On November 25, 2019, Cue Biopharma, Inc. (the "Company") reported that entered into an At-The-Market Equity Offering Sales Agreement (the "Sales Agreement") with Stifel, Nicolaus & Company, Incorporated, as agent ("Stifel"), pursuant to which the Company may offer and sell, from time to time through Stifel, shares of its common stock, par value $0.001 per share (the "Common Stock"), for aggregate gross proceeds of up to $20.0 million (the "Shares") (Filing, 8-K, Cue Biopharma, NOV 25, 2019, View Source [SID1234551682]). The offer and sale of the Shares will be made pursuant to a shelf registration statement on Form S-3 and the related prospectus (File No. 333-229140) that became effective on February 3, 2019, as supplemented by a prospectus supplement dated November 25, 2019 and filed with the Securities and Exchange Commission pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the "Securities Act").

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Pursuant to the Sales Agreement, Stifel may sell the Shares in sales deemed to be "at-the-market" equity offerings as defined in Rule 415 promulgated under the Securities Act, including sales made directly on or through the Nasdaq Capital Market. If agreed to in a transaction notice, the Company may sell Shares to Stifel as principal, at a purchase price agreed upon by Stifel and the Company. Stifel may also sell Shares in negotiated transactions with the Company’s prior approval. The offer and sale of the Shares pursuant to the Sales Agreement will terminate upon the earlier of (a) the issuance and sale of all of the Shares subject to the Sales Agreement or (b) the termination of the Sales Agreement by Stifel or the Company pursuant to the terms thereof.

The Company has agreed to pay Stifel a commission of up to 3.0% of the aggregate gross proceeds from any Shares sold by Stifel and to provide Stifel with customary indemnification and contribution rights, including for liabilities under the Securities Act. The Company also will reimburse Stifel for certain specified expenses in connection with entering into the Sales Agreement. The Sales Agreement contains customary representations and warranties and conditions to the placements of the Shares pursuant thereto.

A copy of the Sales Agreement is filed as Exhibit 1.1 to this Current Report, and the description of the terms of the Sales Agreement is qualified in its entirety by reference to such exhibit. A copy of the opinion of K&L Gates LLP relating to the legality of the issuance and sale of the Shares is attached as Exhibit 5.1 hereto.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Shares, nor shall there be any offer, solicitation, or sale of the Company’s Common Stock in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On November 25, 2019 Kazia Therapeutics Limited (ASX: KZA;NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is reported to share with investors interim data from its ongoing phase II study of GDC-0084 in glioblastoma, the most common and most aggressive form of primary brain cancer (Press release, Kazia Therapeutics, NOV 25, 2019, View Source [SID1234551670]). This data is the subject of a poster presentation at the annual meeting of the Society for Neuro-Oncology (SNO), held in Phoenix, AZ from 20 – 24 November 2019.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Key Points

Data from first nine patients in the study; total study will be around 29 patients
Median progression-free survival (PFS) calculated at 8.4 months, implying that GDC-0084 may delay progression of glioblastoma
Median overall survival (OS) could not yet be calculated due to insufficient death events on study. 75% of evaluable patients remained alive at analysis cut-off date
As reported in May 2019, a maximum tolerated dose (MTD) of 60mg was established, which is higher than the 45mg dose determined in an earlier phase I study in late-stage patients
Nine patients participated in Stage 1 of the study, of which eight were evaluable for efficacy. Progression-free survival (PFS) in this initial group of patients was determined to be 8.4 months. The existing standard of care, temozolomide, has a reported PFS of around 5.3 months[1], although cross-study comparisons must always be treated with caution. Overall survival (OS) could not yet be calculated, with 75% of evaluable patients still alive at the cut-off date for analysis. In aggregate, these early results provide a strong signal that GDC-0084 may provide clinical benefit in this patient population.

The safety of GDC-0084 was also broadly consistent with prior experience, with hyperglycaemia (raised blood sugar), oral mucositis (mouth ulcers), and rash among the most common drug-related toxicities. Two dose-limiting toxicities (DLTs) were observed at a dose of 75mg, and these were hyperglycaemia and oral mucositis.

