On March 30, 2023 Trobix Bio, a company utilizing CRISPR, phage, and synthetic biology technologies to develop advanced precision microbiome oncology therapeutics, reported the successful closing of a US $3 million equity investment by Chartered Group, a well-established global private investment group (Press release, Trobix Bio, MAR 30, 2023, View Source [SID1234644366]).

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The proceeds from this Series A extension round are being utilized to advance the development of Trobix Bio’s products and cutting-edge proprietary platform technology, which addresses the gastrointestinal side effects of oncology treatments and other gastrointestinal diseases impacted by the microbiome.

Dr. Adi Elkeles, CEO of Trobix Bio, said, "In these troubled financial markets I am grateful to Chartered Group for their trust in our team and confidence in our products and technology. Treating side effects caused by leading cancer therapeutics represents a significant unmet need, often limiting patients’ ability to undergo critical treatments as well as severely reducing their quality of life. This represents a significant opportunity for our business and a moral imperative for our team. We are highly encouraged by our early preclinical data for both TBX201 and TBX301, which are designed to complement Irinotecan and immune checkpoint inhibitor therapeutics. We strongly believe that these treatments may have the capacity to relieve patients’ agonizing side effects, enhancing their quality of life, and facilitate physicians’ ability to deliver more effective treatment regimens with these life-saving medications."

Eyal Agmoni, Chairman of Chartered Group, which has a technologies’ investment arm that solely invests in disruptive deep tech innovations, said "Trobix Bio has developed highly promising therapeutic candidates thanks to their revolutionary technology and highly impressive team, experienced in driving continued growth and development. Given our support at this critical time of trying market conditions, we believe they now have the resources to deliver on their promise of addressing significant unmet medical needs. Based on our due diligence, we believe they will deliver products that will make a huge impact on human wellbeing, creating immense value."

The Trobix TBX platform technology converges computational, synthetic, and synthetic biology technologies in a proprietary way to engineer phages as medicines that reprogram, with exceptional precision, targeted microbiome bacteria, resulting in a robust and durable therapeutic effect.

TBX201 is an orally available capsule designed to specifically alter the gut microbiome to reduce the incidence and severity of severe diarrhea caused by irinotecan. Irinotecan is a first-line chemotherapy drug for the treatment of several metastatic cancer indications; however, its clinical use in over 100,000 patients annually is associated with life-threatening toxicity and treatment interruptions for many patients.

TBX301 is an orally available capsule designed to specifically alter the gut microbiome to reduce the incidence and severity of colitis in patients receiving immune checkpoint inhibitors (ICI). The number of patients receiving treatment with ICI, such as CLTA-4, PD1 or PDL1 inhibitors, is rapidly increasing, with currently over 1 million patients globally treated annually with ICI. Severe life-threatening and treatment-limiting colitis is one of the lead adverse reactions to ICI treatment.

On March 30, 2023 Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, reported its financial results for the fiscal year ended December 31, 2022 and provided a business update (Press release, Fennec Pharmaceuticals, MAR 30, 2023, View Source [SID1234631942]).

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"It was an outstanding year for Fennec as we achieved FDA approval of PEDMARK in the fourth quarter and evolved into a commercial-stage pharmaceutical company. For 2023, we are focused on building upon our early commercial launch momentum by continuing to execute on our strategic plans, expand our prescriber base, and increase the utilization of PEDMARK," said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. "We are very proud of Fennec’s patient-centric approach and the performance across the entire organization, and we continue to be motivated by the positive responses that we are receiving from the pediatric cancer patient community, healthcare providers and payors. Fennec remains dedicated to growing its revenues both in the U.S. and worldwide as we seek to expand PEDMARK’s presence and availability to patients globally."

Recent Developments and Highlights:

Received U.S. Food and Drug Administration (FDA) approval of the PEDMARK New Drug Application (NDA) on September 20, 2022. PEDMARK is the first and only FDA-approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients one month of age and older with localized, non-metastatic solid tumors.
Initiated U.S. commercial launch of PEDMARK on October 17, 2022. The Fennec HEARS program offers comprehensive patient services, including access to care coordinators, financial and prescription drug support.
The National Comprehensive Cancer Network (NCCN) updated its clinical practice guidelines for Adolescent and Young Adult (AYA) Oncology to include PEDMARK (sodium thiosulfate injection) in January 2023.
The FDA granted Orphan Drug Exclusivity to PEDMARK (sodium thiosulfate injection) in January 2023. The FDA’s Orphan Drug Designation program is designed to advance the development of drugs that treat a condition affecting 200,000 or fewer U.S. patients annually. The seven-year market exclusivity for PEDMARK began on September 20, 2022, the date of its FDA approval, and continues until September 20, 2029. Additionally, in the approved prescribing label, the FDA has explicitly directed that PEDMARK is not substitutable with other sodium thiosulfate products.
Financial Results for the Fourth Quarter and Fiscal Year Ended December 31, 2022

