On July 9, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that it has commenced a public offering (the "Offering") of 27,800,000 ADSs (the "Firm ADSs"), representing 2,780,000 of its ordinary shares, pursuant to a registration statement on Form F-1, as amended, filed with the U.S. Securities and Exchange Commission (the "SEC") and has today filed a preliminary prospectus with the SEC in connection with the Offering (Press release, Genmab, JUL 9, 2019, View Source [SID1234537430]). In addition, Genmab has decided to grant the underwriters a 30-day option to purchase up to 4,170,000 additional ADSs, representing 417,000 ordinary shares (the "Option ADSs").

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ADSs are U.S. dollar-denominated negotiable instruments represented by American Depositary Receipts ("ADRs") issued by a depositary bank that facilitate U.S. trading and investment in shares of non-U.S. companies. The ADSs will be issued under Genmab’s existing ADR program, which is administered by Deutsche Bank Trust Company Americas. Each ADS represents one-tenth of one ordinary share of Genmab.

Genmab intends to use the net proceeds from the Offering to continue the development of its proprietary product candidates, to continue its pre-commercial activities, to continue building its commercial capabilities and to advance its earlier stage product candidates. The expected use of the net proceeds from the Offering represents Genmab’s intentions based upon its current plans and business conditions, which could change in the future as Genmab’s plans and business conditions evolve. Genmab cannot predict with certainty all of the particular uses of the net proceeds of the Offering or the amounts that it will actually spend on the uses set forth above.

Genmab’s ordinary shares are currently listed on Nasdaq Copenhagen under the symbol "GEN" and an application has been made to list the ADSs on the Nasdaq Global Select Market in the United States under the symbol "GMAB." It is expected that the ordinary shares underlying the ADSs will be admitted to trading and official listing on Nasdaq Copenhagen upon issuance. The filing of the preliminary prospectus and the application for listing on the Nasdaq Global Select Market has no implications for Genmab’s listing on Nasdaq Copenhagen in Denmark.

Genmab’s board of directors (the "Board") has in accordance with article 4A of Genmab’s articles of association exercised an authorization granted by Genmab’s annual general meeting held on April 10, 2018, to increase Genmab’s share capital by issue of up to 3,197,000 new shares underlying the ADSs (covering both the Firm ADSs and Option ADSs), of which 2,780,000 new shares (the "Firm Shares") will cover the Firm ADSs and up to 417,000 new shares will cover the Option ADS (the "Option Shares").

Pricing of the Offering is expected to take place during the week commencing July 15, 2019.

If all the Firm Shares and all the Option Shares are subscribed for, the Firm Shares will represent 4.3% of Genmab’s share capital and the Option Shares will represent 0.6%.

The Board has not yet finally decided whether to complete the Offering and whether to proceed with the listing. Even if the Board determines to complete the Offering, the Offering may not be consummated. Neither the timing, number of Firm ADSs and Option ADSs, number of underlying ordinary shares of Genmab nor the price of the ADSs and thereby the subscription price of the underlying ordinary shares have been finally determined. If consummated, the final price per ADS (and thereby the subscription price per underlying share) will be determined following a book-building process.

A registration statement relating to the ADSs referred to herein has been filed with the SEC but has not yet been declared effective. These ADSs may not be sold nor may offers to buy these ADSs be accepted prior to the time such registration statement becomes effective. The securities referred to in this Company Announcement are to be offered only by means of a prospectus.

BofA Merrill Lynch, Morgan Stanley and Jefferies are acting as joint book-running managers for the proposed Offering. Guggenheim Securities and RBC Capital Markets are acting as joint lead-managers and Danske Markets, H.C. Wainwright & Co. and Kempen are acting as co-managers for the proposed Offering.

A copy of the preliminary prospectus relating to the Offering may be may be obtained from BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email: [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone: 1-877-821-7388, or by email: [email protected]. Copies of the preliminary prospectus related to the Offering are also available at www.sec.gov. No Danish prospectus will be issued or offered.

