On April 12, 2021 Onxeo S.A. (Euronext Growth Paris: ALONX; Nasdaq First North Growth Copenhague: ONXEO, a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR), in particular against rare or resistant cancers, reported the result of its capital increase through the issuance of new shares (the "New Shares") with shareholders’ preferential subscription rights (PSR), whose subscription took place from March 19 to March 31, 2021 included in France and from March 19 to March 26, 2021 included in Denmark (Press release, Onxeo, APR 12, 2021, View Source [SID1234580416]).

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The gross amount of the capital increase, including the issue premium, amounted to 9.7 million euros and resulted in the creation of 13,677,125 New Shares, at a subscription price per share of 0.71 euro (5.287 DKK on the basis of an exchange rate of 7.447 DKK for 1 euro on March 9, 2021).

The proceeds from this issue of New Shares are intended to finance primarily the expansion and acceleration of the clinical development of AsiDNA, in particular in combination with other anti-cancer agents.

The Company also intends to:

continue the optimization and preclinical development of new candidates selected on the platON platform,
optimize pharmaceutical development and compound manufacturing operations, and
more generally, finance the Company’s operations.
Judith Greciet, CEO of Onxeo, said: "We would like to thank all our investors, both historical and new, who have contributed to the success of this fundraising. The renewed confidence in our long-term strategy by our two core shareholders, Financière de la Montagne and Invus, as well as by many other shareholders, secures the ramp-up of our development and extends our visibility until the end of 2022. With the funds raised, the Company will accelerate the development of AsiDNA with other clinical trials, notably in non-small cell lung cancer, with a phase 2 study designed to be extended as a potential pivotal trial. The clinical program should also include the United States as part of the acceleration plan. Additionally, we will expand our portfolio with other compounds from our platON platform."

The Board of Directors of Onxeo, in its meeting on April 12, 2021, recorded the amount of subscriptions and decided on the final terms of the capital increase with preferential subscription rights of shareholders decided on March 9, 2021.

RESULT OF THE RIGHT ISSUE

At the end of the subscription period, subscriptions totaled 13,677,125 shares, divided as follows:

6,111,797 New Shares were subscribed on an irreducible basis;
7,565,328 Shares News were requested on a free basis.
As the Company has decided to exercise the extension clause provided for in the 20th resolution of the General Meeting of June 19, 2020 for 4.8% of the initial offer, the new shares applied for on a free basis were fully allocated.

Consequently, the gross amount of the capital increase, including issue premium, amounts to 9,710,758.75 euros and results in the issue of 13,677,125 new shares, at a unit subscription price of 0.71 euros, corresponding to a subscription rate of approximately 104.8%.

The Company’s share capital following the capital increase will amount to 22,998,733.75 euros, divided into 91,994,935 shares with a par value of 0.25 euros each.

The settlement-delivery of the New Shares and their admission to trading on Euronext Growth Paris and Nasdaq First North Growth Copenhagen are scheduled for April 16 and April 19, 2021, respectively.

The New Shares will carry dividend rights and will be traded on the same quotation line as the existing shares (ISIN FR0010095596).

Impact of the issue on the shareholding structure

The following table presents the distribution of capital, to the Company’s knowledge, before and after the completion of the capital increase.

The commitments of the existing shareholders, Financière de la Montagne and Invus Public Equities LP, were fully subscribed for a total amount of 7 million euros, respectively 3 and 4 of which approximately 2.1 million euros were on an irreducible basis and 4.9 million euros on a free basis. The subscriptions of other investors thus amount to about 2.7 million euros.

Actionnaires Number of shares before the issue % of capital and voting rights(1) shares before the issue Number of shares after the issue % of capital and voting rights(1) shares after the issue
Financière de la Montagne 10,462,560 13.36% 14,708,767 15.99%
Invus Public Equities LP 8,397,270 10.72% 14,031,073 15.25%
Free float 59,457,980 75.92% 63,255,095 68.76%
Total 78,317,810 100.00% 91,994,935 100.00%
Theoretical voting rights. All shares have the same voting rights, with the exception of treasury shares held by the Company.
DILUTION

For information purposes, the impact of the issue on the capital ownership of a shareholder holding 1% of the Company’s share capital prior to the issue and who did not subscribe to the issue (calculations based on a number of 78,317,810 shares making up the Company’s share capital at December 31, 2020) is as follows:

Shareholder’s interest (%)
(en euro par action) Non-diluted basis Diluted basis (1)
Before issue of New Shares 1.00 0.95
After issue of 13,677,125 New Shares 0.85 0.81
(1) Taking into account the 4,335,740 options and warrants giving access to the share capital granted and outstanding as of today.

