Prospectuses and communications, business combinations

link=blue lang="EN-US">

Filed by Nivalis Therapeutics, Inc.

Pursuant to Rule 425 under the Securities Act of 1933

And d eemed filed pursuant to Rule 14a-12

Of the Securities Exchange Act of 1934, as amended

Subject Company: Nivalis Therapeutics, Inc.

Commission File No.: 001-37449

On April 18, 2017, Nivalis Therapeutics, Inc. (“Nivalis”) and Alpine Immune Sciences, Inc. (“Alpine”) hosted an investor conference call at 4:30 p.m. Eastern Time to discuss the entering into a definitive merger agreement under which Alpine will merge with a wholly-owned subsidiary of Nivalis in an all-stock transaction. The conference call related to such proposed merger is set forth below:

*          *          *          *          *

C O R P O R A T E   P A R T I C I P A N T S

Matt Clawson, Investor Relations, Pure Communications

Michael Carruthers, Interim President and Chief Financial Officer, Nivalis Therapeutics

Dr. Mitchell Gold, Executive Chairman and Chief Executive Officer, Alpine Immune Sciences

Dr. Jay Venkatesan, President and Director, Alpine Immune Sciences

C O N F E R E N C E   C A L L   P A R T I C I P A N T S

Tom Shrader, Stifel Nicolaus

Phil Nadeau, Cowen & Company

Wangzhi Li, Ladenburg Thalmann



Greetings and welcome to the Nivalis Therapeutics and Alpine Immune Sciences conference call. At this time all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star, zero on your telephone keypad. As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Mr. Matt Clawson from Pure Communications. Thank you, Mr. Clawson. You may begin.

Matt Clawson:

Thank you, Michelle and good afternoon everyone. Joining for the call from Nivalis are Mike Carruthers, Interim President and Chief Financial Officer, and Janice Troha, Chief Operating Officer. Joining from Alpine Immune Systems are Dr. Mitchell Gold, Executive Chairman and Chief Executive Officer, and Dr. Jay Venkatesan, President and Director.

Before we begin I’d like to remind everyone that our call today will include remarks about future expectations, plans and prospects for Nivalis and Alpine, which constitute forward-looking statements for the purpose of the Safe Harbor provisions under applicable federal securities laws. These forward-looking statements include, without limitation, statements regarding the completion of the transaction, the combined company’s expected cash position, Nivalis and Alpine’s expectations with respect for future performance; the nature, strategy, and focus of the combined company, and the safety, efficacy, and projected development timeline and commercial potential of any product candidates. These forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expected, including the risk that the conditions to the closing of the transaction are not satisfied and uncertainties as to the timing of the consummation of the transaction, and the ability of each of Nivalis and Alpine to consummate the transaction. Information regarding factors that could cause results to differ are described more fully in Nivalis periodic reports filed with the SEC.

All forward-looking statements are made as of the date of this call and Nivalis and Alpine disclaim any duty to update such statements.

You are advised to read when available Nivalis filings with the SEC, including a registration statement that will contain a proxy statement to be used in connection with solicitation of proxies for the special meeting of shareholders to approve the transaction, because these documents will contain important information about the transaction and the participants’ interest in such transaction. These documents can be obtained without charge at the SEC’s Internet website,

Now I’ll turn the call over to Mike Carruthers, Interim President and CFO of Nivalis Therapeutics. Good afternoon, Mike, and congratulations.

Michael Carruthers:

Thank you, Matt. Good afternoon and thank you all for joining the call.

Let’s talk about the transaction and why we’re extremely pleased with this transformative event. Today, we issued a news release announcing Nivalis and Alpine Immune Sciences have agreed to merge. I’ll provide details about the structure and the terms of the transaction and then Dr. Gold will provide an overview of Alpine’s unique technology platform and pipeline products as well as upcoming milestones. Then we’ll open the call to questions.

As Nivalis announced in early January, we formed a Special Committee to explore and evaluate a range of strategic alternatives focused on maximizing shareholder value. A thorough process was conducted which generated formal proposals from over 80 companies. From this, ten companies were selected to participate in the final diligence process. After conducting an extensive and thorough review of each of our strategic alternatives, Nivalis decided to enter into a definitive merger agreement with Alpine Immune Sciences a well-funded, privately-held biotechnology company with a robust discovery platform designed to identify multi-specific molecules capable of directly modulating the immune system. Alpine is using its proprietary

platform technology to develop innovative potential new therapies for people living with cancer and autoimmune disorders. Dr. Gold will go into more detail on Alpine’s technology in just a bit.

