Entry into Material Definitive Agreement

On September 30, 2020, Plus Therapeutics, Inc. (the "Company") reported that it entered into a purchase agreement (the "Purchase Agreement") and a registration rights agreement (the "Registration Rights Agreement") with Lincoln Park Capital Fund, LLC ("Lincoln Park"), pursuant to which Lincoln Park has committed to purchase up to $25 million of the Company’s common stock, $0.001 par value per share (Filing, 8-K, PLUS THERAPEUTICS, SEP 30, 2020, View Source [SID1234572291]).

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Under the terms and subject to the conditions of the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $25.0 million of the Company’s common stock. Such sales of common stock by the Company, if any, will be subject to certain limitations, and may occur from time to time, at the Company’s sole discretion, over the 36-month period commencing on the date that a registration statement covering the resale of shares of common stock that have been and may be issued under the Purchase Agreement, which the Company agreed to file with the Securities and Exchange Commission (the "SEC") pursuant to the Registration Rights Agreement, is declared effective by the SEC and a final prospectus in connection therewith is filed and the other conditions set forth in the Purchase Agreement are satisfied.

Lincoln Park has no right to require the Company to sell any shares of common stock to Lincoln Park, but Lincoln Park is obligated to make purchases as the Company directs, subject to certain conditions. There are no upper limits on the price per share that Lincoln Park must pay for shares of common stock. Actual sales of shares of common stock to Lincoln Park will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the Company’s common stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations.

The net proceeds under the Purchase Agreement to the Company will depend on the frequency and prices at which the Company sells shares of its stock to Lincoln Park. The Company expects that any proceeds received by the Company from such sales to Lincoln Park will be used for working capital and general corporate purposes.

On June 16, 2020, the Company received stockholder approval pursuant to Nasdaq Listing Rules 5635(a), 5635(b) and 5635(d) to permit issuances of the Company’s common stock (including the issuance of more than 19.99% of the Company’s common stock) to Lincoln Park pursuant to the Purchase Agreement. Based on the closing price of the Company’s common stock of $1.05 per share on March 16, 2020 (the Company’s lowest closing sale price since January 1, 2020 as reported on Nasdaq.com) the maximum number of shares the Company could issue and sell under the Purchase Agreement is approximately 23.8 million shares. Accordingly, the Company requested and received stockholder approval for the issuance of up to 23.8 million shares of the Company’s common stock under the Purchase Agreement. The Company would seek additional stockholder approval before issuing more than 23.8 million shares.

The Company has agreed with Lincoln Park that it will not enter into any "variable rate" transactions with any third party for a period defined in the Purchase Agreement. Lincoln Park has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of the Company’s shares.

As consideration for Lincoln Park’s irrevocable commitment to purchase shares of the Company’s common stock upon the terms of and subject to satisfaction of the conditions set forth in the Purchase Agreement, upon execution of the Purchase Agreement, the Company issued 180,701 shares of its common stock to Lincoln Park as commitment shares.

The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, conditions and indemnification obligations of the parties. The Company has the right to terminate the Purchase Agreement at any time, at no cost or penalty. During any "event of default" under the Purchase Agreement, Lincoln Park does not have the right to terminate the Purchase Agreement; however, the Company may not initiate any regular or other purchase of shares by Lincoln Park, until such event of default is cured. In addition, in the event of bankruptcy proceedings by or against the Company, the Purchase Agreement will automatically terminate.

The foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement are qualified in their entirety by reference to the full text of such agreements, copies of which are attached hereto as Exhibits 10.1 and 10.2, respectively, and each of which is incorporated herein in its entirety by reference. The representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements and may be subject to limitations agreed upon by the contracting parties.

Theralase Announces Warrant Extension

On September 30, 2020 Theralase Technologies Inc. ("Theralase" or "Company") (TSXV:TLT)(OTCQB:TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds ("PDCs") and their associated drug formulations intended to safely and effectively destroy various cancers, reported that the Company proposes to extend the expiry date of 3,157,059 share purchase warrants, all of which are exercisable at $0.50 per share (collectively, the "Warrants") (Press release, Theralase, SEP 30, 2020, View Source [SID1234569760]).