This Company Announcement does not constitute an offer to sell nor 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 July 9, 2019 Eli Lilly and Company (NYSE: LLY) reported that it will announce its second-quarter 2019 financial results on Tuesday, July 30, 2019 (Press release, Eli Lilly, JUL 9, 2019, View Source [SID1234537448]). Lilly will also conduct a conference call on that day with the investment community and media to further detail the company’s financial performance.

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The conference call will begin at 9 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at View Source A replay will also be available on the website following the conference call.

On July 9, 2019 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing therapies designed to activate a patient’s immune system against cancer, reported it has completed recruitment for enrollment in its Phase 2 study investigating HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo) or Merck’s pembrolizumab (Keytruda) (Press release, Heat Biologics, JUL 9, 2019, View Source [SID1234537431]). In total, approximately 120 patients have been enrolled in the trial.

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Lori McDermott, Heat’s VP of Clinical Development, said, "We are pleased to report that our Phase 2 enrollment targets were achieved on schedule. Last month, we reported promising interim results from the study showing that the addition of HS-110 to nivolumab may restore anti-tumor activity in patients whose disease has progressed after checkpoint inhibitor therapy. These results continue to support our mechanistic hypothesis that the broad, T-cell mediated immune response activated by HS-110 may improve clinical outcomes for those patients who are least likely to respond to a checkpoint inhibitor, including those whose disease has worsened during or after checkpoint inhibitor therapy."

Jeff Wolf, Heat’s CEO, commented, "We are pleased to achieve this important milestone and delighted with the patient mix which includes those whose disease has progressed after prior checkpoint inhibitor treatment failure. We look forward to reporting additional results later this year."

On July 9, 2019 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage, Precision Cancer Medicine oncology therapeutics company, reported the initiation of patient enrollment of its Phase 1b/2 study of onvansertib in combination with FOLFIRI and Avastin (bevacizumab) for second-line treatment of patients with metastatic colorectal cancer (mCRC) with a KRAS mutation (NCT03829410) (Press release, Trovagene, JUL 9, 2019, View Source [SID1234537449]). Trovagene is developing onvansertib, a first-in-class, third-generation, oral and highly-selective Polo-like Kinase 1 (PLK1) inhibitor that targets the key master regulator of tumor cell division, for the treatment of leukemias, lymphomas and solid tumor cancers. The trial is being conducted at USC Norris Comprehensive Cancer Center, Hoag Cancer Center and The Mayo Clinic, under the leadership of recognized colorectal cancer key opinion leaders, Heinz-Josef Lenz, MD, FACP, Section Head of GI Oncology and Co-Director of the Colorectal Center at USC Norris, and Afsaneh Barzi, MD, PhD, oncologist at USC Norris and principal investigator of the trial.

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"It is well-recognized that there is a significant medical need for better treatment options for KRAS-mutated gastrointestinal cancers," said Dr. Lenz, who is also a professor of medicine at Keck School of Medicine of USC. "We are targeting these patients in this trial because in onvansertib preclinical studies, tumor cells that harbor KRAS mutations, when treated with onvansertib, have what we call ‘synthetic lethality,’ or in other words, have a greater susceptibility to tumor cell death."

"We look forward to this trial and the opportunity to examine a potential therapy for a patient population in need of options," said Dr. Barzi, who is also an associate professor of clinical medicine at the Keck School. "Use of genomic profiling to understand the molecular underpinnings of mCRC is critical to our precision medicine approach and treating our patients. In addition, KRAS profiling in this trial, by a simple blood test, is anticipated to enable us to get a very early indication of response to treatment. This is key not only for this trial, but for how we can quickly assess response and, in real-time, integrate this approach as part of future patient management."

