On July 13, 2021 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported that dosing of the first patient in the Company’s multi-cohort Phase 1/2 study of oral fadraciclib in patients with advanced solid tumors (Press release, Cyclacel, JUL 13, 2021, View Source [SID1234584817]).

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"Advancing oral fadraciclib, our lead candidate, into this Phase 1/2 trial, represents a key clinical milestone and corporate objective for our team," said Spiro Rombotis, Cyclacel’s President and Chief Executive Officer. "This is the first of four streamlined Phase 1/2 studies we plan to open over the coming months as we expand our clinical programs to evaluate the potential of fadraciclib and CYC140, our oral PLK1 inhibitor, first in solid tumors and lymphomas and then in leukemias. We look forward to providing periodic updates on our clinical progress and data from these open-label studies."

"We are pleased to have dosed the first patient in this study and are delighted by the enthusiasm and strong interest from current and prospective investigators," said Mark Kirschbaum M.D., Senior Vice President & Chief Medical Officer of Cyclacel. "The study has initially opened at City of Hope and MD Anderson Cancer Center with more sites to join later on. We are building an excellent network of participating institutions both in terms of clinical and scientific expertise. In previous studies with single agent, intravenous fadraciclib we have observed durable suppression of MCL1 and other mechanistically-related proteins, including cyclin E and MYC, at tolerated doses. In addition, a patient with MCL1 amplified, advanced endometrial cancer experienced deep PR and 100% shrinkage of her target tumor lesions on single agent fadraciclib treatment. We are excited to begin mid-stage development of fadraciclib with the objective of registration-enabling outcomes and offering a new treatment option for patients with advanced solid tumors or lymphomas."

"Based upon prior clinical activity shown to date, further exploration of this novel CDK2/9 inhibitor is warranted across a number of solid tumor histologies," said Miguel Villalona-Calero, M.D., co-leader of the Developmental Cancer Therapeutics Program and Professor, Department of Medical Oncology & Therapeutics Research at the City of Hope, a world-renowned, independent research and treatment center for cancer, diabetes and other life-threatening diseases. "We look forward to enrolling patients in this trial and evaluating the potential treatment benefit of this experimental therapy both as a single agent and in combinations."

The Phase 1/2 registration-directed trial (CYC065-101) uses a streamlined design and will first determine the recommended Phase 2 dose (RP2D) for single-agent, oral fadraciclib. Once RP2D has been established, the trial will immediately enter into proof-of-concept, cohort stage, using a Simon 2-stage design, where single agent fadraciclib will be administered to patients in up to eight cohorts defined by histology thought to be sensitive to the drug’s mechanism of action and informed by the clinical activity of fadraciclib in previous studies. The cohorts will include patients with breast cancer (selected for metastatic, hormone receptor positive, HER-2 negative, post-CDK4/6 inhibitor; HER-2 refractory; or triple negative), colorectal (including KRAS mutant), endometrial, hepatocellular and ovarian cancers, as well as certain lymphomas. An additional basket cohort will enroll patients with biomarkers relevant to the drug’s mechanism, including MCL1, MYC and cyclin E, regardless of histology. The protocol allows for expansion of a cohort based on response which may allow acceleration of the clinical development and registration plan for fadraciclib.

About Cyclin-Dependent Kinases and Fadraciclib

Cyclin-dependent kinases (CDKs) are critical for cell cycle control and transcriptional regulation. Dysregulated CDKs have been linked to the cancer hallmarks of uncontrolled proliferation and increased cancer cell survival. Fadraciclib, a next generation CDK inhibitor, is a highly selective, potent, orally and intravenously available, inhibitor of CDK2 and CDK9. CDK2 drives cell cycle transitions and CDK9 regulates transcription of genes through phosphorylation of the carboxy-terminal domain (CTD) of RNA polymerase II (RNAP II). By inhibiting CDK2 and CDK9 fadraciclib causes apoptotic death of cancer cells at sub-micromolar concentrations.