Professor Patrick Wen from Dana-Farber Cancer Institute, who was the lead author on the poster presentation, commented, "There is an urgent need for new therapies in glioblastoma. GDC-0084 has the potential to be an important new addition to the treatment of this very challenging disease. My colleagues and I look forward to examining further data as the study progresses."

Kazia CEO, Dr James Garner, added, "This is early ‘first look’ data from the study, representing around a third of the total patients to be enrolled, but it has already exceeded our expectations. We see a clear signal that GDC-0084 is providing clinical benefit in this group of patients. Although it has not yet been possible to calculate overall survival, the fact that the majority of patients in the first stage of the study remain alive more than a year after diagnosis suggests that a meaningful OS benefit may emerge as the study matures. That would be a remarkable finding."

The poster can be downloaded from Kazia’s website via: View Source

Next Steps

Stage 2 of the study continues to enrol patients, and further data is expected early in calendar 2020. In addition to this ongoing phase II study in glioblastoma, GDC-0084 is also the subject of four other ongoing clinical trials in DIPG and brain metastases, several of which are also expected to report interim data during the early part of calendar 2020. Given the early positive signal from this study, Kazia intends to accelerate activities to initiate a pivotal study for registration in calendar 2020 and will share more detailed plans with shareholders in the near future.

Investor Conference Call

Kazia is pleased to invite investors to attend a conference call to discuss the results further.

The call will be held on Tuesday 26 November 2019 at 9:00am, Sydney time (AEDT), which is 2pm on Monday 25 November 2019 in San Francisco (PST) and 5pm on Monday 25 November 2019 in New York (EST). Dial-in details are provided below:-

Australian toll free:

1800 123 296

Australian local (Sydney):

+61 2 8038 5221

Hong Kong:

3008 2034

New Zealand:

0800 452 782

Singapore:

800 616 2288

United Kingdom:

0808 234 0757

United States:

1855 293 1544

Conference ID:

5796625

Professor Ben Ellingson Delivers Oral Presentation on Analysis of Phase I Imaging Data

In addition to the poster presentation for the ongoing phase II study, Professor Ben Ellingson, Director of the UCLA Brain Tumor Imaging Laboratory, was invited to give an oral presentation at the SNO conference on a retrospective analysis of the phase I study of GDC-0084 in recurrent glioma that was completed by Genentech.

Professor Ellingson’s analysis showed that specific changes on MRI and PET scans correlated closely with the concentration of GDC-0084 in the patient’s blood. Moreover, the data showed that this specific signature on MRI and PET scans was associated with longer progression-free survival (PFS). The importance of this data is that it strengthens the empirical connection between the concentration of GDC-0084, its effect on the biology of the tumour, and the clinical outcome for the patient. This strongly supports Kazia’s understanding of the mechanism of action of GDC-0084 and provides further confirmation that the drug is active.

On November 25, 2019 Kazia Therapeutics Limited (ASX: KZA;NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is reported to share with investors interim data from its ongoing phase II study of GDC-0084 in glioblastoma, the most common and most aggressive form of primary brain cancer (Press release, Kazia Therapeutics, NOV 25, 2019, View Source [SID1234551670]). This data is the subject of a poster presentation at the annual meeting of the Society for Neuro-Oncology (SNO), held in Phoenix, AZ from 20 – 24 November 2019.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Key Points

Data from first nine patients in the study; total study will be around 29 patients
Median progression-free survival (PFS) calculated at 8.4 months, implying that GDC-0084 may delay progression of glioblastoma
Median overall survival (OS) could not yet be calculated due to insufficient death events on study. 75% of evaluable patients remained alive at analysis cut-off date
As reported in May 2019, a maximum tolerated dose (MTD) of 60mg was established, which is higher than the 45mg dose determined in an earlier phase I study in late-stage patients
Nine patients participated in Stage 1 of the study, of which eight were evaluable for efficacy. Progression-free survival (PFS) in this initial group of patients was determined to be 8.4 months. The existing standard of care, temozolomide, has a reported PFS of around 5.3 months[1], although cross-study comparisons must always be treated with caution. Overall survival (OS) could not yet be calculated, with 75% of evaluable patients still alive at the cut-off date for analysis. In aggregate, these early results provide a strong signal that GDC-0084 may provide clinical benefit in this patient population.