"Our Phase 1b/2 trial is an opportunity for us to demonstrate the potential for onvansertib to provide a new, safe and efficacious treatment for patients who are faced with a poor prognosis and who have limited therapeutic options," said Thomas Adams, PhD, Chief Executive Officer and Chairman of Trovagene. "Importantly, we have preclinical in-vitro and in-vivo data demonstrating that tumors harboring KRAS mutations are more sensitive to onvansertib-induced tumor death. Furthermore, onvansertib has significant synergy in combination with Camptosar (irinotecan) and an additive effect with Avastin, both of which are components of the standard-of-care treatment regimen that will be used in our trial. We are excited to commence this trial, which already has funding in place through a previously announced agreement with PoC Capital, LLC."

About Colorectal Cancer

Colorectal cancer (CRC) is the second leading cause of cancer mortality in the U.S. Despite significant progress in the treatment of mCRC, the majority of patients with metastatic disease succumb to the disease. Therefore, improving the treatment options and effectiveness is critical in changing the outcomes for this patient population. KRAS is a common mutation in the CRC population and approximately 50% of patients with CRC carry RAS mutations. In the U.S., FOLFOX (5-flourouracil, leucovorin, oxaliplatin) and FOLFIRI (fluorouracil, leucovorin, irinotecan) are standard-of-care options for patients with metastatic CRC in the first-line setting, irrespective of the KRAS mutation status. The majority of CRC patients respond to first-line therapy with a response rate of > 50%. The efficacy of second-line therapy in terms of survival prolongation and response remains very limited, particularly in the KRAS-mutated population, where treatment options are more restricted. FOLFIRI (a chemotherapy regimen of irinotecan, fluorouracil [5-FU], and leucovorin) + Avastin (bevacizumab) in the second-line setting is the standard treatment in US. The response rate in the second-line setting is less than 5% as reported in a large international trial of bevacizumab in the second-line setting.

About the Phase 1b/2 Clinical Trial of Onvansertib in mCRC

In this open-label, Phase 1b/2 trial, onvansertib in combination with standard-of-care FOLFIRI and Avastin is being evaluated for safety and efficacy. The trial, A Phase 1b/2 Study of Onvansertib (PCM-075) in Combination with FOLFIRI and Bevacizumab for Second‑Line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS Mutation (NCT03829410), will enroll up to 44 patients with a KRAS mutation and histologically confirmed metastatic and unresectable disease. In addition, patients must have failed treatment or be intolerant of FOLFOX (fluoropyrimidine and oxaliplatin) with or without Avastin (bevacizumab). The trial is being conducted at three prestigious cancer centers: USC Norris Comprehensive Cancer Center, Hoag Cancer Center and The Mayo Clinic.

About Onvansertib

Onvansertib is a first-in-class, third-generation, oral and highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK 1) enzyme, which is over-expressed in multiple cancers, including leukemias, lymphomas and solid tumors. Onvansertib targets the PLK1 isoform only (not PLK2 or PLK3), is orally administered and has a 24-hour half-life with only mild-to-moderate side effects reported. Trovagene believes that targeting only PLK1 and having a favorable safety and tolerability profile, along with an improved dose/scheduling regimen will significantly improve on the outcome observed in previous studies with a former panPLK inhibitor in AML.

Onvansertib has demonstrated synergy in preclinical studies with numerous chemotherapies and targeted therapeutics used to treat leukemias, lymphomas and solid tumor cancers, including irinotecan, FLT3 and HDAC inhibitors, taxanes and cytotoxins. Trovagene believes the combination of onvansertib with other compounds has the potential to improve clinical efficacy in acute myeloid leukemia (AML), metastatic castration-resistant prostate cancer (mCRPC), non-Hodgkin lymphoma (NHL), colorectal cancer, triple-negative breast cancer (TNBC), as well as other types of cancer.

Trovagene has an ongoing Phase 1b/2 clinical trial of onvansertib in combination with low-dose cytarabine or decitabine in patients with relapsed or refractory AML that was accepted by the National Library of Medicine (NLM) and is now publicly viewable on www.clinicaltrials.gov. The NCT number assigned by clinicaltrials.gov for this study is NCT03303339. Onvansertib has been granted orphan drug designation by the FDA in the U.S. and by the EC in the European Union for the treatment of patients with AML.

