On November 18, 2021 Treadwell Therapeutics, a clinical-stage biotechnology company developing novel, cross-modality medicines for unmet needs in cancer, reported the closing of an oversubscribed Series B financing, which raised more than $91 million (Press release, Treadwell Therapeutics, NOV 18, 2021, View Source [SID1234595784]). The financing was led by Sino Biopharmaceutical Limited and 3W Fund Management Limited ("3W Fund"), and included new investors including renowned culture entrepreneur and investor Mr. Adrian Cheng, Prosperous Alliance, Alpha Win Capital, Fortune Ocean Growth Fund L.P. and, along with existing investors TIO Bioventures, and other undisclosed institutional and individual investors.

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"Our team is very excited to announce the closing of this transformative Series B financing, and are very grateful to our investors, both old and new, for their belief, commitment and support of our goal to build a globally impactful Biotechnology organization," said Shane Burgess, Chairman and co-CEO of Treadwell Therapeutics. "Since our company was founded in July 2019, we have made significant strides in building and validating our clinical stage small molecule portfolio, as well as broadening our pre-clinical pipeline of novel biologic and cell therapy assets. The funding will allow us to further the development of our product candidates, as well as to continue building out our organization in all functions with the talent necessary to support our mission, which is to translate novel scientific insights into hope for patients in need," added Dr. Michael Tusche, co-CEO of Treadwell Therapeutics.

"Treadwell Therapeutics is a company steeped in world class science and has an exciting pipeline of first in class drugs with compelling signs of clinical activity," said Dr. Mao Li, Chief Medical Officer at Sino Biopharmaceutical Limited. "We are excited to be part of Treadwell in the next phase of its growth."

"We are excited to support Treadwell to further develop its strong pipeline of first in class drugs to help patients worldwide." said Cathy Chen of 3W Fund. "We look forward to significant growth of Treadwell in the near future."

The proceeds from this financing will allow Treadwell to continue the clinical and pre-clinical development of its broad, multi-modality pipeline. This includes the company sponsored TWT-101 study of CFI-402411 in advanced solid tumors as a monotherapy and in combination with pembrolizumab; the company sponsored TWT-202 study of CFI-400945 in leukemia as a monotherapy and in combination with decitabine or azacitidine, an IND filing in late 2021 and subsequent company sponsored study of CFI-402257 in metastatic ER+ Breast cancer, as well as other opportunistic trials. The Series B financing will also support Treadwell’s continued development and validation of its preclinical pipeline of novel biologic and cell therapy approaches, the latter of which is expected to enter the clinic around early 2023. Lastly, the funding will allow Treadwell to continue to grow and operationalize the organization with world class talent and infrastructure.

On November 18, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that an exclusive interview with CEO Snehal Patel will air on the upcoming The RedChip Money Report on Bloomberg TV, this Saturday November 20th at 7 pm ET. Bloomberg TV airs in an estimated 73 million homes across the United States (Press release, Greenwich LifeSciences, NOV 18, 2021, View Source [SID1234595801]).

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In the interview Mr. Patel discusses the Phase IIb clinical trial results in HER2 positive patients, where no metastatic breast cancer recurrences were observed over 5 years of follow-up, an overview of the next steps in the upcoming FLAMINGO-01 Phase III clinical trial, potential Phase IIb and Phase III clinical data publications in 2022, the impact of joining the Russell 2000, and examples of recent comparable strategic transactions in breast cancer and immunotherapy.

To view a preview of the interview, please click here.

About The RedChip Money Report

The RedChip Money Report delivers insightful commentary on small-cap investing, interviews with Wall Street analysts, and financial book reviews, as well as featured interviews with executives of public companies.

About FLAMINGO-01 and GLSI-100

The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100. The Phase III trial is comprised of 2 blinded, randomized, placebo-controlled arms for approximately 500 HLA-A*02 patients and 1 open label arm of up to 100 patients for all other HLA types. An interim analysis has been designed to detect a hazard ratio of 0.3 in IDFS, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently being registered on clinicaltrials.gov and the link and trial identifier will be published shortly. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On November 18, 2021 Tavotek Biotherapeutics, a fast-growing biotech company, reported it has raised $35M in Round B financing (Press release, Tavotek, NOV 18, 2021, View Source [SID1234595818]). CS Capital, a leading private equity fund manager in China, led this finance round followed by Fontus Capital. This round of financing will be used to accelerate the Phase 1 clinical development of several antibody drugs to start in early 2022. The upcoming antibody drugs were developed by the company based on its TavoPrecise antibody platform for various immune-related disorders. In addition, the funding will also be used to accelerate the CMC and IND development of multiple other oncology pipelines and the development of the company’s multicyclic intracellular peptide (MIP) programs.

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Tavotek Biotherapeutics, established in early 2019, is committed to using innovation to improve the well-being of patients with unmet medical needs. The company has two R&D centers: one in Lower Gwynedd, Pennsylvania and another in Suzhou, China. The core team members have decades of successful drug development experiences at multinational pharmaceutical firms (Johnson & Johnson, Abbott/Abbvie, GlaxoSmithKline and Eli Lilly) which include many blockbuster drugs with annual sales of more than $1 billion.

Tavotek’s research platforms are built upon three breakthrough technologies: TavoSelect (an innovative Phage Display Library that generates conformational selective human full-length and single domain antibodies); TavoPrecise (a differentiated engineering platform for next generation tissue-specific biologics); and TavoMIP (a multicyclic peptide platform that makes undruggable targets more accessible). With the new infusion of capital, Tavotek is developing novel biologics targeting oncology and autoimmune diseases for patients. The company plans to bring multiple innovative antibodies into human clinical trials in 2022.