Preclinical data suggest that fadraciclib may benefit patients with certain cyclin E-addicted or MYC-amplified solid tumors, including certain forms of breast cancer, neuroblastoma, ovarian cancer, uterine serous carcinoma and adult and pediatric hematological malignancies, such as ALL, AML, B-cell lymphoma, CLL, and multiple myeloma. Similarly to FDA-approved CDK4/6 inhibitors, fadraciclib may be useful in combination with other anticancer drugs, including HER2 inhibitors, such as trastuzumab, or BCL2 inhibitors, such as venetoclax.

In a prior Phase 1 open-label trial (CYC065-01), patients with high copy CCNE (cyclin E), MYC or MCL1 showed sensitivity to intravenously-administered, single-agent fadraciclib. A heavily pretreated patient with MCL1 amplified endometrial cancer achieved a radiographically confirmed partial response (PR) after a month and a half on fadraciclib. This patient continues on therapy for almost two years and reduction in her target tumor lesions has reached 100%. An additional patient with cyclin E amplified ovarian cancer achieved stable disease with 29% shrinkage in her target tumor lesions.

On July 13, 2021 ISA reported the closing of a EUR 26 million funding round with participation from new investors including Invest-NL and existing investors including Regeneron (Press release, ISA Pharmaceuticals, JUL 13, 2021, View Source [SID1234584799]). The proceeds of this round will be used to advance the lead product ISA101b towards first marketing authorization as well as to broaden the clinical pipeline of immunotherapies based on the Synthetic Long Peptide (SLP) platform technology.

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Gerben Moolhuizen, CEO of ISA Pharmaceuticals, said, "We are very happy with the continued support of our existing partners and shareholders. Invest-NL’s support underlines the innovation at ISA Pharma and potential impact of our SLP immunotherapies for the treatment of serious diseases."

SLP immunotherapies act through the specific activation of the patient’s own immune system. Lead product ISA101b targets cancers caused by human papilloma virus type 16 (HPV16). It is in late stage clinical development in three trials for the treatment of advanced stages of HPV16-positive head and neck cancer and cervical cancer in combination with Libtayo (cemiplimab, anti-PD1 immunotherapy), which is being co-developed by Regeneron and Sanofi.

Leo Holwerda, Director Capital at Invest-NL, notes: "Our investment in ISA Pharmaceuticals is a good example of how our TOPSS program can help promising Dutch start-ups and innovative companies which were affected by COVID-19. Invest-NL is happy to support ISA Pharmaceuticals to accelerate its clinical studies and we are confident that the company will succeed in bringing its lead therapy for patients with HPV16-positive head & neck cancer and cervical cancer to the market. This innovative and impactful therapy will strengthen the prospects of many patients."

Persistent HPV16 infection can cause head & neck, cervical and anogenital cancers. These cancers can be severe and life-threatening with low overall survival rates once these cancers progress to advanced stages. HPV16 is a major cause of head & neck cancer with over 25,000 new cases and 11,000 deaths in Europe (source) and 46,000 new cases and 9,000 deaths in the US (source).
HPV16 is also responsible for about 50% of cervical cancer cases. Cervical cancer is the 2nd most common cancer in women aged 15 to 44 years in Europe, with over 60,000 new diagnoses and 25,000 deaths each year in Europe. Globally there are more than 500,000 new patients and 300,000 deaths (source).

The SLP technology platform is at the basis of several ISA pipeline products that are scheduled to proceed into clinical trials over the next few years. Three promising products are in the final stages of pre-clinical development. ISA104 targets the hepatitis B virus (HBV) in chronically infected patients. Chronic HBV is a major cause of liver cirrhosis and liver cancer and affects over 250 million people worldwide (source). ISA103 is aimed at tumours that express PRAME, a protein closely associated with the malignant behaviour of cells in numerous types of cancers. ISA106 is a potential treatment for high risk COVID-19 infected patients.

On July 13, 2021 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported financial results for the fourth quarter and fiscal year 2021, which ended May 31, 2021 (Press release, AngioDynamics, JUL 13, 2021, View Source [SID1234584818]).