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The Warrants were issued on October 3, 2018 pursuant to a private placement involving the issuance of 3,157,059 units of the Company. The Company proposes to extend the expiry date of the Warrants that remain outstanding from the original expiry date of October 3, 2020 to October 3, 2022.

All other terms and conditions of the Warrants will remain unchanged. The Warrant expiry date extension is subject to final acceptance by the TSX Venture Exchange.

Tiziana Life Sciences plc Interim Results for the Six Months Ended 30 June 2020

On September 30, 2020 Tiziana Life Sciences plc ("Tiziana", AIM: TILS, NASDAQ: TLSA), a biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases reported its interim results for the six months ended 30 June 2020 (Press release, Tiziana Life Sciences, SEP 30, 2020, View Source [SID1234568598]).

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Highlights during the period:

RESEARCH & DEVELOPMENT

CLINICAL PROGRAMMES

Foralumab

TZLS-401

Foralumab is a fully human engineered anti-CD3 monoclonal antibody (mAB). It was in-licensed in December 2014 from Novimmune.

As the only fully human engineered human anti-CD3 mAB in clinical development, Foralumab has significant potential advantages such as a shorter treatment duration and reduced immunogenicity. With completion of the intravenous dosing for our Phase 2a trial in Crohn’s Disease, Foralumab’s ability to modulate T-cell response enables potential extension into a wide range of other autoimmune and inflammatory diseases, such as multiple sclerosis, inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis.

Foralumab is being developed as both an immunosuppressive and immunomodulatory agent, with therapeutic benefits of rendering T-cells unable to orchestrate an immune response and induction of immune tolerance via maintenance of regulatory T-cells. There is further potential for Foralumab to be combined with the Company’s TZLS-501, a fully human anti-IL-6R mAB in development to target autoimmune and inflammatory diseases.

On 16 April, 2018, the Group entered into an exclusive license agreement with The Brigham and Women’s Hospital, Inc. relating to a novel formulation of Foralumab dosed in a medical device for nasal administration. An investigational new drug application (IND) for the first-in-human evaluation of the nasal administration of Foralumab in healthy volunteers for progressive multiple sclerosis indication was filed in the second quarter of 2018. Phase 1 clinical data demonstrated that nasally administered Foralumab, was well-tolerated and no drug-related safety issues were reported at any of the doses. No drug-related changes were observed in vital signs among subjects at pre-dose, during treatment and at discharge. The mean blood pressure (BP) during the 5 days of treatment were; Cohort A (10 µg/d):124/73, Cohort B (50 µg/d): 119/67 and Cohort C (250 µg/d):113/65 compared to placebo:118/67). Heart rates, respiratory rates and oral temperatures were unchanged among the 3 cohorts compared to the placebo. Nasally administered Foralumab at the 50 µg dose suppressed cytotoxic CD8+ as well as perforin secreting CD8+ cells, which have been implicated in neurodegeneration in multiple sclerosis (MS). Treatment at 50 µg stimulated production of anti-inflammatory cytokine IL-10 and suppressed production of pro-inflammatory cytokine IFN-γ. Taken together, the treatment showed significant positive effects on the biomarkers for activation of mucosal immunity, which are capable of inducing site-targeted immunomodulation to elicit anti-inflammatory effects. Based on the results we intend to conduct a Phase 2 trial in secondary progressive MS patients. Protocol for Phase 2 nasal clinical trial is finalized. The briefing package and protocol was submitted to FDA on July 22, 2020 requesting type C meeting and FDA response expected by mid October, 2020. The trial is anticipated to begin in Q4 2020.

An enteric-coated capsule formulation has been developed for oral administration of Foralumab. cGMP manufacturing of clinical trial materials for a Phase 1 study has been completed. The Phase 1 clinical trial for Foralumab in healthy volunteers was a single-center, single-arm, ascending dose study in which low doses (1.25, 2.5 and 5.0 mg/dose) of Foralumab and placebo were orally administered. The primary endpoint of the Phase 1 study was safety and tolerability of oral Foralumab in humans. The Phase 1 trial was initiated on December 2, 2019and results were reported on January 20, 2020 The proprietary oral formulation, comprising the lyophilized and stabilized free-flowing powder of formulated Foralumab encapsulated in an enteric-coated capsule, was well-tolerated at all doses tested and there were no drug-related safety issues even at the highest dose of 5 mg in this trial. Based on the positive outcome of the Phase 1 trial, a Phase 2 trial in Crohn’s Disease patients is expected to begin in Q2/Q3 2021.