Cash Position – There was a $2.7 million increase in cash and cash equivalents between December 31, 2022 and December 31, 2021. The net increase was the result of cash operating expenses, offset by the net $20.0 million received from the Petrichor note and $0.9 million received from the exercise of 273,000 options. During the period ended December 31, 2022, cash for operations was used mainly on the pre-commercialization activities of PEDMARK prior to FDA approval and then commercialization activities post NDA approval.
Commercial launch of PEDMARK commenced in October 2022. The company recorded net product sales of $1.54 million in fiscal 2022. The Company recorded discounts and allowances against sales in the amount of $0.2 million and cost of products sold of $0.1 million. The Company had gross profit of $1.4 million for fiscal year ended 2022. In fiscal 2021, the Company had no revenues.
Research and Development (R&D) Expenses – R&D expense decreased by $1.5 million in fiscal 2022 as compared to fiscal 2021. The Company reduced research and development costs when it received FDA approval of PEDMARK. The majority of traditional research and development expenses associated with PEDMARK are now recorded as general and administrative expenses or capitalized into inventory and eventually recorded to costs of product sales.
Selling and Marketing (S&M) Expenses – The Company began recording selling and marketing expenses when it expanded its payroll to include an internal salesforce. Selling and marketing expenses include distribution costs, logistics, shipping and insurance, advertising, wages commissions and out-of-pocket expenses. The Company recorded $2.8 million in selling and marketing expenses in fiscal 2022.
General and Administrative (G&A) Expenses – There was a $5.5 million increase of general and administrative expenses in fiscal 2022 compared to fiscal 2021. Payroll and benefits related expenses rose by $4.0 million in fiscal 2022 compared to fiscal 2021 as our headcount increased from 10 to 36 over the course of fiscal 2022. There was an increase in legal costs of $1.4 million in fiscal 2022 over fiscal 2021. This net increase is comprised of an increase in $0.2 million in class action suit defense, a decrease in general legal expense of $0.2 million and an increase of $1.4 million in intellectual property litigation. Pre-commercialization activities rose by $0.2 million in fiscal 2022 over fiscal 2021. Non-cash expenses associated with equity remuneration increased by $0.2 million.
Net Loss – Net losses for the fourth quarter and year ended December 31, 2022 of $6.9 million ($0.26 per share) and $23.7 million ($0.90 per share), respectively, compared to $4.4 million ($0.18 per share) and $17.3 million ($0.67 per share), respectively, for the same periods in 2021.
Financial Guidance – The Company believes its cash and cash equivalents on hand as of December 31, 2022 will be sufficient to fund the Company’s planned commercial activities for 2023.
Financial Update

The selected financial data presented below is derived from our audited, condensed consolidated financial statements, which were prepared in accordance with U.S. generally accepted accounting principles. The complete audited, condensed consolidated financial statements for the period ended December 31, 2022, and management’s discussion and analysis of financial condition and results of operations, will be available via www.sec.gov and www.sedar.com. All values are presented in thousands unless otherwise noted.

On March 31, 2023 GenScript Biotech, the world’s leading biotech company, reported its annual results as of December 31, 2022 (Press release, GenScript, MAR 30, 2023, View Source [SID1234630452]).

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In times of macroeconomic challenges, GenScript Group continued to deliver strong growth in 2022. "The Group has maintained growth momentum across the business portfolio under long-term strategy. Benefiting from our insights into the industry and continuous investment in R&D and production processes, our life science business saw steady growth by offering diversified life science services and products. This has positioned us as a reliable life science partner for customers. In biologics CDMO business, our antibody and protein CDMO and GCT CDMO services continued rapid growth. Our proven one-stop solutions helped ProBio drive significant share gain. Our industrial enzyme business reported improved profitability, driven by enhanced R&D and sales capabilities. Also, we are exploring new opportunities in the synthetic biology field. In cell therapy business, Legend Biotech, along with its partner Janssen, has successfully commercialized CARVYKTI. We are also moving forward on other pipelines," said Ms. Sherry Shao, Rotating CEO of GenScript.