Trovagene has an ongoing Phase 2 clinical trial of onvansertib in combination with Zytiga (abiraterone acetate)/prednisone in patients with mCRPC who are showing signs of early progressive disease (rise in PSA but minimally symptomatic or asymptomatic) while currently receiving Zytiga. The trial was accepted by the NLM and is now publicly viewable on www.clinicaltrials.gov. The NCT number assigned by clinicaltrials.gov for this study is NCT03414034.

Trovagene licensed onvansertib (also known as NMS-1286937 and PCM-075) from Nerviano Medical Sciences (NMS), the largest oncology-focused research and development company in Italy, and a leader in protein kinase drug development. NMS has an excellent track record of licensing innovative drugs to pharma/biotech companies, including Array (recently acquired by Pfizer), Ignyta (acquired by Roche) and Genentech.

On July 9, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported an equity financing to raise approximately A$10 million comprising the following (Press release, Immutep, JUL 9, 2019, View Source [SID1234538762]):

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a placement of 190.5 million new fully paid ordinary shares in the Company ("Shares") to multiple new and existing Australian and foreign institutional and professional investors at an issue price of A$0.021 per Share ("Offer Price") (representing a 16.7% discount to the volume weighted average price ("VWAP") of the Company’s Shares as traded on the ASX over the 5 days up to and including 4 July 2019) ("Placement"), raising a total of A$4 million before transaction-related expenses.

a 1 for 11.8 fully underwritten pro rata non-renounceable entitlement offer of new Shares at the Offer Price to raise approximately A$6 million ("Entitlement Offer").

The New Shares to be issued under the Placement will be issued under the Company’s available placement capacity under ASX Listing Rule 7.1 and 7.1A.

Use of Funds

The Company will use the proceeds received from the Placement and the Entitlement Offer to finance its LAG-3 related clinical program in immuno-oncology and autoimmune disease. This includes the ongoing clinical development of eftilagimod alpha ("efti" or "IMP321"), via its TACTI-mel, TACTI-002, and INSIGHT clinical studies, development of IMP761 and for general corporate purposes.

Subject to sufficient and clinically meaningful data from the Company’s most advanced and potentially pivotal clinical trial, AIPAC (expected in Q1 of calendar year 2020) the funds raised may also be applied to pursue the appropriate regulatory pathways for efti and to explore ways to bridge Immutep’s research efforts in metastatic breast cancer to the US.

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Immutep CEO Marc Voigt commented: "We are pleased to welcome new institutional investors to our register and receive further support from our existing institutional shareholders in Australia and overseas. We are also providing eligible existing shareholders with the opportunity to participate on the same terms via the Entitlement Offer. We are pleased with the excess demand and support that Immutep is receiving ahead of reporting first data from our Phase IIb AIPAC trial in Q1 of calendar year 2020.

"Immutep has built a strong clinical trial pipeline and has a data-heavy period ahead. This financing provides important funding for our immuno-oncology and autoimmune programs. In particular, we will allocate funding for our value creating work for efti."

Details of Entitlement Offer

Under the Entitlement Offer, eligible shareholders are invited to subscribe for 1 new Share for every 11.8 existing Shares (Entitlement) held as at 7.00pm (Sydney, Australia time) on 12 July 2019 (Record Date) at an offer price of A$0.021 per new Share.

Eligible shareholders may also apply for New Shares in excess of their Entitlement (Additional New Shares) at the Offer Price, up to a maximum of A$20,000. The Company may apply any scale-back to applications for Additional New Shares in its absolute discretion.

The Offer Price of A$0.021 represents:

a discount of 16.0% to the closing price of the Shares on 4 July 2019;

a 16.7% discount to the VWAP of the Company’s Shares as traded on the ASX over the 5 days up to and including 4 July 2019; and

a 14.3% discount to the theoretical ex-rights price.1

Approximately 287.2 million new Shares will be issued under the Entitlement Offer. Shares issued under the Entitlement Offer will rank equally with existing Shares as at their date of issue.