INDICATIVE TIMETABLE OF THE OPERATION

April 16, 2021 Issuance of New Shares – Settlement and Delivery.
April 19, 2021 Admission of the New Shares to trading on Euronext Growth Paris and Nasdaq First North Growth Copenhagen.

Contributors

– Invest Securities acted as Lead Manager and Bookrunner of the transaction.

– Invest Corporate Finance acted as Listing Sponsor.

– Nordea Denmark, a subsidiary of Nordea Bank Abp, Finland, acted as underwriting agent in Denmark.

AVAILABILITY OF THE PROSPECTUS

The Prospectus, having received the approval n°21-063 dated March 9, 2021 from the Autorité des marchés financiers ("AMF"), consists of (i) the Universal Registration Document of Onxeo filed with the AMF on April 27, 2020 under number D.20-0362 (the "Universal Registration Document"), (ii) the Amendment to the Universal Registration Document, filed with the AMF on March 9, 2021 under number D.20-0362-A01, (iii) a Securities Note and (iv) a summary of the Prospectus (included in the Securities note).

Copies of the Prospectus are available free of charge at the registered office of Onxeo, 49, boulevard du Général Martial Valin – 75015 Paris. The Prospectus may also be consulted on the websites of the AMF (www.amf-france.org) and Onxeo (www.onxeo.com) and from the Lead Manager and Bookrunner.

In connection with the opening of the public offering in Denmark, an unofficial translation into English of all the documents constituting the prospectus has also been prepared by the Company. In the event of any discrepancy between the French prospectus and the English translation, the French version will prevail. These documents are also available free of charge at Onxeo’s registered office at 49, boulevard du Général Martial Valin – 75015 Paris and on Onxeo’s website (www.onxeo.com).

Risk Factors

Investors are invited to carefully consider the risk factors detailed in section 3 of the Universal Registration Document, section 2 of the Amendment to the Universal Registration Document and section 2 of the Securities Note. The occurrence of all or part of these risks may have an adverse effect on the Group’s business, financial position, results or ability to achieve its objectives.

On April 10, 2021 Tallac Therapeutics, Inc., a privately held biopharmaceutical company harnessing the power of innate and adaptive immunity to fight cancer, reported the first presentation of preclinical data demonstrating potent single-agent anti-tumor activity in preclinical cancer models with systemically administered TAC-001, the company’s lead clinical candidate from its novel Toll-like Receptor Agonist Antibody Conjugate (TRAAC) platform (Press release, Tallac Therapeutics, APR 10, 2021, View Source [SID1234579743]). The data will be presented today as part of the Immunomodulatory Agents and Interventions Session at Week I of the American Association of Cancer Research’s (AACR) (Free AACR Whitepaper) 2021 Virtual Annual Meeting (#AACR21) taking place April 10-15, 2021.

Toll-like receptor (TLR) agonists are a novel class of immunotherapy that generate both an innate and
adaptive immune response which may produce more robust and durable anti-cancer immunity to help
overcome resistance to standard-of-care oncology treatments. TLR9 is a key intracellular TLR present in
broad immune cell populations such as B lymphocytes and myeloid cells. Recent studies have shown that
the likelihood of patients responding to immune checkpoint inhibitor therapy may depend on B cells in
the tumor.i B cells play pivotal roles in the immune defense system, which bridge the innate and the
adaptive immunities against cancers.ii In preclinical studies, the activation of TLR9 in human and mouse
models drives B cell proliferation and differentiation.iii

"The results presented today at AACR (Free AACR Whitepaper) elucidate the unique properties of TAC-001 responsible for
integrating B cells and TLR9 activation which trigger innate and adaptive immune responses to create
potent, systemically delivered anti-tumor immunity across solid tumor types," said Dr. Hong I. Wan,
president, CEO and co-founder of Tallac Therapeutics. "The emerging data on TAC-001 continues to
strengthen our understanding of the roles that B cells and TLR9 activation play in eliciting anti-tumor
immunity in checkpoint inhibitor resistant and refractory settings and will help guide our clinical
development strategy."