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"The AngioDynamics team demonstrated excellent performance, resilience, and strong execution in what was a uniquely challenging year. We saw the pressure from COVID-19 gradually alleviate over the course of the year, and our business is now trending close to normalized run rates. During fiscal 2021, we took significant steps forward in our transformation into a growth-oriented, technology-driven company, building on the foundation we put in place over the past several years," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "Our investments in our key technology platforms are driving our growth, as evidenced by a strong first-year contribution from Auryon and continued strength from AngioVac. I am excited about the future of AngioDynamics as we continue to develop differentiated products like AlphaVac, which we anticipate launching later this year, to serve larger and faster growing markets, pursue regulatory milestones and expand our patient base."

Fourth Quarter 2021 Financial Results

Net sales for the fourth quarter of fiscal 2021 were $76.8 million, an increase of 31.7% compared to the prior-year quarter. All year-over-year comparisons have been affected by the disruption to procedure volumes resulting from the COVID-19 global pandemic.

Foreign currency translation did not have a significant impact on the Company’s sales in the quarter.

Endovascular Therapies (formerly Vascular Interventions and Therapies) net sales were $38.1 million, an increase of 72.3%, compared to $22.1 million a year ago. Growth was driven by broad strength across the business relative to the prior-year period, led by sales of the Auryon and AngioVac platforms. Auryon sales during the quarter were $4.6 million.
Oncology net sales were $14.3 million, an increase of 14.2%, compared to $12.5 million in the prior-year period. The year-over-year growth was primarily due to increased sales of NanoKnife and Microwave disposables and sales of the BioSentry Tract Sealant System, partially offset by continued softness in capital spending and our international markets.
Vascular Access net sales were $24.5 million, an increase of 3.2%, compared to $23.7 million a year ago.
U.S. net sales in the fourth quarter of fiscal 2021 were $63.6 million, an increase of 42.6% from $44.6 million a year ago. International net sales were $13.2 million, a decrease of 3.6%, compared to $13.7 million a year ago.

Gross margin for the fourth quarter of fiscal 2021 was 55.1%, an increase of 330 basis points compared to the fourth quarter of fiscal 2020, primarily due to a reduction in COVID-related costs. During the quarter, gross margin was negatively impacted by macro forces including labor shortages and increased costs for labor, raw materials, and freight. Gross margins also continued to be impacted by Auryon startup costs. During the fourth quarter, inventory was reduced by $0.4 million when compared to inventory levels on February 28, 2021. During the fiscal year, inventory levels have been reduced by $11.3 million.

The Company recorded a net loss of $19.5 million, or a loss per share of $0.51, in the fourth quarter of fiscal 2021. This compares to a net loss of $157.0 million, or a loss per share of $4.13, a year ago. The current-year net loss includes a $14.0 million write-off of the OARTrac intangible assets, while the prior-year net loss includes a goodwill impairment charge of $158.6 million.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net loss for the fourth quarter of fiscal 2021 was $0.1 million, and adjusted earnings per share was $0.00, compared to adjusted net loss in the prior-year period of $2.1 million and adjusted loss per share of $0.06.

Adjusted EBITDA in the fourth quarter of fiscal 2021, excluding the items shown in the reconciliation table below, was $4.5 million, compared to $0.6 million in the fourth quarter of fiscal 2020.

In the fourth quarter of fiscal 2021, the Company generated free cash flow of $3.1 million. As of May 31, 2021, the Company had $48.2 million in cash and cash equivalents compared to $54.5 million in cash and cash equivalents on February 28, 2021. The Company reduced its debt outstanding under its revolving credit facility at May 31, 2021, to $20.0 million compared to $30.0 million on February 28, 2021.