Anti IL-6R mAb

TZLS-501, formerly NI-1201

TZLS-501 is a fully human engineered mAb targeting the interleukin-6 receptor (IL-6R). Tiziana Life Sciences licensed the intellectual property from Novimmune in January 2017. This fully human mAb has a unique mechanism of action that binds to both the membrane-bound and soluble forms of the IL-6R resulting in lowering of circulating levels of IL-6 in the blood. Excessive production of IL-6 is regarded as a key driver of chronic inflammation, associated with autoimmune diseases such as multiple myeloma, oncology indications and rheumatoid arthritis, and the Group believes that TZLS-501 may have potential therapeutic value for these indications.

In preclinical studies, TZLS-501 demonstrated the potential to overcome limitations of other IL-6 blocking pathway drugs. Compared to tocilizumab and sarilumab, while binding to the membrane-bound IL-6R complex TZLS-501 has shown a higher affinity for the soluble IL-6 receptor as seen from the antibody binding studies conducted in cell culture. TZLS-501 also demonstrated the potential to block or reduce IL-6 signalling in mouse models of inflammation. The soluble form of IL-6 has been implicated to have a larger role in disease progression compared to the membrane-bound form. (Kallen, K.J. (2002). "The role of transsignalling via the agonistic soluble IL-6 receptor in human diseases". Biochimica et Biophysica Acta. 1592 (3): 323–343.).

On April 9, 2020 Tiziana announced the clinical development of anti-IL6R mAb as a treatment for "cytokine storm" induced lung damage in COVID-19 patients. Early clinical studies conducted by doctors in China suggest that anti-IL6R mAb may be used in clinical practice for treatment of COVID-19. Consequently, China’s National Health Commission has recommended the use of Roche’s blockbuster drug, Actemra for treatment of patients infected with COVID-19, with serious lung damage and elevated IL6 levels. Actemra was first approved by the FDA in 2010 for rheumatoid arthritis. Besides Actemra, Sanofi and Regeneron are currently exploring Kevzara, an FDA-approved anti-IL-6 receptor therapy for rheumatoid arthritis, for treatment of severe COVID-19. The Company believes that of TZLS-501 may have greater clinical effect than Actemra or Kevzara based on higher binding affinity for IL6 receptor complex compared to Actemra and Kevzara. Also TZLS-501 reduces circulating levels of IL6 via the trans-signaling pathways.

The treatment utilizes a novel mode of administrationusing hand-held nebulizer to deliver aerosolized anti-IL6R mAb solution to inflamed tissue of deep lung. On April 9,2020, Tiziana announced filing of patent application in support of treatment of COVID-19 utilizing Anti-IL6R via inhaled delivery (Kunwar Shailubhai, inventor). Initial work on CMO selection, technology transfer and transfer of lead cell line candidate from Novimmune to CMO initiated in April 2020. A rigorous CMO selection process was initiated in April and STC Biologics, a boutique CMO located in Newton MA was selected as the finalist based on their ability to deliver drug substance (DS) in approximately 10 months timeline and most competitive pricing. Tiziana shipped a lead non-clonal cell line from Novimmune to STC Biologics in June 2020. STC Biologics is expanding the cell line, establishing monoclonality, screening for cell line stability and antibody titer and expanding the monoclonal cell line to larger scale for development and cGMP manufacturing. Concurrently they are purifying a batch of monoclonal antibody from the 70L Novimmune pilot batch, manufactured using the lead, non-clonal cell line. STC’s generic downstream process is being used for the purification of test article for Inhalation Safety Toxicology studies using Cynomolgous monkeys at ITR Laboratories Canada

Work at Sciarra Laboratories in Hicksville, NY was initiated in May 2020, Sciarra is currently evaluating two hand-held nebulizer devices for use in the study and characterizing physical/performance characteristics. Once a device has been selected, a few candidate formulations of anti-IL6R mAb, from formulation development studies at STC Biologics, will be manufactured at small scale and evaluated using the devices. Sciarra will execute cGMP manufacturing of drug product solution, packaging and ICH stability studies in Q1 2021.

