On December 30, 2021 Akari Therapeutics, Plc (Nasdaq: AKTX) ("Akari" or the "Company"), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement and/or leukotriene systems are implicated, reported that it has entered into definitive agreements with institutional investors and accredited investors, led by existing investors of the Company, including Dr. Ray Prudo, the Company’s Chairman, to receive gross proceeds of approximately $6.0 million (Press release, Akari Therapeutics, DEC 30, 2021, View Source [SID1234598027]).

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In connection with the offering, the Company will issue approximately 4,310,839 registered American Depository Shares (ADSs) of Akari at a purchase price of $1.40 per ADS in a registered direct offering. Additionally, for each ADS purchased by investors, the investors will receive a registered warrant to purchase one-half ADS. The warrants will have an exercise price of $1.65 per ADS, will be exercisable upon their issuance and will expire five years from the issuance date. The closing of the offering is expected to take place on or about January 4, 2022, subject to the satisfaction of customary closing conditions.

Paulson Investment Company, LLC, is acting as the exclusive placement agent in connection with this offering.

The securities described above are being offered by Akari pursuant to an effective shelf registration statement on Form F-3 (File No. 333-251673) previously filed with the Securities and Exchange Commission (the "SEC") on December 23, 2020 and declared effective by the SEC on December 31, 2020. The offering of the securities will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

The Company will file a prospectus supplement and the accompanying base prospectus with the SEC relating to the securities being offered. When available, electronic copies of the prospectus supplement and the accompanying base prospectus may be obtained at the SEC’s website at View Source, or by contacting Donald A. Wojnowski Jr. of Paulson Investment Company, LLC, at (855) 653-3444 or at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein. There shall not be any offer, solicitation of an offer to buy, or sale of securities in any state or jurisdiction in which such an offering, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On December 30, 2021 Polyphor and EnBiotix Inc. reported the closing of the merger of the two companies and the change of name of the combined company to Spexis AG (Press release, Polyphor, DEC 30, 2021, View Source [SID1234639732]). Pursuant to completion of the capital increase approved at the extraordinary general meeting of shareholders convened on October 28, 2021, Polyphor and EnBiotix, a privately held late clinical-stage rare disease company focused on products for rare, chronic respiratory diseases, have merged, via a transaction whereby Polyphor acquired 99.6% (with the remaining 0.4% expected to follow shortly) of the outstanding capital stock of EnBiotix in exchange for 35’150’961 shares of Polyphor common stock. The acquired capital stock of EnBiotix also includes shares issued by EnBiotix via the full conversion of the USD 11 million convertible debenture financing which was communicated on December 29, 2021.

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Starting January 3, 2022, all 46’375’777 Spexis AG shares recorded in the commercial registry will be listed under the ticker symbol SPEX on the SIX Swiss Exchange under the International Reporting Standard and include all former Polyphor AG shares, which remain listed under the unchanged ISIN number (CH0106213793).

As resolved on October 28, 2021, by the Shareholders’ Meeting, Jeffrey Wager is replacing Kuno Sommer as chairman. Kuno Sommer and Bernard Bollag remain Board members. Dennis Ausiello has been elected vice-chair, Dan Hartman and Robert Clarke have also joined the Board thereby replacing Andreas Wallnöfer, Hugh O’Dowd, and Silvio Inderbitzin. The Executive Committee is led by Jeffrey Wager with Stephan Wehselau, Hernan Levett and Juergen Froehlich, thereby replacing Gökhan Batur, Franziska Müller, Daniel Obrecht and Frank Weber.

"We are pleased with the successful closing of the business combination and welcome the shareholders of EnBiotix and Polyphor to Spexis", said Jeffrey D. Wager, M.D., Chairman and Chief Executive Officer of Spexis. "We believe Spexis will pursue a unique strategy as a rare disease and oncology company. As such, we very much look forward to advancing an innovative R & D pipeline and to engaging in unique strategic corporate development to create long-term shareholder value."