Under the terms of the definitive merger agreement, and subject to the satisfaction or waiver of customary closing conditions, including approval of the transaction by each party’s shareholders, Alpine will merge into Nivalis, with Alpine surviving. The transaction is intended to qualify as a tax-free reorganization.

Unlike many companies that indicated interest in pursuing a strategic transaction with Nivalis, Alpine is already very well capitalized. Alpine’s existing investors include: Frazier Healthcare Partners, Alpine BioVentures, and OrbiMed Advisors. Immediately prior to the close, these investors will invest an additional $17 million into Alpine. As a result, we currently anticipate the combined company will have approximately $90 million in cash and equivalents at closing, and we believe is sufficient to achieve a number of important development milestones.

This transaction has been unanimously approved by the boards of directors of both companies and is expected to close in the third quarter of 2017. At the closing of the merger, each outstanding share of Alpine common stock will be converted into the right to receive shares of Nivalis common stock. Immediately following the effective time of the merger, current shareholders of Nivalis are expected to own approximately 26% of the outstanding capital stock of the combined company on a fully diluted basis, and current Alpine shareholders are expected to own approximately 74% of the outstanding capital stock of the combined company on a fully diluted basis. The exchange ratio for the transaction is based on a valuation of Nivalis of $50 million, which includes approximately $44 million in cash expected to be held by Nivalis at the time of closing. Once the transaction closes, the name of the combined company will become Alpine Immune Sciences and will trade on the NASDAQ Global Market with a new ticker symbol to be announced at a later date.

Regarding management of the combined company, Dr. Gold will become the Chairman and Chief Executive Officer, and the corporate headquarters will be located in Seattle. Following the closing of the transaction, the board of directors of the combined company will expand to seven seats. The board will be comprised of two representatives designated by Nivalis, and four current Alpine board members, and one independent nominee.

This transaction represents an optimal path forward for both companies and we expect the transaction to advance important new potential therapies for patients and to create significant value for shareholders. For Nivalis shareholders, this transaction will provide a significant equity stake in a promising new biotechnology company. Alpine is led by a talented and experienced management team that has successfully brought immunotherapies to market and possesses a next-generation platform capable of developing multiple, potentially transformative immune therapies for very sick patients.

I’m looking forward to working with the Alpine team, which has a great track record and has already received strong validation of its technology and approach through a collaboration with Kite Pharma, a leading cancer immunotherapy company.

With that, I would like to turn the call over to Mitch.

Dr. Mitchell Gold:

Thank you, Mike and good afternoon everyone. The Alpine team believes the potential of this transaction represents a unique opportunity to accelerate the development of a novel immunotherapy platform focused on both inflammation and immuno-oncology. By bringing together the substantial resources of both Nivalis and Alpine, we are creating a unique, publicly-traded company with sufficient capital to achieve meaningful value-creating milestones without the near-term need to raise additional capital. We expect the combined balance sheet has sufficient, is sufficient, to fund operations for approximately 3 years.

Our goal is to become a clinical-stage company in the second half of 2018 with our lead dual ICOS/CD28 antagonist program. I’ll talk more about that program in just a bit. With the additional capital on our balance sheet as a result of this combination, we expect we will be filing an IND for two additional programs in either Immuno-Oncology or Inflammation after our lead is filed.

While difficult to predict, we believe Alpine’s platform provides a highly productive opportunity for partnering with potential access to more than 400 targets. Of these, we have prioritized more than a dozen for further active development. We believe these partnering opportunities are potentially value creating as they allow us to advance the platform into disease areas we might not pursue on our own.

Now let me now take you through the history of Alpine, our technology platform, and our programs, before I turn to upcoming value-driving milestones.