The safety of GDC-0084 was also broadly consistent with prior experience, with hyperglycaemia (raised blood sugar), oral mucositis (mouth ulcers), and rash among the most common drug-related toxicities. Two dose-limiting toxicities (DLTs) were observed at a dose of 75mg, and these were hyperglycaemia and oral mucositis.

Professor Patrick Wen from Dana-Farber Cancer Institute, who was the lead author on the poster presentation, commented, "There is an urgent need for new therapies in glioblastoma. GDC-0084 has the potential to be an important new addition to the treatment of this very challenging disease. My colleagues and I look forward to examining further data as the study progresses."

Kazia CEO, Dr James Garner, added, "This is early ‘first look’ data from the study, representing around a third of the total patients to be enrolled, but it has already exceeded our expectations. We see a clear signal that GDC-0084 is providing clinical benefit in this group of patients. Although it has not yet been possible to calculate overall survival, the fact that the majority of patients in the first stage of the study remain alive more than a year after diagnosis suggests that a meaningful OS benefit may emerge as the study matures. That would be a remarkable finding."

The poster can be downloaded from Kazia’s website via: View Source

Next Steps

Stage 2 of the study continues to enrol patients, and further data is expected early in calendar 2020. In addition to this ongoing phase II study in glioblastoma, GDC-0084 is also the subject of four other ongoing clinical trials in DIPG and brain metastases, several of which are also expected to report interim data during the early part of calendar 2020. Given the early positive signal from this study, Kazia intends to accelerate activities to initiate a pivotal study for registration in calendar 2020 and will share more detailed plans with shareholders in the near future.

Investor Conference Call

Kazia is pleased to invite investors to attend a conference call to discuss the results further.

The call will be held on Tuesday 26 November 2019 at 9:00am, Sydney time (AEDT), which is 2pm on Monday 25 November 2019 in San Francisco (PST) and 5pm on Monday 25 November 2019 in New York (EST). Dial-in details are provided below:-

Australian toll free:

1800 123 296

Australian local (Sydney):

+61 2 8038 5221

Hong Kong:

3008 2034

New Zealand:

0800 452 782

Singapore:

800 616 2288

United Kingdom:

0808 234 0757

United States:

1855 293 1544

Conference ID:

5796625

Professor Ben Ellingson Delivers Oral Presentation on Analysis of Phase I Imaging Data

In addition to the poster presentation for the ongoing phase II study, Professor Ben Ellingson, Director of the UCLA Brain Tumor Imaging Laboratory, was invited to give an oral presentation at the SNO conference on a retrospective analysis of the phase I study of GDC-0084 in recurrent glioma that was completed by Genentech.

Professor Ellingson’s analysis showed that specific changes on MRI and PET scans correlated closely with the concentration of GDC-0084 in the patient’s blood. Moreover, the data showed that this specific signature on MRI and PET scans was associated with longer progression-free survival (PFS). The importance of this data is that it strengthens the empirical connection between the concentration of GDC-0084, its effect on the biology of the tumour, and the clinical outcome for the patient. This strongly supports Kazia’s understanding of the mechanism of action of GDC-0084 and provides further confirmation that the drug is active.

On November 25, 2019 Kazia Therapeutics Limited (ASX: KZA;NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is reported to share with investors interim data from its ongoing phase II study of GDC-0084 in glioblastoma, the most common and most aggressive form of primary brain cancer (Press release, Kazia Therapeutics, NOV 25, 2019, View Source [SID1234551670]). This data is the subject of a poster presentation at the annual meeting of the Society for Neuro-Oncology (SNO), held in Phoenix, AZ from 20 – 24 November 2019.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Key Points

Data from first nine patients in the study; total study will be around 29 patients
Median progression-free survival (PFS) calculated at 8.4 months, implying that GDC-0084 may delay progression of glioblastoma
Median overall survival (OS) could not yet be calculated due to insufficient death events on study. 75% of evaluable patients remained alive at analysis cut-off date
As reported in May 2019, a maximum tolerated dose (MTD) of 60mg was established, which is higher than the 45mg dose determined in an earlier phase I study in late-stage patients
Nine patients participated in Stage 1 of the study, of which eight were evaluable for efficacy. Progression-free survival (PFS) in this initial group of patients was determined to be 8.4 months. The existing standard of care, temozolomide, has a reported PFS of around 5.3 months[1], although cross-study comparisons must always be treated with caution. Overall survival (OS) could not yet be calculated, with 75% of evaluable patients still alive at the cut-off date for analysis. In aggregate, these early results provide a strong signal that GDC-0084 may provide clinical benefit in this patient population.

