstrated minimal activity against closely related kinases, including PDGFR.
In a nonclinical safety pharmacology study in rodents, bezuclastinib demonstrated minimal brain penetration with a low brain-to-plasma ratio.
Appointed Dana Martin as Chief Patient Officer & Senior Vice President, Medical Affairs
Dr. Martin joins with over 20 years of experience in the biopharmaceutical industry. Prior to joining Cogent, he held several roles of increasing leadership responsibility in the areas of clinical pharmacy, medical affairs, and patient advocacy at Genzyme Corporation, Synageva BioPharma, Sarepta Therapeutics, and Kiniksa Pharmaceuticals. Dr. Martin has contributed to the clinical development and/or product launch of multiple rare disease therapeutics, including first-to-market treatments for Fabry disease, Pompe disease, lysosomal acid lipase deficiency, and Duchenne muscular dystrophy. He holds a Bachelor of Science in pharmacy and a Doctor of Pharmacy from Massachusetts College of Pharmacy-Boston.
Appointed Courtney Watson as Vice President of Clinical Development Operations
Mrs. Watson joins Cogent with nearly 15 years of experience in the biopharmaceutical industry. Prior to joining Cogent, Mrs. Watson was the Head of Clinical Operations at Fusion Pharmaceuticals. Previously, she served in various Clinical Operations roles of increasing responsibility at Forma Therapeutics, Synageva BioPharma, and Ziopharm Oncology. Mrs. Watson holds a Bachelor of Arts from the University of Southern Maine.
Third Quarter 2021 Summarized Financial Results

R&D Expenses: Research and development expenses were $14.8 million for the third quarter of 2021 as compared to $5.0 million for the third quarter of 2020. Research and development expenses include non-cash stock compensation expense of $1.4 million for the third quarter of 2021 compared to $1.9 million for the third quarter of 2020.
G&A Expenses: General and administrative expenses were $5.0 million for the third quarter of 2021 as compared to $5.6 million for the third quarter of 2020. General and administrative expenses include non-cash stock compensation expense of $2.0 million for the third quarter of 2021 compared to $1.6 million for the third quarter of 2020.
Net Loss: Net loss was $19.1 million for the third quarter of 2021 as compared to a net loss of $50.0 million for the third quarter of 2020, which included $46.9 million resulting from the accounting treatment related to the asset acquisition of Kiq LLC. During the third quarter of 2021, the company spent $15.2 million of its cash and cash equivalents.
Cash and Cash Equivalents: As of September 30, 2021, Cogent had cash and cash equivalents of $202.9 million. The company believes that its cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into 2024.