Ms. Shao added, "Our success is enabled by customer trust, our global high-caliber team, and support from our investors. I would like to express my heartfelt gratitude again. We are confident that we will deliver on our commitment to "make people and nature healthier through biotechnology."

Results Analysis of the Four Business Segments

For the year ended December 31, 2022

Life-science services and products

Biologics development services

Industrial synthetic biology products

Cell therapy

US$’000

US$’000

US$’000

US$’000

Revenue

360,540

125,009

38,664

117,005

Adjusted gross profit

201,120

42,857

16,609

53,038

Adjusted selling and distribution expenses

51,414

13,898

3,559

89,796

Adjusted administrative expenses

43,382

22,847

5,437

68,700

Adjusted research and development expenses

40,214

7,260

4,755

316,637

Adjusted operating profit/(loss)

66,110

(1,148)

2,858

(422,095)

As the Group has reallocated back office administrative expenses into each business segment following the establishment of Probio legal entities in the second half of 2021, segment operating profit is not directly comparable to the same period in 2021. The adjusted expenses exclude the impact from (i) share-based compensation expenses, (ii) consultation and other related costs for the Investigation, and (iii) service fees and other costs for equity financing activities.

Life-science services and products

During the Reporting Period, revenue from life-science services and products was approximately US$360.5 million, representing an increase of 14.2% as compared with approximately US$315.8 million for the year ended December 31, 2021. The adjusted gross profit was approximately US$201.1 million, representing an increase of 8.0% as compared with approximately US$186.2 million for the year ended December 31, 2021. The adjusted gross profit margin decreased slightly from 59.0% for the same period in 2021 to 55.8% this Reporting Period. The adjusted operating profit of life-science services and products was approximately US$66.1 million.

The increase in revenue was driven by a combination of (i) the increased demand in each of the segment’s principal businesses with particular strength in molecular biology, protein and antibody business, and (ii) the successful commercialization of innovative platforms such as sgRNA, and was partially offset by the decreased demand for testing to diagnose COVID-19. The decrease in adjusted gross profit margin was primarily attributable to the (i) increment in labor, overhead and facility cost related to overseas site operation, (ii) increased freight and duty costs, and (iii) changes in product portfolio strategy. The adjusted operating profit was positively impacted from operational efficiency, while negatively impacted by increased research and development efforts focused on the enhancement to existing services and development of new products.

Biologics development services

During the Reporting Period, revenue from biologics development services was approximately US$125.0 million, representing an increase of 53.6% as compared with approximately US$81.4 million for the year ended December 31, 2021. The backlog increased to US$233.3 million as at December 31, 2022, with a growth at 18.2%. The adjusted gross profit was approximately US$42.8 million, representing an increase of 54.5% as compared with approximately US$27.7 million for the year ended December 31, 2021. Adjusted gross profit margin kept stable in the two years. The adjusted operating loss of biologics development services was approximately US$1.1 million.

The growth of revenue and adjusted gross profit was mainly attributable to the (i) increase in the number of projects from protein and antibody drug development, and plasmid, (ii) expanded capacity and increased capacity utilization rate in process development and manufacturing, and (iii) continuously shortened delivery timeline.

Industrial synthetic biology products

During the Reporting Period, revenue from industrial synthetic biology products was approximately US$38.7 million. The adjusted gross profit was approximately US$16.6 million, representing an increase of 46.9% as compared with approximately US$11.3 million for the year ended December 31, 2021. Adjusted gross profit margin increased from 29.3% for the same period in 2021 to 42.9% this Reporting Period. The adjusted operating profit of industrial synthetic biology products was approximately US$2.9 million whilst it just arrived operating break-even for the same period in 2021.

The increase in both adjusted gross profit and adjusted operating profit was primarily attributable to the (i) adjustment of product portfolio and enhancement of the promotion of high-margin products, together with active pruning of low or negative profit products, (ii) upgrade of the workflow and improvement of production process, and (iii) profit from the license of certain patents.