The safety of GDC-0084 was also broadly consistent with prior experience, with hyperglycaemia (raised blood sugar), oral mucositis (mouth ulcers), and rash among the most common drug-related toxicities. Two dose-limiting toxicities (DLTs) were observed at a dose of 75mg, and these were hyperglycaemia and oral mucositis.

Professor Patrick Wen from Dana-Farber Cancer Institute, who was the lead author on the poster presentation, commented, "There is an urgent need for new therapies in glioblastoma. GDC-0084 has the potential to be an important new addition to the treatment of this very challenging disease. My colleagues and I look forward to examining further data as the study progresses."

Kazia CEO, Dr James Garner, added, "This is early ‘first look’ data from the study, representing around a third of the total patients to be enrolled, but it has already exceeded our expectations. We see a clear signal that GDC-0084 is providing clinical benefit in this group of patients. Although it has not yet been possible to calculate overall survival, the fact that the majority of patients in the first stage of the study remain alive more than a year after diagnosis suggests that a meaningful OS benefit may emerge as the study matures. That would be a remarkable finding."

The poster can be downloaded from Kazia’s website via: View Source

Next Steps

Stage 2 of the study continues to enrol patients, and further data is expected early in calendar 2020. In addition to this ongoing phase II study in glioblastoma, GDC-0084 is also the subject of four other ongoing clinical trials in DIPG and brain metastases, several of which are also expected to report interim data during the early part of calendar 2020. Given the early positive signal from this study, Kazia intends to accelerate activities to initiate a pivotal study for registration in calendar 2020 and will share more detailed plans with shareholders in the near future.

Investor Conference Call

Kazia is pleased to invite investors to attend a conference call to discuss the results further.

The call will be held on Tuesday 26 November 2019 at 9:00am, Sydney time (AEDT), which is 2pm on Monday 25 November 2019 in San Francisco (PST) and 5pm on Monday 25 November 2019 in New York (EST). Dial-in details are provided below:-

Australian toll free:

1800 123 296

Australian local (Sydney):

+61 2 8038 5221

Hong Kong:

3008 2034

New Zealand:

0800 452 782

Singapore:

800 616 2288

United Kingdom:

0808 234 0757

United States:

1855 293 1544

Conference ID:

5796625

Professor Ben Ellingson Delivers Oral Presentation on Analysis of Phase I Imaging Data

In addition to the poster presentation for the ongoing phase II study, Professor Ben Ellingson, Director of the UCLA Brain Tumor Imaging Laboratory, was invited to give an oral presentation at the SNO conference on a retrospective analysis of the phase I study of GDC-0084 in recurrent glioma that was completed by Genentech.

Professor Ellingson’s analysis showed that specific changes on MRI and PET scans correlated closely with the concentration of GDC-0084 in the patient’s blood. Moreover, the data showed that this specific signature on MRI and PET scans was associated with longer progression-free survival (PFS). The importance of this data is that it strengthens the empirical connection between the concentration of GDC-0084, its effect on the biology of the tumour, and the clinical outcome for the patient. This strongly supports Kazia’s understanding of the mechanism of action of GDC-0084 and provides further confirmation that the drug is active.

On November 25, 2019 Luminex Corporation (NASDAQ: LMNX) reported that Harriss Currie, Senior Vice President of Finance and CFO, will participate in investor meetings and present at the Piper Jaffray 31st Annual Healthcare Conference on Wednesday, December 4, 2019 in New York, NY (Press release, Luminex, NOV 25, 2019, View Source [SID1234551671]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of Luminex’s presentation will be available at 10:30 a.m. Eastern Time on Wednesday, December 4th and may be accessed at Luminex Corporation’s website at investor.luminexcorp.com. The presentation will be archived for six months on the website using the ‘replay’ link.