We built Alpine with a team of experts in the field of recombinant protein immunotherapies. Having participated in the approval of the world’s first immunotherapy, we have a deep appreciation and understanding of the power and complexity of the immune system. Our objective in starting Alpine was to design truly novel, protein-based therapeutics capable of interfacing with a multitude of ligands simultaneously and be able to have applicability for not only oncology applications but also inflammatory diseases as we see these as two opposite sides of the same coin.

Alpine received its seed funding from Alpine BioVentures and based on promising pre-clinical data, we signed a significant collaboration with Kite Pharma, a leader in the field of immuno-oncology, to enhance

their CAR-T and TCR products with our unique molecules. The collaboration with Kite provides for up to $535 million in upfront and potential milestone payments, plus royalties on marketed products.

The uniqueness of our platform allowed us to attract some of the best scientists from the Seattle biotech community, including proven leaders like Dr. Stanford Peng, the former Chief Medical Officer at Stemcentrx. I am fortunate to be able to say this is the best scientific team I’ve had the privilege to work with.

In June of last year, we attracted two new blue-chip investors Peter Thompson from OrbiMed Advisors and Jamie Topper from Frazier Healthcare Partners who joined Jay and me in closing a $48 million Series A financing. Now in our third year, we are well positioned to take multiple programs into the clinic. We believe our combination with Nivalis is the next logical step.

We all know great value can be created when talented scientists come together with complimentary skill sets to create game changing therapies. Alpine was established with the goal of capitalizing on our deep understanding of immunology and protein engineering to create a robust discovery platform, which we call Variant Ig Domains or vIgDs.

vIgDs are created using our process of directed evolution to exploit the native interactions commonly occurring as a natural way to regulate the immune system. We have generated a large library of vIgDs exhibiting exhibit favorable biology. Our lead program is a first-in-class, dual ICOS/CD28 inhibitor which blocks multiple co-stimulatory signals simultaneously for use in inflammatory and auto-immune diseases. Multiple in vivo studies from this program suggest it may potentially be superior to current forms of existing treatment options. Its ability to block two principle co-stimulatory signals may open up new disease areas of interest that have been recalcitrant to current forms of treatment. We expect to begin Phase I studies of this program in the second half of next year.

In addition to our vIgD technology as our standalone protein therapeutics, we can use these same proteins to help companies focused on engineered cell therapies, or ECTs such as CAR-Ts or TCRs. Researchers in the ECT space seek to engineer immune system cells to attack diseased cells. Early data here have shown great promise, particularly in hematologic cancers. Our proprietary Transmembrane Immunomodulatory Protein, or TIP, program potentially enhances ECTs and may possibly increase the specificity, persistence, and efficacy of engineered cell therapies.

In support of this approach, in October 2015, we entered into a research and collaboration and license agreement with Kite Pharma. Under this agreement, Kite exclusively licensed two programs from our TIP technology, which it has rights to further engineer into CAR-T’s and TCR product candidates.

With this merger, we expect we will have sufficient financial resources to move three of our programs into the clinic, the first being our dual ICOS/CD28 inhibitor in the second half of 2018. We also have two active programs in Oncology.

In oncology, the immune system can be suppressed by the tumor microenvironment and multiple inhibitory signals known as checkpoints. While blocking single checkpoints has yielded impressive clinical data, approximately 70-80% of patients still don’t respond to checkpoint therapy alone. We have designed a unique multi checkpoint inhibitor that can potentially block multiple check point pathways and perhaps expand the responder population. The potential ability of vIgDs to attack multiple checkpoints with a single molecule in the tight confines of the immune synapse and in a way that mimics the native interactions of the ligands of a particular pathway is a powerful and unique attribute of our platform.

Our third product candidate comes out of our V-mAb platform where we link our co-stimulatory vIgDs to a well-known therapeutic anti

The above information was disclosed in a filing to the SEC. To see the filing, click here.

To receive a free e-mail notification whenever Nivalis Therapeutics, Inc. makes a similar move, sign up!

Other recent filings from the company include the following:

Confidential treatment order - March 19, 2019
Securities to be offered to employees in employee benefit plans - March 18, 2019
Securities to be offered to employees in employee benefit plans - March 18, 2019
General form for registration of securities under the Securities Act of 1933 - March 18, 2019
Nivalis Therapeutics, Inc. Just Filed Its Annual Report: Net Loss Per ShareBa... - March 18, 2019

Auto Refresh