Full-Year 2021 Financial Results

For the twelve months ended May 31, 2021:

Net sales were $291.0 million, an increase of 10.2%, compared to $264.2 million for the same period a year ago.
The Company’s net loss from continuing operations was $31.5 million, or a loss per share of $0.82, compared to a net loss of $166.8 million, or a loss of $4.39 per share, a year ago. The current-year net loss includes a $14.0 million write-off of the OARTrac intangible assets, while the prior-year net loss includes a goodwill impairment charge of $158.6 million.
Gross margin declined 300 basis points to 53.9% from 56.9% a year ago due to the Company’s COVID-related operating plan and increased labor, material, and freight costs, as well as Auryon start-up costs.
Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income was $1.9 million, with adjusted earnings per share of $0.05 per share, compared to adjusted net income and adjusted earnings per share of $3.5 million, or $0.09 per share, a year ago. Adjusted net income and adjusted earnings per share in fiscal 2021 includes a $1.9 million, and $0.04 per share benefit, respectively, related to the reimbursement of certain expenses under the CARES Act.
Adjusted EBITDA, excluding the items shown in the reconciliation table below, was $19.5 million, compared to $18.0 million for the same period a year ago.
Fiscal Year 2022 Financial Guidance

The Company expects its fiscal year 2022 net sales to be in the range of $305 to $310 million, gross margin to be approximately 55.0% and adjusted earnings per share in the range of $0.00 to $0.05 as the Company continues to invest in new product launches to drive future growth.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its fourth quarter and fiscal year 2021 results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13720741.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Tuesday, July 13, 2021, until 11:59 p.m. ET on Tuesday, July 20, 2021. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13720741.

As a reminder, the Company will also be hosting its Investor and Technology Day beginning at 9:30 a.m. ET this morning. Additional information and registration instructions can be found on the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the event will be archived on the same site.

Use of Non-GAAP Measures

Management uses non-GAAP measures to establish operational goals and believes that non-GAAP measures may assist investors in analyzing the underlying trends in AngioDynamics’ business over time. Investors should consider these non-GAAP measures in addition to, not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this news release, AngioDynamics has reported adjusted EBITDA, adjusted net income, adjusted earnings per share, and free cash flow. Management uses these measures in its internal analysis and review of operational performance. Management believes that these measures provide investors with useful information in comparing AngioDynamics’ performance over different periods. By using these non-GAAP measures, management believes that investors get a better picture of the performance of AngioDynamics’ underlying business. Management encourages investors to review AngioDynamics’ financial results prepared in accordance with GAAP to understand AngioDynamics’ performance taking into account all relevant factors, including those that may only occur from time to time but have a material impact on AngioDynamics’ financial results. Please see the tables that follow for a reconciliation of non-GAAP measures to measures prepared in accordance with GAAP.

On July 13, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, reported an update on the ongoing development of its product candidates, eftilagimod alpha ("efti") and IMP761 for the quarter ended 30 June 2021 (Press release, Immutep, JUL 13, 2021, View Source [SID1234584834]).

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"In the past quarter Immutep has entered a new phase as a biotech company at the forefront of the LAG-3 immunotherapeutic landscape. We are now advancing the development of efti in multiple different cancers and have the ongoing support of large pharma collaboration partners, including MSD and Merck Germany, for many of our trials. We have begun planning for our new Phase III study in metastatic breast cancer which, if positive, could provide us with registration data and have a number of new and ongoing other trials progressing at pace. Manufacturing scale up of efti to potential commercial quantities is progressing well," said Marc Voigt, CEO of Immutep.

"All of this company activity is taking place in an exciting LAG-3 landscape where the interaction between MHC class II and LAG-3 has just recently been validated as a therapeutic mechanism for regulating the body’s immune system to fight cancer. With more LAG-3 related programs under development than any other biotech or pharma in the space, we are very excited about the future," he concluded.

Efti Development Program

AIPAC – Phase IIb clinical trial – ongoing

The trial is on track to report final overall survival (OS) data in H2 of calendar year 2021. Immutep previously reported OS data from approximately 60% of events in Dec 2020.

TACTI-003 – Phase IIb clinical trial – new

Immutep received Fast Track designation in 1st line recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) from the United States Food and Drug Administration (FDA) in April 2021. This opens the potential for expedited development and review of efti in 1st line HNSCC with the FDA.

Following the close of the quarter, Immutep completed the necessary regulatory steps with the US FDA and obtained institutional review board approval in the US to commence the TACTI-003 trial. Patient recruitment is expected to begin in this quarter.

Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000

ABN: 90 009 237 889

LOGO

TACTI-002 (also designated KEYNOTE-798) – Phase II clinical trial – ongoing

At ASCO (Free ASCO Whitepaper) 2021, Immutep reported updated interim results from TACTI-002 showing the combination therapy of efti and pembrolizumab demonstrates a very favourable overall response rate (ORR) together with very encouraging duration and depth of response in 1st line non-small cell lung cancer (NSCLC) (Part A) and 2nd line HNSCC (Part C). Tumor responses were seen in all PD-L1 subgroups, including in low PD-L1 expressing patients which are typically less responsive to anti-PD-1 therapy. Importantly, the combination therapy continues to be safe and well tolerated.

Recruitment continues for the additional 74 1st NSCLC patients for the expansion of Part A, with 33 patients already enrolled and for Stage 2 of Part B, which has 8 patients now enrolled. Recruitment is tracking better than projected for the expansion cohort of Part A and as originally projected for Stage 2 of Part B. Immutep expects to report further interim data for TACTI-002 in calendar year 2021 or early calendar year 2022.

INSIGHT

INSIGHT is an investigator-initiated phase I trial investigating different combination treatments with efti and a different route of administration for efti. INSIGHT consists of 5 different arms from stratums A to E.

INSIGHT-005 – combination with bintrafusp-alpha – new

Immutep signed a collaboration and supply agreement with Merck KGaA, Darmstadt, Germany for a new stratum in 12 patients with solid tumours, known as Stratum E or INSIGHT-005. The trial will be run as an amendment to the protocol of the ongoing INSIGHT trial as the fifth arm and will evaluate efti in combination with Merck KGaA’s and GlaxoSmithKline’s bintrafusp alfa. The first patient is expected to be enrolled in H2 of calendar year 2021.

INSIGHT-004 – combination with avelumab – final data

At ASCO (Free ASCO Whitepaper) 2021, Immutep also reported encouraging final data from its INSIGHT-004 arm (stratum D). Promising activity signals were demonstrated from the combination of efti and avelumab, with a response rate of 41.7% in patients with different solid tumours. In addition, deep and durable responses were seen in patients with low or no PD-L1 expression and in indications such as gastroesophageal and cervical cancer which typically do not respond to immune checkpoint therapy. Importantly, the combination therapy showed a good safety profile.

INSIGHT-003 – triple combination – new

INSIGHT-003 is a new stratum in up to 20 patients with various solid tumours, also referred to as Stratum C. This is Immutep’s first evaluation of efti in a triple combination therapy of efti, chemotherapy and anti-PD-1 therapy. All regulatory and ethical approvals have already been received, enabling patient recruitment to commence. The first patient is expected to be enrolled in Q3 of calendar year 2021, with first interim results expected in 2022.

The results of INSIGHT-003 are expected to inform a potential Phase II evaluating efti as part of a triple combination therapy along with an anti-PD-1 therapy and a chemotherapy, potentially in NSCLC.

EAT COVID – Phase II clinical trial – ongoing

The randomised portion of the investigator-initiated EAT COVID study is progressing at the University Hospital Pilsen in the Czech Republic. It is evaluating efti in up to 110 hospitalised patients with COVID-19.

Preclinical Pipeline

Immutep continues to work on GMP manufacturing preparations for IMP761 and is planning for toxicology studies and other pre-clinical evaluations.

In addition, under a collaboration project commenced in 2019 with Cardiff University, Immutep has advanced the discovery and development of a potential new generation of small molecule anti-LAG-3 therapies. The project aims to make an oral treatment available to cancer patients and at a lower cost compared with the current anti-LAG-3 antibodies being developed by several other companies.

Partnerships

Immutep’s licensing and collaboration partnerships with Labcorp, GSK, Novartis, EOC Pharma and CYTLIMIC continue to progress.

Intellectual Property

Immutep was granted three new patents during the quarter, further expanding the company’s global patent estate. The European Patent Office granted a patent directed to combination therapy with leramilimab (LAG525), Immutep’s IMP701 antibody which is out-licensed to Novartis AG, and also a new divisional patent for efti in combination with a PD-1 or PD-L1 inhibitor. In addition, the Chinese Patent Office granted a new patent for efti in combination with chemotherapy, building on corresponding Australian, European, Japanese and United States patents.