In July 2020, Tiziana engaged FHI clinical as CRO to conduct Phase1/2 clinical trials of TZLS-501 in for the COVID-19 indication. FHI Clinical is a CRO specializing in infectious disease and COVID-19 clinical trials, located in Durham North Carolina. Initial scope of work is regulatory, preparing for a FDA Type C meeting in Q4 2020. FHI will help design a multisite, Phase1/2 adaptive trial with sites located mostly ex-US in COVID-19 hot spots to speed enrollment to start in Q1 2021

In August 2020, Brand Institute was engaged for selection, qualification and Application for INN and USAN non-proprietary names for anti-IL6R mAb (TZLS-501)

ITR Laboratories Canada specializes in inhalation toxicology studies in primates and will start inhalation safety toxicology studies in Cynomolgous monkeys in October 2020 using the purified, characterized anti-IL6R mAb test. Results from the study will be used to establish dosing for the Phase 1 study in healthy volunteers.

The Company is actively evaluating alternative, non-parenteral routes of monoclonal antibody (mAb) administration, namely oral, nasal and inhalation routes, to facilitate topical or local therapeutic action.

Milciclib

TZLS-201

Milciclib, Tiziana’s lead small molecule drug, was exclusively licenced in January 2015 from Nerviano Medical Sciences. Milciclib is an orally bioavailable, broad spectrum inhibitor of Cyclin Dependent Kinases (CDKs): 1, 2, 4, 5 and 7 and Src family kinases. Cyclin dependent kinases are a family of highly conserved enzymes that are involved in regulating the cell cycle. Src family kinases regulate cell growth and potential transformation of normal cells to cancer cells. A unique feature of Milciclib is its ability to reduce microRNAs, miR- 221 and miR-222, which silence gene expression. miR-221 and miR-222 promote the formation of blood vessels (angiogenesis) that are important for the spread of cancer cells (metastasis). Levels of these microRNAs are consistently increased in hepatocellular carcinoma ("HCC") patients and may contribute towards resistance to treatment with Sorafenib. As a result, the Group are investigating Milciclib both as a monotherapy and as a combination treatment with Sorafenib.

To date, Milciclib has been studied in a total of eight completed and ongoing Phase 1 and 2 clinical trials in 316 patients. In these trials, Milciclib was observed to be well-tolerated and showed initial signals of anti-tumour action.

The Group initiated a Phase 2a trial (CDKO-125a-010) of Milciclib safety and tolerability as a single therapy in Sorafenib-resistant patients with HCC in the first half of 2017. Typically, this population of patients have an advanced form of the disease with poor prognosis and an average overall survival expectancy of 3-5 months In May 2018, the Independent Data Monitor committee (IDMC) completed an interim analysis of tolerability data from the first eleven treated patients and recommended expansion of the initial cohort to an additional 20 patients to complete the trial enrolment, which was completed in December 2018. .

The Phase 2a trial was completed in June 2019 with clinical safety and efficacy result reported in July 2019. Since overexpression of CDKs and dysregulation in pRB pathway (regulates transcription factors critical for cell cycle progression) are prominently associated with tumor cell resistance to certain chemotherapeutic drugs, inhibition of multiple CDKs is an appealing approach to improve clinical responses in cancer patient’s refractory to existing treatment options. A Phase 1 dose-escalation study of Milciclib in combination with gemcitabine in patients with refractory solid tumors exhibited clinical activity in patients including those refractory to gemcitabine. We plan to explore a combination approach in patients with HCC.

On May 14, 2020 the Company announced the online publication of two abstracts on clinical studies with Milciclib, a small molecule pan-inhibitor of cyclin dependent kinases (CDKs) in the proceedings of the virtual annual meeting of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 (ASCO20). The first abstract reported Phase 2a clinical data with orally administered Milciclib in sorafenib-resistant hepatocellular carcinoma (HCC) patients, for which it met the primary endpoint, that oral treatment with Milciclib was well tolerated with manageable toxicities and no recorded drug-related deaths. The second abstract reported preliminary clinical data from an ongoing investigator-originated trial with a combination of orally administered Milciclib and Regorafenib in liver transplant patients with recurrent HCC. Thus far, the study has shown mean AFP levels (a common tumor biomarker) reduced by approximately 20% within one month of treatment.