The initial pipeline of Spexis includes:

– ColiFin(R) which EnBiotix has in-licensed from PARI Pharma GmbH, a global leader in nebulized therapies, for worldwide rights ex-Europe. Approved in Europe since 2010 as a front-line therapy for lung infections in cystic fibrosis ("CF"), ColiFin(R) has a proven safety, efficacy and commercial track record which the company aims to leverage towards the U.S. and global markets – and both within and outside the field of CF.

– Inhaled murepavadin, a novel class inhaled antibiotic specifically targeting Pseudomonas aeruginosa ("PA"), is being developed for the treatment of these infections in people with CF and is beginning Phase I development using eFlow(R) Technology nebulizer (PARI Pharma GmbH).

– EBX-002, a combination of amikacin (AMK) and a potentiator molecule for NTM infections which preclinical studies to date have shown potential for superior activity compared to ARYKACE(R).

– Balixafortide, a potent and highly selective blocker of CXCR4. Following the closure of its Phase 3 program in advanced breast cancer, additional oncology and non-oncology indications for balixafortide will be evaluated both alone and in collaboration with Fosun Pharma who owns China rights.

– New CXCR4 inhibitor program focused on orphan, hematological malignancies.

– Preclinical OMPTA BamA and LptA programs funded by CARBX targeting WHO Priority 1 bacterial infections planned to be developed for hospital acquired bacterial infections.

– Company aims to in-license or acquire other rare disease and oncology assets that will consolidate its position in these therapeutic areas.

On December 30, 2021 BeyondSpring Inc. (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, reported its financial results for the third quarter ended September 30, 2021, and provided an update on recent corporate events (Press release, BeyondSpring Pharmaceuticals, DEC 30, 2021, View Source;utm_medium=rss&utm_campaign=beyondspring-announces-third-quarter-2021-financial-results-and-provides-a-corporate-update [SID1234597851]).

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"In the third quarter, we continued to move forward in developing plinabulin’s potential as a ‘pipeline in a drug’ for patients in need. We are developing a wealth of clinical data showing plinabulin’s dual benefit as an anti-cancer agent, shown with OS benefit in Dublin-3 study, with additional benefit in preventing CIN, which we believe will support the important role of plinabulin as a versatile cancer treatment option, and potentially, as a ‘cornerstone’ therapy in IO combinations," said Dr. Lan Huang, co-founder, chairwoman and chief executive officer of BeyondSpring.

"We look forward to executing on our plans for the potential commercial launch of plinabulin in CIN, our first indication in China, where we are excited to work with a leading oncology company, Hengrui, in the commercialization and co-development of plinabulin. Our discussions will continue with the U.S. FDA regarding the potential regulatory pathway for CIN in the U.S. market. At the same time, we are very focused on preparing for our NDA filing for plinabulin in NSCLC. Based on discussions with regulatory agencies in the U.S. and in China, we now anticipate submitting our NDA in the 2H 2022. The year ahead will be very busy and significant for BYSI, and we remain dedicated to enabling plinabulin to achieve its full potential and to bringing added value to the treatment of cancer patients," concluded Dr. Huang.