Financial Summary – Q4 FY21

Cash receipts from customers for the quarter was $10k, compared to $59k in Q3 of FY 2021 (i.e. the quarter ended 31 March 2021).

The net cash used in G&A activities in the quarter was $409k compared to $242k in Q3. The increase compared with last quarter is mainly related to capital raising related activities. Payments to Related Parties, detailed in Item 6 of the Appendix 4C cash flow report for the quarter includes $128k in payment of Non-Executive Director’s fees and Executive Director’s salary.

The net cash used in Research and Development activities in the quarter was $5.45 million, compared to $1.74 million in Q3. The significant increase is mainly due to the payment of upfront costs for the TACTI-003 clinical trial in Q4. Cash flow used in R&D activities for FY2021 was $12.47 million compared to $19.87 million for FY 2020. The decline of cash used in R&D activities in FY 2021 compared with FY 2020 is mainly due to the declining AIPAC expenses since patients in the AIPAC Phase IIb clinical trial have completed the treatment and moved into the follow-up phase and due to more material expenses related to the Phase IIb TACTI-003 clinical trial only starting to become payable during Q4 FY 2021. Total net cash outflows used in operating activities in the quarter was $5.71 million. In comparison, total net cash outflows from operating activities in Q3 was $3.05 million.

Immutep received a A$1,155,055 cash rebate from the Australian Federal Government’s R&D tax incentive program during the quarter.

In June 2021, Immutep secured commitments for $60 million via a two-tranche institutional placement which was supported by multiple institutional investors in Australia and offshore.

The Company’s cash and cash equivalent balance as at 30 June 2021 was $60.59 million compared to a balance of $51.7 million as at 31 March 2021. This includes $13.7m from the first tranche of the institutional placement and $605k from the exercise of US warrants over American Depository Shares.

A further $46.3 million will be raised from the second tranche of the placement conditional on shareholder approval at the Company’s Extraordinary General Meeting on 26 July 2021.

In addition, Immutep is seeking to raise a further ~$5 million from eligible shareholders via a Share Purchase Plan (SPP), which closes on Monday, 19th July 2021 at 5pm (Sydney, Australia time).

On July 13, 2021 Nimbus Therapeutics, a biotechnology company designing breakthrough medicines through structure-based drug discovery and development, reported the closing of a $105 million private financing round (Press release, Nimbus Therapeutics, JUL 13, 2021, View Source [SID1234584800]). The round was led by BVF Partners L.P. (BVF), with participation from existing investors including RA Capital Management and Atlas Venture. Access Biotechnology, Commodore Capital, Logos Capital, Surveyor Capital (a Citadel company), and a large alternative asset manager joined as new investors in this financing.

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"This financing from some of the world’s leading investors is validation of the exciting potential within Nimbus’ product pipeline and the singular expertise Nimbus brings in advancing these products forward. Spurred by compelling data from studies of our novel allosteric TYK2 inhibitor, we will be embarking upon multiple Phase 2 clinical studies in 2021 and 2022 to elucidate the full range of potential patient benefit from this novel therapeutic," said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. "Our clinical expertise with this molecule to date combined with our strong capital position make Nimbus uniquely well-resourced to advance this important medicine through the clinic in the years to come."

In addition to the Phase 2 studies of Nimbus’ allosteric TYK2 inhibitor, the financing will support a first-in-human study of the company’s HPK1 inhibitor candidate in cancer patients with solid tumors, which will begin later this year, and will accelerate preclinical programs against multiple targets in oncology and immunology. The company expects to initiate IND-enabling studies on two novel agents in 2022.

"Nimbus’ pipeline is positioned to deliver multiple clinical readouts over the next 18 months that have the promise to help transform patients’ lives," said Bruce Booth, D.Phil., co-founder and Chairman of the Board of Nimbus. "We are fortunate to have the support of many new investors joining Nimbus, and we welcome Sam Huang from BVF to the Board."

"We’re proud to lead this most recent financing round, and we see the tremendous potential of Nimbus’ vision, pipeline, and team," said Mark Lampert, founder and CEO of BVF.