StemPrintER

StemPrintER is a multi-gene signature assay intended for use in patients diagnosed with estrogen-receptor positive ER+/HER2 negative breast cancers. The Group believes this in-vitro prognostic test will be used in conjunction with clinical evaluation to identify those patients at increased risk for early and/or late metastasis.

On May 29,2020, the Company announced results from from a poster selected for discussion session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Conference, demonstrating the superiority of StemPrintER stem cell based genomic prognostic tool versus the market leader, Oncotype DX, in predicting recurrence in ER+/HER2- postmenopausal breast cancer patients. A second poster describing results on prediction of distant recurrence using a next generation StemPrintER model, named SPARE, presented in a separate ASCO (Free ASCO Whitepaper) session, showed even more refined accuracy than standard clinicopathological markers in predicting risk of distant recurrence. The company also announced its plans to demerge StemPrintER and SPARE technology and create a separate company to advance commercialization of the technology.

Intellectual Property

On April 24.2020 the Company announced that it has acquired all of the intellectual property relating to a nanoparticle-based formulation of Actinomycin D (Act D; a.k.a. Dactinomycin), from Rasna Therapeutics, Inc for potential use as a treatment for Coronavirus infection.
On June 19, 2020, the Company announced that the United States Patent and Trademark Office ("USPTO") has granted a patent covering its proprietary platform technology for the oral administration of Foralumab, its proprietary fully human monoclonal antibody, and all other anti-CD3 monoclonal antibodies (mAb).
Three US Patent Applications filed in the reporting period:
IL-6 Antibodies for the treatment of Coronavirus (COVID-19; No. 62/987,837 filed March 10, 2020)
IL-6/IL-6R Antibodies to treat Coronavirus (No. 63/006,612 filed April 7, 2020)
Composition of IL-6/IL-6R antibodies and Dactinomycin and methods of use thereof (No. 63/014,800 filed April 24, 2020)
Highlights post period:

Three US Patents were issued in September 2020:
Patent No. 10,759,858 B2: Use and methods of treatment of Crohn’s disease with Foralumab (Tiziana Press Release August 18, 2020)
Patent No. 10,758,541 B2: Use of Milciclib in Combination with Tyrosine Kinase Inhibitors for Treatment of Hepatocellular Carcinoma and other Cancers (Tiziana Press Release August 21, 2020)
Patent No. 10,759,862 B2: Methods and Use of Anti-IL-6/IL-6 receptor mAbs as Prophylactic and Therapeutic Interventions for Covid-19 and other pulmonary diseases (Tiziana Press Release August 24, 2020)
Two US Patent Applications were filed:
CD-3 Antibodies for the treatment of Coronavirus (No. 63/058,978 filed July 30, 2020)
Composition and methods for augmenting chimeric antigen receptor (CAR) T cell therapies (No. 63/058,783 filed July 30, 2020)
On September 16, 2020 the Company announced its plans for demerging its StemPrintER asset into a separate and independently listed public company, Accustem Sciences Limited. Accustem Sciences will begin the process of seeking CE Mark approval in November of 2020 with anticipated commercialization in Europe in the second quarter of 2021. Subsequently, the Company also intends to seek FDA approval.
FINANCIAL

For the six months to 30 June 2020 the consolidated Group made a loss of £3.91m (restated six months to 30 June 2019: £3.57m).
The Group ended the period with £7.2m cash as at 30 June 2020 (31 December 2019: £153k).
The Company continues to carefully manage its working capital position and continues the process, as referred to below, to seek to raise further funds through the issue of ADSs through a United States Offering as well as through private placements.