In the e-poster, titled "TAC-001, a toll-like receptor 9 (TLR9) agonist antibody conjugate targeting B cells,
promotes anti-tumor immunity and favorable safety profile following systemic administration in
preclinical models," investigators present data providing evidence that in vitro targeted delivery of TAC001 leads to superior TLR9 activation in B cells, increased expression of co-stimulatory molecules and
cross-presentation leading to T cell proliferation. In vivo, TAC-001 demonstrated robust, curative and
durable single agent anti-tumor activity in checkpoint inhibitor resistant and refractory tumor models.
Additionally, the systemic administration of TAC-001 was shown to trigger both innate and adaptive
immunity by increasing B cell infiltration, T effector cell functions and modulation in suppressive myeloid
cells within the tumor microenvironment. These results support the development of TAC-001 for a broad
range of solid tumor malignancies.

AACR Poster Presentation Details:

Title: TAC-001, a toll-like receptor 9 (TLR9) agonist antibody conjugate targeting B cells, promotes antitumor immunity and favorable safety profile following systemic administration in preclinical models
Session Type: E-Poster Session
Session Category: Immunology
Session Title: Immunomodulatory Agents and Interventions
Track: Immunology, Clinical Research Excluding Trials
Permanent Abstract Number: 1721
About TAC-001
TAC-001 is a Toll-like Receptor Agonist Antibody Conjugate (TRAAC) comprised of a potent Toll-like
Receptor 9 agonist (T-CpG) conjugated to an anti-CD22 antibody, a receptor restricted to B cells.
TAC-001 is designed to systemically deliver T-CpG to B cells by binding to CD22, leading to internalization
of TAC-001, TLR9 signaling, B cell activation and a cascade of immune reactions. Preclinical studies
demonstrate that the innate and adaptive immune responses triggered by TAC-001 leads to potent antitumor activity. TAC-001 is being developed to systemically deliver targeted immune activation in solid
tumor cancers.

On April 12, 2021 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX-V:BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, reported the presentation of results from clinical studies with its lead product candidate, Bria-IMT, summarized in a poster session held at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, a virtual meeting, held over two weeks (Week 1: April 10-15; Week 2: May 17-21) (Press release, BriaCell Therapeutics, APR 12, 2021, View Source [SID1234578327]).

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The findings indicate disease control in advanced breast cancer patients, including stable disease (SD), partial responses (PR) or complete responses (CR). Disease control was especially noted in patients with Grade I/II (i.e. well or moderately differentiated) tumors or those that matched Bria-IMT at 2 or more HLA alleles. Patients with low or undetectable levels of circulating cancer cells were more likely to benefit from therapy.

Patients were treated with the Bria-IMT regimen alone (i.e. monotherapy study) or the Bria-IMT regimen in combination with immune checkpoint inhibitors, including pembrolizumab (KEYTRUDA; manufactured by Merck & Co., Inc.), and, more recently, Incyte’s retifanlimab (INCMGA00012, under a corporate collaboration with Incyte Corporation). Dr. Bill Williams, BriaCell’s President & CEO, presented the results of the clinical and pathological analysis. The patient data summarized and discussed belong to previously disclosed patients (i.e., no incremental numbers enrolled).