The Entitlement Offer has been fully underwritten by Bell Potter Securities Limited.

Eligibility to participate in Entitlement Offer

Shareholders with a registered address in Australia or New Zealand on the Record Date (Eligible Shareholders) will be invited to participate in the Entitlement Offer. The Entitlement Offer will open on 16 July 2019.

Entitlements are non-renounceable and cannot be traded on the ASX or any other exchange, nor can they be privately transferred. Shareholders who do not take up their Entitlements in full will not receive any payment or value for those Entitlements they do not take up.

The theoretical ex-rights price (TERP) is a theoretical price at which Shares should trade immediately after the ex-date of the Entitlement Offer. The TERP is a theoretical calculation only and the actual price at which Shares trade immediately after the ex-date for the Entitlement Offer will depend on many factors and may not be equal to TERP.

ME_162090922_1

Further details on the Entitlement Offer are set out in the Entitlement Offer booklet provided to ASX today. These documents contain important information including key risks and foreign selling restrictions with respect to the Entitlement Offer.

Details of the Placement

The Company has secured commitments from institutional investors to subscribe for A$4 million in new Shares. Shares to be issued under the Placement will be issued at the Offer Price and will be issued on 18 July 2019.

Indicative Timetable

Event

Date

Placement and Entitlement Offer announced Pre-market open 9 July 2019
Lodge Appendix 3B, cleansing notice and ‘Appendix 3B’ letter for Entitlement Offer Pre-market open 9 July 2019
Shares quoted on an ‘ex’ basis 11 July 2019
Record date for the Entitlement Offer (Record Date) 12 July 2019
Entitlement Offer opens 16 July 2019
Settlement of Placement 16 July 2019
Issue of Shares under Placement 17 July 2019
Normal settlement trading of Shares issued under Placement 18 July 2019
Entitlement Offer closes 30 July 2019
New Shares and Additional New Shares quoted on a deferred settlement basis 31 July 2019
Issue of New Shares and Additional New Shares 6 August 2019
Normal trading of New Shares and Additional New Shares expected to commence on ASX 7 August 2019
Dates and times are indicative only and subject to change. All times and dates refer to Sydney, Australia time.

The Company reserves the right, subject to the Corporations Act, ASX Listing Rules and other applicable laws, to vary the dates of the Placement and Entitlement Offer without prior notice, including extending the Placement and Entitlement Offer or accepting late applications, either generally or in particular cases, or to withdraw the Entitlement Offer without prior notice. Applicants are encouraged to submit their personalised Entitlement and Acceptance Forms as soon as possible. No cooling-off rights apply to applications submitted under the Entitlement Offer. The commencement of quotation of new Shares is subject to confirmation from ASX.

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Bell Potter Securities Limited acted as the Lead Manager to the Placement and Entitlement Offer.

About Immutep

Immutep is a globally active biotechnology company that is a leader in the development of immunotherapeutic products for the treatment of cancer and autoimmune disease. Immutep is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders. Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States.

Immutep’s current lead product candidate is eftilagimod alpha ("efti" or "IMP321"), a soluble LAG-3Ig fusion protein based on the LAG-3 immune control mechanism. This mechanism plays a vital role in the regulation of the T cell immune response. Efti is currently in a Phase IIb clinical trial as a chemoimmunotherapy for metastatic breast cancer termed AIPAC; a Phase II clinical trial being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada) referred to as TACTI-002 (Two ACTive Immunotherapies) to evaluate a combination of efti with KEYTRUDA (pembrolizumab) in several different solid tumours (clinicaltrials.gov identifier NCT03625323); a Phase I clinical trial being conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. referred to as INSIGHT-004 to evaluate a combination of efti with avelumab (clinical trials.gov identifier NCT03252938); and a Phase I combination therapy trial in metastatic melanoma termed TACTI-mel (clinicaltrials.gov identifier NCT02676869).

Further information can be found on the Company’s website www.immutep.com or by contacting:

U.S. Investors:

Jay Campbell, Chief Business Officer, Immutep Limited