On November 18, 2021 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported that leading independent proxy advisory firm, Glass Lewis & Co. (Glass Lewis), joins Institutional Shareholder Services (ISS) in recommending that Advaxis stockholders vote "FOR" the stockholder proposals relating to the Company’s proposed merger with Biosight (Press release, Advaxis, NOV 18, 2021, View Source [SID1234595769]).

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In its report dated November 11, 2021, Glass Lewis stated1:

We believe the strategic rationale for the proposed transaction is generally reasonable from the perspective of Advaxis shareholders.

We find that the analyses presented by the advisor are reasonable and contain adequate disclosure. In particular, we note from the advisor’s Comparable Initial Public Offerings Analysis that the implied value of the proposed consideration for Biosight ($218 million) falls within the fair value range derived by the advisor using pre-money equity values observed in seven IPOs involving Phase 2 companies without completing a crossover financing ($187 million to $406 million) and well below the range derived using equity values observed in 12 IPOs involving Phase 2 companies with a focus on oncology ($648 million to $819 million).

Overall, we see no cause for significant shareholder concern with the strategic rationale or financial aspects of the proposed transaction, which would allow Advaxis shareholders to benefit from the development pipeline and stronger financial position of the combined company.

Based on the forgoing factors and the support of the board, we believe the proposed transaction is in the best interests of shareholders.
Commenting on the reports, Kenneth A. Berlin, President, Chief Executive Officer and Interim Chief Financial Officer of Advaxis, said, "We are pleased that both Glass Lewis and ISS support our proposed combination with Biosight and recommend that Advaxis shareholders vote "FOR" the stockholder proposals relating to the merger. Our Board, which unanimously approved this transaction, is confident that merging with Biosight will create a well capitalized and better-positioned Company to advance a broader portfolio of drug candidates aimed at addressing both liquid and solid tumors. We strongly urge all Advaxis stockholders to follow the recommendations of ISS and Glass Lewis and vote "FOR" the shareholder proposals relating to the proposed combination with Biosight."

The Special Meeting, initially held on November 16, 2021, has been adjourned to December 7, 2021 at 10:00 AM Eastern Time unless postponed or adjourned to a later date, in order to obtain the stockholder approvals necessary to complete the merger and related matters. Advaxis stockholders will be able to attend and participate in the Advaxis special meeting online by visiting www.virtualshareholdermeeting.com/ADXS2021SM where they will be able to listen to the meeting live, submit questions and vote.

On November 18, 2021 Calliditas Therapeutics reported that (Press release, Calliditas Therapeutics, NOV 18, 2021, View Source [SID1234595785])

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"Following on from the positive top line read out of Part A our Phase 3 study, we initiated a structured process to select our commercial partner for Nefecon in Europe. In this case, the result of the process was a partnership with Stada Arzneimittel, which has proven to be an excellent match. We also took the opportunity to complement our predominant source of equity capital with a $75m credit line from Kreos.

In the third quarter, the U.S. Food and Drug Administration (FDA) requested further analyses of data from the NeflgArd clinical trial in connection with our NDA submitted for approval under the FDA’s Accelerated Approval Program. The FDA classified the additional analyses received as a major amendment to the NDA and extended the PDUFA goal date by three months from September 15, 2021 to December 15, 2021. The third quarter also saw the European Medicines Agency (EMA) deciding to revert to standard review timelines for our submission, which we estimate will result in the issuance of an opinion in Q1, 2022. We remain confident that we have presented a compelling data package and look forward to continuing our regulatory interactions with the goal of making an approved treatment available for patients in need.

We remain ready for commercial launch in the US. Our field medical directors are in dialogue with nephrologists across the country and we are proceeding with market access related conversations as well as other pre-commercial activities. We are excited about our strong US capabilities reflected by the highly experienced and well-prepared team in place."

Renée Aguiar-Lucander, CEO

Summary of Q3 2021
July 1 – September 30, 2021

Net sales amounted to SEK 198.2 million for the three months ended September 30, 2021. No net sales were recognized for the three months ended September 30, 2020.
Operating profit (loss) amounted to SEK 7.9 million and SEK (104.9 million) for the three months ended September 30, 2021 and 2020, respectively.
Earnings (loss) per share before dilution amounted to SEK 0.21 and SEK (2.77) for the three months ended September 30, 2021 and 2020, respectively.
Cash amounted to SEK 1,163.8 million and SEK 1,396.9 million as of September 30, 2021 and 2020, respectively.
Significant events during Q3 2021, in summary
In July 2021, Calliditas signed a loan agreement of up to the EUR equivalent of $75 million with Kreos Capital.
In July 2021, Calliditas and STADA Arzneimittel AG entered into a license agreement to register and commercialize Nefecon in the European Economic Area (EEA) member states, Switzerland and the UK valued at a total of EUR 97.5 million (approx. $115m) in initial upfront and potential milestone payments, plus royalties.
In August 2021, Calliditas received FDA fast track designation for setanaxib in PBC.
In August 2021, Calliditas completed an accelerated book building procedure and resolved on a directed share issue in the amount of 2.4 million shares, raising proceeds of SEK 324.0 million (approx. $37m) before transaction costs.
In September 2021, Calliditas announced that the FDA extended the PDUFA goal date for its New Drug Application (NDA) seeking accelerated approval for Nefecon to December 15, 2021.
In September 2021, Calliditas announced that the European Medicine Agency’s (EMA) Committee for Human Medicinal Products (CHMP) decided to continue the assessment of the marketing authorization application (MAA) for Nefecon under standard procedure assessment timelines.
Investor presentation November 18, 14:30 CET
Audio cast with teleconference, Q3 2021, November 18, 2021, 14:30 (Europe/Stockholm)

Financial calendar
Year-end Report for the period January 1 – December 31, 2021 February 24, 2022