Details and results on the poster presentation are summarized below:

Poster Title: Predictors of response to a modified whole tumor cell immunotherapy in patients with advanced breast cancer from two phase I/IIa trials

Analysis and Discussion:

• The Bria-IMT regimen with or without checkpoint inhibitors is able to induce an effective immune response and disease control in heavily pre-treated advanced breast cancer patients. The patients were all heavily pretreated and failed multiple prior regimens.
• Delayed Type Hypersensitivity (DTH) to Bria-IMT analysis identified a group with significantly higher rates of disease control and progression-free survival (8 months) in both monotherapy and combination therapy studies suggesting a robust immune response is predictive of clinical benefit in these patients.
• Highest levels of disease control and PFS was observed in patients who matched Bria-IMT at 2 or more HLA alleles in the monotherapy study but not in the combination therapy study supporting our strategy to develop Bria-OTS, an off-the-shelf personalized immunotherapy for advanced breast cancer.
• Patients with Grade I/II tumors (median of 8 prior therapy regimens) were more likely to respond with disease control (67%) and longer progression free survival. The response was more pronounced in the patients in the combination therapy study suggesting additive or synergistic effects of checkpoint inhibitors when combined with the Bria-IMT regimen. Bria-IMT, with a molecular signature most closely related to Grade I/II tumors, may result in disease control and clinical benefit especially in this subset of patients.

A copy of the poster is posted at the following: View Source

On April 12, 2021 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX-V:BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, reported that it has completed the sale of an additional 882,352 shares at the public offering price of US$4.24 per share pursuant to the underwriter’s over-allotment option granted in connection with the Company’s recent public offering, resulting in additional gross proceeds of approximately US$3.7 million (Press release, BriaCell Therapeutics, APR 12, 2021, View Source [SID1234578326]). After giving effect to the full exercise of the over-allotment option, the total gross proceeds for the public offering increased to approximately US$28.7 million.

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ThinkEquity, a division of Fordham Financial Management, Inc., acted as sole book-running manager for the offering.

The Company intends to use the net proceeds to fund clinical trials and research and development and for general working capital and general corporate purposes.

A registration statement on Form F-1 (File No. 333-234292) relating to the offering was filed with the Securities and Exchange Commission ("SEC") and declared effective on February 23, 2021. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, or by email at [email protected]. Investors may also obtain these documents at no cost by visiting the SEC’s website at View Source

No securities regulatory authority has either approved or disapproved the contents of this news release. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On April 12, 2021 Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, reported that the National Medical Products Administration (NMPA) of China has granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy (Press release, Shanghai Junshi Bioscience, APR 12, 2021, View Source [SID1234578061]). This is the third approved indication for toripalimab in China. In December 2018, the NMPA granted a conditional approval to toripalimab for the second-line treatment of unresectable or metastatic melanoma. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy.

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"Following the approval of indications in melanoma and nasopharyngeal carcinoma, toripalimab has reached a new milestone in the treatment of urothelial carcinoma, under the joint efforts of patients, investigators, and our R&D personnel," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "Junshi Biosciences has pioneered clinical exploration for unselected UC patients in China and achieved remarkable results, which makes us very excited and confident in the development potential of toripalimab as an anti-tumor drug with a broad therapeutic profile. We also look forward to providing Chinese UC patients with more treatment options that work better and cost less through the company’s collaboration with AstraZeneca."

The supplemental NDA is based on the POLARIS-03 study (NCT03113266) led jointly by Professor Guo Jun of the Peking University Cancer Hospital and Professor Huang Yiran of Renji Hospital affiliated to the Shanghai Jiao Tong University School of Medicine. Among the 136 patients with locally advanced or metastatic urothelial carcinoma after failure of platinum-based chemotherapy including neoadjuvant or adjuvant chemotherapy within 12 months, the evaluation results of the Independent Review Committee (IRC) indicated that the overall objective response rate (ORR) was 27.2%, the disease control rate (DCR) was 46.3% and the median overall survival (mOS) reached 14.6 months. The median duration of response (DOR) had not yet reached a mature stage, with 67.1% of patients with objective responses continuing after a 12-month period.

POLARIS-03 is the first pivotal clinical study on the treatment of advanced urothelial carcinoma with an unselected population after failure of first-line standard treatment in China. Data showed that toripalimab demonstrated explicit anti-tumor activity and continuous efficacy among all patients and within each subgroup. ORR of all patients was 27.2%. ORR of PD-L1 positive patients reached 42.2%. ORR of PD-L1 negative patients reached 18.8%. Therefore, advanced urothelial carcinoma patients benefit from toripalimab regardless of PD-L1 expression. In addition, the safety and tolerability of toripalimab were consistent with previous research results.