Cell therapy

During the Reporting Period, revenue from cell therapy segment was approximately US$117.0 million, representing an increase of 70.0% compared to approximately US$68.8 million for the year ended December 31, 2021. The increase in revenue was primarily attributed to the collaboration revenue involving the commercial launch of CARVYKTI in the U.S.. On February 28, 2022 the FDA approved CARVYKTI for adults with relapsed or refractory patients with MM who have received four or more prior lines of therapy. CARVYKTI has received conditional marketing authorizations from European Commission in May 2022 and approval from Japan’s Ministry of Health, Labour and Welfare for the treatment of adults with relapsed or refractory multiple myeloma limited to cases meeting certain conditions on September 26, 2022.

During the Reporting Period, the operating loss of approximately US$458.1 million whilst the operating loss for the same period in 2021 was approximately US$394.0 million. The continued investment in research and development costs of approximately US$335.6 million during the Reporting Period compared to approximately US$313.3 million for the same period in 2021 is the primary driver of the operational expenditures as Legend focused on investment in early lines of therapy for cita-cel as well as progressing Legend’s pipeline. Additionally, incurred approximately US$93.4 million in selling and distribution expenses and approximately US$80.6 million in administrative expenses during the Reporting Period compared to approximately US$102.5 million and approximately US$47.0 million, respectively, for the same period in 2021. Also, incurred approximately US$65.4 million during the Reporting Period towards cost of collaboration revenue to support the commercial supply of CARVYKTI.

FINANCIAL REVIEW

2022

2021

Change

US$’000

US$’000

US$’000

Revenue

625,698

490,096

135,602

Gross profit

304,083

282,518

21,565

Loss after income tax

(427,971)

(518,327)

90,356

Adjusted net loss

(359,416)

(327,826)

(31,590)

Loss attributable to owners of the Company

(226,851)

(358,712)

131,861

Adjusted net loss attributable to owners of the Company

(167,786)

(181,007)

13,221

Loss per share (US cent per share)

(10.82)

(17.67)

6.85

Revenue

In 2022, the Group recorded revenue of approximately US$625.7 million, representing an increase of 27.7% from approximately US$490.1 million in 2021. This was primarily attributable to (i) the stable market share growth and brand awareness of non-cell therapy business with new competitive services and products, especially in biologics development services, and (ii) the product sales of CARVYKTI after the commercialization approval from the FDA.

Gross Profit

In 2022, the Group’s gross profit increased by 7.6% to approximately US$304.1 million from approximately US$282.5 million in 2021. The increase in gross profit was primarily attributable to the expansion of the revenue, and was partially offset by (i) the increased share-based compensation expenses in production teams, particularly in biologics development services, (ii) the adjustment of product and service portfolio, and (iii) the increased shipping cost. The adjusted gross profit increased by 10.1% over the same period in 2021.

Selling and distribution expenses

The selling and distribution expenses was approximately US$168.3 million in 2022, roughly unchanged over the same period in 2021.

Administrative expenses

The administrative expenses increased by 35.7% to approximately US$182.5 million in 2022 from approximately US$134.5 million in 2021. This was mainly caused by (i) the increased investment on talent with recruiting experienced personnel with competitive package and share-based compensation expenses for all business segments, (ii) the reinforcement of some key administrative functions and information technology infrastructure to support the Group’s overall business, and (iii) the enhanced corporate governance and compliance measures. The adjusted administrative expenses increased by 34.1% over the same period in 2021.

Research and development expenses

The research and development expenses increased by 8.8% to approximately US$390.1 million in 2022 from approximately US$358.4 million in 2021. This was mainly due to the continued investment in talents with competitive package and share-based compensation expenses. The adjusted research and development expenses increased by 7.2% over the same period in 2021.

On March 30, 2023 Oxcia AB (publ) reported that three abstracts on OXC-101, its clinical candidate for cancer, have been selected for poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual meeting held in Orlando, Florida, 14-19[th] April, 2023 (Press release, Oxcia, MAR 30, 2023, View Source [SID1234629861]). The abstracts concern the clinical safety, further understanding of the broad anti-cancer efficacy and the mechanism of action and will be published in the online Proceedings supplement of the AACR (Free AACR Whitepaper) journal Cancer Research.

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Many cancers suffer from oxidative stress and high levels of endogenous oxidative DNA damage. The enzyme MTH1 protects cancer cells from oxidative DNA damage by preventing incorporation of oxidized DNA base pairs. OXC-101 is a dual-action mitotic disruptor and MTH1 inhibitor, i.e. a mitotic MTH1 inhibitor, stopping cancer cells from dividing, causing more oxidative stress and oxidative DNA damage, thereby killing cancer cells. It effectively takes advantage of the high level of oxidative DNA damage in cancer cells.