To view the complete Interim Accounts click here: View Source

Sermonix Pharmaceuticals Partners With Exactis Innovation for ELAINE 1 Clinical Trial Sites in Canada

On September 30, 2020 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company focused on the development of female oncology products in the precision medicine metastatic breast cancer arena, reported a collaboration with Exactis Innovation, a pan-Canadian Network of Centres of Excellence (NCE) in precision medicine, expanding a Phase 2 clinical trial of Sermonix’s lead investigational drug, lasofoxifene, into Canada (Press release, Sermonix Pharmaceuticals, SEP 30, 2020, View Source [SID1234568153]).

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The NCE is a Canadian government initiative that funds partnerships between universities, industry, government and not-for-profit organizations to create large-scale research networks integrating precision oncology across Canada.

With the recent Health Canada agreement to proceed, the open-label, randomized Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE 1, NCT03781063) study will now include Exactis Network sites in Quebec, Ontario, Nova Scotia and New Brunswick. The study, which began U.S. enrollment in September 2019, is assessing the efficacy of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation and progression-free survival as the primary endpoint.

"Sermonix is honored to collaborate with Exactis Innovation, a truly esteemed international center of excellence in precision medicine," said David Portman, Sermonix founder and chief executive officer. "Our ELAINE trials are solely focused on women with ESR1 mutations, for whom there is such great need of targeted treatments that potentially can prolong and enhance their lives. Working with Exactis furthers that mission."

With exclusive global rights to develop and commercialize lasofoxifene in the oncological arena, Sermonix is also adding ELAINE 1 study sites in Israel, further providing important international data as the company looks to fulfill its global mission of addressing the unmet needs of women with metastatic breast cancer.

Personalize My Treatment

Personalize My Treatment (PMT) is Exactis’ active pan-Canadian, Research Ethics Board-approved cancer patient registry that collects clinical and molecular patient data to match sub-populations in precision oncology research. Exactis will utilize its PMT registry, pre-screening patients to identify ESR1 mutations to both inform genomic cancer profiling during the patient’s treatment journey and potentially identify candidates for the ELAINE trial participation.

Exactis Chief Medical Officer Dr. Gerald Batist will work closely with Sermonix on the PMT/ELAINE collaboration. Dr. Batist is currently professor and former chair of the Department of Oncology at McGill University and is director of both the McGill Centre for Translational Research in Cancer and the Segal Cancer Centre at Sir Mortimer B. Davis-Jewish General Hospital in Montreal.

"The synergy between Sermonix’s precision medicine focus – through its ELAINE 1 study of lasofoxifene – and the Exactis network and PMT registry creates an ideal collaborative opportunity," said Dr. Batist. "We look forward to identifying and enrolling Canadian women into this trial, extending the frontier of research in the ESR1-mutated breast cancer arena and offering Canadian patients participation in this very promising clinical trial."

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

Entry into a Material Definitive Agreement

On September 30, 2020, Zentalis Pharmaceuticals, Inc. (the "Company") reported that it entered into a lease (the "Lease") with TPSC IX, LLC (the "Landlord"), pursuant to which the Company agreed to lease an aggregate of approximately 117,929 rentable square feet of office and laboratory space located at 10275 Science Center Drive, San Diego, California and 10285 Science Center Drive, San Diego, California (the "Premises") (Filing, 8-K, Zentalis Pharmaceuticals, SEP 30, 2020, View Source [SID1234567979]).

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The term of the Lease commences on the earlier of (i) the date of the Landlord’s notification to the Company that the tenant improvements are complete and (ii) the date in which the Company first commences to conduct business in the Premises, and lasts for a period of ten (10) years and eight (8) months. The term of the Lease is estimated to begin on November 1, 2021 and end on June 30, 2032. The Lease provides that base rent for the Premises will be approximately $625,000 per month, or $5.30 per square foot, subject to an annual upward adjustment of 3% of the then current rental rate, starting on the first anniversary of the first payment of rent under the Lease, and other potential adjustments based on the Company’s utilization of certain tenant improvement allowances. The Company has the right to terminate the lease after each of (i) 92 months and (ii) 104 months, upon 12 full calendar months’ written notice prior to the such date. Pursuant to the Lease, the Company has delivered a letter of credit to the Landlord in the amount of approximately $1.1 million. The Lease contains customary representations and warranties, covenants, obligations and indemnities in favor of either party.