Recent Clinical and Corporate Highlights

Presented positive final Phase 3 DUBLIN-3 data with the plinabulin/docetaxel combination versus docetaxel alone in 2nd/3rd line non-small cell lung cancer patients with EGFR Wild Type at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2021 Congress
The combination showed superior efficacy benefit in overall survival, progression-free survival (PFS), overall response rate (ORR), and significant reduction of grade 4 neutropenia vs. docetaxel alone.
The combination also demonstrated superior and clinically meaningful Quality of Life benefit: 18.4% of relative improvement in Q-TWiST (Quality-adjusted Time Without Symptoms of Disease and Toxicity).
Presented new data on plinabulin from its Chemotherapy-Induced Neutropenia (CIN) prevention program in three posters at the ESMO (Free ESMO Whitepaper) 2021 Congress (titles below):
Severe Neutropenia (Grade 4, Gr4N) as a Population-Based Predictor for Adverse Clinical Outcome of Chemotherapy Induced Neutropenia (CIN)
Prediction of Febrile Neutropenia (FN), Hospitalization (Hosp) Rates, and Infection (Inf) Rates in Chemotherapy-Induced Neutropenia (CIN) Patients (pts) Treated with the Plinabulin and Pegfilgrastim Combination (Plin+Peg) using a Meta-Analysis (MA)-based Tool
Impact of Adding Plinabulin to Pegfilgrastim for the Prevention of Chemotherapy Induced Neutropenia (CIN), on Patient Quality of Life (QoL)
Announced first patient treated in its Phase 2 study of plinabulin in combination with nivolumab + ipilimumab in patients in extensive-stage small-cell lung cancer (SCLC) who progressed after at least one platinum-based chemotherapy regimen and checkpoint inhibitors
The investigator-initiated study (IIT) is being conducted through the Big Ten Cancer Research Consortium in 7 U.S. clinical centers.
In Phase 1 study, plinabulin combination with nivolumab + ipilimumab had ORR of 43% in SCLC patients who had progressed on platinum and checkpoint inhibitors (presented at ASCO (Free ASCO Whitepaper) 2021).
Announced new patient-derived (PDX) cancer model data for plinabulin monotherapy, which further supports the positive clinical data in the treatment of SCLC
At the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC virtual international conference on molecular targets and cancer therapeutics, the Company presented additional preclinical data in plinabulin monotherapy activity in PDX models in glioblastoma multiforme, bladder cancer, gastric cancer, sarcoma, triple-negative breast cancer, and SCLC, with IC70 at 35 nM in SCLC.
Entered into an exclusive commercialization and co-development partnership between Jiangsu Hengrui Pharmaceuticals Co., Ltd. ("Hengrui") and Wanchunbulin, BeyondSpring’s China subsidiary, for plinabulin in Greater China
Hengrui, a leading oncology R&D and commercial company in China, has exclusive commercialization and co-development rights to all indications for plinabulin. Hengrui will pay all commercialization costs for all indications of plinabulin, and half of clinical development costs for new indications.
Wanchunbulin will supply plinabulin, retaining manufacturing rights. Wanchunbulin will receive all proceeds from sales of plinabulin products and pay Hengrui a pre-determined percentage of such sales.
Wanchunbulin received 200M RMB (est. US$30M) upfront, and will be eligible to receive up to 1.1B RMB (est. US$170M) in regulatory and sales milestones.
NDA for plinabulin-G-CSF combination in CIN Prevention under review in China; received complete response letter from U.S. FDA, with plans for further discussions with FDA on future regulatory pathway
Changes to the Company’s Board of Directors
Mark Santos, RPh joined the Company’s Board of Directors in November 2021. Mr. Santos has more than 30 years of experience in healthcare industries. He is SVP of Pharma Strategy & Contracting at OneOncology and past President of ION Solutions, the leading group purchasing organization (GPO) in the U.S. He serves as a board member for the American Cancer Society (South Texas Center), NY Cancer Foundation, and Leukemia Texas Foundation, among other organizations.
On December 22, 2021, Dr. Ravi Majeti resigned from the Board.
On July 27, 2021, Dr. Quanqi Song resigned from the Board of Directors and the Audit Committee, and Brendan Delaney, an independent Director, was appointed to the Audit Committee.
Upcoming Milestones

1H 2022: expected regulatory update for CIN indication in China; continuing discussions with FDA on regulatory pathway for CIN in the U.S.
2H 2022: NDA Submission for plinabulin in NSCLC
2H 2022: Phase 2 data from the Big Ten Cancer Research Consortium, IIT study expected in plinabulin + nivolumab + ipilimumab in platinum and checkpoint inhibitor-resistant SCLC.
2H 2022: Preliminary Phase 1 data and plinabulin immune mechanism data from the MD Anderson Cancer Center, IIT study expected in plinabulin + PD-1/PD-L1 inhibitors + radiation in patients with seven cancer types.
Third Quarter Financial Results