The first abstract summarizes the report on the favorable safety profile of OXC-101 in the MASTIFF (MTH1, A Phase I, Study on Tumors Inhibition, First-in-Human, First in Class) study (Title: : OXC-101 shows favorable safety profile in first-in-human phase 1 trial in patients with advanced solid cancer. Authors: Jeffrey Yachnin, Lars Ny, Teresa Sandvall, Kumar Sanjiv, Martin Scobie, Björn Platzack, Pawel Baranczewski, Olof Breuer, Vassilis Gorgoulis, Ioannis S Pateras, Maria Klockare, Austin Smith, Ulrika Warpman Berglund, Thomas Helleday). MASTIFF is a first- in- human phase 1 study, with the primary aim to assess safety, tolerability, and pharmacokinetics of OXC-101 in patients with advanced solid malignant tumors. All patients had progressive, stage 4 disease with palliative care or participations in clinical trials as only treatment options. The AACR (Free AACR Whitepaper) poster presentation takes place Tuesday April 18th,2023, 9.00am-12.30pm. The abstract (Number CT182) will be published online in Proceedings supplement to the AACR (Free AACR Whitepaper) journal Cancer Research Friday April 14th , 2023.

The second abstract is related to the further understanding of the underlying mechanism of action of OXC-101 and the broad and cancer specific effects in solid cancers. (Title: OXC-101 kills cancer by disturbing microtubule polymerization and inhibiting MTH1. Authors: Ulrika Warpman Berglund, Helge Gad, Ann-Sofie Jemth, Oliver Mortusewitz, Lars Brautigam, Kumar Sanjiv, Juha Rantala, Thomas Helleday). The AACR (Free AACR Whitepaper) poster presentation takes place Monday April 17th ,, 2023, 9.00am-12.30pm. The abstract (Number 1569) will be published online in Proceedings supplement to AACR (Free AACR Whitepaper) journal Cancer Research Friday, March 31st, 2023.

The third presentation supports the proposed mechanism of action of OXC-101 and demonstrates an enhanced efficacy of OXC-101 in combination with other compounds that stop cancer cell cycle progression and DNA repair, such as DNA-PK inhibitors (Title:DNA-PK inhibition augment the cancer specific cytotoxicity of MTH1 inhibitor and microtubule poisons. Authors: Akhilesh Nagesh Danda, Helge Gad, Martin Scobie, Thomas Helleday, Ulrika Warpman Berglund, Kumar Sanjiv). The AACR (Free AACR Whitepaper) poster presentation takes place Wednesday April 19, 2023, 9.00am-12.30pm. The abstract (Number 6204) will be published online in Proceedings supplement to AACR (Free AACR Whitepaper) journal Cancer Research Friday, March 31s, 2023.

"We are thrilled to be presenting OXC-101 clinical first-in-human safety data as well as new preclinical data supporting the unique dual mechanism of OXC-101 and broad anti-cancer efficacy at the AACR (Free AACR Whitepaper) Annual meeting, one of the biggest conferences for cancer research." says Ulrika Warpman Berglund, CEO at Oxcia.

On March 30, 2023 Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, reported that it has entered into definitive agreements with certain institutional investors and accredited investors (Press release, Akari Therapeutics, MAR 30, 2023, View Source [SID1234629648]). The direct offering includes participation by all members of the Akari Board of Directors, including Chairman Dr. Ray Prudo, as well as Akari President and CEO Rachelle Jacques. Akari is expected to receive gross proceeds of approximately $4 million. The definitive agreements include no warrants.

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In connection with the offering, the Company will issue approximately 26,666,667 registered American Depository Shares ("ADSs") of Akari at a purchase price of $0.15 per ADS, each representing one hundred ordinary shares of the Company, par value $0.0001 per share, in a registered direct offering. The closing of the offering is expected to take place on or about March 31, 2023, subject to the satisfaction of customary closing conditions.

Net proceeds from the transaction are expected to support advancement of Akari’s two priority pipeline programs investigating nomacopan, a bispecific recombinant inhibitor of complement C5 and leukotriene B4 (LTB4). The first pipeline priority is the acceleration of the Phase 3 clinical trial of nomacopan in severe pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA) into pivotal Part B, expected later this year. The second pipeline priority is the promising pre-clinical program investigating long-acting PAS-nomacopan as a potential treatment for geographic atrophy (GA).

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.

Akari 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 (646) 553-3691 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.