Research and development ("R&D") expenses were $8.5 million for the quarter ended September 30, 2021, compared to $8.6 million for the quarter ended September 30, 2020. The decrease was primarily due to lower clinical development expenses, which were partially offset by higher personnel and non-cash stock-based compensation expenses.
General and administrative ("G&A") expenses were $10.2 million for the quarter ended September 30, 2021, compared to $6.7 million for the quarter ended September 30, 2020. The $3.5 million increase was primarily due to higher personnel costs and expenses associated with plinabulin pre-commercialization activities.
Net loss attributable to the Company was $18.4 million for the quarter ended September 30, 2021, compared to $14.5 million for the quarter ended September 30, 2020.
As of September 30, 2021, the Company had cash, cash equivalents, and short-term investments of $91.6 million. The Company believes it has sufficient cash to support its ongoing clinical programs over the next year, including its immuno-oncology pipeline.
Year-to-Date Financial Results

R&D expenses were $31.1 million for the nine-month period ended September 30, 2021, compared to $33.4 million for the nine-month period ended September 30, 2020. The $2.3 million decrease was primarily due to lower clinical development expense, partially offset by higher personnel and professional services expenses, as well as PDUFA NDA application fees to FDA.
G&A expenses were $25.7 million for the nine-month period ended September 30, 2021, compared to $12.2 million for the nine-month period ended September 30, 2020. The $13.5 million increase was primarily due to higher personnel costs, non-cash stock-based compensation expense and pre-commercialization expenses for plinabulin.
Net loss attributable to the Company was $54.7 million for the nine-month period ended September 30, 2021, compared to $43.4 million for the nine-month period ended September 30, 2020.

On December 30, 2021, Personalis, Inc., or the Company, reported that entered into an At-the-Market Sales Agreement, or the Sales Agreement, with BTIG, LLC, or BTIG, under which it may offer and sell its common stock having aggregate sales proceeds of up to $100.0 million from time to time through BTIG as its sales agent (Filing, 8-K, Personalis, DEC 30, 2021, View Source [SID1234597952]). Sales of the Company’s common stock through BTIG, if any, will be made by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, including without limitation sales made directly on the Nasdaq Global Market or any other existing trading market for its common stock. BTIG will use commercially reasonable efforts to sell the Company’s common stock from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay BTIG a commission of up to 3.0% of the gross sales proceeds of any common stock sold through BTIG under the Sales Agreement. The Company has also provided BTIG with customary indemnification rights.

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The Company is not obligated to make any sales of common stock under the Sales Agreement. The offering of shares of the Company’s common stock pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of all common stock subject to the Sales Agreement, or (ii) termination of the Sales Agreement in accordance with its terms.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. This Current Report on Form 8-K also incorporates by reference the Sales Agreement into the Registration Statement (as defined below).

The Company’s common stock is being offered and sold pursuant to the Company’s effective shelf registration statement on Form S-3 and an accompanying prospectus (Registration Statement No. 333-251824) declared effective by the U.S. Securities and Exchange Commission, or SEC, on January 8, 2021, or the Registration Statement, and a prospectus supplement dated December 30, 2021.

On December 30, 2021 Blueprint Medicines Corporation (NASDAQ: BPMC) reported that the company has successfully completed its previously announced acquisition of Lengo Therapeutics and lead compound LNG-451, a potential best-in-class oral precision therapy in development for the treatment of non-small cell lung cancer (NSCLC) in patients with EGFR exon 20 insertion mutations (Press release, Blueprint Medicines, DEC 30, 2021, View Source [SID1234597852]). An investigational new drug (IND) application for LNG-451 was submitted to the U.S. Food and Drug Administration (FDA) by Lengo Therapeutics in December 2021.

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"The acquisition of Lengo Therapeutics and its lead candidate LNG-451 enables Blueprint Medicines to expand our pipeline in lung cancer and harness our experience and expertise to advance precision oncology therapies for the patients who need them," said Fouad Namouni, M.D., President of Research & Development. "I want to thank the Lengo Therapeutics team, again for their work to advance the highly selective therapeutic candidate LNG-451, but also for completing the IND submission with a continued sense of urgency. Pending FDA clearance of the application, we plan to advance LNG-451 into the clinic in the first quarter of 2022."

As previously disclosed, under the terms of the agreement, Blueprint Medicines acquired Lengo Therapeutics for $250 million in cash plus up to $215 million in additional potential payments based on the achievement of certain regulatory approval and sales-based milestones.